Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular-focused biopharmaceutical company, today reported the results of operations for the three and nine month periods ended February 29, 2008. All amounts referenced herein are in Canadian dollars unless otherwise noted. At the close of business on February 29, 2008, the exchange rate was CAD$1.00 equals US$1.02.
Clinical Update
On February 22, 2008 the Company announced that an analysis of the data from its pivotal phase 3 MEND-CABG II clinical trial showed that it did not meet the primary endpoint. The trial was designed to evaluate the effect of Medicure's lead product MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal myocardial infarction up to and including 30 days following coronary artery bypass graft (CABG) surgery. Based on the results, the Company does not plan on submitting an application for MC-1 marketing approval to the U.S. Food and Drug Administration for the CABG surgery indication at this time.
Although Medicure has decided not to continue pursuing MC-1's acute clinical development at this time, the Company remains optimistic in the potential clinical utility of MC-1 in the treatment of certain chronic cardiovascular and metabolic conditions, including for the treatment of hypertension, type II diabetes and dyslipidemia. The Company has been developing MC-1 for use in two fixed dose combinations for these chronic indications, including MC-4232 (combination of MC-1 and lisinopril) and MC-4262 (combination of MC-1 and an Angiotensin Receptor Blocker). Due to the Company's decision to discontinue the development of MC-1 as a monotherapy for acute indications such as CABG surgery, the Company may also develop MC-1 as a monotherapy for one or more of these chronic indications.
Corporate Update
Subsequent to the end of the fiscal period ended February 29, 2008, Medicure announced a restructuring plan upon which the organization eliminated approximately 50 employees and full-time consultants.
These changes follow the Company's announcement that it does not plan on submitting an application for MC-1 marketing approval to the U.S. Food and Drug Administration for the CABG surgery indication at this time. This decision was based on an analysis of the data from its pivotal phase 3 MEND-CABG II clinical trial that showed that the study did not meet the primary endpoint.
Due to the restructuring of the Company's operations, Charles Gluchowski, PhD resigned as the Company's Vice President, Research and Development to pursue other interests. The Company will continue to work with Dr. Gluchowski on a consulting basis. "We thank Charlie for his dedicated service, and his commitment to continue to serve Medicure as an advisor," stated Medicure's President and CEO, Albert D. Friesen, PhD.
AGGRASTAT® Update
During the third quarter of fiscal 2008, sales of AGGRASTAT® improved over the prior quarterly results by $379,000 but were lower as compared to the same period in fiscal 2007.
"We were very pleased with the data recently presented on AGGRASTAT® at the Late Breaking Sessions of the American College of Cardiology 57th Annual Scientific Session," commented Dr. Friesen. "While revenues were lower than the same quarter in the previous fiscal year, we are encouraged to see growth over the second quarter of fiscal 2008," stated Dr. Friesen.
Following the fiscal quarter, Medicure's Vice President, Marketing, Brian Best resigned from his current position due to personal reasons but will continue to remain active with the Company in an advisory role going forward. Brian will advise the commercial operations along with Bonnie Zell, former VP of Sales with Millennium Pharmaceuticals, Inc. "Brian and Bonnie's leadership has been instrumental in building a highly skilled sales force and commercial operation at Medicure", stated Dr. Friesen. "We are confident that we have a strong commercial plan in place and look forward to their continued leadership as advisors to build our commercial operation."
"I continue to be optimistic about the long-term prospects for AGGRASTAT® and while my position is changing, I look forward to my continued involvement with the team," commented Brian Best.
Financial Results:
Net product revenues for the third quarter of fiscal 2008 were $703,000 compared to $2,522,000 for the same period in fiscal 2007. Revenues for the nine month period to date were $1,506,000 compared to $4,221,000 in the same period last year.
AGGRASTAT® revenues were lower for the three and nine month periods ended February 29, 2008 as compared to the same periods in fiscal 2007 for several reasons including the reconfiguring of the Company's commercial operations during the first quarter of fiscal 2008.
