New licensing deals move drugs between Valeant and Leo Pharma.
AstraZeneca has rejiggered licenses to two dermatological therapies as it shifts its focus to other disease areas.
First, it has licensed European rights to brodalumab, a monoclonal antibody aimed at treating plaque psoriasis, to the Danish dermatology specialist Leo Pharma. To do so, AstraZeneca must pay to end part of an agreement with Valeant Pharmaceuticals, the largely generic drugs firm that has been in the news for its pricing practices.
Valeant has been a partner of AstraZeneca since September 2015 when it paid $100 million, and agreed to pay $345 million more in milestone payments, for rights to brodalumab, except in Asia. Valeant will retain rights to brodalumab in the U.S. and other markets. Japan’s Kyowa Hakko Kirin has Asian rights.
Valeant had stepped in a couple of months after Amgen, the drug’s originator, ended a codevelopment pact with AstraZeneca after reports of suicidal ideation and behavior in Phase III trials. Despite positive clinical results, Amgen anticipated that the drug’s use would be restricted.
Now under regulatory review, brodalumab works by binding to the interleukin-17 (IL-17) receptor to block inflammatory signaling. If approved, it and similar biologics will compete with the long-standing anti-tumor necrosis factor (anti-TNF) blockbusters Humira, Remicade, and Enbrel, which also will face biosimilar competition.
Dominated by biologics, sales of psoriasis drugs are expected to grow 4% per year and reach $9 billion by 2019, according to the market research firm IMS Health. Interleukin-targeting antibodies will account for 31% of sales; anti-TNF agents will make up 44%.
In a second deal, AstraZeneca is licensing tralokinumab to Leo Pharma for dermatology uses. Leo will pay AstraZeneca $115 million and up to $1 billion in commercial milestones, as well as royalties.
Tralokinumab is an anti-IL-13 monoclonal antibody that has completed a Phase IIb study for treating atopic dermatitis. Along with manufacturing the antibody, AstraZeneca is keeping rights in other areas including respiratory diseases, where it is in Phase III trials against asthma.
By licensing the two AstraZeneca antibodies, Leo is making its first foray into biologics for dermatology.
Novo Holdings has concluded the acquisition of all outstanding shares of commercial-stage biopharmaceutical company Paratek Pharmaceuticals for nearly $462m (€433.67m) to bolster its antimicrobial resistance (AMR) expertise. Paratek develops and commercialises new treatments for life-threatening ailments. Its speciality pharmaceutical platform aids in developing new therapeutics.
Glenmark Pharmaceuticals has signed a definitive agreement for the divestiture of a 75% stake in its division, Glenmark Life Sciences (GLS), to Indian company Nirma in a deal valued at Rs56.51bn ($679.85m). Glenmark Life Sciences focuses on producing active pharmaceutical ingredients (API).
Pierre-Alain Ruffieux, CEO of Lonza, will leave the Basel-based company at the end of September. According to the Swiss Contract Development and Manufacturing Organization (CDMO), the separation is by mutual agreement.