CHESTER, N.J. and SALT LAKE CITY, Sept. 19 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. and Lipocine Inc., a privately- held, leading drug delivery company that uses clinically validated proprietary technologies to address key unmet drug delivery and therapeutics needs, today announced that they have entered into a license and collaboration agreement to develop new prescription adult cough products.
Commenting on the agreement, COO Robert D. Casale said, "This collaboration with Lipocine provides Adams with access to an additional proprietary platform technology and fits with our strategy of taking established compounds and adding increased functionality to create patent- protected, value-added products. The products developed through this collaboration could offer doctors a non-narcotic prescribing option to treat cough with an enhanced dosing regimen. In addition, these products will help Adams compete in the $1.1 billion prescription cough and cold market in the United States."
"Given the large and growing size of the respiratory market, and how patients can benefit from enhanced dosage forms and regimens, we are very pleased to partner with Adams, a company highly respected for its commercialization accomplishments," said Dr. Mahesh Patel, president and CEO of Lipocine Inc.
Lip'ral(TM) and Lip'ral(TM)-SSR are clinically proven oral delivery technologies for water insoluble drugs that improve absorption and can be extended to enable controlled release of insoluble drugs and drugs with pH- sensitive solubility. Multiple patents have been issued and are pending on these proprietary technologies.
Under the terms of the agreement, Adams receives an exclusive, royalty- bearing license from Lipocine to develop and market multiple prescription adult cough products in North America. Lipocine is responsible for completing the product development work and will be eligible to receive reimbursements and payments in exchange for completing certain pre-defined development milestones. Adams will be responsible for performing all aspects of clinical development, regulatory submission, manufacture and commercial operations. Financial terms of the deal are not being disclosed. Adams reconfirms that it expects diluted earnings per share in fiscal 2008 to be in the range of $1.55 to $1.75, as previously disclosed in an August 21, 2007 press release.
About Adams Respiratory Therapeutics, Inc.
Adams is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders.
About Lipocine Inc.
Lipocine Inc. is a pharmaceutical company leveraging its proprietary drug delivery technologies to commercialize innovative pharmaceutical products. Lipocine business objectives are to develop products with established drugs that have patient friendly attributes such as faster absorption, lower dose, fewer side effects, less frequent dosing, and no food effect.
Adams Respiratory Therapeutics Forward-Looking Statement
This press release contains certain "forward-looking" statements, including Adams' application of the Lip'ral(TM) technology to prescription cough products, Adams' competitiveness in the prescription cough and cold market and Adams' future financial performance. Such forward-looking statements can be identified by the words "could," "will" and similar expressions and are subject to risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially include, among others: Adams' successful consummation of the license and collaboration agreement with Lipocine, Inc.; Adams' ability to expand its product portfolio in the prescription cough and cold market; Adams' ability to successfully utilize the Lip'ral(TM) and Lip'ral(TM)-SSR technologies to develop prescription cough products; the continued success of Adams' existing products and the successful commercialization of future products; Adams' ability to compete against other branded products and generic competition; the severity of the cough and cold season and other risk factors set forth Item 1A. Risk Factors in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2007. Except to the extent required by applicable securities laws, Adams is not under any obligation to (and expressly disclaims any such obligation to) update its forward-looking statements, whether as a result of new information, future events, or otherwise. All statements contained in this press release are made only as of the date of this release.
Adams Respiratory Therapeutics, Inc.