Amid FDA partial hold, Meek jumps ship from Ipsen to lead new gene therapy startup

Ipsen CEO David Meek
Ipsen CEO David Meek (Ipsen)

A new gene therapy spinout has nabbed Ipsen chief executive David Meek to help sell its new drug.  

FerGene, launched just last month by Ferring Pharmaceuticals and Blackstone Life Sciences, sees Meek take the top spot from Jan. 14, leaving his tenure at French biotech Ipsen.

This comes just a few weeks after the FDA placed two trials of rare disease drug palovarotene on partial clinical hold, itself coming just eight months after Ipsen gained the drug in its $1 billion (€900 million) takeover of Clementia Pharmaceuticals.

Ipsen is developing palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP), a rare bone disease. At the time of the Clementia takeover, the now-departing Meek called the asset “largely derisked,” reflecting a belief that phase 2 data generated on the episodic use of the drug will support FDA approval in that indication next year.

However, Ipsen now faces risks associated with palovarotene. The prospects of the chronic use of the therapy in children with FOP have been thrown into doubt by reports of patients experiencing early growth plate closure while taking the drug.

Ipsen will now face clearing this partial hold without Meek, who joins biotech FerGene at a time when it is gearing up for a potential commercial launch.

This company came about after Ferring Pharmaceuticals spun out its late-phase gene therapy nadofaragene firadenovec with the support of Blackstone Life Sciences. The two organizations in November put up $570 million to support the spinout as it works to bring the bladder cancer drug to the U.S. and other markets.

RELATED: Ferring, Blackstone spin out gene therapy with $570M in funding

“I’m honored to lead FerGene in this exciting role and spearhead the effort to develop and commercialize this critical and innovative therapy and advance its clinical development. We will build a committed, patient-centric team and with the support from Ferring and Blackstone Life Sciences, I am confident we can efficiently and effectively bring this life changing therapy to patients in need,” said Meek.

FerGene recently announced that its phase 3 study of nadofaragene firadenovec hit its primary endpoint with more than half of patients with high-grade, BCG unresponsive non-muscle invasive bladder cancer achieving a complete response at three months.

Nadofaragene firadenovec consists of a virus designed to introduce a gene into bladder cells, thereby hijacking the molecular machinery for production of the cancer-fighting interferon alpha-2b protein. Ferring picked up an option on the therapy from FKD Therapies last year.

The FDA has already accepted a filing for approval and granted it priority review, putting Ferring on course to secure clearance to sell nadofaragene firadenovec in the U.S. in 2020. With the launch date looming, Ferring has teamed with Blackstone to fund the commercial rollout.

Ipsen was down 5% this morning on the news.