Theravance Biopharma and SciClone Pharmaceuticals 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.
"Partnering with SciClone and expanding into the large and growing China market is a key component of Theravance Biopharma's strategy to leverage regional partners to broaden our commercial reach and establish VIBATIV as a valuable global brand," said Frank Pasqualone, Senior Vice President, Development and Operations at Theravance Biopharma. "Our companies share the belief that VIBATIV can play a significant role in combating difficult-to-treat infections. SciClone's proven experience and expertise in navigating the complex regulatory and commercial landscape in China provide us confidence in their ability to obtain regulatory approval of VIBATIV in China and maximize the value of VIBATIV in its licensed regions."
"We believe that VIBATIV is a very valuable addition to our portfolio of high quality, differentiated products, and targets a key, under-appreciated public health concern in China, namely the high level of antibiotic resistance," said Friedhelm Blobel, PhD, Chief Executive Officer of SciClone. "We believe that its many attractive product attributes, including its dual mechanism of action, bactericidal activity and well documented evidence of in vitro potency against a broad collection of difficult-to-treat and multi-drug resistant Gram-positive clinical pathogens, including MRSA, can establish VIBATIV as a valuable asset in the antibacterial armamentarium in China for multiple infection types. If VIBATIV is approved in China, we intend to leverage our deep knowledge of the infectious disease segment and our ZADAXIN® regulatory and commercial infrastructure to support the market success of this important brand."