Upsher-Smith Laboratories, Inc. Vigorously Resists FTC Complaint and Stands Behind Pro-Competitive Settlement Agreement

Apr 02, 2001, 01:00 ET from Upsher-Smith Laboratories, Inc.

    MINNEAPOLIS, April 2 /PRNewswire/ --
 
     The following statement was released today from Upsher-Smith President and
 COO Ian Troup:
 
     "Upsher-Smith vigorously resists the FTC's complaint.  We stand by our
 pro-competitive settlement agreement which enables us to bring another
 affordable alternative for K-Dur(R) to market on a date certain nearly five
 years prior to its patent expiration -- and much earlier than had we continued
 with risky and protracted litigation.  Upsher-Smith supports competition in
 the pharmaceutical industry; there is no similarity between the Upsher-Smith
 agreement and other patent settlements that have been subjected to recent FTC
 actions.
     "Schering Plough's K-Dur(R) is a popular potassium product, but it is not
 the only potassium on the market.  Upsher-Smith in fact has been manufacturing
 and actively marketing a 20 mEq potassium chloride generic powder for nearly
 20 years.  Upsher-Smith offers a broad range of potassium products and was the
 first to bring consumers an affordable generic potassium.  All of our
 potassium products are available to consumers at a fraction of the cost of
 K-Dur(R).
     "We also licensed a sustained-release niacin product and four other
 products to Schering-Plough for $60 million, knowing that our niacin product
 alone was worth at least that much based on the projected sales of a similar
 KOS product, NIASPAN(R).  We spent more than 50% of our R & D budget over a
 five year period on developing our sustained-release niacin.  We are so
 confident in its value that we offered to have an objective valuation of the
 product be conducted by an independent economist acceptable to the FTC.
 Unfortunately, the FTC declined our offer.
     "The FTC also erroneously claims that the settlement improperly created a
 "bottleneck" under the 180-day exclusivity provisions of the Hatch-Waxman Act,
 an outcome that was legally impossible under the law and FDA regulations at
 the time of the settlement.
     "Upsher-Smith is a strong competitor in bringing consumers alternative
 brand, affordably priced pharmaceutical products.  We have a proven record of
 developing generically priced alternatives to existing products, including the
 cholesterol lowering agent Prevalite(R), our potassium product Klor-Con(R) and
 antiarrythmic medication Pacerone(R) -- an alternative to American Home
 Product/Wyeth-Ayerst's Cordarone(R).
     "We support competition in the pharmaceutical industry and in fact, have
 built our business on it."
 
 

SOURCE Upsher-Smith Laboratories, Inc.
    MINNEAPOLIS, April 2 /PRNewswire/ --
 
     The following statement was released today from Upsher-Smith President and
 COO Ian Troup:
 
     "Upsher-Smith vigorously resists the FTC's complaint.  We stand by our
 pro-competitive settlement agreement which enables us to bring another
 affordable alternative for K-Dur(R) to market on a date certain nearly five
 years prior to its patent expiration -- and much earlier than had we continued
 with risky and protracted litigation.  Upsher-Smith supports competition in
 the pharmaceutical industry; there is no similarity between the Upsher-Smith
 agreement and other patent settlements that have been subjected to recent FTC
 actions.
     "Schering Plough's K-Dur(R) is a popular potassium product, but it is not
 the only potassium on the market.  Upsher-Smith in fact has been manufacturing
 and actively marketing a 20 mEq potassium chloride generic powder for nearly
 20 years.  Upsher-Smith offers a broad range of potassium products and was the
 first to bring consumers an affordable generic potassium.  All of our
 potassium products are available to consumers at a fraction of the cost of
 K-Dur(R).
     "We also licensed a sustained-release niacin product and four other
 products to Schering-Plough for $60 million, knowing that our niacin product
 alone was worth at least that much based on the projected sales of a similar
 KOS product, NIASPAN(R).  We spent more than 50% of our R & D budget over a
 five year period on developing our sustained-release niacin.  We are so
 confident in its value that we offered to have an objective valuation of the
 product be conducted by an independent economist acceptable to the FTC.
 Unfortunately, the FTC declined our offer.
     "The FTC also erroneously claims that the settlement improperly created a
 "bottleneck" under the 180-day exclusivity provisions of the Hatch-Waxman Act,
 an outcome that was legally impossible under the law and FDA regulations at
 the time of the settlement.
     "Upsher-Smith is a strong competitor in bringing consumers alternative
 brand, affordably priced pharmaceutical products.  We have a proven record of
 developing generically priced alternatives to existing products, including the
 cholesterol lowering agent Prevalite(R), our potassium product Klor-Con(R) and
 antiarrythmic medication Pacerone(R) -- an alternative to American Home
 Product/Wyeth-Ayerst's Cordarone(R).
     "We support competition in the pharmaceutical industry and in fact, have
 built our business on it."
 
 SOURCE  Upsher-Smith Laboratories, Inc.