Few companies would be capable of sustaining a half-million-square-foot campus and 1,500 employees prior to launching their second product.
In that respect, Regeneron Pharmaceuticals Inc., New York”™s largest biotech employer and fastest-growing biotech company, in addition to having one of the 10-largest research and clinical development programs in the U.S. biotech industry, defies the odds.
The company”™s second drug, VEGF Trap-Eye, also known as EYLEA, received unanimous approval from the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration last month for the treatment of the neovascular ”“ or “wet” ”“ form of age-related macular degeneration (AMD), a condition that is one of the leading causes of blindness in the elderly.
The FDA is expected to reach a decision on EYLEA on Aug. 20. Pending approval, Regeneron anticipates a U.S. product launch in the fall of this year.
“There”™s a tremendous sense of exhilaration and satisfaction and excitement,” said Murray A. Goldberg, senior vice president and CFO of Regeneron, which is based in Tarrytown. “You can almost taste it.”
Each year, more than 210,000 Americans are diagnosed with wet AMD, which can lead to blindness as a result of abnormal blood vessel growth below the macula. There are currently 1.8 million people in the U.S. who have been diagnosed with either the wet or dry form of AMD, which can progress to wet AMD, and that number is expected to increase to three million by 2020. The market for wet AMD treatments globally is a $3 billion-a-year industry.
For Goldberg and the management team at Regeneron, which includes founder and CEO Leonard S. Schleifer and former Merck and Co. Inc. CEO P. Roy Vagelos as chairman of the board, the excitement is about more than the expected launch of EYLEA. It is rather about a deep pipeline of drug candidates that promise to support the transformation of Regeneron from a biotech company that works almost entirely in research and development to a commercial pharmaceutical entity in the not-too-distant future, Goldberg said.
“Within 12 months, we can be launching three products,” Goldberg said. “Right now we have eight (other) antibodies in various phases of clinical development. Most biotechnology companies can”™t support that before they”™re commercial.”
Along with EYLEA, antibodies for the treatment of gout and certain types of prostate cancer are currently in Phase 3 clinical trials, which is the last phase of clinical testing.
“These are not just drugs, but drugs that can make a major difference in the quality of people”™s lives,” Goldberg said.
While the majority of Regeneron”™s employees work in the company”™s research and development areas, Goldberg said that the next step is to build a commercial sales team.
“As you become a big pharma company you now have all these people doing commercial (sales),” he said. “What we”™re poised for, we believe, is we”™ll have our own sales.”
The strength of Regeneron and why it is poised for such growth dates to its founding, according to, Laura Lindsay, the company”™s associate director of corporate communications.
Founded in 1988 in a studio apartment in Manhattan, Schleifer was able to surround the new company with a number of sharp advisers and partners. The initial advisory team included three future Nobel laureates, and in 1993, Vagelos came on board after retiring from Merck, and advocated for broadening the pipeline.
“Len (Schleifer) likes to say, ”˜It”™s multiple shots on goal.”™” Lindsay said, referencing the company”™s ability to build a diverse drug development program.
The company established its headquarters in Tarrytown in 1989, and entered into a number of collaborations that allowed it to greatly expand its research and development programs. But: “The great challenge for a biotech company is to find the cash to fund your operations,” Goldberg said.
In 2003, Regeneron partnered with Aventis, a French pharmaceutical company that was taken over by Sanofi in 2004 to form Sanofi-Aventis. In 2007, Regeneron entered into an agreement with Sanofi-Aventis for the development of antibody technology, a deal that was worth $160 million a year in funding.
The partnership was so successful initially that it was extended in 2009 to run through 2017, giving Regeneron eight years of guaranteed funding of $160 million a year to conduct discovery research, with Sanofi-Aventis funding the development of treatments that proved successful. Additionally, Regeneron partnered with Bayer HealthCare for the global development of EYLEA.
“That was a significant major increment for us,” Goldberg said of the extended Sanofi-Aventis deal.
The partnership allowed the company to expand from 650 employees in 2007 to 1,400 by the end of 2010, with expectations of adding approximately 600 more by the end of this year. Regeneron has satellite offices in Basking Ridge, N.J., and additional lab facilities in upstate Rensselaer.
Total research and development spending for 2010, including spending by Sanofi-Aventis and Bayer HealthCare, totaled nearly $700 million.
Goldberg stressed the importance of that financial support, saying that it has enabled Regeneron to set the ambitious goal of developing four to five new antibodies each year.
“Many biotechs go through their lifetime and die without ever getting a drug approved,” he said, adding that a company”™s first drug typically takes more than 10 years and hundreds of millions of dollars to develop.
He said that the clinical trial phases for some treatments may move along faster, using gout as an example, but said that testing treatments for neurological diseases such as ALS, Alzheimer”™s and Huntington”™s could take longer periods of time.
“That”™s why it takes up to 10 years or even more depending on the drug,” Goldberg said. “We”™ve got to perfect the antibody.”
I am waiting for those products….