Novartis took the opportunity of its full-year 2004 financial results to tout its late-stage product pipeline, which boasts potentially the first oral drug to treat multiple sclerosis (FTY720) and has shown efficacy in Phase II trials, in addition to a potential blockbuster cancer agent, known as PTK787, and first-in-class diabetes and hypertension offerings – LAF237 and SPP100 respectively – that are expected to be filed with the regulators in the first half of next year.

Joerg Reinhardt, head of pharma development with the Swiss pharmaceutical giant told PharmaTimes News Online in an interview yesterday that there was a lot of potential in the late-stage pipeline, and that the firm would be revealing more about its early-stage products towards the end of next year.

However, Dr Reinhardt rebuffed questions about whether Novartis was still considering an acquisition or any in-licensing deals in the near future. He explained that the firm had made a mistake talking about mergers and acquisitions in the past, so could not comment. Last year, Novartis openly entered into merger negotiations with Aventis [[22/04/04a]], when the latter was trying to fend off an approach from Sanofi-Synthelabo [[26/01/04a]]. However, the French company ultimately prevailed when it stepped in with a superior offer [[26/04/04a]].

- Meanwhile, the company remains “cautiously optimistic” about the future of its COX-2 inhibitor, Prexige (lumiracoxib). He explained that the company will have to wait for the outcome of the European and US inquiries into the class – spurred on as a result of Merck & Co’s withdrawal of its COX-2 offering, Vioxx (rofecoxib) [[01/10/04a]] – to determine the route forward. He explained that the question remains whether an increased risk of heart attack is a general class-effect, but noted that no increase in blood pressure has been seen with Prexige in clinical trials. The question remains whether this is this enough to show Prexige is safer than other drugs?

Late last year, Novartis withdrew the compound’s regulatory dossier in Europe – a move it said would enable it to “further document” the product’s safety and efficacy profile by adding additional data to the regulatory dossier [[30/11/04a]]. Although the product is already approved in the UK [[16/09/03b]], and has been approved in 20 other countries around the world, including Australia, New Zealand and several Latin American countries, it has also faced a delay in the important US market after the Food and Drug Administration called for more clinical trial data [[24/09/03a]].

- In other news, Novartis says it has won a positive opinion from the European advisory board for Aclasta (zoledronic acid) as a single infusion treatment for Paget’s disease – paving the way for the product’s first global approval. The European Commission is expected to issue its final decision on whether to issue final approval for the drug later this year.

Paget’s disease is a painful and chronic disorder of bone metabolism, the biochemical process controlling the normal breakdown and formation of bone. In Paget’s disease, accelerated breakdown and formation of bone produces new bone that is weaker than normal.