BioWatch: Martek shifts some operations from its Kentucky plant
-Columbia developer of nutritional products idling 45 workers
This story was corrected on Friday, July 9, 2010. An explanation follows the story.
Martek Biosciences, which develops and produces nutritional products with essential fatty acids, is downsizing its manufacturing plant in Winchester, Ky., to cut costs.
The Columbia company said it would lay off about 45 of its 95 employees there and shift some manufacturing and distribution operations to its plant in Kingstree, S.C.
The remaining workers will concentrate on lab and pilot scale development, innovation, production and supply-chain management.
Martek expects to incur cash charges of $1.5 million in connection with the changes. Noncash asset impairment charges could total $30 million to $40 million. The company's stock fell almost 6 percent on July 1 when the news was announced.
The company also is exploring leasing or selling some of the Kentucky location.
Otherwise, Martek has reported solid results. Its most recent quarterly sales were up 34 percent to $124.0 million from $92.4 million a year earlier, with its profit growing to $12.5 million from $11.0 million. The increased sales include the company's acquisition of Amerifit Brands in February, while its bottom line took a $3.5 million quarterly charge related to that deal.
"I continue to be encouraged by the demand for Martek's products as our base infant formula business is expected to post solid growth this year, our non-infant formula DHA business is growing rapidly, and our Amerifit division continues to perform well," CEO Steve Dubin said in a statement in connection with the Kentucky cutbacks.
Martek's lead product is life'sDHA, a vegetarian source of algal docosahexaenoic acid for brain, heart and eye health, for use in infant formula, pregnancy and nursing products, foods and beverages and dietary supplements. It also sells probiotics and over-the-counter products for urinary tract infections and menopause symptoms.
In other Maryland bioscience industry news:
Privately held Advanced BioNutrition of Columbia and former CEO David Kyle have paid the federal government $934,000 to settle claims they fraudulently obtained a phase 2 Small Business Innovation Research grant from the National Science Foundation and submitted false progress reports, according to a statement from federal prosecutors.
Albert Cunniff Jr., a whistleblower who sued the company three years ago, will receive $105,275 from the settlement.
Advanced BioNutrition, founded by a former Martek Biosciences executive in 2001, won a phase 1 SBIR grant in February 2005 to develop technology to micro-encapsulate probiotic bacteria into particles. In January 2006, the company applied for a phase 2 grant to continue the project. Two months later, the National Science Foundation awarded the grant, based on the fraudulent progress reports from the phase 1 work, prosecutors said. Those fraudulent reports continued under the phase 1 work.
Both the company and Kyle deny the allegations, according to the statement.
As part of the settlement, the company agreed to a five-year compliance integrity agreement and Kyle agreed to be excluded for five years from all federal procurement and nonprocurement programs.
"Anyone who participates in government funded research must truthfully and accurately report the results of that research," U.S. Attorney Rod J. Rosenstein said. "Companies and individuals that misrepresent results in order to obtain government funding undermine the integrity of the government grant process."
"The SBIR program is a valuable tool in advancing [the National Science Foundation's] mission to promote the progress of science by increasing opportunities for small businesses to undertake cutting-edge scientific research, and it is essential to protect the integrity of this program," said Allison Lerner, the foundation's inspector general.
Sirnaomics, a privately held Gaithersburg biotech that is developing treatments for brain cancer and flu, including seasonal and H1N1 flu, has received two Small Business Innovation Research grants from the National Institutes of Health.
The grants $269,298 from the National Cancer Institute and one from the National Institute of Allergy and Infectious Diseases are designed to help the three-year-old company develop its RNA interference therapeutics. Its multi-targeted programs use nanoparticle-enhanced delivery technologies.
Neither Sirnaomics nor NIH responded to inquiries about the amount of the second grant.
Sirnaomics' programs are under development for treating cancer and respiratory infections, and for scarless wound healing.
"The collaboration among scientists and clinicians from Sirnaomics and Duke University provides the solid foundation for the success of such a novel therapeutic approach," CEO Patrick Y. Lu said in a statement. "Continuous government funding is critical for the growth of a therapeutic product company like Sirnaomics, especially in the current financial environment."
Sirnaomics also has a subsidiary in Suzhou, China, for greater research and development capacity and to reach a larger potential market.
GlycoMimetics reported launching a phase 2 clinical trial of its lead candidate to treat sickle cell disease. The Gaithersburg company also said the Food and Drug Administration has granted GMI-1070 fast-track designation.
The trial is on hospitalized sickle cell disease patients in the U.S. and Canada with vaso-occlusive crisis, "a painful and life-threatening condition affecting individuals with sickle cell disease in which the flow of blood is blocked as sickle cells become stuck within a blood vessel," according to a GlycoMimetics statement.
"Evaluating GMI-1070 in the treatment of sickle cell patients hospitalized with vaso-occlusive crisis represents a critical next step towards fulfilling an important medical need in this historically underserved patient population," said Helen Thackray, vice president of drug development, in the statement.
