Bay Area Biotech Durect Snags $293 Million Pain Drug Pact With Novartis



May 8, 2017
By Mark Terry, Breaking News Staff


Cupertino, Calif. – Durect Corporation (DRRX) inked a development and commercialization deal with Sandoz AG, a division of Novartis (NVS) totaling around $293 million

Novartis paid Durect $20 million up front to develop and market in the U.S., Durect’s Posimir (Saber-Bupivacane), with a potential up to another $43 million in various regulatory and development milestone payments. In addition, there are another possible $230 million in sales milestones, including tiered double digit royalties on product sales in the U.S.

Posimir is a locally-acting, non-opioid analgesic that is designed to provide up to three days of continuous post-surgery pain relief. Posimir is being investigated in an ongoing PERSIST Phase III clinical trial in patients undergoing gall bladder removal, also known as laparoscopic cholecystectomy. The study is comparing the effects of Posimir, which is described as an “extended-release depot utilizing Durect’s patented SABER technology” to bupivacaine HCL. Durect expects that the dosing stage of the trial will be completed in the third quarter of this year, with top-line results shortly afterwards.

“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 Brown, president and chief executive officer of Durect, in a statement. “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 ongoing efforts to reduce the use of opioid-based medications following surgery.“

On April 24, Durect presented clinical data on DUR-928 at The International Liver Congress 2017 held in Amsterdam. This was a Phase Ib trial in patients with nonalcoholic steatohepatitis (NASH). Sometimes called the “silent liver disease,” NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. However, it can be severe and lead to cirrhosis. There are currently no specific treatments aside from weight loss, increased physical activity, and avoiding alcohol and unnecessary medications.

“DUR-928 was well tolerated in this study and plasma exposure of the molecule was not significantly increased in NASH patients compared to matched control subjects with normal liver function,” Brown said in a statement. “Importantly, treatment with a single dose of DUR-928 was associated with a decrease in cell death markers, an improvement of a biomarker of liver function, and decreases in certain biomarkers associated with inflammation.”

The company will release its first-quarter 2017 financials on Wednesday, May 10. In its 2016 financial reports, it reported total revenues of $3.5 million with a net loss of $8.8 million for the fourth quarter. For the year total, revenues were $14 million and net loss was $34.5 million.

Today’s announcement about the Sandoz deal is undoubtedly well-timed. At the end of last year, the company reported $5.4 million in cash and cash equivalents, with total assets of $40.5 million.

Durect stock is currently trading for $0.80. Shares traded on July 29, 2016 for $1.94, dropped to $1.16 on Sept. 26, 2016, then to $1.13 on Nov. 4, 2016. Shares rallied to $1.43 on Nov. 23, 2016, but has trended primarily downward ever since.



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