|
Index of
Rockwell News
2008 & 2009
Click on underlined dates to view complete story
June 30, 2009 -
RMTI Appoints Ajay Gupta M.D. as Chief Scientific Officer
June 29, 2009 - Rockwell Medical Technologies Named to Russell Indexes
June 5, 2009 - Renal Business
Today publishes article about Rockwell Medical
May 11, 2009 - Rockwell
Reports Results for First Quarter 2009
April 30, 2009 - RMTI
Schedules Investor Conference Call
April 29, 2009 - RMTI
Announces Patient Enrollment Complete for Dose Range Study
April 16, 2009 - RMTI
Announces Updated DSMB Interim Results
March 16, 2009 - RMTI Reports
Q4 2008 Results; Sales Increase 20% Year-Over-Year
Mar 02, 2009 - Rockwell
Appoints VP of Drug Development and Medical Affairs
Nov. 13, 2008 - RMTI Reports
Third Quarter Results; Sales Gain of 22.2%
Nov. 4, 2008 - Rockwell
Schedules Investor Conference Call
Oct 29, 2008 - DSMB Identifies
No Safety Concerns for SFP
Oct 27, 2008 - Rockwell to
Present at Oppenheimer Healthcare Conference
Aug 12, 2008 - RMTI Reports
Second Quarter Sales Increase of 15.5%
Aug. 5, 2008 - Rockwell
Schedules Investor Conference Call
July 9, 2008 - RMTI Appoints
Dr. Richard Hurrell to Scientific Advisory Board
June 17, 2008 - RMTI Appoints
Dr. James D. Cook to Scientific Advisory Board
June 10, 2008 - RMTI Appoints
Dr. Richard Zager to Scientific Advisory Board
May 20, 2008 - Rockwell to
Present at Barrington Research Healthcare Conference
May 7, 2008 - Rockwell Reports
First Quarter; Sales Increase 31%
Apr. 22, 2008 - RMTI Schedules
Investor Conference Call
March 6, 2008 - RMTI Reports
Q4 2007 Results; Year-end Sales Increase 50%
Feb. 26, 2008 - Rockwell
Schedules Investor Conference Call
Jan. 31, 2008 - Patients Begin
Dosing in NIH Funded SFP Clinical Study
Jan. 23, 2008 - Patient
Enrollment Begins for NIH Funded SFP Clinical Study
Features
Nov 2005 - Rockwell
Predicted as "Future Pharma" by "Crain's Detroit Business"
June 2005 - Rockwell CEO
Receives Entrepreneur of the Year Award
Oct 2001 - Chioini chosen for
"Forty under Forty" by "Crain's Detroit
Business"
(return to News
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Monday, June 30, 2009
Rockwell Medical Appoints Ajay Gupta M.D. as Chief Scientific Officer
Dr. Gupta will support SFP clinical development, utilize SFP technology
to address new anemia-related opportunities and facilitate development of new drugs
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that it has appointed Ajay Gupta M.D. as its Chief Scientific Officer.
Dr. Gupta will be responsible for the identification and development of new drug opportunities in the areas of women's health, oncology and parenteral nutrition based on the SFP platform, as well as new drugs for other targeted renal therapies and indications. Dr. Gupta will continue to play an integral role in the development and commercialization of the Company's lead drug Soluble Ferric Pyrophosphate (SFP), indicated for the treatment of iron deficiency anemia in hemodialysis patients.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are thrilled to have Ajay join Rockwell and strengthen our scientific team. His decades of work in both the academic and medical fields, coupled with his extensive knowledge in the anemia and iron space, will be an invaluable asset to us as we continue to drive SFP through clinical development and capitalize on other potential therapeutic opportunities, positioning Rockwell as a dynamic bio-pharma company." Mr. Chioini further stated, "Successful commercialization of SFP will continue to be our primary focus while Dr. Gupta's appointment puts in place a structure that will facilitate the identification, development and commercialization of a pipe-line of promising technologies that we have identified, as well as future opportunities yet to be discovered."
Prior to joining Rockwell, Dr. Gupta spent the last seven years as an Associate Professor of Medicine at UCLA and Charles Drew University Schools of Medicine, Los Angeles, CA where he has had an active nephrology practice. Prior to that, Dr. Gupta served on the faculty at Henry Ford Hospital, Detroit, MI, University of Alabama, Birmingham, State University of New York, Syracuse and Washington University, St. Louis. Dr. Gupta also completed a clinical fellowship in Nephrology from Wayne State University, Detroit, Michigan and a research fellowship in Nephrology from Washington University, St. Louis, Missouri.
Dr. Gupta, who is the Founder and Chairman of the Indian Society for Bone and Mineral Research, earned his MBBS degree and completed his residency in Internal Medicine from All India Institute of Medical Sciences (AIIMS), New Delhi. Dr. Gupta is the inventor of dialysate iron therapy using Soluble Ferric Pyrophosphate (SFP) and is also the inventor of intravenous (IV) iron therapy using slow continuous infusion of SFP, including as an adjunct to parenteral nutritional admixtures. He has filed a number of patents in the areas of drugs, medical devices and diagnostic tests.
Dr. Gupta commented, "I'm truly excited to join Rockwell to pursue my life-long passion of focusing on the science and drug development of SFP, and eventually expanding the platform technology to target new markets and unmet needs, specifically in the areas of oncology, parenteral nutrition and women's health. I look forward to working with Dr. Richard Yocum, Vice President of Drug Development and Medical Affairs at Rockwell, to successfully commercialize SFP as well as to help grow our therapeutic pipeline."
About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a molecular and cellular level, similar to normal, healthy, dietary iron uptake. SFP is designed as a continuous maintenance treatment consisting of small iron doses administered with every dialysis session in order to offset iron losses during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate,
has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatment. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million
annually while global market potential is approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad,
Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release.
These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
(return to News
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Monday, June 29, 2009
Rockwell Medical Technologies Named to Russell Indexes
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, is pleased to announce that it has been added to the Russell 2000, 2500, 3000 and Global Indexes. Rockwell will also maintain its membership in the Russell Microcap Index.
The Russell Index reconstitution process is followed closely by many investors because the Russell Indexes currently have over $4.3 trillion in world-wide assets benchmarked to them. These indices are reconstituted on an annual basis to include the 4,000 largest U.S. stocks, ranking them by total market capitalization. Rockwell's membership in these new Russell Indexes remains in place for one year.
"We are pleased to be included in these new Russell U.S. and Global Indexes." said Robert Chioini, President and CEO. "Russell's industry-leading indexes are highly regarded and we hope that our inclusion will continue to generate additional institutional investor interest in Rockwell as an investment."
Russell 2000 is a leading small cap index that is widely used by investment firms that utilize indexing strategies in their investment portfolios. Rockwell's inclusion in the Russell 2000 Index will make it possible for the Company to be included in those portfolios using the Index as a benchmark for their investments. The Russell 2500 Index measures the performance of the small to mid-cap segment of the U.S. equity universe,
the Russell 3000 Index measures the performance of the largest 3000 U.S. companies representing approximately 98% of the investable U.S. equity market; while the Russell Global measures the performance of the global equity and includes approximately 10,000 securities in 70 countries and covers 98% of the investable global market.
For more information about Russell indices, visit www.russell.com.
About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate,
has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad,
Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 395,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release.
These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
(return to News
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Monday, May 11, 2009
Rockwell Medical Reports Results for First Quarter 2009
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
fully-integrated biopharmaceutical company offering innovative products and
services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD)
and iron deficiency anemia, reported first quarter 2009 sales of $12.8 million,
up 3.1% from $12.4 million for the same period of 2008. Loss for the first
quarter 2009 was ($1.7) million or ($.12) per share compared to ($1.2) million
or ($.09) per share for the same period 2008.
