Featured Company News – DURECT-SANDOZ Collaboration Clears HSR Review; Paves Path for POSIMIR Development and Marketing in the U.S.

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LONDON, UK / ACCESSWIRE / June 21, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for DURECT Corp. (NASDAQ: DRRX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=DRRX. The Company revealed on June 19, 2017, that the previously announced development and commercialization agreement with SANDOZ AG, a division of Novartis (NYSE: NVS), to develop and market United States SABER-Bupivacaine, has cleared review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and has become effective. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The Agreement

On May 08, 2017, DURECT announced the development and commercialization agreement with Sandoz, to develop and market DURECT’s POSIMIR in the United States.

Sandoz is currently the global leader in delivering patients with sustainable access to high-quality healthcare. The Company’s differentiated product portfolio includes a range of state-of-the-art technologies, formulations, and devices. Particularly, in the US, Sandoz holds a dedicated hospital sales and marketing organization, with expertise and relationships, employed to deliver POSIMIR to the market.

Under 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 and an additional $230 million in sales, based on milestones, and a tiered double digit royalty on product sales in the United States. DURECT will be responsible for completing the ongoing PERSIST Phase-3 clinical trial for POSIMIR and FDA’s interactions throughout the approval process.

POSIMIR (SABER-Bupivacaine)

POSIMIR is an investigational locally-acting, non-opioid analgesic intended to deliver up to three days of continuous pain relief after surgery. The analgesic may be instilled directly into the surgical incisions or injected into targeted anatomic spaces under endoscopic guidance. According to clinical and nonclinical studies, once the POSIMIR is placed, it forms a biodegradable depot that releases bupivacaine directly at a stable rate for 72 hours.

Based on the Company’s SABER Technology, POSIMIR is expected to play a crucial role in modern multimodal postoperative pain management protocols, including:

Improvement of postoperative pain control in multiple surgical procedures.
Reduction in use of postoperative opioids and their attendant side effects.
Reduction in duration and cost of hospital stays.
Reduction in resources required to manage postoperative pain and opioid-related side effects.

DURECT started enrolling patients in PERSIST, a Phase-3 clinical trial, in November 2015. About 350 patients undergoing laparoscopic cholecystectomy participated in the two sequential parts of the trial. In part-1, patients were randomized on a 1:1 basis to receive POSIMIR or placebo as a one-time intra-incisional instillation at the close of the surgery. In part-2, patients were randomized on the 1:1 basis to receive POSIMIR or the active control bupivacaine HCI.

Company Growth Prospects

DURECT is a leading biopharmaceutical Company involved in the active development of new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. The Company expects to finish dosing patients in PERSIST, a POSIMIR Phase-3 clinical trial, where the patients are the ones undergoing laparoscopic cholecystectomy (gallbladder removal) surgery, in the Q2 FY17, and to have top-line results in the Q4 FY17, according to the announcement made on May 10, 2017. Additionally, in a previous clinical trial of 50 patients in the same surgical model, POSIMIR was compared the active control bupivacaine HCI, against which POSIMIR showed an approximately 25% reduction in pain intensity on movements for the first 3 days after the surgery, and for the first 2 days after surgery, employing the same statistical methodology specified for current trial.

Last Close Stock Review

DURECT’s share price finished yesterday’s trading session at $1.44, climbing 2.86%. A total volume of 1.21 million shares have exchanged hands, which was higher than the 3-month average volume of 912.82 thousand shares. The Company’s stock price soared 58.21% in the last three months, 17.07% in the past six months, and 15.20% in the previous twelve months. Additionally, the stock gained 7.46% since the start of the year. The stock currently has a market cap of $202.92 million.

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