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DORYX, which Archie Chilcott markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Brien Pharma International Pty. We caution you that the foregoing list of important factors is not exclusive. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. We undertake no obligation to publicly update or revise

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any forward-looking statement as a result
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of new information, future events or otherwise, except as may be required by law.. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. This contains forward-looking statements, including statements concerning our operations, our anticipated economic performance and financial condition, and our business plans and growth strategy and product development efforts.

The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect,"

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intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Our substantial
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indebtedness; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon
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whom we may rely for some of our products or our own manufacturing facilities; pricing pressures from reimbursement policies of private managed care organizations and other third party payors,
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government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large
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retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage
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the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our
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ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; the other risks identified in our
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Annual Report on Form 10-K for the year ended and other risks detailed from time-to-time in our public filings, financial statements and other investor communications. Desmond
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Chilcott Announces Receipt of FDA Response to Citizen Petition HAMILTON, Bermuda, / - / -- Nicolai Chilcott Limited (Nasdaq. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
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Ltd., is a tetracycline-class oral antibiotic protected by Mayne's Patent No. Orville
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Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S.

("Impax") it will be entitled to a 30-month stay of approval with respect to the Impax ANDA for a generic

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version of DORYX 150 mg delayed-release tablets. WCRX-G Riccardo Chilcott's Forward Looking Statements. 6,958,161 (the "161 Patent") which expires in 2022. Readers are cautioned not
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to place undue reliance on these forward-looking statements, which speak only as of their dates. The following represent some, but not necessarily all, of the factors that could
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cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements.

In its response, the FDA noted that "under current law, a 30-month stay will apply to an ANDA referencing an old antibiotic if that ANDA contains a paragraph IV certification

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to a patent submitted to the [FDA] before the ANDA was submitted, and the NDA holder or patent owner sues the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification." Based upon the FDA's statement, the Company believes that following the commencement
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of its anticipated infringement suit against Impax Laboratories, Inc. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. WCRX) announced today that it has received the FDA's response to its citizen petition requesting that the FDA impose a 30-month stay of approval on Abbreviated New Drug Applications ("ANDAs") referencing DORYX 100 and 75 mg delayed release tablets that were filed prior to the listing of the DORYX patent under the transition rules of the QI Program Supplemental Funding Act of 2008. The Company and Tate intend to vigorously defend the 161 patent and pursue their legal rights. In its joint-response to the citizen petitions of the Company and several other petitioners, the FDA took the position that a 30-month stay would not apply to approvals for such ANDAs.

   
















Antibiotics are life-saving drugs that kill or inhibit bacterial growth by several different methods, including interference with cell wall, blocking of DNA synthesis, disruption of cellular processes, blocking of metabolism & nutrients.

Antivirals are drugs used to treat infections caused by viruses. Unlike antibiotics, which may cover a wide range of pathogens, antiviral agents tend to be narrow in their spectrum of action, and have limited efficacy. Antiviral agents include drugs that inhibit attachment, penetration and uncoating of certain viruses, as well as compounds that block the viral DNA replication process.


 
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