Friday March 10, 6:31 pm Eastern Time
Company Press Release
Technical Chemicals and Products' Total Cholesterol Home Screening Test Requires Submission of New Clinical Data to Obtain FDA Marketing Clearance
TCPI To Conduct Concurrent Clinical Trials For New Total and HDL Cholesterol Home Screening Test And Professional Use TriMeter For Physician Office Measurement
POMPANO BEACH, Fla.--(BUSINESS WIRE)--March 10, 2000-- Technical Chemicals and Products, Inc. (Nasdaq:TCPI - news), a developer, manufacturer and marketer of diagnostic products and drug delivery technologies, announced today that the United States Food and Drug Administration (FDA) has not cleared TCPI's new HealthCheck© Total Cholesterol Home Screening Test for over-the-counter (OTC) marketing.
Pursuant to recent discussions with the FDA, the Company plans to modify the format of the color chart in which test results are displayed and obtain clinical data for a new regulatory submission of this consumer total cholesterol screening test. Concurrently, the Company will conduct clinical trials for its new HealthCheck© HDL Cholesterol Home Screening Test for the OTC market and its new professional use TriMeter(TM) for measurement of Total and HDL cholesterol and fingerstick blood glucose in the physician's office. The Company anticipates it will be able to initiate regulatory filings for these products later this year.
``We are obviously disappointed by the FDA's decision, but see this as a temporary setback now that all of our new cholesterol testing products are at a point where it is both cost and time-effective to conduct parallel clinical trials,' said Elliott Block, Ph.D., Chief Executive Officer of Technical Chemicals and Products, Inc. ``We continue to believe in the merits of our home cholesterol screening tests and will work to resolve the format issue to make it easier for consumers to interpret their results so that we can commercialize these useful products as soon as possible,' Block added.
According to American Heart Association statistics, about 98.1 million American adults (52%) have total blood cholesterol levels of 200 mg/dL and higher, and about 39.4 million American adults (20%) have levels of 240 mg/dL or higher. The National Cholesterol Education Program guidelines state a total cholesterol result less than 200 mg/dL (5.2 mmol/L) is defined as Desirable where there is most likely a low level of risk for heart disease. A result between 200-239 mg/dL (5.2 - 6.2 mmol/L) is defined as Borderline-High where there is an increased risk for heart disease, and the user is instructed to seek the advice of a physician. A result of 240 mg/dL (6.2 mmol/L) or above is defined as High where there is an increased risk for heart disease, whether or not there are additional risk factors, and the user is instructed to seek the advice of a physician.
TCPI, with headquarters in Pompano Beach, Florida, is primarily engaged in the design, development, manufacture and marketing of a wide-range of point-of-care medical diagnostic products for use at home, in physician offices, and other healthcare locations. TCPI also owns a broad, patent-protected proprietary portfolio of transdermal and dermal drug delivery technologies.
Copies of this and other news releases may be obtained free of charge by calling TCPI's automated fax service at (800) 464-9217. Additional information on the Company can be obtained from TCPI's Web site at techchem.com.
Information in this press release, including any information incorporated by reference herein, includes ``forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe-harbor created by such sections. The Company's actual results may differ significantly from the results discussed in such forward-looking statements.
Statements regarding development and FDA clearance of the products mentioned herein as well as future products, future prospects, business plans and strategies, future revenues and revenue sources, future liquidity and capital resources, health care market directions, future acceptance of the Company's products through Internet sales, possible recommendations of health care professionals or governmental agencies regarding use of diagnostic products, possible growth in markets for at-home diagnostic testing including Internet sales, as well as other statements contained in this release that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future, and similar statements are forward looking statements. These statements are based upon assumptions and analyses made by the Company in light of current conditions, future developments and other factors the Company believes are appropriate in the circumstances, or information obtained from third parties, and are subject to a number of assumptions, risks and uncertainties. Readers are cautioned that forward-looking statements are not guarantees of future performance and that actual results might differ materially from those suggested or projected in the forward-looking statements. Factors that may cause actual future events to differ from those predicted or assumed include, but are not limited to: the satisfactory completion of clinical trials; FDA clearance of 510(k) submission for the products mentioned herein; risks associated with the Company's ability to successfully develop and market new products on a profitable basis or at all, including competing in the Internet sales market; availability of labor and sufficient parts and materials; receipt of any required regulatory approvals; future advances in technologies and medicine; the uncertainties of health care reform; risks related to the early stage of the Company's existence and its products' development; the Company's ability to execute on its business plans, including competing in the Internet sales market; competition from major pharmaceutical, medical and diagnostic companies; risks and expense of government regulation and affects of changes in regulation (including risks associated with obtaining requisite governmental approvals for the Company's products); the limited experience of the Company in manufacturing and marketing products; uncertainties connected with product liability exposure and insurance; risks associated with domestic and international growth and expansion; risks associated with international operations (including risk associated with international economies, currencies and business conditions); risks associated with obtaining patents and other protections on intellectual property; results of litigation and appeals; the Company's limited cash reserves and sources of liquidity; uncertainties in availability of expansion capital in the future and other risks associated with capital markets, as well as those listed in the Company's other press releases and in its other filings with the Securities and Exchange Commission. The Company may determine to discontinue or delay the development of any or all of its products under development at any time. For a complete description of the Company's products and business, see Part I, Item 1 of the Company's Annual Report on Form 10-K for the year ended December 31, 1998.
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Contact:
Technical Chemicals & Products, Inc., Pompano Beach
Howard A. Goldman
Vice President/Investor Relations
954/979-0400 x233
E-Mail: invrel@techchem.com
or
Media Contacts:
Weber Public Relations
Sandy Baksys, 217/793-8864
Robert Gill, 305/448-7450
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