First Quarter
- Quarterly sales of $12.8 million increased 3.1% compared to the first
quarter of 2008.
- Domestic sales increased 5.5% compared to the first quarter of 2008.
- Gross profit totaled $1.2 million compared to $.7 million in the first
quarter of 2008.
- Gross profit margins increased to 9.3% from 5.8% in the first quarter of
2008.
- SFP related R&D expense increased 71% to $1.3 million compared to $.8
million in the first quarter 2008.
- Loss of ($1.7) million compared to loss of ($1.2) million in the first
quarter 2008.
Drug Development Progress
- Completed SFP Phase 2b study enrollment; subject treatments expected to be
completed in October.
- Data Safety Monitoring Board (DSMB) review noted no safety concerns with
SFP and recommended continuation of Phase 2b study.
- Appointed Richard Yocum, M.D. to VP of Drug Development & Medical
Affairs in February 2009.
Mr. Robert L. Chioini, Chairman and CEO stated, "We are
pleased with our first quarter performance. We continue to make solid progress
clinically. We anticipate our Phase 2b data will be available by year end and
that our Phase 3 program will begin sometime thereafter. Both our business and
clinical development progress is in line with our expectations."
Rockwell will be hosting a conference call to review its first quarter results
and to provide investors with an update on its business development efforts on
Wednesday, May 7, 2008 at 11:00 am EST.
Rockwell will be hosting a conference call to review its 2009 first quarter
results on Monday, May 11, 2009 at 4:15 pm EDT. Investors are encouraged to
call a few minutes in advance at (877) 718-5111to listen to the call or on the
web at:
http://investor.shareholder.com/media/eventdetail.cfm?eventid=68448&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF
The call will be available for replay for one week at the same link above.
About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy
designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a
proprietary, water-soluble form of iron that travels directly to the
bloodstream and transfers iron at a cellular level, similar to normal healthy
iron uptake. SFP is designed as a continuous maintenance treatment consisting
of small doses administered with every dialysis session to maintain iron status
tests stable within target, as per Kidney Disease Quality Outcomes Initiative
(KDOQI) recommendations. Clinical trials to date suggest that SFP delivered
during each dialysis treatment, via the Company's dialysate, has the ability to
maintain optimal iron balance and avoid liver toxicity while decreasing
associated pharmaceutical intravenous (IV) iron administration costs. Recent
academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments. Rockwell has licensed exclusive world-wide rights and has secured
patents for SFP in multiple countries, including the three largest dialysis
markets in the world: the United States, Japan, and the European Union. The
total U.S. market for IV iron is approximately $500 million annually while
global market potential is approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD), and iron deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell provides products that are used to maintain human life by
removing toxins and replacing critical nutrients in the dialysis patient's
bloodstream. Dialysis is a process that duplicates kidney function for patients
who suffer from ESRD. There are approximately 375,000 ESRD patients in the
United States, a number that is growing at an annual rate of 4 percent, and
approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies
for iron treatment. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy, while
decreasing drug administration costs and improving patient convenience.
Rockwell is developing a pipeline of drug therapies, including extensions of
SFP for indications outside of hemodialysis.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the federal
securities laws. Words such as "may," "might,"
"will," "should," "believe," "expect,"
"anticipate," "estimate," "continue,"
"predict," "forecast," "projected,"
"intend" or similar expressions, or statements regarding intent,
belief, or current expectations, are forward-looking statements. While the
Company believes these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release. These forward
looking statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties, including without limitation those
set forth in the Rockwell's SEC filings. Thus, actual results could be
materially different. Rockwell expressly disclaims any obligation to update or
alter statements whether as a result of new information, future events or
otherwise, except as required by law.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three months ended March 31, 2009 and March 31, 2008
(Unaudited)
|
| |
3 Months ended Mar 31, 2009 |
3 Months ended Mar 31, 2008 |
| Sales |
$ 12,796,772 |
$ 12,412,037 |
| Cost of Sales * |
11,603,825 |
11,694,736 |
| Gross Profit |
1,192,947 |
717,301 |
| Selling, General, Admin * |
1,560,815 |
1,289,752 |
| Research & Product Devel. |
1,338,310 |
782,713 |
| Operating (Loss) |
(1,706,178) |
(1,355,164) |
| Interest Expense (Income), net |
9,265 |
(144,991) |
| Net (Loss) |
$ (1,715,443) |
$ (1,210,173) |
| Basic Earnings (Loss) per share |
$ (0.12) |
$ (0.09) |
| Diluted Earnings (Loss) per share |
$ (0.12) |
$ (0.09) |
Note:
*The Company has reclassified certain quality assurance and operations
management expenses totaling $140,000 from selling, general and administrative
expense to cost of sales in the 2008 consolidated income statement to conform
with the current year presentation.
|
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of March 31, 2009 and December 31, 2008
|
| |
Mar. 31, 2009
(Unaudited) |
Dec. 31, 2008 |
| Assets |
| Cash and Cash Equivalents |
$ 3,353,468 |
$ 5,596,645 |
Accounts Receivable,
net of a reserve of $83,000 in 2009and $97,000 in
2008 |
4,869,201 |
5,229,656 |
| Inventory |
2,815,829 |
3,161,625 |
| Other Current Assets |
484,898 |
440,765 |
| Total Current Assets |
11,523,396 |
14,428,691 |
| Property and Equipment, net |
3,263,906 |
3,249,003 |
| Intangible Assets |
235,305 |
240,656 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
123,387 |
120,887 |
| Total Assets |
$ 16,066,739 |
$ 18,959,982 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
139,202 |
176,850 |
| Accounts Payable |
3,834,491 |
5,210,972 |
| Accrued Liabilities |
1,240,579 |
1,464,828 |
| Customer Deposits |
208,751 |
245,186 |
| Total Current Liabilities |
5,423,023 |
7,097,836 |
Long Term Notes Payable & Capitalized Lease Obligations
|
28,976 |
41,203 |
| Shareholders' Equity: |
Common Shares, no par value,
14,132,712 and 14,104,690 shares issued and
outstanding |
35,172,916 |
34,799,093 |
Common Share Purchase Warrants,
2,134,169 and 2,114,169 shares issued and
outstanding |
3,513,815 |
3,378,398 |
| Accumulated Deficit |
(28,071,991) |
(26,356,548) |
| Total Shareholders' Equity |
10,614,740 |
11,820,943 |
| Total Liabilities and Shareholders'
Equity |
$ 16,066,739 |
$ 18,959,982 |
(return to News
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Thursday, April 30, 2009
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI) announced today that it will hold an investor conference call on Monday,
May 11, 2009 at 4:15 p.m. EDT to discuss its first quarter results and to
provide investors with a business update. Robert Chioini, Chairman and CEO, and
Thomas Klema, CFO, will be hosting the call to review Rockwell's results and
answer questions from investors. Rockwell will be releasing results on the same
date after the market closes.
The conference call will be held on:
Monday, May 11, 2009
Starting Time 4:15 p.m. EDT
Dial in Number: (877) 718-5111
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?eventid=68448&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF
International Investors may dial in directly on 719-325-4789.
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at www.rockwellmed.com.
We appreciate your interest in Rockwell.
(return to News
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 |
Wednesday, April 29, 2009
Rockwell Medical Announces Patient Enrollment
Complete for Phase 2b Dose Range Study
- Data Expected in the 4th Quarter of 2009 -
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a fully-integrated biopharmaceutical company offering innovative
products and services targeting end-stage renal disease (ERSD), chronic kidney
disease (CKD), and iron deficiency anemia, reported today that patient
enrollment has been completed for it's ongoing Phase 2b dose-ranging study for
its iron deficiency anemia drug soluble ferric pyrophosphate (SFP).
