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The Iceland based generic pharmaceutical company, Actavis, recently announced that its third-party sales division, Medis, has delivered around 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market.

Atorvastatin efficiently regulates the blood cholesterol levels and is one of the most effective drugs used in the therapy of primary hypercholesterolemia. Read more…

Actavis Group, the international generic pharmaceuticals company, launched Pantoprazole tablets in Germany, Ireland, and the Netherlands as the patent expired on 6 May. This is Actavis Group’s first own brand launch of this molecule.

In Germany and the Netherlands, the product was also launched by Actavis’ third party sales division’s (Medis’) customers at the same time. Earlier this year, Medis’ customers launched the product in Hungary and Poland.

Pantoprazole, a proton pump inhibitor (PPI), is used to treat acid-related stomach and throat problems, including acid reflux (GERD), erosive esophagitis, and Zollinger-Ellison syndrome. Pantoprazole Actavis is the generic equivalent of Wyeth’s Protonix®.

Pantoprazole Actavis is available in 20mg and 40mg tablets. The product was developed by Actavis R&D in Iceland, and manufactured by Actavis Malta.

IMS Health reported EU Brand sales of EUR1.1 bln in 2008. Read more…

Little Falls facility resumes production with FDA approval of critical pain solution

Reykjavik, Iceland, 17 April 2009 — Actavis Group, the international generic pharmaceuticals company, today announced the reintroduction by its subsidiary in the United States of Oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis’ Little Falls, NJ facility following a recently completed FDA inspection.

In December 2008, Actavis Inc. in the US announced that it reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company’s Actavis Totowa LLC subsidiary. This Decree only impacted operations at Actavis Totowa’s three facilities in the US: two in Totowa, NJ and one in Little Falls, NJ.

Actavis agreed to not distribute any products from the Actavis Totowa facilities until it certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. Read more…

Actavis Group, the international generic pharmaceuticals company, today announced the launch of Fluvastatin SR in the UK and the Netherlands. Actavis was first to market in both countries.

Fluvastatin SR extended release tablets from Actavis are the generic equivalent of Novartis’ Luvinsta® SR / Lescol® XL and are available in 80mg tablets in both markets. Fluvastatin SR is used to treat high cholesterol levels in the blood.

Fluvastatin SR tablets are manufactured by Actavis Malta and developed by Actavis’ R&D in Iceland.

This launch was possible after Actavis won a court case in January 2009 in the UK, whereby Novartis’ formulation patent for Fluvastatin SR, which prevented launch of the product until 2017, was revoked. The formulation patent has also been revoked in the Netherlands. Read more…

Actavis Group and Japan’s ASKA Pharmaceutical formally signed contracts recently establishing a new joint company called Actavis ASKA K.K. The new business will be headquartered in Tokyo.

The joint company intends to enter the Japanese generic pharmaceutical market right away in April 2009. ASKA will hold a 55 percent stake in the venture and Actavis will hold 45 percent.

“We are convinced this is the best way to enter the Japanese market,” says Actavis CEO Sigurdur Oli Olafsson. “We bring the power of a global generic pharmaceutical company to the table, while ASKA is an experienced local partner. We are very much looking forward to a long and successful partnership. The government’s policy to increase the share of generics during the next few years is key to our decision to enter at this time.”

Contributing to society by developing and providing innovative pharmaceutical products, ASKA Pharmaceutical is a research and development (R&D) orientated company located in Tokyo. ASKA concentrates its management resources on specific therapeutic areas.

Actavis is one of the world’s biggest generic pharmaceutical companies. Established in 1956, the group has more than 10,000 employees operating in over 40 countries around the globe. Actavis’ headquarters are in Iceland.

Actavis Group and ASKA Pharmaceutical formally signed the agreement establishing the new joint company: Actavis ASKA K.K following the signature of a preliminary agreement last November.

For further details, visit www.actavis.com

Entering the Irish market last week, Actavis plans to create up to 25 new local jobs over the next five years and to launch more than 120 generic drugs in Ireland, with the potential to save millions of euro off the country’s annual health bill.

The new roles Actavis will create are in addition to 11 corporate employees currently based in Ireland.

“Over the next five years, we plan to rapidly expand our offering in Ireland in all channels – hospital-specific, prescription and over the counter medicines,” says Actavis Ireland Managing Director Tony Hynds.

The arrival of Actavis into the Irish market, Hynds said, came at a time when the country was struggling to meet the rapidly rising cost of healthcare.

“In Ireland, Actavis has established a team with deep expertise in the local industry, people who understand the nature of the market here, and has given them the backing of a vast global product pipeline,” Hynds added.

Actavis launched a generic cancer treatment drug, Gemcitabine, on the Irish market last Monday. It was made available for prescription from 9th March, on day one when the patent for Gemcitabine expired in Ireland.

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.

At the annual SMaRT Awards last week in Birmingham, UK, Actavis were triumphant, winning Best POM to P Switch of the Year Award for Clamelle. The Clamelle training materials were also awarded Highly Commended in the Best Educational Initiative for Pharmacists category.

