Drug Development

Valeant nosedives on CRL for plaque psoriasis, raising concerns over touted $1B pipeline

Valeant is suffering another hit this morning as the FDA kicked back its application for a drug the pharma giant touted as one of seven “significant” products meant to recharge the company’s revenue.

US regulators gave a thumbs down to Valeant’s Duobrii, a lotion meant to treat plaque psoriasis. The complete response letter (CRL) didn’t cite any deficiencies when it came to clinical safety or efficacy, Valeant noted, but took issue with some pharmacokinetic data (how the body reacts to a treatment, including duration and intensity of a drug’s effect). The company’s explanation didn’t go further than that.

Joe Papa

The slowdown could be a real setback for Valeant, and its 8% stock dive today reflects that concern. After being pummeled with bad publicity for its disastrous corporate strategies, the company has been laboring to convince investors it can recover and build out a promising pipeline. Duobrii was one of Valeant’s “significant seven,” so-called for their ability to raise over $1 billion over the next five years.

“We are working to resolve this matter expeditiously and have already requested a meeting with the FDA,” said the company’s chairman and CEO Joe Papa. “We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible.”

Following a slew of investigations into Valeant’s accounting and pricing practices, Valeant reported last month that its changing its name to Bausch Health Cos. Inc. The company likely hopes the rebrand will distance itself from scandals under previous management, and better reflect the full scope of the company.

Image: YouTube (CNBC)

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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