GlaxoSmithKline won’t license two Cytokinetics drugs
LONDON British drug maker GlaxoSmithKline will not license two drugs from Cytokinetics under a drug discovery, development and commercialization agreement between the two companies.
The two drugs, SB-743921 and ispinesib, are kinesin spindle protein inhibitors for treating cancer.
The collaboration between the Cytokinetics and GSK, set up in 2001, will continue, focusing on the GSK drug candidate GSK-923295. Cytokinetics will retain all rights to the two drug candidates.
“While we are disappointed in this outcome, we understand GSK?s business decision,” Cytokinetics president and chief executive officer Robert Blum said in a statement. “We are encouraged by the safety and tolerability of each of ispinesib and SB-743921, as well as the amplified activity observed with the more dose-dense scheduling of these novel drug candidates.”
FDA approves Novadel’s Zolpimist for short-term insomnia treatment
FLEMINGTON, N.J. The Food and Drug Administration has approved a drug by NovaDel Pharma for the short-term treatment of insomnia characterized by difficulties with sleep initiation, NovaDel announced Monday.
NovaDel said that Zolpimist (zolpidem tartrate) is its second product approved by the FDA that uses its proprietary NovaMist spray technology. The active ingredient in Zolpimist is the same as the one in Sanofi-Aventis’ Ambien.
“We believe that the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” NovaDel board chairman and interim CEO Steven Ratoff said.
Ambien had worldwide sales of $559.3 million for first six months of 2008, according to Sanofi-Aventis financial data.
AstraZeneca considering entering biosimilars market
LONDON AstraZeneca may soon start developing biosimilars, according to published reports.
David Brennan, the company’s CEO, told the Financial Times that depending on legislation being considered, the Anglo-Swedish drug maker might expand into creating follow-on versions of biologics that have lost patent protection.
Merck and Eli Lilly have also said they might develop biosimilars. Merck announced earlier this month that it would create a new biosimilars division, Merck BioVentures, to make follow-on and novel biologics using engineering technology from GlycoFi, a company it acquired in 2006. The Whitehouse Station, N.J.-based drug maker plans to launch its first biosimilar, the anemia drug MK-2578, in 2012 and have at least five biosimilar candidates at that time.