Valneva SE priced its previously flagged and fully underwritten €40 million (US$53.3 million) rights issue at €2.65 per share, a steep discount on the company's prevailing share price of €4.61 immediately prior to the final pricing decision. The move will give the Lyon, France-based company enough fuel to achieve its main strategic objective, to become financially self-sustaining by 2015. The strategy also depends on the company rolling over an existing €20 million debt facility to an
By Cormac Sheridan | BioWorld Today | Monday, June 17, 2013
Conatus Pharmaceuticals Inc., which has quietly labored on liver drug emricasan (IDN-6556) since gaining global rights to the asset in its 2010 acquisition of Pfizer Inc. spin-out Idun Pharmaceuticals Inc., became the latest biotech to register with the SEC for an initial public offering (IPO). Filing its S-1 as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, the San Diego-based firm is seeking to raise up to $69 million to continue the clinical development of
By Marie Powers | BioWorld Today | Monday, June 17, 2013
When Trevor Baglin, a hematologist at Addenbrooke's Hospital at Cambridge University had a head injury patient with a much better-than-expected outcome, he did something unusual. He got very curious. Physicians had found in the patient a degree of anticoagulation consistent with severe hemophilia, and yet the bleeding stopped normally. Rather than writing it off as good luck, Baglin teamed up with Jim Huntington, of the Cambridge Institute for Medical Research, to design a synthetic version of
By Catherine Shaffer | BioWorld Today | Monday, June 17, 2013
Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, Sweden. The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high-risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation, Phase I part of the SGI-110-01 study. The study enrolled
The Appraisal Committee of the National Institute for Health and Care Excellence (NICE) of the UK issued a positive appraisal of Iluvien (fluocinolone acetonide), by Alimera Sciences Inc., of Atlanta, for pseudophakic patients with chronic diabetic macular edema that is insufficiently responsive to available therapies. The update to a published guidance issued in January 2013 takes into consideration a patient access plan submitted by Alimera. The committee also noted that the cost
Company (Location) Product Description Indication Status Date Abbvie Inc. (Chicago) Atrasentan Investigational compound Kidney disease and Type II diabetes Initiated a Phase III study 5/21/13 Actavis Inc. (Parsippany, N.J.) Norethin-drone Transdermal Delivery System Progestin-only transdermal contraceptive patch To prevent pregnancy FDA accepted the NDA for filing 5/14/13 Allergan Inc. (Irvine, Calif.) Juvederm Voluma XC An injectable hyaluronic acid dermal filler for cheek augmentation To
Company Drug Indication Algeta ASA Xofigo Castration-resistant prostate cancer Genentech Inc. Tarceva Metastatic non-small-cell lung cancer Genentech Inc. Actemra Polyarticular juvenile idiopathic arthritis Raptor Pharmaceutical Corp. Procysbi Nephropathic cystinosis
The Supreme Court ruled last week that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. The FDA etched a distinct line between orphan drug designation and exclusivity in a final rule making it clear that getting the designation doesn't guarantee seven years of market exclusivity. The FDA
Financings Agios Pharmaceuticals Inc. filed for an IPO to raise up to $86 million to fund its pipeline. Avaxia Biologics Inc. raised an additional $5 million to bring its total Series B funding to $11.4 million. Biotime Inc. closed its equity financing and received gross proceeds of about $9.1 million. Dermira Inc. generated $35 million in a Series B financing. Esperion Therapeutics Inc. filed terms for its IPO, planning to raise $63 million. Prism Pharma Co. Ltd. has closed a Series C round of
Company (Location) Product Description Indication Status Date AUTOIMMUNE Novan Therapeutics Inc. (Durham, N.C.) SB204 Nitric oxide-releasing compound Acne Reduced colonization of skin in a Phase I trial 5/31/13 Soligenix Inc. (Princeton, N.J.) SGX203 Oral beclomethasone 17, 21-diproprionate Pediatric Crohn's disease Began its first trial 5/16/13 Xenetic Biosciences plc (London) Myeloxen Vaccine based on the Imuxen liposomal technology Multiple sclerosis Completed the Phase I safety study 5/13
Johnson & Johnson has jumped into the early stage development pool with both feet. With the opening of its California Innovation Center based in Menlo Park earlier this month, the New Brunswick, N.J.-based company has established regional innovation centers, incubators, and entrepreneurs in residence to get J&J closer to early stage products that might be licensed or acquired by the health-care giant. Previously, J&J was interacting with the outside world through different channels, but now
By Brian Orelli | BioWorld Insight | Monday, June 17, 2013
Two initiatives from different ends of the drug development spectrum are shining a bright light on nagging weaknesses in translational medicine and the urgent need to improve speed and efficiency in moving early stage discoveries into therapeutic candidates. Glaxosmithkline plc's (GSK) Discovery Fast Track competition is designed to serve as a funnel, enabling the London-based pharma to quickly sift a large number of academic discoveries and identify 10 candidates for its Discovery Partnerships
By Marie Powers | BioWorld Insight | Monday, June 17, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Sarilumab Fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex Moderate to severe rheumatoid arthritis Enrolled their first patients in Phase III trials 5/16/13 Xenoport Inc. (Santa Clara, Calif.) Arbaclofen placarbil A prodrug of the R-isomer of baclofen Spasticity due to multiple sclerosis Terminated the
Company (Location) Product Description Indication Status Date AUTOIMMUNE GW Pharmaceuticals plc (Porton Down, UK) Sativex Cannabinoid product Moderate to severe spasticity in multiple sclerosis Received commercial approval for Sativex in Italy 5/8/13 CANCER Aveo Pharmaceuticals Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Astellas no longer intends to submit an MAA and will not fund any
It has been 10 years since the international human genome project (HGP) was officially declared completed two years ahead of schedule. This monumental undertaking has helped fuel the biopharmaceutical sector to its current lofty heights and one of the reasons that bioscience discoveries in overdrive can be traced back to the completion of the sequencing of the human genome. (See BioWorld Today, April 16, 2003.) This truly remarkable achievement has been the underpinning of a new wave of genomics
By Peter Winter | BioWorld Insight | Monday, June 17, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Plegridy Peginterferon beta-1a Multiple sclerosis Submitted a BLA 5/22/13 CANCER Algeta ASA (Oslo, Norway) and Bayer AG (Leverkusen, Germany) Xofigo Radium Ra 223 dichloride; an alpha particle-emitting radioactive therapeutic agent Castration-resistant prostate cancer FDA approved it 5/16/13 Aveo Oncology Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase
"There are a lot of situations where people use only an animal model and take a shot at a clinical trial and are disappointed after spending resources that could have been spent elsewhere." – Gene Williams, executive chairman and CEO of DART Therapeutics Inc., discussing its use of Biovista Inc.'s clinical outcomes search space technology to identify potential drug candidates for in-licensing in Duchenne's muscular dystrophy "I think the biggest challenge today for selling into BRIC for global
Valneva SE priced its previously flagged and fully underwritten €40 million (US$53.3 million) rights issue at €2.65 per share, a steep discount on the company's prevailing share price of €4.61 immediately prior to the final pricing decision. The move will give the Lyon, France-based company enough fuel to achieve its main strategic objective, to become financially self-sustaining by 2015. The strategy also depends on the company rolling over an existing €20 million debt facility to an