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     357  0 Kommentare Theravance Biopharma and SciClone Pharmaceuticals Enter Into Development and Commercialization Agreement for VIBATIV(R) (Telavancin) in China

    GEORGE TOWN, GRAND CAYMAN and FOSTER CITY, CA--(Marketwired - May 27, 2015) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma"), through an affiliate, and SciClone Pharmaceuticals (NASDAQ: SCLN) ("SciClone"), a U.S.-based, China-focused specialty pharmaceutical company, today announced they have entered into a development and commercialization agreement granting SciClone exclusive development and commercial rights for the antibiotic VIBATIV® (telavancin) in China and certain adjacent territories. The companies plan to pursue development and commercialization of VIBATIV in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Additional indications may include complicated skin and skin structure infections (cSSSI), and potentially bacteremia.

    VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug's proven efficacy against difficult-to-treat infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections studied to date. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

    Under the terms of the agreement, Theravance Biopharma has granted SciClone exclusive development and commercialization rights to VIBATIV in China, as well as the Hong Kong SAR, the Macau SAR, Taiwan and Vietnam. In exchange, Theravance Biopharma will be eligible to receive upfront and regulatory milestone payments totaling $6 million. SciClone will be responsible for all aspects of development and commercialization in the partnered regions, including pre- and post-launch activities and product registration. Theravance Biopharma will sell to SciClone all clinical and commercial product required to develop and commercialize VIBATIV in China. 

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    Theravance Biopharma and SciClone Pharmaceuticals Enter Into Development and Commercialization Agreement for VIBATIV(R) (Telavancin) in China GEORGE TOWN, GRAND CAYMAN and FOSTER CITY, CA--(Marketwired - May 27, 2015) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma"), through an affiliate, and SciClone Pharmaceuticals (NASDAQ: SCLN) ("SciClone"), a U.S.-based, …