SUPERPHARM EX-VP TECHNICAL SERVICES AZEEM AND TWO OTHERS CHARGED

SUPERPHARM EX-VP TECHNICAL SERVICES AZEEM AND TWO OTHERS CHARGED in a three-count indictment and one-count criminal information handed down by the Baltimore federal court on May 3. The indictment charges former Superpharm VP-Technical Services Mohammed Azeem and Muhammed Mannan, an ex-R&D department manager, with one count of conspiracy to make false statements about ANDAs and two counts of filing false statements for two ANDAs. A third former Superpharm employee, Liaquat Hossain, the ex-manager of product development, was charged with making false statements to FDA about one Superpharm product. Azeem left Superpharm in the summer of 1986 and Mannan in the summer of 1990. Azeem was just released in April from jail after serving a six-month sentence for offering illegal cash gratuities to a number of FDA employees. He did so in his capacity as a consultant for American Therapeutics and its former CEO and President Raju Vegesna in the years after he left Superpharm. Azeem was sentenced in Baltimore federal court last June ("The Pink Sheet" June 11, T&G-3). Azeem and Mannan, whose "present whereabouts are unknown," a May 3 press release from Maryland U.S. Attorney Richard Bennett notes, "falsified batch records, testing summaries, inventory records and laboratory reports to cover up their actual procedures and results." Further, Azeem directed Superpharm employees, including Mannan, "to subvert the FDA review process by creating false data for inclusion in Superpharm's [ANDA] applications and records rather than adhering to the required research and development experimentation process," the indictment press release states. The conspiracy charged in the first count of the indictment involved: hydralazine HCl/hydrochlorothiazide 50/50 mg capsules; ibuprofen 400 mg tablets; diazepam 2, and 10 mg tabs; lorazepam 0.5 mg tabs; and propranolol HCl 10 mg tabs. Counts two and three of the charge center on false statements made by Azeem and Mannan concerning the antihypertensive/diuretic combo hydralazine/hydrochlorothiazide and the beta blocker propranolol. The latter two charges allege that Azeem and Mannan "mispresented the dissolution test results of one lot" of hydralazine/hydrochlorothiazide "as test results for another lot." The two are also accused of misrepresenting to FDA "the batch size actually produced, the date the lot was produced, the lot number of the active ingredient actually used and the color of" its propranolol product. Hossain, like Azeem, stopped working at Superpharm in summer 1986. He is also charged with making false statements associated with the company's ANDA filing for propranolol. Superpharm, headquartered in Bayshore, N.Y., had three ANDAs for its diazepam 2, 5, and 10 mg tablets withdrawn by FDA in an April 25 Federal Register notice for "making untrue statements of material fact," and because the drug lacks substantial evidence of effectiveness. Superpharm withdrew a request for a hearing on the ANDAs. FDA had published the withdrawal proposal in May. FDA also has proposed to withdraw the ANDA for ibuprofen 400 mg due to untrue statements of material fact, and Superpharm has petitioned FDA to withdraw 11 ANDAs and is preparing to withdraw 26 more ("The Pink Sheet" March 11, In Brief). ANDAs for the drugs mentioned in the Superpharm indictments and criminal information were all approved by FDA and the products were marketed with the exception of the antihypertensive/diuretic combination product. Vitarine former VP-R&D Steven Colton, who was charged with three counts of making false statements to FDA on April 24, is scheduled to be arraigned in Baltimore federal court on May 13 at 9:30 a.m. Colton faces a maximum of five years in prison and $ 750,000 in fines ("The Pink Sheet" April 29, T&G-5).