Indivior given October court date with Dr Reddy's, delays Perseris launch

After winning approval from the US drug regulator late on Friday for its once-monthly injectable treatment for schizophrenia in adults, the FTSE 250-listed company said it would delay the timing of the launch until it knew more about the Dr Reddy's litigation.

Dr Reddy's launched an appeal after Indivior was granted a preliminary injunction that prevented the generic drugmaker from selling its version of Indivior's Suboxone, a buprenorphine/naloxone sublingual film that is used as a treatment for opioid addiction.

The US Court of Appeals for the Federal Circuit has now granted-in-part a motion to expedite Dr Reddy's appeal of the preliminary injunction that prohibits its from using, importing, selling, or offering to sell its generic sublingual film, meaning oral argument are scheduled to be held during the first week of October.

Dr Reddy's appeal also requested a stay of the injunction but the CAFC has not yet ruled on this.

Although the US Food & Drug Administration late on Friday approved Perseris, a once-monthly injection to treat adult schizophrenia, Indivior said that, as it had indicated in its half-year results last week, it will hold back from launching this new treatment due to the uncertainty over the Dr Reddy's generic.

The company assured that would provide details of the "appropriate launch timing" for Perseris "as soon as reasonably practicable, but no later than its Q3 2018 results currently scheduled for November 1st".

Perseris is the first once-monthly injectable formulation of risperidone, which is a well-established oral treatment for schizophrenia. It has been adapted by Indivior using the Atrigel formulation via 'depot' delivery system that is delivered subcutaneously to provides month-long therapeutic doses , which is not the case for all long-acting treatments for schizophrenia, which often require top-up oral dosing.

Shares in Indivior fell in early trading on Monday but by 0930 BST were up 2% to 321.4p.

Broker Numis felt the expedited appeal was a positive development for Indivior but as the Federal Appeals Court has yet to rule on the motion to remove the injunction, this "remains a near term risk", along with other generic drug manufacturers Alvogen/Lotus expected to seek to launch “at-risk” in the fourth quarter pending FDA approval.

"Settling with Alvogen would be a positive development, in our view."

On Perseris, Numis said it would serve to diversify the business and generate additional cash-flow to re-invest in R&D in addiction and related disorders, forecasting sales of $23m for the 2019 financial year, rising to $172m in FY25, "although it will be disappointing for patients, management and shareholders that the ongoing uncertainties over Suboxone Film have compromised the launch timing of this important drug".