The SmaRT (Sales, Marketing and Retail Training) Awards, sponsored by Numark, exist to acknowledge the excellence of training initiatives and sales and marketing support programmes provided by drug manufacturers to pharmacists and their staff.

Best switch

Clamelle was awarded the title of Best POM to P switch in the pharmaceutical industry in 2008. Following the reclassification of azithromycin 500mg from prescription-only (POM) to pharmacy (P, OTC) medicine status, the Clamelle Chlamydia Test Kit and Clamelle Azithromycin 500mg tablets were launched in November 2008, under the banner of the Clamelle Chlamydia Service.

Competition in this category was fierce with Feminax Ultra (naproxen), Bayer and Voltarol (diclofenac), Novartis Consumer Health.

Excellent Educational Initiative

The Clamelle training materials which were prepared to support the launch of Clamelle were highly commended in this category. All UK pharmacists and pharmacy assistants received the training materials which were accredited by both NPA and CPP.

Actavis Group is pleased to announce that Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia Test Kits are now available for pharmacy distribution in the UK.

Clamelle Chlamydia Service

The Clamelle Chlamydia Service is a private service that is paid for by the consumer. It consists of the Clamelle Chlamydia Test Kit and Clamelle Azithromycin 500mg Tablets. The Clamelle test kit is purchased in a UK pharmacy, a urine sample posted off by the consumer to the laboratory and the result can be sent to the consumer by post or obtained from the pharmacy. If a confirmed positive test is received and if the treatment is deemed appropriate, following a sexual health consultation with the pharmacist, Clamelle Azithromycin 500mg Tablets can be supplied.

The Clamelle Chlamydia service is run jointly by Actavis, the NPA and Gordon Laboratory Group (GLG), a private laboratory which carries out the gold standard Nucleic Acid Amplification Technique (NAAT) testing, manages the test results and the Clamelle customer database.

Clamelle Chlamydia Test Kit and Tablets can only be sold by pharmacies that have registered with the NPA for the Clamelle Chlamydia service, obtained the NPA chlamydia resource pack and registered with GLG. Since the NPA launched the service three months ago, over 7,500 pharmacies have registered with the NPA and received the chlamydia resource pack. Read more…

Actavis announced a preliminary agreement with ASKA Pharmaceutical concerning the establishment of a joint company: Actavis ASKA Co., Ltd. – planning to enter the Japanese generic pharmaceutical market in April 2009.

Actavis will hold 45% of shares in the joint venture; ASKA 55%

Strategic Rationale

Japanese government policy requires an increase in the generic share of the total pharma market (in volume) so that this share grows to more than 30% by 2012. Measures – for example, the re-amendment of the prescription form in April 2008 – are being taken to facilitate this policy objective and, therefore, increase the usage of generic products.

Through this business alliance, ASKA will have the ability to enter the market with the benefit of Actavis’ product portfolio and in addition will have the possibility of exploring the export potential for its new products and value-added formulations via Actavis’ global marketing channels.

Actavis has the opportunity to enter the Japanese market and utilize its wide product portfolio, both existing and in the pipeline, in co-operation with an experienced and resourceful partner.

Takashi Yamaguchi, CEO, ASKA Pharmaceutical:

“This business alliance will enable ASKA to combine the benefits of its expertise in developing and marketing pharmaceutical products in Japan with Actavis’ broad range of products marketed globally. Thus, the new joint company will be able to maximize the different and complementary strengths of its founders, and will aim to become a leading company in the Japanese generic products’ market.”

Sigurdur Oli Olafsson, CEO, Actavis Group:

“This is an excellent opportunity for Actavis to enter the Japanese market – the second biggest pharmaceutical market in the world. The government’s policy to increase the share of generics during the next few years is key to our decision to enter the Japanese market at this time. We are very much looking forward to a long and successful partnership with ASKA, a strong partner with an excellent local network.”

About Actavis

Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. The company has operations in 40 countries, with 11,000 employees. Further information about Actavis can be found on the corporate website: www.actavis.com.

About ASKA

Located in Tokyo, Japan, ASKA Pharmaceutical is a research and development (R&D) oriented company, which contributes to society by developing and providing innovative pharmaceutical products, concentrating its management resources to the specific therapeutic areas. Additional information about ASKA, is available through its corporate website, http://www.aska-pharma.co.jp/english.

Summary of joint company
Name: Actavis ASKA Co., Ltd.
Head Office: Tokyo
Capital: 200 million Yen (planned)
Investment ratio: ASKA: 55%, Actavis: 45%

Establishment: April 2009 (planned)

Enquiries
Actavis Group
Hjördís Árnadóttir
Director – External Communications
Tel: (+354) 535 2300 / 840 7476

E-mail: harnadottir@actavis.com

Any statements contained in this press release that refer to Actavis’ estimated or anticipated future results or future activities are forward-looking statements which reflect the Company’s current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.