Obesity play Zafgen files for IPO
Zafgen Inc. (Cambridge, Mass.) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by Leerink; Cowen; Canaccord; and JMP Securities. Zafgen is developing beloranib, a subcutaneous formulation of a methionine aminopeptidase 2 (MetAP2) inhibitor. This year, Zafgen plans to start Phase III testing to treat Prader-Willi syndrome, a severe form of genetic obesity with a prevalence of about 5,000-7,000 people in the U.S. Next half, Zafgen plans to start a Phase IIb trial in severely obese patients.
FDA briefing docs rebuff MoxDuo IR
FDA's Bob Rappaport said the agency's review team has been "unable to conclude that there is a safety benefit" for MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY), which is under review to treat moderate to severe acute pain. The comments from Rappaport, who is director of the Division of Anesthesia and Analgesia and Addiction Drug Products at FDA's Center for Drug Evaluation and Research, came in briefing documents released ahead of Tuesday's meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the immediate-release combination of oxycodone and morphine.
FDA committee to discuss olaparib
FDA's Oncologic Drugs Advisory Committee will meet on June 25 to discuss an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for olaparib as maintenance treatment of platinum-sensitive relapsed ovarian cancer. The pharma said it submitted the NDA this year, but declined to disclose when it did so or the PDUFA date. The poly(ADP-ribose) polymerase (PARP) inhibitor is also under review in Europe.
POLITICS & POLICY
ACC, AHA to start including cost/value assessments
The American College of Cardiology and American Heart Association are the latest physician groups to integrate value assessments for treatments into clinical practice guidelines and performance measures. In a joint statement published in Circulation and the Journal of the American College of Cardiology, the groups cited the "need for more explicit and transparent assessment" of value and proposed using quality-adjusted life year (QALY) measures to sort treatments into "level of value" categories. The groups -- which currently only explicitly consider clinical efficacy and outcomes -- did not provide specifics or a time frame for implementing the change.
NCI researchers: cancer treatments costly to compare
In an article published in the New England Journal of Medicine, researchers at NIH's National Cancer Institute made several proposals on how to fund comparative effectiveness trials for expensive new cancer drugs vs. cheaper drugs. The researchers noted that high prices protect market share because they preclude "comparative effectiveness trials that would seek to establish equally effective but cheaper alternatives."
VA: doctors should defer HCV treatment for some
The U.S. Department of Veteran Affairs recommended regimens containing Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and Olysio simeprevir from Johnson & Johnson (NYSE:JNJ) for most HCV patients, but said it would be "reasonable" for doctors to defer treatment for some patients until newer therapies are available. According to new treatment guidelines released by the VA, physicians should take into account stage of liver fibrosis and whether a patient has cirrhosis or hepatocellular carcinoma (HCC) when deciding whether to wait for new interferon-free and ribavirin-free regimens, which the VA said are expected to be safer and less complex to administer and are expected to be approved in the next 12-24 months.
Mapi-Pharma sets IPO range
Mapi-Pharma Ltd. (Ness Ziona, Israel) amended its IPO on NASDAQ and now plans to sell 2.9 million shares at $13-$15. At the $14 midpoint, the company would raise $40 million and be valued at $215 million. Aegis Capital is underwriter. Mapi-Pharma filed to raise up to $46 million in the offering last month.