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Celgene in $7bn shot on Impact

Published on 08/01/18 at 10:01am

Billions of dollars do not often get put down for drugs that have been dropped by a major pharma company, usually it’s a case of once bitten, twice shy – with smaller company’s being left to attempt to take the gamble through to market.

This more or less what happened in the case of Celgene, Impact Biomedicines and fedratinib, except Celgene has jumped in before an NDA could be submitted.

In the process, the big biotech is prepared to wager $1.1 billion and $1.25 billion in contingent payments that fedratinib will succeed this time round. Should sales exceed $5 billion for the drug, the previous figures will include a further $4.5 billion.

It’s a lot of money but with most of it being tied to the drug being successful, it should not sting Celgene too badly if the gamble doesn’t pay off. For Impact, gaining $1.1 billion upfront is a huge coup for a company only two years old.

Fedratinib had previously been bought then developed by Sanofi, only for serious safety issues to arise in clinical trials. The treatment for myelofibrosis, a bone marrow disorder, was shown to cause cases of the neurological condition Wernicke’s encephalopathy.

The incidents caused Celgene to drop the JAK2 kinase inhibitor, only for Impact to pick up the treatment and for the FDA to release the hold it had placed on trials into the drug, after the previous safety issues had arisen.

Celgene announced that an NDA would likely be submitted mid-way through 2018, meaning that there could potentially be quick turnaround from acquisition to approval.

“Myelofibrosis is a disease with high unmet medical need as the number of patients who are ineligible for or become resistant to existing therapy continues to increase,” said Nadim Ahmed, President, Haematology and Oncology for Celgene. “We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets.”

The biotech is definitely in need of a successful story, with the biotech still struggling to diversify from its main product, Revlimid. The blood cancer drug still represents more than 60% of total sales for the company but is poised to lose its exclusivity on the drug by 2022.

Ben Hargreaves

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