Presumably hands were shaken and lawyers and executives read the fine print, putting a collaboration on anti-obesity drug Contrave between Japan's Takeda Pharmaceuticals and San Diego-based Orexigen Therapeutics ($OREX) back on track after a tussle broke out in May over the termination of a trial that opened up other issues in the partnership.
At first, the termination of the trial to assess the cardiovascular safety started a dispute process that also fed off a separate issue of earlier data breaches by Orexigen. At the time, the Cleveland Clinic issued its own statement that the study was halted because trial data was leaked by Orexigen in March and may have compromised data integrity.
By the middle of July, the two were said to still be feuding over how they will split the cost of a new post marketing study on the drug's cardio effects after cancellation and then Takeda had to recall a lot of the obesity drug because tablets in a batch were coming apart.
But in an Aug. 6 release, all seemed to be forgiven and smooth sailing as Orexigen and Takeda "announced execution of an amended and restated collaboration agreement that resolves all outstanding disputes between the companies and aligns the partnership for the continued long-term success of Contrave."
There were however other bumps in the road between May and Aug. 6.
First is the competition from other obesity meds on the scene such as Qsymia maker Vivus ($VVUS) and Belviq from Arena ($ARNA) and Japan's Eisai that have shown lackluster sales--partly driven by the same issues confronting Contrave on reimbursement and doctor enthusiasm for the drugs.
Indeed the word count in list of disclaimers for Contrave on the Aug. 6 release dwarfed the actual statements about the collaboration. Qsymia and Belviq have also taken steps on medicine packaging to note that exercise and good diets are keys for weight loss as well.
Then in June, Orexigen and Takeda filed a patent infringement lawsuit against Dublin-based Actavis to fend off a generic, which automatically stays any U.S. FDA approval of the knockoff for 30 months, assuming a district court doesn't first declare Contrave's patents invalid, unenforceable or not infringed.
There was no word in the release on the cost of a new post marketing study, with some analysts suggesting a figure as high as $200 million. There also wasn't any word as to who would pick up the tab, though parsing the statements may provide a clue who came out on the sharp end.
|Orexigen CEO Mike Narachi|
"Takeda's market-leading share of voice through the sales organization, combined with the partnership's commitment to patient support, has enabled a strong launch and early results for Contrave," said Mike Narachi, CEO of Orexigen.
"We are pleased to have realigned our partnership and look forward to working closely with Takeda to deliver continued success for Contrave in the United States."
- here's the Takeda and Orexigen release