Acorda Therapeutics Inc., of Ardsley, N.Y., reported data from a preclinical study of dalfampridine for post-stroke deficits, showing that it improved motor function. The company previously completed a proof-of-concept study in humans that showed dalfampridine improved walking in people with post-stroke deficits. The data were published online ahead of print in Stroke and will be included in the July 2013 print edition. Dalfampridine is the active ingredient in Ampyra extended-release tablets
Adaptive Biotechnologies, of Seattle, entered a collaboration with Bristol-Myers Squibb Co., of New York, for the discovery of immunological biomarkers in oncology. Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response. Financial terms were not disclosed. Merck & Co. Inc., of Whitehouse Station, N.J., is facing a $100 million individual and class-action suit filed by Sanford Heisler LLP on behalf of all
Trevena Inc.'s deal with a subsidiary of Forest Laboratories Inc. brings a $30 million equity investment in exchange for an option to license worldwide rights to TRV027, an angiotensin II Type I receptor (AT1R) biased ligand for acute decompensated heart failure (ADHF), after results are clear from a 500-patient Phase IIb trial, slated to begin by the end of the year. If the option is exercised, New York-based Forest will make payments of up to $430 million, depending upon the achievement of
By Randy Osborne | BioWorld Today | Friday, May 10, 2013
Hours after reporting its first quarterly earnings as a commercial entity following FDA approval of Kynamro (mipomersen) in January and subsequent launch of the antisense drug, Isis Pharmaceuticals Inc. turned its attention to other candidates in its pipeline. The Carlsbad, Calif.-based company priced an underwritten public offering of 9 million shares of its common stock at $19 per share, seeking to raise $171 million from the offering, which is expected to close on or about May 14. Isis
By Marie Powers | BioWorld Today | Friday, May 10, 2013
Acucela Inc., of Bothell, Wash., and Otsuka Pharmaceutical Co. Ltd., of Tokyo, reported results of a Phase IIa trial of emixustat hydrochloride for geographic atrophy (GA) of dry age-related macular degeneration at the Association for Research in Vision and Ophthalmology meeting in Seattle. The objective of the 72-patient study was safety and tolerability of emixustat hydrochloride doses in subjects with GA compared to placebo. Biological activity of emixustat hydrochloride in the retina also
Eisai Inc., of Woodcliff Lake, N.J., said antiepileptic drug Fycompa (perampanel) showed a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to two new analyses of early clinical experience. Data were presented at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland.
Receptos Inc., of San Diego, priced its initial public offering (IPO) of 5.2 million shares of common stock at $14 per share, for a total raise of $72.8 million. The stock began trading on Nasdaq under the symbol "RCPT" Thursday, closing at $14. The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the
By Catherine Shaffer | BioWorld Today | Friday, May 10, 2013
When is a drug compounder a manufacturer vs. a pharmacy? That's the question the Senate Health, Education, Labor and Pensions Committee grappled with Thursday as it closed in on a bill it can send to the Senate floor that would better regulate compounding pharmacies without opening a loophole around the drug approval process. The committee's draft bill proposes a new category of drugmakers, "compounding manufacturers," which would be subject to FDA regulation and user fees. Traditional
By Mari Serebrov | BioWorld Today | Friday, May 10, 2013
Researchers have identified a protein that can reverse cardiac hypertrophy, the thickening of the heart muscle that is one of the key features of diastolic heart failure. More generally, though the researchers have not specifically looked at life span yet, they said they believe that the protein in question may turn out to be a whole-body regulator of the aging process. The team published its findings in the May 10, 2013, issue of Cell. The authors identified the factor, GDF-11, with so
By Anette Breindl | BioWorld Today | Friday, May 10, 2013
Exelixis Inc. , of South San Francisco, reported net revenues for the quarter ended March 31, 2013, were $9.7 million, compared to $18.5 million for the comparable period in 2012. The amount included $1.9 million resulting from the sale of Cometriq (cabozantinib), which became commercially available for the treatment of progressive, metastatic medullary thyroid cancer on Jan. 24, 2013. The quarterly decrease in non-product revenues was primarily due to $10.7 million in revenue recognized in
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo. Takeda will pay $35 million up front and up to $215 million contingent on various clinical and commercial milestones. The transaction will be conducted through Takeda's wholly owned subsidiary Takeda America
By Peter Winter | BioWorld Today | Thursday, May 9, 2013
Shares of Alexza Pharmaceuticals Inc. jumped 29 percent Wednesday after the firm disclosed a U.S. commercialization partner for recently approved Adasuve, a version of antipsychotic drug loxapine delivered via the company's Staccato technology. Mountain View, Calif.-based Alexza is picking up $40 million up front in the licensing and supply deal with Teva Pharmaceutical Industries Ltd. The big pharma will take over responsibility for post-approval studies and has the right to conduct additional
By Jennifer Boggs | BioWorld Today | Thursday, May 9, 2013
With Phase II trials on the runway for several forms of adult and pediatric cholestatic liver disease, a rare condition for which no therapy exists, Lumena raised $23 million in a Series A financing that is expected to get the company through those studies, after which the firm will deliberate the matter of whether to bring aboard a partner in the rare-disease effort. "These studies should read out in the second half of next year, and the funding will take us through the end of 2014," said Mike
By Randy Osborne | BioWorld Today | Thursday, May 9, 2013
Responding to drugmakers' growing interest in pediatric trials, the Biotechnology Industry Organization (BIO) is teaming up with the ViS Research Institute on a two-phase initiative to tackle the biggest challenge in conducting the trials – finding qualified sites that can recruit pediatric subjects. Using ViS' online analytics platform, the initiative is expected to reduce the barriers to global pediatric clinical research by helping drugmakers identify patients, enabling streamlined trial
By Mari Serebrov | BioWorld Today | Thursday, May 9, 2013
Oncobiologics Inc. allied with Zhejiang Huahai Pharmaceutical Co. Ltd. to develop, manufacture and commercialize biosimilar monoclonal antibody products equivalent to Humira, Rituxan, Avastin and Herceptin in a rapidly expanding subsector which has reached $2.4 billion – a 20 percent increase from 2012. The products will be commercialized by Huahai and manufactured in China at a Huahai biologics facility for the China market. The companies will also establish a co-development and
By Catherine Shaffer | BioWorld Today | Thursday, May 9, 2013
Cardio3 BioSciences (C3BS) closed a €19 million ($25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. The new cash comes from the company's existing investors. C3BS, of Mont-Saint-Guibert, Belgium, is developing a therapy that originated at the Mayo Clinic, in Rochester, Minn. C-Cure (formerly
By Cormac Sheridan | BioWorld Today | Thursday, May 9, 2013
