Bold Bets - Pharmaceutical Executive

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Bold Bets
Serono is muscling its way into the US market with head-to-head trials and big marketing partners.


Pharmaceutical Executive


Canaccord Capital reports: "Even if Tysabri takes 75 percent of new patients and almost half of those switching between treatments, revenues from Rebif in the US should continue to grow at our forecast level—$558 million in 2008." One mitigating factor for the newcomer is that the drug is a monthly infusion, which may not be convenient for some patients. Some analysts also point out that there aren't enough MS infusion centers to meet a high patient demand, if it arises.

Nick Turner, an analyst with Jeffries, says, "Neurologists are not accustomed to switching patients off their existing medications if those medications are working. We have to conclude that Tysabri will take the patient population that have failed on, or are unwilling to take, existing drugs."

Pipeline Projects Although Serono is a currently a biotech company with three therapeutic franchises, its pipeline looks more like that of a full-scale pharma company's. In addition to new and better biologics, the company has small molecules, oral agents, and whole new therapeutic areas in development, including autoimmune diseases, gastroenterology, and oncology. "We don't define products by market; we define products by complementing the portfolio, market leadership, and addressing unmet medical needs," says Firouz. (See "Priority Pipeline,") Here are four of its most promising projects:

Oral cladribine. This R&D compound is still in Phase II, but it has stirred some interest from investors. Cladribine, in its current form, is an antineoplastic used to treat hairy cell leukemia, a cancer of the blood and bone marrow, but Serono's R&D team is developing an oral version for multiple sclerosis patients. "Early clinical trial results have shown an impressive reduction in brain lesions on MRI scans with this compound," says Lammers.

TACI-Ig. This Phase I project is a crossover drug that may someday treat autoimmune diseases such as lupus and rheumatoid arthritis, as well as some cancers such as B-cell malignancies. TACI-Ig is a fusion protein inhibitor of B-cell activation.

Lammers explains how it works: "B lymphocytes develop in bone marrow and then transfer to the spleen, where final cell maturation takes place. The latter leads, for example, to the production of plasma cells that, in turn, produce antibodies. During this maturation phase is when the cells get some of their 'immunological instructions' that could affect the type of antibodies they are going to produce. If these instructions are wrong, they could, for example, start producing so-called autoantibodies directed against otherwise healthy tissue cells. So with this drug, we are trying to attack and disturb that incorrect instruction process without touching what happens in the bone marrow."

Onercept. To complement Raptiva and bolster its new psoriasis franchise, Serono is developing this binding protein of tumor necrosis factor alpha (TNFa) to treat moderate-to-severe psoriasis. In Phase II trials, 50 percent of patients treated three times a week had a "major response" to therapy. "With psoriasis, it's all immune system driven," Lammers notes. "It is just a matter of where in the process you pick your place to interact." He also estimates that between 2 and 3 percent of the population has psoriasis and says, "It is a phenomenal business opportunity for us." The company also plans to test the drug in endometriosis as a potential addition to its reproductive health franchise.

Anastrozole. In development for ovulation induction, this treatment is intended to help infertile women in the first phase of trying to become pregnant and perhaps save them the expense and trouble of completing IVF (in vitro fertilization) cycles. "A product like anastrozole fits into the early stages of treatment and is further demonstration of our commitment to provide a complete portfolio of infertility treatments," Lammers says. "It works almost the same as clomiphene in initiating ovulation induction, but it's more focused and is expected to induce a higher pregnancy rate."


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