PHARMACY

GSK files NDA with FDA for promacta/revolade

BY Drew Buono

WASHINGTON GlaxoSmithKline has filed a new drug application with the Food and Drug Administration to market the drug promacta/revolade for the treatment of chronic idiopathic thrombocytopenic purpura, a disease characterized by low blood platelet counts. The drug application was submitted based on a Phase II and III trial.

Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding. The drug, also known as eltrombopag, is an oral drug that causes the cells in bone marrow to produce platelets.

“Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor,” said Paolo Paoletti, M.D., senior vice president of the Oncology Medicine Development Center at GSK. “GSK is pleased with the data provided to support the NDA and hopeful that, if approved, promacta/revolade may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease.”

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BioSante makes milestone payment of $875,000 to Antrares for Elestrin

BY Drew Buono

EWING, N.J. Antares Pharma has received an additional payment of $875,000 from BioSante Pharmaceuticals in relation to a marketing agreement with Bradley Pharmaceuticals for the drug Elestrin.

Elestrin is a low dose transdermal estradiol therapy that is used for the treatment of hot flashes in menopausal women. Antares allowed BioSante to use its advanced transdermal delivery gel system for the drug. Additional sales based milestone payments could bring the deals total value to more than $13 million, not including royalties based on third party sales.

“We look forward to continued marketing progress with Elestrin in 2008. The December 2006 FDA approval of this product has validated our ATD gel system and that has been a significant milestone for Antares and our potential pipeline products including Anturol—our proprietary ATD gel based overactive bladder product—currently in pivotal trials,” said Jack Stover, president and chief executive officer of Antares Pharma.

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GSK, Santaris ink deal worth a potential $700 million

BY Drew Buono

LONDON GlaxoSmithKline has signed a deal with the biotech company Santaris Pharma to develop new antiviral medicine, in a deal that could be worth more than $700 million, according to Reuters. The deal involves drug candidates discovered and developed under the agreement in up to four different viral disease programs.

As part of the deal, Santaris will receive an upfront payment of $3 million for the first antiviral program and an equity investment of $5 million. The deal could be worth more than $700 million based on upfront payments and development and regulatory milestone payments, depending on the success on early-stage research in RNA antagonist compounds.

Santaris will also get high single- to double-digit percentage royalties on worldwide sales of marketed products. GSK will have the option to develop drug candidates in up to four different viral disease programs. It also has an option to include as an additional program Santaris’ pre-clinical hepatitis C compound SPC3649.

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