CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

DURHAM, N.C., October 22, 2013 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., and ILDONG Pharmaceutical Co., Ltd., announced today that they have entered into a distribution and supply agreement for Lasmiditan in South Korea and Southeast Asia.

Under the terms of the agreement, CoLucid will receive upfront and milestone payments in addition to consideration for product supply in exchange for exclusive rights to ILDONG for development and commercialization of Lasmiditan in the territory. ILDONG will be responsible for the costs and activities related to development and regulatory approvals in the territory and will also participate in key registration trials as part of the global development plan.

New Data Highlight Value of Corus® CAD in Reducing Unnecessary Cardiac Testing and Costs for Women with Symptoms Suggestive of Obstructive Coronary Artery Disease

Corus® CAD Has Potential to Reduce Cardiac Diagnostic Costs in Women by More Than $500 per Patient

PALO ALTO, Calif., Oct. 10, 2013 /PRNewswire/ -- CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced results of two studies indicating that Corus® CAD, a blood-based gene expression test, may help reduce unnecessary cardiac testing and costs by aiding clinician decision-making in the evaluation of women with symptoms suggestive of obstructive coronary artery disease (CAD). The studies were presented at The North American Menopause Society (NAMS) 2013 Annual Meeting, taking place October 9-12, 2013 in Dallas, TX.

Ultragenyx Announces the Presentation of Data from a Single Dose Phase 1 Study, Conducted by Kyowa Hakko Kirin Co. Ltd. (KHK), of KRN23 in X-linked Hypophosphatemia (XLH) in Adults

KRN23 increased phosphate levels and was safe and well tolerated
NOVATO, CA – October 6, 2013— Ultragenyx Pharmaceutical Inc., a biotechnology company, announced the release of data from a first-in-human, randomized, double-blind, placebo-controlled, single dose study of a human monoclonal anti-FGF23 antibody (KRN23) in X-linked hypophosphatemia in adults. X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease characterized by short stature and skeletal deformities. A Phase I study (US-02) was conducted by KHK with KRN23 to assess its safety and tolerability and to measure changes in biochemical markers in adult patients with XLH. Thirty-eight adults with XLH were randomized to receive single doses of KRN23 or placebo via intravenous (IV) (0.003 to 0.3 mg/kg) or subcutaneous (SC) (0.1 to 1.0 mg/kg) routes.

Chimerix Announces Publication of Positive Phase 2 Results of Brincidofovir (CMX001) in the New England Journal of Medicine

Phase 2 Trial Evaluated Brincidofovir for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Cell Transplant Recipients

DURHAM, N.C., Sept. 26, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the publication of results from its Phase 2 Study CMX001-201 evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) recipients. The article, entitled "CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation," appears in the September 26th issue of the New England Journal of Medicine (N Engl J Med 369:1227-36).

Ultragenyx Announces Three Abstracts Accepted for Poster Presentation at 18th Annual World Muscle Society Congress

NOVATO, Calif., Sep 26, 2013 (GLOBE NEWSWIRE via COMTEX) -- Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced that three abstracts related to UX001 Sialic Acid for Hereditary Inclusion Body Myopathy, also known as GNE Myopathy, were accepted for poster presentation at the 18th Annual World Muscle Society Congress, October 1-5, 2013 in Asilomar, California.

Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases

Company Pursuing Orphan Path to Development in Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis, Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis

SAN DIEGO – September 26, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001, the company’s lead drug candidate. LUM001 received Orphan Designation in four rare cholestatic liver diseases including Alagille syndrome (ALGS); progressive familial intrahepatic cholestasis (PFIC); primary biliary cirrhosis (PBC); and primary sclerosing cholangitis (PSC).

Lumena Pharmaceuticals Launches Global Clinical Program to Evaluate Safety and Efficacy of LUM001 in Children with Alagille Syndrome

First patient dosed in U.K. in Phase II IMAGO Study; Phase II ITCH Study to start in U.S.

Cooperative Research and Development Agreement established with the National Institutes of Health and the Childhood Liver Disease Research and Education Network (ChiLDREN)

SAN DIEGO – September 26, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the initiation of a global clinical program to evaluate its drug candidate LUM001 in children with Alagille syndrome (ALGS). The first patient has been dosed in the IMAGO Phase II study being conducted in the U.K., and enrollment of pediatric patients is expected to begin later this year in the ITCH Phase II study in the U.S.

Chimerix Presents Brincidofovir (CMX001) Adenovirus Phase 2 Results

Positive Phase 2 Study Results Presented as Late Breaker at ICAAC

DURHAM, NC, September 11, 2013 – Chimerix, Inc. (NASDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the results from its exploratory Phase 2 Study 202 evaluating brincidofovir (CMX001) in hematopoietic cell transplant (HCT) recipients with early adenovirus (AdV) infection. Study 202 was the first trial of an antiviral agent in AdV infection. Brincidofovir (CMX001) is an investigational oral nucleotide analog lipid-conjugate that has demonstrated activity against all pathogenic families of double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses, and polyomaviruses.

Liquidia Technologies Announces Extension of Collaboration with PATH to Develop Next Generation Pneumococcal Vaccine

RESEARCH TRIANGLE PARK, NC– May 21, 2013 – Liquidia Technologies today announced that its collaborative agreement with PATH, a global health nonprofit organization, has been extended. The extension of this agreement allows for the continuation of preclinical proof-of-concept studies on a next generation pneumococcal vaccine. If successful, the vaccine could potentially allow for broadened efficacy and manufacturing efficiencies that translate to greater access to the vaccine by the global population. Pneumonia kills approximately 1.3 million children under the age of five years every year—more than any other illness. Nearlyhalf of these deaths are caused by Streptococcus pneumoniae, a bacterium that has many variations globally and is becoming increasingly resistant to antibiotics.

“We are exceptionally proud of the work we have done with PATH and excited about the opportunity to continue this work with them,” said Neal Fowler, Chief Executive Officer at Liquidia Technologies. “Our shared goal to improve vaccine performance and reduce manufacturing costs using our transformative technology remains unchanged as does our confidence that this collaboration has the potential to significantly impact the spread of pneumonia in the developing world.”

Art Pappas Elected to NVCA Board of Directors

RESEARCH TRIANGLE PARK, N.C., May 15, 2013 — The National Venture Capital Association (NVCA) today announced the election of Arthur M. Pappas, managing partner of Pappas Ventures, to its board of directors. He will serve a four-year term. The appointment was made official at the association’s annual meeting – VentureScape 2013 – in San Francisco.

Mr. Pappas has over 30 years of operating experience as a pharmaceutical and biotechnology industry executive and venture capital investor in life science companies. He founded Pappas Ventures in 1994, and works with a team that has invested in numerous life science companies that have created novel innovative products addressing unmet medical needs. Prior to forming Pappas Ventures, he held senior level leadership positions at several multinational pharmaceutical companies, for which he led operations and was responsible for the development, licensing and launch of a number of global products.

The NVCA serves as the venture capital community’s trade association, representing more than 400 members by advocating for policies that encourage innovation and reward long term investment.