DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01
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Entry into a Material Definitive Agreement |
On May 5, 2017, DURECT Corporation (the Company) and Sandoz AG
(Sandoz) entered into a license agreement to develop and market
POSIMIR (SABER-bupivacaine) in the U.S. POSIMIR is the Companys
investigational post-operative pain relief depot currently in
Phase III clinical development in the U.S. that utilizes the
Companys patented SABER technology to deliver bupivacaine to
provide up to three days of pain relief after surgery. The
Company retains commercialization rights in the rest of the
world.
Under terms of the agreement, Sandoz will make an upfront payment
of $20 million, with the potential for up to an additional $43
million in milestone payments based on successful development and
regulatory milestones, and up to an additional $230 million in
sales-based milestones. Sandoz will have exclusive
commercialization rights in the U.S. upon regulatory approval
with sole funding responsibility for commercialization
activities. Sandoz will pay the Company a tiered double digit
royalty on product sales for a defined period, after which the
license granted to Sandoz shall convert to a non-exclusive, fully
paid, royalty-free, irrevocable and perpetual license. The
Company will remain responsible for the completion of the ongoing
PERSIST Phase 3 clinical trial for POSIMIR as well as FDA
interactions through approval. The term of the agreement shall be
for the duration of Sandozs obligation to pay royalties for
product sales under the Agreement. The agreement provides each
party with specified termination rights, including the right of
Sandoz to terminate at will after a specified period and for each
party to terminate the agreement upon material breach of the
agreement by the other party. The agreement also contains terms
and conditions customary for this type of arrangement, including
representations, warranties and indemnities. Closing of the
transaction is anticipated to occur in the second quarter of 2017
and is contingent solely on completion of review under the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
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Item 8.01 |
Other Events |
The Company issued a press release announcing this event on May
8, 2017, a copy of which is attached hereto as Exhibit 99.1.
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Item 9.01. |
Financial Statements and Exhibits |
(d) Exhibits
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99.1 |
Press Release of DURECT Corporation dated May 8, 2017 |
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. DURECT CORPORATION (NASDAQ:DRRX) Recent Trading Information
DURECT CORPORATION (NASDAQ:DRRX) closed its last trading session up +0.019 at 0.800 with 1,589,343 shares trading hands.