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Executive Summary

FOREST LABS' AEROBID SALES REACH $9.5 MIL. in fiscal 1990 (ended March 30), and prescriptions for the flunisolide 250 mcg per metered dose inhalation system are ahead 40% for the current year, Forest said in its recently released annual report. Sales of Aerobid have "quadrupled" from $2.4 mil. in 1986, when Forest acquired the product from Schering. The company expects to expand Aerobid sales as it enlarges its sales force. The sales force is being increased via the integration of the UAD Labs sales staff and an internal sales rep recruitment effort. Forest may get a boost from extended market protection on flunisolide. The company maintains that a patent covering its product has been allowed and is set to issue "shortly," protecting Aerobid until 2007. The company also markets the Aerochamber device to enhance the delivery of aerosol spray products, including asthma medications. Aerochamber "is now the fastest growing product in its category," according to the company. Both Aerobid and Aerochamber, as well as Forest's Theocron (controlled release theophylline), sold by its Inwood Labs subsidiary, were detailed last year by the Forest sales force. With the addition of the approximately 130-person sales staff from UAD Labs (acquisition completed in 1989), and the rep recruitment program, Forest hopes to have 400 sales people in the field by 1991. The sales rep expansion will be focused initially on Forest's incontinence product Micturin (terodiline). Forest acquired U.S. marketing rights to the twice-daily dosing oral tabs in December 1987 from the Swedish drug firm KabiVitrum. The NDA was filed on Aug. 30, and the company said it is "sanguine about the prospects for an approval sometime in 1991," maintaining that the FDA review is "going smoothly." While the NDA is based on Kabi data -- the registration dossier contained data from 28 clinical studies of over 700 patients as well as information on its use overseas -- Forest is augmenting that with ongoing studies in the U.S. The clinical program consists of five clinicals at 33 U.S. medical centers with over 500 patients enrolled. Forest is preparing for the launch with pre-marketing activities, including symposia and the dissemination of educational materials. The company has predicted that Micturin sales could reach$40-$50 mil. annually. Terodiline is marketed by Kabi in 19 countries as Micturol and has been used to treat over 500,000 patients worldwide. In the U.K., where the drug was introduced in 1986, it has an 85% share of the incontinence market with 1989 sales of over $15 mil., according to Forest. The drug is also the biggest dollar volume incontinence product in Japan, two years after introduction, the annual report says. Forest also has an Alzheimer's treatment Synapton (physostigmine) under development. Formerly called Cogmine, physostigmine is in pivotal Phase III double-blind, placebo-controlled efficacy and formulation trials at 26 U.S. and U.K. medical centers. Forest has been working on the drug for three years. Physostigmine had shown promise in small-scale clinicals in an immediate release form, but the drug's very short half-life (dosing every two hours) made it impractical for Alzheimer's patients. Forest's version of the drug employs its Synchron extended-release technology. The Synapton project has been pursued under an R&D partnership with PruBache (PruTech III), which is providing $6.7 mil. in financing in exchange for future royalties on the drug ("The Pink Sheet" March 27, 1989, T&G-6). Forest sees Synapton as a good quid pro quo bargaining chip. The foreign rights to Synapton "appear to be a most valuable consideration," and one that the firm expects "will lead to additional product opportunities" in the U.S. and U.K., Forest said. Net sales in FY 1990 reached $141.4 mil., an increase of$33.8 mil. for the year, with other income of $7.6 mil. Sales of the antitussives Tessalon (benzonatate) increased by 40% and Endal HD by 39%, due in part to the severity of the flu season, Forest said. Of the total corporate net sales increase, $32 mil. came from the introduction of two new controlled-release generic products, Inwood's propranolol and indomethacin, and $7.1 mil. resulted from price increases. Earnings totaled $29.7 mil. Research revenues decreased by $2.7 mil. in FY 1990 as a result of Forest's having completed much of the earlier PruTech I contracts, which were for other products in development, the annual report notes. Forest's R&D budget was $9.6 mil.

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