MS Research Roundup: April 4, 2014
Embryonic Stem Cells Need Ancient Viral Remnants; Collaborating on Cures; Copaxone Goes to Highest Court
MS Research Roundup collects items of interest to multiple sclerosis researchers from around the Web. Send us your tips: tips@msdiscovery.org.
Ancient Viral Remnants Revisited
Remember those MS-related human endogenous retroviruses (HERVs) we wrote about recently here and here? Another HERV subfamily plays a crucial role in maintaining the pluripotent power of human embryonic stem cells (hESCs), researchers reported online March 30 in Nature Structural & Molecular Biology. HERV-H was implicated more tenuously in the etiology of multiple sclerosis about 10 years ago. In the new study, “HERVH is a nuclear long noncoding RNA required to maintain hESC identity,” the authors wrote in the abstract. “A better understanding of how HERV-H works might help researchers chemically reprogram ordinary cells into becoming pluripotent stem cells, which could help lead to regenerative medicine therapies," said computational biologist Guillaume Bourque of McGill University in Montreal, Canada, a co-author. Those therapies could treat conditions such as diabetes, stroke, multiple sclerosis, Parkinson's disease, and brain and spinal cord injury, speculated an article in National Geographic. (National Geographic)
European Drug Regulators Change the Game
Wouldn’t it be great if researchers, companies, regulators, patients, payers, and all players involved in MS treatments—especially for progressive forms of the disease—could collaborate to develop better drugs at lower cost and more quickly? On March 19, the European Medicines Agency announced a pilot project to test a new way to find cures. Called adaptive licensing, the innovative framework brings together key stakeholders “in a ‘safe harbor’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilization pathways in a confidential manner and without commitment from either side,” according to the press release. The concept has buy-in from the European Federation of Pharmaceutical Industries and Associations, which calls it “a bold step” and “an exciting direction.” This could be good news for MSers if companies with MS drugs in development apply for the project. (MS Research blog )
Here Comes the Judge
Teva Pharmaceutical Industries’ best-selling MS drug Copaxone (glatiramer acetate) will come off patent protection in May—at least for a while. On Monday, March 31, the U.S. Supreme Court agreed to hear Teva’s appeal of a lower-court ruling that invalidated a patent that would have protected Copaxone until September 2015. “Without that patent,” Bloomberg News pointed out, “Teva would lose legal protection this May on Copaxone, which brings in $3.2 billion in annual U.S. sales and accounts for more than half its profit.” On the other hand, “a generic version of Copaxone could provide needed cost relief to the health care system,” the New York Times wrote. “The list prices of Copaxone and other older MS drugs have roughly quadrupled over the last decade, to about $60,000 a year.” Two rival makers of generic glatiramer acetate have not said whether or how the pending case will affect their target May launch. A more immediate concern for them is getting marketing approval from the U.S. Food and Drug Administration. In other moves, Teva recently “began trying to switch Copaxone patients from a once-daily treatment to a three-times-a-week version, for which there wouldn’t be a generic available,” the Wall Street Journal reported. “Such re-formulations are a common tactic by brand-name drug makers seeking to prevent patients from switching to generic versions once patent protection expires on the older formulation.” The Supreme Court is scheduled to take up the case in the term that begins in October. (Bloomberg News, New York Times, Wall Street Journal)
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