Takeda hits major snags with Contrave and Alisertib
pharmafile | May 14, 2015 | News story | Sales and Marketing | Contrave, Takeda, alisertib, obesity, orexigen
Takeda is threatening to end its partnership with Orexigen to market the obesity drug Contrave, as allegations around its heart benefits grow.
As the row escalates Takeda has started a dispute resolution procedure with Orexigen, asking the firm to pay the full $200 million to run a trial to end the growing doubts surrounding the cardiovascular effects of Contrave (naltrexone hydrochloride/bupropion hydrochloride).
In March Orexigen fell foul of FDA regulators for prematurely releasing data suggesting that Contrave significantly reduced heart attacks, strokes and other cardiovascular event by 41% compared to placebo. However, officials overseeing the trial and others from the FDA slammed the leak and said the results were unreliable and misleading.
Orexigen has come under severe pressure to release the full trial data, but so far has refused and conceded only to stopping the trial.
Now Dr Steve Nissen, a leading cardiovascular researcher and chair of cardiology at the Cleveland Clinic – who oversaw the trial – has alleged that Orexigen deliberately misled patients and investors about Contrave’s benefits.
In a press release issued by the clinic and in an interview with Forbes magazine, Nissen says the data from 9,000 patients actually shows that Contrave’s benefits waned over time to a statistically insignificant 12% compared to placebo – and that Orexigen has actively prevented the full data from being published.
“Patients were misled, investors were misled,” Nissen says. “It is so critically important that investors and other people understand why early data in a trial are unreliable or unstable.”
Orexigen chief executive Mike Narachi responded to allegations during a Bank of America Merrill Lynch Healthcare Conference on Tuesday, saying: “Contrary to allegations cited today by a journalist, Orexigen has never misled patients.”
“At the time of the patent issuance in March, we stated plainly and clearly that the effect of Contrave on cardiovascular morbidity and mortality has not been established and that a larger number of events are required to precisely determine the effect of Contrave on cardiovascular outcomes.”
It appears though that Takeda is taking measures to both remove itself from the partnership and step back from the growing scandal, or at the very least offset the potential financial damage.
In a statement to Bloomberg, its spokesperson Sandy Rodriguez says: “Takeda sent a dispute letter to Orexigen on 12 May whereby Takeda seeks termination of its collaboration agreement with Orexigen based on Orexigen’s material breach of the agreement. Takeda is working closely with Orexigen to try to resolve the situation and avoid termination of the agreement.”
In other bad news for Takeda, the Japanese pharma giant has been forced to scrap a Phase III trial of alisertib (MLN8237), an oral selective inhibitor of proteins expressed by a gene called Aurora A kinase, which is investigated by Takeda for the treatment of small cell lung cancer.
An interim analysis of results from the trial, in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), indicated alisertib is “unlikely to meet the primary endpoint of superior progression-free survival over the standard-of-care in this treatment setting”.
Michael Vasconcelles, global head of the Takeda oncology therapeutic unit, says: “While we are disappointed that alisertib will not be further investigated for relapsed or refractory peripheral T-cell lymphoma, we are optimistic about alisertib’s clinical development programme in small cell lung cancer.
“The Phase II study of alisertib in small cell lung cancer will continue as planned and is currently underway. Takeda also continues to support investigator initiated research with alisertib and will evaluate its potential use in other oncology indications going forward.”
Read the Forbes.com entry here.
Read the Cleveland Clinic statemet here.
Lilian Anekwe
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