MedImmune is teaming up with a Chinese company to launch a joint venture designed to develop and commercialize in China a new biologic therapy for rheumatoid arthritis and other autoimmune and inflammatory diseases.
Under the venture, the Gaithersburg biotech will provide technical and development expertise and WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support.
Chinese law requires companies that conduct clinical trials to manufacture the experimental treatments locally when they haven't yet been approved in other markets, according to a MedImmune statement. MEDI5117, as the new treatment is called, is in phase 1 clinical trials in the U.S. and Europe.
"This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca's investment in this important emerging market," Bahija Jallal, MedImmune's executive vice president for research and development, said in the statement. MedImmune is the global biologics division of British pharma giant AstraZeneca.
The two companies will have equal ownership of the joint venture; AstraZeneca has the option to acquire full commercialization rights for MEDI5117. WuXi AppTec will earn revenue based on services provided to the joint venture, and MedImmune will receive milestone payments as the program progresses.
"WuXi is working to build long-term drug development partnerships with leading biopharmaceutical companies like MedImmune to help accelerate the development of novel medicines for the large and rapidly growing Chinese pharmaceutical market," Ge Li, chairman and CEO of WuXi AppTec, said in the statement.
China's pharmaceutical market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS Health, is projected to grow to more than $100 billion by 2014, MedImmune said.
In other Maryland bioscience industry news:
Rockville biotech 20/20 GeneSystems reported that it will receive the final payment of about $1 million from a three-year, $2.75 million federal grant it won to help develop a test that predicts how well a breast tumor will respond to the cancer drug Herceptin.
The Small Business Innovation Research grant was from the National Cancer Institute.
Company executives were scheduled to report results from a study of its PredicTOR test at this week's Breast Cancer Symposium in San Francisco.
About half of breast tumors treated with Herceptin do not respond to the drug, according to a 20/20 statement. In the study, the new test, which measures proteins in a cancer-causing pathway, correctly classified 28 of 32 tumors that ultimately responded to the drug and 10 of 13 tumors that failed to respond. Using the test results, oncologists could prescribe an additional drug to make the Herceptin treatment more effective.
20/20 said it plans more studies of the test and, if successful, would market the test by this time next year.
"The mTOR pathway is of large interest in personalized cancer therapy and breast cancer in particular. A number of pharmaceutical companies, including Pfizer and Novartis, are commercializing mTOR inhibitors," Saranya Chumsri, an assistant professor and oncologist in the breast cancer unit at the Greenebaum Cancer Center at the University of Maryland, said in the statement. "These drugs can be very powerful but they are highly targeted and do have concerning side effects. It may only work in small subsets of patient populations. A test identifying likely responders could be of tremendous value to personalized oncology."
Nutritional supplements can help children read and behave better, a new study reports.
Schoolchildren with low reading levels who ingested algal docosahexaenoic acid, an omega-3 fatty acid, showed the improvements in a clinical study conducted at the University of Oxford (U.K.)
"Poor reading skills as a child impact all learning and can lead to a host of problems in adulthood," lead investigator Alex Richardson, senior research fellow at the University of Oxford and director of Food and Behavior Research, said in a statement. "The DHA Oxford Learning and Behavior trial showed that taking daily algal DHA supplements improved reading performance for the worst readers, and helped these children catch up with their peer group."
The study was funded by DSM Nutritional Products, the Dutch company that in 2011 acquired, for $1.1 billion, Martek Biosciences of Columbia, which produces the algal DHA omega-3 oil that was used in the trial.
The 16-week trial involved 362 healthy children, ages 7 to 9, from mainstream schools who were underperforming in literacy skills. They were not taking medications for attention deficit hyperactivity disorder, according to DSM's statement.
A follow-on study is under way at the University of Oxford to explore a larger sample size of children who are underperforming in reading performance.
First, Human Genome Sciences was sold. Now, third-party rights to some royalties from its flagship lupus drug have changed hands.
Biotech pioneer Biogen Idec of Weston, Mass., reported selling its portion of royalties from sales of Benlysta to DRI Capital of Toronto, a life sciences investment company.
Benlysta was approved by the Food and Drug Administration in early 2011, the first new approved lupus drug in a half-century. In July 2011, European regulators approved it.
Sales of the drug could hit $1.6 billion in 2015, according to an HGS regulatory filing.
Biogen had a license agreement with GlaxoSmithKline and its development partner, Rockville biotech Human Genome Sciences, that included some sales royalties. This summer, Glaxo acquired HGS for $3.6 billion.
