|Momenta in Spotlight as Interest in Biotech Copycats Rises; Alexion to Acquire Enobia|
|By Staff and Wire Reports|
|Wednesday, 28 December 2011 18:39|
Momenta Pharmaceuticals (NASDAQ:MNTA) inked a deal with drug and medical products maker Baxter International (NYSE:BAX) just before Christmas that marks the latest push among companies to develop cheaper, copycat versions of expensive brand-name biotech medicines.
Dubbed biosimilars, the Baxter wager on the business is initially $33 million -- the upfront payment to Momenta to help the company develop as many as six biotech drug replicas. The companies didn’t say what drugs they’re targeting. As partnerships with big companies go, there is potentially more than $400 million in additional milestone payments for Momenta.
Whether Momenta earns those future payments remains to be seen. But the deal is a much-needed positive for the company, which watched its stock go on a roller coaster ride this year.
Momenta traded to almost $21 a share in July but sank to below $11 in September on news of a potential competitor winning US approval for a version of Sanofi’s (NYSE:SNY) blood-thinning drug Lovenox. Momenta and Novartis (NYSE:NVS) sell M-Enoxaparin, a generic version of Lovenox, but appeared to face its own competition from closely held Amphastar Pharmaceuticals and generic drug maker Watson Pharmaceuticals (NYSE:WPI) last September. In October, Momenta and Novartis succeeded in holding up the sale of the rival Amphastar drug by winning a preliminary injunction tied to a patent dispute. Momenta shares rebounded a bit from the September slump.
It’s clearly a new and risky area of drug development, but biosimilar products are likely to be on more investors’ radars in 2012. The US Food and Drug Administration is readying its procedures to approve the cheaper biotech drugs, which also are being encouraged as a health care cost-saving measure under Obamacare. According to at least one estimate, the market for these drugs may reach almost $5 billion in the next few years.
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Enobia Pharma Corp. announced the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada and Cambridge, Massachusetts, which is focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.
Enobias lead product candidate ENB-0040 (asfotase alfa), is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy for patients suffering with hypophosphatasia (HPP), an ultra-rare, life-threatening, genetic metabolic disease for which there are no approved treatment options. Alexion will acquire full worldwide development and commercial rights to asfotase alfa. Asfotase alfa was awarded orphan drug designation in the U.S. and EU in 2008 and Fast Track status in the U.S. in 2009, and is currently in Phase II clinical development.
Hypophosphatasia is an ultra-rare and life-threatening disease, and those patients who survive live with debilitating morbidities including skeletal deformity, severe muscle weakness, and progressive damage to vital organs, said Leonard Bell, M.D., Chief Executive Officer of Alexion. Asfotase alfa has shown very compelling Phase II clinical data in infants and juveniles with hypophosphatasia. The acquisition of Enobia is very well aligned with Alexions objective to develop and deliver life-transforming therapies for patients suffering with ultra-rare, severe, and life-threatening disorders.
"Alexion has proven expertise in developing and commercializing therapies to transform the lives of patients with severe and ultra-rare disorders, making them the ideal partner to advance the work of the Enobia team and bring asfotase alfa to HPP patients around the world," said Jonathan Silverstein, General Partner of OrbiMed and Enobia Chairman. OrbiMed is a controlling shareholder in Enobia.
Enobia and our scientific collaborators have developed an elegant compound showing very promising clinical results to date, said Dr. Robert Heft, President and Chief Executive Officer of Enobia. Together with Alexion, we share a sharp focus on transforming the lives of patients with severe and ultra-rare disorders. The hypophosphatasia patient community will be well served by the experience and international scope of Alexion.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Ron Cohen, M.D., President & CEO, will present at the 30th Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2012 at 10:00 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco, CA.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the publication of promising pre-clinical results in Experimental Neurology (doi:10.1016/j.expneurol.2011.11.020) related to its ALN-HTT program, an RNAi therapeutic drug-device combination for the treatment of Huntington’s disease.
Celgene Corporation (NASDAQ: CELG) today announced its presentations at two upcoming investor conferences will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com. Celgene management will provide an overview of the company.
Emergent BioSolutions Inc. (NYSE:EBS) today announced plans for its TRU-016 program following receipt of a notice from Abbott that it is terminating its co-development and co-commercialization agreement.
Today eHealth, Inc (NASDAQ: EHTH), the parent company of eHealthInsurance, released two new infographics to accompany its recently published report describing the impact of smoking and body mass index (BMI) on average monthly premiums paid for individual health insurance.
Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL).
Lakeland Industries, Inc. (NASDAQ: LAKE) today responded to the Schedule 13D filed with the Securities & Exchange Commission on December 23, 2011 by Ansell Limited ("Ansell").
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company's $5,000,000 private placement offering to sell convertible notes and warrants has been fully subscribed.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today announced the achievement of a commercial milestone when it received its 100th NC-stat® DPNCheck™ order.
As Rainbow Coral Corp. (OTCBB:RBCC) continues its due diligence on Nano3D Biosciences (n3D), it’s not just the early-stage biotech firm’s groundbreaking technology that has impressed RBCC—It’s also n3D’s revenues.
TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that the Company is ready for the beta launch of version 2.0 of its flagship local search engine www.TheDirectory.com next Tuesday January 3, 2012.
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) is updating stockholders on the status of strategic discussions related to its ophthalmic drug candidate, RGN-259.