Problems Pile Up at Ipsen after Further Clinical Setback

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These are worrying times for iconic French mid-cap Ipsen. Trials for palovarotene, a treatment for rare bone disorders, have been plagued by setbacks, perhaps contributing to erstwhile CEO David Meek’s decision to quit the firm in December 2019. The company’s share price has since plummeted.

 

Meek’s resignation to join biotech FerGene was a significant blow for Ipsen, coming, as it did, soon after the FDA slammed the brakes on the company’s paediatric clinical studies of palovarotene – an investigational chronic treatment for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO). The partial clinical hold was issued following safety reports concerned about early growth plate closure in paediatric patients with FOP treated with the drug in question.

In late January 2020, palovarotene suffered another setback when it failed a futility test in its pivotal trial, leading dosing to be halted. Ipsen’s share price – already having fallen from around EUR 100 to around the EUR 80 mark in December, fell again to around EUR 65 on January 27th.

Palovarotene was acquired by Ipsen after buying Clementia Pharmaceuticals Inc for USD 1.3 billion in February 2019. In preparation for competition from cheap generic versions of its lead product, Somatuline, a treatment for hormone-fueled tumours of the stomach and pancreas, the French company was in a hurry to find a substitute.

 

A Successful Tenure

US national Meek became the first-ever non-French CEO of Ipsen in 2016. In conversation with PharmaBoardroom back in 2018, Meek was keen to highlight Ipsen’s expansion at a rate of over 20 percent per annum under his stewardship within the areas of oncology, neuroscience and rare diseases.

During Meek’s tenure, Ipsen’s sales grew from USD 1.5 billion to over 2.8 billion fueled by the growth of its oncology portfolio. Furthermore, the firm expanded its global reach by gaining a firm foothold in the United States and China. “The United States market now makes up 25 percent of our overall business and our Chinese affiliate is also thriving,” stated Meek.

Meek also pointed to increased R&D productivity as a key tenet of his time as CEO, noting that Ipsen is “now shooting for one new NDA or meaningful new indication every year” and “over the past two years, Ipsen and its partners have received six FDA approvals, four CHMP Positive Opinions, six EMA validations/EC approvals and one MHRA approval.”

 

Hope for the Future?

Upon Meek’s departure in December, Ipsen’s board moved to appoint Chief Financial Officer Aymeric Le Chatelier as Interim CEO; a position he still holds. Despite the numerous clinical setbacks that palovarotene has suffered, Le Chatelier is bullish on the drug’s prospects.

“While the study has met pre-specified statistical futility, we are encouraged by the results observed in the preliminary post-hoc analyses and look forward to discussing these with regulators as quickly as possible to determine the next steps for the palovarotene program,” he said, in a statement.

“We gratefully acknowledge the ongoing support and trust from patients, their families and the healthcare professionals involved in these trials. We are deeply committed to drug development in the area of rare and ultra-rare diseases where there are multiple high unmet medical needs and often a limited understanding of the disease itself.”

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