Toronto Stock Exchange Symbol: MS
EDMONTON, Aug. 12 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the second quarter ended June 30, 2008. BioMS Medical, in partnership with Eli Lilly and Company (Lilly), is developing MBP8298 (dirucotide), a drug for the treatment of MS undergoing pivotal trials in Canada, Europe and the US.
"The three randomized late-stage clinical trials for MBP8298 (dirucotide) continue to progress very well. We recently announced that MAESTRO-03, our U.S. phase III secondary progressive MS trial, was fully recruited with approximately 510 patients," said Kevin Giese, President and CEO of BioMS Medical. "During the quarter, BioMS was also honored to receive the Gold Leaf Award from BIOTECanada in recognition of our selection as "Company of the Year".
Currently, BioMS is conducting three clinical trials and one open-label follow-on trial for MBP8298 (dirucotide):
(x) MAESTRO-01: A randomized, double-blind pivotal phase II/III trial in Canada and Europe evaluating MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The study has completed full recruitment of 611 patients at 47 trial sites in 10 countries. Patients are administered either MBP8298 (dirucotide) or placebo every six months for a period of two years. To date, there have been eight positive safety reviews from the Data Safety Monitoring Board (DSMB).
(x) MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal trial. Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial may choose to receive MBP8298 (dirucotide) on an un-blinded basis. To date, approximately 95% of patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02.
(x) MAESTRO-03: A U.S. pivotal phase III trial evaluating MBP8298 (dirucotide) for the treatment of SPMS. Enrollment for the randomized, double-blind study was initiated in June, 2007 and on July 31, 2008, BioMS completed full recruitment of approximately 510 patients at 68 sites across the U.S. To date, the DSMB has conducted two reviews of the data from this trial and has recommended it continue.
(x) MINDSET-01: A phase II clinical trial evaluating MBP8298 (dirucotide) for the treatment of relapsing-remitting MS (RRMS). The randomized, double-blind study has completed recruitment with 218 patients enrolled at 24 trial sites in six countries across Europe. The DSMB has completed five safety reviews to date and recommended that the trial continue as per the protocol. Completion of the trial is expected at the end of 2008 with results anticipated in the first half of 2009.
Licensing and Development Agreement
On December 17, 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 (dirucotide). Under the terms of the agreement, Lilly and BioMS will collaborate on the development of MBP8298 (dirucotide) and will also share in certain development costs with Lilly being responsible for future research and development, manufacturing and marketing activities. The transaction closed on January 25, 2008 with the receipt of an upfront payment of US$87 million. BioMS has the potential to receive additional development and sales milestones of up to US $410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 (dirucotide) is commercialized.
The consolidated net loss for the three months ended June 30, 2008 was $0.4 million or ($0.00) per share compared to a consolidated net loss of $11.8 million or ($0.14) per share for the three months ended June 30, 2007. The consolidated net loss for the six months ended June 30, 2008 was $7.1 million or ($0.08) per share compared to a consolidated net loss of $24.6 million or ($0.31) per share for the same period of 2007.
Revenue for the three months ended June 30, 2008 was $11.2 million compared to $nil for the same period of 2007. Revenue for the six months ended June 30, 2008 was $24.0 million compared to $nil for the same period of 2007. The revenue is the result of recognizing a portion of the upfront payment received on the completion of the licensing agreement with Eli Lilly and Company.
Total consolidated expenses for the three months ended June 30, 2008 were $11.4 million compared to $12.1 million for the same period of 2007. Total consolidated expenses for the six months ended June 30, 2008 were $33.6 million compared to $25.4 million for the period of 2007.
Research and development expenses for the three months ended June 30, 2008 totaled $9.3 million compared to $10.2 million for the three months ended June 30, 2007. It is expected that total research and development expenses will remain constant over the next two years as the MAESTRO-01 and MINDSET-01 clinical trials near completion and MAESTRO-02 and MAESTRO-03 increase in number of patients under treatment. General and administrative expenses were $1.7 million for the three months ended June 30, 2008 compared to $1.5 million for the three months ended June 30, 2007.
At June 30, 2008, cash and short-term investments totaled $96.1 million as compared to $38.0 million at December 31, 2007. At June 30, 2008, the Corporation had working capital of $93.1 million (excluding the current portion of deferred revenue which does not represent a cash obligation) as compared to $34.8 million at December 31, 2007. Management estimates that the current working capital is sufficient for the Corporation to meet its obligations in respect of the currently initiated clinical trials for which it is responsible under the Lilly agreement.
As at June 30, 2008 there were 91,163,323 common shares of the Corporation issued and outstanding, 26,021,528 warrants and 9,161,500 stock options.
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, MBP8298 (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. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 (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.
This press release may contain forward-looking statements, which reflect the Corporation's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that MBP8298 will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
|SOURCE BioMS Medical Corp.|
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