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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: jeeza who wrote (598)4/3/1997 6:22:00 PM
From: jeeza   of 1172
 
interesting stuff from 10-K

FUTURE ACCUMETER(R) PRODUCTS

The Company believes that its AccuMeter(R) cassette system is an enabling technology and will be applicable to a broad range of general chemistry and immunoassay tests, including the following:

Theophylline Test

Theophylline is a drug prescribed for use by people suffering from asthma and other respiratory difficulties. Approximately six million patients take theophylline to relieve or prevent symptoms of asthma. The drug is effective only over a limited range: too little is ineffective, too much causes
side effects that include headache, nausea, vomiting, low blood pressure, tachyccardia, arrhythmia, and convulsions. Also, the safe and effective range for theophylline varies from patient to patient. Monitoring theophylline levels helps clinicians establish and maintain safe and effective dosages in both
acute and chronic treatment, and over 20 million theophylline tests are routinely performed in clinical laboratories in the United States every year,with results sometimes not available for hours or even days. ChemTrak's AccuMeter(R) Theophylline Test enables the physician to monitor theophylline
drug levels with ease -- during a single office visit. The test is simple enough to be prescribed for home use to check night-time or early morning concentrations of the drug, information which could improve patient management
critically. Theophylline levels must be monitored carefully during therapy, as low levels are ineffective and high levels can be toxic. The Company believes
that approximately 25 million theophylline tests are performed annually in the United States. Currently, most theophylline testing requires costly instruments that are not suitable for use either in physician offices or homes. The Company
believes that the only existing non-instrumented test requires a complex procedure and exact measurement of the blood sample.

ChemTrak's test for quantifying blood levels of theophylline for use in professional settings has been reformulated and completed. The Company is in the
process of preparing an FDA 510(k) filing for its theophylline test.

Are we looking at another BLOCKBUSTER test ??? 25M tests a year
how far are we from filing 510 ?

Through its corporate partner alliances, ChemTrak expects to more
effectively reach the international consumer retail and United States physician
office markets. ChemTrak has non-material distribution arrangements with a
number of independent health care supply organizations domestically and
worldwide. ChemTrak has in effect material contractual relationships with the
following corporate partners:

Corporate Partner Market Country Product
-----------------------------------------------------------------------------------------

Astra Merck Inc. Consumer retail United States H. pylori
Physician office Puerto Rico

The Boots Company PLC Consumer retail United Kingdom Cholesterol Test

Helena Laboratories, Inc. Consumer retail Canada Cholesterol Test

Jokoh, Inc. Physician office Japan Theophylline Test

Orion Diagnostica Physician office United States Cholesterol Test

Selfcare, Inc. Consumer retail All of Europe and AWARE(R) Home
Scandinavia HIV Test Service

VERY CURIOUS
is theophylline already sold in Japan ???

OUR present cash cow
Astra Merck Inc. (AMI). In March 1995, the Company entered into a
multi-year license and supply agreement with AMI to market the Company's H.
pylori test in the United States and Puerto Rico. The initial term expires
either six years from March 1, 1995 or four years after the first
over-the-counter sale, whichever is earlier. After the initial term, the
agreement provides for renewal on an annual basis. AMI has been granted
exclusive United States marketing rights to ChemTrak's H. pylori test for both
professional markets and for over-the-counter retail outlets. In return,
ChemTrak is entitled to receive separate cash payments from AMI upon realization
of certain milestones ultimately leading to the commercialization of the H.
pylori test. The Company will also receive a per unit price for each product it
manufactures and sells to AMI. The Agreement calls for AMI to purchase certain
minimum quantities during specified periods commencing on the first shipment to
the professional market. The agreement may be terminated by either party on
sixty days notice if the other party commits a material breach of the
agreement. The H. pylori test has received FDA clearance for sale to the
professional market with the first shipment expected in April 1997. The Company
expects to commence the process of seeking FDA approval for over-the-counter
retail sales later in 1997.

they have about $6M in cash + investments
they are burning up about $7M a year

1. can they survive on milestone payments by astra-merck and selfcare OR
2. more funding will be needed to scale up manufacturing

I think their present manufacturing capabilities only cover
cholestrak manufacturing...not sure how they manage Hpchek

their product sales/revenues were just $2.46M in 1996
if they can manage about 1-1.5M a quarter...that would put them in pretty good shape...wishful thinking for the present
given that the test is distributed in canada and UK
cholestrak sales are nothing to cheer about..BUT then these are 1996 numbers...we may have surprises for 1997
I would sure like to see some alliances to distribute in Japan & far east ....also possibilities with warner lambert

the company pays for the life insurance of Singh on a $1M policy....how much premium are they paying every year?
is this a significant amount or a luxury we can grant to the founder

art & dave ...I sure hope u guys are able to visit the company and give us a detailed perspective of events down in sunnyvale
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