FDA panel backs dapagliflozin
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 that the benefit-risk profile of dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) supported approval as an adjunct to diet and exercise to treat Type II diabetes. The panel also voted 10-4 that the pharma had demonstrated an acceptable cardiovascular risk profile for the sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Emergent to acquire Cangene
Emergent BioSolutions Inc. (NYSE:EBS) will acquire Cangene Corp. (TSX:CNJ) for US$3.24 per share in cash, or about $222 million. The price is a 28% premium to Cangene's close of C$2.70 ($2.53) on Wednesday, before the deal was disclosed. The deal -- which is subject to approval by Cangene shareholders but has been approved by the boards of both companies -- is slated to close next quarter. BofA Merrill Lynch advised Emergent, and Credit Suisse advised Cangene.
FDA panel backs Merck, Stallergenes grass allergy products
FDA's Allergenic Products Advisory Committee voted 9-0 on Thursday that available data support the efficacy of Grastek grass Allergy Immunotherapy Tablet (AIT) from Merck & Co. Inc. (NYSE:MRK) to treat Timothy grass pollen induced allergic rhinitis, with or without conjunctivitis, in individuals five years of age and older. The panel also voted unanimously that available data support the safety of the tablet-based sublingual allergen immunotherapy when administered with the understanding that auto-injected epinephrine will be made available at home.
POLITICS & POLICY
AEI scholar predicts January ACA train wreck
The Obama administration's decision to extend the deadline for purchasing insurance from a federal- or state-run exchange is likely to cause problems for consumers and insurance companies in January, according to American Enterprise Institute scholar Joe Antos. Due to problems with HealthCare.gov, the federal healthcare exchange website, the White House pushed back to Dec. 23 from Dec. 15 the deadline for purchasing insurance policies that become effective Jan. 1. The new deadline doesn't provide insurance companies sufficient time to process orders and confirm the identity of customers, Antos said. As a result, many consumers who purchase insurance on an exchange close to the deadline may find it impossible to access care in early January. "Rolling into January, there are going to be thousands of people who will go to the doctor and find they are not on the books. That's going to be a traumatic experience for many people," Antos noted.
Reps. introduce bill for antibiotic approval pathway, breakpoints
A bipartisan group of representatives introduced in the U.S. House of Representatives a bill that would create an accelerated approval pathway for antibiotics and antifungals for use in limited populations and would update the criteria that HHS uses to determine breakpoints for drugs. Under the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, FDA could approve antibiotics and antifungals for limited populations based on a smaller number of patients or alternative endpoints, as well as data from Phase II trials or pharmacologic or pathophysiologic data. The Infectious Diseases Society of America (IDSA) first proposed the approval pathway. Though new legislative authority is not needed to implement the pathway, stakeholders have said congressional enactment of the regulatory framework could be valuable (see BioCentury Extra, July 31).
First calls for proposals under EU's Horizon 2020
The European Commission announced the first calls for proposals under Horizon 2020, the EU research and innovation program for 2014-20. The first calls have a budget of more than EUR 15 billion ($20.6 billion) and cover funding opportunities for 2014-15. Horizon 2020 categorizes funding calls into broad research topics, in contrast to the EU's current research program, Framework Programme 7 (FP7), which categorizes funding calls based on specific research modalities. Based on BioCentury's analysis, Horizon 2020's first calls earmark at least EUR 1.1 billion ($1.5 billion) for 2014 and EUR 1 billion ($1.4 billion) for 2015 for broad research topics that contain subtopics that mention drug-related research.
French Parliament OKs biosimilar substitution
The French Parliament passed a bill that would allow pharmacists to dispense a biosimilar in place of an innovator product to patients initiating treatment or who are already receiving treatment with a biosimilar. The provisions, included in a bill to set the country's social security budget for 2014, also would require pharmacists to alert prescribers of the substitution. Prescribers would be able to expressly rule out biosimilar substitution for reasons unique to the patient. The legislation also would charge the French National Agency for Drug Safety (ANSM) to create a directory of biosimilar products, which would list all approved biosimilars with the reference biologic. The bill is subject to review by the French Constitutional Coucil.
