Toronto Stock Exchange Symbol: MS
EDMONTON, March 18 /CNW/ - 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
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
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 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.
For further information:
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: email@example.com, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: