Business Briefs: GSK, Astellas, Vertex and Orexigen
GSK and Astellas are competing to develop a new type of anemia drug that fools the body into believing it's at a high altitude so, in turn, it will boost red cell production. At a National Health Service meeting last month, GSK chief executive Andrew Witty drew attention to his firm's candidate, GSK1278863, which is currently in Phase II: “When you go and exercise at altitude, you produce a lot of red blood cells, so it has all sorts of potential applications in terms of helping people with blood disorders.” Astellas's candidates FG-4592 and ASP1517, both of which have begun Phase III tests this past December, were licensed from FibroGen. Astellas Urology and Nephrology head, Mike Allen said in a recent interview with Reuters that such a product "is a priority in our portfolio, and we do think that as a novel mechanism for this medical need, it is very creative and shows great promise.”
Orexigen Therapeutics CEO Michael Narachi is adding a new title to his resume: director of the industry interest group, PhRMA. Narachi, who is also on the board of the Biotechnology Industry Organization (BIO) and AMAG Pharmaceuticals, will serve as director for two years. Orexigen is one of several companies looking to join the prescription weight-loss fray. Its contenders are the experimental treatments Contrave and Empatic.
Merck and Bristol-Myers Squibb are joining forces in a non-exclusive agreement that will pair company medications during a hep. C Phase II trial that marries BMS's NS5A daclatasvir and Merck's NS3/4A protease inhibitor MK-5172. A success could further the development of a once-a-day oral combination regimen, but Merck noted in a statement Monday that the alliance is currently limited to Phase II and that “activities beyond the Phase II study are not covered as part of this agreement.” Merck is also testing MK-5172 with other medications, including Merck's own NS5A protease inhibitor, MK-8742. A continued partnership could boost BMS's hep.-C efforts. The company trashed an experimental therapy last year after a patient-safety issue, and the drug that is part of this Phase II exploration—daclatasvir—is set to launch in 2015.
Novartis eye care subsidiary Alcon scored FDA approval for its glaucoma drug Simbrinza. The eye drop works on the only controllable part of the disease—eye pressure—and is the first fixed-dose combination treatment that does not list beta-blockers among its components. The treatment fuses a carbonic anhydrase inhibitor and alpha 2 adrenergic receptor agonist and is applied three-times-a-day. The one-drop, two-medication dose reduced the number of daily eye drops by half.
Ireland's first preferred drugs list has put the proton pump inhibitor lansoprazole and statin simvastatin among its roster of choose-this medications, reported PharmaTimes. There are currently five PPIs and statins on the Irish market, and PharmaTimes says the country's Health Service Executive estimates that swapping lansoprazole for another PPI would shave about $10 million from overhead prescription costs. Converting one quarter of statin prescriptions to simvastatin could save around the same.
Compounding headaches continue: the FDA announced Monday that Axium Healthcare's Balanced Solutions Compounding Pharmacy Inc., has voluntarily recalled its drugs over sterility quality concerns. The FDA notice indicates inspectors found “poor practices and conditions, which may have exposed the company's sterile products to microbial contamination,” and the concerns were later confirmed by further analysis. Oddly enough, the recall indicates it is for “all lots of its sterile” drugs which have not expired.
Novo Nordisk unveiled its new US headquarters Friday. The Plainsboro, NJ, site was a $225-million redevelopment project which used recycled and locally sourced materials, and is a LEED Silver certified campus. The company said in a statement that the facility is powered by wind, solar and water sources and was built with growth in mind—Novo will immediately use 75% of the site, with the remainder set aside for expected expansion needs.
The United Kingdom says GlaxoSmithKline has been abusing pay-for-delay tactics to insulate its antidepressant Seroxat (AKA Paxil) from generics, various news outlets reported. The UK's Office of Fair Trade alleges that GSK signed anti-competitive agreements with three potential players a decade ago, driving up the cost the company's National Health Service has paid for medications that could have been purchased on the relative cheap had generics been for sale.
Vertex Pharmaceuticals unveiled promising Phase II data Thursday for an experimental cystic fibrosis (CF) combo drug of Kalydeco and VX-661. The cocktail improved lung functioning by 9% and 7.5% in two control groups, over a 28-day period. Robert Beall, president and CEO of the Cystic Fibrosis Foundation, which provided scientific, clinical and financial support to the drug's development, said of the findings, “While these results are still very early, they show that another potential therapy from our ongoing collaboration with Vertex can be combined with Kalydeco to achieve promising improvements in health. The data further validate our strategy of using small-molecule compounds to address the basic genetic defect in [CF].” On the promise of that data, analysts are raising expectations for Vertex in the CF market, with estimates reaching $4 billion in annual revenue for Vertex from CF treatments.