Novartis’ generics and biosimilar unit Sandoz announced on Monday a new agreement with Durect Corp. for one of the small drug developer’s pain medications — Posimir (bupivacaine), a post-surgery pain reliever currently in late-stage testing.
The candidate caught the eye of Novartis, which is paying $20 million upfront for U.S. commercialization and development rights. Durect can also receive $273 million in milestones, with $43 million for R&D achievements and another $230 million for meeting sales goals, as well as tiered double-digit royalties should the drug make it to market.
- Durect remains responsible for completing the Phase 3 PERSIST trial of Posimir, which has an estimated enrollment of 264 patients and primary completion date of August. The smaller biotech is also responsible for handling approval processes with the Food and Drug Administration.
Prescription pain medications cause almost 50% of all U.S. opioid overdoses, which kill 91 people each day, according to the Centers for Disease Control. As lawmakers, healthcare stakeholders and consumers grapple with that epidemic, more drugmakers in the pain space are focusing on the development of non-opioid-based products.
The Swiss pharma has beefed up its neurology pipeline in recent years through M&A — acquiring Australian company Spinifex and its neuropathic pain medication EMA401 in 2015 for $200 million upfront, and rejiggering a collaboration with Amgen for the development of the migraine treatment erenumab last month.
Posimir’s addition keeps the trend going, and is a potentially lucrative bet given the expansive size of the post-surgical pain population. A study published in the journal Current Medical Research and Opinion in 2014 found that, in a survey of 300 patients who had undergone surgery in the previous five years, about 86% reported pain after their operations and 74% still said that pain continued through their hospital discharge.
Durect, meanwhile, has been an avid dealmaker. Impax Laboratories, Santen Pharmaceutical Co. and Pain Therapeutics are just a few of the partners helping the company’s candidates through the clinic.
This newest deal, however, provides Durect with much-needed access to a huge player touting a wealth of experience rolling out products. The company had that access for a brief spell with Pfizer, which picked up rights to another bupivacaine-based Durect candidate through the 2010 acquisition of King Pharmaceuticals, but lost it once the big pharma handed back those rights in 2012.
Posimir may need Novartis’ helping hand too. The FDA rejected the product’s New Drug Application in 2014, citing a lack of safety evidence. Since then the agency has also recommended a revised protocol for the PERSIST trial in which Posimir is compared to the active control bupivacaine HCl instead of to placebo.