BioWorld International Correspondent
PARIS - Serono SA has consolidated its position as the world's third largest biotechnology company by driving its revenues through the $1.5 billion mark in 2002.
Amgen Inc. and Genentech Inc. are the largest biotech companies.
Serono's total revenues rose 12.4 percent to $1.55 billion last year, with product sales up 13.9 percent at $1.42 billion. Net income edged up 1.3 percent to $320.8 million, but on a like-for-like basis it increased by 14.6 percent to $333.8 million (excluding a $16.3 million restructuring charge).
The company's performance was particularly strong in the fourth quarter, when revenues bounded by 20.9 percent to $442.1 million. For 2003, it is forecasting a further increase of 15 percent to 20 percent in both revenues and net income.
Serono said its gross margin on sales rose to 84.3 percent last year from 82.9 percent in 2001 "as a result of the continued increase in the proportion of biotechnology products in total sales" and of more efficient manufacturing practices. Serono also said it has created a "unique genetics and genomics discovery platform" as a result of its takeover of Genset SA, indicating that it has now completed the integration of the French genomics company.
The company's top selling product in 2002 was its interferon beta 1-a, Rebif, for multiple sclerosis. Worldwide sales of Rebif jumped by 44.6 percent to $548.8 million, following its March 2002 launch on the U.S. market, where Serono is co-promoting it with Pfizer Inc. In the fourth quarter in particular, sales of Rebif were 55.3 percent ahead of a year earlier.
Serono provided the following status report on 10 products that are at an advanced stage of its research and development pipeline:
• Onercept (r-TBP-1): A successful Phase II clinical trial in psoriasis and psoriatic arthritis conducted in 2002 is due to be followed by a Phase III trial in the second half of 2003.
• Raptiva: Licensed from Genentech Inc., the product will be filed in Europe for moderate to severe psoriasis this quarter and is currently in Phase II trials for rheumatoid arthritis.
• Serostim: It completed a positive Phase III trial for the treatment of short bowel syndrome in 2002 and a regulatory submission in that indication was filed with the FDA in the fourth quarter. Serostim also completed a positive Phase II/III trial in the indication of HARS (HIV-associated adipose redistribution syndrome) last year.
• r-IL-18 binding protein: It underwent a Phase I study last year, and further studies in patients suffering from psoriasis and rheumatoid arthritis are planned in 2003.
• Anastrozole: This product, designed to induce ovulation, is due to be tested in a large Phase II trial in the U.S. starting this quarter.
• r-IFN-beta 1a: A Phase III study on Asian patients suffering from chronic hepatitis C is under way.
• PEG-GHRF (pegylated growth hormone releasing factor): A Phase I trial of the product, which is being developed for disorders related to growth hormone deficiency, started in late 2002.
• Oral formulation of cladribine: A Phase I trial of this product, which is being co-developed IVAX Corp., is scheduled to begin in 2003.
• r-hLIF: A Phase II trial for the treatment of embryo implantation failure will be initiated early this year.
• r-IL-6 (atexakin alfa): This product being developed for diabetic neuropathy is to be taken directly into a Phase II trial in 2003 on the strength of preclinical results.