Deals and Financings

Celltrion (KOSDAQ: 068270) of South Korea partnered with Teva (NYSE/TASE: TEVA) to commercialize two of its bio similar cancer drugs in the US and Canada (see story). Teva paid $160 million upfront, though $60 million could be returned under certain (undisclosed) conditions. The two products have major potential markets because they are versions of Rituxan® and Herceptin®, two very important Roche/Genentech (SIX: ROG) cancer treatments. Celltrion will be responsible for clinical tests and regulatory submissions, while it will share in the profits with Teva. Rituxan loses its US patent protection in 2018 and Herceptin in 2019. As patent-protected medications, the two drugs currently produce revenues of $6.5 billion in the US and Canada. 

Enable Injections, a Cincinnati medical device company, announced a $30 million A round funding led by ORI Healthcare Fund of Hong Kong (see story). Enable has developed a wearable, large volume injection system that delivers biologics and high volume drugs subcutaneously. The company said it would use the proceeds to commercialize its drug delivery product. ORI Healthcare, a $200 million VC fund, invests in innovative healthcare companies. 

Emmaus Life Sciences, a Los Angeles rare and orphan disease pharma, raised a net $6 million from Korean investors in a deal with an unusual structure (see story). The two Korean companies, KPM Tech and Hanil Vacuum, invested $20 million in Emmaus, and  Emmaus, in turn, invested $14 million in them. Emmaus recently filed an NDA in the US for its oral pharmaceutical-grade L-glutamine (PGLG) treatment for sickle cell disease. 

HitGen, a Chengdu early-stage CRO, set up a global multi-target collaboration with Janssen Biotech (see story). The partnership will discover new small molecule candidates for oncology and metabolics targets, an operation facilitated by Johnson & Johnson (NYSE: JNJ) Innovation. HitGen will search its DNA encoded libraries, which include more than 6 billion drug-like compounds, for drug leads. Financial details were not disclosed. 

New Silkroutes Group of Singapore formed a private equity JV that will concentrate initially on healthcare opportunities in Asia Pacific, including Japan an Australia (see story). The group did not disclose how much investment capital it plans to raise. The JV, New Silkroutes Asset Management, is made up of four groups and is led by Terence Ong Sea Eng, a former United Overseas Bank executive who also owns 30% of the JV. 

Government and Regulatory

According to an investigation conducted by the CFDA, 80% of the applications for new drugs in China rely on compromised data (see story). The results contained fabricated or fraudulent numbers, omitted adverse events, offered incomplete or missing source documents, or other infractions. The CFDA closely examined the clinical data from 1,622 new drug applications to arrive at the 80% failure rate. In the case of generic drugs, data was simply made up to prove bioequivalence in 90% of the cases, according to the CFDA report, which was released in the Economic Information Newspaper, a state-owned organ.  

Company News

WuXi AppTec, a China-US CRO/CMO, officially opened a 150,000-square-foot biomanufacturing facility in Philadelphia (see story). This facility will produce viral vector-based cell therapy products such as chimeric antigen receptor T cell (CAR T cell) therapies. The new plant will also expand production of viral vector manufacturing to support gene therapy programs, including large-scale production in 2,000L single-use bioreactors. In Philadelphia, WuXi is already operating two smaller plants. Together, WuXi says the three facilities position the company as a single-source for process development, clinical and commercial cGMP manufacturing, and analytical testing for cell and gene therapy products. 

As part of a global consolidation, Novartis (NYSE: NVS) will close down its Shanghai biologics R&D operations, cutting 18 jobs (see story). In June, the Swiss biopharma officially opened its new $1 billion Shanghai R&D center to great fanfare. Most of the center's work will be unaffected. Novartis' Shanghai NIBR (Novartis Institutes for Biomedical Research) currently employs 500, the company said, and its mission remains to develop novel therapies that address unmet needs of China patients. 

Trials and Approvals

TLC (TT: 4152), a Taiwan novel drug developer, was approved to begin US trials of an oncology drug (TLC178), a lipid-encapsulated form of vinorelbine (see story). Using its NanoX™ nanotechnology platform, TLC devised the lipid delivery formulation with the goal of targeting the chemotherapy and lowering its toxicity. TLC hopes the technology will increase the indications for TLC178 beyond non-small cell lung cancer (NSCLC) to lymphomas and other advanced solid tumors. 

Shanghai's Ascentage Pharma, a novel drug developer with clinical stage assets, reported its Analytical Laboratory was certified by the China National Accreditation Service for Conformity Assessment (see story). Normally, the company explained, a drug developer doesn't apply for Conformity Assessment, but Ascentage wanted to show its commitment to drug quality in its labs as well as the drugs that will be the ultimate products of those labs.