Antares Pharma, Inc. (Amex: AIS) announced that it has signed a worldwide development and license agreement with an as yet undisclosed global pharmaceutical and consumer products company, with multi-billion dollar revenues. The planned product, in the field of opioid analgesia, will be delivered transmucosally using Antares’ proprietary EasyTec™ oral disintegrating tablet (ODT) delivery platform. Signing this agreement demonstrates successful completion of a feasibility agreement which was initiated in October 2006.
“Our EasyTec™ (ODT) platform has a versatility compatible to a broad range of actives, conducive to both high and low drug loading and is cost competitive. EasyTec is also protected by patents granted in the U.S., Europe and several other countries. Significant progress in EasyTec’s novel buccal absorption profile has been made since the feasibility agreement was initiated and we are certainly pleased to have entered into this worldwide development and license agreement with a company of this stature,” said Jack E. Stover, President & CEO.
Antares will receive an upfront payment, clinical and regulatory milestone payments and continued funding where applicable for product development and technology transfer activities during the term of the contract. Antares will also receive royalties on product sales upon commercialization, including minimum royalties. Total milestones and royalty payments could generate significant multi-million dollar revenues during the term of the agreement. Antares’ partner accepts responsibility for development and commercialization of this product candidate and will cover the costs of clinical trials, regulatory filings, and all manufacturing and marketing.
About EasyTec™ Orally Disintegrating Tablet (ODT) Fast-Dissolve Technology
Antares Pharma’s EasyTec™ is a simple, cost-efficient, and robust technology platform which uses direct compression during the tablet making process. EasyTec™ relies on the combination of classic disintegrants and a specific excipient to enhance rates of disintegration. All excipients are compendial, low cost, and do not involve special production or manufacturing equipment. EasyTec™ tablets satisfy pharmacopoeial requirements for hardness and friability when compared to conventional tablets, therefore conventional high-speed rotary tablet presses are used for tablet compression and there is no requirement for specialized packaging. The disintegration time is generally less than 10 seconds for EasyTec tablets with a mass lower than 200 mg, increasing up to 30 seconds for tablets with a mass approaching 1000 mg. EasyTec™ technology is compatible with a broad range of actives, with high or low drug loading, and can be used with traditional and specialized excipient categories in addition to the incorporation of taste-masking and flavouring technologies.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated drug delivery platforms: the ATDTM Advanced Transdermal Delivery system, subcutaneous injection technology platforms including both VibexTM disposable mini-needle injection device and ValeoTM/Vision® reusable needle-free injection devices; and Easy TecTM oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements, within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2006 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential provide Antares' current expectation or forecasts of future events. Antares' results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares' ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.