Almirall Discontinues R&D for Two Drugs in the U.S.

Published: Oct 02, 2017

Almirall Discontinues R&D for Two Drugs in the U.S September 29, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Barcelona, Spain – Almirall SA has announced it plans to halt all research into P3058 (onychomycosis) and P3073 (nail psoriasis) in the U.S. However, clinical trials planned in Europe will continue as scheduled.

Almirall is a global pharmaceutical company focused on dermatology and aesthetics. Founded in 1943, it is listed on the Spanish Stock Exchange under the ticker ALM. Last year it’s total revenues were 859.3 million euros. The company has more than 2,000 employees.

Earlier this month, Almirall announced it was developing an online open innovation platform—sort of a crowdsourced research platform—to work on dermatology therapeutics. Using crowdsourcing technology company Innocentive, it has a site, sharedinnovation.almirall.com, where dermatology researchers can post the answers or solutions to challenges listed there.

“Our R&D strategy is based on three important aspects: Science, innovation, and partnerships,” said the company’s chief scientific officer, Bhushan Hardas, in a statement. “We are convinced that there are plenty of breakthrough ideas and innovation outside our walls. With this in mind, we have created AlmirallShare, our open innovation platform, to help us identify and progress innovative solutions for skin health.”

Innocentive’s clients also include AstraZeneca and Boehringer Ingelheim. The site’s calls recently covered preclinical models and high throughput systems for topical drug delivery. Almirall’s first call for research proposals involved skin pathology in psoriasis, atopic dermatitis, acne and rosacea. Once proposals are submitted, the company’s team will review them and suggest the best way forward.

“AlmirallShare is about shared innovation,” said Maribel Crespo, AlmirallShare’s leader, in a statement. “With this platform, we want to share our passion for science with experts worldwide to start a journey where cooperation will result in better solutions for skin health. We want to help move science forward.”

The company hasn’t offered specifics about why it’s terminating its U.S. research-and-development efforts on P3058 and P3073 in the U.S. P3058 is a nail lacquer in HPCH technology and is in Phase III for the treatment of onychomycosis. P3073, whose active ingredient is calcipotriol, in HPCH technology, is in Phase III trials for nail psoriasis.

The company did indicate, however, that Phase III results are expected in the next six months for P3073 and by the end of 2018 for HP3058.

At the company’s half-year financial report in July, it noted that dermatology accounted for 37 percent of total net sales, which was down from 43 percent in the same period in 2016. Most of the loss was in the U.S. In Europe and the rest of the world, dermatology sales combined grew 3.4 percent year-on-year. In the U.S., however, dermatology dropped 68.2 percent year-on-year.

At that time, the company stated, “We have recently obtained the EU approval of Skilarence, a new oral formulation of dimethyl fumarate, as a first-line induction and long-term treatment for adults with moderate-to-severe chronic plaque psoriasis. Initial EU launch of this product is planned for Q3 2017.

“We have recently submitted the regulatory filing in Europe of our first biologic, tildakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. This, together with our pipeline and a healthy balance sheet provide potential catalysts for the growth of the company.”

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