Panel backs Merck's suvorexant
FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of once-daily suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. The panel concluded suvorexant is an effective sleep aid but suggested it should be given at lower starting doses than those Merck has proposed. The pharma is seeking a label recommending use of 20-40 mg suvorexant in non-elderly patients and 15-30 mg in elderly patients.
Portola, Alcobra price IPOs
Portola Pharmaceuticals Inc. (NASDAQ:PTLA) raised $122.1 million and Alcobra Ltd. (NASDAQ:ADHD) raised $25 million after pricing their IPOs on Wednesday. Portola sold 8.4 million shares at $14.50, the mid-point of its proposed $13-$16 range. The price values the company at $491.3 million. Earlier this month, Portola had amended its IPO and said it planned to sell 6.9 million shares at $13-$16. Morgan Stanley; Credit Suisse; Cowen; William Blair; and Sanford C. Bernstein are underwriters. Portola's betrixaban is an oral Factor Xa inhibitor in Phase III testing for hospital and post-discharge prevention of venous thromboembolism (VTE) in high-risk acutely medically ill patients.
Ironwood raises $136.5M, NPS raises $87.2M
Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) raised $136.5 million and NPS Pharmaceuticals Inc. (NASDAQ:NPSP) raised $87.2 million in follow-ons on Wednesday. Ironwood sold 10.5 million shares at $13 in a follow-on underwritten by JPMorgan; BofA Merrill Lynch; Morgan Stanley; Cowen; Ladenburg; and Mizuho, while NPS sold 6 million shares at $14.53 in a follow-on underwritten by JPMorgan; Morgan Stanley; Canaccord; Leerink; Oppenheimer; and Wedbush. Ironwood had proposed to sell 10.5 million shares and NPS had proposed to sell 6 million shares late Monday, when Ironwood's share price was $13.83 and NPS's share price was $14.11.
BARDA awards GSK up to $200M for antibacterials
HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) $40 million for an initial 18-month period to develop GSK's portfolio of antibacterial candidates to treat illnesses caused by bioterrorism agents and antibiotic resistance. If GSK and BARDA renew the partnership, the pharma is eligible for up to $200 million in total for a five-year period. HHS said the award is the first where BARDA is working with a company as "strategic partners with a portfolio approach," instead of providing funding for a contract for a single medical countermeasure.
FDA to discuss Lotronex's REMS
FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the REMS with elements of safe use (ETASU) for Lotronex alosetron from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Prometheus Laboratories Inc., a unit of Nestle S.A. (SIX:NESN). Lotronex's ETASU require healthcare providers to be specially certified and enrolled in a prescribing program. Additionally, patients must sign a form acknowledging the risks of the product, and pharmacists can only fill paper prescriptions bearing a sticker showing the prescriber is certified in the program. The committee will discuss whether the REMS with ETASU assures safe use, is not unduly burdensome to patient access and minimizes burden to the health care delivery system.
AMAG slides on Rienso recall in Switzerland
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) fell $2.68 (11%) to $22.40 on Wednesday after disclosing in an SEC filing that partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) is recalling a batch of anemia drug Rienso ferumoxytol from the Swiss market. According to AMAG, the decision was based on four reports of hypersensitivity reactions, including one fatality. AMAG said the companies are investigating the recalled batch of the IV iron replacement therapy, which the company said only affects the Swiss market, and the reported adverse events.
Salix planning NDA submission for budesonide for UC
Salix Pharmaceuticals Inc. (NASDAQ:SLXP) said budesonide rectal foam given twice daily for two weeks and then once daily for four weeks met the primary endpoint in a pair of Phase III trials to treat ulcerative colitis (UC). Budesonide rectal foam led to a greater proportion of patients achieving remission at the end of six weeks of treatment or withdrawal vs. placebo foam. The identical trials enrolled patients with active mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis.
USL255 PREVAILs in Phase III epilepsy, FDA to review NDA
Upsher-Smith Laboratories Inc. (Maple Grove, Minn.) said on Wednesday that once-daily USL255 as adjunctive therapy met the primary endpoint in the Phase III PREVAIL trial, and that FDA accepted for review an NDA for USL255 as adjunctive treatment of epilepsy in patients with refractory partial-onset seizures. In the trial, USL255 reduced from baseline weekly partial-onset seizure frequency during the titration plus maintenance phase vs. placebo (p<0.001). The double-blind, international trial enrolled more than 200 epileptic patients. Upsher-Smith, which has an SPA from FDA for the trial, said the data will be submitted for presentation at the American Epilepsy Society meeting in December.
POLITICS & POLICY
Committee sends bill on compounding, drug tracing to full Senate
The U.S. Senate Health, Education, Labor and Pensions (HELP) committee agreed by voice vote on Wednesday to send to the full Senate a bill that would streamline drug tracking and make compounding manufacturers subject to stricter regulation by FDA. The committee voted to incorporate the previously separate Drug Supply Chain Security Act into the Pharmaceutical Compounding Quality and Accountability Act. The joint bill, S. 959, would create an electronic, unit-level system for tracking and tracing pharmaceutical products to be phased in over 10 years. The bill also would define compounding manufacturers as entities that make sterile products without or in advance of a prescription and sell those products across state lines. It would enable FDA to specify drugs that cannot be compounded, including biologics and drugs with complex formulations. A vote by the full Senate on the combined bill has not yet been scheduled (see BioCentury Extra, May 15).
FDA's Woodcock: personalized medicine a reality
Personalized medicine has "come of age," but a number of scientific and policy challenges must be overcome before it can mature, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said Tuesday at a meeting of the Personalized Medicine Coalition.