DURECT Corp (DRRX) Announces $293M Development and Commercialization Agreement for POSIMIR with Sandoz (NVS)

May 8, 2017 7:06 AM EDT

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DURECT Corporation (Nasdaq: DRRX) today announced a development and commercialization agreement with Sandoz AG, a division of Novartis (NYSE: NVS), to develop and market in the United States DURECT's POSIMIRĀ® (SABERĀ®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery.

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.

"We are delighted to collaborate with a company with the market presence and resources of Sandoz to commercialize POSIMIR in the United States," said James E. Brown, president and CEO of DURECT Corporation. "We believe that POSIMIR has the potential to become a cornerstone of multi-modal post-operative pain management. As a non-opioid local analgesic, we believe POSIMIR may be an important contributor to the on-going efforts to reduce the use of opioid-based medications following surgery."

Under the terms of the agreement, Sandoz will make 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 will remain responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval. Closing of the transaction is anticipated to occur in the second quarter of 2017 and is contingent on completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.

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