By Cormac Sheridan Staff Writer German biotech received a badly needed boost this week with the news that GlaxoSmithKline plc was in-licensing MOR103, an antibody in clinical development in rheumatoid arthritis (RA) and multiple sclerosis (MS) at veteran antibody developer Morphosys AG, in return for an up-front payment of €22.5 million (US$29 million), plus another potential €423 million in milestones linked to its progress through clinical development, regulatory approval and sales
3SBio Inc., of Shenyang, China, said it completed its merger with Decade Sunshine Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. The firm also requested that trading of its American depositary shares on Nasdaq be suspended, while it works to delist its registered securities. Addex Therapeutics SA, of Geneva, completed a previously announced restructuring, and Bharatt Chowrir stepped down effectively immediately as CEO and as director of
LONDON – A new study has given hope that it may one day be possible to develop a specific treatment for neuroblastoma, which is a rare type of childhood cancer. Researchers in Sweden have shown that blocking the function of a molecule that is overexpressed in neuroblastoma cells can shrink tumors and prolong survival in a mouse model of that disease. A similar strategy may also work for many other cancers, the scientists suggested, because the molecule that is overexpressed in neuroblastoma is
By Sharon Kingman | BioWorld International | Wednesday, June 5, 2013
German biotech received a badly needed boost this week with the news that GlaxoSmithKline plc was in-licensing MOR103, an antibody in clinical development in rheumatoid arthritis (RA) and multiple sclerosis (MS) at veteran antibody developer Morphosys AG, in return for an up-front payment of €22.5 million (US$29 million), plus another potential €423 million in milestones linked to its progress through clinical development, regulatory approval and sales. Martinsried, Germany-based Morphosys also
By Cormac Sheridan | BioWorld International | Wednesday, June 5, 2013
GHENT, Belgium – The pharmaceutical industry has enjoyed 60 years of stability and is now – whether it likes it or not – ripe for disruption. That was the main message Bernard Munos, of InnoThink Center for Research in Biomedical Innovation in Indianapolis, delivered to delegates at a heavily attended keynote at the Knowledge for Growth meeting at the International Convention Center last week. "Disruption is a good thing when it happens to others, but we fear it when it happens to us," Munos
By Cormac Sheridan | BioWorld International | Wednesday, June 5, 2013
LONDON – Bergenbio AS has raised $6 million in a Series B round supported by all the existing investors, providing funding for a number of Phase I trials of its lead product BGB 324, a first-in-class AXL receptor tyrosine kinase inhibitor. AXL kinase is central to the cell-to-cell signal transduction process known as epithelial-mesenchymal transition (EMT), by which cancer cells escape to form metastases and also is involved in the development of resistance to chemotherapeutics, most notably
By Nuala Moran | BioWorld International | Wednesday, June 5, 2013
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
By Nuala Moran | BioWorld International | Wednesday, June 5, 2013
LONDON – Nanobiotix SA presented positive safety data from the first clinical study of NBTXR3, a nanoparticle drug that enhances the effects of radiotherapy on tumor cells without damaging healthy tissue, at the American Society of Clinical Oncology (ASCO) meeting in Chicago on Saturday. The results of the Phase I trial in soft-tissue sarcoma now will pave the way for the Paris-based company to intensify negotiations with potential partners for North American rights. NBTXR3, a nanoparticle
By Nuala Moran | BioWorld International | Wednesday, June 5, 2013
GHENT, Belgium – Patrik De Haes, CEO of Thrombogenics NV, rang the opening bell – albeit remotely – on the NYSE Euronext Brussels exchange to kick off proceedings at the 2013 Knowledge For Growth meeting at the International Convention Center in Ghent, Belgium, last Thursday. The ceremony marked the company's recent entry into the BEL20 index of Belgium's 20 most heavily traded stocks. It represents a coming of age for Leuven-based Thrombogenics and further evidence of the evolution of the
By Cormac Sheridan | BioWorld International | Wednesday, June 5, 2013
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
By Randy Osborne | BioWorld Today | Wednesday, June 5, 2013
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
By Mari Serebrov | BioWorld Today | Wednesday, June 5, 2013
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
By Marie Powers | BioWorld Today | Wednesday, June 5, 2013
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
By Catherine Shaffer | BioWorld Today | Wednesday, June 5, 2013
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
By Larry Schuster | BioWorld Today | Wednesday, June 5, 2013
Antisense Therapeutics Ltd., of Victoria, Australia, said it is conducting a chronic, six-month primate toxicology study in China designed to underpin and validate plans to secure a partner to take second-generation antisense drug ATL1102 into a Phase IIb study in multiple sclerosis patients. Dosing in the preclinical study is set to be completed by the end of this year, with data on track to be reported early in 2014. Biotie Therapies Corp., of Turku, Finland, obtained an exclusive option to
German biotech received a badly needed boost this week with the news that GlaxoSmithKline plc was in-licensing MOR103, an antibody in clinical development in rheumatoid arthritis (RA) and multiple sclerosis (MS) at veteran antibody developer Morphosys AG, in return for an up-front payment of €22.5 million (US$29 million), plus another potential €423 million in milestones linked to its progress through clinical development, regulatory approval and sales. Martinsried, Germany-based Morphosys also
By Cormac Sheridan | BioWorld Today | Wednesday, June 5, 2013
CSL Behring, of King of Prussia, Pa., dosed the first patient in Part 3 of its AFFINITY trial program. The open-label Phase I/III study is evaluating the efficacy, safety and pharmacokinetics of its recombinant coagulation single-chain Factor VIII compared with recombinant human antihemophilic Factor VIII (octocog alpha) for the treatment of hemophilia A.
Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy. Under priority review, the FDA aims to complete its review within an eight-month review cycle. Metreleptin, a recombinant analogue of human hormone leptin, was developed by San Diego-based Amylin Pharmaceuticals Inc., which
By Cormac Sheridan Staff Writer German biotech received a badly needed boost this week with the news that GlaxoSmithKline plc was in-licensing MOR103, an antibody in clinical development in rheumatoid arthritis (RA) and multiple sclerosis (MS) at veteran antibody developer Morphosys AG, in return for an up-front payment of €22.5 million (US$29 million), plus another potential €423 million in milestones linked to its progress through clinical development, regulatory approval and sales