We are pleased to have achieved this important milestone following two
positive safety reviews from the data safety monitoring board (DSMB). We
anticipate having study data available in the fourth quarter of 2009 and
shortly thereafter commencing our Phase 3 program, stated Mr. Robert L.
Chioini, Chairman, CEO and President of Rockwell Medical.
The Phase 2b dose-ranging study is a six-month, controlled multi-center,
double-blind study consisting of approximately 130 hemodialysis patients at
multiple dialysis centers in the United States and Canada. Subjects are
randomized to receive one of several concentrations of SFP or placebo in
dialysate during their normal three times/week dialysis regimen. The primary
objectives of the study are to evaluate both safety and efficacy of SFP at
varying dose levels and to determine the optimal concentration of SFP that will
maintain iron balance within the target hemoglobin range.
About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy
designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a
proprietary, water-soluble form of iron that travels directly to the
bloodstream and transfers iron at a cellular level, similar to normal healthy
iron uptake. SFP is designed as a continuous maintenance treatment consisting
of small doses administered with every dialysis session to maintain iron status
tests stable within target, as per Kidney Disease Quality Outcomes Initiative
(KDOQI) recommendations. Clinical trials to date suggest that SFP delivered
during each dialysis treatment, via the Company's dialysate, has the ability to
maintain optimal iron balance and avoid liver toxicity while decreasing
associated pharmaceutical intravenous (IV) iron administration costs. Recent
academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments. Rockwell has licensed exclusive world-wide rights and has secured
patents for SFP in multiple countries, including the three largest dialysis
markets in the world: the United States, Japan, and the European Union. The
total U.S. market for IV iron is approximately $500 million annually while
global market potential is approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD), and iron deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell provides products that are used to maintain human life by
removing toxins and replacing critical nutrients in the dialysis patient's
bloodstream. Dialysis is a process that duplicates kidney function for patients
who suffer from ESRD. There are approximately 375,000 ESRD patients in the
United States, a number that is growing at an annual rate of 4 percent, and
approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies
for iron treatment. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy, while
decreasing drug administration costs and improving patient convenience.
Rockwell is developing a pipeline of drug therapies, including extensions of
SFP for indications outside of hemodialysis.
Certain statements in this press release constitute
``forward-looking statements'' within the meaning of the federal securities
laws. Words such as ``may,'' ``might,'' ``will,'' ``should,'' ``believe,''
``expect,'' ``anticipate,'' ``estimate,'' ``continue,'' ``predict,''
``forecast,'' ``projected,'' ``intend'' or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such forward-looking
statements, which are based on information available to us on the date of this
release. These forward-looking statements are based upon current estimates and
assumptions and are subject to various risks and uncertainties, including
without limitation those set forth in the Rockwell's SEC filings. Thus, actual
results could be materially different. Rockwell expressly disclaims any
obligation to update or alter statements whether as a result of new
information, future events or otherwise, except as required by law.
(return to News
Index)
 |
Thursday, April 16, 2009
Rockwell Medical Announces Updated DSMB Interim Results;
No Safety Issues Reported
- Phase 2b trial will continue as planned; 20 µg/dl dose group not
needed -
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a fully-integrated biopharmaceutical company offering innovative
products and services targeting end-stage renal disease (ERSD), chronic kidney
disease (CKD), and iron deficiency anemia, reported today that the independent
Data Safety Monitoring Board (DSMB) providing oversight for the ongoing SFP
Phase 2b dose-range study reviewed the unblinded cumulative interim study data
and informed the Company that it has identified no safety concerns. The DSMB
also determined there is no need to add the highest dose group of 20 µg/dl
and recommended continuation of the study with the current five dose groups.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated We
are again encouraged by the DSMB's favorable comments regarding our current SFP
Phase 2b study. These recommendations from the DSMB suggest that the data from
this study will meet the study objective of identifying the dose of SFP to be
carried forward into the subsequent Phase 3 clinical program. We also expect to
reach our target for completion of enrollment very soon, as screening for new
patients has already met its objective and has been stopped. The successful
completion of our SFP development program remains our top priority."
About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, investigational, physiological iron maintenance therapy
designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a
proprietary, water-soluble form of iron that travels directly to the
bloodstream and transfers iron at a cellular level, similar to normal healthy
iron uptake. SFP is intended as a continuous maintenance treatment consisting
of small doses administered with every dialysis session to maintain iron status
tests stable within target, as per Kidney Disease Quality Outcomes Initiative
(KDOQI) recommendations. Clinical trials to date suggest that SFP delivered
during each dialysis treatment, via the Company's dialysate, has the ability to
maintain optimal iron balance and avoid liver toxicity while decreasing
associated pharmaceutical intravenous (IV) iron administration costs. Recent
academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments. Rockwell has licensed exclusive world-wide rights and has secured
patents for SFP in multiple countries, including the three largest dialysis
markets in the world: the United States, Japan, and the European Union. The
total U.S. market for IV iron is approximately $500 million annually while
global market potential is approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD), and iron deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell provides products that are used to maintain human life by
removing toxins and replacing critical nutrients in the dialysis patient's
bloodstream. Dialysis is a process that duplicates kidney function for patients
who suffer from ESRD. There are approximately 375,000 ESRD patients in the
United States, a number that is growing at an annual rate of 4 percent, and
approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies
for iron treatment. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy, while
decreasing drug administration costs and improving patient convenience.
Rockwell is developing a pipeline of drug therapies not only for iron
deficiency in kidney disease, but for other critical care conditions such as
oncology and gastroenterology.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the federal
securities laws. Words such as "may," "might,"
"will," "should," "believe," "expect,"
"anticipate," "estimate," "continue,"
"predict," "forecast," "projected,"
"intend" or similar expressions, or statements regarding intent,
belief, or current expectations, are forward-looking statements. While the
Company believes these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release. These forward
looking statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties, including without limitation those
set forth in the Rockwell's SEC filings. Thus, actual results could be
materially different. Rockwell expressly disclaims any obligation to update or
alter statements whether as a result of new information, future events or
otherwise, except as required by law.
(return to News
Index)
 |
Monday, March 16, 2009
Rockwell Medical Reports Fourth Quarter 2008 Results;
Sales Increase 20% Year-Over-Year to $51.6 Million
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
fully-integrated biopharmaceutical company offering innovative products and
services targeting end-stage renal disease (ERSD), chronic kidney disease
(CKD), and iron deficiency anemia, reported record fourth quarter 2008 sales of
$13.5 million, up 13.3% from $11.9 million for the same period of 2007. Loss
for the fourth quarter was $3.0 million or ($.22) per share compared to $1.2
million or ($.09) per share for the same period of 2007.
Year-end 2008 results were highlighted by record sales of $51.6 million,
increasing over 20% compared to 2007. Loss for the year ended December 31, 2008
was $7.9 million or ($.57) per share compared to $3.7 million or ($.32) per
share in 2007. The increased loss was due to higher costs for raw materials and
fuel as well as investments in infrastructure to support core business growth.
Fourth Quarter
- Record quarterly revenue $13.5 million, up 13.3% over fourth quarter 2007.
- Loss per share ($.22) vs. ($.09) in 2007.
- R&D costs were $1.3million vs. $0.9 million in the fourth quarter of
2007.
Year End 2008
- Revenue increased to $51.6 million, up 20% in 2008 compared to 2007.
- Loss per share ($.57) vs. ($.32) in 2007.
- Unit volume growth up15% over 2007.
- Domestic sales increased $5.5 million or greater than 13.4% over 2007.
- International sales were up 160% or $3.1 million over 2007.
- 2008 Loss includes a $.9 million charge related to the settlement of a
legal dispute.
- R&D costs were $3.8 million compared to $3.3 million in 2007.
