Shortly after unveiling its newest clinical candidate for infantile spasms and nephrotic syndrome, Retrophin Inc. filed for a $40 million initial public offering (IPO), with plans to move its stock to Nasdaq, trading under “RTRX.”
Depomed Inc. boosted its pain portfolio with the purchase of Nautilus Neurosciences Inc.’s migraine drug, Cambia (diclofenac potassium for oral solution) for $48.7 million. Nautilus is eligible for an additional $5 million payment based on achievement of sales milestones. Cambia is the only single agent non-steroidal anti-inflammatory specifically indicated for migraine, with $18 million in sales over the past 3 months.
Depomed Inc. boosted its pain portfolio with the purchase of Nautilus Neurosciences Inc.’s migraine drug, Cambia (diclofenac potassium for oral solution) for $48.7 million. Nautilus is eligible for an additional $5 million payment based on achievement of sales milestones. Cambia is the only single agent non-steroidal anti-inflammatory specifically indicated for migraine, with $18 million in sales over the past 3 months.
Amgen Inc. is hot on the heels of Regeneron Pharmaceuticals Inc., reporting that its monoclonal antibody targeting PCSK9, evolocumab, reduced low-density lipoprotein cholesterol (LDL-C) in a 12-week Phase III trial.
Shares of Agenus Inc. bounced 12.7 percent Monday on Phase II results published in Neuro-Oncology showing more than 90 percent of recurrent glioblastoma multiforme (GBM) patients treated with Prophage Series G-200 were alive at six months after surgery, and 30 percent survived 12 months, with median overall survival of 11 months. That is an improvement over typical median survival of three to nine months.
The Compounding Quality Act, part of the Drug Quality and Security Act, signed into law last month, creates a volunteer registration of “outsourcing facilities” that will be subject to scrutiny by the FDA, including routine inspections.
The hits keep coming for Aveo Pharmaceuticals Inc., as its once-daily VEGF receptor tyrosine kinase inhibitor failed another indication, this time colorectal cancer (CRC). The Cambridge, Mass.-based biotech’s already beaten-down stock fell 9 percent on news that the drug, tivozanib, foundered during an interim analysis in the Phase II BATON-CRC study, being carried out in partnership with Astellas Pharma Inc.
In day two of the FDA’s Allergenic Products Advisory Committee meeting, it reviewed Alk-Abello A/S and Merck and Co. Inc.’s Grastek sublingual tablet. Members agreed unanimously that available data support efficacy of Grastek for treatment of Timothy grass pollen-induced allergic rhinitis in patients 5 to 65 years and that adrenaline auto-injectors must be made available for patients at home.
The FDA’s Allergenic Products Advisory Committee will issue a recommendation on Stallergenes SA’s Oralair grass allergy tablet, a therapy that’s well established in Europe, for first-time approval in the U.S. market. Until now, the FDA has only approved subcutaneous therapies involving allergen extracts. Stallergenes is seeking approval for Oralair to treat allergic rhinitis or conjunctivitis in patients 5 years of age and older.
Enanta Pharmaceuticals Inc. reported an impressive 96 percent sustained virologic response after 12 weeks of treatment (SVR12) for hepatitis C virus (HCV) in its Phase III (SAPPHIREII) study of a regimen containing protease inhibitor ABT-450 (ritonavir).