Global pharmaceutical companies have recognized China as a force to be reckoned with, as evidenced by their lockstep establishment of R&D and commercial operations in the country. However, a China strategy is a bit trickier for U.S. biotechs to achieve. Although Amgen Inc., Celgene Corp. and Gilead Sciences Inc. are among the big biotechs with offices in China, most small-cap firms have deferred a presence in the country. EntreMed Inc. is a contrarian in that respect. The Rockville, Md.-based

CytomX Therapeutics Inc.'s oncology deal with Pfizer Inc. to develop Probody-drug conjugates (PDCs) gives the pharma giant rights to develop selected candidates in exchange for a potential $25 million up front, as well as $610 million if regulatory and sales milestones are met, and tiered royalties into the double digits on sales of resulting products. The $25 million "incorporates the up-front research funding and near-term milestone payments, as we move [PDCs] through various stages of

Astellas Pharma US Inc., of Northbrook, Ill., part of Astellas Pharma Inc., entered a distribution agreement with Tecnofarma International Ltd., of Buenos Ares, Argentina, to distribute enzalutamide (Xtandi in the U.S.) in Latin America, excluding Brazil, upon regulatory approvals in the various countries. Financial terms of the agreements were not disclosed. Bayer AG, of Leverkusen, Germany, said it has been offered 96.4 percent of the shares (about 32 million) of Conceptus Inc., of Mountain

ARCA Biopharma Inc., of Broomfield, Colo., said it closed its public offering of Series A convertible preferred stock and warrants, issuing to investors 125,000 shares of preferred stock and warrants to purchase 6.25 million shares of common stock. ARCA received about $18 million in net proceeds, which will be used primarily to fund the Phase IIb portion of the GENETIC-AF trial comparing lead compound Gencaro (bucindolol hydrochloride) to metoprolol CR/XL to prevent atrial fibrillation in

TAIPEI, Taiwan – It's been a long wait, but Taiwan's drug development industry might just be coming of age. While the island nation is still awaiting its first home-grown innovator drug, a number of companies are almost there. As evidence, market capitalization of companies in the sector has skyrocketed at an astounding rate over the past few years, jumping from $3 billion in 2009 to $15 billion in 2013, according to Taiwan's Bio Industry Organization. It's about time, since at least the mid

Execs at BioMarin Pharmaceutical Inc. hope to repeat their Phase II success with PEG-PAL (PEGylated recombinant phenylalanine ammonia lysate) for phenylketonuria in a new Phase III program. The open-label study will evaluate safety and tolerability of the self-administered therapy on about 90 treatment-naïve adult PKU subjects during induction, titration and maintenance dosing. Secondary objectives include blood phenylalanine (Phe) levels. A double-blind, placebo-controlled Phase III will

The FDA revised its 2002 guidance on developing antiretroviral drugs to treat HIV-1 to provide more details on the nonclinical development of antiretrovirals and greater emphasis on recommended designs for trials evaluating the drugs in patients with multidrug-resistant virus and few remaining therapeutic options. The draft guidance also discusses use of a primary endpoint evaluating early virologic changes for studies in heavily treatment-experienced patients and use of the traditional path

LONDON – A new company has been spun out of genomics pioneer Oxagen Ltd. to take forward the lead compound OC459 in fresh indications. The product has successfully completed Phase IIb development in asthma, but following the Phase II failures of two other compounds in the same class that were being developed by AstraZeneca plc and Amgen Inc., it proved impossible to raise the funding, or secure a partner, to take the CRTH2 antagonist into a Phase III asthma study. Instead, the rights to OC459

Second Genome Inc. brought on board its first big pharma partner, signing Janssen Biotech Inc. to a multiyear deal focused on using the San Bruno, Calif.-based biotech's microbiome modulation platform to discover drugs for ulcerative colitis. Specific financial terms were not disclosed, but Second Genome will earn an up-front payment, with Janssen, through the Johnson & Johnson Innovation Center and Janssen Research & Development LLC, committing to research support. Second Genome also could

Andromeda Biotech Ltd., of Yavne, Israel, reported findings from an extension study of its Phase III trial of DiaPep277 in Type I diabetes. The open-label, 24-month extension study was designed to evaluate long-term safety, tolerability and efficacy for two years following the completion of the Phase III study, DIA-AID 1 in November 2011 . Forty-three patients who completed two years in the DIA-AID 1 study and who had residual beta cell function (stimulated C-peptide over 0.2 nmol/L) were

Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the FDA agreed to an expedited development pathway for next-generation compound AVP-786, requiring only a limited preclinical package as part of the investigational new drug application. Upon completion of those studies, the company intends to proceed directly into human testing. AVP-786, a drug product consisting of a combination of deuterium-modified dextromethorphan and ultra-low dose quinidine, is in development for neuropathic pain

Although efficacy below AstraZeneca plc's standard caused the pharma firm to give up rights to fostamatinib, the spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis (RA) met important endpoints, and Rigel Pharmaceuticals Inc. could find another partner and explore new diseases with it. "It works, but maybe not as well as AstraZeneca had hoped, in terms of having a robust bone benefit, in particular," said Raul Rodriguez, president and chief operating officer for South San Francisco

The president is getting gruff with patent trolls, using his executive powers to waylay their frivolous lawsuits and urging Congress to pass legislation that would make trolling far less appetizing. Unlike patent intermediaries that foster the transfer of technology from inventors to businesses looking to develop products, the trolls – also known as patent assertion entities (PAEs) – stake their claim around patents for ideas that failed in the marketplace or they buy up hundreds of thousands of

Shares of Pluristem Therapeutics Inc. stumbled Tuesday on word that the FDA placed a clinical hold on the U.S. Phase II study (IND 15038) of its allogeneic cell therapy in intermittent claudication (IC), a subset of peripheral artery disease (PAD), following a serious allergic reaction that required the patient's hospitalization. Zami Aberman, chairman and CEO of the Haifa, Israel-based firm, said the allergic event was the first to occur among 74 patients enrolled to date in trials of its

A bit more than a year after handing in positive results in a Phase II study for AKB-6548 in chronic kidney disease (CKD), Akebia Therapeutics Inc., of Cincinnati, secured a $41 million Series C financing to fund ongoing development of the drug. Spread out over the next 18 months, the company will put the funds to work supporting preparations for Phase III studies, including a Phase IIb study in patients with anemia associated with CKD. "In 2012, we completed a 93-patient Phase II study, the

Debiopharm Group, of Lausanne, Switzerland, said it treated the first patients in a Phase I study of Debio 1143, a small-molecule neutralizing inhibitor of apoptosis protein, combined with carboplatin and paclitaxel in patients with squamous non-small-cell lung cancer, platinum-refractory ovarian cancer and basal-like/claudin low-triple-negative breast cancer. The study will evaluate the safety and tolerability of the drug, establish a maximum tolerated dose and establish dosing for a further

BEIJING – As manufacturers of biologics reflect on the price of foreign products in China, they say there must be a better way. For example, at a panel discussion on biosimilars and biologics at the ChinaBio Partnering Forum in Beijing last week, Michael Yu, president and CEO of Innovent Biologics Inc., of Suzhou, China, noted that Herceptin (trastuzumab, Roche AG) is even more expensive in China than in the U.S. And thus, it reaches about 4,000 patients in China, or only 1 percent of the 400