Regeneron is fighting some serious enemies. Regeneron Pharmaceuticals develops protein-based drugs used to battle a variety of diseases and conditions, including cancer, inflammatory ailments, and eye diseases. The biotechnology company's first commercialized product is ARCALYST, a treatment for rare inflammatory diseases including Muckle-Wells Syndrome. Regeneron collaborates with Sanofi to develop candidate aflibercept (VEGF Trap) as a possible treatment for cancerous tumors. It is also developing aflibercept with Bayer HealthCare to treat eye diseases using intraocular delivery, with EYLEA approved in the US (2011) and Australia (2012) as a treatment of neovascular age-related macular degeneration (wet AMD).
In 2012 the company entered into a non-exclusive license to certain patents relating to VEGF receptor proteins and a partial settlement agreement with Roche member company, Genentech, related to ophthalmic sales of EYLEA (aflibercept) Injection in the US. Under the agreement, Regeneron will make payments to Genentech based on sales of EYLEA in the US through May, 2016. It will pay Genentech $60 million when US sales of EYLEA reach $400 million and royalties of 4.75% on cumulative US sales of EYLEA between $400 million and $3 billion and 5.5% on those that exceed $3 billion.
Also that year, Regeneron and Bayer HealthCare converted their 50/50 global profit share agreement for marketing EYLEA (aflibercept) Injection as a treatment for wet AMD outside the US into a royalty arrangement in Japan, where approval for the treatment is pending authorization. Applications for marketing EYLEA have been submitted by Bayer HealthCare in other countries and in Europe. The treatment is also in Phase 3 clinical studies for other indications including diabetic macular edema, myopic choroidal neovascularization, and branch retinal vein occlusion.
ARCALYST (rilonacept) was approved by the FDA in 2008 and subsequently became the company's first market-stage product. Regeneron has built up a small marketing force to promote the product in the US; ARCALYST is manufactured at the company's plant in New York and is distributed through third parties. ARCALYST targets Cryopyrin-Associated Periodic Syndromes (CAPS), a series of diseases caused by genetic mutations including Muckle-Wells Syndrome and Familial Cold Auto-inflammatory Syndrome. The drug is also being tested for the treatment of gout.
The company expanded the applications of its protein-based technology to include the creation of human monoclonal antibodies (laboratory produced cloned proteins). Outside of their partnership on aflibercept, Regeneron has an antibody development agreement with Sanofi that includes $475 in potential milestone payments and covers potential treatments for ailments including cancer, rheumatoid arthritis, pain, cholesterol, and allergic conditions.
As its largest partner, Sanofi (which also owns a 19% stake in Regeneron), accounts for about 65% of sales. The company's other collaborations account for more than 15% of sales; firms are working together to treat ophthalmic diseases including diabetic macular edema and wet age-related macular degeneration.
The company also licenses its human antibody technology out to drug developers, which then use Regeneron's technology in researching their own antibody drugs. Licensing partners include AstraZeneca and Astellas Pharma. Astellas extended its agreement in 2010, licensing the technology for a longer period of time in a deal worth up to $295 million.
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