Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex.

The Bravo study completed patient enrollment in June 2009, recruiting more than 1,200 patients at 156 sites in the US, Europe, Israel and South Africa.

Allegro, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia, said Teva. The trial is currently ongoing.

Moshe Manor, Teva’s group vice president of global branded products, said: “Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating multiple sclerosis therapy that provides efficacy while maintaining safety. We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for relapsing-remitting multiple sclerosis patients.”

View full article here: http://www.tmcnet.com/usubmit/2009/06/26/4246746.htm

Merck KGaA on Wednesday presented detailed results from a previously announced Phase III study of investigational oral multiple sclerosis drug cladribine at the American Academy of Neurology annual conference. The findings demonstrated that annual short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients with relapsing-remitting MS, and also led to a significant increase in the proportion of patients who remained relapse-free, the drugmaker said.

The CLARITY study involved 1326 patients who were randomised to receive one of two doses of cladribine or placebo. Results showed that patients treated with the low-dose regimen of cladribine experienced a 58-percent relative reduction in annualised relapse rates, compared with placebo, while those in the high-dose regimen group experienced a relative reduction of 55 percent. The company also stated that, over the two-year course of the study, treatment with cladribine also led to a more than 30-percent reduction in the risk of disability progression relative to placebo.

Lead author Gavin Giovannoni noted that “our study shows that cladribine tablets prevent relapses and slow down the progression of the disease, making patients feel better. Importantly, it does so without the need for constant injections that are associated with unpleasant side effects.” He added that “we will continue to follow the patients in the trial to see how they fare in the long-term.” Meanwhile, Lee Dunster, head of research at the MS Society, commented that the drug’s oral formulation “will be a huge step forward for people with MS.”

Merck reiterated that it plans to submit the drug for approval by US and EU regulators in mid-2009.

View full article here: http://www.firstwordplus.com/Fws.do?articleid=BDCD24CD3CA5428BBE3225FD9B646E12

A case report on the patient who developed the condition after taking part in a Phase III clinical trial of the medicine — one of the big hopes in the Swiss group’s pipeline — was published in the March edition of the journal Neurology.

Novartis said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.

‘As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators,’ spokesman Eric Althoff said.

‘It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed,’ Althoff said.

Citigroup analysts said they were still concerned about the safety of FTY720 and saw the most recent side effect report as a small positive for Merck KGaA, whose rival MS pill cladribine may be the first MS drug taken by mouth, as opposed to injection, to hit the market.

Novartis said last year that two patients taking FTY720 in clinical trials had problems with infections and one died, but the role of the drug in the cases was unclear.

Novartis shares fell 1.6 per cent to 41.80 Swiss francs by 1230 GMT, versus a 1.1 per cent drop in the European healthcare sector. Merck shares fell 2.6 per cent. — Reuters

Read entire article here: http://www.themalaysianinsider.com/index.php/business/23315-novartis-ms-drug-linked-to-new-side-effect

This was the fourth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

About MAESTRO-03
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 67 clinical sites who will be administered either dirucotide 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 70% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com

Edmonton, Alberta, March 17, 2009 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the year ended December 31, 2008.

“Dirucotide has demonstrated the ability to safely affect MS progression in previous studies and we look forward to the results of the Canadian/European trial (MAESTRO-01) in the second half of this year,” said Kevin Giese, President and CEO of BioMS Medical. “Our hope is that the results of this trial will confirm that dirucotide is able to significantly slow the progression of MS, specifically in patients with secondary progressive multiple sclerosis.”

Currently, BioMS is conducting two clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):

• MAESTRO-01: On January 22, 2007, BioMS announced that this pivotal phase III trial, being conducted in Canada and Western Europe, had completed full recruitment of 611 SPMS patients at 47 trial sites in ten countries. To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB). The primary clinical endpoint for MAESTRO-01 (and MAESTRO-03) 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.

On August 13, 2008, the DSMB conducted a scheduled interim analysis of efficacy and safety and recommended that the trial continue to completion. The interim analysis evaluated the first 200 patients to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial. Based on the DSMB decision, Eli Lilly and Company (Lilly) provided a US $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.

BioMS anticipates MAESTRO-01 will be completed in 2009 with results from the trial expected in the second half of this year.

• MAESTRO-02: Eligible patients who have successfully completed MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in this open-label follow-on study. To date, approximately 95% of the eligible patients who have successfully completed the MAESTRO-01 trial have enrolled in this follow-on study.