- Cash on hand $5.6 million.
Drug Development Progress
- Modified Phase IIb protocol to effectively address black box warning issued
by FDA on erythropoietin stimulating agents.
- Filed patent on SFP proprietary API synthesis process.
- Completed protocol to begin NIH-funded study.
- Data Safety Monitoring Board (DSMB) review of Phase IIb dosing indicated
strong safety profile for SFP and study continuation.
- Expanded Scientific Advisory Board to further strengthen expertise in
anemia and iron deficiency.
- Hired experienced Vice President of Drug Development and Medical Affairs to
lead clinical development.
Mr. Robert L. Chioini, Chairman and CEO stated,
"Overall, we are pleased with our drug development program. We have
continued to make solid progress in randomizing patients in our Phase IIb study
and we expect to complete enrollment shortly. In the fourth quarter the DSMB
recommended that we continue the Phase IIb study, which demonstrated SFP's
strong safety profile. We added three new members to our Scientific Advisory
Board and we recently hired Dr. Richard Yocum to spearhead SFP's clinical
progress. We believe these actions will enable us to advance SFP through to
commercialization."
Mr. Chioini also stated, "Our fourth quarter sales and margin results were
in line with our expectations, and although margins suffered during the year
due to higher raw material and fuel costs, we anticipate improvement in Q1 2009
and going forward. We also expect the investments we made in our quality
systems, information technology infrastructure and personnel to provide
improved financial results going forward."
Rockwell will be hosting a conference call to review its 2008 fourth quarter
and year-end results on Monday, March 16, 2008 at 4:30 pm EDT. Investors are
encouraged to call in several minutes in advance at (888) 572-7030 to hear the
call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?eventid=66691&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF
The call will be available for replay for one week at the same link above.
About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, physiological iron maintenance therapy designed to treat or
prevent iron deficiency anemia in ESRD patients. SFP is a proprietary,
water-soluble form of iron that travels directly to the bloodstream and
transfers iron at a cellular level, similar to normal healthy iron uptake. SFP
is a continuous maintenance treatment consisting of small doses administered
with every dialysis session to maintain iron status tests stable within target,
as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations.
Clinical trials have shown that SFP delivered during each dialysis treatment,
via the Company's dialysate, maintains optimal iron balance and avoids liver
toxicity while decreasing associated pharmaceutical intravenous iron
administration costs. Recent academic studies have shown that more frequent
maintenance doses of iron improve the therapeutic response and benefits of
recombinant erythropoietin treatments. Rockwell has licensed exclusive
world-wide rights and has secured patents for SFP in multiple countries,
including the three largest dialysis markets in the world; the United States,
Japan and the European Union. The total U.S. market for IV-iron is
approximately $500 million annually while global market potential is
approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD) and iron deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell's products are used to maintain human life by removing toxins
and replacing critical nutrients in the dialysis patient's bloodstream.
Dialysis is a process that duplicates kidney function for those patients who
suffer from ESRD. There are approximately 375,000 ESRD patients in the United
States growing at an annual rate of 4 percent and approximately 2 million ESRD
patients world-wide
The Company is currently developing unique, proprietary renal drug therapies
for iron treatment. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy, while
decreasing drug administration costs and improving patient convenience. Please
visit www.rockwellmed.com for more information.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the federal
securities laws. Words such as "may," "might,"
"will," "should," "believe," "expect,"
"anticipate," "estimate," "continue,"
"predict," "forecast," "projected,"
"intend" or similar expressions, or statements regarding intent,
belief, or current expectations, are forward-looking statements. While the
Company believes these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release. These forward
looking statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties, including without limitation those
set forth in the Rockwell's SEC filings. Thus, actual results could be
materially different. Rockwell expressly disclaims any obligation to update or
alter statements whether as a result of new information, future events or
otherwise, except as required by law.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and twelve months ended
December 31, 2008 and December 31, 2007
(Whole dollars)
(Unaudited)
|
| |
3 Months ended Dec 31, 2008 |
3 Months ended Dec 31, 2007 |
12 Months ended Dec 31, 2008 |
12 Months ended Dec 31, 2007 |
| Sales |
$ 13,537,674 |
$ 11,948,905 |
$ 51,666,033 |
$ 43,045,304 |
| Cost of Sales |
13,248,807 |
11,073,295 |
48,694,478 |
40,015,466 |
| Gross Profit |
288,876 |
875,610 |
3,016,555 |
3,029,838 |
| Selling, General, Admin |
2,087,942 |
1,084,987 |
7,271,617 |
3,374,458 |
| Research & Product Devel. |
1,272,416 |
944,281 |
3,830,134 |
3,263,733 |
| Operating (Loss) |
(3,071,491) |
(1,153,658) |
(8,085,196) |
(3,608,353) |
| Interest Expense (Income), net |
(38,657) |
9,185 |
(221,139) |
110,542 |
| Net (Loss) |
($3,032,834) |
($1,162,843) |
($7,864,057) |
($3,718,895) |
| Basic Earnings (Loss) per share |
$ (0.22) |
$ (0.09) |
$ (0.57) |
$ (0.32) |
| Diluted Earnings (Loss) per share |
$ (0.22) |
$ (0.09) |
$ (0.57) |
$ (0.32) |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of December 31, 2008 and December 31, 2007
|
| |
Dec. 31, 2008 |
Dec. 31, 2007 |
| Assets |
| Cash and Cash Equivalents |
$ 5,596,645 |
$ 11,097,092 |
Accounts Receivable,
net of a reserve of $97,000 in 2008 and $69,000
in 2007 |
5,229,656 |
4,687,229 |
| Inventory |
3,161625 |
2,559,051 |
| Other Current Assets |
440,765 |
302,573 |
| Total Current Assets |
14,428,691 |
18,645,945 |
| Property and Equipment, net |
3,249,003 |
2,840,331 |
| Intangible Assets |
240,656 |
270,446 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
120,887 |
125,667 |
| Total Assets |
$18,959,982 |
$22,803,134 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
176,850 |
194,239 |
| Accounts Payable |
5,210,972 |
2,982,899 |
| Accrued Liabilities |
1,464,828 |
1,122,737 |
| Customer Deposits |
245,186 |
337,396 |
| Total Current Liabilities |
7,097,836 |
4,637,271 |
Long Term Notes Payable & Capitalized Lease Obligations
|
41,203 |
204,837 |
| Shareholders' Equity: |
Common Shares, no par value,
14,104,690 and 13,815,186 shares issued and
outstanding |
34,799,093 |
33,415,106 |
Common Share Purchase Warrants,
2,114,169 and 1,204,169 shares issued and
outstanding |
3,378,398 |
3,038,411 |
| Accumulated Deficit |
(26,356,548) |
(18,492,491) |
| Total Shareholders' Equity |
11,820,943 |
17,961,026 |
| Total Liabilities and Shareholders'
Equity |
$18,959,982 |
$22,803,134 |
(return to News
Index)
Monday, March 2, 2009
Rockwell Medical Appoints Richard Yocum, M.D.,
as VP of Drug Development and Medical Affairs
Dr. Yocum will spearhead clinical development
of lead product SFP and renal therapeutics pipeline
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a fully-integrated biopharmaceutical company offering innovative
products and services targeting end-stage renal disease (ERSD), chronic kidney
disease (CKD), and iron deficiency anemia, reported today that it has appointed
Richard Yocum, M.D. to Vice President of Drug Development and Medical Affairs,
a newly formed position. Dr. Yocum will be responsible for leading the clinical
development of Soluble Ferric Pyrophosphate (SFP), the Company's proprietary
iron maintenance product currently progressing through a U.S. Phase 2 clinical
study, as well as overseeing all aspects of clinical research and development.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
welcome Richard to the Rockwell team. He brings a wealth of experience and
knowledge in clinical development and has coordinated clinical drug development
processes across the United States, Europe and Japan. In addition, he has
direct hands-on experience in all stages of the clinical development process,
from pre-IND through post-marketing trials. We are confident that Richard's
expertise will enable Rockwell to successfully bring SFP to the market, as well
as to develop proprietary SFP related extensions to penetrate additional
markets.
