eNewsWire

The international generic pharmaceuticals company, Actavis Group, has launched the oncology product Gemcitabine in EU markets, at patent expiry. This launch represents a significant milestone in Actavis’ developing hospital business.

The pharmacuetical drug Gemcitabine is the first major oncology product to be made available by Actavis on the date of patent expiry in Western Europe.

Actavis will be manufacturing the product at two of its manufacturing sites. Coupled with three registered sources for APIs (Active Pharmaceutical Ingredients), this will ensure one of the most robust and competitive supply chains in the industry.

Gemcitabine will be launched in eight EU markets in March, including Germany, France and the UK. The product will be launched in the remaining EU markets as tender cycles permit later in the year. The product has also previously been launched in several less regulated markets around the world.

Speaking about the event, Scott Richards, EVP of Actavis’ Hospital Business, said: “The day one launch of Gemcitabine is a great achievement for Actavis’ hospital business, which was formed just over two years ago. This launch demonstrates our ability to compete in the demanding generic oncology arena. We will be selling this product alongside our growing range of other injectable generic products via our own hospital sales teams around the world and via select partners and distributors in various countries”.

The originator product, Lilly’s Gemzar, is estimated to have generated around US$ 1.5 billion in annual revenue. Gemcitabine is used in the treatment of cancer including lung cancer, pancreatic cancer, bladder cancer and breast cancer.

Actavis’ generic breast cancer drug, Epirubicin Hydrochloride Injection, has been approved for sale in the US by the Food & Drug Administration (FDA).

Epirubicin Hydrochloride is now the second oncology drug from Actavis approved in the US following Irinotecan Hydrochloride which was authorised earlier this year.

Epirubicin Hydrochloride Injection, the generic to Pfizer’s Ellence®, has been approved in 10 mg / 5 mL, 50 mg / 25 mL, and 200 mg / 100 mL configurations and is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumour involvement following resection of primary breast cancer.

Annual US sales of brand and generic Epirubicin HCl Injection were US$17.5 million for the 12 months ending June 2008 according to IMS Health data.

Actavis currently markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anesthetics and analgesics.

Epirubicin HCl Injection, is developed by Actavis scientists in Romania.

Actavis’ Global Hospital Business Unit, established in 2006 following the acquisition of Sindan in Romania, is comprised of a small team of commercial and technical specialists with extensive experience in the generic hospital market.

The Unit is responsible for the strategic and operational development of a world-class hospital channel business for Actavis in all-important markets worldwide.

Actavis is a leading generic drugs manufacturer based in Iceland. The company has operations in 40 countries and 11,000 employees.

For more information on Actavis and their products, visit www.actavis.com.