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PAR HAS 13 TABLET/CAPSULE PRODUCTS AND 26 INJECTABLES PENDING AT FDA; AGENCY HAS APPROVED 12 SEPARATE PAR PRODUCTS IN FIRST HALF OF 1986

Executive Summary

Par has an ANDA catalog of various dose forms of 13 oral and 26 injectable drugs currently under review at FDA, the firm noted in an Aug. 21 filing with the Securities & Exchange Commission. The filing is related to the firm's acquisition of BetaMed. Par noted that it "currently has applications for approvals pending before the FDA relating to 50 tablet and capsule products (representing various dosages of 18 drugs)." Through BetaMed, in which Par acquired an 80% controlling interest last year, "Par has entered the generic injectable drug market with emphasis on drugs for the treatment of cancer and cancer-related illnesses," Par noted. The firm said that "it is currently awaiting FDA approval for . . . 86 injectable products (representing various dosages of 26 drugs)." The firm has sustained a steady volume of new generic product approvals recently and, Par noted in the filing, it already has received approvals in the first half of 1986 for 27 tablet and capsule products representing various dosages of 12 separate drugs. In the preceding three fiscal years, Par said it has received approvals for various oral forms of 5, 10, and 8 separate drugs. Pointing out that its first injectable product approvals, through BetaMed, came in January 1986; Par said that since then it has received approvals for 39 injectable products covering 13 drugs. The SEC filing was made in connection with Par's issuance of a maximum of 27,564 shares pursuant to its total acquisition of BetaMed. Par purchased 80% of BetaMed in February 1985 and is now acquiring the remaining 20% of the firm, consisting of 978,514 publicly held shares, at 50› per share, in cash or in Par stock. Since the initial acquisition, Par has operated BetaMed under the new name Quad Pharmaceuticals. Par noted that Quad's liquid injectable vincristine, approved by FDA April 29, is being marketed by Adria Labs. The product is the first generic version of Lilly's Oncovin. Par explained that in April 1986, BetaMed entered into an agreement with Adria Labs "under which Adria is the exclusive distributor (other than BetaMed itself) of a certain anti-cancer drug in the U.S. and Puerto Rico." Par reported that sales of the drug to Adria accounted for 49% of Quad's net sales during the nine months ended May 31, 1986. The agreement is for an initial term of one year and may be extended by Adria for successive six month periods. Par indicated, however, that Lilly may claim patent rights for the liquid formulation. Lilly has a pending patent application for liquid vincristine, which has previously been available only in powder form for reconstitution. "In May 1986, BetaMed was notified by a trade name drug manufacturer that it had applied for, and expected to receive, a patent for the anti-cancer drug that is the subject of the Adria agreement," Par stated. The firm said that if the patent is granted, "BetaMed would be required to cease production and may be required to accept returns from or otherwise compensate purchasers of the drug other than Adria." BetaMed also has a major distribution agreement with American Critical Care, the Baxter Travenol division recently acquired by DuPont. Under the agreement, entered into in January, American Critical Care is the "exclusive distributor to the U.S. hospital market (subject to BetaMed's retention of the right to sell its injectable products directly) of 12 injectable drugs (representing 26 products)," Par stated. The firm noted that FDA has approved eight of these drugs. Par said approximately 29% of BetaMed's net sales for the nine months ended May 31, 1986, were derived from American Critical Care. Among its other customers, Par noted that it has signed an agreement to supply "a major drug company" through Sept. 30, 1988 "with a substantial portion of its requirements for" 200 mg OTC ibuprofen. Par's two largest customers are United Research Laboratories and Generix Drug Corp., which "each accounted for over 10%, and, in the aggregate, approximately 34% of the company's net sales" during the 1985 fiscal year, Par said. Reporting on its financial status, Par stated that as of June 30, 1986 it had cash and temporary investments amounting to $15.6 mil. and working capital of $20.5 mil. By comparison, as of Sept. 30, 1985, the firm said it had cash and temporary investments of $4.7 mil. and working capital of $8 mil. Par also noted that "in the 1986 period, operations generated cash of $1.2 mil. as compared with $982,000 in the 1985 period." The firm noted in its filing that it intends "to increase marketing activities for its products. Accordingly, Par has hired a marketing director for its tablet and capsule products and a marketing director and four field sales employees for its injectable products. Par is also seeking to expand its customer base by, among other things, hiring additional sales employees, entering into joint ventures and selected supply and distribution agreements, and developing a regional distribution capability." Par noted that in an effort to increase the marketing of its products internationally, it appointed Marcel Zyto director of the international department in July. Zyto was previously a VP of American Home Products' Whitehall Div. Par also recently appointed Bob Gunter VP of marketing and sales.

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