SOURCE: Theravance

December 05, 2005 17:10 ET

Theravance and Astellas Finalize Collaboration on Telavancin, Investigational Antibiotic for Serious Infections

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- December 5, 2005 -- Theravance, Inc. (NASDAQ: THRX) announced today that the previously announced collaboration with Astellas Pharma Inc. for the development and commercialization of Theravance's investigational antibiotic, telavancin, was finalized after receiving US regulatory clearance on November 28th. As a result of the finalization of this transaction, Theravance received an upfront payment of $65 million.

Telavancin is a novel lipoglycopeptide injectable antibiotic discovered by Theravance that targets serious Gram-positive infections including drug-resistant Staphylococcus aureus strains. Previously presented data demonstrated that telavancin has a unique multifunctional mechanism of action that the companies believe results in bacterial killing and may help reduce the risk of inducing resistance. Telavancin is currently in Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) and Hospital-Acquired Pneumonia (HAP).

Collaboration Arrangements

Theravance is eligible to receive up to an additional $156 million in clinical and regulatory milestone payments which include $136 million for completion of enrollment, filing and approval in the ongoing Phase 3 programs in cSSSI and HAP and $20 million if the Phase 3 data demonstrates telavancin's superiority over vancomycin for patients infected with MRSA. Theravance will receive royalties on aggregate, annual global sales of telavancin that, on a percent basis, range from the high teens to the upper twenties.

Under the terms of the collaboration, Theravance will lead the development of telavancin for cSSSI and HAP and collaborate substantially with Astellas in marketing in the US for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities worldwide, except Japan. Theravance will be responsible for substantially all costs to develop telavancin for cSSSI and HAP and Astellas will be responsible for substantially all costs associated with commercialization and further development of telavancin. Japan is excluded from the agreement and Theravance will continue to explore partnering options for this market.

In addition to the license rights to telavancin, Astellas also receives an option to commercialize and further develop TD-1792, a unique heterodimer antibiotic compound which combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. TD-1792 is currently in IND-enabling pre-clinical studies.

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Of the five programs in development, two are in late stage -- telavancin, and the Beyond Advair collaboration with GlaxoSmithKline. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal disorders. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at www.astellas.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc. This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Examples of such statements include statements relating to the goals and expected results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates, the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, and statements concerning expectations for product candidates through development and commercialization. These statements are based on the current estimates and assumptions of the management of Theravance, Inc. as of the date of this press release and are naturally subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, and delays or failure to achieve regulatory approvals, and risks of collaborating with a third party to develop and commercialize products. These and other risks are described in greater detail under the heading "Factors Affecting Results, Including Risks and Uncertainties" contained in Item 2, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2005 and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

Contact Information

  • Contact Information:

    Theravance
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    Theravance, Inc.
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    SVP and CFO
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