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Top 10 Bio/Pharma Deals: 2013
Company Company Deal Value Inspiration Biopharmaceuticals Inc. Baxter International Inc. $700M Chiasma Inc. Roche AG $595M Edison Pharmaceuticals Inc. Dainippon Sumitomo Pharma Co. Ltd. $545M Trevena Inc. Forest Laboratories Inc. $460M Abide Therapeutics Inc. Merck & Co. Inc. $430M Moderna Therapeutics Inc. AstraZeneca plc $420M Isis Pharmaceuticals Inc. Roche AG $393M Ambrx Inc. Astellas Pharma Inc. $300M Resolve Therapeutics LLC Takeda Pharmaceutical Co. Ltd. $255M Alchemia Ltd. AstraZeneca -
Mirna Puts First MicroRNA Mimic into the Clinic
Mirna Therapeutics Inc. announced last week that it has initiated a Phase I trial of MRX34, its microRNA (miRNA) mimic. Andreas Bader, director of research at Mirna, told BioWorld Insight the company believes it's the first miRNA mimic to enter the clinic. Strictly speaking, it's not the first drug in the clinic involving a miRNA. That distinction belongs to Santaris Pharma A/S, which has been in the clinic since 2008 with miravirsen (SPC3649), its inhibitor of miR-122, a liver specific miRNA -
Word on the Street
"Provided that these experiments are reproducible in the hands of others, the findings offer the potential to accelerate progress toward the development [of these cells] to treat a range of degenerative diseases." – Mary Herbert, professor of reproductive biology at Newcastle University, on the success in cloning human embryonic stem cells from skin cells via somatic cell nuclear transfer "After going over there and seeing how the landscape was changing, it seemed like there was a growing -
Week in Washington
Amending an oversight in the Jumpstart Our Business Startups (JOBS) Act, the House voted 416-6 to set a deadline for the SEC to implement Regulation A changes. The National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules. Under the proposal, as long as an initial human study of certain human gene transfers is approved by a registered institutional biosafety committee (IBC -
Week in Review
Financings Acadia Pharmaceuticals Inc. priced a $100 million public offering of 8 million shares of common stock. Ambit Biosciences Corp. completed its IPO for gross proceeds of about $65 million. AxoGen Inc. filed a registration statement on Form S-1 for a proposed $15 million public offering. Discovery Laboratories Inc. closed a $14.25 million public offering of 9.5 million shares at $1.50. Dyax Corp. completed a $30 million registered direct offering to fund R&D activities. Erytech Pharma SA -
Embryonic Stem Cells: Individual Medicine - But With 2 Individuals
Last week, researchers from Oregon Health & Science University reported that they had created embryonic stem cells via somatic cell nuclear transfer (SCNT), with a high enough efficiency to bring the creation of patient-specific embryonic stem cell lines into the realm of the possible. Successful medicine, though, takes more than scientific progress. And embryonic stem cells have always been the poster child for that fact. The scientific challenges are formidable in their own right. The hope of -
Bench Press: BioWorld Looks at Translational Medicine
Why PARP Inhibitors Kill BRCA Mutants Inhibitors of the enzyme poly(ADP-ribose) polymerase (PARP) selectively kill cells with BRCA mutations, and researchers at the University of Michigan have discovered one reason that they do so. In their studies, the authors showed that poly(ADP-ribose) (PAR) recruits BRCA1, in complex with the protein BARD1, to sites of DNA damage. When PAR polymerization is inhibited, such binding cannot occur, and BRCA1 cannot be recruited to repair DNA damage. Many BRCA1 -
Stock Movers
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As Markets Fancy Biotech, PTC Therapeutics Joins IPO Queue
PTC Therapeutics Inc. made last week a biotech trifecta for initial public offerings (IPO), filing an S-1 with the SEC seeking to raise up to $85 million. Earlier, gene therapy firm bluebird bio Inc. and Esperion Therapeutics Inc., a company working on a drug to lower LDL-cholesterol, joined the IPO queue. PTC, which filed as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, plans to list its common stock on the NASDAQ Global Market under the symbol "PTCT." The -
Other News To Note
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said preclinical data showed that RNAi therapeutics targeting ALAS-1 (aminolevulinate synthase-1) can completely block the abnormal production of toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of acute intermittent porphyria (AIP). Data were presented at the International Congress of Porphyrins and Porphyrias in Lucerne, Switzerland. Alnylam is developing ALN-AS1 as part of its "Alnylam 5x15 -
Sepsis Patients May Need Bigger Immune Response
Through the indirect targeting of toll-like receptors via their co-receptor, researchers have boosted the immune response to infection, and helped animals with experimentally induced sepsis fight off the bacteria that set off the septic response. Given that one effect of sepsis is massive hyperinflammation, the notion of helping sepsis patients by boosting their innate immune response might seem counterintuitive at best, or like the punch line of a bad mother-in-law joke, at worst. But the -
'JAK'ing Up Myelofibrosis; Sanofi's Phase III Data Solid
As sales of Incyte Corp.'s approved JAK inhibitor Jakafi (ruxolitinib) begin to pick up steam, a competing myelofibrosis candidate from Sanofi SA moved a step closer to market. The Paris-based big pharma, which gained rights to JAK drug SAR302503 in its 2010 buyout of TargeGen Inc., reported solid top-line data from the Phase III study dubbed JAKARTA, showing that both dose groups of the drug hit the primary endpoint of reducing spleen volume. The study was conducted under a special protocol -
Oncos Targets Solid Tumors With Oncolytic Virus Approach
Taking an inventive route to drug development, Oncos Therapeutics Ltd. has its roots in a type of compassionate use program that was started in 2007 at the international comprehensive cancer center, Docrates, in Helsinki, Finland. The Advanced Therapy Access Program for experimental treatments with the company's oncolytic viruses was made possible through European Union (EU) regulation EC/1394/2007, designed to improve safe access by patients across the EU to gene therapy, somatic cell therapy -
Pharma: Other News To Note
Bristol-Myers Squibb Co., of New York, said it has notified the New York Stock Exchange (NYSE) of its intention to voluntarily delist its $2 convertible preferred stock from the NYSE, a decision driven by the low number of shares outstanding, low daily trading volume, listing fees and compliance administration costs. Mylan Inc., of Pittsburgh, said its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals received final approval from -
Appointments and Advancements
Aeterna Zentaris Inc., of Quebec City, added Marcel Aubut, David A. Dodd, José P. Dorais, Carolyn Egbert, Juergen Ernst, Pierre Lapalme and Gérald Limoges to its board. AltheRx Pharmaceuticals Inc., of Exton, Pa., named Jim Bennethum CEO, appointed Charles E. Becker board chairman and named Jeffrey O'Donnell and Anthony Zook to its new board of directors. BG Medicine Inc., of Waltham, Mass., appointed Paul Sohmer president and CEO. Biota Pharmaceuticals Inc., of Rockville, Md., added Anne -
Pharma: Clinic Roundup
UCB SA, of Brussels, Belgium, said data from a double-blind, placebo-controlled study found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate to severe restless legs syndrome (RLS)/Willis-Ekbom disease. The data were presented at the annual meeting of the American Society of Hypertension. Results showed that rotigotine -
Clinic Roundup
Cellular Biomedicine Group Inc., of Palo Alto, Calif., achieved 50 percent enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of human adipose-derived mesenchymal progenitor cells therapy for knee osteoarthritis. No severe adverse effects have been reported so far. Cytos Biotechnology AG, of Zurich, Switzerland, and Singapore's Agency for Science, Technology and Research (A*STAR) said the first healthy volunteer has been -
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