Healthcare Review: Celgene, Emisphere, NovaBay Pharmaceuticals, Amicus Therapeutics, Novartis Print E-mail
By Staff and Wire Reports   
Wednesday, 20 August 2014 13:44

U.S. stocks moved higher in early afternoon trading Wednesday as investors prepared for the release of minutes from the Federal Reserve's latest policy meeting. The Dow Jones industrial average was up 46 points, or 0.3 percent, to 16,966 as of 1:30 p.m. Eastern. The Standard & Poor's 500 index rose four points, or 0.2 percent, to 1,985 and the Nasdaq composite was mostly flat at 4,529.

The U.K.'s National Institute for Health and Care Excellence reverses its position and now supports the use of Celgene's ($CELG) Revlimid (lenalidomide) by the National Health Service for the treatment of myelodysplastic syndromes. The healthcare cost and quality of care advisor changed its opinion after the company submitted revised analyses and a proposal to limit the cost of the drug, including agreeing to provide Revlimid free of charge to anyone requiring more than 26 monthly cycles of treatment.

Emisphere (OTCQB:EMIS) sets up a $20M loan facility with MHR Fund Management (and certain MHR affiliates) to fund the U.S. commercialization of Eligen B12. The facility will mature on December 31, 2019 and bear interest of 13% per year. The company and MHR also consummate an agreement that obligates Emisphere to pay MHR royalties on the sale and licensing of Eligen B12 and related products.

Shares of NovaBay Pharmaceuticals (NYSEMKT:NBY) are off 40% after the company announced that its ophthalmic formulation for viral conjunctivitis, NVC-422, failed to achieve its primary or secondary endpoints in a Phase 2 clinical trial.

Share of Amicus Therapeutics (NASDAQ:FOLD) are up 37% in response to its report of positive results for its Fabry disease drug candidate, migalstat HCL, in a Phase 3 clinical trial (Study 012). Study 012 compared oral migalstat to standard-of-care enzyme replacement therapies (ERT), Fabrazyme (agalsidase beta) (NYSE:SNY) and Replagal (agalsidase alfa) (NASDAQ:SHPG), for Fabry disease. The co-primary endpoints were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by descriptive comparisons on migalstat and ERT over 18 months.

Novartis ($NVS) signs a licensing agreement with the Global Alliance for TB Drug Development for its experimental tuberculosis drugs that have been discovered at the Novartis Institutes for Tropical Diseases. Among the product candidates is a class of meds called indolcarboxamides which target drug resistant and multi-resistant strains of TB. One of the compounds, NITD304, works by blocking a protein this is essential for the TB bacterium's survival.


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