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Cell Pathways Signs Agreement with John O. Butler Company for Marketing of Gelclair to U.S. and Canadian Dental Markets.


Business Editors and Health/Medical Writers

BIOWIRE2K

HORSHAM, Pa.--(BUSINESS WIRE)--Aug. 21, 2002

Cell Pathways, Inc. (Nasdaq:CLPA CLPA CC-Link Partner Association
CLPA Club Loisirs et Plein Air (Montpellier, France)
CLPA Child Labour Programme of Action (national plan to eliminate child labour in South Africa) 
) today announced the signing of a four-year marketing agreement with the John O. Butler Company, a leading international supplier of oral health care products, for Gelclair(TM) Concentrated Oral Gel. John O. Butler will market Gelclair to the dental market within the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Butler will also market Gelclair in Canada, once the product is approved for sale in that country. Financial terms of the agreement were not disclosed.

Gelclair, a prescription bioadherent oral gel, received clearance by the U.S. Food and Drug Administration in December 2001 as a medical device for the management and relief of oral pain due to various causes. In addition to oral mucositis, a large cancer treatment-related market opportunity addressed by Cell Pathways through its own oncology sales force, the dental indications include irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures or disease and diffuse aphthous ulcers aphthous ulcer Canker sore Oral pathology A small, often painful mouth ulcer due to injury to the oral mucosal, viral infection or vitamin deficiency .

"Based on our market research, we believe that Gelclair addresses an opportunity of approximately $100 million within the dental market," said Robert J. Towarnicki, Cell Pathways' chairman and chief executive officer. "John O. Butler is a leading provider of quality oral health care products, and we are delighted to partner with them in the United States and Canada to help realize the full market potential of Gelclair outside the oncology arena."

"We believe that Gelclair addresses a significant unmet need for safely and effectively relieving oral pain, and we are very pleased to obtain U.S. and Canadian dental marketing rights for Gelclair," said Tom Studney, vice president of New Product and Business Development at John O. Butler. "We expect to introduce Gelclair to the dental market within the next 90 days."

About Gelclair Concentrated Oral Gel

Gelclair, a bioadherent oral gel, adheres to the mucosal surface of the mouth where it creates a protective film barrier. This barrier is designed to reduce oral pain by protecting irritated ir·ri·tate  
v. ir·ri·tat·ed, ir·ri·tat·ing, ir·ri·tates

v.tr.
1. To rouse to impatience or anger; annoy: a loud bossy voice that irritates listeners.
 tissue and exposed or sensitized sensitized /sen·si·tized/ (sen´si-tizd) rendered sensitive.

sensitized

rendered sensitive.


sensitized cells
see sensitization (2).
 underlying nerve endings from over-stimulation. Gelclair is provided in 15 ml, single-dose packets whose contents are mixed with one to three tablespoons of water prior to use. The product is intended to be used at least three times daily or as needed as needed prn. See prn order. , and should be applied at least one hour before eating and drinking. Gelclair has no known interactions with medications or other products. Federal law restricts Gelclair to sale by or on the order of a physician or properly licensed medical practitioner.

About John O. Butler Company

John O. Butler Company, along with its parent company, Sunstar, Inc., is committed to advancing oral health worldwide through quality oral health care products and a leadership role in education, innovation, and partnership with consumers and dental professionals. In addition to its U.S. operations in Chicago, Illinois, the company has subsidiaries or branch operations in Canada, Germany, France, Italy, Spain, and Sweden, as well a distributor network covering 40 other countries.

About Cell Pathways

Cell Pathways, Inc., headquartered in Horsham, Pa., is a development stage pharmaceutical company focused on the discovery, development and commercialization of novel and unique medications to treat and prevent cancer and to treat certain inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation
disease - an impairment of health or a condition of abnormal functioning

NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants;
. The company additionally markets and sells oncology-related products manufactured by others. For additional information on Cell Pathways, Inc., visit the Company's web site at http://www.cellpathways.com.

Editor's Note Editor's Note (foaled in 1993 in Kentucky) is an American thoroughbred Stallion racehorse. He was sired by 1992 U.S. Champion 2 YO Colt Forty Niner, who in turn was a son of Champion sire Mr. Prospector and out of the mare, Beware Of The Cat.

Trained by D.
: Gelclair is a trademark of Sinclair Pharma, Ltd.