Prior to joining Rockwell, Dr. Yocum spent 15 years in clinical drug
development and project team management within the biopharmaceutical industry.
Dr. Yocum worked as Vice President, Clinical Development & Medical Affairs
at Halozyme Therapeutics; as Vice President, Clinical Development & Medical
Affairs at Chugai Pharma USA; as Executive Medical Director of Clinical
Research at Ligand Pharmaceuticals and as Associate Director of Clinical
Research at Gensia. Dr. Yocum graduated summa cum laude from Dartmouth College
and earned his medical degree from Johns Hopkins University School of Medicine.
He later completed his internal medicine residency at the University of
California San Diego and had a General Medicine practice for 11 years.
Dr. Yocum commented, Rockwell is an exciting company with a breakthrough
iron product to treat anemia. I believe SFP addresses an important unmet need
for patients, has high probability of FDA market approval and the potential to
improve the standard of care for dialysis patients throughout the world. I look
forward to working with Rob and the rest of the Rockwell team to guide SFP
through clinical development, and ultimately market approval.
About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, physiological iron maintenance therapy designed to treat or
prevent iron deficiency anemia in ESRD patients. SFP is a proprietary,
water-soluble form of iron that travels directly to the bloodstream and
transfers iron at a cellular level, similar to normal healthy iron uptake. SFP
is a continuous maintenance treatment consisting of small doses administered
with every dialysis session to maintain iron status tests stable within target,
as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations.
Clinical trials have shown that SFP delivered during each dialysis treatment,
via the Company's dialysate, maintains optimal iron balance and avoids liver
toxicity while decreasing associated pharmaceutical intravenous iron
administration costs. Recent academic studies have shown that more frequent
maintenance doses of iron improve the therapeutic response and benefits of
recombinant erythropoietin treatments. Rockwell has licensed exclusive
world-wide rights and has secured patents for SFP in multiple countries,
including the three largest dialysis markets in the world; the United States,
Japan and the European Union. The total U.S. market for IV-iron is
approximately $500 million annually while global market potential is
approximately $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD), and iron deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell's products are used to maintain human life by removing toxins
and replacing critical nutrients in the dialysis patient's bloodstream.
Dialysis is a process that duplicates kidney function for those patients who
suffer from ESRD. There are approximately 375,000 ESRD patients in the United
States growing at an annual rate of 4 percent and approximately 2 million ESRD
patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies
for iron treatment. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy, while
decreasing drug administration costs and improving patient convenience.
Rockwell is developing a pipeline of drug therapies not only for iron
deficiency in kidney disease, but for other critical care conditions such as
oncology and gastroenterology.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward- looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Thursday, November 13, 2008
Rockwell Medical Reports Second Quarter Sales Increase of 15.5%;
Margins Increase Sequentially
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., an
innovative specialty pharma company developing renal drug therapies and
manufacturing dialysate products, reported third quarter 2008 sales of $13.5
million, an increase of 22.2% over sales of $11.1 million in the third quarter
of last year. Sales for the first nine months of 2008 were $38.1 million, an
increase of 22.6% over the first nine months of 2007. Loss per share in the
third quarter of 2008 was ($.18) compared to ($.04) in the third quarter of
2007. Loss per share in the first nine months of 2008 was ($.35) compared to a
loss per share of ($.22) in the first nine months of 2007.
Third Quarter Financial Highlights:
- Quarterly sales of $13.5 million increased 22.2% or $2.5 million compared
to 2007
- Domestic sales were up 12.3% compared to the third quarter of 2007
- Sequential domestic revenue increased 11.1% in the third quarter over the
second quarter.
- Gross profit decreased due to higher than expected transportation costs.
- SG&A expense in 2008 included a litigation settlement charge of
$750,000 and non-cash charges for stock options and warrants of $0.3 million.
- SFP related R&D spending of $1.0 million or 7.3% of sales in 2008.
- Loss of ($2.5 million) compared to a loss of ($.4 million) in the third
quarter 2007.
- Cash position at September 30, 2008 was $7.5 million.
Nine Month Financial Highlights:
- Sales increased 22.6% or $7.0 million to $38.1 million in the first nine
months of 2008 vs. 2007
- Domestic sales increased 16.7% while international sales were up 147%
compared to the first nine months of 2007.
- Gross profit increased by $573,000 or 26.6% compared to the first nine
months of 2007.
- SG&A expense in 2008 included a litigation settlement charge of
$750,000 and non-cash charges for stock options and warrants of $1.1 million.
- R&D expense was $2.6 million for the first nine months of 2008 compared
to $2.3 million in the first nine months of 2007.
- Loss of ($4.8 million) compared to a loss of ($2.6 million) in the first
nine months of 2007.
SFP Business Highlights:
- Data Safety Monitoring Board (DSMB), which oversees the SFP Phase IIb
dose-range study, met in October and cited no safety issues; recommended
continuation of study.
- More than 1,500 doses of SFP administered amongst Phase IIa, Phase IIb and
National Institutes of Health (NIH) study with no serious adverse events
reported.
- Implemented changes to SFP Phase IIb study protocol to accelerate
enrollment.
- Increased number of SFP clinical trial sites to 25+.
- NIH study continuing to enroll patients.
- Added significant expertise to the Company's Scientific Advisory Board with
the appointment of additional iron experts in the renal field.
- Progressed in recruitment of a Chief Medical Officer.
"We continue to make progress on our SFP clinical
development and have focused efforts on completing our Phase IIb study,"
stated Mr. Robert L. Chioini, Chairman and CEO of Rockwell. Mr. Chioini also
stated, "The DSMB's recent positive review of SFP and the ongoing trial
strengthens our confidence in this innovative drug and its superior safety
profile. We will also continue to expand Rockwell's scientific team to advance
the development of SFP and explore future opportunities in the specialty pharma
market with an emphasis on renal drug therapies."
Rockwell will be hosting a conference call to review its third quarter results
and to provide investors with an update on its business development efforts on
Thursday, November 13, 2008 at 4:30 pm EST.
Investors are encouraged to call in several minutes in advance at (877)
604-9669 to hear the call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=34179&c=RMTI&mediakey=D10A5E1DF7A97FB10085D02719B0AE67&e=0
See www.rockwellmed.com for more details and playback options.
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing necessary nutrients in the
dialysis patient's bloodstream. Rockwell is currently developing unique,
proprietary renal drug therapies for iron maintenance utilizing its dialysate
as the delivery mechanism. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy while
decreasing cost.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our anticipated future financial
condition, operating results, cash flows or business plans, as well as the
timing and cost of obtaining FDA approval of our new SFP product, we are making
forward-looking statements. While we believe these forward-looking statements
are reasonable, you should not place undue reliance on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond our control or are subject to change,
actual results could be materially different. Factors which could cause such a
difference include, without limitation, the risk factors and other risks and
uncertainties set forth in the Company's SEC filings, including its Form 10-K
for the year ended December 31, 2007 and its Forms 10-Q filed during 2008. The
forward- looking statements should be considered in light of these risks and
uncertainties. We do not undertake, and expressly disclaim any obligation, to
update or alter our statements whether as a result of new information, future
events or otherwise, except as required by law.
