Drug Research
Drug Discovery & Development

Novartis’ Sandoz, Durect sign $293m deal for pain killer Posimir

PBR Staff Writer Published 09 May 2017

Biopharmaceutical firm Durect has entered into a development and commercialization agreement with Novartis subsidiary Sandoz for Posimir (Saber-Bupivacaine) in the US.

Posimir is Durect’s investigational locally-acting and non-opioid analgesic, which is being developed to offer up to three days of continuous pain relief after surgery.

Posimir is an investigational extended-release depot using Durect’s patented SABER technology to continuously deliver bupivacaine to the surgical site for 72 hours, enabling to offer up to three days of continuous pain relief after surgery.

As per the terms of the deal, Durect will secure an upfront payment of $20m from Sandoz, as well as an additional $43m development and regulatory milestones payments.

The deal will also include an additional payment of $230m based on the achievement of sales based milestones, as well as tiered double digit royalty on product sales in the US.

Durect will take the responsibility to complete ongoing PERSIST Phase 3 clinical trial for Posimir, in addition to FDA interactions through approval.

At present, Durect is carrying out PERSIST study, which is a phase 3 trial in patients undergoing laparoscopic cholecystectomy (gall bladder removal). It is comparing the effects of Posimir to bupivacaine HCl.

The company is planning to complete the recruitment of patients in the trial by the end of the third quarter this year, which will be followed by the announcement of top-line results.

Subject to review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, the deal is expected to complete in the second quarter of 2017.

Durect president and CEO James Brown said: “We believe that Posimir has the potential to become a cornerstone of multi-modal post-operative pain management.

“As a non-opioid local analgesic, we believe POSIMIR may be an important contributor to the on-going efforts to reduce the use of opioid-based medications following surgery."

Image: Novartis Logo, Basel Headquarters. Photo: courtesy of Novartis AG.