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Press releases

Stay current with the latest press releases from within the industry.

ACCESS ANNOUNCES LAUNCH OF ZINDACLIN IN THE UNITED KINGDOM European Registration Process Initiated - Approval Anticipated By Year End

Release issued 22nd March 2002

DALLAS, TEXAS, March 22, 2002, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC) today announced that Strakan, Ltd., the worldwide licensee of its ResiDerm® technology, has launched Zindaclin on the United Kingdom market. Also, the process to achieve marketing authorization throughout Europe has been initiated and the first country approvals are expected by the end of 2002.

The United Kingdom Medicines Control Agency approved Zindaclin for once-a-day application for the treatment of acne. Zindaclin is a clindamycin zinc complex in a gel formulation with a prolonged residence in the skin, providing a sustained release effect, which reduces absorption of the drug into the systemic circulation and the associated side effects. Clinical studies confirmed that once-daily dosing was equivalent to the market leading clindamycin product which requires twice per day application.

Commenting on the announcement, Kerry P. Gray, President and CEO stated, "Having a product which can be applied once-daily in the evening is an important patient benefit as acne treatment is a long-term therapy. We are confident that Strakan, which has built a United Kingdom sales force capable of effectively reaching the target prescribing audience, will be highly successful with Zindaclin."

The advantages of Zindaclin over competitive products include:

• Convenient once-daily application (ability to apply last thing in the evening)

• Desired cosmetically acceptable formulation

• Stable gel formulation which does not require reconstitution before dispensing

• Reduced systemic drug exposure

Zinc, which is a component of the formulation to maintain drug concentration in the skin, is also an anti-microbial which reduces acne bacteria and may help to minimize the patients that become resistant to the antibiotic. The once-daily usage could also reduce skin irritation which is a common long-term problem for acne suffers.

ACCESS now has two marketed products and two product candidates which are anticipated to be marketed within two years. Zindaclin is advancing in the United States where additional clinical data is required prior to filing a New Drug Application with the Food and Drug Administration.

Mr. Gray continued, "As there are no expenses associated with this project, the anticipated revenues to be received from out-licensing milestones and royalties commencing in 2002 are expected to provide a meaningful contribution to our objective of becoming near-term cash flow positive."

ACCESS Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. In conjunction with GlaxoSmithKline (previously Block Drug Company), ACCESS has developed Aphthasol®, the only FDA-approved product for the treatment of canker sores, and is developing products for mucositis and other dermatological indications. ACCESS is also developing unique polymer platinates for use in the treatment of cancer and has developed in conjunction with its partner Strakan, Ltd., a topical zinc delivery system called ResiDerm® that provides rapid delivery and reservoir of a drug in the skin.

This press release contains certain statements that are forward-looking and that involve risks and uncertainties, including but not limited to the uncertainties associated with research and development activities, clinical trials, the integration of acquired companies and technologies, the timing of regulatory approval, dependence on others, collaborations, future projected cash flow, the timing and receipt of licensing revenues, the future success of the Company's amlexanox and polymer platinate programs and other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2000, and other reports filed by the Company with the Securities and Exchange Commission.

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If you want to find out more about the company visit Access Pharmaceuticals profile.

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