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and nine months ended September 30, 2008 and September 30, 2007
(Unaudited)
|
| |
3 Months ended Sept 30, 2008 |
3 Months ended Sept 30, 2007 |
6 Months ended Sept 30, 2008 |
6 Months ended Sept 30, 2007 |
| Sales |
$ 13,533,986 |
$ 11,073,774 |
$ 38,128,359 |
$ 31,096,399 |
| Cost of Sales |
12,755,377 |
9,953,863 |
35,400,671 |
28,942,171 |
| Gross Profit |
778,609 |
1,119,911 |
2,727,688 |
2,154,228 |
| Selling, General, Admin |
2,314,188 |
765,457 |
5,183,675 |
2,288,903 |
| Research & Product Devel. |
993,262 |
735,393 |
2,557,718 |
2,319,452 |
| Operating (Loss) |
(2,528,841) |
(380,939) |
(5,013,705) |
(2,454,127) |
| Interest Expense (Income), net |
(17,795) |
51,973 |
(182,482) |
101,924 |
| Net (Loss) |
$ (2,511,046) |
$ (432,912) |
$ (4,831,223) |
$ (2,556,051) |
| Basic Earnings (Loss) per share |
$ (0.18) |
$ (0.04) |
$ (0.35) |
$ (0.22) |
| Diluted Earnings (Loss)per share |
$ (0.18) |
$ (0.04) |
$ (0.35) |
$ (0.22) |
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of September 30, 2008 and December 31, 2007
|
| |
Sept 30, 2008
(Unaudited) |
Dec. 31, 2007 |
| Assets |
| Cash and Cash Equivalents |
$ 7,481,792 |
$ 11,097,092 |
Accounts Receivable,
net of a reserve of $82,000 in 2008 and $69,000
in 2007 |
5,356,536 |
4,687,229 |
| Inventory |
3,166,566 |
2,559,051 |
| Other Current Assets |
535,437 |
302,573 |
| Total Current Assets |
16,540,331 |
18,645,945 |
| Property and Equipment, net |
3,332,569 |
2,840,331 |
| Intangible Assets |
248,338 |
270,446 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
116,850 |
125,667 |
| Total Assets |
$21,158,833 |
$22,803,134 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
187,682 |
194,239 |
| Accounts Payable |
3,977,321 |
2,982,899 |
| Accrued Liabilities |
2,252,257 |
1,122,737 |
| Customer Deposits |
331,043 |
337,396 |
| Total Current Liabilities |
6,748,303 |
4,637,271 |
Long Term Notes Payable & Capitalized Lease Obligations
|
58,190 |
204,837 |
| Shareholders' Equity: |
Common Shares, no par value,
13,834,953 and 13,815,186 shares issued and
outstanding |
34,224,870 |
33,415,106 |
Common Shares Purchase Warrants,
1,414,169 and 1,204,169 warrants issued and
outstanding |
3,413,433 |
3,038,411 |
| Accumulated Deficit |
(23,323,714) |
(18,492,491) |
| Total Shareholders' Equity |
14,352,340 |
17,961,026 |
| Total Liabilities and Shareholders'
Equity |
$21,158,833 |
$22,803,134 |
(return to News
Index)
Tuesday, November 4, 2008
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI) announced today that it will hold an investor conference call on
Thursday, November 13, 2008 at 4:30PM EST to discuss its third quarter 2008
results and to provide investors with a business update. Robert Chioini,
Chairman and CEO, and Thomas Klema, CFO, will be hosting the call to review
Rockwell's results and answer questions from investors. Rockwell will be
releasing results on the same date after the market closes.
The conference call will be held on:
Thursday, November 13, 2008
Starting Time 4:30 p.m. EST
Dial in Number: 877-604-9669
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=34179&c=RMTI&mediakey=D10A5E1DF7A97FB10085D02719B0AE67&e=0
International Investors may dial in directly on 719-325-4880.
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at www.rockwellmed.com.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Wednesday, October 29, 2008
Rockwell Announces Updated DSMB Results;
Identifies No Safety Concerns for SFP
- Phase II-b trial to continue as planned -
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, reported today that the independent Data Safety Monitoring Board
(DSMB) providing oversight for the SFP Phase II-b iron maintenance therapy
dose-range study reviewed the cumulative safety data from the ongoing clinical
study and informed the Company that it has identified no safety concerns. The
DSMB also recommended the continuation of the study with no modifications.
"We are encouraged by the DSMB's favorable comments regarding our current
Phase II-b iron maintenance therapy dose-range study. We are pleased with the
safety profile of SFP. Amongst all clinical studies to date, more than 1,500
clinical doses of SFP have been administered without a single adverse
reaction," stated Mr. Robert L. Chioini, Chairman, CEO and President of
Rockwell. "In an effort to increase the speed of patient enrollment and to
complete the trial more rapidly we have increased the number of clinical trial
sites to 25-30, from 10. The successful completion of our SFP development
program remains our top priority."
About SFP:
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide
physiological-iron-maintenance-therapy for treatment of anemia, with initial
indication for end stage renal disease (ESRD). SFP is delivered direct to the
bloodstream of the ESRD patient, via dialysate, during each kidney dialysis
treatment, maintaining optimal iron balance, avoiding liver toxicity and
decreasing associated nursing and pharmaceutical IV iron administration costs.
Recent academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments. The Company is currently conducting a FDA Phase IIb study and
sponsoring an on-going NIH-funded study in anticipation of gaining FDA market
approval. Rockwell has licensed exclusive world-wide rights and has secured
patents for SFP in multiple countries, including the three largest dialysis
markets in the world: the United States, Japan and the European Union. The
total U.S. market for IV-iron is approximately $525 million annually while
global market potential is approximately $800 million.
About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing necessary nutrients in the
dialysis patient's bloodstream. Rockwell is currently developing unique,
proprietary renal drug therapies for iron maintenance utilizing its dialysate
as the delivery mechanism. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy while
decreasing cost.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward-looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Tuesday, October 27, 2008
Rockwell Medical to Present at 2008
Oppenheimer 19th Annual Healthcare Conference
WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, today announced that Robert L. Chioini, Chief Executive Officer,
will present at the Oppenheimer 19th Annual Healthcare Conference at the
Waldorf Astoria Hotel in New York.
The Rockwell presentation will take place on Tuesday, November 4, 2008 at
2:40PM EST.
About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell is currently developing unique, proprietary
renal drug therapies for both iron maintenance and carnitine supplementation
utilizing its dialysate as the delivery mechanism. These exclusive renal drug
therapies support disease management initiatives to improve the quality of life
and care of dialysis patients and are designed to deliver safe and effective
therapy to these patients while decreasing cost.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward- looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Tuesday, August 12, 2008
Rockwell Medical Reports Second Quarter Sales Increase of 15.5%;
Margins Increase Sequentially
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., an
innovative specialty pharma company developing renal drug therapies and
essential dialysate products, reported second quarter 2008 sales of $12.2
million, an increase of 15.5% over sales of $10.5 million in the second quarter
of last year. First half 2008 sales of $24.6 million increased 22.8% over the
first half of 2007. Loss per share in the second quarter of 2008 was ($.08)
compared to ($.04) in the second quarter of 2007. Loss per share in the first
half of 2008 was ($.17) compared to a loss per share of ($.18) in the first
half of 2007.
Second Quarter Financial Highlights:
- Quarterly revenue of $12.2 million increased 15.5% or $1.6 million
compared to 2007.
- Domestic sales were up 16.4% compared to the second quarter of 2007
- Sequential domestic revenue increased 5.5% in the second quarter over the
first quarter although total sales were 1.9% lower due to lower international
orders compared to the first quarter.
- Gross profit margins rose sequentially 2.1 percentage points to 9.0%
compared to the first quarter but were down 1.6 percentage points compared to
the second quarter of 2007.
- SG&A expense included non-cash charges for stock options and warrants
of $.3 million.