Under the new deal, HGS and Glaxo now pay royalties directly to DRI, which will pay Biogen a multiple of certain royalties covering October 2011 to September 2014. Thereafter, DRI will retain the royalties.
So far, DRI has paid Biogen $18.3 million, covering the royalty period from October 2011 to March 30.
“The sale of our Benlysta royalty and other rights allows us to accelerate payments that would otherwise have been spread over a longer time period as we prepare for multiple pivotal trial data readouts and potential product launches in multiple sclerosis, hemophilia, and amyotrophic lateral sclerosis, or ALS,” Steven H. Holtzman, executive vice president, corporate development at Biogen, said in a statement.
British regulators have approved Sucampo Pharmaceuticals' drug for chronic idiopathic constipation.
Lubiprostone, sold under the brand name Amitiza, already has been approved for such use in the U.S., Switzerland and, most recently, Japan.
“The approval of Amitiza in the U.K. is an important step in Sucampo’s comprehensive initiative to increase" the drug's global reach, CEO Ryuji Ueno said in a statement. "We look forward to expanding the Amitiza franchise into additional indications, such as opioid induced constipation, and geographic locations so that more patients can access this breakthrough medication.”
BioFactura has been awarded the final milestone payment of $50,000 from the MdBio Foundation for its work in developing its StableFast Biomanufacturing Platform.
The Rockville bioscience company developed the cell culture system to improve the yield, speed and ease of manufacturing biological drugs, such as monoclonal antibodies and biosimilars, it said in a statement.
Under the terms of the foundation's Project Accelerator Award, the company "has made significant progress in developing a system that is highly efficient and expected to be used in the production of biosimilar drugs for the pharmaceutical industry."
"The MdBio Foundation was one of the earliest investors in BioFactura's StableFast technology," Darryl Sampey, the company's CEO, said in the statement. "The foundation's continued support has been instrumental in completing the commercialization of our biomanufacturing platform and bringing a valuable alternative to pharmaceutical companies developing new, lower cost biosimilar versions of today's life saving drugs."
With the award to BioFactura, the foundation has now completed its Project Accelerator Award Program, which originated about 15 years ago and was responsible for providing funding for 30 bioscience companies in Maryland," J.J. Finkelstein, chairman of the foundation, said in the statement.
The nonprofit foundation is an affiliate of the Tech Council of Maryland in Rockville.
A new study shows that paraplegic rats recovered "significant locomotor function" when injected with Neuralstem's spinal cord stem cells.
The study, published in the scientific journal Cell, involved the same kind of cells that the Rockville biotech said it used in its recently completed phase 1 clinical trial to treat humans with amyotrophic lateral sclerosis.
The treated rats, whose spinal cords had been severed a week earlier, regained movement in all lower extremity joints and the transplanted neural stem cells turned into neurons that grew a "remarkable" number of axons that extended for "very long distances" over 17 spinal segments, making connections both above and below the point of severance, according to the study's report. The study involved 12 paralyzed rats; half received stem cell treatments.
Besides ALS, Neuralstem has applied to the FDA for a trial to treat chronic spinal cord injury with its stem cells.
"This study demonstrates that our neural stem cells can induce regeneration of injured spinal cord axons into the graft and serve as a bridge to reconnect to gray matter motor neurons for many spinal cord segments below the injury," Karl Johe, Neuralstem's chairman and chief scientific officer, said in a statement. "This is important in spinal cord injury because the nerve connections below the point of injury die, causing paralysis. Our cells built a bridge that received inputs from regenerating rat axons above the injury. They also sent out new human axons which made new synaptic connections with the host motor neurons in the gray matter below the injury. The fact that these cells induce regeneration of axons and partial recovery of motor function makes them relevant for testing for the treatment of human spinal cord injury."
Lupin Pharmaceuticals of Baltimore reported receiving FDA approval to market a generic version of Forest Laboratories' Lexapro tablets to treat major depressive disorder in adults and teenagers, plus general anxiety disorder in adults.
U.S. sales of Lexapro totaled about $2.7 billion in the 12 months ending in June, according to a Lupin statement.
The company is the U.S. subsidiary of Lupin Ltd. of Mumbai, India.
The Maryland Biotechnology Center in Baltimore this week began taking applications for its fiscal 2013 biotechnology development awards.
Since 2010, the program has made nearly two dozen awards totaling $4.5 million to Maryland companies, according to a statement from the state agency. Grants range from $50,000 to $200,000.
“Though we’re just entering the third year of our awards program, it already has enabled organizations to begin translating their research to reality,” Executive Director Judith Britz said in the statement.
Oct. 17 is the application deadline. Information: marylandbiocenter.org.