Biotech Values

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Merck KGaA gaining rights to Peptimmune PI-2301 program.

German drug major Merck KGaA (MRK: DE) is taking another look at the multiple sclerosis market, where it is already a leader with its Rebif (interferon beta-1qa), acquiring worldwide exclusive rights to PI-2301, an experimental drug for multiple sclerosis, previously developed by privately-held US biotech Peptimmune. PI-2301 has completed Phase Ib in multiple sclerosis and is ready to initiate Phase II clinical trials.
Merck suffered a disappointment in its attempts to develop an oral MS drug, Movectro (cladribine), finally deciding to drop the program and leaving the tablet sector clear for Swiss drug major Novartis’ Gilenya (fingolimod), which gained regulatory clearance last year (The Pharma Letter June 23). The advent of oral MS treatments is expected to expand the already $10 billion a year MS market to some $15 billion.
“Over the years we have continuously worked on developing innovative treatment options that meet the individual needs of people living with multiple sclerosis,” said Susan Herbert, head of global portfolio development at the Merck Serono division, adding: “We are pleased to strengthen our development pipeline with the PI-2301 compound, which could play a valuable role in the treatment of this debilitating disease.”
Option previously granted to Novartis
The acquisition of PI-2301 covers its worldwide exclusive development and commercialization rights. Financial terms of the deal were not disclosed. Peptimmune previously granted Novartis an exclusive option to obtain exclusive worldwide rights to develop and commercialize PI-2301 that could have earned it as much as $500 million (TPL January 26, 2009), which clearly the Swiss firm has not taken up.
PI-2301 is a second-generation peptide copolymer from a similar compound class as Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate). The compound works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in autoimmune diseases such as multiple sclerosis. PI-2301 has been optimized using Peptimmune’s novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis and other autoimmune diseases where immune modulation may be effective, such as Crohn’s disease, rheumatoid arthritis and autoimmune uveitis.

http://www.thepharmaletter.com/file/107412/merck-kgaa-has-another-stab-at-multiple-sclerosis-gaining-rights-to-peptimmune-pi-2301-program.html