- SFP related R&D spending of $.8 million was 6.4% of sales.
- Loss of ($1.1 million) compared to a loss of ($.5 million) in the second
quarter 2007.
- Cash position at June 30, 2008 was $9.7 million.
Six Month Financial Highlights:
- Sales increased 22.8% or $4.6 million to $24.6 million in the first half
of 2008 vs. 2007
- Domestic sales increased 19.1% while international sales were up 94%
compared to the first half of 2007.
- Gross Profit margins increased 2.8% to 7.9% compared to the first half of
2007.
- SG&A expense included non-cash charges for stock options and warrants
of $.7 million.
- R&D expense was $1.6 million in the first half of 2008 and in the
first half of 2007.
- Loss of ($2.3 million) compared to a loss of ($2.1 million) in the first
half of 2007.
SFP Business Highlights:
- Added significant expertise to the Company's Scientific Advisory Board
with the appointment of three additional renal failure and iron experts in the
renal field.
- Modified SFP Phase II-b Dose Ranging Study protocol to reflect changes to
industry hemoglobin standards.
- Modified SFP Phase II-b Dose Ranging Study protocol to accelerate
enrollment and study completion.
- Commenced enrollment for a 9-month National Institutes of Health (NIH)
funded SFP study.
- Commenced recruitment for a Chief Medical Officer.
Mr. Robert L. Chioini, Chairman and CEO stated, "Our
SFP clinical development program continues to progress and we are confident
that we have taken necessary actions to complete the trial as effectively as
possible. We have increased the resources devoted to development and revised
the protocol to facilitate enrollment wherever practical. We look forward to
advancing the SFP study and expanding our senior management team as we begin to
distinguish ourselves within the specialty pharma market. Overall, second
quarter results were in line with our expectations."
Rockwell will be hosting a conference call to review its second quarter results
and to provide investors with an update on its business development efforts on
Tuesday, August 12, 2008 at 11:00 am eastern time.
Investors are encouraged to call in several minutes in advance at (877)
440-5803 to hear the call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=32850&c=RMTI&mediakey=803E36B7FDC0F7E12EBCE5CA76E150CB&e=0
See www.rockwellmed.com for more details and playback options.
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing necessary nutrients in the
dialysis patient's bloodstream. Rockwell is currently developing unique,
proprietary renal drug therapies for iron maintenance utilizing its dialysate
as the delivery mechanism. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy while
decreasing cost.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our anticipated future financial
condition, operating results, cash flows or business plans, we are making
forward-looking statements. While we believe these forward-looking statements
are reasonable, you should not place undue reliance on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond our control or are subject to change,
actual results could be materially different. Factors which could cause such a
difference include, without limitation, the risk factors and other risks and
uncertainties set forth in the Company's SEC filings, including its Form 10-K
for the year ended December 31, 2007 and its Forms 10-Q filed during 2008. The
forward-looking statements should be considered in light of these risks and
uncertainties. We do not undertake, and expressly disclaim any obligation, to
update or alter our statements whether as a result of new information, future
events or otherwise, except as required by law.
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and six months ended June 30, 2008 and June 30, 2007
(Unaudited)
|
| |
3 Months ended June 30, 2008 |
3 Months ended June 30, 2007 |
6 Months ended June 30, 2008 |
6 Months ended June 30, 2007 |
| Sales |
$ 12,182,336 |
$ 10,548,243 |
$ 24,594,373 |
$ 20,022,625 |
| Cost of Sales |
11,090,558 |
9,431,207 |
22,645,294 |
18,988,308 |
| Gross Profit |
1,091,778 |
1,117,036 |
1,949,079 |
1,034,317 |
| Selling, General, Admin |
1,439,735 |
797,787 |
2,869,487 |
1,523,446 |
| Research & Product Devel. |
781,743 |
761,539 |
1,564,456 |
1,584,059 |
| Operating (Loss) |
(1,129,700) |
(442,290) |
(2,484,864) |
(2,073,188) |
| Interest Expense (Income), net |
(19,696) |
34,335 |
(164,687) |
49,951 |
| Net (Loss) |
$ (1,110,114) |
$ (476,625) |
$ (2,320,177) |
$ (2,123,139) |
| Basic Earnings (Loss) per share |
$ (0.08) |
$ (0.04) |
$ (0.17) |
$ (0.18) |
| Diluted Earnings (Loss)per share |
$ (0.08) |
$ (0.04) |
$ (0.17) |
$ (0.18) |
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of June 30, 2008 and December 31, 2007
|
| |
June 30, 2008
(Unaudited) |
Dec. 31, 2007 |
| Assets |
| Cash and Cash Equivalents |
$ 9,735,902 |
$ 11,097,092 |
Accounts Receivable,
net of a reserve of $82,000 in 2008 and $69,000
in 2007 |
4,352,087 |
4,687,229 |
| Inventory |
2,712,486 |
2,559,051 |
| Other Current Assets |
458,715 |
302,573 |
| Total Current Assets |
17,259,190 |
18,645,945 |
| Property and Equipment, net |
3,179,529 |
2,840,331 |
| Intangible Assets |
256,021 |
270,446 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
148,636 |
125,667 |
| Total Assets |
$21,764,121 |
$22,803,134 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
192,466 |
194,239 |
| Accounts Payable |
3,195,379 |
2,982,899 |
| Accrued Liabilities |
1,358,996 |
1,122,737 |
| Customer Deposits |
362,189 |
337,396 |
| Total Current Liabilities |
5,109,030 |
4,637,271 |
Long Term Notes Payable & Capitalized Lease Obligations
|
101,467 |
204,837 |
| Shareholders' Equity: |
Common Shares, no par value,
13,834,953 and 13,815,186 shares issued and
outstanding |
33,976,532 |
33,415,106 |
Common Shares Purchase Warrants,
1,394,169 and 1,204,169 warrants issued and
outstanding |
3,389,760 |
3,038,411 |
| Accumulated Deficit |
(20,812,668) |
(18,492,491) |
| Total Shareholders' Equity |
16,553,624 |
17,961,026 |
| Total Liabilities and Shareholders'
Equity |
$21,764,121 |
$22,803,134 |
(return to News
Index)
Tuesday, August 5, 2008
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Tuesday,
August 12, 2008 at 11:00AM EST to discuss its second quarter 2008 results and
to provide investors with a business update. Robert Chioini, Chairman and CEO,
and Thomas Klema, CFO, will be hosting the call to review Rockwell's results
and answer questions from investors.
The conference call will be held on:
Tuesday, August 12, 2008
Starting Time 11:00 a.m. Eastern
Dial in Number: 877-440-5803
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=32850&c=RMTI&mediakey=803E36B7FDC0F7E12EBCE5CA76E150CB&e=0
International Investors may dial in directly on 719-325-4920.
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at www.rockwellmed.com.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Tuesday, July 9, 2008
Rockwell Appoints Dr. Richard Hurrell,
International Iron Expert, to Scientific Advisory Board
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, reported today that it has added Dr. Richard Hurrell, an
internationally recognized expert in the field of iron, with a specialty in SFP
and its role in nutrition, to its Scientific Advisory Board (SAB).
