Orexigen ($OREX) and Contrave marketing partner Takeda have been feuding over how they will split the cost of a postmarketing study on the drug's cardio effects after the initial study had to be canceled because of a "data leak" by Orexigen's CEO. Now they have a new splitting issue to bicker about. Takeda is having to recall a lot of the obesity drug because tablets in a batch were coming apart.
According to the most recent FDA enforcement report, the Japanese drugmaker is voluntarily recalling one lot of Contrave because of a possible defect causing the bilayer to split and tablets to break into two drug components. Takeda manufactures the drug, which Orexigen ($OREX) developed.
In May, Takeda threatened "termination of its collaboration agreement with Orexigen claiming that Orexigen had breached their agreement. That came after a Cleveland Clinic-led exec committee decided to can a clinical trial, claiming that it was compromised when Orexigen put out positive--and potentially misleading--results from a 25% interim analysis. A new study is going to cost about $200 million and instead of splitting the cost, Takeda thinks Orexigen needs to pony up for all of that.
Whether the manufacturing issue will morph into the need to recall more product will have to be seen, but for now, it is recalling only 3,619 bottles. That is a far cry from the 121,680 bottles of competing obesity drug Belviq that had to be recalled earlier this year because of missing or unreadable labels. That recall was initiated by Eisai, also a Japanese drugmaker, who manufactures and sells the drug for developer Arena Pharmaceuticals ($ARNA).
- read the FDA notice