Toronto Stock Exchange Symbol: MS
EDMONTON, March 18 /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 year ended December 31, 2007.
"We continue to focus on the worldwide development of MBP8298, our proprietary synthetic peptide drug for the treatment of multiple sclerosis, which is being evaluated in several late-stage trials in the U.S., Canada and across Europe," said Kevin Giese, President and CEO of BioMS Medical. "The magnitude of the partnership we formed with Lilly at the end of 2007 for the global rights to MBP8298 underscores the enormous potential of our drug and is a validation of all the years of hard work performed by our team."
Currently, BioMS is conducting three clinical trials and one open-label
follow-on trial for MBP8298:
- MAESTRO-01: A pivotal phase II/III trial in Canada and Western Europe
evaluating MBP8298 for the treatment of secondary progressive MS
("SPMS"). On January 22, 2007, BioMS announced that the trial had
completed full recruitment of 611 patients at 47 trial sites in
10 countries. Patients are administered either MBP8298 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"). An interim analysis on the first 200 patients is expected
- 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 on
an un-blinded basis.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating MBP8298 for the
treatment of SPMS. Enrollment for the randomized, double-blind study
was initiated in June, 2007 and to date there has been in excess of
200 patients enrolled. The trial will include approximately 510
patients at approximately 65 sites across the U.S. The DSMB has
conducted its first review of the data from this trial and has
recommended it continue. The trial is expected to complete enrollment
- MINDSET-01: A phase II clinical trial evaluating MBP8298 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 6 countries across Europe. The DSMB has
completed three safety analyses to date and recommended that the
trial continue as per the protocol.
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 its lead MS compound, MBP8298. Under the terms of the agreement, Lilly and BioMS will collaborate on the development of MBP8298 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 is commercialized. BioMS will continue to oversee the current trials. The completion of the transaction resulted in licensing bonuses, as contemplated in a number of pre-existing employment agreements, paid to all Company personnel in February 2008 of $9.0 million which was reviewed and approved by the independent Compensation Committee, and supported by an independent compensation consultant review.
The consolidated net loss for the year ended December 31, 2007 was $47.2 million or ($0.56) per share compared with a consolidated net loss of $40.9 million or ($0.62) per share for the previous year. The consolidated net loss for the fourth quarter ended December 31, 2007 was $11.7 million or ($0.13) per share compared with a consolidated net loss of $14.1 million or ($0.20) per share for the fourth quarter of the previous year.
Total consolidated expenses for the year ended December 31, 2007 were $48.0 million compared to $42.2 million for the previous year. Total consolidated expenses for the three months ended December 31, 2007 were $12.1 million compared to $14.4 million for the same quarter of the previous year.
Research and development expenses for the year ended December 31, 2007 totaled $38.9 million compared with $35.2 million in 2006. The increase was due primarily to the start up and initial enrollment of patients in the MAESTRO-02 follow-on trial, the full enrollment and continuation of the MINDSET-01 clinical trial and the start-up and commencement of enrolment of the MAESTRO-03 clinical trial. It is expected that research and development expenses will increase over the next two years as the current clinical trials for MBP8298; MAESTRO-01, MAESTRO-02, MAESTRO-03 and MINDSET-01, continue in Canada, Europe and the U.S.
Research and development expenses were $9.3 million for the fourth quarter ended December 31, 2007 compared to $12.5 million for the fourth quarter of the previous year. The reduction in expenses was the net result of reduced costs for the MAESTRO-01 trial, as more patients are completing or near completion of their two years on the trial, and a reduction in the number of batches of MBP8298 manufactured in the year, offset by start-up costs for the MAESTRO-02 and MAESTRO-03 trials.
General and administrative expenses were $7.5 million for the year ended December 31, 2007 compared to $5.4 million for the year ended December 31, 2006. General and administrative expenses were $2.3 million for the three months ended December 31, 2007 compared with $1.5 million for the fourth quarter of 2006. The increase was primarily due to expenses related to conducting partnering discussions with various interested parties.
During the year, the Corporation strengthened its cash position through the issuance of 16,100,000 units by way of a public offering at $2.75 per share, for gross proceeds of $44.3 million.
At December 31, 2007, cash and short-term investments totaled $38.0 million as compared to $43.1 million at December 31, 2006. At December 31, 2007, the Corporation had working capital of $34.8 million as compared to $37.4 million at December 31, 2006. The Corporation's cash position and working capital were increased by $87 million in January 2008 with the completion of the agreement with Lilly and the receipt of the upfront payment. Management estimates that the current working capital is sufficient for BioMS to meet its obligations in respect of the currently initiated clinical trials through to the end of the MAESTRO-01 clinical trial.
As at December 31, 2007 there were 91,410,323 Class "A" common shares of the Corporation issued and outstanding.
Notice of AGM
BioMS will be holding its Annual General Meeting on Friday, May 9, 2008 at 2:00 pm (MST) at the Delta Edmonton South Hotel and Conference Centre, 4404 Gateway Boulevard, Edmonton, Alberta.
About BioMS Medical Corp.
BioMS Medical is a biotechnology corporation engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, 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. 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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