Swiss giant Novartis has this morning dropped the veil on a brand new strategy for its pharmaceuticals division, and said it plans to concentrate its discovery capabilities on disease pathways shared by a broad range of conditions rather than the traditional route of pharmaceutical development.
The unraveling of the human genome has triggered an about-face in drug discovery, with scientists increasingly focusing - for example - on interacting pathways of proteins, which may be at the root of several diseases, rather than on identifying single genes or proteins. And, in a bid to cut attrition rate, Novartis says compounds will only enter full-scale clinical development after undergoing proof-of-concept trials. This, it hopes, will allow the company to pull the plug on weaker elements of its product portfolio earlier on in the process.
Said Mark Fishman, who heads up the Novartis Institutes for BioMedical Research: “We are harnessing the power of the genome to invent a ‘new grammar’ of drug discovery that will translate breakthroughs in biology and chemistry into innovative medicines for patients.”
And the company has also taken the opportunity to highlight some promising candidates, including a novel antibody, dubbed ACZ885, for inflammatory conditions. It is directed towards interleukin-1 beta and, in proof-of-concept trials, relieved rash, joint aches, fevers and migraine headaches within days amongst patients with a condition known as Muckle-Wells syndrome. Also in the cooking pot is LBM642, a dual agonist of PPAR alpha and gamma, which may prove a new weapon against the metabolic syndrome (obesity, diabetes and high cholesterol) and avoid the disadvantages of previous PPAR agonists – namely weight gain and oedema. Furthermore, Novartis is developing a follow-up to its highly successful anticancer drug, Gleevec/Glivec (imatinib) – AMN107 – which has now entered Phase II development to treat patients with chronic myeloid leukaemia who are resistant to its originator drug.
Overall, NIBR has 63 new molecular entities currently in advanced pre-clinical development, of which 16 are antibodies. Novartis as a whole has 75 projects in clinical development and 55 of them in Phase II, III or registration. “All of our late-stage projects are progressing well in an increasingly challenging industry environment marked by an intensified focus on drug safety,” said Joerg Reinhardt, Head of Development, Novartis Pharma AG. “This year will be one with strong newsflow with Phase III data and regulatory submissions expected for key products. We expect to see dynamic progress in our pipeline.”
Just this morning it has filed Exjade (deferasirox), a once-daily oral iron chelator, for US and EU approval. And other submissions planned for this year include the Phase III compound LDT600 for the treatment of hepatitis B, as well as new indications for Gleevec/Glivec for acute lymphoblastic leukaemia and the breast cancer agent Femara (letrozole) for use in the early adjuvant (post-surgery) setting. Phase III data for LAF237 (vildagliptin) as a monotherapy and in combination with other anti-diabetic agents is expected at the end of 2005.
- Meanwhile, Cephalon has revealed that it no longer faces a challenge from Novartis’ generics unit Sandoz regarding its narcolepsy drug Provigil (modafinil). Sandoz has dropped its pursuit of generic modafinil until patent expiry in 2014 and Cephalon in turn says it will not pursue its lawsuit against Sandoz for patent infringement. Meanwhile, Cephalon has also noted that a recent filing against Gabitril (tiagabine) by SUN Pharmaceuticals does not impact the composition patent and therefore this compound will remain protected until patent expiration in 2011.