Questcor Provides Progress Report on New H.P. Acthar Gel Strategy.UNION CITY, Calif. -- Questcor Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :QSC QSC Quality Service Communications (Cologne, Germany) QSC Quilter Sound Company (QSC Audio Products Inc.) QSC Queens Surface Corporation QSC Low-Traffic Ship (radiotelegraphy) ) provided today a progress report on the company's new pricing strategy for H.P. Acthar Gel(R), a natural form of adrenocorticotropic hormone adrenocorticotropic hormone (ədrē`nōkôr'təkōtrŏp`ĭk), polypeptide hormone secreted by the anterior pituitary gland. (ACTH ACTH: see adrenocorticotropic hormone. ACTH in full adrenocorticotropic hormone Polypeptide hormone made in the pituitary gland. ). Since August 27, 2007, when the new strategy was announced, results have met Questcor's expectations. Specifically, while overall units shipped have decreased, the company has seen an expansion of revenues, reflecting a positive pattern of ordering and insurance reimbursement at the new pricing level. In conjunction with the new strategy, Questcor has significantly expanded its sponsorship of Acthar patient assistance and co-pay assistance programs, which provide an important safety net for uninsured and under-insured patients using Acthar. These initial trends may not reflect orders in the steady state due to a number of transition factors. These factors include inventory practices at specialty and hospital pharmacies, greater use of the safety net established for Acthar patients, the pattern of usage of Acthar by the health care community and reimbursement policies of insurance companies. Don Bailey, Interim President, commented, "The overriding goal of this new strategy is to ensure the continued long-term availability of Acthar for those patients who need it most. Although it is early in the implementation of the strategy, the initial results are positive. We are encouraged by both the continuing pace of orders for Acthar and the initial pattern of insurance coverage. We are also pleased to see expanded utilization of the Acthar patient assistance and co-pay assistance programs, which are sponsored by Questcor and independently operated by the National Organization for Rare Disorders (NORD Nord (nôr), department (1990 pop. 2,533,000), N France, bordering on the North Sea and Belgium. Lille is the capital. )." Mr. Bailey continued, "If these early trends continue, Questcor will have positive cash-flow in the near future. In addition, this trend would make it likely that Questcor could become consistently profitable, thereby assuring the continued availability of Acthar." Questcor believes that this financial stability may allow the company to fund important research and development activities, including efforts to better understand Acthar's utility in the treatment of neurological disorders This is a list of major and frequently observed neurological disorders (e.g. Alzheimer's disease), symptoms (e.g.back pain), signs (e.g. aphasia) and syndromes (e.g. Aicardi syndrome). . "One of our interests going forward is to invest in research to develop a better understanding of Acthar's actions on the central nervous system. Acthar is a complex biologic product consisting of the 39-amino-acid peptide ACTH and multiple peptide fragments. We would like to better understand what makes Acthar effective in the treatment of certain rare neurological diseases, such as infantile spasms infantile spasm n. Brief muscular spasms in infants, usually lasting from one to three seconds and often appearing as nodding spasms. and opsoclonus-myoclonus," stated Steve Cartt, Questcor's Executive Vice President. "Such exploration has the potential to not only optimize how Acthar is used but may also result in a better understanding of the diseases themselves. In addition, we also look forward to continuing our efforts to optimize key Acthar manufacturing processes, and to conducting additional clinical research if required by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in pursuit of an indication for infantile spasms." Acthar is currently approved in the U.S. for the treatment of MS exacerbations and other conditions. No drug is approved in the U.S. for the treatment of infantile spasms (IS), a very rare and potentially life-threatening form of epilepsy that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 by A.B. Baker of the University of Minnesota to advance the art and science of neurology, and thereby promote the best and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, with this condition. In June 2006, Questcor submitted a Supplemental New Drug Application for IS to the Food and Drug Administration (FDA). Questcor has a meeting scheduled with the Agency to discuss its application. Questcor currently plans to report its third quarter financial results during the week of November 12. About H.P. Acthar Gel H.P. Acthar Gel(R) is a natural adrenocorticotropic hormone (ACTH) designed to provide a prolonged release after intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. or subcutaneous injection Noun 1. subcutaneous injection - an injection under the skin injection, shot - the act of putting a liquid into the body by means of a syringe; "the nurse gave him a flu shot" . Acthar is currently indicated for the treatment of a wide range of conditions with an inflammatory component, like acute exacerbations of multiple sclerosis, various types of arthritis and ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . For full prescribing information and safety information on Acthar, please visit http://www.acthar.com. About Questcor Questcor Pharmaceuticals, Inc[R] (AMEX:QSC) is a specialty pharmaceutical company that develops and sells therapeutics for the treatment of neurological disorders. Questcor's products include H.P. Acthar[R] Gel (repository corticotropin corticotropin (kôr'təkōtrōp`ən): see adrenocorticotropic hormone. injection) and Doral[R] (quazepam), which is indicated for the treatment of insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information, please visit www.questcor.com. Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause Questcor's results to differ from those reported herein. Factors that may cause such differences include, but are not limited to, Questcor's ability to continue to successfully implement the new pricing strategy for Acthar, Questcor's ability to identify and hire a permanent Chief Executive Officer, Questcor's ability to accurately forecast the demand for its products, the gross margin achieved from the sale of its products, Questcor's ability to enforce its product returns policy, the accuracy of the prescription data purchased from independent third parties by Questcor, the sell-through by Questcor's distributors, the inventories carried by Questcor's distributors, and the expenses and other cash needs for upcoming periods, Questcor's ability to obtain finished goods from its sole source contract manufacturers on a timely basis if at all, Questcor's potential future need for additional funding, Questcor's ability to utilize its net operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. carry forwards to reduce income taxes on the sale of its non-core products, research and development risks, uncertainties regarding Questcor's intellectual property and the uncertainty of receiving required regulatory approvals in a timely way, or at all, other research, development, and regulatory risks, and the ability of Questcor to acquire products and, if acquired, to market them successfully and find marketing partners where appropriate, as well as the risks discussed in Questcor's annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2006 and other documents filed with the Securities and Exchange Commission. The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects and future financial performance. Questcor undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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