Sanofi Inks Multiple Deals, Sarilumab under FDA Review

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Sanofi SNY came up with important announcements on both the deal making and pipeline front.

Partnership Extended with Warp Drive Bio

Sanofi and a privately held biotech company, Warp Drive Bio, announced that they have extended and reshaped their existing collaboration utilizing the latter's proprietary SMART (Small Molecule Assisted Receptor Targeting) and Genome Mining platforms for the discovery of novel oncology therapeutics and antibiotics. We note that Warp Drive was launched in 2012 through a strategic partnership with Sanofi and with financing from Third Rock Ventures and Greylock Partners. The partnership was focused on the development of drugs targeting important human oncogenes including RAS, which has one of the highest mutation rates in cancer and new antibiotics targeting Gram-negative bacteria.

While Warp Drive will be in charge of the research collaboration for a period of five years, Sanofi will receive worldwide exclusive licenses to develop and commercialize the candidates discovered during the research term. The deal could see Sanofi shelling out cumulative payments of more than $750 million across four successful collaboration programs including an equity investment by Sanofi, research, clinical and regulatory milestones and research and development services.

Initially, both companies will focus on three defined oncology programs targeting different mutants and states of the RAS oncogenic protein. Warp Drive has the option to lead the development of the therapeutic candidates following the filing of an investigational new drug up to phase II studies with Sanofi continuing the development through the filing of new drug applications. Sanofi will lead commercial activities worldwide on product(s) resulting from the collaboration and Warp Drive has the option to co-commercialize oncology therapeutics in the U.S. Sanofi will control all ex-U.S. commercial activities and Warp Drive will be entitled to receive commercial milestones and tiered royalties on product sales.

On the other hand, the antibiotic collaboration will focus on the discovery and development of novel Gram-negative therapeutics with Sanofi heading all development activities. Sanofi will be responsible for the commercialization of the antibiotic products across the world and will pay Warp Drive research, clinical, and regulatory milestone payments plus tiered royalties and commercial milestone payments based on global sales.

The deal is a result of Sanofi's Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that support the company’s expert development and commercialization abilities.

Inks Immuno-Oncology Deal with Innate Pharma

Meanwhile, Sanofi and Innate Pharma S.A. IPHYF announced that they have entered into a research collaboration and licensing agreement focused on using Innate Pharma's new proprietary technology for the development of innovative bispecific antibody formats engaging natural killer (NK) cells to kill tumor cells through the activating receptor NKp46.

The collaboration focuses on the generation and evaluation of up to two bispecific NK cell engagers using Innate Pharma’s technology and Sanofi's proprietary bispecific antibody format as well as tumor targets. Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the collaboration. Innate Pharma will be entitled to receive development and commercial milestone payments of up to €400 million plus royalties on net sales.

Sarilumab’s BLA Accepted by FDA

Sanofi and its partner Regeneron Pharmaceuticals, Inc. REGN announced that the biologics license application (BLA) for sarilumab has been accepted for review by the FDA. A response from the FDA is expected by Oct 30, 2016. Sarilumab, an anti interleukin-6 receptor monoclonal antibody, is under review for the treatment of patients suffering from active, moderate-to-severe rheumatoid arthritis.

Sanofi is a Zacks Rank #2 (Buy) stock. Anika Therapeutics Inc. ANIK is another favorably ranked stock in the health care sector, carrying a Zacks Rank #1 (Strong Buy).

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