Cerecor raises $15 million in B round
Cerecor Inc. (Baltimore, Md.) raised $15 million in the first tranche of a planned $32 million series B round. New investors New Enterprise Associates; Apple Tree Partners; and MPM Capital led the tranche. Cerecor's CERC-301 is in Phase II testing as adjunctive therapy for major depressive disorder (MDD), with data expected by year end. Cerecor has exclusive, worldwide rights to develop and commercialize the small molecule NMDA receptor NR2B subtype (GRIN2B; NR2B) antagonist from Merck & Co. Inc. (NYSE:MRK).
TB Alliance's high-dose regimen meets in Phase IIb
The not-for-profit Global Alliance for TB Drug Development said once-daily 200 mg PA-824 in combination with moxifloxacin and pyrazinamide -- what the alliance calls the PaMZ TB regimen -- met the primary endpoint vs. once-daily Rifafour rifampicin/isoniazid/ethambutol/pyrazinamide in the Phase IIb NC-002 trial to treat tuberculosis (TB) infection. The dose of PA-824 in combination with moxifloxacin and pyrazinamide led to a greater average daily reduction in colony forming units (CFUs) counts over eight weeks vs. once-daily Rifafour from Sanofi (Euronext:SAN; NYSE:SNY) (p<0.05). A 100 mg dose of PA-824 in combination with moxifloxacin and pyrazinamide missed the primary endpoint vs. Rifafour.
POLITICS & POLICY
Right-to-try bill moves through Michigan legislature
The Michigan Senate will vote on Aug. 13 whether to pass a right-to-try (RTT) bill (SB001). The bill, which the Michigan Senate Health Policy Committee approved last Wednesday, would allow eligible terminally ill patients access to investigational products that have completed a Phase I trial but have not been approved by FDA. Under the proposed law, manufacturers may either provide the product for free or require patients to pay.
CVS joins PBMs in questioning Sovaldi cost
Pharmacy benefit manager CVS Caremark Corp. (NYSE:CVS) has joined the debate over the price of HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD). In an article in the Journal of the American Medical Association, CVS CMO Troyen Brennan and CSO William Shrank stressed the need for "effective approaches to control costs for high-priced medications" such as Sovaldi. They noted that Sovaldi is a huge outlier among specialty medications due to its high cost and large population eligible for treatment. The authors estimated there may be as many as 3 million HCV patients eligible for sofosbuvir in the U.S.
HHS issues interpretative rule on 340B and Orphan drugs
As expected, HHS's Health Resources and Services Administration (HRSA) issued an interpretative rule on Monday that states that Orphan drugs can be discounted under Medicare's 340B program when used for non-Orphan indications. The 340B program requires manufacturers to deeply discount outpatient drugs to hospitals and clinics bearing the brunt of healthcare for low income and other special populations. In 2010, Congress amended the program to exclude Orphan drugs from discounting, but the law was unclear on whether the exclusion applied when the drugs were used for non-Orphan indications.
India wants price controls on cancer generics
India's National Pharmaceutical Pricing Authority (NPPA) requested pricing information on generic cancer drugs from six pharma companies so the agency can fix the products' ceiling prices. The products, which are included on the country's national list of essential medicines, include Refolinon folinic acid from Pfizer Inc. (NYSE:PFE); cyclosporine from Biocon Ltd. (NSE:BIOCON; BSE:BIOCON), Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359) and Cipla Ltd. (Mumbai, India); mercaptopurine from Cipla; and cyclophosphamide, marketed as Endoxan by Drugs Dropship (Haryana, India) and as Cycloxan by Biochem Pharmaceutical Industries Ltd., which is part of Zydus Cadila Group (NSE:CADILAHC; BSE:532321).
FDA to discuss best practices for developing biomarkers
FDA will explore scientific and regulatory approaches to biomarker development, including their acceptance and utility in drug development programs, during a public meeting on Sept. 5. The meeting will focus on identifying challenges and best practices for biomarker-based development programs, including co-development of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials. The meeting satisfies an FDA commitment under PDUFA V.
Marletta to leave as TSRI president and CEO
The Scripps Research Institute Chairman Richard Gephardt announced on Monday that President and CEO Michael Marletta "has indicated his desire to leave" Scripps. Gephardt said in a statement the board is working with Marletta on a transition plan.
Allergan beats Street, to cut 13% of workforce
Allergan Inc. (NYSE:AGN) reported 2Q14 financial results on Monday that beat the Street but said the company will reduce headcount by about 1,500 (13%) to about 10,200. The cuts include about 700 R&D positions and about 250 positions from the company's sales force. Allergan said all R&D programs that are in the clinic will continue; however, the company cut earlier stage programs, including a preclinical acne program and Phase I programs in rosacea and glaucoma. The company will have about 1,450 R&D positions and 1,450 sales positions after the cuts. In addition to the staff cuts, Allergan said it will eliminate 250 vacant positions. The company said the cuts will generate pre-tax savings of about $475 million in 2015.
Auris, Avalanche, Tobira, Loxo set IPO terms
Audiology company Auris Medical AG (Zug, Switzerland), ophthalmic play Avalanche Biotechnologies Inc. (Menlo Park, Calif.), infectious disease company Tobira Therapeutics Inc. (San Francisco, Calif.) and Loxo Oncology Inc. (Stamford, Conn.) amended NASDAQ IPOs on Monday.
FDA panel to discuss NPS's Natpara
FDA's Endocrinologic and Metabolic Drug Products Advisory Committee will meet on Sept. 12 to discuss a BLA from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) for Natpara to treat hypoparathyroidism. The PDUFA date is Oct. 24. The product is a recombinant human parathyroid hormone 1-84 (PTH).