Eli Lilly has been cleared to license BioMS Medical's multiple sclerosis drug MBP8298.

 

The US Federal Trade Commission has cleared the global licensing and development agreement that grants Eli Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis compound, MBP8298. This represents a major step forward for Lilly, as the company looks to diversify its traditionally psychiatry-focused CNS offerings by expanding into neurology.

 

In December 2007, Lilly and BioMS entered into a global licensing and development agreement granting Lilly exclusive worldwide rights to the company's lead multiple sclerosis (MS) compound, MBP8298.  The synthetic peptide compound consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP).

 

 

MBP8298 is currently being evaluated in two pivotal Phase III clinical trials in secondary progressive MS (SPMS) and one Phase II trial in relapsing-remitting MS (RRMS).  BioMS will continue to oversee all current clinical trials, while Lilly will be responsible for all future R&D, manufacturing and marketing activities.

 

 

MBP8298 offers Lilly an ideal entry point into neurology.  Estimated to be worth $5.2 billion across the seven major markets - US, Japan, France, Germany, Italy, Spain, and the UK - in 2007, the MS market has shown consistently strong annual growth, and is estimated to be the largest neurology indication by value.  Additionally, with only Bayer Schering's Betaseron (interferon-beta 1b) and Merck Serono's Novantrone (mitoxantrone) approved for SPMS, this segment of the MS market represents an underserved and yet potentially high-value niche.

 

 

Lilly's psychiatry portfolio is coming to the end of its lifecycle, and the acquisition of MBP8298 represents its focus on investing in its future CNS offering ahead of the patent expiry of its antidepressant Cymbalta (duloxetine) in 2013. Lilly will be able to utilize its well-established expertise in the psychiatry sector, to help MBP8298 realize its full potential within the neurology arena.

 

 

Datamonitor anticipates the launch of MBP8298 for SPMS in the EU in 2011 and 2012 in the US.  With the additional approval for RRMS expected by the end of 2013, Datamonitor expects the dosing of once every six months to be highly favourable among a significant number of patients, and by 2016 sales are forecast to be in excess of $450 million.

 

Global Licensing and Development Agreement

 

 

Under the terms of the agreement, Lilly and BioMS Medical will collaborate on the development of MBP8298 and will also share in certain development costs with Lilly being responsible for future R&D, manufacturing and marketing activities. BioMS Medical will receive an upfront payment of $87 million, as well as potential development and sales milestones up to $410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 is successfully commercialized. BioMS Medical will continue to oversee the current clinical trials. Other terms of the deal were not disclosed.

 

"Lilly is pleased to add yet another promising late-stage compound to our portfolio," said Dr. William W. Chin, M.D., vice president of discovery research and clinical investigation for Lilly. "Multiple sclerosis is a disease with significant unmet patient needs. MBP8298 has shown potential in slowing the progression of secondary progressive MS, and thus may provide an effective therapeutic option for patients with this debilitating disease. We are also hopeful that MBP8298 may prove beneficial in treating patients with relapsing remitting MS. We intend to fully leverage our expertise in neuroscience to continue the development of this novel molecule."

 

"We are very pleased to collaborate with Lilly on the worldwide development of MBP8298," said Kevin Giese, President and CEO at BioMS Medical. "Lilly's well established leadership in the neurology arena and considerable resources, expertise and proven ability to launch first-in-class drugs will help MBP8298 to realize its full development and commercial potential."

 

About MBP8298

 

MBP8298 is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of MBP8298 is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

 

The apparent mechanism of action of MBP8298 is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide delivered periodically by the intravenous route. The potential benefit of MBP8298 for any individual patient is therefore expected to be related to the role this peptide plays in that patient's immune system.  The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

 

The results of phase II and long-term follow-up treatment of MS patients with MBP8298, published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with the genes - HLA types DR2 and/or DR4. Thus, MBP8298 has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

 

MBP8298 is being developed in three late-stage clinical trials: 

 

  • MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe. 
  • MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States. 
  • MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

 

About MAESTRO-03

 

 

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

 

Recently the Company announced that more than 133 patients have been enrolled in its MAESTRO-03 trial. An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial.

 

 

Source: BioMS Medical Corp (12/12/07) Source: BioMS Medical Corp. (18/12/07)