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REGENERON (REGN): Tasting The Firm's Sweet Ripened fruits

Prohost Biotech - Friday, May 14, 2010

Things happen for reasons. Curiosity is an advantage and the ability to satisfy it is a luxury restricted to humans. Those who ignore such natural gifts miss causes and outcomes of meaningful activities and events that go around them. They miss chances to opportunities. Satisfying one’s inherent curiosity is the road to wellbeing and in some instances, life-saving.

When Sanofi-Avantis made a major endorsement of Regeneron's (REGN) technology in 1997 and signed a drug-development partnership with the company, we asked why? And when the top class pharmaceutical firm has willingly decided to offer Regeneron $160 million a year to develop therapeutic antibodies that they can equally share their revenues, we, again, asked why? We also asked: What did the French giant drug maker expect to get from Regeneron, which it could not itself provide or get from other biotech firms?

We satisfied our built-in curiosity as early as a few days after the signature of the cooperative agreement between the two firms. We learned at the right time that Sanofi had fallen in love with Regeneron’s antibody technology and that it expected the small firm to be capable of advancing several antibodies into clinical trials each year through 2017. It was obvious that Sanofi-Aventis decided to pay the costs of developing Regeneron’s drugs because it wanted the small firm to focus on building the therapeutic molecules under no tension that would cause unnecessary delays.

In November 2007, we wrote: “ … Regeneron (REGN) will have exciting news. Prohost rule of thumb is that nothing but good news must be expected from biotech firms that have str ong scientific fundamentals, especially from those firms that have breakthrough validated technologies and product pipeline born to these technologies. Prohost selected Regeneron for long-term investment years ago (see Prohost Table), so we were the least surprised to see it sign a global collaboration agreement with a Sanofi-Aventis to discover, develop and commercialize fully-human therapeutic antibodies developed through its proprietary technologies. ….. Sanofi is a big, wise boy. When such a competent firm decides to pay $26, for a stock that’s trading between $17 and $19, investors must draw some conclusions.”

Some investors have, indeed, drawn conclusions. They decided that Regeneron has a huge potential. But others did not even bother to look at the firm’s technologies, or consider the positive impact Sanofi’s agreement would have on Regeneron’s scientific plans and on its finances. They typically confined their research to its quarterly financial results. In the mean time, Regeneron’s scientists were working hard to advance several therapeutic antibodies decided upon by the partners into clinical trials. The candidate products comprsed: REGN88, a therapeutic antibody targeting interleukin-6 receptor for rheumatoid arthritis. REGN727 - a therapeutic antibody aimed at PCSK9, a novel target for LDL cholesterol reduction. REGN421 - a therapeutic antibody targeting delta-like ligand-4 (Dll4) as anti-angiogenesis to deprive cancer from the blood supply. REGN475 – a therapeutic antibody targeting nerve growth factor (NGF), a novel target for the treatment of pain and REGN668 – a therapeutic antibody targeting Interleukin 4 receptor that modulates the effects of IL4 and IL13 in allergic conditions.

Recent news announced by Regeneron confirmed that we are beginning to witness the sweet taste of the ripening fruits of the Sanofi/Regeneron agreement. The anti-cholesterol and anti-arthritis drugs demonstrated safety and strong efficacy. With regard to the anti-cholesterol drug, a single dose of REGN727 produced a maximum mean reduction in "bad" LDL cholesterol of more than 60 percent, which the company hailed as "highly significant" efficacy result that lasted for a month. The positive results validated the potency of the antibodies developed through Regeneron engineered mice and stressed the fact that Regeneron’s drug will be the first to reach the market from among all other drugs developed by other firms that aim at the same PCSK9 target.

With regard to arthritis, Regeneron announced that REGN475 demonstrated "significant improvements" at the two highest doses given for controlling the pain of osteoarthritis of the knee. The drug was generally well tolerated. In an attempt to explain the superiority of its antibodies compared to other firms’ antibodies, Regeneron stated that the transgenic mice used by rival companies are somewhat immunodeficient, meaning that the immune systems of the mice they use are not as good as those of its own mice and therefore do not as easily produce satisfactory antibodies.

Is that all? No. Regeneron has a marketed product, ARCALYST Injection, for Subcutaneous use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. The drug is approved in the U.S. and the European market. With regard to the firm’s pipeline, it is, indeed, rich and very promising. It comprises eight investigational product candidates progressing in clinical trials for many diseases, including cancer, eye diseases, inflammatory diseases, pain, cardiovascular/metabolic diseases and allergic conditions. Six clinical studies are in phase 3 trials and the rest are in various phases. In addition to Sanofi-Avantis, Bayer HealthCare is another supporter, partner and believer in Regeneron’s technologies and products. This pharmaceutical company is also a contributor to the firm’s efforts aimed at putting on the market far-reaching breakthrough treatments.

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