Teva Pharmaceutical Industries says that it has been given the green light by regulators in the USA to sell its generic version of AstraZeneca’s cancer blockbuster Arimidex.

The Israeli company has received US Food and Drug Administration approval and commercial launch for its copycat version of Arimidex (anastrozole) which is indicated for the treatment of certain forms of breast cancer in postmenopausal women. The treatment is a major earner for the Anglo-Swedish company and Arimidex has annual sales of $916.8 million in the USA, based on IMS sales data, Teva noted.

Loss of Arimidex earnings will clearly hurt AstraZeneca, which has warned that generic competition would hurt its figures in the second half. The patent on the drug was due to expire in December, but the company was granted a six-month extension; a reissued patent had paediatric exclusivity until June 27.

The patent extension was granted in November 2007 as a result of two studies assessing the potential of Arimidex in two paediatric conditions resulting from an increase in oestrogen production: gynaecomastia (excessive breast development) in pubertal boys and early-onset puberty in girls with McCune-Albright Syndrome. However, these studies failed to demonstrate a clear benefit with Arimdex over placebo and, consequently, AstraZeneca said it would not be seeking an indication in either of these conditions.

This morning, APP Pharmaceuticals has also announced it will immediately begin marketing generic anastrozole tablets in the USA.

AstraZeneca malaria pact
Meantime, AstraZeneca has become the latest company to agree to grant the Medicines for Malaria Venture access to its extensive compound library.

Under the terms of the agreement, scientists working with MMV will screen 500,000 compounds in AstraZeneca’s library for activity against Plasmodium falciparum, the most lethal of malaria parasites. Promising compounds identified through the screening process will be progressed through “a discovery cascade” at AstraZeneca’s R&D facility in Bangalore, India, to find suitable candidates for clinical testing.

AstraZeneca chief executive David Brennan said “our experience with infection research, and indeed with all of our R&D efforts, has taught us that we will only find solutions to today’s global health challenges through collaborative efforts”. He added that “opening up our compound library to MMV is an important step toward addressing the enormous unmet medical needs of the developing world”.

Tim Wells, chief scientific officer at MMV, a not-for-profit public-private partnership, said the screening of AstraZeneca’s library “will give us some new unique starting points” as the “additional advantage is the Indian perspective”. The country has “millions of cases of malaria per year” and in addition has a balance between Plasmodium falciparum and Plasmodium vivax.

He concluded by saying that “understanding and eliminating Indian malaria is one of the keys to eliminating malaria worldwide.”