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Long-Term Study Suggests Patients on a New Anti-Hypertensive May Fare Better Than Those on Most Widely-Prescribed Treatment

Lercanidipine Acts in a Unique Way to Lower Blood Pressure While Offering Fewer Side Effects

NEW YORK, NY -- November 11, 2002 -- Forest Laboratories, Inc. (NYSE: FRX) announced that findings from a multi-center, randomized study published this month in the American Journal of Hypertension show that lercanidipine, an investigational drug for the treatment of hypertension, was significantly better tolerated than amlodipine (Norvasc®), the most commonly-prescribed calcium channel blocker, allowing substantially more patients to remain on treatment. Lercanidipine is a next-generation dihydropyridine (DHP) calcium antagonist currently under review by the U.S. Food & Drug Administration (FDA).

The study authors of the COHORT trial reported that 3 times less patients withdrew from the trial due to edema (leg and ankle swelling) when treated with lercanidipine in comparison with those on amlodipine (2.1% vs. 8.5%, p=<0.001). The results suggest lercanidipine may help address a persistent problem with an otherwise highly effective class of anti-hypertensive medication -- namely edema, a bothersome side effect that may often cause patients to discontinue treatment. In addition, the incidence of edema in patients treated with lercanidipine was more than 50 percent lower than in those taking amlodipine (8.3% vs. 18.5%, p=<0.001). Edema is among the most commonly reported side effects of calcium antagonist therapy.(1)

Researchers believe that lercanidipine's novel chemical structure that allows the molecule to be held in the membrane in order to block the calcium channel receptor in a gradual and constant fashion may explain its steady reduction in blood pressure and overall low incidence of side effects.

"This is the first meaningful advance in calcium channel blockers in six years," said Franz Messerli, MD, of the Ochsner Clinic Foundation and Clinical Professor of Medicine, Tulane University School of Medicine, New Orleans. "The results are exciting because they suggest lercanidipine, even at the highest dose, is a well tolerated medication patients can maintain long-term, helping to ensure adequate control of their hypertension." Untreated or hypertension, often a symptomless disease, poses a serious public health threat, often resulting in stroke, heart attack, or other serious complications.

COHORT was a double-blind, parallel-group study of 828 people, age 60 or older, with hypertension. The study was designed to evaluate the tolerability of lercanidipine and a similar agent, lacidipine, with that of amlodipine. Patients were assigned to receive lercanidipine 10-20 mg, amlodipine 5-10 mg, or lacidipine 2-4 mg, and were treated for up to 24 months. All treatments were used as a single agent, or as the starting agent in combination with other anti-hypertensive medications.

The COHORT results demonstrate that, while all patients showed a comparable level of blood pressure control, patients taking the next- generation CCBs lercanidipine and lacidipine, reported significantly fewer edema-related symptoms than amlodipine at the six-month mark (8.3%, 4.3% and 18.5%, respectively). The incidence of other side effects, including flushing, headache, dizziness, vertigo, asthenia (loss of strength), palpitations (irregular heart beat), and tachycardia (rapid heartbeat), did not differ among the treatments.

About Hypertension
Hypertension is a major public health threat that contributes to significant cardiovascular-related morbidity and death. An estimated nine out of 10 middle-aged and older adults are likely to develop hypertension in their lifetime. More than three-quarters (1 in 4) of the estimated 50 million Americans who have hypertension do not have their condition under control.(2) Oftentimes, this lack of control can be attributed to medication tolerability, leading to poor treatment compliance. At least one-fourth of patients taking anti-hypertensive medication discontinue treatment within the first year due to side effects.(3,4,5,6)

About Lercanidipine
Lercanidipine is licensed to Forest Laboratories, Inc. (NYSE: FRX) from the Italian pharmaceutical company Recordati S.p.A. (Italian Stock Exchange, Reuters RECI.MI, Bloomberg REC IM), which developed lercanidipine. Lercanidipine is actively marketed in 41 countries and, as of last June, its use cumulatively accounted for over 15 million patient months of experience.

About Forest Laboratories
Forest Laboratories develops, manufactures, and sells ethical pharmaceutical products that are used for the treatment of a wide range of illnesses. Forest's growing line of products includes: Lexapro™, indicated as initial as well as maintenance treatment of major depressive disorder; Celexa™, also indicated for the treatment of depression; Tiazac®, a once- daily diltiazem, which is indicated for the treatment of angina and hypertension; and Aerobid® an inhaled steroid indicated for the treatment of asthma. The Company has also entered into a co-promotion agreement with Sankyo of Japan for the marketing of Benicar™ for the treatment of
hypertension.

* Benicar is a licensed trademark of Sankyo Pharma.

(1) Conlin PR, Williams GH. Use of Calcium Channel Blockers in Hypertension. Advances in Internal Medicine. 1998; 43: 533-562.
(2) The Sixth Report of the Joint National Committee on Prevention Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: National Heart, Lung, and Blood Institute, National Institutes of Health; 1997. NIH publication 98-4080.
(3) Aranda P, Tamargo J, Arnada FJ, et al. Use and adverse reactions of antihypertensive drugs in Spain. Blood Press Suppl. 1997;1:11-16.
(4) Caro JJ, Speckman JL, Salas, M et al. Persistence with treatment for
hypertension in actual practice. CMAJ. 1999;160(1):31-37.
(5) Dursing R, Weisser B, Mengden T, et al. Changes in antihypertensive therapy -- the role of adverse events and compliance. Blood Press. 1998;7(5-6):313-315.
(6) Payne KA, Esmonde-White S. Observational studies of antihypertensive medication use and compliance: is drug choice a factor in treatment adherence? Curr Hypertens Rep. 2000; 2(6):515-524.


SOURCE: Forest Laboratories, Inc.

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