The FDA previously granted orphan drug designation for the GMI-1070.
The fast-track program's goal is quicker development and review of new drugs intended to treat serious conditions and that demonstrate the potential to address unmet medical needs.
To help maintain compliance with Nasdaq listing requirements, EntreMed of Rockville effected a one-for-11 reverse stock split.
At the Rockville company's annual meeting in June, shareholders authorized the board to take such action.
"After in-depth consideration of our options, the Board determined that a reverse split of the Company's stock is in the best interest of stockholders and is the appropriate next step in order to execute our clinical development objectives for ENMD-2076," said Michael M. Tarnow, executive chairman of EntreMed, in a statement.
EntreMed has received orphan drug designation from the FDA for ENMD-2076 to treat ovarian cancer, multiple myeloma and acute myeloid leukemia. The company has completed a phase 1 study in patients with solid tumors and is conducting a phase 2 study in ovarian cancer and phase 1 studies in multiple myeloma and leukemia.
SAIC-Frederick is collaborating with Fluidigm of South San Francisco, Calif., to decode the entire genome of the Epstein-Barr virus.
Herpes-related Epstein-Barr is one of the most common viruses in humans and can sometimes lead to cancer, according to a joint statement.
"Understanding the virus at the genetic level should provide insights into why some infected individuals become ill, while others do not," the companies said. "This knowledge could help medical scientists design new, more effective approaches to treatment."
SAIC-Frederick, a wholly owned subsidiary of Science Applications International Corp. of McLean, Va., is prime contractor for the National Cancer Institute's research and development unit in Frederick.
Lupin Pharmaceuticals of Baltimore has won federal regulatory approval to market its Famotidine for oral suspension, the generic version of Merck's Pepcid to treat gastric ulcers and acid reflux disease.
Sales of Pepcid totaled $29 million in the year ended March, according to Lupin, a subsidiary of Lupin Ltd. of Mumbai, India.
United Therapeutics has struck a deal with a Chinese partner to sell its treatment for pulmonary arterial hypertension there.
Lee's Pharmaceutical of Hong Kong will distribute the Silver Spring drug-maker's injectable Remodulin.
"We believe that Remodulin will be an important addition to the currently available treatment options for PAH patients in China," said Roger Jeffs, president and COO of United Therapeutics, in a statement.
Lee's Pharmaceutical will be responsible for obtaining market authorization in China, including conducting necessary bridging studies.
Northwest Biotherapeutics, which is developing a personalized cancer vaccine, said it raised $2.65 million in purchases of its restricted common stock in the second quarter.
That included a total of $900,000 by SDS Capital and by Linda F. Powers, Northwest's chairwoman. Powers together with Toucan Capital of Bethesda, of which she is managing director and co-founder owns controlling interest in the company.
Northwest also said it continued to make progress on restructuring its balance sheet through debt conversions and extensions with its largest creditors, including SDS.
For the third straight year, STB Lifesaving Technologies of Rockville has won Pentagon funding to help develop its products designed to stop blood loss.
The $2.85 million will advance development of its Fibrin Adhesive STat dressing to stop all types of blood loss, including severe arterial and venous bleeding, according to a company statement.
At least half of all combat-related deaths are caused by uncontrolled bleeding, STB said.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House," CEO Richard Moscarello said in the statement. "We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well."
MedImmune of Gaithersburg, the biologics division of AstraZeneca of London, said it was notified that the FDA has rescheduled to Aug. 27 a decision on its review of motavizumab.
Motavizumab is a candidate to help prevent serious respiratory syncytial virus disease in infants. It is MedImmune's follow-up to its biggest money-maker, Synagis, which also helps prevent this disease. Synagis sales last year fell 12 percent to $1.08 billion from 2008, according to the 2009 annual report of MedImmune's parent, AstraZeneca of London.
MedImmune filed a biologics license application for motavizumab in January 2008. But this spring, an FDA advisory panel voted 14-3 to reject the application.
Among the panel's concerns was that motavizumab has a higher degree of hypersensitivity than Synagis, "with some questions about motavizumab's efficacy," according to FDA documents. As many as 125,000 American infants are hospitalized each year with severe RSV infections.
Meanwhile, MedImmune has sold the development and commercial rights to a protein technology to Cornerstone Therapeutics of Cary, N.C.
The technology was the subject of a 2003 exclusive license and collaboration agreement between Cornerstone and MedImmune in which MedImmune used the technology to develop antibodies to help reduce chronic inflammation from various medical conditions, according to a Cornerstone statement.
The technology could help treat patients with conditions including stroke, heart attacks, arthritis, pneumonia, meningitis and sepsis, the company said.
Celsis In Vitro of Baltimore is suing CellzDirect, a subsidiary of Invitrogen, claiming patent infringement.
