article posted by big money picks on ymb
The importance of this old article hasn't diminished by time. There aren't many late stage cardiovascular drugs up for licensing. With statins and arbs comming off of patent protection the fact that mc-1 has all of the patents in this area this could lead to a large deal
There will be howls of joy or buckets of tears coming out of drug developer Medicure Inc. over the next few weeks.
The Winnipeg-based company has completed two mid-stage clinical trials with its MC-1 flagship drug and is set to release those results by mid-September and late October. And without enough money in the bank to continue large-scale testing on its own, the company needs a positive outcome to pave the way for a corporate partnership with a drug company to finish development.
Success here could target cardiovascular markets in the billions of dollars, either with MC-1 on its own or in combination with other heart drugs. So far, the company has invested $25-million in developing the drug.
"I'm not superstitious but we've been very fortunate developing MC-1 so far," said Medicure president and chief executive officer Albert Friesen, who is known as the founding father of biotechnology in Manitoba.
Medicure and MC-1 trace their roots to a business lunch in Winnipeg nine years ago. As a trained chemist and CEO of Novopharm Biotech Inc. at the time, Mr. Friesen recalls how impressed he was with University of Manitoba professor Naranjan Dhalla's drug discovery.
"What hit me was the beauty of the molecule, how safe it is and the huge opportunity in cardiovascular disease," he recalls. Mr. Dhalla is now chief scientific officer of Medicure.
Mr. Friesen's claim to fame, however, precedes founding Novopharm, which is now Viventia Biotech Inc. In 1969, he was the first employee of the Winnipeg Rh Institute, which pioneered development of the WinRho drug to protect newborns from anemia, heart failure and brain damage associated with Rh disease.
The drug was approved by Health Canada in 1980. WinRho is also used to treat a clotting disorder known as ITP.
Mr. Friesen also began WinRho's approval process with the U.S. Food and Drug Administration until the institute was acquired in a hostile takeover by Toronto-based Apotex Inc. and became Cangene Inc.
"MC-1 was a chance to take an idea all the way to the marketplace again," he said.
MC-1 is what's called a metabolite of vitamin B6, one of three chemical compounds left over from reactions between the vitamin and enzymes in the body. The metabolite binds naturally with the protein albumin, circulates in the blood and is slowly released in the heart and other organs.
What impresses analysts about MC-1 is that it is a new drug class, with the potential to reduce damage to heart tissue.
"Our belief is that Medicure may be able to build a business solely on using MC-1 in combination with other therapies," National Bank Financial analyst André Uddin said in a recent research report.
After posting positive results in an earlier mid-stage study with patients undergoing an angioplasty procedure, Medicure combined MC-1 with an angiotensin-converting enzyme (ACE) inhibitor, which is used to treat high blood pressure. The combined therapy, known as MC-4232, was then used to test 120 diabetic patients with hypertension to see if it would reduce blood pressure, triglycerides and blood glucose levels. Those study results are set to be released in the next few weeks.
Medicure has at least three other combination drugs in early research for heart disease.
In late October, the company will learn how MC-1 performed on its own with 900 patients undergoing coronary bypass surgery. The Phase II study is not designed to show statistical significance, which could make investors skittish, but rather a trend toward reducing heart attacks and strokes in the first 30 days after surgery.
If we can show a reduction of 15 to 25 per cent in clinical events, it would be a home run," Mr. Friesen said. "If we succeed, I believe we have a high probability to repeat in a pivotal Phase III study."
He said Medicure is in "active discussions" to team up with a large drug company specializing in cardiovascular disease and mid-sized specialty drug companies to take MC-1 into late-stage clinical testing, which could require several thousand patients.
"When I started Medicure, I thought it would take 10 to 13 years to develop MC-1 and we're still on schedule."
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