Certain statements herein, and oral statements made in respect hereof, constitute "forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such statements are those which express plan, anticipation, intent, contingency or future development and/or otherwise are not statements of historical fact. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Statements of historic fact must also be understood in the context of, and subject to, these risks. Such risks and uncertainties relate to, among other factors: early stage of development; absence of approved products; history of operating losses operating loss

The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income.
; the need for further financing, whether through issuance of equity or debt, corporate collaborations or strategic alliances, or revenues generated from the marketing and/or distribution of in-licensed products; dependence on the development, regulatory approval and market acceptance of one or more of our product candidates for one or more significant disease indications; the costs, delays and uncertainties inherent in scientific research, basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both our current product candidates and our future product candidates, if any; the risks that CP461 will not exhibit safety and efficacy in its current and future clinical trials in cancer indications, in Crohn's disease Crohn's disease: see colitis.  or in any other disease indication; the risks that accrual accrual,
n continually recurring short-term liabilities. Examples are accrued wages, taxes, and interest.
 of our Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  trial of Aptosyn(R) and Taxotere(R) is not completed by year-end and that safety and efficacy are not demonstrated by this combination therapy in this trial; limitations on, or absence of, the predictive value pre·dic·tive value
n.
The likelihood that a positive test result indicates disease or that a negative test result excludes disease.



predictive value

a measure used by clinicians to interpret diagnostic test results.
 of data obtained in laboratory tests, animal models and human clinical trials when planning additional steps in product development; uncertainty that additional studies, if any, of Aptosyn(R), CP461 or any other compound may not be positive; uncertainty of obtaining regulatory approval of any compound for any disease indication whether due to adequacy of the development program, changing regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country.  or otherwise; the risk that the Company does not conduct the clinical studies it may have planned to conduct or does not pursue development plans it may have planned to pursue; the risk that the U.S. Food and Drug Administration may stop or delay any clinical study for reasons of safety or otherwise; the risk that a registration strategy for CP461 in cancer is not fully developed by year-end, whether due to the nature or timing of further clinical results or otherwise; the risk that clinical studies do not result in the safety and efficacy necessary to obtain regulatory approvals; the risks of conducting clinical trials, including the risk of conducting clinical trials of our drugs in combination with other drug therapies; the commercial risk and risk of liability in marketing and selling Gelclair Concentrated Oral Gel, including the risk that the prescribers do not prescribe the product and sales do not materialize, the risk that the market opportunity available to Gelclair is smaller than estimated, due to inaccurate assumptions, competition or other factors, the risks associated with the product launch, manufacturing and marketing risks, and the risk that the Company's sales of Gelclair are less than the Company's minimum purchase obligations; the risk that the John O. Butler Company may fail to rapidly and effectively promote the use of Gelclair in the dental market; the commercial risk and risk of liability in providing marketing services promoting Nilandron(R) (nilutamide) manufactured by Aventis Pharmaceuticals, Inc., including the risk that Aventis' sales of Nilandron do not exceed the threshold entitling the Company to a percentage of gross margin; the risk that the Company may enter into, or may fail to enter into, licensing, partnership or collaborative arrangements or strategic alliances which accord to other companies rights with respect to one or more Company compounds, technologies or programs in exchange for financing and operational assistance, or in which the Company acquires rights and obligations; the volatility of the market price of our Common Stock; our ability to sell securities registered under the shelf registration statement or otherwise; the risk of dilution through the effects of further financings or strategic alliances; acceptance of any product candidates by physicians and providers of healthcare reimbursement Reimbursement

Payment made to someone for out-of-pocket expenses has incurred.
; the actions of competitors; the pace of technological changes in the biopharmaceutical industry; dependence upon third parties; the validity, scope and enforceability of patents; the risk of pending or future class action securities litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
; potential product liability claims; and availability and adequacy of insurance. These and other risks are detailed in our reports filed from time to time under the Securities Act and/or the Securities Exchange Act, including the sections entitled "Business," "Risk Factors," "Management's Discussion and Analysis Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
 of Financial Condition and Results of Operations" and "Other Events" in our annual reports on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
, quarterly reports on Form 10-Q Form 10-Q

See 10-Q.
 and periodic reports on Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
 and in such registration statements on Form S-3 as we may file from time to time. You are encouraged to read these filings as they are made. They are available over the Internet from the SEC in its EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king.  database at http://www.sec.gov and from the Company. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. No forward-looking statement can be guaranteed; actual future results may vary materially. Both forward-looking statements and statements of historic fact must be understood in the context of, and subject to, the risks referred to above which characterize our development stage business. We undertake no obligation to update or revise the statements made herein or the risk factors that may relate thereto.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Comment:Cell Pathways Signs Agreement with John O.
Publication:Business Wire
Geographic Code:1USA
Date:Aug 21, 2002
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