FDA presents Neurocrine with second approvable letter for indiplon
SAN DIEGO The Food and Drug Administration has sent a second approvable letter to Neurocrine Biosciences informing the company that its new drug application for indiplon 5 mg and 10 mg capsules is approvable pending additional and preclinical data.
The first letter was received on May 15, 2006. The 2006 approvable letter requested that the company reanalyze data from certain preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules for sleep initiation and middle of the night dosing. The first approvable letter also requested reexamination of the safety analyses.
The requirements listed by the FDA in the second letter, which Neurocrine received Dec. 12, include a clinical trial in elderly patients, a safety study assessing the rates of adverse events while using indiplon compared with a marketed product and a preclinical study to evaluate indiplon use during the third trimester of pregnancy. Nothing in the letter asked for the company to look over any issues previously raised by the FDA.
BioSante makes milestone payment of $875,000 to Antrares for Elestrin
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.
GSK, Santaris ink deal worth a potential $700 million
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.