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news.Theravance Biopharma has entered into a development and commercialization agreement with SciClone Pharmaceuticals, under which the latter will have exclusive development and commercial rights for the antibiotic Vibativ (telavancin) in China and certain adjacent territories.
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Under the deal, the parties plan to pursue development and commercialization of Vibativ in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The company said that additional indications for Vibativ, a bactericidal, once-daily, injectable lipoglycopeptide antibiotic, may include complicated skin and skin structure infections (cSSSI), and potentially bacteremia.
Vibativ has in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
SciClone will now have exclusive development and commercialization rights to Vibativ in China, as well as the Hong Kong SAR, the Macau SAR, Taiwan and Vietnam.
In return, Theravance will be eligible to receive upfront and regulatory milestone payments totaling $6m and it will sell to SciClone all clinical and commercial products required to develop and commercialize Vibativ in China.
The deal will see SciClone responsible for all aspects of development and commercialization in the partnered regions, including pre- and post-launch activities and product registration.
Theravance Biopharma Development and Operations senior vice-president said: "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.
"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."
In the US, Vibativ for injection is approved to treat HABP/VABP caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
SciClone CEO Friedhelm Blobel said: "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."
Image: Vibativ for injection is approved in the US to treat HABP/VABP. Photo: courtesy of Baitong333/ freedigitalphotos.net.