|AVEO Soars On Phase II Results Vs. Avastin; Hospira Issues Statement on FDA Approval of First Biosimilar in US|
|By Josh Gee|
|Friday, 06 March 2015 19:54|
Aveo Pharmaceuticals, Inc. (NASDAQ: AVEO) shares soared Friday after the company said its tivozanib cancer drug obtained superior results compared with Roche Holding Ltd.'s RHHBY 0.47% Avastin in a subgroup of patients in a Phase II trial. Aveo changed hands recently at $1.72, up 21 percent.
The study of 265 colorectal cancer patients, compared the two treatments in combination with standard chemotherapy. The increase in progress-free survival among certain patients treated with the Aveo drug compared with bevacizumab "is both interesting and encouraging," Principal Investigator Al B. Benson III said.
Benson added that the findings "warrant further study " in a trial involving patients suffering from what he called low serum NRP-1 metastatic colorectal cancer.
Roche's Avastin, or bevacizumab, had estimated sales last year of more than $6.9 billion was approved for marketing in 2004. A number of companies are seeking to develop comparable drugs.
Hospira, Inc. (NASDAQ: HSP), applauds Sandoz and the U.S. Food and Drug Administration (FDA) on today's FDA approval of the first biosimilar in the United States. This is a watershed moment for improving patient access to safe, effective and more affordable biologic medicines. As a leading global provider of biosimilars, Hospira has seen first-hand the positive impact of biosimilars in other countries, and we are a proud participant in these early stages of the development of a pathway for these medicines in the United States.
Hospira is the only U.S.-based company currently marketing biosimilars in the highly regulated markets of Europe and Australia, where we have seen biosimilars decrease the costs of biologics by 20 to 30 percent. This has allowed European healthcare systems to reduce their healthcare spending, while at the same time increasing patient access to these important biologic medicines.
"Biosimilars represent a transformational opportunity to improve patient access and provide much-needed financial relief to the U.S. healthcare system," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "This approval is good news for the entire healthcare system and brings us one step closer to making these important medications available for the patients who need them.
"With two biosimilar applications currently under review by the U.S. FDA, Hospira is committed to bringing more affordable biologic medicines to patients in the United States. We look forward to continuing to partner with the FDA on the approval pathway for our biosimilars, so that more and more patients and healthcare providers have access to the benefits of biosimilars," continued Ramachandra.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results for the fourth quarter and full year 2014.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that Timothy Trost, Senior Vice President and Chief Financial Officer of Chimerix, will present at the Barclays Global Healthcare Conference on Thursday, March 12, 2015 at 8:30 a.m. ET at the Loews Miami Beach Hotel in Miami, FL.
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that members of its management team will present and host investor meetings at the following upcoming investor conferences.
Digirad Corporation (Nasdaq:DRAD) today reported its financial results for the fourth quarter and twelve months ended December 31, 2014.
Digirad Corporation (Nasdaq:DRAD), announced today that it acquired MD Office Solutions, Inc. ("MD Office"), a mobile diagnostic imaging provider servicing customers in Northern California.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the company is scheduled to present at the 27th Annual ROTH Conference at 12:30 p.m. PT, Wednesday, March 11, 2015.
iKang Healthcare Group, Inc. (Nasdaq:KANG), today announced that it has acquired a 70% equity interest in WA Centers HK Limited ("WA Health Care").
Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that David Chang, M.D., Ph.D., Kite's Executive Vice President, Research and Development, and Chief Medical Officer, will present a company overview at the Barclays Global Healthcare Conference at the Loews Miami Beach Hotel. The presentation will take place on Tuesday March 10, 2015, at 9:30 a.m. EDT.
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 27th Annual ROTH Conference on Monday, March 9, 2015 at 1:30 PM PT (4:30 PM ET).
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic hepatitis B infection (HBV), today announced that Patrick T. Higgins, Tekmira's COO, and Mike McElhaugh, Tekmira's Chief Business Officer, will participate in an analyst-led fireside chat at the 2015 Barclays Global Healthcare Conference on Wednesday, March 11, 2015 at 10:05 – 10:30 pm (PT) / 1:05 pm – 1:30 pm (ET) in the Americana Salon 2 at The Loews Miami Beach Hotel in Miami, Florida.
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, will present at the 27th Annual ROTH Conference, being held at the Ritz Carlton in Laguna Niguel, CA.
Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that Nick Colangelo, president and CEO, and Gerard Michel, chief financial officer and vice president of corporate development, will present at the 27th Annual ROTH Conference at The Ritz-Carlton Hotel in Dana Point, California, on Wednesday, March 11, 2015, at 9:30am Pacific time.
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced it was selected to present data from its ongoing Extension Study of pre-pubertal children with moderate growth hormone deficiency (GHD) in a poster presentation at The Endocrine Society's 97th Annual Meeting & Expo (ENDO 2015) in San Diego, CA.