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Multiple Sclerosis

Brief Marketplace Overview

3Q, 2007

The Multiple Sclerosis market is growing at a rate of 7% annually, with global sales of approximately $5 billion.  70% of market share is comprised of Interferon products, with the majority of remaining share belonging to Copaxone.  Progressive market growth is expected to continue through the end of the decade.

Copaxone is a non-interferon treatment frequently prescribed as initial therapy.  It is available in the EU and recently approved by the US FDA for the treatment of relapsing, remitting MS (RRMS).  A Phase III trial is underway to confirm increased efficacy and an acceptable safety profile of the 40 mg vs. the marketed 20 mg dose.  Teva also has a non-exclusive agreement with Medi-Ject Corporation (now Antares Pharma) to develop a customized, needle-free delivery system.  Analysis of the PROMISE study data revealed significant delay in accumulated disability among male patients with PPMS receiving Copaxone vs. placebo, however, the results in women were not significant.  Since no significant treatment outcome could be projected for the primary endpoint, (time to progression of EDSS, i.e., change of 1.0 EDSS point or greater for entry EDSS of 3.0 – 5.0 or 0.5 for entry EDSS of 5.5 – 6.5), the trial was terminated early.

Merck Serono maintains a non-exclusive license to import, manufacture and sell Rebif in the US.  Current share is expected to enlarge as a result of new formulation marketing without human serum albumin, minimizing injection site reactions.  Superior performance of Rebif in comparative clinical studies resulted in loss of Avonex’ Orphan Drug Status.

The ONWARD 2 year, 260 patient (with a history of relapse while on Rebif), Phase III trial was initiated in evaluation of the new 44 mcg Rebif formulation administered SQ 3 times per week + oral cladribine, as a follow-on to the CLARITY monotherapy cladribine Phase III trial.  The REFLEX Phase III trial in early MS, is targeting at-risk patients with suggestive MS lesions in conjunction with a recently experienced isolated demyelinating event.

Biopartners and Rentschler Biotechnologie are collaborating in the clinical development of an improved formulation of recombinant interferon beta which is free of human serum albumin.  Rentschler maintains development rights while Biopartners holds exclusive worldwide commercialization rights for the improved formulation in RRMS.  Biopartners announced the Biferonex MAA submission on August 20th.

Genzyme/Bayer’s Campath encountered delays relating to the incidence of ITP in their Phase II trial.  Highest doses were eliminated, and, after discussions with the FDA, Phase III trials are resuming.  Encouraging Phase II results were presented at AAN 2007.

Accentia’s Revimmune shows promise in MS as well as other autoimmune diseases.  Ultra-high intensity, short-course Cyclophosphamide is administered by IV infusion, sparing stem cells and temporarily eliminating peripheral immune cells.  New cells originating are significantly less likely to target self-antigens.

Vaccinex/Teva are partnering on VX15, a human antibody preparation in preclinical development.  Additional Preclinical compounds include Lexicon’s LX2931 and Chronos’ CHR-1103.

Recent evidence indicates that initial black hole and T2 lesions on MRI at diagnosis can be predictive of cerebral atrophy during the subsequent 2 years.  Acorda found statistically significant walking improvement results receiving Fampridine-SR, leading to pressure from majority shareholders to divest the company.

BioMS, an innovator in the field, has initiated enrollment of the 60 site, 510 patient  MAESTRO-03, a Phase III MBP8298 secondary progressive MS trial initiated June 2007.  MAESTRO-01 has closed enrollment of 611 patients in the EU and Canada, evaluating SPMS.  MINDSET-01, a 15 month Phase II MBP8298 RRMS trial completed enrollment of 215 patients as of May, 2007.  Phase II results have demonstrated median time to disease progression delay in progressive MS HLA-DR2 or HLA-DR4 positive patients.

Opexa is evaluating the T-cell vaccine Tovaxin in the 52 week Phase IIb TERMS trial, targeting 150 patients at 35 US sites with enrollment now complete.  Endpoints include cumulative contrast enhancing T1 summed lesions, change in T2 lesions and the annualized relapse rate.

Novartis’ is developing fingolimod, a sphingosine-1-phosphate receptor agonist with oral once daily first-line potential usage.  The FREEDOMS trial, comparing 0.5 and 1.25 mg.  doses with placebo, is currently enrolling.  Our sources state that enrollment closure may occur as early as September/October, with LPLV projected for 4Q, 2009.  Regulatory filing may, however, occur sooner.  In Japan it will be co-developed and co-marketed by Mitsubishi.  Revenues of $338 million in 2010, growing to $936 million in 2012 have been forecast.

Fampridine , a potassium channel blocker has been shown to restore conduction in demyelinated axons, resulting in improved walking ability, leg strength and muscle spasticity. Acordia, with exclusive worldwide rights to Fampridine-SR has been granted Orphan Drug status, utilizing Elan’s proprietary Intestinal Protective Drug Absorption System technology.  Fampridine-SR Phase III Trials are now rapidly enrolling with closure projected, according to our sources, for as early as September.  Preliminary results evidence a 30% response rate while on treatment, 30% response rate realized after discontinuation of therapy, 30% non-responders, and a 10% dropout rate.  Neurorecovery, Inc. has disclosed that it has a competitive immediate release form of fampridine in Phase II trials for peripheral nervous system diseases.

Phase II Daclizumab trial results have demonstrated benefit as an add-on to interferon therapy in MS patients with aberrant T cell activity.  Millennium’s development of MLN1202, a humanized monoclonal antibody, continues.  Teriflunomide is an orally active dihydro-orotate dehydrogenase inhibitor in Phase III clinical trials for the treatment of multiple sclerosis in France.

MS improvement in pregnancy points to Prolactin as a potential beneficial agent in promoting myelin production.  It has been found that regulatory T-cell augmentation in the presence of parasitic disease may benefit those with MS.  Zymogenetics and Merck Serono plan further atacicept (TACI-Ig) MS development, and Immune Response’s Neurovax T-cell receptor peptide vaccine is progressing.

Teriflunomide is an orally active dihydro-orotate dehydrogenase inhibitor in Phase II clinical trials for the treatment of multiple sclerosis in France.
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