DUBLIN, Ireland – Elan Corp. plc is putting down a $1 billion bet that the respiratory franchise shared by Theravance Inc. and GlaxoSmithKline plc will pay generous dividends over the next decade. Elan is acquiring a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with London-based GSK. One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily
By Cormac Sheridan | BioWorld Today | Tuesday, May 14, 2013
BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety monitoring board (DSMB) again recommended continuing the ReLive Phase III trial without modification. On Nov. 19, 2012, the DSMB unanimously recommended continuing the trial without modification. ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag (doxorubicin Transdrug) on survival in 400 patients with hepatocellular carcinoma after
Relypsa Inc., which last summer closed an $80 million Series C to fund its pivotal Phase III program of nonabsorbed oral potassium binder patiromer (RLY5016), has fully enrolled the two-part trial, which is evaluating efficacy and safety in treating hyperkalemia in patients with chronic kidney disease (CKD). The study is being conducted under a special protocol assessment (SPA) with the FDA, with top-line data expected to report in the fall. (See BioWorld Today, Aug. 16, 2012.) Launched in
By Marie Powers | BioWorld Today | Tuesday, May 14, 2013
LONDON – Shares in Erytech Pharma SA began trading in Paris last week following an initial public offering (IPO) that exceeded the €15 million (US$19.5 million) target, raising €16.7 million. The Lyon, France-based company added a further €11 million, mostly through the conversion of bonds, providing sufficient funding to take the lead program Graspa through to approval in Europe and to start a U.S. Phase Ib trial of the product in the treatment of acute lymphoblastic leukemia (ALL). "I'm very
By Nuala Moran | BioWorld Today | Tuesday, May 14, 2013
A U.S. appellate court blocked Genentech Inc.'s end run around foreign arbitration that could give Sanofi SA a share of the royalties on blockbuster biologic Rituxan. In a precedent-setting decision Friday, the U.S. Court of Appeals for the Federal Circuit upheld a district court's decision to deny Genentech's request for an injunction on foreign arbitration over its terminated licensing contract for DNA enhancers allegedly used in the making of the biologic. Genentech, part of the Basel
By Mari Serebrov | BioWorld Today | Tuesday, May 14, 2013
Actavis Inc., of Parsippany, N.J., reported the FDA has accepted for filing its new drug application for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon
Dyax Corp. is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE). Burlington, Mass.-based Dyax already is well established in the HAE space, having gained approval of Kalbitor (ecallantide) for acute HAE attacks in late 2009. The drug, which Dyax markets on its own in the U.S., pulled in
By Jennifer Boggs | BioWorld Today | Tuesday, May 14, 2013
Aastrom Biosciences Inc., of Ann Arbor, Mich., reported in an 8-K filing with the SEC that it was notified by Nasdaq that the bid price for its common stock closed below the minimum $1 per share requirement for 30 consecutive business days. Nasdaq provided the company 180 calendar days, or until Nov. 5, to regain compliance with the minimum bid price rule by closing at or above $1 per share for a minimum of 10 consecutive business days prior to that date. The company's shares tumbled in March
Biotie Therapies Corp., of Turku, Finland, began a Phase II study evaluating nepicastat (SYN117) in cocaine dependence. The randomized, double-blind, placebo-controlled 11-week trial is expected to enroll about 180 treatment-seeking cocaine-dependent subjects at approximately 12 U.S. clinics and take approximately two years to complete. The National Institute on Drug Abuse at the National Institutes of Health is funding the study under a Collaborative Research and Development Agreement signed
Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Lilly said it will stop development of enzastaurin, a serine/threonine kinase inhibitor of the PKC beta and AKT pathways, and
Company (Location) Product Description Indication Status Date Activartis Biotech GmbH (Vienna, Austria) AVO113 Consists of dendritic cells loaded with antigens derived from each patient's tumor Glioblastoma The first interim analysis in a Phase III trial indicated there will be an overall survival benefit in treated patients 4/10/13 Aprea AB (Stockholm, Sweden) APR-246 Designed to reactivate mutant p53 Ovarian cancer Results showed that APR-246 acts synergistically with platinum compounds and
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement
Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Testosterone Gel 1.62%, a generic version of AbbVie Inc.'s AndroGel 1.62% Absence of endogenous testosterone Filed an abbreviated NDA with the FDA 4/2/13 Almirall SA (Barcelona, Spain) and Forest Laboratories Inc. (New York) Aclidinium bromide and formoterol fumarate A long-acting muscarinic beta2 agonist and a long-acting beta2 agonist Chronic obstructive pulmonary disorder Top-line Phase III data
Few of the pundits and tea-leaf readers handicapping the chances for approval of once-daily inhaled Breo (fluticasone furoate /vilanterol) in the wake of last month's FDA advisory panel were surprised by the agency's go-ahead for the chronic obstructive pulmonary disease (COPD) treatment from GlaxoSmithKline plc and Theravance Inc. Breo Ellipta, as the product is branded, will launch in the third quarter of this year. Theravance CEO Rick Winningham said his firm owes GSK a $30 million
By Randy Osborne | BioWorld Today | Monday, May 13, 2013
Company (Location) Product Description Indication Status Date Pfizer Inc. (New York) Prevenar 13 Pneumococcal polysaccharide conjugate vaccine Infections Phase III data showed it met all primary and secondary objectives focused on immunogenicity, tolerability and safety in adults 18 to 49 4/30/13 Tetraphase Pharmaceuticals Inc. (Watertown, Mass.) Antibiotics Two next-generation antibiotic candidates Community-acquired multidrug-resistant infections Studies demonstrated efficacy 4/30/13 Trius
The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda. 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
As regulators, payers and drug developers become more comfortable with their use, interest in companion diagnostics to help direct targeted medicines to the right patient populations has surged in the past couple of years. Drug companies are certainly recognizing that companion diagnostics, when co-developed with potential therapeutics, can assist in regulatory approvals. The early applications have mainly been with cancer therapies and 2011 served as a pivotal year in the demonstration of the
By Peter Winter | BioWorld Insight | Monday, May 13, 2013
Company (Location) Product Description Indication Status Date AbbVie Inc. (Chicago) and Enanta Pharmaceuticals Inc. (Watertown, Mass.) ABT-450/r, ABT-267 and ABT-333 In combination with ribavirin; direct-acting antivirals Hepatitis C virus genotype 1 Phase IIb data showed greater than 90% sustained viral response rates 4/24/13 Achillion Pharmaceuticals Inc. (New Haven, Conn.) ACH-3102 Pan-genotypic NS5A inhibitor Hepatitis C virus genotype 1 Phase II data showed it was active against both wild
DUBLIN, Ireland – Elan Corp. plc is putting down a $1 billion bet that the respiratory franchise shared by Theravance Inc. and GlaxoSmithKline plc will pay generous dividends over the next decade. Elan is acquiring a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with London-based GSK. One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily