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Biotech / Medical : IMI:TSE International Medical Innovations Inc. -- Ignore unavailable to you. Want to Upgrade?


To: gg cox who wrote (29)9/10/2003 10:35:07 AM
From: gg cox  Read Replies (1) | Respond to of 66
 
globeinvestor.com

Investors flock to IMI after deal struck
Skin cholesterol test to be used in study



By LEONARD ZEHR
00:00 EDT Friday, August 29, 2003

Investors jumped into IMI International Medical Innovations Inc. yesterday after the medical devices maker signed a collaborative research pact to supply its flagship skin cholesterol test for a major late-stage clinical study of an anti-inflammatory pill to target hardening of the arteries.

The stock closed up 14 cents at $3.25 on the Toronto Stock Exchange as volume climbed to 75,200 shares, almost four times the daily average.

Under the accord, Toronto-based IMI will supply its Cholesterol 1,2,3 test to AtheroGenics Inc., which is undertaking a $40-million (U.S.) Phase III trial to test 4,000 patients at 180 cardiac clinics in North America, Britain and South Africa with its AGI-1067 drug. In return, it will have full access to the trial data.

"The use of Cholesterol 1,2,3 in this large clinical trial will serve to raise the product's visibility with opinion leaders at some of the leading cardiac centres throughout the world," said Loewen Ondaatje McCutcheon Ltd. analyst Mark Knapp.

He rates the stock a "speculative buy," with a 12-month target price of $6 (Canadian).

Another analyst, who asked not to be identified, said the agreement with AtheroGenics will not affect IMI's bottom line and valuation. "But it will give the skin test wider recognition with cardiologists and could validate the relationship between skin cholesterol readings and cardiac events."

IMI president and chief executive officer Dr. Brent Norton said the study will provide some of the most important data ever collected on skin cholesterol testing. "Joining the . . . study is consistent with our strategy of leveraging large trials led by other corporate and government organizations," he added.

Rob Scott, chief medical officer of Alpharetta, Ga.-based AtheroGenics, said skin cholesterol appears to correlate with cholesterol levels in other tissue, such as the artery wall.

"This in turn may correlate with the progression of coronary artery disease and associated clinical events such as heart attack or death, as well as the effect of AGI-1067 on atherosclerosis," he said.

IMI's 1,2,3 skin test has already been cleared for sale, with an expected launch through Johnson & Johnson's McNeil Consumer Healthcare unit in the fourth quarter, Paradigm Capital Inc. analyst David Ng said in a recent report.

Various delays in the launch have "caused uncertainty and has resulted in a depressed stock price over the last 12 months," he said.

Still, he rates the stock a "buy," with a 12-month target price of $8.

© The Globe and Mail



To: gg cox who wrote (29)9/16/2003 12:03:23 AM
From: gg cox  Read Replies (2) | Respond to of 66
 
Overview 2003, 2004:
cash on hand $8.9 Million Aug 2003 (2-3 years at current burn)
13 new clinical trials commenced in 2003
30 total trials in the field of which we pay only 20%

Currently 4 products are in the pipeline.
They should hit the market at the rate of 1 pipe per year in this order:
CH123/ D'tect
ColorectAlert
LungAlert
BreastAlert

CH123 is 3 products: Tape Test, Wallet Test, Lab test attacking 6 markets:
Physicians offices, Insurance testing, Occupational Health, Home, Co- Promotion, Pharmacies

Completed Milestones by timeline:

CH123: Pivotal trials commence November 1997
ColorectAlert: IMI licences test for detection of early stage colorectal
cancer May 1998
ColorectAlert: IMI files patent application for colorectal cancer detection
test January 1999
LungAlert: IMI files patent application for lung cancer detection test
January 1999
ColorectAlert: Announced May 2000, clinically more accurate than fecal
occult blood testing (FOBT)
CH123: January 29, 2001, Canadian marketing clearance
LungAlert: May 2001 American Thoracic Society, 1st and only early stage test
CH123: June 11, 2001 FDA submission
CH123: July 10, 2001 DCL agrees to make CH123
CH123: September 5, 2001 SG Cowen Securities hired
CH123: October 29, 2001 resubmission to FDA, shares tank to $3.00
CH123: February 25, 2002 Multi-Ethnic Study of Atherosclerosis (MESA 6500 souls)
CH123: April 8, 2002 Sprecher breakthrough at American Heart Association
ColorectAlert: April 15, 2002 ColorectAlert beats FOBT financially
CH123: May 10, 2002 McNeil CDN partnership announced
CH123: June 2002 American Journal of Cardiology paper, Mancini
CH123: June 24, 2002 FDA approval
CH123: Sept. 2002 European approval
CH123 @ home: Oct Q4 2002 Unveiling of 2 new modified home tests
CH123: Oct. 28th 2002 McNeil demos 123 at the Canadian Cardiovascular Congress, Edmonton
CH123: December 2002 signs agreement with McNeil to expand US marketing to the insurance industry, no FDA required
CH123: Feb 27th 2003 Revenue commences with Milestone Payment $100,000
CH123: June 2003 Australian Approval
CH123: June 2003 Found to be reliable and harmless in testing Pediatric cholesterol
D-TECT: Feb 27th 2003 new Coronary Heart Disease Predictor announced
SEC Approval: March 12th 2003 clears IMI for a US listing
American Association for Cancer Research to publish Cancer Suite
Papers, Toronto meeting cancelled due to SARS Apr. 2, 2003
ColorectAlert Trial results announced Apr. 5, 2003 detected 54% early stage
colon cancer, 85% accurate clearing non cancer patients
LungAlert: Q2 2003, Japanese trial with major Japanese Partner commences
LungAlert: Trial results announced Apr. 5, 2003 detected 57% early stage
lung cancer, only 10% false positives
BreastAlert Apr 03 preliminary trial results encouraging
John Hopkins Aug 03; Skin cholesterol is more strongly associated with Arteiosclerosis than blood tests
AtheroGenics Aug 03. a $40-million Phase III trial to test 4,000 heart patients uses CH123
Amex Sept 19 2003: IMI begins trading on the American Stock Exchange symbol IME

Milestones yet to come with approximate timing:

CH123: ISO certification Q4 2003
CH123: Japanese Approval Process completing Q4 2003
CH123: Revenue stream commences Q4 2003
CH123: Announcement of World Wide and or US Partners 2004
D-TECT: McNeil to launch in multiple markets 2004

ColorectAlert: Canadian Approval 2004
ColorectAlert: FDA trials commence 2004

LungAlert: Canadian Approval 2004
LungAlert: FDA trials commence 2004

BreastAlert: expanded trials 2003 -2004

US and EU Development Partners on the Cancer Suite 2004

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