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"The three randomized late-stage clinical trials for MBP8298 (dirucotide)continue to progress very well. We recently announced that MAESTRO-03, ourU.S. phase III secondary progressive MS trial, was fully recruited withapproximately 510 patients," said Kevin Giese, President and CEO of BioMSMedical. "During the quarter, BioMS was also honored to receive the Gold LeafAward from BIOTECanada in recognition of our selection as "Company of theYear".
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Currently, BioMS is conducting three clinical trials and one open-labelfollow-on trial for MBP8298 (dirucotide):
(x) MAESTRO-01: A randomized, double-blind pivotal phase II/III trial inCanada and Europe evaluating MBP8298 (dirucotide) for the treatment ofsecondary progressive MS (SPMS). The study has completed full recruitment of611 patients at 47 trial sites in 10 countries. Patients are administeredeither MBP8298 (dirucotide) or placebo every six months for a period of twoyears. To date, there have been eight positive safety reviews from the DataSafety Monitoring Board (DSMB).
(x) MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotaltrial. Eligible patients who have successfully completed the blinded, placebocontrolled MAESTRO-01 trial may choose to receive MBP8298 (dirucotide) on anun-blinded basis. To date, approximately 95% of patients enrolled inMAESTRO-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, BioMScompleted full recruitment of approximately 510 patients at 68 sites acrossthe U.S. To date, the DSMB has conducted two reviews of the data from thistrial 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 24trial sites in six countries across Europe. The DSMB has completed five safetyreviews to date and recommended that the trial continue as per the protocol.Completion of the trial is expected at the end of 2008 with resultsanticipated in the first half of 2009.
Licensing and Development Agreement
On December 17, 2007, BioMS entered into a licensing and developmentagreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298(dirucotide). Under the terms of the agreement, Lilly and BioMS willcollaborate on the development of MBP8298 (dirucotide) and will also share incertain development costs with Lilly being responsible for future research anddevelopment, manufacturing and marketing activities. The transaction closed onJanuary 25, 2008 with the receipt of an upfront payment of US$87 million.BioMS has the potential to receive additional development and sales milestonesof up to US $410 million and escalating royalties on sales commensurate withthe current stage of development of the product if MBP8298 (dirucotide) iscommercialized.
Financial Results
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 $11.8million or ($0.14) per share for the three months ended June 30, 2007. Theconsolidated net loss for the six months ended June 30, 2008 was $7.1 millionor ($0.08) per share compared to a consolidated net loss of $24.6 million or(
