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- 02/28/2017

Investors and biotech insiders are waiting for the U.S. Food and Drug Administration to rule on six therapies

Pharma Horizon
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  1. Merck: Merck is hoping its anti PD-1 drug Keytruda will receive an expanded indication for microsatellite instability-high cancer. Keytruda has already been approved for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma. Sales of Keytruda continue to grow, particularly as rival drug Opdivo has lost some market share.  The FDA is expected to rule on March 8.

  2. Endo will meet with the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss abuse concerns for its severe pain-relief drug Opana ER. Following the concerns raised, sales of Opana ER declined to $120.05 million from $132.16 million last year. Company officials will meet with the FDA committee on March 13.

  3. Mylan is expecting to hear from the FDA on its generic version of Advair inhaler (GlaxoSmithKline) on March 28.  Advair lost its patent protection in August 2016, since then sales  have been declining.  Advair generated $4.7 billion in revenue last year.

  4. Roche is waiting, also on March 28, to hear from FDA regarding its multiple sclerosis drug Ocrevus.  Some analysts project the drug could generate between $2.6 and $3.8 billion. Roche last year submitted submitted additional data regarding commercial manufacturing, dalaying the FDA  rule by three months, as the first report from FDA was exptected in december 2016.

  5. Regeneron has big hopes on  Dupixent, an injectable drug proposed for the treatment of moderate to severe atopic dermatitis in adults. Dupixent was developed in partnership with France-based Sanofi (SNY). The drug is also being explored for additional indications, including asthma. According to analysts, Dupixent could reach peak annual sales of up to $3 billion if approved for atopic dermatitis and asthma. The FDA is expected to rule on March 29.

  6. Radius Health is awaiting decision for Abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. If approved Abaloparatide-SC would be the first new bone anabolic treatment option in the U.S. since 2002 for postmenopausal women with osteoporosis”
    FDA will decide on March 30.