Big Pharma Moves Out of CVD, Big Biotech Moves In

BioWorld Insight Staff Writer

Big pharma pioneered the treatment of heart disease and continues to rule the cardiovascular kingdom today, thanks to cholesterol-lowering drugs like Pfizer Inc.'s Lipitor (atorvastatin) and blood thinners like Bristol-Myers Squibb Co.'s Plavix (clopidogrel bisulfate).

But there are plenty of challenges to cardiovascular drug development: The clinical trials are big and expensive, drugs usually have to prove benefit above and beyond a well-established standard of care, market penetration requires a large sales force, and prices aren't as high as in biologics-dominated fields like cancer.

And so, with patent expirations looming, some big pharmas have turned toward greener pastures. Pfizer Inc. said last fall that it was moving away from cardiovascular disease to focus on oncology, immunology and inflammation, among other areas – a move furthered by its $68 billion acquisition of non-cardio-centric Wyeth in January.

Mark Monane, an analyst with Needham & Co., explained that most other big pharmas aren't so much moving away from cardiovascular disease as moving beyond it.

But while big pharma has diversified out of cardiovascular, big biotechs Amgen Inc. and Gilead Sciences Inc. are diversifying into the space.

Amgen is looking to pick up the slack from its erythropoietin-stimulating agents Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), which have been pummeled by regulatory and reimbursement issues. Its pipeline star is osteoporosis and bone cancer drug denosumab, but the company also has placed a few bets in the cardiovascular space.

A few months ago, Amgen exercised its option to license the Phase II heart failure drug CK-1827452 from Cytokinetics Inc. The move prompted Cytokinetics President and CEO Robert Blum to note that Amgen had "doubled down on its commitment to cardiology at the same time some companies are walking away" from the field. Credit Suisse Securities LLC analyst Michael Aberman agreed that CK-1827452 could become a "very prominent" program for Amgen.

Amgen spokesperson Mary Klem said the company hasn't talked publicly about its cardiovascular strategies, but she noted that the Sensipar (cinacalcet) programs as well as the Phase III TREAT and REDHF trials with Aranesp "represent a substantial investment by Amgen in this area."

TREAT was designed to see if Aranesp could reduce cardiovascular events and deaths in patients with chronic kidney disease, anemia and Type II diabetes. Data released last week showed no significant efficacy difference between the drug and placebo groups. The REDHF trial, designed to see if Aranesp can reduce deaths in anemic heart failure patients, is still ongoing.

For Gilead Sciences Inc., cardiovascular drugs offer diversification away from the company's hugely successful antiviral franchise. Patent expirations on the blockbuster HIV drugs are still a ways off, but it never hurts to plan ahead.

A few years ago, Gilead ponied up $2.5 billion to acquire Myogen Inc., gaining access to two endothelin receptor antagonists: Letairis (ambrisentan) for pulmonary arterial hypertension and darusentan for resistant hypertension. Letairis sales are growing but have been slower than expected, while darusentan met its endpoints in its first Phase III trial this spring. (See BioWorld Insight, April 13, 2009.)

Gilead took its cardiovascular play even further in March, outbidding Astellas Pharma Inc. to acquire CV Therapeutics Inc. for $1.4 billion. That buy-out added the marketed chronic angina drug Ranexa (ranolazine extended-release tablets) and pharmacologic stress agent for cardiac imaging Lexiscan (regadenoson).

Monane doesn't believe other biotechs will follow the bellwethers into the cardiovascular arena, although he noted that as the leading cause of death in the U.S., the indication is always going to attract a few takers.

In the big pharma space, for example, Merck & Co. Inc. has remained committed to its cardiovascular roots, recently inking an $800 million deal with Cardiome Pharma Corp. for atrial fibrillation drug vernakalant and a $470 million deal with Portola Pharmaceuticals Inc. for anticoagulant betrixaban. And on the biotech side, companies like Portola and Aegerion Pharmaceuticals Inc. are dedicated to serving the space.

But for most biotechs, it's much more "fashionable" to be in cancer, Monane said.

Published: August 31, 2009