- Funding Slated for Further Commercial Deployment of the Corus® CAD Blood Test and Continued Development of Next Generation Products -
REDWOOD CITY, CA – December 18, 2014 - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the close of $35 million in total equity financing. Alberta Investment Management Corporation (AIMCo) participated in this round together with the company's existing investors.
CardioDx Raises $35 Million in Equity Financing
Chimerix and ContraVir Pharmaceuticals Establish Strategic Collaboration for Antiviral Drug Candidate CMX157
DURHAM, N.C. and EDISON, N.J., Dec. 18, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc. (OTCBB:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157. CMX157 is a highly potent analog of the successful antiviral drug tenofovir DF (Viread®).
Under the agreement, ContraVir licenses CMX157 from Chimerix in exchange for an upfront payment consisting of 120,000 shares of ContraVir preferred stock with a stated value of $1.2 million. In addition, Chimerix is eligible to receive up to approximately $20 million in clinical, regulatory and initial commercial milestones in the United States and Europe, as well as royalties and additional milestones based on commercial sales in those territories.
Anthera Pharmaceuticals Licenses Japan Rights for Blisibimod to Zenyaku Kogyo Co., Ltd.
Anthera Pharmaceuticals Licenses Japan Rights for Blisibimod to Zenyaku Kogyo Co., Ltd.
- Anthera to receive up to $48,000,000 plus future product margin on commercial supply
- Zenyaku to reimburse Anthera for a portion of future blisibimod worldwide development costs
- Zenyaku to assume full responsibility for development and associated costs in Japan and potentially other Asian territories in the future
- Companies will collaborate on blisibimod development for both IgA Nephropathy ("IgAN") and Systemic Lupus Erythematosus ("Lupus")
HAYWARD, Calif., Dec. 15, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced today that Anthera and Zenyaku Kogyo Co., Ltd. of Tokyo, Japan executed an exclusive license agreement for the development and commercialization of subcutaneous blisibimod in Japan and potentially other countries throughout Asia. Anthera retains full development and commercialization rights for all other global territories including North America and the European Union. Zenyaku currently markets Rituxan™, an anti-CD20 antibody, in Japan where it is approved for CD20 Positive B-Cell Lymphoma, B-cell Lymphoproliferative disorder, ANCA associated vasculitis (GPA, MPA), and Pediatric Nephrotic Syndrome.
Ultragenyx Announces Initiation of Phase 3 Study of Recombinant Human Beta-Glucuronidase in Mucopolysaccharidosis Type 7
Agreement Reached With Both FDA and EMA on Pivotal Trial Design
NOVATO, Calif., Dec. 15, 2014 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the dosing of the first patient in the pivotal Phase 3 study of recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of Mucopolysaccharidosis 7 (MPS 7, Sly syndrome).
"We are pleased to have reached alignment with both the FDA and EMA on our single pivotal study design for this devastating disease," commented Sunil Agarwal, M.D., Chief Medical Officer of Ultragenyx. "This is an important step forward for these patients who have no approved treatment options. It is also an important milestone for Ultragenyx as it is the start of our first Phase 3 program."
The Phase 3 global, randomized, placebo-controlled, blind-start clinical study will assess the efficacy and safety of rhGUS in 12 patients between 5 and 35 years of age. Patients will be randomized to one of four groups. One cohort begins rhGUS therapy immediately, while the other three start on placebo and cross over to rhGUS at different predefined time points in a blinded manner. This novel trial design generates treatment data from all 12 patients, improving the statistical power of the study relative to a traditional parallel-group design. Based on data from the Phase 1/2 study, patients will be dosed with 4 mg/kg of rhGUS every other week for up to a total of 48 weeks, and all groups will receive a minimum of 24 weeks of treatment with rhGUS.
IlluminOss Medical Caps off Flagship Year with Addition of New Patents to Bone Fixation Portfolio
2014 Marked by Continued Success in International Orthopedics Markets and Conditional Clearance for First U.S. Clinical Trial to Begin in 2015
East Providence, RI (December 10, 2014) – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has been issued two new patents related to its internal bone fixation system. IlluminOss now owns 25 issued U.S. patents and its complete intellectual property portfolio includes over 55 issued patents in 17 countries around the world - with many more patent applications Hollister Outlet currently pending related to its revolutionary IlluminOss System for minimally invasive fixation and treatment of broken bones.
Afferent Clinical Data Demonstrating AF-219 Treatment Reduces Cough Frequency by 75% in Chronic Cough is Published in The Lancet
SAN MATEO, Calif.--(BUSINESS WIRE)-- Afferent Pharmaceuticals today announced publication of results from a Phase 2 clinical trial demonstrating that the company’s novel drug candidate, AF-219, reduced daytime cough frequency by 75% compared to placebo in patients with treatment-refractory chronic cough. These data are featured in an article titled, "P2X3 Receptor Antagonist (AF-219) in Refractory Chronic Cough: A Randomised, Double-Blind, Placebo-Controlled Phase 2 Study," which is appearing online in The Lancet. These results support Afferent’s current development strategy to initiate a Phase 2b clinical trial early in 2015. AF-219 is a selective, non-narcotic and orally administered agent that targets the mechanism by which certain nerve fibers become hyper-sensitized and lead to chronic and debilitating symptoms such as cough.
Milestone Announces Positive Phase 1 Data for MSP-2017; Supports Advancement into Phase 2 in PSVT Patients
Montreal, QC, November 24, 2014 – Milestone Pharmaceuticals, Inc. today announced data from a Phase 1 clinical trial conducted in Melbourne, Australia of MSP-2017, a novel calcium channel antagonist for the potential treatment of paroxysmal supraventricular tachycardia (PSVT). The results demonstrated that an intra-nasal formulation of MSP-2017 was well tolerated at single doses up to and including 140 mg with an excellent safety profile, desirable PK properties including rapid onset, and validating proof of concept by PR interval prolongation as measured by ECG. Milestone expects to initiate a Phase 2 clinical trial of MSP-2017 in patients with PSVT during the first half of 2015.
IlluminOss Medical Announces Conditional FDA Approval for Clinical Trials of Groundbreaking Photodynamic Bone Stabilization System in the U.S.
Currently Recruiting Clinical Sites for Trial that May Offer Significant Advantages to Surgeons Treating Impending and Pathologic Fractures
East Providence, RI (November 18, 2014) – IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received conditional approval from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss expects to begin enrolling clinical sites and initiate the trial shortly.
Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa by International Consortium
DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.
Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)
Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)
- Achillion Achieves 100% SVR12 in Eight-Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy Study") Including Nine of 12 Patients With Viral Loads Higher Than 6 Million IU/ml at Baseline -
- Reports Additional Preclinical Results for ACH-3422, Uridine-Analog Nucleotide NS5B Polymerase Inhibitor -
NEW HAVEN, Conn., Nov. 8, 2014 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the presentation of results from the ongoing Phase 2 study of ACH-3102 in a late breaker poster and data in three preclinical posters on ACH-3422. The poster presentations are being made at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting 2014, which takes place through November 11, 2014 in Boston, MA.
