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Release issued 23rd July 2002
OraDisc - A is a polymer disc technology which adheres to the disease site and slowly degrades, releasing the drug locally. It is an improved delivery vehicle for the oral delivery of amlexanox. Utilizing this technology the drug can be delivered conveniently and more precisely to the disease site whilst also improving patient compliance, thereby increasing the effectiveness of the product.
The Phase III study will enroll 700 patients at 28 sites throughout the United States. The study is a double-blind placebo controlled study with three arms which compares the active disc to placebo and no treatment. 150 pediatric patients will be enrolled in this study with the objective of expanding the label to include use in patients 12 years and older.
Once the study has been completed and the New Drug Application assembled, the company plans to submit this improved dosage form for approval in the United States. The registration dossier will also be submitted in the United Kingdom, as the first step towards European approval. It is anticipated that the registration submission will occur in the first half of 2003.
With the acquisition of the amlexanox patents, Access has secured the worldwide rights to amlexanox in this formulation. Access believes that this superior delivery form can significantly expand the market potential for the canker sore indication of amlexanox. Market research conducted on the disc technology clearly indicates that consumers prefer this dosage form over alternate oral formulations.
Kerry P. Gray, President and CEO of Access Pharmaceuticals, Inc., stated, "OraDisc - A is an important component of our strategy to expand the amlexanox business opportunity both in the United States and abroad. The clinical data supporting amlexanox for the prevention and treatment of canker sores is very strong. Through the implementation of an aggressive marketing program for Aphthasol in the United States and the expected future introduction of a product line extension which is favorably viewed by consumers, we are optimistic that the sales potential of amlexanox can be realized. The successful development of OraDisc - A will assist in establishing the true value of the amlexanox program."
Mr. Gray continued, "Now that the European registration process is underway, and the Phase III OraDisc - A program is nearing completion, significant interest has been expressed by companies desiring to license amlexanox for the treatment of canker sores. This not only includes interest in the remaining European markets where amlexanox is not currently licensed but also, markets in Latin America and the Pacific Rim. The product profile of Aphthasol and the potential to significantly expand the market through the introduction of the OraDisc - A formulation makes this opportunity attractive to potential licensing partners."
Access continues to evaluate the various marketing alternatives for the canker sore indication of amlexanox, in the United States. This includes the possibility of licensing this opportunity to a pharmaceutical company that could exploit both the prescription opportunity and, ultimately, the OTC potential of this product.
Mr. Gray also stated, "The recent developments with amlexanox, including the acquisition of the worldwide marketing rights and the advancement of the OraDisc - A program, significantly adds to the value of this franchise. Where previously, Access was receiving limited revenues from international licensing activities, commencing almost immediately, revenues from worldwide licensing activities and product sales in the United States will generate significant revenues for Access. Amlexanox 5% paste and Zindaclin, which are scheduled for European launch in 2003, are projected to establish a strong revenue base from which to aggressively build the company."
Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both low development risk product candidates and novel technologies with longer-term major product opportunities. Access markets 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., the marketed product Zindaclin, which utilizes its 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 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, 2001, and other reports filed by the Company with the Securities and Exchange Commission.
If you want to find out more about the company visit Access Pharmaceuticals profile.
(14th January 2003) ACCESS PHARMACEUTICALS, INC. TO CONDUCT CONFERENCE CALL - Company To Discuss Today's Announcements
(14th January 2003) ACCESS PHARMACEUTICALS, INC. SIGNS AMLEXANOX LICENSING AGREEMENT WITH ZAMBON GROUP
(19th December 2002) ACCESS PHARMACEUTICALS, INC., ANNOUNCES ZINDACLIN® RECEIVES APPROVAL IN EIGHT ADDITIONAL EUROPEAN MARKETS - Additional License Agreements Executed
(11th December 2002) ACCESS PHARMACEUTICALS, INC. ANNOUNCES BOARD APPOINTMENT