Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer. The product previously received orphan status in the U.S. and Japan. Lenvatinib is in Phase III testing in several indications, including thyroid cancer. In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting
Array BioPharma Inc.'s Phase III trial planned for this summer in recurrent low-grade serous ovarian cancer (LGSOC) with its Novartis AG-partnered MEK inhibitor is one of a handful of late-stage studies expected to roll out this year. "We're looking at five pivotal trials, all starting this year, across our two MEKs," said Ron Squarer, Array's CEO. "There could be more, based on data that's emerging at [the American Society of Clinical Oncology (ASCO) meeting] this year." Called MILO (MEK
By Randy Osborne | BioWorld Today | Wednesday, May 8, 2013
Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported its first revenue from cancer drug Iclusig (ponatinib), which was approved in December for use in adults with chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. Net sales totaled $6.4 million for the quarter ending March 31. Ariad posted a net loss for the quarter of $64.7 million, or 36 cents per share, a narrower loss
Astellas Pharma Inc., of Tokyo, and Drais Pharmaceuticals Inc., of Bridgewater, N.J., will repeat for the third time a spinout maneuver that has been successful with two other programs in the past. The companies partnered to develop and commercialize Astellas's compound ASP7035, a vasopressin V2 receptor selective agonist in development for nocturia, by means of a licensing arrangement to a new virtual company, Tacurion Pharma Inc., to be managed by the Drais executive team. InterWest Partners
By Catherine Shaffer | BioWorld Today | Wednesday, May 8, 2013
Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD). Clinical success rates – the percentage of investigational compounds that eventually obtain FDA approval – for cancer therapeutics rose from 9.9 percent for drugs that entered the clinic in the
By Marie Powers | BioWorld Today | Wednesday, May 8, 2013
Generic drugmakers appear to be winning in the showdown with biologics makers over state legislation that would limit the automatic substitution of future biosimilars. Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology Industry Organization (BIO) has identified as core safeguards for patients
By Mari Serebrov | BioWorld Today | Wednesday, May 8, 2013
The immune system is able to kick out many viral invaders after a few days to weeks. But others, from herpes to hepatitis C, can come to be in a permanent standoff with the immune system, controlled but not eliminated altogether. In chronic viral infection, CD8 "killer" T cells enter a state that has been called "exhausted." Such cells no longer produce cytokines to any appreciable effect, and many scientists thought they were incapable of dividing. But a team from the Swiss Vaccine Research
By Anette Breindl | BioWorld Today | Wednesday, May 8, 2013
By Peter Winter BioWorld Insight Editor Partnerships are a key component in the operating playbook of emerging and developing biotechnology companies. Although this year is shaping up as a very big one for deals, according to data from the Biotechnology Industry Organization (BIO) and biopharma consulting firm Campbell Alliance Group, they are not as lucrative for generating cash in the early stages as they once were. Deal structures now emphasize a heavy dose of risk-sharing with downstream
After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class. With the Biomedical Advanced Research and Development Authority (BARDA) looking to procure a hefty supply of a granulocyte colony-stimulating factor (G-CSF) such as Neupogen for emergency use in case of a
By Mari Serebrov | BioWorld Today | Tuesday, May 7, 2013
Cel-Sci Corp., of Vienna, Va., reported findings from an efficacy study in a second animal model of rheumatoid arthritis (RA) using its LEAPS technology. The study evaluated the LEAPS vaccine's effect in the Proteoglycan-induced arthritis (PGIA) model of RA with a dominant T helper 1 (Th1) cytokine profile. Disease severity, measured on the basis of the Arthritis Index and histopathology, was significantly suppressed in mice treated with the LEAPS vaccine compared to controls. The reduction in
Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S. for the investigational oral Bruton's Tyrosine Kinase inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics Inc., of Sunnyvale, Calif. The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib
Concert Pharmaceuticals Inc.'s third deal in just over two years with its deuterium-modifying platform brought Celgene Corp. aboard for a single project at first – an up-front payment along with more than $300 million possible in milestone rewards – but with the potential for more compounds that would bring similar financial terms. The focus of the agreement with Summit, N.J.-based Celgene is on cancer and inflammation. Roger Tung, president and CEO of Concert, would not say which area the
By Randy Osborne | BioWorld Today | Tuesday, May 7, 2013
Aegerion Pharmaceuticals Inc., of Cambridge, Mass., added Anne M. VanLent to its board. Afraxis Inc., of San Diego, named Carmine Stengone president and CEO, and Christopher Rex chief scientific officer. BioDelivery Sciences International Inc., of Raleigh, N.C., added Thomas W. D'Alonzo to its board. Cleveland BioLabs Inc., of Buffalo, N.Y., added Julia Brown and Anthony Principi to its board, and appointed David Hohn board chairman. IntelGenx Corp., of Saint Laurent, Quebec, named
Armed with a novel technology and a new target – a class of disease modifying therapies that preserve intracellular S-nitrosoglutathione (GSNO), a regulator of organ repair, regeneration and healing – N30 Pharmaceuticals Inc. has quietly evolved from a 2007 start-up into a development-stage biotech with 30 employees. Along the way, the Boulder, Colo.-based company attracted $60 million in private capital and is making steady progress in its goal to increase endogenous nitrous oxide (NO) by
By Marie Powers | BioWorld Today | Tuesday, May 7, 2013
AMAG Pharmaceuticals Inc., of Lexington, Mass., said a new subgroup analysis from IDA-301, a Phase III, randomized, placebo-controlled trial, was presented at the first poster session of the American College of Obstetrics and Gynecology annual meeting in New Orleans. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline
In the wake of promising preclinical data for its hepatitis B virus (HBV) candidate, Arrowhead Research Corp. shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection. The cash infusion is the largest in Arrowhead's history – the firm pulled in $21 million in a 2006 funding round – and, at the current burn rate, should sustain operations into 2015, long enough to reach
By Jennifer Boggs | BioWorld Today | Tuesday, May 7, 2013
Type of Financing January February March April Total ($M) Public offerings 2,305.0 195.5 753.9 416.8 3,671.2 Public/other 530.4 218.9 599.3 103.5 1,452.2 Private biotechs 194.7 135.6 73.3 416.9 820.5 Total ($M) 3,030.1 550.0 1,426.5 937.2 5,943.9 Notes: Public offerings = Initial, follow-on. Private biotechs = Financings of private firms. Public/other = Other financings of public companies, including loans, bridge financings, exercises of warrants, debt offerings, rights offerings, standard
Esperion Therapeutics Inc., of Ann Arbor, Mich., disclosed full results of a Phase II trial of ETC-1002 in patients with Type II diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent, and was associated with improvements in control of other cardiometabolic risk factors. ETC-1002 was well tolerated. The data were presented in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology 2013 Scientific
Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer. The product previously received orphan status in the U.S. and Japan. Lenvatinib is in Phase III testing in several indications, including thyroid cancer. In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting