Drug Development

Shire bags a quick thumbs up for its newly won cancer drug pipeline

Shire is ready to cash in its first cancer drug chip won in its acquisition of Baxalta.

The biotech company says that the EMA’s Committee for Medicinal Products for Human Use has given it a thumbs up on an application to market Onivyde — an irinotecan liposome injection combined with 5-fluorouracil and leucovorin to fight metastatic pancreatic cancer as a second-line drug after gemcitabine therapy.

The recommendation, a likely harbinger of a formal EU approval, is primarily significant because it flags the pipeline of cancer drugs Shire $SHPG picked up in the Baxalta deal. Baxalta licensed the ex-U.S. rights to the drug from Merrimack $MACK, which picked up an FDA approval last year.

Shire CEO Flemming Ornskov was primarily interested in bagging Baxalta to help establish the company as a leader in rare diseases. But Baxalta continued to ink a flurry of cancer deals even after the two companies reached a deal on buyout terms.

Those pacts included a sharp focus on immuno-oncology, with a $105 million upfront to Precision BioSciences to get partnered on CAR-T programs as well as a deal with Copenhagen-based Symphogen to collaborate on checkpoint cancer therapies, paying a hefty $175 million upfront in a package worth up to $1.6 billion.

Shire picked up the pipeline without the oncology chief who put it together. David Meek is headed to Paris as the new CEO of Ipsen, where he will likely do some more cancer deals. At the end of last week, Meek heralded a positive CHMP opinion on cabozantinib, which Ipsen is partnered on with Exelixis.

“There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years. We therefore welcome the CHMP positive opinion for Onivyde, a regulatory milestone which brings us a step closer to helping patients with this devastating disease,” said Philip J. Vickers, Shire’s R&D chief, in a statement.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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