Archive for June, 2014

U.K. Health-Cost Agency Says It May Reject Gilead’s Sovaldi Drug

Posted on June 16th, 2014 by Valorem Life Sciences

June 16 (Bloomberg) — The U.K.’s health cost regulator said it’s inclined to reject Gilead Sciences Inc.’s $60,000 hepatitis C drug Sovaldi, and asked for more data before deciding whether the government should pay for the treatment.

Sovaldi lacks evidence for some patient groups, the National Institute for Health and Care Excellence said in an e- mailed statement today. The agency said it has asked Foster City, California-based Gilead for more information, including about Sovaldi’s cost-effectiveness in patients with and without liver damage and HIV.

Sovaldi, approved in Europe in January, has been shown in trials to clear the hepatitis C virus in more than 90 percent of patients, transforming the disease from a potentially deadly malady to one that is easily curable. Still, the cost of the drug has sparked debate about which patients should get it. A standard 12-week course of Sovaldi, also known as sofosbuvir, costs 34,983 pounds ($59,385) in the U.K., NICE said.

“The committee is minded not to recommend sofosbuvir,” NICE said in the statement. “The committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources,” NICE said, referring to the National Health Service that funds health care in the U.K.

Gilead has until July 4 to respond to NICE’s draft guidance, according to the statement. The company didn’t immediately respond to a voice-mail and e-mail requesting comment sent outside of normal business hours.

The NHS in April agreed to pay for Sovaldi for about 500 patients who are at significant risk of dying or needing a liver transplant unless they receive the drug.

Analysts predict Sovaldi will amass more than $9 billion in annual sales this year and more than $14 billion by 2017, according to data compiled by Bloomberg.

Source: Washington Post

ArGEN-X Enters Long-term Strategic Alliance With Shire Pharmaceuticals in Therapeutic Antibodies

Posted on June 4th, 2014 by Valorem Life Sciences

arGEN-X a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases today announced it has entered into a long-term strategic alliance with Shire Pharmaceuticals. Under the agreement arGEN-X will bring its entire suite of human antibody discovery technologies to a partnership focused on multiple targets aligned with Shire’s therapeutic focus. The multi-year initiative aimed at helping augment the Shire development pipeline follows an initial research and development collaboration undertaken in March 2012.

“Our partnering philosophy at arGEN-X is to create alliances for the long term with select top tier companies. We have certainly upheld this principle by repeatedly expanding our collaboration with Shire with today’s announcement marking our most ambitious and exciting venture with them to date” said Tim Van Hauwermeiren CEO of arGEN-X. “We have enjoyed consistent success in our collaboration recognizing important synergies in combining our strengths and capabilities. While we continue to see Shire as our development partner in this new alliance we value this opportunity to bring programs into our own pipeline to further our ambitions as a clinical stage product-focused company.”

Shire will make a total upfront investment of €15 million (US$20.4 million) in arGEN-X consisting of €3 million in cash and €12 million in equity. In addition it will fund the collaborative research programs at arGEN-X and pay fees clinical regulatory and sales milestones as well as single digit royalties on therapeutic product sales. Shire will be responsible for clinical development and commercialization of products with arGEN-X having the right to license any programs not pursued by Shire into its own development pipeline.

Dr. Philip J. Vickers Global Head of Research and Development at Shire commented: “Our arGEN-X collaboration has exceeded our expectations in delivering highly differentiated antibody programs within our therapeutic focus. The time is right to commit more significantly to the company through a longer term investment in its unique world class technologies”.

Source: Pharmiweb