Dr. Hurrell is the Professor for Human Nutrition and Head of the Laboratory of
Human Nutrition at the Institute of Food Science and Nutrition, Swiss Federal
Institute of Technology (ETH), Zurich, Switzerland. He specializes in the iron
fortification of foods and has helped develop improved methods to fortify food
products without causing adverse organoleptic changes. He was awarded the
International Prize for Modern Nutrition for studies on the influence of food
processing and preparation on food quality and is a member of the British
Nutrition Society, the Swiss Nutrition Society and the European Academy of
Nutrition. Dr. Hurrell is President of the Swiss Committee of International
Union of Nutritional Scientists, the editor of the International Journal for
Vitamin and Nutrition Research, and a member of the WHO Task Force on Food
Fortification and the WHO International Micronutrient Advisory Group. He has
been on the Editorial Board of the Zeitschrift fuer Ernaehrungswissenschaft and
The British Journal of Nutrition and on the Editorial Advisory Board of the
journal Trends in Food Science and Technology. Dr. Hurrell is a consultant on
food fortification to leading multinational food companies and international
agencies and was previously the Head of the Micronutrient Research Team and the
Coordinator for Infant Nutrition Research at the Nestlé Research Center,
Lausanne. Dr. Hurrell has more than 130 publications in the areas of iron
bioavailability, iron fortification, iron and iodine nutrition in developing
countries, mineral absorption using stable isotopes, influence of food
processing on nutritional value of foods. Dr. Hurrell holds a PhD in Nutrition
from Cambridge University and BSc Honors Degree in Food Technology from Reading
University.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated,
Dr. Hurrell has accomplished a tremendous amount of work with iron
pyrophosphate and is the top expert in iron nutrition at the international
level, specifically for SFP, and we are delighted to have him join our
Scientific Advisory Board as one of our expert consultants. As we evaluate and
develop other SFP applications, outside of iron maintenance via dialysate, we
believe Dr. Hurrell's expertise and experience in the industry will be of great
benefit to the Company.
Dr. Hurrell is the sixth iron expert added to Rockwell's current SAB.
Rockwell's seven-member SAB currently advises the Company on clinical
development for its proprietary iron-maintenance renal drug SFP, currently in
FDA Phase IIb clinical trials, as well as proprietary SFP-related extensions
and the evaluation of new renal drug opportunities. Rockwell's SAB consists of
experts in the fields of renal anemia, iron therapy, nutrition, nephrology,
parenteral, enteral and FDA regulatory affairs.
About SFP:
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide
physiological-iron-maintenance-therapy for treatment of anemia, with initial
indication for end stage renal disease (ESRD). SFP is delivered direct to the
bloodstream of the ESRD patient, via dialysate, during each kidney dialysis
treatment, maintaining optimal iron balance, avoiding liver toxicity and
decreasing associated nursing and pharmaceutical IV iron administration costs.
Recent academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments.
About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell is currently developing unique, proprietary
renal drug therapies for both iron maintenance and carnitine supplementation
utilizing its dialysate as the delivery mechanism. These exclusive renal drug
therapies support disease management initiatives to improve the quality of life
and care of dialysis patients and are designed to deliver safe and effective
therapy to these patients while decreasing cost.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward- looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Tuesday, June 17, 2008
Rockwell Appoints Dr. James D. Cook to Scientific Advisory Board
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, reported today that it has added Dr. James D. Cook, an
internationally recognized expert in the field of iron, to its Scientific
Advisory Board (SAB). Dr. Cook has published over 200 peer-reviewed articles on
all aspects of human iron metabolism with emphasis on iron absorption, internal
iron kinetics and the clinical assessment of iron status in a career spanning
over 40 years. Rockwell's SAB currently advises the Company on clinical
development and market preparation for its proprietary iron-maintenance product
SFP, currently in Phase IIb clinical trials. Rockwell's SAB consists of experts
in the fields of renal anemia, iron therapy, nephrology and FDA regulatory
approval.
Dr. Cook graduated from Queen's University, Canada with an M.D. degree in 1960
and M.Sc (Med) in 1963. He obtained his clinical training in Internal Medicine
at Boston City Hospital and hematology training at the University of
Washington, Seattle where he remained on faculty until 1975. He was then
appointed the Phillips Professor of Medical Research and Director of
Hematology, Department of Medicine at the Kansas University Medical Center,
Kansas City, Kansas. Dr. Cook retired from teaching and clinical practice as
Professor Emeritus at Kansas University in 2007.
In the late 1960s Dr. Cook, in collaboration with Dr. Joseph Eschbach, studied
disorders of erythropoiesis and iron absorption in patients with kidney
failure. In his distinguished career, Dr. Cook has served as Chairman on
several national and international research/advisory committees including the
Expert Panel on Iron, International Committee for Standardization in Hematology
(1981); Subcommittee on Nutritional Anemia, American Society of Hematology
(1979); Subcommittee on Iron Methodology, National Committee for Clinical and
Laboratory Standards (1979-95); International Center for Control of Nutritional
Anemia (ICCNA), University of Kansas Medical Center (1982-94), and Iron
Subcommittee, FAO/WHO Expert Consultation on Requirements of Vitamin A, Iron,
Folate and Vitamin B12 (1985). Dr. Cook has also served as a member/consultant
on the Editorial Board, Journal of Nutrition (1978-1983); NIH Hematology Study
Section (1983-1987), Tanzania Nutritional Anemia Consultative Group, Dar es
Salaam, Tanzania (1991-92); US National Committee, International Union of
Nutritional Sciences (1986-1992); Joint Micronutrient Consultative Group,
Nutrition Foundation (1992-94); British Task Force on Iron Nutrition (1992-93);
National Nutrition Council, Stockholm, Sweden (1993); Scientific Subcommittee
on Iron and Heme, American Society of Hematology (2001- 2004); and
International Federation of Clinical Chemistry Working Group on Laboratory
Management of r-HuEPO Therapy (2002-2005).
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We
are excited to have added Dr. Cook to our SAB. Dr. Cook's expertise and wealth
of experience in the iron field will be invaluable to Rockwell as the Company
further exploits the unique properties of SFP that make it ideally suited for
the oral, nutritional and parenteral and enteral administration markets. We
have assembled a first-class team to help facilitate not only FDA market
approval of SFP in ESRD but to also pursue regulatory approval of other SFP
applications within CKD and other new markets as well."
Rockwell's current SAB consists of:
- Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology
and Senior Staff Physician, Henry Ford Hospital, Detroit and lead Principal
Investigator for the Phase II-b dose range study.
- Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of
Medicine, Indianapolis.
- Richard Zager, MD, Director of Nephrology, Fred Hutchinson Cancer Research
Center and Professor of Medicine, University of Washington, Seattle.
- James Cook, MD, former Phillips Professor of Medical Research and Director
of Hematology, and currently Professor Emeritus, Kansas University, Kansas
City, Kansas.
- Bert Spilker, PhD, MD, President Bert Spilker & Associates, LLC.
- Ajay Gupta, MD, Associate Professor of Medicine, UCLA and Charles Drew
University Schools of Medicine, Los Angeles; the inventor of SFP as a
parenteral iron supplement (via hemodialysis and peritoneal dialysis solutions,
intravenously and as an adjunct to parenteral nutritional admixtures. Dr. Gupta
is the Principal Investigator for the ongoing NIH sponsored clinical trial
examining oxidative stress and inflammation in response to SFP versus IV iron.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide
physiological-iron-maintenance-therapy for treatment of anemia, with initial
indication for end stage renal disease (ESRD). SFP is delivered direct to the
bloodstream of the ESRD patient, via dialysate, during each kidney dialysis
treatment, maintaining optimal iron balance, avoiding liver toxicity and
decreasing associated nursing and pharmaceutical IV iron administration costs.
Recent academic studies have shown that more frequent maintenance doses of iron
improve the therapeutic response and benefits of recombinant erythropoietin
treatments.
The Company is currently conducting a Phase IIb study and sponsoring an
on-going NIH-funded study in anticipation of gaining FDA market approval.
Rockwell has licensed exclusive world-wide rights and has secured patents for
SFP in multiple countries, including the three largest dialysis markets in the
world: the United States, Japan and the European Union. The U.S. dialysis
market for IV-iron delivery is approximately $500 million annually while global
market potential is approximately $800 million.
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focus |