DURECT Corp. is a biopharmaceutical company focused on two areas of active drug development: New therapeutics based on its proprietary drug delivery platforms and new chemical entities derived from its epigenomic regulator program. Its drug development expertise is being applied primarily to the fields of pain management, central nervous system disorders, acute organ injury and metabolic diseases such as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Late-stage development programs include POSIMIR (SABER-bupivacaine) and REMOXY (ORADUR-oxycodone). DURECT's epigenomic regulator program includes the lead molecule DUR-928 in Phase 1 development. DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival.

Expert Comments:

Ed Arce, H.C. Wainwright & Co. (6/28/17)
"Early completion of enrollment for PERSIST, at 12% higher enrollment than targeted, has positive implications for Posimir. . .DURECT Corporation announced it has completed patient enrollment into its pivotal Phase 3 trial of Posimir, an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for continuous pain relief for up to three days post surgery. Importantly, we note that while the expected enrollment number for PERSIST was 264 patients, actual enrollment was notably higher, at 296 patients, as a result of rapid enrollment toward the end of the trial."

Ed Arce
NASH is an epidemic in the U.S., with more than 100 million people believed to be affected. Yet no FDA-approved treatments are available, with the exception of liver transplantation for end-stage disease. In part two of his interview with The Life Sciences Report, Ed Arce, managing director in equity research and senior analyst covering companies in the biopharmaceuticals and specialty pharmaceuticals sectors for H.C. Wainwright, and organizer of the recent inaugural NASH Investor Conference, says that small companies are rushing to fill the pipeline, with numerous compounds in trials.
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Ed Arce, H.C. Wainwright & Co. (5/24/17)
"DURECT Corp. is a company that has an epigenetic regulator. This was something that was done in-house over a number of years. Even though this is quite early, it has a lot of potential because, unlike a lot of companies that will look at preclinical models—often a mouse model or a rat model of NASH—and use that as a basis for moving forward into clinical studies, DURECT has done a very thorough preclinical program with its compound. DURECT looked at all the available preclinical models, not only in rats and mice but, also, in several other species. It has seen very consistent results in both NASH overall, as well as anti-fibrotic effects. So we're very eager to see what the impacts of this could be in the clinic. The company also released encouraging clinical data at EASL last month, in an early Phase 1b study."

Grant Zeng, Zacks Equity Research (5/18/17)
"DURECT Corp. announced a development and commercialization agreement with Sandoz to develop and market in the United States Durect's POSIMIR. . .The company is in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for outside the US. . .we think this is a great deal for Durect. Sandoz has a very strong sales/marketing team and has a great presence in the US. . .Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. . .The deal not only boosts Durect s balance sheet, but also validate the company's technology and clinical program."

Ed Arce, H.C. Wainwright & Co. (5/12/17)
"DURECT Corp. announced an exclusive U.S. license and collaboration agreement with Sandoz AG to develop and commercialize Posimir. . .this deal comes with substantial economics for DURECT as it includes an upfront payment of $20M, and aggregate potential milestone payments of $273M ($43M in development and regulatory milestones in addition to $230M in salesbased milestones) as well as tiered double digit royalties on product sales. . .this deal with a large Pharma partner with strong economics not only eliminates investor uncertainty of whether sufficient financial resources exist to support the full development of DUR-928 but it also provides critical Big Pharma validation of Posimir."

Francois Brisebois, Laidlaw & Company (5/11/17)
"DURECT Corp. showed solid progress as they came to impressive terms with Sandoz for development and commercialization of Posimir. . .we don’t believe DRRX could have asked for a better partner as Sandoz has a team of dedicated institutional sales professionals with significant presence in the hospital market. We view the deal as providing important large pharma validation and enabling DRRX to get a substantial up-front non-dilutive funding to help with their other ambitious program, DUR-928. . .DRRX announced their Phase 1b data DUR-928 in NASH at EASL displaying its impressive ability to reduce levels in CK-18, hsCRP, bilirubin, and IL-18 after a single oral dose."

DURECT Corp. and Sandoz AG, a division of Novartis, have signed a development and commercialization agreement for the U.S. for POSIMIR.
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Grant Zeng, Zacks Equity Research (5/8/17)
"Durect Corp. announced a development and commercialization agreement with Sandoz AG, a division of Novartis (NVS), to develop and market in the United States DURECT's POSIMIR. . .we think this is a great deal for Durect. Sandoz has a very strong sales/marketing team and has a great presence in the US. Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. . .Sandoz Inc. has a dedicated hospital sales and marketing organization, with expertise and relationships, which will be employed to deliver POSIMIR to the market."

Positive results in a Phase 1b trial of DURECT Corp.'s candidate for the treatment of nonalcoholic steatohepatitis (NASH), which were presented at the 2017 International Liver Congress, prompted comments from a pair of analysts.
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Management Q&A: View From the Top
James Brown
DURECT has a pipeline of drugs for a wide range of indications, from NASH to psoriasis to postoperative pain. In this interview with The Life Sciences Report, Dr. James Brown, DURECT's President and CEO, discusses the potentially groundbreaking epigenetic regulator DUR-928, POSIMIR's late-stage testing for postoperative pain and an abuse-deterrent oral technology.
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More Expert Comments

Experts Following This Company

Ed Arce, Managing Direction and Senior Research Analyst – H.C. Wainwright & Co.
Francois Brisebois, Healthcare Research Analyst – Laidlaw & Company
Chen Lin What Is Chen Buying? What Is Chen Selling?
Jim Molloy, Analyst – Laidlaw & Company
Ram Selvaraju, Managing Director; Head of Healthcare Equity Research – Rodman & Renshaw
David Sherman, Analyst – LifeSci Capital
Len Yaffe, Fund Manager, analyst, MD – Stoc*Doc Partners
Grant Zeng, Senior Biotech Analyst – Zacks Investment Research, Zacks Small-Cap Research

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Investing Highlights
DUR-928, in Phase 1, is an Endogenous Small Molecule with Compelling Animal Data
Two Late Stage Pain Products Addressing Large Markets
Company Holds the WW Rights to DUR-928 and POSIMIR