Financings Arrowhead Research Corp. completed a $36 million private offering to advance its pipeline. Cardio3 BioSciences closed a $25 million investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure. Galapagos NV raised $70.7 million in an over-subscribed private placing. Idera Pharmaceuticals Inc. closed a $16.5 million underwritten public offering. Isis Pharmaceuticals Inc. priced a public offering seeking to raise $171 million. Lumena
"It's very clear that we need certain types of data in animal models before we move into the clinic, and then in Phase I or Phase Ib see evidence of proof of concept in a pre-selected patient population. If we don't see that, we cannot bring such a drug into Phase III and just see what happens. Patients don't benefit from this type of approach." – Carlo Toniatti, head of research at the Institute for Applied Cancer Science and the Center for Co-Clinical Trials at the University of Texas MD
LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. "We are delighted by the outcome," said Eliot Forster, CEO. "In addition to some benefits in terms of the underlying disease, CT327 showed a highly significant impact on itch, which in psoriasis and other dermatological
By Nuala Moran | BioWorld Today | Monday, May 13, 2013
In a footnote to its recent 10-Q filing, Pfizer Inc. shared results of a March meeting with the FDA to discuss a June 2011 complete response letter (CRL) for Remoxy (oxycodone) saying that it may not continue development, and if so, it would not have a response to the CRL before mid-2015. Partners Durect Corp. and Pain Therapeutics Inc. both took major hits on Friday as a result: Durect (NASDAQ:DRRX) plummeted 54 cents, or 34 percent, to close at $1.05. Pain Therapeutics (NASDAQ:PTIE) fell $2
By Catherine Shaffer | BioWorld Today | Monday, May 13, 2013
Discovery Laboratories Inc., of Warrington, Pa., said it priced a $14.25 million public offering of 9.5 million shares of common stock at $1.50, an 8.5 percent discount to Thursday's closing price. Net proceeds of about $13.2 million will be used primarily to support the commercial introduction of Surfaxin, its surfactant product approved last year for respiratory distress syndrome in premature infants, and the Afectair aerosol-conducting airway connector for infants, as well as for general
Company Drug Indication BioAlliance Pharma SA Sitavig Recurring herpes labialis Sucampo Pharmaceuticals Inc. Amitiza Opioid-induced constipation Tris Pharma Inc. Karbinal ER Seasonal and perennial allergic rhinitis
Thai Trial Analysis Shows Antibody Competition Follow-up analyses of the RV144 trial of Sanofi SA's ALVAC HIV and VaxGen Inc.'s AIDSVAX B/E HIV vaccine by a team from Duke University has provided evidence that the competition of two different types of antibodies may have lowered the efficacy of the vaccine. The RV144 trial was the first trial to provide any protection against HIV, but at a risk reduction of about 30 percent; that protection was not enough to justify going into large-scale
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
Financings Arrowhead Research Corp. completed a $36 million private offering to advance its pipeline. Cardio3 BioSciences closed a $25 million investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure. Galapagos NV raised $70.7 million in an over-subscribed private placing. Idera Pharmaceuticals Inc. closed a $16.5 million underwritten public offering. Isis Pharmaceuticals Inc. priced a public offering seeking to raise $171 million. Lumena