Serono hails progress towards MS gene map
pharmafile | March 22, 2005 | News story | Sales and Marketing |Â Â Â
Serono has announced it has reached a major milestone towards identifying the genes involved in multiple sclerosis.
The company has identified for the first time the 80 genes involved in the inflammatory and neuro-degenerative pathways of the complex and little-understood disease.
Professor Daniel Cohen, vice president and worldwide head of genetics at Serono, said: "The completion of the MS Whole Genome Scan in 2006 will lead to a comprehensive catalogue of potential MS drug targets providing a basis for the future development of innovative MS therapies."
When the entire genome is mapped Serono will be able to identify proteins that can be used either as targets for drug development or directly as therapeutics.
The work by researchers at the Serono Genetics Institute (SGI) was based on a 40% genome scan comparing the genetic profiles of 1,800 people, divided evenly between those with MS and healthy individuals in French, Swedish and US populations.
Researchers at SGI used Affymetrix's GeneChip technology to scan over 100,000 single nucleotide polymorphisms (SNPs) to identify the genes involved in MS. The next step will be to continue this screening and apply next generation GeneChip technology to scan over 500,000 SNPs and thus complete the MS Whole Genome Scan during 2006.
Serono is the world's third largest biotech company and MS treatment Rebif is its biggest selling brand. Sales of the product grew 33% in 2004, breaking the $1 billion mark for the first time and is currently the leading treatment for relapsing MS outside the US and the fastest growing MS treatment in the US.
The company recently started phase III clinical trials of a new treatment for the disease.
Collaborating with Ivax, Serono has started a two-year phase III clinical trial of Mylinax (a proprietary oral formulation of cladribine) as a treatment for patients with relapsing forms of MS.
Ernesto Bertarelli, chief executive of Serono, said: "As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with multiple sclerosis.
"With the initiation of the phase III programme of Mylinax, we are getting closer to realising our objective to bring the first oral disease-modifying treatment to people with multiple sclerosis."
More than 1,200 patients will be enrolled for the two-year trial, which will measure clinical relapses, disability progression and MRI brain scans.
Serono's Rebif received a boost recently after the marketing of Elan and Biogen Idec's Tysabri was suspended following the death of a patient.
The drug was to be a major competitor but its withdrawal after less than three months was a major blow for its co-marketers, but a boost for Serono which saw its sales climb 20% on the news.
Elan and Biogen Idec stopped marketing their potential blockbuster Tysabri and asked doctors not to prescribe it after two patients developed progressive multi-focal leukoencephalopathy (PML) and one died.
Analysts Goldman Sachs commented: "Any threat to Serono's Rebif from Biogen Idec/Elan's Tysabri diminished significantly with the announcement of Tysabri's marketing suspension and the occurrence of PML.
The analysts consequently increased their long-term sales forecast for Rebif on the news and now expect it to reach $2.1 billion by 2009. They also say Serono will now need to spend less on sales and marketing to protect the product sales.
