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DURECT Receives Return on Schizophrenia Drug Approval

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A new, once-monthly injectable treatment for schizophrenia uses patents of a small-cap, U.S.-based pharmaceutical firm.

One year ago, the pharmaceutical company DURECT Corp. (DRRX:NASDAQ) entered into a patent purchase agreement where DURECT assigned to Indivior UK Limited, an affiliate of Indivior Plc (INDV:LON), certain patents that may provide further intellectual property protection for its schizophrenia medication PERSERIS (risperidone).

Indivior made an upfront non-refundable payment to DURECT of $12.5 million and also agreed to make an additional $5 million payment when the FDA approved the New Drug Application (NDA) of the medication. That approval was received in July 2018, and Indivior made the payment at the end of August.

In addition, DURECT will receive quarterly earn-out payments based on a single digit percentage of U.S. net sales for products covered by the assigned patent rights, including PERSERIS. The patent rights extend through at least 2026.

Indivior has described PERSERIS as the "first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults."

"Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease. It is important to have additional treatment options available to physicians to help them improve their patients' symptom severity," said Maurizio Fava, executive vice chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Indivior clinical research consultant. "The studies carried out by Indivior suggest that PERSERIS may offer patients, caregivers and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia."

"We are pleased to see PERSERIS receive FDA approval as an innovative treatment option for patients suffering from the very difficult medical condition of schizophrenia," stated James E. Brown, D.V.M., president and CEO of DURECT. "Our agreement with Indivior provides us with an economic interest in PERSERIS with the potential for our shareholders to benefit from future sales of this product."

Indivior recently announced that it anticipates launching PERSERIS in the U.S. in February 2019, "with an expected field force of 40 to 60 representatives." This timing assumes that the preliminary injunction against Dr. Reddy's is upheld by the U.S. Court of Appeals for the Federal Circuit.

Indivior has estimated the annual U.S. market for PERSERIS is $200300 million if there is no material change in U.S. market circumstances.

Matt Hogan, DURECT's Chief Financial Officer, noted, "This deal illustrates the potential value embedded in our extensive patent portfolio, having received $17.5 million to date from Indivior with more to come through the expected future earn-out payments arising from the sales of PERSERIS"

DURECT has in its pipeline DUR-928, which may be a treatment for acute organ injury, hepatic and rental diseases such as NASH, and inflammatory skin conditions such as psoriasis. It also has advanced oral and injectable delivery technologies that could "enable new indications and enhanced attributes for small-molecule and biologic drugs."

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Disclosure:
1) John McPhaul compiled this article for Streetwise Reports LLC and provides services to Streetwise reports as an employee. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: DURECT Corp. Click here for important disclosures about sponsor fees.
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