A year of hope and heartache for pharma

Kaitlyn Dmyterko, senior writer

For pharmaceutical companies, 2012 will be a year of both heartache and hope as new drugs are developed to treat and prevent cardiovascular disease, and others are phased out due to patent expiries.

Patent expiries of major U.S. blockbuster drugs are set to occur later this year, like Bristol-Myers Squibb and Sanofi-Aventis’ Plavix (clopidogrel) and Takeda’s Actos (pioglitazone). And while pharma companies will see a dip in their profits, patients will benefit from cheaper, generic drugs.

Pfizer’s Lipitor (atorvastatin) lost its dominance after the drug’s patent, with sales worth nearly $11 billion, expired. Already, FDA has approved a more affordable, generic version of the drug to be developed by Ranbaxy Laboratories.

In the world of anticoagulants, as the road to find newer therapeutic agents widens, warfarin may lose traction in the market in which it once was top dog. With approved therapeutic agents such as dabigatran and rivaroxaban, warfarin may be replaced. Whether these new anticoagulants will ever outshine the vitamin K antagonist warfarin, which has dominated the market for the last four decades, remains to be seen; however, new research might confirm pitfalls.

Research in NEJM showed that warfarin is responsible for the most hospitalizations in the elderly population and nearly two-thirds of these hospitalizations were due to unintentional overdoses. While newer approved anticoagulants like dabigatran and rivaroxaban may help resolve these types of issues, a correspondence published Nov. 24 in NEJM noted that the FDA should conduct more pragmatic trials of these newer agents.

But while warfarin has many limitations—drug-food interactions, a narrow therapeutic window, etc.—dabigatran also has its woes, including contraindications for patients with renal failure and a potential to increase myocardial infarction.

Earlier this week, FDA accepted a new drug application (NDA) to review apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), a factor Xa inhibitor shown to reduce stroke or systemic embolism by 21 percent and major bleeding by 31 percent.  While these newer drugs seem poised to replace warfarin, without more data they may not be out of the woods yet.

While newer drugs on the market will surely make an impact, we have yet to find a superior drug without pitfalls.

On these topics or others feel free to contact me.

Kaitlyn Dmyterko
Cardiovascular Business, Senior Writer
KDmyterko@trimedmedia.com