Novartis on NME trail

Since 2001, the pharma giant has increased the number of NMEs in its pipeline by 86 per cent. These are drugs that contain ingredients that have never before been marketed in the US, as defined by the US Food and Drug Administration (FDA). "We now report 56 NMEs out of 139 projects, demonstrating that research and early development is pulling new medicines through into the portfolio,"​ said James Shannon, head of development at Novartis, in a presentation to investors. A lack of innovation is a criticism that has often levelled at the pharma industry, especially recently with the number of NME drugs being approved only increasing by 7 per cent between 1993 and 2004, despite R&D spending rocketing up by 147 per cent to $40bn (€28.8bn). Shannon highlighted several of Novartis' NME drugs currently in clinical trials during his talk that also have the potential be the first in a new class of therapy to be approved, starting with those in Phase III trials. Valdoxan (Agomelatine, AG0178) ​ Valdoxan is a novel anti-depressant originally in-licensed from Servier for an undisclosed amount. While it's efficacy is only comparable with other selective serotonin reuptake inhibitors (SSRIs) - such as GlaxoSmithKline's (GSKs) Seroxat (paroxetine) - it potentially has an improved tolerability profile, including in terms of sexual side effects, and better sleep. The drug activates both MT1 and MT2 melatonin receptors while also blocking serotonin-2C (5-HT2c) receptors. The two pivotal studies needed for filing for approval in the US are expected to be completed in the coming days to weeks, with the company expecting to file the drug this year. Fingolimod (FTY720) ​ Fingolimod could be the first in a new class of oral drugs for multiple sclerosis (MS). Shannon described it as a "fantastic drug with unprecedented efficacy in a devastating disease"​. It is thought to function through multiple mechanisms of action. It binds to the sphingosine 1-phosphate receptor-1 (S1P-R1) and traps some lymphocytes in the lymph nodes, thus reducing the number of circulating pro-inflammatory T-cells. In MS, lymphocytes in the central nervous system (CNS) attack the myelin sheath that surround and protects nerve fibres.​​Fingolimod is also thought to activate S1P receptors on astrocyte cells, which can help repair nervous tissue and increase the number of oligodendrocytes. These are cells that help form myelin in the CNS. Novartis hopes to file the drug in the second half of 2009. Mycograb ​​Mycograb is a human recombinant antibody (hence the 'grab' part of the name) that targets heat shock protein 90 (HSP90) for the treatment of life-threatening fungal infections, such as systemic candidiasis. In combination with Amphotericin B (Amph B), Novartis said it is potentially superior to monotherapy in Candida​ infection. Again, it hopes to file for approval in 2009. Tifacogin (TFP561) ​​Tifacogin is a recombinant tissue factor inhibitor for severe community-acquired pneumonia, which Novartis hopes to file in 2008. AEB071 ​​This drug is currently in Phase II trials and is potentially a first in class non-CNI12 oral immunosuppressive to use in renal transplants. It inhibits the action of Protein kinase C (PKC) and is expected to move through to filing by 2010.