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Amoxicillin: Amoxicillin Pulsys
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Amoxicillin is currently not approved for once-daily dosing to treat pharyngitis. If approved for marketing, physicians prescribing Amoxicillin PULSYS would have available the first once-daily product in the aminopenicillin class for the treatment of pharyngitis while utilizing approximately one-half the amount of amoxicillin currently used. About 15 million patients annually seek relief of sore throat symptoms in the United States.
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Under the terms of the agreement, Par made quarterly payments to Advancis to fund the development of the Amoxicillin PULSYS product. Par's $4.75 million payment for the third quarter of 2005 fulfills Par's final obligation to Advancis. By terminating the partnership at this time, Par is no longer responsible for the fourth-quarter installment of $4.75 million, which would have represented Par's final payment to Advancis. If Advancis succeeds in developing and marketing any amoxicillin PULSYS product, Par will be reimbursed from the proceeds for up to half of its development expenses.
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The Company ... announced that it was on schedule to complete its ongoing pivotal Phase III trial of Amoxicillin PULSYS for adolescents and adults with pharyngitis/tonsillitis by the end of this cold/flu season. Advancis enrolled a total of 574 patients as of the close of business May 12, 2006, and expects to enroll a total of at least 600 patients into the trial by the end of May. The Company plans to announce top-line trial results in the third quarter of 2006.
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Under the terms of the agreement, $7.5 million will be immediately received by the Company with an additional $2.5 million to become available, if necessary, if and when the Company receives U.S. Food and Drug Administration (FDA) approval of Amoxicillin PULSYS. The agreement is designed to provide the Company with the financial flexibility to continue its ongoing strategic discussions beyond the PDUFA date for Amoxicillin PULSYS. The cash provided from the Deerfield agreement will ... allow MiddleBrook to repay in full its outstanding loan facility with Merrill Lynch and eliminate the associated interest and principal payments.
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Advancis Pharmaceutical announced that the FDA had informed the drug developer that it had enough data to submit an application for marketing approval of the strep throat therapy Amoxicillin Pulsys. Advancis says it will file for approval in December or January. Report
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Amoxicillin Pulsys