Abbott Pinning Tricor Growth On Improved Formulation, Combination Use
Executive Summary
Abbott is hoping to build the lipid-lowering agent Tricor into a major global brand with the introduction of a new formulation and use as a combination therapy
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Abbott is hoping to build the lipid-lowering agent Tricor into a major global brand with the introduction of a new formulation and use as a combination therapy. "We feel extremely confident about our strategy to manage Tricor for the longer term," Abbott Divisional VP-Investor Relations John Thomas told investors attending the Goldman Sachs health care conference in Laguna Niguel, Calif. June 9. "We expect that Tricor will eventually achieve a billion dollars in sales," Thomas declared. Tricor (fenofibrate) generated U.S. sales of $566 mil. in 2003. Thomas cited several reasons for the company's high expectations, including an "improved formulation of Tricor." Abbott is expected to provide more details on the new formulation "in the not too distant future," Thomas said. Abbott tweaked the Tricor formulation once before; the company introduced a fenofibrate tablet formulation in 2001, which eventually replaced Tricor capsules (1 (Also see "TriCor Tablet Replaces Lower Bioavailability Capsule; Abbott Adds HDL Claim" - Pink Sheet, 15 Oct, 2001.), p. 15). Abbott's conversion of the marketplace to the capsule formulation succeeded in largely negating the impact of generic fenofibrate entry. Teva's September 2002 launch of generic fenofibrate capsules followed a trial court ruling against Abbott in a patent infringement case. The noninfringement ruling was affirmed on appeal (2 'The Pink Sheet' March 31, 2003, In Brief). Teva's Gate Pharmaceuticals division markets fenofibrate under the brand Lofibra . Impax also received ANDA approval to market fenofibrate capsules, but opted not to launch due to modest demand for the capsule formulation. One factor contributing to the low demand for fenofibrate capsules is the fact that Tricor tablets are more bioavailable than the capsules and, consequently, come in different strengths, thereby complicating substitution from tablet to capsule. Abbott also believes fenofibrate "has a unique role down the road in combination therapy," Thomas said. Abbott could be considering combining fenofibrate with a statin, following in the footsteps of Merck and Schering-Plough. The companies' NDA for Vytorin , the Zocor / Zetia cholesterol-lowering combination therapy, is pending at FDA with a user fee date of July 23 (3 (Also see "Schering/Merck Ready For Vytorin; Lipid Market Growth Returns" - Pink Sheet, 26 Apr, 2004.), p. 9). Alternatively, Abbott could be looking to pair Tricor with an antihypertensive agent, as Pfizer did in combining Lipitor with Norvasc to create Caduet (4 (Also see "Pfizer Caduet Launch Set For May; Inspra Starts Slow" - Pink Sheet, 26 Apr, 2004.), p. 6). Abbott's antihypertensive agents include Mavik (trandolapril), Tarka (trandolapril/ verapamil) and Micardis (telmisartan), which the company co-promotes under a deal with Boehringer Ingelheim. Abbott recently acquired full rights to Mavik and Tarka from Aventis (5 'The Pink Sheet' June 7, 2004, In Brief). Abbott also could be looking to combine Tricor with the obesity agent Meridia (sibutramine). In its December 2000 announcement of the Knoll acquisition, Abbott pointed to marketing synergies for the two products, both of which are positioned for use by diabetics (6 (Also see "Abbott Sees Metabolic Growth In Knoll: Meridia May Mesh With TriCor" - Pink Sheet, 18 Dec, 2000.), p. 3). Abbott believes it can defend Tricor tablets from generic competition. "We have four strong formulation patents on the current tablet that extend out to 2018, and we have a plan to vigorously defend those patents," Thomas told investors. Abbott is involved in infringement litigation with five companies over the fenofibrate tablet formulation: Teva, Impax, Par, Ranbaxy and Cipher. Teva, Impax and Ranbaxy hold tentative approvals. The trial in Abbott's lawsuits against Teva and Impax is slated to begin in June 2005. Cipher's NDA for a "novel" formulation of fenofibrate has been "approvable" at FDA since January, pending additional information on chemistry, manufacturing and labeling. [Editor's Note: A version of this story first appeared in 7 "The Pink Sheet" DAILY June 11. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.] |