Dive Brief:
- During the annual J.P. Morgan Healthcare Conference in San Francisco on Monday, Regeneron Pharmaceuticals Inc. and longtime pharma partner Sanofi SA announced they would be expanding their investment in immuno-oncology as well as in allergic diseases.
- Already partnered on three approved treatments, the pair will expand their investment on further indications for Dupixent, particularly in the area of allergic reactions.
- Regeneron and Sanofi are also committing another $1 billion to the advancement of their PD-1 inhibitor cemiplimab, expanding on a 2015 deal.
Dive Insight:
Noting it was the 30th anniversary of the company's founding, Regeneron CEO Len Schleifer and his longtime pal CSO George Yancopoulos used their famed banter to charm investors at the J.P. Morgan Healthcare Conference.
Schleifer quipped that the company has grown a lot since its 1988 inception, showing a slide with the company’s "original" safe harbor statement, noting Regeneron now has 6,000 employees and six compounds on the market.
The pair was particularly bullish on two of their Sanofi-partnered assets.
"Dupilumab is a pipeline in and of itself," Yancopoulos told the investor audience. The companies locked down a Food and Drug Administration approval in March 2017 for the treatment of atopic dermatitis and have already submitted a supplemental Biologics License Application in asthma.
Regeneron and Sanofi are also studying the drug in nasal polyps, COPD and eosinophilic esophagitis. The announcement this morning added further plans to study Dupixent (dupilumab) in peanut allergy and grass allergy.
Moving beyond Dupixent is Regeneron’s interest in the immuno-oncology space. The new investment in cemiplimab builds on a 2015 agreement that included a $640 million upfront payment from Sanofi, as well as a $750 million commitment to discovery research in the space from the French company.
"Some of what has changed [since the 2015 agreement] is that we now have some of the most impressive data for a solid tumor that has been seen with an anti-PD-1 class of therapy,' said Scleifer. "That data had a nearly 50% response rate and it wasn’t just a response, but a durable response."
Schleifer hopes the companies will be able to file on that data and get an approval for the drug this year.
"The space remains incredibly exciting. A lot of people thought, collectively as an industry, we’d be a lot further along in the immuno-oncology field. It’s a situation where we need some new players in the game that have some important new approaches that can take immuno-oncology to the next step. We are in a very exciting position right here because we have a foundational therapy right here," added Yancopoulos, citing a report he’d seen that "discounted all the PD-L1s" and further supported the PD-1 approach.
The Chief Scientific Officer noted that only one drug in the class so far has shown evidence of efficacy in the first-line lung cancer setting — Merck & Co.’s Keytruda — and that Regeneron expects cemiplimab to perform well in the setting.
As part of the agreement, Regeneron is allowing Sanofi to sell a limited number of its shares in order to fund the deal. Sanofi has the option to sell 1.4 million shares, or about 6% of its ownership of Regeneron, back to the biotech in private transactions through the end of 2020. If Regeneron does not purchase the stock, Sanofi has the right to sell the shares on the open market.