McNeil Reaches Consumer Cholesterol Testing Licensing Deal With IMI

McNeil Consumer Health is seeking to leverage the potential Rx-to-OTC switch of J&J/Merck's Mevacor (lovastatin) with an agreement to license International Medical Innovations' predictive tests for coronary artery disease (CAD).

Under the worldwide licensing agreement, McNeil will market and distribute IMI's predictive tests under the brand name PREVU(x) Coronary Heart Disease Predictor.

In addition to the point-of-care diagnostic tests, IMI is currently developing a PREVU Home Test, which would be sold over the counter in a pharmacy setting. The product would provide a single-use, "semi-quantitative" test for consumers at risk for CAD.

PREVU will be the new brand name for IMI's Cholesterol 1,2,3 testing technology. McNeil signed a prior Canadian licensing deal with Toronto-based IMI for the technology in 2002 (¹ 'The Tan Sheet' July 1, 2002, In Brief).

The new agreement applies to all current and future formats of the test, which are being jointly developed by McNeil and IMI for the medical, laboratory and home use markets.

IMI has several PREVU-related studies currently underway, including clinical trials involving Mevacor. The firm hopes to position the technology within an OTC paradigm using McNeil's strengths in marketing and distribution.

IMI will sell the products to McNeil and collect ongoing sales royalties. The firm will receive an upfront $2.2 mil. payment and a series of milestone payments of up to $11.6 mil over several years, in addition to $2.4 mil. from the firms' prior licensing agreement.

PREVU will be McNeil's first predictive medicine product, according to IMI CEO Brent Norton, MD. Predictive medicine is "an important growth market, particularly at professional and consumer levels," Norton maintained in a conference call May 28. "The great potential of predictive medicine is that it empowers individuals to take charge of their own health."

Norton cited studies finding that between 2002 and 2007, the total OTC home testing market is expected to increase by nearly 50%, with compound annual growth of 8%. "The international opportunity for both IMI and McNeil in this market is significant," Norton maintained.

IMI believes the global market is especially promising given the switch of J&J/Merck's Zocor (10 mg simvastatin)in the UK, which will be marketed by McNeil Europe as Zocor Heart-Pro (² (Also see "Non-Rx Zocor Will Be Available In UK Without Cholesterol Screen Requirement" - Pink Sheet, 17 May, 2004.), p. 5).

The Zocor Heart-Pro approval has led J&J/Merck to file for a switch of Mevacor in the U.S., which would target a moderate to intermediate risk group with a 20 mg dose (³ (Also see "J&J/Merck Developing Mevacor 20 Mg As OTC For Moderate Risk Group" - Pink Sheet, 17 May, 2004.), p. 3). The joint venture hopes to go before an FDA panel by May 2005.

Though IMI has traditionally focused on the North American market, the firm is now positioned to enter the European market "in a tax-advantaged manner" through its Swiss subsidiary, according to Norton. The global deal could double the PREVU technology's market potential, he maintained.

While McNeil will handle marketing and distribution for the products, IMI will continue to focus on expanding scientific support and identifying new opportunities. The firm will retain control over manufacturing and product development.

The PREVU technology works by placing two color-changing drops of liquid on the skin to measure the level of cholesterol in the tissue, called "skin sterol." IMI maintains skin cholesterol is an independent risk factor for CAD that can be added to the list of established risk factors, including blood cholesterol, blood pressure, body weight, smoking history, family history of heart disease and diabetes.

Skin sterol can be used to assess CAD risk "in persons with a history of heart attack and/or in persons suspected of having clinically significant coronary artery disease," according to the firm's ⁴ website. IMI defines "clinically significant" CAD as greater than 50% blockage in more than one vessel.

Considered along with clinical evaluation, blood cholesterol and other risk factors, skin cholesterol test results "can aid physicians in focusing diagnostic and patient management options," the firm maintains.