SOUTH SAN FRANCISCO, Calif., March 28 /PRNewswire-FirstCall/ -- Theravance, Inc. today announced that the U.S. Food and Drug Administration has granted “fast track” designation to telavancin for the treatment of Hospital Acquired Pneumonia (HAP) and complicated skin and skin structure infections (cSSSI).
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The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs.
The FDA granted fast track designation for the following reasons: -- Telavancin is being developed for treatment of HAP including those infections due to methicillin-resistant strains of Staphylococcus aureus (MRSA) and multi-drug resistant strains of Streptococcus pneumoniae. These infections are serious because of the virulence of the associated pathogens, the resistance of these pathogens to multiple antimicrobials and the morbidity and mortality associated with HAP. -- Telavancin is being developed for treatment of cSSSI due to MRSA. These infections are serious because of the virulence of the associated pathogens, the resistance of these pathogens to multiple antimicrobials, the potential for extension of these pathogens to other anatomic sites, and the morbidity and mortality associated with cSSSI. -- Telavancin has the potential to address an unmet medical need because of its in vitro activity against Staphylococcus aureus including methicillin-resistant and vancomycin-tolerant strains. It may therefore provide alternative therapy for HAP and cSSSI due to these pathogens, thereby meeting an unmet medical need.
Telavancin, a rapidly bactericidal injectable antibiotic, is a novel lipoglycopeptide that was discovered by Theravance through the application of multivalent drug design. Previously presented data demonstrated that telavancin has a unique multifunctional mechanism of action that the company believes speeds bacterial killing and reduces the risks of inducing resistance. This antibacterial activity results from interaction with D-Ala- D-Ala-containing peptidoglycan intermediates that leads, at submicromolar concentrations, to inhibition of the transglycosylation step of peptidoglycan synthesis during cell wall synthesis. Also, at higher, clinically-achievable concentrations, direct effects on bacterial plasma membrane function, such as membrane potential depolarization and increased permeability, are observed. Telavancin is currently in Phase 3 studies for the treatment of HAP and cSSSI.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Of the six 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, overactive bladder and gastrointestinal motility 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 http://www.theravance.com/.
NOTE: THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE(R) 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 expected timing, scope and results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates and the enabling capabilities of proprietary insights. These statements are based on the current estimates and assumptions of the management of Theravance 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 its 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. These and other risks are described in greater detail under the headings “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Theravance’s prospectus dated October 5, 2004 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Other Factors Affecting Operating Results” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. Given these uncertainties, you should not place undue reliance on these forward- looking statements. Theravance assumes no obligation to update its forward- looking statements.
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CONTACT: investors, Greg Sturmer, VP, Finance, +1-650-808-4100, orgsturmer@theravance.com, or media, David Brinkley, SVP, CommercialDevelopment, +1-650-808-3784, or, dbrinkley@theravance.com, both ofTheravance, Inc.; or Greg Tiberend of The Ruth Group, +1-646-536-7005, orgtiberend@theruthgroup.com, for Theravance, Inc.
Web site: http://www.theravance.com/
