March 9, 2015
By Alex Keown, BioSpace.com Breaking News Staff
MALVERN, Penn. – Pennsylvania-based Recro Pharma announced Monday morning it has acquired the pain medication meloxicam IV/IM and a manufacturing facility in Gainesville, Ga. from Dublin, Ireland-based Alkermes plc in a $170 million deal.
Meloxicam IV/IM is a proprietary, Phase III-ready, long-acting COX-2 NSAID used to target moderate to severe acute pain. Meloxicam IV/IM is a nonsteroidal anti-inflammatory drug... In five phase II studies treating more than 700 patients with acute pain, meloxicam IV/IM demonstrated positive effect on treating rapid onset of pain relief and” time to peak” analgesic effect, 18 to 24 hour duration of pain relief as well as favorable tolerability.
Under the terms of the agreement, Recro Pharma will pay Alkermes $50 million up front and an additional $120 million in milestone payments following the company’s achievement of regulatory and sales milestones. The $50 million up-front payment will be funded via a five-year senior secured term loan with an affiliate of OrbiMed. Alkermes will also receive a seven-year warrant to buy 350,000 Recro shares. The deal is expected to be finalized sometime in the second quarter of this year.
Gerri Henwood, Recro Pharma‘s president and chief executive officer, said the acquisition of meloxicam will be a complimentary therapy for Recro’s Dex-IN, an intraranasal form of dexmedetomidine, which has been tested as an analgesic drug for post-operative pain. Last year the company’s lead drug passed a Phase Ib trial that demonstrated its proof of concept in providing effective pain relief. However, in September Recro Pharma halted a trial of its lead product candidate Dex-IN. The company decided to stop the trial because it does not believe the study would achieve “statistical significance” in its current design. Recro Pharma has an upcoming interim analysis of ongoing Post Op Day 1 Phase II trial for Dex-IN, and depending on clinical success, the possibility for two proprietary compounds to enter Phase III by year end.
Recro Pharma is also exploring the use of Dex-IN may also provide a good alternative therapeutic for cancer breakthrough pain relief. It is estimated that 80 percent of patients taking long-acting medication for chronic pain experience breakthrough pain.
The 85,000-square foot Gainesville facility was acquired by Alkermes in 2011 as part of its business combination with Elan Drug Technologies. The site, which currently has 165 employees, manufactures five commercial products. In a press release James Frates, chief financial officer of Alkermes, said the deal with Recro is part of an effort by the company to streamline manufacturing operations for the company’s commercial products and late-stage pipeline of medicines targeting central nervous system diseases.
In March 2014, Recro Pharma went public, which netted the company $30 million to fund the Dex-IN trials. Both Recro Pharma’s and Alkermes’ stock were down slightly this morning.
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?
