Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER(TM), an Abuse-Deterrent Analgesic for Chronic Pain

CANTON, Mass., Sept. 11, 2015 -- Collegium Pharmaceutical, Inc. (COLL) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to support the approval of Xtampza ER(TM) (oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Xtampza ER, Collegium's lead product candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. The FDA will consider the advisory committees' recommendation as it continues its review of Xtampza ER. The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza ER New Drug Application (NDA).

Orexigen Raises $60 Million in Sale of Common Stock to Baupost

SAN DIEGO, Sept. 10, 2015 -- Orexigen Therapeutics, Inc. (OREX) today announced that funds managed by The Baupost Group, L.L.C. have purchased 20 million shares of its common stock and warrants to purchase 5 million shares of its common stock in a Private Placement, at a purchase price of $3 per share of common stock and 0.25 of a warrant, raising $60 million.  The warrants are exercisable for five years at $6 per share.

Orexigen intends to use the funds to strengthen its balance sheet as the Company advances plans for the commercial launch of Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) in Europe while in parallel continuing partnering discussions for the rights to Contrave^® (naltrexone HCl and bupropion HCl extended release) and Mysimba in markets in Europe and other territories outside the U.S.

ALN-PCSsc Achieves Quarterly and Potentially Bi-Annual Subcutaneous Dose Regimen Profile for Effective LDL-C Lowering in Phase 1 Clinical Study

– Investigational First-in-Class PCSK9 Synthesis Inhibitor Achieves up to 83% Maximal and 64% Mean Maximum LDL-C Lowering, Comparable to Published Results with Anti-PCSK9 Monoclonal Antibodies, but with Clinically Significant Reductions in LDL-C Clamped Down for More than 140 Days after Just a Single Dose –

– ALN-PCSsc Generally Well Tolerated with No Clinically Significant Drug-Related Adverse Events to Date –

– Program Lead Transitions from Alnylam to The Medicines Company, who Together Launch “ORION™” Development Program, with Initial Phase 2 Start Planned by End-2015 and Phase 3 Start Expected in 2017; ORION to Include Comparative Study with Anti-PCSK9 Monoclonal Antibodies –

– Companies to Host Conference Call Today, Sunday, August 30th, at 9:30 a.m. ET to Discuss Results –