UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
September 9, 2019
Date of Report
(Date of earliest event reported)
DURECT CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware |
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000-31615 |
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94-3297098 |
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(State or other jurisdiction of incorporation or organization) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
10260 Bubb Road
Cupertino, CA 95014
(Address of principal executive offices) (Zip code)
(408) 777-1417
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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Common Stock $0.0001 par value per share Preferred Share Purchase Rights |
DRRX |
The NASDAQ Stock Market LLC (The Nasdaq Capital Market) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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On September 9, 2019, DURECT Corporation issued a press release announcing further development of a long-acting injectable HIV investigational product utilizing DURECT’s SABER® technology has triggered a $10 million milestone payment from Gilead Sciences, Inc. to DURECT under the license agreement between the companies. 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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Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DURECT Corporation |
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Date: September 9, 2019 |
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By: |
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/s/ James E. Brown |
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James E. Brown |
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President and Chief Executive Officer |
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Exhibit 99.1
DURECT Earns $10 Million Milestone Payment for Further Development of a Long-Acting Injectable HIV Investigational Product Utilizing DURECT’s SABER® Technology
CUPERTINO, Calif., September 9, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that further development of a long-acting injectable HIV investigational product utilizing DURECT’s SABER® technology has triggered a $10 million milestone payment from Gilead Sciences, Inc. to DURECT under the license agreement between the companies.
“We are pleased that Gilead has been rapidly advancing this program,” stated James E. Brown, President and CEO of DURECT. “We believe that long-acting injectables using our SABER platform have the potential to improve the lives of people with HIV.”
“Our license agreement with Gilead is part of DURECT’s broader strategy to enter into selective collaborations and other arrangements for our technologies and product development programs,” continued Dr. Brown. “By leveraging our resources with corporate collaborators, we believe we can retain commercial interest in multiple product candidates and maximize value for our shareholders.”
DURECT’s Collaboration with Gilead
In July 2019, DURECT and Gilead entered into an agreement granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product utilizing DURECT’s SABER® technology. Under the terms of the agreement, Gilead made an upfront payment to DURECT of $25 million, and further development has triggered an additional $10 million milestone payment. Remaining milestones include the potential for up to an additional $65 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered royalties on product sales. Gilead also received exclusive access to the SABER platform for HIV and hepatitis B virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory and sales based milestones as well as tiered royalties on sales. The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.
About SABER® Technology
DURECT’s SABER Technology (Sucrose acetate isobutyrate extended release) is a patented technology designed to provide sustained release for long-acting injectable products. The SABER technology is also the basis of POSIMIR® (bupivacaine extended release solution under investigation for the management of postoperative pain).
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as alcoholic Hepatitis (AH) and acute kidney injury (AKI), chronic hepatic diseases such as nonalcoholic steatohepatitis (NASH), and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, a long-acting injectable SABER-based HIV investigational product being developed with Gilead, and ORADUR™-Methylphenidate ER Capsules, approved in Taiwan as Methydur Sustained Release Capsules, where it is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). In addition, for the assignment of certain patent rights, DURECT receives single digit sales-based earn-out payments from U.S. net sales of Indivior’s PERSERIS™ (risperidone) drug for schizophrenia, which was commercially launched in February 2019. For more information about DURECT, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the development of a long-acting HIV investigational product, potential milestone and royalty payments to DURECT, and the potential licensing by Gilead of additional products directed to HIV and HBV and, as well as statements about potential uses and benefits of DUR-928 and DURECT’s oral and injectable delivery technologies, as well as potential revenues from commercial sales of Indivior’s PERSERIS, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that additional milestones triggering payments to DURECT by Gilead will not be achieved and that the long-acting HIV product will not be developed, that Gilead may decide not to license additional products from DURECT, that potential adverse effects may arise from the testing or use of DUR-928, that POSIMIR may not be approved by the FDA, that ORADUR-Methylphenidate ER may not be commercially successful in territories where it is approved or approved in other territories, that Indivior will not generate significant sales of PERSERIS, that DURECT may not avoid infringing patents held by other parties or be unable to secure and defend its own patents, and DURECT’S ability to manage and obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT’s Form 10-Q filed on August 2, 2019 under the heading “Risk Factors.”
NOTE: POSIMIR®, SABER® and ORADUR™, are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928, POSIMIR and ORADUR-Methylphenidate ER Capsules are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities. Full prescribing information for PERSERIS, including BOXED WARNING, and Medication Guide can be found at www.perseris.com.
Corporate Contact
Mike Arenberg
DURECT
Chief Financial Officer
+1-408-346-1052
mike.arenberg@durect.com
Media Contact
Alison Chen
LifeSci Public Relations
+1-646-876-4932
achen@lifescipublicrelations.com