In principle, Teva will not launch a generic version sooner than March 28, 2011, the expiry of the fibrate's first composition patent. The settlement involves the 145 milligram dose of TriCor (fenofibrate), which is the cholesterol lowering drug's most popular strength.
TriCor raises high-density lipoproteins (HDL), the so-called good cholesterol, and reduces the production of triglycerides, a type of fat circulating in the bloodstream. TriCor is used as monotherapy to treat patients with high triglyceride levels and in combination therapy with the popular statins for patients with mixed dyslipidemia (characterized by both elevated low-density lipoproteins (LDL), the "bad" cholesterol, and triglyceride levels, combined with decreased levels of HDL cholesterol).
The commercial appeal of TriCor -- in a crowded fibrate-treatment market -- is accented in its contribution to Abbott's 2008 revenue: $1.3 billion, or about 15 percent of U.S. pharmaceutical sales. Although Teva is but one of four generic companies challenging TriCor's exclusivity, it is a global powerhouse and the deal buys Abbott more time to convert existing and new patient starts to TriCor's next-generation successor TriLipix.
TriLipix contains the extended release form of TriCor's active ingredient, fenofibric acid (does not need to be "activated" by first passing through the liver). Critics allege that the drug is nothing more than a "me-too" fibrate, and a thinly veiled guise at "product switching" -- whereby Abbott phases out field support of TriCor, replacing it with an updated version that prevents automatic generic substitution. Notwithstanding legitimate cost concerns, the drug can be given safely when used concomitantly with statins -- unlike other fibrates (higher risk of side effects, such as a debilitating muscle-wasting condition called rhabdomyolysis. Miles White, chairman and chief executive of Abbott, opined on the company's third-quarter 2009 earnings call that TriLipix's peak annual sales potential is one billion plus.
The sales force of British-based AstraZaneca, drug manufacturer of the $3.6 billion statin Crestor (rosuvastatin), began co-promoting TriLipix during the third quarter. Abbott reps took up Crestor selling responsibilities last year. This cross-selling activity should help to expand reach and brand awareness of TriLipix. Of greater interest, the two drug makers are collaborating on a fixed-dose combination of TriLipix and Crestor, to be called Certriad. The new drug application was submitted to the FDA in June, with an anticipated launch window planned for spring 2010.
Certriad holds revenue generating potential for both companies -- as both TriLipix and Crestor now face threats from a newer and more potent statin being readied for a U.S. launch. Livalo (pitavastatin), owned by private Japanese drug maker Kowa Pharmaceuticals, is the flagship product in the company's cardiovascular portfolio, with $340 million in Japanese sales. Kowa currently promotes the fibrate Liprofen (fenofibrate capsules) in the U.S.
Efforts to broaden the commercial appeal of Abbott's lipid franchise, which also includes Niaspan (extended-release niacin) and Simcor (simvastatin/niacin extended release), could face a more direct threat: Pfizer's Lipitor (atorvastatin) -- with almost $12.4 billion in 2008 revenue -- loses patent protection come 2010.
In addition to ensuring a stronger presence with doctors, Astra and Abbott's duel-combo marketing and pending Certriad treatment signal to physicians and competitors alike that this Transatlantic partnership is ready to mix it up in a cardiovascular market increasingly dominated by combination drugs: Pfizer's blood pressure/lipid lowering drug Caduet delivered $589 million in 2008 sales; Merck's dual lipid-lowering pill Vytorin has already generated $1.5 billion in global sales in 2009.
The incremental lipid-lowering effect that combination therapy can provide does not necessarily guarantee success. To date, Simcor sales have been disappointing. A demonstrated ability to reduce the mortality and morbidity associated with high cholesterol-serum levels, such as heart attacks, would go a long way in justifying the higher prices paid by patients for a TriLipix or Certriad compared to a generic statin.