SciClone dumps cancer drug after failed IIb

Posted under Blog, Cancer, China, Companies, Diagnostics, Funding, Hepatitis C, Medical Devices, Medical Supply, Pharmaceuticals, SciClone, Startups, Universities, Videos by John Carroll

Foster City, CA-based SciClone Pharmaceuticals ($SCLN) has come up empty-handed again after concluding its latest Phase IIb trial for SCV-07 should be shuttered after proving ineffective for oral mucositis, a common side effect for cancer patients. Investigators earlier tried and failed to demonstrate the treatment might be effective for hepatitis C. SciClone said on Friday it is washing its hands of the drug as it shifts all of its focus to China's specialty drug market. Release
 

Shanghai-based CRO Newsummit outlines $80M IPO

Posted under Biotech IPO, Blog, China, Companies, CRO, Diagnostics, Funding, Medical Devices, Medical Supply, outsourcing, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Shanghai-based Newsummit Biopharma, a fledging CRO, has filed to go public with plans to raise $80 million in the U.S. for its clinical trial services organization. According to its F-1 statement filed with the SEC, Newsummit has set up operations at a variety of China's booming life science parks, with some two dozen INDs to its credit.

Newsummit styles itself as a one-stop shop for developers trying to get a drug through the clinic and to China's regulatory agencies for a prospective approval. Starting with 50 clients back in 2009, the research group now claims more than 100. And it's touting the growing focus on China R&D as a reason to believe in a big future for itself.

"Our clients are primarily drug discovery companies who have completed initial exploratory discovery and obtained promising laboratory research results or patents, but generally lack the various resources and expertise in managing and navigating through the regulatory submission process for their new drug development projects," noted Newsummit in its filing.

The CRO says that it now plans to establish post-approval services for its biopharma clients.

- here's the F-1
- get the story from Dow Jones

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Pfizer amps up R&D partnering activity in China and India

Posted under Asia, Biocon, Blog, China, Companies, Diagnostics, Funding, Generics, india, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by John Carroll

A day after Pfizer ($PFE) inked a deal with a joint venture partner in China to develop new generic drugs, the pharma giant is spreading the word that it's in the hunt for local drug development partners in the fast-growing Asian marketplace.

Dr. Richard Cornell, Pfizer’s Asian R&D exec, said the Big Pharma outfit is actively exploring more tie-ups with Indian biotechs. "Oncology is where there is a massive medical need and there is a significant breakthrough in science," Cornell said, as quoted by the The Economic Times. "Indian companies are very strong in bio-chemistry and so we are looking for partners here."

Pfizer announced Monday it will work with Zhejiang Hisun Pharmaceutical, investing $250 million in a branded generics venture which will be 51% owned by the Chinese partner. Barclay’s Jason Mann gave his nod to the tie-up, noting Zhejiang Hisun is a big manufacturer of active ingredients in China, giving Pfizer an edge in advancing new products acceptable to Chinese regulatory authorities.

"We are exploring business development opportunities, including partnerships with local companies that allow us to successfully expand into the generics segment of the market," a Pfizer spokesman told Reuters.

Pfizer’s made it clear for some time it sees a big future for itself in Asia’s emerging markets. More than a year ago the pharma company tied up with India’s Biocon on a deal to develop insulin generics. Pfizer paid Biocon $200 million upfront for the opportunity to pair up with the Indian company.

- read the press release on the Asian JV
- get the story from The Economic Times on oncology pacts
- and here's the Reuters story

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Takeda opens new drug development center in China

Posted under Blog, China, Companies, Diagnostics, drug development, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by John Carroll

Japan's Takeda is adding a new drug development center in Shanghai intended to complement the international clinical work now under way in Singapore and Cambridge, MA. Both of the existing operations, including the cancer drug developer Millennium in Cambridge, work with contract research organizations to advance new treatments through the clinic. Now the Shanghai operation will draw on the international team to study new drugs catering to the fast-growing market in China. Story