• MAESTRO-03: Enrollment was initiated in June, 2007 and completed on August 1, 2008 for this pivotal U.S. phase III trial of approximately 510 SPMS patients at 67 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and recommended it continue. The next DSMB review is expected to take place in the second quarter of fiscal 2009.

• MINDSET-01: MINDSET-01 was a randomized, double-blind study that recruited 218 relapsing-remitting MS patients at 24 trial sites in six countries across Europe. BioMS recently announced that the top line results of this exploratory study did not meet its primary endpoint of effecting annualized relapse rate or associated secondary magnetic resonance imaging (MRI) endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the EDSS and the MS Functional Composite (MSFC) score. Changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III SPMS trials.

The data also showed that dirucotide was generally well tolerated. The most common side effects reported were redness and burning sensation at the injection site. No patients withdrew due to adverse events.

Eligible patients in this trial are now receiving dirucotide on an un-blinded basis to the end of their 27th month in the trial.

Licensing and Development Agreement with Lilly
On December 17, 2007, BioMS entered into a licensing and development agreement (the “Agreement”) granting Lilly exclusive worldwide rights to dirucotide. The transaction closed on January 25, 2008 and BioMS received an upfront payment of US $87 million. In September 2008, BioMS received a development milestone payment of US $10 million as a result of the positive interim analysis from the DSMB for MASESTRO-01. BioMS has the potential to receive future development and sales milestones up to US $400 million and escalating royalties on sales if dirucotide is commercialized.

Not later than sixty (60) days following receipt of the final written report of the results of the MAESTRO-01 trial, Lilly shall notify BioMS in writing whether Lilly will terminate the Agreement or alternatively Lilly shall bear 100% of any and all continuing development costs incurred by Lilly or BioMS for dirucotide.

HYC750 and BioCyDex
On May 9, 2008, BioMS entered into a Royalty and Assignment Agreement with Orcrist Bio. Inc. for HYC750, a technology based on hyaluronic acid that has a number of potential therapeutic uses and is being developed as a treatment for the side effects of chemotherapy. BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the Royalty and Assignment Agreement, BioMS terminated its license with the University of Alberta and the University entered into a direct license with Orcrist. BioMS assigned all BioMS owned patents relating to HYC750 and transfered all HYC750 assets to Orcrist. Under the terms of the agreement, BioMS will receive certain milestone payments in addition to a royalty on net sales of products which otherwise would have infringed on patents related to the HYC750 technology.

BioMS also ceased all development activities with respect to BioCyDex. Future development or licensing activities will be the responsibility of BioCyDex.

Financial Results
The consolidated net loss for the year ended December 31, 2008 was $0.5 million or ($0.01) per share compared with a consolidated net loss of $47.2 million or ($0.56) per share for the previous year. The consolidated net income for the three months ended December 31, 2008 was $0.3 million or $0.01 per share compared with a net loss of ($11.7) million or ($0.13) per share for the previous year.

Revenue of $52.6 million was recorded for the year ended December 31, 2008 compared to $Nil for the year ended December 31, 2007. The revenue is the result of the amortization of the upfront payment and development milestone received from the Agreement with Lilly. Investment income earned on funds invested for the year ended December 31, 2008 increased to $2.4 million from $1.6 million for 2007 due to the increase in cash and cash equivalents as a result of the Agreement with Lilly. The increase was partially offset by a general reduction in interest rates experienced in the market. The investment income is earned from the short-term investment of cash reserves in low risk term deposits and bankers acceptance notes.

Total consolidated expenses for the year ended December 31, 2008 were $61.9 million compared with $48.0 million for 2007. Total consolidated expenses for the three months ended December 31, 2008 totaled $16.5 million as compared to $12.1 million in the same quarter the previous year.

Research and development expenses for the year ended December 31, 2008 totaled $46.5 million compared with $38.9 million in 2007. Research and development expenses were $13.9 million for the three months ended December 31, 2008 compared to $9.3 million for the same quarter the previous year. The increase in expenses was the net result of: achieving full enrolment of clinical sites and patients in the MAESTRO-03 trial; increased costs for the MAESTRO-02 trial as patients enter the trial; reduced costs of the MAESTRO-01 and MINDSET-01 trials as more patients complete these trials; a decrease in drug manufacturing expenses as the manufacture of validation batches is completed; a licensing bonus payment related to the Agreement with Lilly, and; additional expenses related to alliance management and support.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com