Durata Therapeutics Announces the U.S. Launch of DALVANCE™
CHICAGO, July 18, 2014 (GLOBE NEWSWIRE) — Durata Therapeutics, Inc. (Nasdaq:DRTX) announced today that Dalvance (dalbavancin) for injection is now available for use to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI). Dalvance was approved by the U.S. Food and Drug Administration (FDA) on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). Durata began shipping Dalvance to its distributors earlier this week. Physicians and Pharmacists may now order Dalvance from ASD Healthcare or their wholesaler, or they may call Durata at 1 855 DURATA1 (1-855-387-2821).
“Dalvance’s unique dosing regimen offers a new approach to treatment of serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions,” said Paul R. Edick, Durata’s CEO. “We are very pleased that DALVANCE is now available to millions of Americans who may benefit from this innovative treatment option for ABSSSI.”
For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions.
“Managing the daily treatment of ABSSSI can be a difficult task for hospitals, physicians and patients,” said John Shannon, Durata’s Chief Commercial Officer. “We are very proud and excited to have hired, trained, and deployed over 100 outstanding commercial professionals to communicate the value of Dalvance and its unique once-a week dosing for two weeks.”
About Dalvance (dalbavancin) for injection
Dalvance is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. Dalvance is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. Dalvance demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
For important prescribing and safety information, see www.dalvance.com.
Dalvance is a trademark of Durata Therapeutics Holding C.V.
About Durata Therapeutics, Inc.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of new therapeutics for patients with infectious diseases and acute illnesses. For more information about the company, visit www.duratatx.com.
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include statements about the impact of Dalvance’s dosing schedule on patient care. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the “Risk Factors” section of our most recent report on Form 10-K, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
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