AstraZeneca and Abbott announced a co-promotion agreement on June 4 for the lipid-lowering drug TriLipix (fenofibric acid) in the U.S., the same day the two drug makers filed a new drug application with the FDA for an investigational Crestor /TriLipix compound.

The co-promotion extends their existing commercial relationship ahead of an FDA decision on the jointly developed rosuvastatin/fenofibrate product, which will be marketed as Certriad , if approved.

The two companies agreed to develop an investigational fenofibrate/statin compound in 2006 for the treatment of mixed dyslipidemia - a combination of two or more lipid abnormalities including high LDL-cholesterol, high triglycerides and low HDL-cholesterol. They decided to use Abbott's TriLipix (then known as ABT-335) with Crestor for the compound in 2007 (¹ 'The Pink Sheet,' Sept. 3, 2007, In Brief).

TriLipix, approved last December, is a next-generation fenofibrate and the only fibrate indicated for use in combination with a statin, which gives the drug a marketing advantage over Abbott's older fenofibrate TriCor (² Also see "TriLipix Approval Strengthens Abbott’s Cholesterol Franchise" - Pink Sheet, 22 December, 2008., p. 8).

Certriad is an important product for both companies, but especially Abbott, given that its leading lipid-lowering drug, TriCor, faces generic competition in 2011; the same threat doesn't face AstraZeneca's Crestor until 2016. The Certriad NDA is backed by data from efficacy and safety studies with 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid, according to the companies.

The American Heart Association estimates that about 34 million people in the U.S. are affected by mixed dyslipidemia. But despite this opportunity, the drug will face an increasingly competitive cardio-metabolic market for fixed-dose combination products. For example, Daiichi Sankyo is developing a triple combination product combining its antihypertensive Azor with hydrochlorothiazide, and Merck and Schering-Plough have a combination of Zetia and Pfizer's Lipitor (atorvastatin) in development, which is expected to launch after Lipitor faces generics ³ Also see "Payer Cost Strategies Weigh On CV Fixed-Dose Combinations" - Pink Sheet, 2 March, 2009., p. 11).

Teaming up to talk up TriLipix

The drug makers hope their co-promotion will extend TriLipix's reach to primary care physicians and cardiovascular specialists. "Working together, we can reach a lot more physicians whose patients can benefit from TriLipix, than Abbott can on its own," said a spokeswoman from Abbott.

Since the launch of TriLipix last December, Abbott reports that an increasing number of physicians are asking about the drug's clinical profile and how it might help patients with lipid disease. The drug maker hopes AstraZeneca's combined forces will help address such inquiries.

Abbott is counting on patient switches from TriCor to TriLipix to cushion the hit from TriCor generics. The co-promotion appears to be another step to secure more scripts for the newer product.

Shortly after the drug's launch, Abbott execs maintained switching efforts were exceeding expectations (⁴ Also see "TriLipix Exceeding Abbott’s Expectations Shortly After Launch, Execs Say" - Pink Sheet, 23 March, 2009., p. 13). Data from SDI, a health care analytics group, shows that TriLipix scripts increased steadily from the date of its approval in December through the end of April, with scripts totaling 94,352 that month. Meanwhile, TriCor scripts ebbed and flowed during the same time period, with 967,549 reported scripts in the month of December, fluctuations in subsequent months, and 866,893 reported scripts during the month of April.

But the drug maker declined to provide any data or comment further on the number of patient switches that have taken place to date.

The TriLipix agreement, which marks the second co-promotion between Abbott and AstraZeneca in the cardiovascular market, gives AstraZeneca non-exclusive rights to sell the drug alongside Abbott in the U.S., excluding Puerto Rico. Abbott agreed to co-promote AstraZeneca's Crestor under similar terms, last August (⁵ Also see "Abbott, AstraZeneca Riding Crestor Wave With Expanded Partnership" - Pink Sheet, 18 August, 2008., p. 7).

For AstraZeneca, "This agreement allows us to further strengthen our presence with physicians by including TriLipix as an offering to physicians for patients with dyslipidemia," Jim Helm, AstraZeneca's cardiovascular vice president, said in a statement. The agreement does not add or take away from total number of sales reps for AstraZeneca, the company said. Abbott declined to comment on details of its own sales force participating in the promotion.

-Carlene Olsen (c.olsen@elsevier.com)

AstraZeneca To Co-Promote Abbott’s TriLipix; NDA Is Filed For Crestor/TriLipix

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