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A.L. LABS ACQUISITION OF ABLE WILL ADD 50 PRODUCTS

Executive Summary

A.L. LABS ACQUISITION OF ABLE WILL ADD 50 PRODUCTS and a projected $17 mil. in 1992 revenues to A.L. Labs' 220-item, $300 mil. line of over-the-counter and prescription drugs. A.L. Labs and privately-held Able announced a definitive acquisition agreement Sept. 16 and said they expected the deal to close "within the next several weeks" pending regulatory approval. Terms of the deal were not disclosed. Along with its current product line, South Plainfield, N.J.- based Able has nine ANDAs pending at FDA, including miconazole vaginal suppositories (generic equivalent to Ortho's Monistat 7) and loperamide (McNeil's Immodium A-D). Suppository specialist Able is also developing another nine products for ANDA submission, including clotrimazole vaginal tablets (Schering-Plough's Gyne- Lotrimin). A.L. Labs said that many elements of the Able product line fit well with its own products and markets. As an example, A.L. pointed out that Able's clotrimazole vaginal tablets and miconazole vaginal suppositories "will directly complement the vaginal creams being developed" by A.L. Labs' NMC topical drugs subsidiary. NMC is working on clotrimazole and miconzole creams. A.L. said that its vaginal yeast infection products and those acquired with Able will be sold under the NMC label, under private labels of drug chains and distributors, and possibly by larger pharmaceutical companies that want to add the products to their lines. Able's focus on research-intensive, technically complex drugs for specialized markets will boost profits in the long term, A.L. Labs maintained. The company noted such products often require clinical trials in addition to bioavailability studies to obtain ANDA approval, thus requiring more capital investment and expertise to bring to market and potentially inhibiting competition. A.L. also said that Able is positioning itself to take advantage of recent and upcoming Rx-to-OTC switches. Both firms are emerging from recent regulatory compliance difficulties. Under a consent decree signed with FDA, A.L. Labs' Barre-National liquid-manufacturing subsidiary must undergo periodic audits by an independent regulatory consultant ("The Pink Sheet" Aug. 3, T&G-15). The consent decree was preceded by multiple inspections of Barre-National and discussions with FDA concerning manufacturing procedures going back to 1989. In July, Able gained its first ANDA approval (for hydrocortisone cream 1%) since 1987. It underwent a court-ordered FDA GMP inspection in March, after which the agency determined that Able did not have to be shut down because it had corrected GMP violations documented in earlier inspections ("The Pink Sheet" March 30, T&G-3). The agency told Able that if it corrected minor GMP violations found during the March 17 inspection, the company would then be "in substantial compliance with CGMPs." Founded in 1984, Able has experienced rapid sales growth. Sales increased from $6.8 mil. in 1990 to $13.5 mil. in 1991 and are expected to hit $17 mil. in 1992, based on sales for the first nine months. Fort Lee, N.J.-based A.L. Labs posted 1991 sales of $260 mil. and sales through the first six months of 1992 totaled $142 mil., The company predicts that its sales for the year ending Dec. 31, 1992 will total $300 mil.
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