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J&J buoyant despite pending expiries

Having published robust performance figures for 2007 Q4, boosted by the weak dollar promoting international drug sales (nearly 26 per cent increase), Johnson & Johnson (J&J) is remaining upbeat for 2008ñ2009 despite the coming patent expiries for two major products.

Having published robust performance figures for 2007 Q4, boosted by the weak dollar promoting international drug sales (nearly 26 per cent increase), Johnson & Johnson (J&J) is remaining upbeat for 2008ñ2009 despite the coming patent expiries for two major products.

Blockbuster schizophrenia treatment Risperdal loses patent protection this year, while its popular Topamax epilepsy drug goes generic in 2009. Chairman and CEO, William Weldon, used the firmís positive 2007 performance, which included the successful purchase of Pfizer Consumer Healthcare, to try to allay fears of a tougher time ahead.

He also pointed to the companyís five new marketing submissions filed in 07 Q4 for a variety of products and said that "the creation of new organisational structures focused on future growth" would serve to see the firm safely through the upcoming patent expiries. 

During the three-month period, J&J sought US and/or EU marketing approval for:

Paliperidone palmitate (US; a monthly antipsychotic injection for schizophrenia)
Ustekinumab (US and EU; a new, human monoclonal antibody for chronic moderate-to-severe plaque psoriasis in adults)
Dapoextine (EU; for premature ejaculation in males aged 18-64)
Velcade (EU; for people with previously untreated multiple myeloma)
Prezista (US; expanded indication for HIV infection in antiretroviral treatment-naïve adults). 

At the start of 2008, the company received accelerated approval in the US for its anti-HIV product Intelence (etravirine; formerly known as TMC125), which the firm claims is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment-experienced adults with NNRTI-resistant disease.

Optimistic outlook
With strong 2007 performances from both Risperdal Consta and Topamax, some analysts expressed uneasiness about J&Jís prospects for growth in 2008 and immediately beyond. However, while the two expiries are significant, they are not a surprise and Weldon assured analysts recently that he felt the company had already got ahead of the challenges and would "power through".  

Full-year worldwide pharmaceutical sales of $24.9bn represented a 6.9 per cent (with a positive impact from currency of 2.6 per cent) versus 2006.  

EC raids
J&J was one of several companies which experienced dawn raids last week in a European Commission-led inquiry into concern over delays in both the development of innovative medicines as well as generic competition appearing on the market following significant branded patent expiries.

Authorities were keen to make clear that the investigation was not based on their having any specific information that the named companies had infringed competition law. However, Competition Commissioner Neelie Kroes said that if "... cheaper generic alternatives to existing products are in some cases being delayed, then we need to find out why and, if necessary, take action".

23rd January 2008

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