FDA 'reviewing options' for biosimilar list
FDA said it is "reviewing options for making a publicly available list of licensed biosimilar products and interchangeable products," but the agency said it does not have a timeline for publishing the list. The agency also said it is "too early" to say whether the list will also contain patent and exclusivity information for innovator biologics. John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said earlier this week that the agency was planning to develop a guide like the Orange Book for biologics. The Orange Book lists all approved generic equivalents for a drug, along with its patent and exclusivity information.
CIRM announces $61 million in grants
The California Institute for Regenerative Medicine awarded $61 million across six grants to five California universities for projects focused on developing stem-cell based therapies for leukemia and solid tumors, sickle cell disease, macular degeneration and airway blockage. CIRM also approved and set aside $200 million for a new program aimed at speeding up development of projects already funded by CIRM. The program is intended for projects that are in or close to the clinic but need additional funding to get through a Phase II trial.
FDA's Taylor to depart
FDA Commissioner Margaret Hamburg announced in an internal memo that John Taylor will depart in January as counselor to the commissioner and acting deputy commissioner for global regulatory operations and policy. Taylor worked at FDA from 1991-2005 and rejoined the agency in 2009. Between his two stints at FDA, Taylor served as VP for federal government affairs at Abbott Laboratories (NYSE:ABT) and as EVP of health at the Biotechnology Industry Organization (BIO).
Endo raises $700 million in bumped-up note deal
Specialty pharma Endo Health Solutions Inc. (NASDAQ:ENDP) raised $700 million through the sale of 5.75% senior unsecured notes due January 2022. Endo had proposed to raise $375 million in the offering early on Wednesday. The company -- which is acquiring fellow specialty pharma Paladin Labs Inc. (TSX:PLB) in a cash and stock deal -- was up $0.15 to $64.04 on Thursday (see BioCentury Extra, Nov. 5).
TetraLogic raises $50.1 million in IPO
Cancer company TetraLogic Pharmaceuticals Corp. (NASDAQ:TLOG) raised $50.1 million in an IPO through the sale of 7.2 million shares at $7, which values TetraLogic at $147.8 million. On Tuesday, the company had amended the offering and said it planned to sell 6.5 million shares at $7. Late last month, TetraLogic was rumored to have postponed its IPO. Earlier in November, the company had amended its IPO and said it planned to sell 6.4 million shares at $13-$15. Oppenheimer; Guggenheim; and Needham are underwriters.
Sarepta, Prosensa jump after Duchenne forum
Duchenne muscular dystrophy (DMD) companies Sarepta Therapeutics Inc. (NASDAQ:SRPT) and Prosensa Holding N.V. (NASDAQ:RNA) both jumped almost 20% on Thursday on comments and presentations made at the Duchenne Policy Forum. At the forum organized by patient advocacy group Parent Project Muscular Dystrophy, FDA and other stakeholders made presentations on topics including potential biomarkers and surrogate endpoints for DMD.
Xoma proposes follow-on
Xoma Corp. (NASDAQ:XOMA) proposed a follow-on late Thursday underwritten by Credit Suisse; Jefferies; Cowen; Piper Jaffray; and RBC Capital Markets. Xoma's gevokizumab (XOMA 052) is in Phase III testing for non-infectious uveitis (NIU) and Behcet's uveitis, with top-line data expected next year. Partner Servier (Neuilly-sur-Seine, France) has worldwide rights to develop and commercialize the humanized IgG2 mAb against IL-1 beta for Type II diabetes and cardiovascular indications and rights outside the U.S. and Japan for all other indications.
Mallinckrodt product meets in Phase III pain trial
Mallinckrodt plc (NYSE:MNK) said MNK-155 met the primary endpoint vs. placebo in a Phase III trial to manage moderate to severe acute pain where the use of an opioid analgesic is appropriate. In the double-blind trial, a loading dose of three tablets of oral MNK-155 followed by two tablets every 12 hours for 48 hours improved the summed pain intensity difference from baseline over 48 hours (SPID48) vs. placebo. The trial enrolled about 400 patients with moderate to severe acute pain following a unilateral first metatarsal bunionectomy.
Paul Keckley stepped down as executive director of the Deloitte Center for Health Solutions on Sept. 6. Wednesday's BioCentury Extra misstated his affiliation.