Saturday, December 9, 2023

Genentech Veteran Named New BioMarin CEO as Gene Treatment Release Ramps Up

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Jean-Jacques Bienaimé, who over the process just about twenty years grew BioMarin Pharmaceutical’s portfolio from a unmarried commercialized asset to a couple of advertised merchandise—together with a landmark approval in gene remedy—is retiring. He’s going to be succeeded by way of Alexander Hardy, CEO of Roche subsidiary Genentech.

The transition will occur Dec. 1, despite the fact that Bienaimé will keep at the BioMarin board of administrators till the corporate’s 2024 annual assembly of stockholders. He’s going to additionally function an guide to the San Rafael, California-based corporate during the finish of subsequent 12 months.

Within the announcement, BioMarin’s lead impartial director, Richard Meier, mentioned the hiring of Hardy is the end result of a multi-year succession making plans procedure and candidate seek. Hardy has greater than 30 years of healthcare and biotech business revel in. Prior to turning into Genentech’s CEO in 2019, Hardy held a number of senior roles at Roche and Genentech. His revel in additionally comprises posts at Novartis, PathoGenesis, and GSK.

BioMarin develops medicine for infrequent sicknesses. When Bienaimé joined BioMarin in 2005, the corporate’s handiest authorized product used to be the enzyme alternative remedy Naglazyme, which treats mucopolysaccharidosis VI. The remedy generated about $26 million in earnings. With a portfolio that now spans 8 commercialized merchandise, BioMarin tasks its 2023 earnings will best $2 billion.

“It’s been a privilege main BioMarin’s exceptionally gifted workforce during the last 18 years, as we’ve labored in combination to ship drugs that experience reworked handle other folks with genetic sicknesses, construction BioMarin into the a success corporate it’s lately,” Bienaimé mentioned in a ready commentary. “Alexander brings an excellent observe document of effectively commercializing new merchandise for sufferers and prioritizing operational potency.”

Hardy is becoming a member of BioMarin as focal point turns to the corporate’s latest product, the hemophilia A gene remedy Roctavian. The remedy gained its long-awaited FDA approval in June and BioMarin is these days within the early levels of the product’s release. No sufferers have won the one-time remedy within the U.S. but, despite the fact that the corporate notes {that a} 2nd affected person has won the remedy in Germany, the place the corporate has a tentative settlement on worth. Ecu regulators authorized Roctavian in 2022, and the corporate mentioned it expects to additionally finalize pricing in Italy by way of the top of this 12 months.

Roctavian carries a wholesale worth of $2.9 million within the U.S. BioMarin had in the past estimated the product may reach $50 million to $150 million in gross sales this 12 months. However in its record of 3rd quarter 2023 monetary effects launched Wednesday, BioMarin mentioned delays securing pricing and compensation for Roctavian have led the corporate to decrease that earnings steerage to not up to $10 million.

In a word despatched to traders Thursday, William Blair analyst Tim Lugo stated the sluggish get started for Roctavian, however added that his company expects gross sales will ramp up in 2024. Lugo mentioned Bienaimé is leaving BioMarin in a excellent place. Past the corporate’s commercialized merchandise, it additionally has a deep rare-disease drug pipeline of 7 disclosed methods.

“We think there is also some pipeline prioritization as new control makes its imprint felt at the group,” Lugo mentioned. “Whilst the retirement of Chairman and CEO J.J. Bienaimé represents a big alternate for the corporate, we predict it used to be now not wholly sudden, and imagine the corporate has recognized an excellent alternative in Alexander Hardy, CEO of Genentech, who’s greater than able to proceeding to force BioMarin’s enlargement.”

Photograph: Getty Photographs

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