DURECT's Collaboration with Sandoz Clears HSR Review and is Effective
Today : Monday 19 June 2017
CUPERTINO, Calif., June 19, 2017 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that the previously disclosed development and commercialization agreement with Sandoz AG, a division of Novartis (NYSE: NVS), to develop and market in the United States DURECT's POSIMIR® (SABER®-Bupivacaine), an investigational locally acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery, has cleared review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and has become effective.
Under the terms of the agreement, Sandoz has made an upfront payment to DURECT of $20 million, with the potential for up to an additional $43 million in development and regulatory milestones, up to an additional $230 million in sales-based milestones, as well as a tiered double-digit royalty on product sales in the United States. DURECT remains responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval.
"We are pleased to be collaborating on POSIMIR with Sandoz given their strong hospital presence in the U.S. and their strong record of commercializing innovative and value-added products that serve unmet medical needs," said James E. Brown, President and CEO of DURECT Corporation.
Sandoz is a global leader in driving sustainable access to high-quality healthcare. Sandoz's differentiated product portfolio includes a range of state-of-the-art technologies, formulations and devices. In the U.S., Sandoz Inc. has a dedicated hospital sales and marketing organization, with expertise and relationships, which will be employed to deliver POSIMIR to the market.
