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12:00 AM
May 30, 2005
 |  BioCentury  |  Strategy

Serono reloads

Although Serono S.A. has a billion-dollar product in multiple sclerosis drug Rebif, the company has a pipeline problem. Minus two Phase III products that experienced setbacks last month, only two of its remaining six Phase III compounds are novel.

This month, Serono (SWX:SEO; SRA, Geneva, Switzerland) added four preclinical compounds and one Phase III product to its pipeline. The company says all are relatively low risk, as they address targets that are validated by marketed products.

"For all the targets, there is quite a body of evidence that they are key targets in their respective indications," said Leon Bushara, senior executive vice president of business development.

SEO's two most recent deals were with BioMarin Pharmaceutical Inc. for Phenoptin sapropterin and Phenylase phenylalanine ammonia lyase, and with NovImmune S.A. for two preclinical human antibodies to treat autoimmune diseases. Earlier in the month, SEO in-licensed HuMax-TAC, a human antibody against the interleukin-2 receptor, from Genmab A/S.

Prior to these deals and after the two setbacks in April, SEO had a pipeline of 20 preclinical and clinical programs; however, nine of them are extensions of already marketed products (see "Serono's Pipeline"). In April, SEO gave up development of Onercept, a recombinant human soluble type 1 TNF receptor (p55) in psoriasis. In addition, SEO and partner CancerVax Corp. (CNVX, Carlsbad, Calif.) discontinued Phase III trials of Canvaxin in stage IV melanoma.A Phase III trial in stage III melanoma is ongoing, with initial results due in the third quarter and final data expected in mid-2006 (see BioCentury, April 11).

For two of the three partners, the deals provide a just-in-time monetization event, while the third transaction fits into a strategy of off-loading programs with high development costs.


The deal with BioMarin (BMRN; SWX:BMRN, Novato, Calif.) is adding a new indication to SEO's portfolio. Phenoptin sapropterin and Phenylase phenylalanine ammonia lyase both are for phenylketonuria (PKU), a genetic disease caused by a deficiency of phenylalanine hydroxylase (PAH) enzyme. PAH is required to metabolize phenylalanine. If the active enzyme is not present in sufficient quantities, phenylalanine accumulates in the blood and brain, resulting in a variety of symptoms, including brain damage, seizures, tremors and cognitive problems. The only existing treatment is an expensive diet.

Phenoptin is in Phase III trials and has...

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