Disopyramide is the first post-1962 product to be approved via the ANDA route under the new ANDA/patent law. Elmwood Park, N.J.-based Biocraft Labs announced Feb. 22 that it had received FDA approval for the generic version of Searle's antihypertensive Norpace. Biocraft said that its generic disopyramide, in both 150 mg and 100 mg caps, will be available to the trade in "two weeks to a month." Biocraft's disopyramide, as well as the first post-1962 ANDA, also appears likely to be the first generic version of Norpace to reach the market. Biocraft first filed a "paper" NDA for disopyramide in the fall of 1981, the firm said. However, following enactment of the new ANDA/patent law, the generic mfr. chose to convert its "paper" NDA into an ANDA. FDA has said that it would give first priority to ANDAs converted from "paper" NDAs. The timing of Biocraft's breakthrough, with both the first post-1962 ANDA approval and first generic disopyramide, may give a boost to the company's upcoming initial public stock offering. The company recently filed a preliminary prospectus and registration statement with the Securities & Exchange Commission relating to a planned 1.8 mil. share offering. Overall, the generic mfr. seeks to raise between $7.8 mil. and $9.6 mil. from the 600,000 shares the company is offering at an anticipated opening price of between $13 and $16 per share. Biocraft Chairman and President Harold Snyder and his family are offering another 1.2 mil. shares in the offering with a potential return of between $15.6 mil. and $19.2 mil. at the anticipated opening price range for the offering. According to the prospectus, Biocraft now has pending applications at FDA to market three generic drugs representing seven products and dosage forms. Biocraft said it is also "developing and intends to seek FDA approval of three drugs (representing eight dosage forms) not presently manufactured by the company and one dosage form of a drug presently manufactured by the company." In addition, Biocraft indicated that it is interested in licensing overseas brandname products for development and marketing in the U.S. "The company is considering developing, manufacturing and selling certain drugs which have been in use several years outside the U.S., but which have not previously been approved for use or marketed in this country," the prospectus states. With the proceeds from the 600,000 shares offered by the company, Biocraft said it would put $2.5 mil. into new product development. The generic company's R&D expenditures are now annualizing at $800,000; Biocraft spent $816,000 for R&D in fiscal 1984 ended March 31 and plans to spend about the same during fiscal 1985, the prospectus indicates. Biocraft also said it is "considering the possibility of constructing a new plant to be used for the manufacture of drugs in injectable dosage form, at an estimated cost of $10 mil." If the company decides to go ahead with the plant construction, $3 mil. from the offering proceeds will go into building the new plant. Besides the $2.5 mil. going toward new product development, and possibly $3 mil. for new plant construction, $1.7 mil. of the proceeds from the offering has been earmarked for purchase of Biocraft's plant facilities, currently under lease from Biocraft principals, Snyder and his wife, the prospectus notes. The offering is being underwritten by Lazard Freres. The disopyramide approval represents Biocraft's first entry into the antihypertensive market. The proceeds from the public offering may enable the firm to further broaden its product line from its current emphasis in the antibiotic area. Semi-synthetic penicillin products in both finished dosage and bulk forms currently make up the largest segment of Biocraft's business. In fiscal 1984 (ended March 31), gross sales of the firm's six semi-synthetic penicillin products, including amoxicillin, ampicillin, ampicillin/probenecid, cloxacillin, dicloxacillin, and oxacillin, accounted for approximately 65% of Biocraft's gross sales, the prospectus reports, or roughly $19.3 mil. Through nine months of fiscal 1985, Biocraft semi-synthetic penicillin sales held steady at 64% of gross sales, or roughly $16 mil. According to the prospectus, bulk sales represented approximately $3.3 mil. of FY 1984 semi-synthetic penicillin sales and $2 mil. of FY 1985 sales, with finished dosage forms accounting for the remainder. Gross sales include returns, allowances and payment discounts and were roughtly $29.7 mil. in FY 1984 and $24.9 mil. through nine months of FY 1985, Biocraft indicated. Overall, Biocraft net sales increased 44.1% in FY 1984 to $29.1 mil., contributing to a 124% jump in net earnings to just under $2.5 mil., the prospectus shows. Biocraft's net income has climbed steadily over the past four years from a net loss of $498,000 in FY 1981 to over $3 mil. through the first nine months of the current fiscal year. At the end of nine months in FY 1985, Biocraft's net margins had improved to over 12% based on net sales of just under $24.6 mil. (FOOTNOTE) Chart omitted.
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