J&J positive about pipeline

Johnson & Johnson (J&J) has released an encouraging update on its pipeline, saying that it plans to file marketing applications for 11 new drugs and over 30 important line extensions between this year and 2015.

The stable of products that are nearing readiness to be filed with regulators in the US and EU includes bapineuzumab IV for Alzheimer's disease, which the company acquired from Elan in 2009; canagliflozen for type 2 diabetes, which performed well in a phase IIB study last year; sirukumab for rheumatoid arthritis, for which J&J released strong phase II data earlier this month; and Dacogen (decitabine), currently sold as a treatment for myelodysplastic syndromes, for the new indication of acute myeloid leukaemia.

Also on the list are fulranumab for osteoarthritis pain; siltuximab for castleman's disease, a rare disorder that is similar to lymphoma; TMC-207 for MDR tuberculosis; TMC 435 for hepatitis C virus; flu-mAb for influenza; FluCell influenza vaccine; and a rabies antibody.

J&J said the planned submissions will build on its existing momentum. The company has had six new medicines approved since it provided its last pharmaceuticals business review in 2009 and has two new drug applications currently pending with the US Food and Drug Administration (FDA).

The pharmaceuticals business generated $22.4bn in sales last year, representing 36 per cent of J&J's total revenue, and invested about $4.4bn in R&D programmes. In the first quarter of this year, the business saw over 6 per cent operational growth, due in part to sales from new products.

Going forward, the pharmaceuticals business will focus on five therapeutic areas: neuroscience; cardiovascular and metabolism; immunology; oncology; and infectious diseases/vaccines.

The business will build its efforts around four strategies for growth that were outlined as part of the business review. The strategies include delivering differentiated medicines; building a "transformational" pipeline through internal R&D, licensing arrangements, partnerships and acquisitions; and investing in talent development, in part by "rotating key talent into important roles to quickly accelerate skills development to address a growing and complex business environment."

The fourth strategy is to strengthen the business' geographic presence in emerging markets and key developed markets. J&J noted that Japan is one key growth market for the pharmaceuticals businesses, which has seven launches planned there for this calendar year.