DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Termination of a Material Definitive Agreement
Item 1.02. Termination of a Material Definitive Agreement
On January 2, 2019, DURECT Corporation (“DURECT”) received written notice from Sandoz AG that effective January 27, 2019, Sandoz AG is terminating the Development and Commercialization Agreement, dated May 5, 2017, as amended (the “Sandoz Agreement”). As a result of this termination, Sandoz AG will be returning its exclusive commercialization rights to develop and market POSIMIR® (bupivacaine extended release solution) in the United States.POSIMIR is DURECT’s investigational post-operative pain relief depot that utilizes DURECT’s patented SABER® technology and is designed to deliver bupivacaine to provide up to three days of pain relief after surgery.
The parties are in dispute with regard to Sandoz AG’s obligation to pay a termination fee to DURECT.DURECT has initiated a formal dispute resolution process related to the termination fee.
A summary of the material terms of the Sandoz Agreement was included in DURECT’s Annual Report on Form 10-K filed on March 8, 2018, which is qualified in its entirety by reference to the full text of the Sandoz Agreement and amendments (filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q (File No. 000-31615) filed on August 9, 2017, and Exhibit 10.2 to our Quarterly Report on Form 10-Q (File No. 000-31615) filed with the SEC on August 2, 2018, respectively, and incorporated by reference).
Item 8.01 Other Events
On January 7, 2019, DURECT issued a press release announcing changes to its strategy for DUR-928 to prioritize indications with the potential to generate near-term data that demonstrates the potential of DUR-928 and creates commercial and partnering value by focusing on patients with non-alcoholic steatohepatitis (NASH) and patients with mild to moderate plaque psoriasis.A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1 |
Press Release of DURECT Corporation dated January 7, 2019 |
DURECT CORP Exhibit
EX-99.1 2 drrx-ex991_6.htm EX-99.1 drrx-ex991_6.htm Exhibit 99.1 DURECT Corporation Provides Corporate Update Live Webcast Today at 8:00 a.m. Eastern Time CUPERTINO,…
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About DURECT CORPORATION (NASDAQ:DRRX)
Durect Corporation is a biopharmaceutical company with research and development programs. The Company’s products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Its other product candidates include POSIMIR (controlled release injection of bupivacaine), REMOXY (oral controlled release oxycodone), ORADUR-ADHD, ELADUR (controlled release injection of bupivicane), Relday (risperidone), ORADUR-based opioid (hydromorphone) and SABER-based ophthalmic. The Company’s ALZET product line consists of miniature, implantable osmotic pumps and accessories used for experimental research in mice, rats and other laboratory animals. The Company also manufactures and sells osmotic pumps used in laboratory research and design; and develops and manufactures a range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products.