DURECT’s Posimir (SABER - Bupivacaine) for post-surgical pain failed its Phase III clinical trial.
DURECT Corporation announced that its Posimir (SABER – Bupivacaine) for post-surgical pain failed its Phase III clinical trial.
Posimir is an investigational extended-release product that uses the company’s SABER technology that continuously delivers bupivacaine to the site of the surgery for 72 hours. In May 2017, DURECT and Sandoz AG inked a license deal to develop and market Posimir in the U.S. The agreement became effective in June 2017. DURECT holds commercialization rights for the rest of the world. Sandoz made an upfront payment of $20 million with a possible payment of $43 million in milestone payments based on development and regulatory markers, and up to another $230 million in sales-based milestones.
Now that the drug failed in trial, Sandoz can terminate the deal upon thirty days’ prior written notice to DURECT.
The drug failed to meet its primary efficacy endpoint of reduction in pain on movement over the first 48 hours after surgery compared to a standard treatment of bupivacaine HCL. The drug showed some positive effects, but did not hit statistical significance.
“We are very surprised and disappointed by these results, which we will be trying to understand more fully over the coming weeks,” said James Brown, DURECT’s president and chief executive officer, in a statement. “We appreciate the efforts of the investigators and patients who participated in PERSIST, and we thank Sandoz for their support.”
This news follows an Oct. 2 announcement that DURECT had made a patent purchase agreement with Indivior UK Ltd., an affiliate of Indivior PLC (INDV). DURECT assigned some of its U.S. patent rights to Indivior, which gives additional intellectual property protection for RBP-7000. This once-monthly injectable risperidone is being developed for the treatment of schizophrenia. Indivior submitted a New Drug Application (NDA) for RBP-7000 to the U.S. Food and Drug Administration (FDA).
Indivior paid DURECT an upfront fee of $12.5 million, with a potential $5 million in regulatory milestones, and quarterly earn-out payments based on a single digit percentage of U.S. net sales for products covered by the patent rights.
“It is rewarding to know that Indivior’s RBP-7000, if approved, has the potential to help patients with schizophrenia and that our shareholders will have the opportunity to participate in potential future revenues from this product,” said Brown in a statement.
Meanwhile, DURECT stock got hammered by the news of the failed clinical trial. It is currently trading at $0.86 per share, a drop of about 57 percent. Shares traded for $1.97 yesterday. The company’s stock has a one-year high of $2.17 and a one-year low of $0.74. It’s 50-day moving average is $1.78 and its 200-day moving average is $1.46.
DURECT’s brands include ALZET, osmotic pumps used in laboratory research, and LACTEL, biodegradable polymers used by pharmaceutical and medical device companies as raw materials for their products.
