Sanofi to produce weight-loss drug for Orexigen
pharmafile | November 11, 2013 | News story | Manufacturing and Production, Sales and Marketing | Contrave, FDA, Sanofi, orexigen
Sanofi has agreed a deal to manufacture Orexigen Therapeutics’ weight-loss candidate Contrave outside North America.
Under the commercial supply agreement, Sanofi Chimie will serve as Orexigen’s contract manufacturer for Contrave (naltrexone/bupropion), and will make the drug at one of several facilities in France according to a statement issued by the companies.
Orexigen completed a Phase III programme for Contrave and filed a marketing application with the FDA in 2010, but was sent a complete response letter by the agency the following January asking for more information on cardiovascular safety.
The company is currently carrying out a placebo-controlled clinical trial called the Light Study – whose primary objective is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
The study is full enrolled – with around 10,000 patients signed up – and Orexigen is hoping to be able to file a second submission in the US before the end of the year, which could result in approval in mid-2014.
Outside the US, Orexigen said recently it is planning to file in Denmark and the UK before the end of the year – ahead of the Light Study results – which could also lead to registration in 2014. The deal with Sanofi helps ensure that Orexigen will have capacity to meet supply if the drug is approved in Europe.
Chief executive Michael Narachi said the agreement “expands and diversifies our existing commercial supply network”.
If approved, Contrave would join a new crop of obesity medicines that have reached the market in the last couple of years, including Arena/Eisai’s Belviq (lorcaserin HCl) and Vivus’ Qsymia (phentermine/topiramate) which debuted last year.
The new generation of therapies have struggled in Europe, however, with Arena withdrawing Belviq’s marketing application in May saying it was clear it would not be approved in its current form. The European Medicines Agency also rejected Vivus’ application for Qsymia in 2012.
“There is no one single solution, but we think Contrave can be an important part,” said Orexigen’s chief commercial officer Mark Booth recently.
He noted that earlier this year, the American Academy of Clinical Endocrinologists (AACE) for the first time started recommending the use of FDA-approved obesity agents, not only in to combat overweight but also to stave off related conditions such as diabetes and cardiovascular disease.
“We think the market is certainly poised for very rapid growth and Contrave’s profile is going to fit into that marketplace extremely well,” added Booth.
In the US Contrave is partnered with Takeda, and Orexigen is responsible for manufacturing the drug for the North American market via an agreement with Patheon, which will produce both the active pharmaceutical ingredient and the finished dosage form.
The company is also in the process of finding commercial partners elsewhere in the world.
Phil Taylor
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