Toronto Stock Exchange Symbol: MS
EDMONTON, May 15 /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 first quarter ended March 31, 2008. BioMS, in partnership with Eli Lilly and Company, is developing dirucotide (also known as MBP8298), a synthetic peptide drug for the treatment of MS undergoing pivotal trials in Canada, Europe and the US.
"During the quarter, we completed our landmark partnership deal with Eli Lilly and Company," said Kevin Giese, President and CEO of BioMS Medical. "We now look forward to multiple clinical milestones for dirucotide (MBP8298) over the next 24 months. In the near-term, the Data Safety Monitoring Board for our MAESTRO-01 pivotal trial will review data from the first 200 patients in the trial and recommend whether the trial should continue. A positive outcome from this review, anticipated in the third quarter of 2008, is expected to trigger a milestone payment from our new partner."
Currently, BioMS is conducting three clinical trials and one open-label
follow-on trial for dirucotide (MBP8298):
- MAESTRO-01: A pivotal phase II/III trial in Canada and Western Europe
evaluating dirucotide (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 dirucotide
(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).
- 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 dirucotide
(MBP8298) on an un-blinded basis. To date, approximately 95% of
patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide
(MBP8298) for the treatment of SPMS. Enrollment for the randomized,
double-blind study was initiated in June, 2007 and to date there have
been in excess of 375 patients enrolled. The trial will include
approximately 510 patients at approximately 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. The trial is expected to
complete enrollment in mid-2008.
- MINDSET-01: A phase II clinical trial evaluating dirucotide (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. 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 dirucotide (MBP8298). Under the terms of the agreement, Lilly and BioMS will collaborate on the development of dirucotide (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 dirucotide (MBP8298) is commercialized. The completion of the licensing agreement with Lilly resulted in a one time payment of a $9.0 million licensing bonus to Corporation personnel, paid in February, 2008.
The consolidated net loss for the first quarter ended March 31, 2008 was $6.7 million or ($0.07) per share compared to a consolidated net loss of $12.9 million or ($0.17) per share for the first quarter of the previous year.
Revenue for the three months ended March 31, 2008 was $12.8 million compared to $nil for the first three months of the previous year. 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 March 31, 2008 were $22.2 million compared to $13.3 million for the first three months of the previous year.
Research and development expenses for the first quarter ended March 31, 2008 totaled $13.1 million compared to $10.3 million for the first quarter of the previous year. The increase of $2.8 million is primarily attributable to: a one time licensing bonus payment of $3.4 million to research and development personnel, a decrease in drug manufacturing costs of $1.4 million and a decrease in clinical trial expenses of $1.7 million. 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 while the MAESTRO-02 and MAESTRO-03 trials increase in number of patients under treatment.
General and administrative expenses were $8.7 million for the three months ended March 31, 2008 compared to $2.6 million for the three months ended March 31, 2007. The increase is primarily attributable to: a one time licensing bonus payment of $5.6 million to corporate administrative personnel; costs associated with the completion of the licensing agreement including travel, consultants, legal advisors and financials advisors; and increased investor relations and media relations costs in support of creating awareness for BioMS in the US and Canada.
Investment income earned on funds invested was $0.7 million for the three months ended March 31, 2008, compared to $0.4 million for the first three months of the previous year.
At March 31, 2008, cash and short-term investments totaled $107.9 million as compared to $38.0 million at December 31, 2007. At March 31, 2008, the Company had working capital of $105.0 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 Company to meet its obligations in respect of the currently initiated clinical trials for which it is responsible under the Lilly agreement.
As at March 31, 2008 there were 91,400,523 common shares of the Company issued and outstanding, 26,021,528 warrants and 9,001,000 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, dirucotide (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. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 in exchange for an US $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 dirucotide (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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