Thomson Reuters

Thomson Reuters' series of reviews covering all aspects of the pharmaceutical marketplace, Pharma Matters.

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Movers/Shakers

Receive Movers & Shakers for more information on featured companies, ANDA approvals, Paragraph IV challenges, and future quarterly reports

 

APRIL - JUNE 2008

That the wave of M&A activity, including cross-border acquisitions, has continued hardly comes as a surprise given the many companies seeking to increase their revenues by entering rapidly growing emerging markets and to lower their costs by achieving economies of scale, acquiring facilities based in lower cost countries or by gaining direct access to active ingredient manufacturing.

We saw a number of deals with impact on the US generics market, among them Fresenius (Germany) bidding for APP (US). Among the most talked about M&As was undoubtedly the proposed acquisition of Ranbaxy (India) by Daiichi Sankyo (Japan).

The US generic market continued to see lots of activity, final approvals were issued on 142 A-rated ANDAs, up from 134 the quarter before. Generic versions of 11 products were approved by the FDA for the first time. Among the products that saw first generic approvals this quarter were such blockbusters as Eisai’s anti-Alzheimer’s product donepezil (Aricept) and Janssen’s anti-psychotic risperidone (Risperdal). We also learned of patent challenges on 7 new products (3 combination products and 4 single active ingredient products), down from 11 the prior quarter.

OPENING MOVES

Based on research of ANDA filings and paragraph IV challenges we highlight three companies who made opening moves in the US generics industry in the last quarter (April-June 2008):

• Amneal Pharmaceutical LLC has grown from an OTC contract manufacturer to a generic Rx manufacturer. With current capacity at over twenty billion tablets/capsules and seven million bottles per year, the goal of Amneal Pharmaceuticals is to become one of the top 10 US generic pharmaceutical companies.
  
• Hikma Pharmaceuticals has operations in seven countries, including the Middle East, North Africa, United States and Europe. Its principal activity is developing, manufacturing and marketing a range of branded, generics and injectible products.
  
  
• Ebewe Pharma reported revenue of 241 million Euro in 2007 and has 830 employees worldwide. Ebewe’s specialty pharmaceuticals business focuses on pharmaceuticals for clinical use in Neurology, Oncology and Immunology. The group is focused on parenteral specialty pharmaceuticals, processing substances into sterile injection medicines.  They produce parenteral medicines, 1-20ml ampoules, 1-100ml vials and pre-filled syringes.
  

 

Ones to Watch

Receive The Ones to Watch for more information on the most promising drugs in PHASE I, II & III this quarter.

APRIL - JUNE 2008

The industry’s continuing willingness to wrestle with the big issues is demonstrated yet again by this quarter’s edition of The Ones to Watch, which shows promising new treatments for cancer and hepatitis C virus infection moving through the pipelines of our most innovative pharmaceutical companies. Whether or not the blockbuster paradigm is dead, we’re pleased to see the balance of drugs that might improve the quality of life of millions of sufferers alongside those targeting small-population niche markets.

THE FIVE MOST PROMISING DRUGS LAUNCHED OR RECEIVING APPROVAL

Who's Making the Biggest Splash

Receive Who's Making the Biggest Splash for reviews of the leading sources of information on medical research.

APRIL - JUNE 2008

The world’s leading pharmaceutical companies maintain their hold within the top 15 organizations making the biggest impact on leading sources of information on medical research, occupying 13 of the 15 spots.

We assess the quantity and quality of the materials published by pharmaceutical companies, research institutions and other non-commercial bodies to identify which organizations have made the biggest splash.

Three new organizations entered into the top tier, Abbott, Forest and the US National Institute of Mental Health, with Abbott breaking into the top 10.