In connection with the suit, filed in U.S. District Court in Chicago, Celsis also seeks a preliminary injunction against Invitrogen, itself a subsidiary of Life Technologies of Carlsbad, Calif.
Celsis claims CellzDirect's in vitro drug testing services infringe on its patent and seeks monetary damages and injunctive relief.
In June, Celsis successfully reached a settlement with XenoTech, Sekisui Chemical and Sekisui Medical in a similar suit involving the same patent.
Celsis, a subsidiary of Celsis International of Chicago, has used the technology to create its LiverPool products for drug discovery research.
PharmAthene of Annapolis has reported progress in developing an anthrax vaccine that is stable in temperatures up to 158 degrees.
The company is working on the lyophilized or freeze-dried recombinant protective antigen vaccine under a challenge grant from the National Institutes of Health. It plans to present nonclinical data at next week's 2010 International Conference on Emerging Infectious Diseases in Atlanta showing the formulation has improved immunogenicity over the liquid formulation.
PharmAthene also reported it recently produced the 14,000th dose of the vaccine, for continued development work.
Biospherics, a subsidiary of Spherix, has signed a license agreement with the University of Kentucky Research Foundation in which Biospherics will have worldwide rights to international patents filed on behalf of the foundation for D-tagatose as a lipid-lowering agent to prevent and treat atherosclerosis, hypertriglyceridemia, and related dyslipidemias.
Spherix, of Bethesda, is developing T-tagatose as a treatment for diabetes and high triglyceride levels.
"Spherix believes that D-tagatose has good potential as a treatment for the underserved triglyceride market," said CEO Claire Kruger in a statement. "Preliminary results from our single-blinded phase 2 clinical trial in diabetes show that low doses of D-tagatose significantly lowered triglyceride levels in people with only mildly elevated triglyceride levels. We are confident that clinical trials dedicated to evaluating D-tagatose in patients with moderately or highly elevated triglycerides will replicate or even improve on those results."
RegeneRx Biopharmaceuticals has received Australian patents for its Thymosin beta 4 and derivatives for treating infections and inflammatory disorders such as colitis, ileitis, gastrointestinal ulcers and gingivitis, according to a statement by the Rockville biotech.
The patent, which expires in 2023, is one of several RegeneRx has been granted in Australia.
Thymosin beta 4 is a synthetic version of a naturally occurring peptide that is in almost all human cells. The company also is studying it to treat other conditions, such as cardiovascular and central nervous system diseases, ophthalmic indications and chronic skin wounds.
Human Genome Sciences recently presented more positive results from one of its two phase 3 trials of its lupus candidate, Benlysta.
Importantly, the results show that Benlysta "did not significantly affect the ability of ... patients to maintain a protective response to [pneumococcal, tetanus and influenza] vaccines, a finding that is consistent with the preservation of memory B-cells," said William W. Freimuth, the company's vice president for clinical research in immunology, rheumatology and infectious diseases, in a statement.
In June, HGS submitted a biologics license application to the FDA for U.S. marketing approval of Benlysta. Its partner, GlaxoSmithKline, applied for licensure in Europe.
Rexahn Pharmaceuticals, which is development treatments for cancer and central nervous system disorders, has established a scientific advisory board in major depressive disorder.
The board will work with Rexahn on clinical development of its Serdaxin to treat the depressive disorder.
"I'm delighted to have five leading international experts in depression advising us on our research and clinical development programs of Serdaxin ...," said CEO Chang Ahn in a statement. "Serdaxin will be advancing into a phase 2b clinical trial later this year."
The new board is chaired by Dr. Michael Thase, professor of psychiatry and chief of the division of mood and anxiety disorders treatment and research program at the University of Pennsylvania.
The other members are Dr. Maurizio Fava, executive vice chairman, department of psychiatry and director of the depression clinical and research program, and executive director of the Massachusetts General Hospital Clinical Trials Network Institute; Dr. Susan Kornstein, professor of psychiatry and obstetrics and gynecology at Virginia Commonwealth University; Dr. Stephen Stahl, adjunct professor of psychiatry at the University of California, San Diego; and Dr. Madhukar Trivedi, professor of psychiatry at the University of Texas Southwestern Medical Center.
Johns Hopkins University in Baltimore is among the 10 new international centers for malaria research that the National Institutes of Health is helping establish.
The National Institute of Allergy and Infectious Diseases plans to spend $14 million to set up the centers.
"One of our primary goals with these centers is to fund cutting-edge research in malaria-endemic areas that will keep up with the rapidly changing epidemiology of the disease," says institute director Anthony S. Fauci in a statement.
The principal Hopkins investigator, Peter Agre, is to study "Malaria Transmission and the Impact of Control Efforts in Southern Africa."
Explanation: The original version of this article incorrectly characterized Advanced BioNutrition as an offshoot of Martek Biosciences.