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Regeneron, Sanofi Expand Investment in Cemiplimab & Dupilumab

Zacks

Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that they will expand their investment for the development of the programmed cell death protein 1 (PD-1) antibody, cemiplimab, in oncology and label expansion of the IL-4/IL-13 pathway-blocking antibody, dupilumab, in Type II allergic diseases.

Per the terms of the expansion, the investment in cemiplimab will be increased to $1.64 billion, an increase of about $1 billion, over the initial 2015 agreement. Meanwhile, Sanofi and Regeneron will continue to equally fund cemiplimab development. Currently, the companies are developing cemiplimab as monotherapy and in combination with other therapies for a wide range of cancers including advanced skin cancers, non-small cell lung cancer, cervical cancer and lymphomas, with more studies in other indications planned to begin in 2018. In the first quarter of 2018, Sanofi and Regeneron expect to submit regulatory filings in the United States and Europe for cemiplimab in advanced cutaneous squamous cell carcinoma.

The increased investment in the label expansion of dupilumab development program will enable the companies to speed up the planned new studies in chronic obstructive pulmonary disease (COPD), peanut allergy and grass allergy as well as in patients who have multiple allergic conditions. The new funding will also support the acceleration and expansion of development of REGN3500, an IL-33 antibody, in atopic dermatitis, asthma and COPD.

Shares of Regeneron have increased 5% against the industry’s decline of 2.8% in the past one year.


Regeneron has agreed to a limited waiver of the "lock-up" clause with Sanofi, thereby enabling the latter to sell a small percentage of the Regeneroncommon stock it owns to fund a portion of the increased investment. Specifically, Sanofi will be allowed to sell up to 1.4 million shares of Regeneroncommon stock to the latter through the end of 2020. This represents about 6% of the 23.9 million shares of Regeneron Sanofi currently owns.If Regeneron opts out of the deal, Sanofi may sell them in the open market.

In a separate release, the company also announced collaborations with AbbVie, Alnylam Pharmaceuticals ALNY, AstraZeneca, Biogen and Pfizer Inc. PFE that will speed its effort to collect genetic information on 500,000 people in the UK Biobank database, a project that could help speed up new drug discovery and improve approval success rates.

The collaborators will each commit $10 million to enable the speeding up of sequencing timelines and additional companies are considering joining the consortium. It was originally planned that sequencing of all 500,000 samples in the UK Biobank would be completed by 2022. But with the inclusion of these companies, it will be possible to complete the exome sequencing of all 500,000 participants by the end of 2019, with all data made broadly available by UK Biobank to researchers by the end of 2020.

This consortium effort thus largely accelerates delivery to the global scientific community of the largest 'big data' resource linking human sequence data to other health-related information. Sequencing of UK Biobank's samples will continue to be performed at the Regeneron Genetics Center (RGC) facility, one of the world's largest and most sophisticated human genetics sequencing centers.

Regeneron Pharmaceuticals, Inc. Price

Zacks Rank

Regeneron carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

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