BMS 2011: Victory from the jaws of defeat

PLAVIX® is soon to go the way of LIPITOR® i.e., a multibillion drug with an expired patent. The loss of exclusivity on the 7 billion dollar anticoagulant is expected to result in a 13% loss in sales revenue for Bristol-Myers Squibb in 2012. Despite the impending revenue bust, Forbes named BMS the “Best Big Drug Company in 2011.”  Pfizer, Abbott and Lilly all enjoyed a very respectable + 15%  increase in stock price in 2011 but BMS achieved an almost incredible +32%.  As usual, innovation made the difference. Two BMS new drugs, YERVOY® and ELIQUIS® are expected to be leaders in their respective classes.

YERVOY(iplimumab injection), has been shown to extend the life of metastic melanoma patients an average of 10  months. It is the first oncology drug to achieve that goal. Iplimumab is a monoclonal antibody which binds CTLA4, a protein that inhibits T-cell activity. Enahnced T-cell activity can increase immune response to certain tumors.

ELIQUIS (apixaban) was shown to be more efficacious than warfarin in reducing the risk of death in patients with atrial fibrillation.Warfarin is the gold standard for this indication. Apixaban is a direct factor Xa Inhibitor. Factor Xa acts by cleaving prothrombin into thrombin, a major step in the coagulation cascade. Oral administration, predictable, outcomes and a reduced need for patient monitoring are some noteworthy advantages of ELIQUIS.

YERVOY was submitted for regulatory approval in May 2011. An NDA for ELIQUIS, already approved in the EU, was submitted to FDA in November 2011 and granted a  priority review status.

It seems the market is responding not only to the novelty of these products in their respective therapeutic areas but to the BMS business strategy. YERVOY was  obtained with the $2.4 billion acquisition of Medarex in 2009. ELIQUIS was developed and commercialized in collaboration with Pfizer, a global leader in the cardiovascular therapeutic field. Innovation in both science and business  is a combination that’s hard to beat.

Key Article http://www.forbes.com/sites/matthewherper/2011/12/26/the-best-big-drug-company-of-2011/

A notable year for personalized medicine

Personalized medicine has long been considered the probable next step in the evolution of pharmaceutical development. Knowledge of the  human genome can and has been used to optimize the treatment of disease and to provide specific cures for specific patients. The coupling of pharmaceuticals with corresponding diagnostics makes sense from a treatment standpoint and also provides a business opportunity. One Pharma highlight of 2011 was that two significant personalized medicine products were approved. XALKORI® (crizotimib) was approved for use in ALK (anaplastic lymphoma positive kinase) and ZELBORAF® (vemurafenib),  for melanoma . Both drugs  were developed for diseases attributable to readily detectable genetic mutations.  Both drugs were approved with corresponding diagnostic kits

XALKORI, supplied by Pfizer, is a kinase inhibitor. In approximately 5% of NSCLSC patients, chromosomal rearrangement leads to formation of the EML-ALK fusion gene. The increased kinase activity results in carcinogenesis. XALKORI has demonstrated excellent remission rates in clinical studies of patients with positive ALK. The Vysis ALK Break Apart FISH Probe Kit  is used to identify suitable candidates for XALKORI treatment by detecting the mutation in tumor cells.

ZELBORAF  is a BRAF Kinase Inhibitor. A mutation of the BRAF gene can be found in over 50% of  patients with melanoma. ZELBORAF was co-developed by Roche and Plexxikon. It too is accompanied by a diagnostic kit; the cobas 400 BRAF V600 Mutation Test. ZELBORAF has been demonstrated to be a useful ameliorative treatment for late stage melanoma patients.

Both approvals are encouraging and significant advances in personal medicine. Although not without its critics, mostly for issues of patient privacy, personalized medicine holds the promise of improved health care in the future – and this year could be a noteworthy first step  in that direction.