Thursday, October 05, 2017 3:50:51 PM
http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2017/DURECT-DRRX-A-175-Million-Patent-Purchase-Agreement-with-Indivior-PLC-/default.aspx?utm_content=buffera1fbf&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
By Grant Zeng, CFA
NASDAQ:DRRX
The Patent Deal
On October 2, 2017, DURECT Corporation (DRRX) announced a patent purchase agreement with Indivior UK Limited, an affiliate of Indivior PLC (INDV.L).
Pursuant to the agreement, DURECT has assigned certain of its U.S. patent rights to Indivior. This assignment may provide further intellectual property protection for RBP-7000, Indivior's investigational once-monthly injectable risperidone product for the treatment of schizophrenia. Indivior has submitted a New Drug Application (NDA) for RBP-7000 to the U.S. Food and Drug Administration (FDA). We expect the approval of RBP-7000 by the FDA in 2H18.
Per the agreement, Indivior has made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based on a regulatory milestone, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the patent rights, including RBP-7000. The patent rights include granted patents extending through at least 2026. Indivior estimates peak US sales of RBP-7000 in the range of 200 and 300 million dollars.
The Implication of the Deal
We think this is a great deal for Durect.
The deal not only boosts Durect’s balance sheet, but also validate the company’s long-acting risperidone formulation technology.
DURECT’s long-acting injectables are designed to achieve stable delivery of small-molecule and biologic therapeutics for periods of days to months following a single subcutaneous, intramuscular, or other localized injection. The company’s biocompatible, bioerodible technologies employ varied and customizable sets of components, allowing the formulation to be fine-tuned to suit the active pharmaceutical ingredient (API), the physiological environment, and the desired performance characteristics of the commercial product.
DURECT’s long-acting injectable technologies demonstrate the following advantages:
• High drug loading—Drug loading as high as 30%, permitting smaller injection volumes
• Controlled onset and release—Rapid onset and stable release of drug over time, with little to no post-injection “burst”
• Stabilization—Proteins, peptides, and small molecules can be shielded from water and biologically active enzymes to prolong in vivo activity
• Ease of administration—Low viscosity and small volumes for easier, less painful injections
• Ease of manufacture—scalable, low-cost manufacturing
• Strong patent protection—covered by U.S. and foreign patents
Recent DRRX News
- DURECT Corporation Announces Late-Breaking Oral Presentation at the EASL Congress 2024 to Discuss AHFIRM Phase 2b Data in Alcohol-Associated Hepatitis • PR Newswire (US) • 04/30/2024 11:00:00 AM
- DURECT Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • PR Newswire (US) • 03/27/2024 08:01:00 PM
- DURECT Corporation to Announce Fourth Quarter and Full Year 2023 Financial Results and Provide a Business Update • PR Newswire (US) • 03/20/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 04:37:57 PM
- DURECT and Charles River Laboratories Enter into Co-Marketing and Collaboration Agreement for ALZET® Product Line in U.S. and Canada • PR Newswire (US) • 03/04/2024 12:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 09:16:39 PM
- DURECT Corporation to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference • PR Newswire (US) • 02/07/2024 11:48:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 09:15:11 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 12/01/2023 09:28:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 09:15:18 PM
- DURECT Corporation Reports Third Quarter 2023 Financial Results and Business Update • PR Newswire (US) • 11/13/2023 09:05:00 PM
- DURECT Corporation to Announce Third Quarter 2023 Financial Results and Provide a Business Update • PR Newswire (US) • 11/09/2023 09:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/07/2023 09:10:15 PM
- DURECT Corporation Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on Mortality • PR Newswire (US) • 11/07/2023 09:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 01:02:52 PM
- DURECT Corporation Announces Last Patient Last Visit in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis • PR Newswire (US) • 09/07/2023 11:00:00 AM
- DURECT Corporation Announces Presentations in Upcoming Investor Conferences • PR Newswire (US) • 08/31/2023 08:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/10/2023 08:21:19 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/10/2023 08:18:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/09/2023 08:23:04 PM
- DURECT Corporation Reports Second Quarter 2023 Financial Results and Business Update • PR Newswire (US) • 08/09/2023 08:05:00 PM
- DURECT Corporation to Announce Second Quarter 2023 Financial Results and Provide a Business Update • PR Newswire (US) • 08/03/2023 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/21/2023 09:13:29 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/21/2023 02:38:08 PM
- DURECT Corporation Announces $15 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules • PR Newswire (US) • 07/20/2023 12:00:00 PM
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