May 11, 2002 Johnson & Johnson unit to market IMI's cardiac risk test Goal is to introduce a 'home version' for sale at pharmacies
Michael Lewis Financial Post
A Toronto-based developer of screening tests for cancer and heart disease says it has signed an agreement that will see a unit of consumer health care giant Johnson & Johnson Inc. market its cardiac risk assessment product in Canada.
IMI International Medical Innovations Inc. said yesterday that McNeil Consumer Health Care will distribute the test first to cardiologists and other physicians with significant cardiac practices. Ultimately, the goal is to introduce a "home version" for sale to consumers over-the-counter at retail pharmacies.
Brent Norton, IMI chief executive, said McNeil will buy the test product and pay IMI a royalty on sales, in addition to so-called milestone payments based on performance and other factors. He would not disclose terms but said payments will be at the high end of the industry norm.
Sales of the screening test would represent IMI's initial revenue from the product, which was cleared for commercial launch in Canada in early 2001. Called Cholesterol 1,2,3, the test has been show in clinical trials to be more reliable than a blood sample in detecting clogged arteries, a frequent cause of heart failure.
IMI says Cholesterol 1,2,3, is a three-minute skin application that does not require fasting, lab testing or a blood sample. Instead, liquid drops on the palm of the hand are examined for evidence of cholesterol deposits, with surface cholesterol residue seen as a more direct indicator of heart disease than deposits within artery walls.
IMI says it is developing a second-generation prototype for the home market that could involve a test strip that turns colour on contact with cholesterol residue.
The current test, which IMI calls the first non-invasive test system to use skin cholesterol to assess coronary artery disease risk, relies on a doctor's colour scanner and computer. IMI said the home product could sell for around $10 per kit -- and at least part of the cost may be eligible for reimbursement under Canadian medicare and drug plans.
Mr. Norton said IMI will maintain manufacturing control, though McNeil under terms of the renewable 15-year deal will participate in product development. He said the agreement with Guelph, Ont.-based McNeil could pave the way for other marketing and distribution pacts outside of Canada, perhaps with other affiliates of New Jersey-based Johnson & Johnson.
A key, however, remains approval from the U.S. Food and Drug Administration, with response to IMI's application expected within weeks.
Assuming regulatory clearance, IMI says it plans to pursue marketing deals in the U.S. and Europe aimed at introducing the test strip to the mass consumer market.
According to a report from New York-based research firm Theta Reports, more than 600-million cholesterol tests were performed globally in 2000, with the market expected to grow over the next two decades by more than 20% per year. Under the pact, IMI says McNeil gains exclusive rights for the Canadian market to both the professional skin cholesterol test system and the eventual home version. Canada is the first market in which the product is commercially available. |