Sandoz and DURECT to develop and market investigational non-opioid analgesic in the US
May 08, 2017
DURECT’s POSIMIR® (SABER®-Bupivacaine) is an investigational locally-acting, non-opioid analgesic intended for pain relief after surgery
Agreement expected to close Q2 2017, with DURECT completing clinical development and FDA interactions; Sandoz providing upfront and milestone payments in addition to commercial resources post approval
Phase 3 clinical trial for POSIMIR expected to complete dosing in Q3 2017 with topline results soon thereafter
Princeton, New Jersey, May 8, 2017–Sandoz AG, a division of Novartis, announced today a development and commercialization agreement with DURECT Corporation to develop and market in the United States through its U.S. affiliate, Sandoz Inc. DURECT’s POSIMIR® (SABER®-Bupivacaine).
POSIMIR is an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery.
“Sandoz has a strong record of commercializing innovative and valued-added products that serve unmet medical needs,” said Peter Goldschmidt, President of Sandoz Inc. “Our dedicated hospital sales and marketing organization in the US have the right expertise and relationships to bring this potentially significant new offering, if approved, to the patients undergoing surgery and healthcare professionals who need a non-opioid pain relief option.”
Under the terms of the agreement, Sandoz will make an upfront payment to DURECT of $20 million, with the potential for additional payments at development and regulatory milestones, as well as a 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.
About POSIMIR® (SABER-Bupivacaine)
POSIMIR is an investigational extended-release depot utilizing DURECT’s patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours, to provide up to three days of continuous pain relief after surgery. DURECT is currently conducting PERSIST, a Phase 3 trial in patients undergoing laparoscopic cholecystectomy (gall bladder removal), comparing the effects of POSIMIR to bupivacaine HCl. DURECT expects to complete dosing patients in PERSIST in the third quarter of 2017 and to have top-line results soon thereafter. POSIMIR is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
The foregoing release contains forward-looking statements that can be identified by words such as “to develop,” “investigational,” “intended,” “expected,” “will,” “potentially,” “potential,” “anticipated,” “contingent,” “ongoing,” “expects,” “under development,” or similar terms, or by express or implied discussions regarding potential marketing approvals for POSIMIR, or regarding potential future revenues from POSIMIR, or regarding the intended goals and objectives of the development and commercialization agreement with DURECT. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the necessary government approvals to close the transaction will be obtained in any particular time frame, or at all. Neither can there be any guarantee that any other closing conditions for the transaction will be met in any particular time frame, or at all. Nor can there be any guarantee that the development and commercialization agreement with DURECT will achieve any of its intended goals and objectives, or in any particular time frame. Neither can there be any guarantee that POSIMIR will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that POSIMIR will be commercially successful in the future. In particular, management’s expectations regarding POSIMIR and the development and commercialization agreement with DURECT could be affected by, among other things, the potential that the intended goals and objectives of the development and commercialization agreement with DURECT may not be achieved or may take longer to achieve than expected; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally, including a failure to obtain necessary government approvals for the closing of the transaction, or delays in obtaining such approvals; the potential that any other closing conditions for the transaction may not be met; the company’s or DURECT’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.