Critical Therapeutics Reports Financial Results for the Quarter Ended March 31, 2007.ZYFLO Prescriptions Grow 56% on Unit Basis Over Prior Year Period Quarter Highlighted By Co-promotion Agreement With Dey, L.P. LEXINGTON, Mass. -- Critical Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. , Inc. (Nasdaq: CRTX), a biopharmaceutical company focused on developing and commercializing innovative products for respiratory, inflammatory and critical care diseases, today reported financial results for the first quarter ended March 31, 2007. For the three months ended March 31, 2007, the Company posted a net loss of $4.7 million, or $0.11 per share, based on 42.5 million weighted average shares outstanding. This compares with a net loss of $16.7 million, or $0.49 per share, for the same period in 2006, based on 34.1 million weighted average shares outstanding. The increase in common shares outstanding resulted primarily from the Company's registered offering of 7.5 million shares in October 2006. During the first quarter of 2007, sales of ZYFLO[R] (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) tablets) totaled $2.9 million, an increase of 183 percent over the same period last year and 49 percent over the fourth quarter of 2006 under U.S. generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting . Through the end of 2006, revenue from product sales of ZYFLO was recognized when the product was dispensed through patient prescriptions rather than when the product was shipped to third parties. Beginning in the first quarter of 2007, the Company converted to recognizing revenue from sales of ZYFLO when the product is shipped to third parties, less an estimate of expected product returns. This change resulted in a net increase in product sales of approximately $953,000 in the first quarter of 2007. Going forward, revenue per prescription should be positively impacted by a six percent price increase for ZYFLO that was implemented in April 2007. As part of the Company's March 2007 co-promotion agreement with Dey, L.P. (DEY), an affiliate of Merck KGaA This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. in Germany, DEY's 200-person sales force began promoting ZYFLO on April 30, 2007. Under the agreement, Critical Therapeutics and DEY will jointly promote the twice-daily, controlled-release formulation of zileuton (zileuton CR), subject to regulatory approval, with a combined sales force of approximately 240 representatives. The total number of ZYFLO prescriptions filled in the first quarter of 2007 was 9,248, compared with 5,938 in the first quarter of 2006, an increase of 56 percent, and 9,404 in the fourth quarter of 2006, a decrease of 1.7 percent. The total number of prescriptions for ZYFLO continues to increase on a quarterly basis in territories where sales representatives still promote ZYFLO. These prescription data are based on third-party data purchased by the Company. "The financial and operational results reflect the significant progress we have made in restructuring and focusing the Company. We have realigned our cost structure to give us more financial flexibility while investing in more focused development opportunities to drive value going forward," said Frank Thomas Frank Thomas may refer to:
Cash and short-term investments as of March 31, 2007 totaled $46.0 million, compared with $49.0 million at December 31, 2006. Net cash used in the first quarter of 2007 was $3.1 million, which was positively impacted by the $3.0 million payment that the Company received from DEY in connection with the signing of the co-promotion agreement for zileuton. This compares with net cash used of $9.9 million in the fourth quarter of 2006 and $18.2 million in the first quarter of 2006. The Company ended the first quarter of 2007 with approximately 43.1 million shares of common stock outstanding, excluding warrants and stock options. Recent Developments Since the beginning of 2007, Critical Therapeutics has accomplished the following: * Signed a co-promotion agreement with DEY that leverages the expertise of both companies in the U.S. respiratory market. A combined sales force of approximately 220 U.S. sales representatives is currently promoting ZYFLO. Pending regulatory approval 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. of zileuton CR, a combined sales force of more than 240 U.S. sales representatives will be promoting zileuton CR to more than 15,000 physicians (allergists, pulmonologists and primary care physicians) across the country. * Gained co-promotion rights to a second product that allows Critical Therapeutics to increase the efficiency of and leverage its sales force. DEY and Critical Therapeutics signed a binding letter agreement that allows Critical Therapeutics to promote DEY's clinical candidate for Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. (COPD COPD chronic obstructive pulmonary disease. COPD abbr. chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) ), if approved by the FDA. A more detailed written agreement between the two companies is being finalized See finalization. . * Continued to increase unit volume and sales of ZYFLO in territories staffed by a sales representative. * Received a product development fee from Beckman Coulter This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , which exercised its option to continue to license patent rights relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc developing a diagnostic to detect and measure levels of HMGB1 in the bloodstream blood·stream n. The flow of blood through the circulatory system of an organism. bloodstream the blood flowing through the circulatory system in the living body. . * Licensed to Innovative Metabolics, Inc. (IMI IMI International Masonry Institute (Washington, DC) IMI Israel Military Industries IMI Institute of the Motor Industry IMI International Market Insight IMI Imposto Municipal Sobre Imóveis (Portugal) ) certain intellectual property rights related to the development and commercialization of medical device approaches to stimulating the vagus nerve vagus nerve n. Either of the tenth pair cranial nerves that originate from the medulla oblongata and supply multiple vital organs, including the lungs, heart, and gastrointestinal viscera. . Upon the completion of IMI's financing in May 2007, Critical Therapeutics received 400,000 shares of junior preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. of IMI and a license fee of $400,000, after payments to The Feinstein Institute. * Executed a publication strategy to enhance the scientific and medical understanding of our commercial and development programs through a series of Critical Therapeutics co-authored publications in peer-reviewed medical journals, including the following:
Zileuton:
-- Respiratory Medicine electronically published a peer-reviewed
article based on a study comparing zileuton with a low-dose
inhaled corticosteroid (beclomethasone dipropionate) to
doubling the dose of beclomethasone. The results suggest that
zileuton with a low dose beclomethasone improves lung function
and may be an effective therapeutic approach to achieving
asthma control in patients with moderate to severe persistent
asthma. The print version of the article will be published in
the June issue of Respiratory Medicine.
-- International Journal of Clinical Practice published a paper
reviewing multiple articles on the clinical development of
zileuton for asthma in its April 2007 issue. This publication
was a summation of several previously published articles.
Alpha-7:
-- Shock published preclinical research work in its April 2007
issue demonstrating that a small molecule alpha-7 agonist
attenuated endotoxin-induced inflammation and peritoneal influx
of neutrophils by a mechanism separate from anti-TNF.
-- Critical Care Medicine published an article in April 2007 in
which a selective alpha-7 receptor agonist was shown to improve
survival in murine endotoxemia and severe sepsis.
HMGB1:
-- Nature Immunology published an article in May 2007
demonstrating that HMGB1 is a critical part of DNA complexes
that can stimulate immune cells to produce potent inflammatory
mediators, suggesting that HMGB1 antibodies could be an
effective therapeutic for the treatment of Lupus and other
chronic autoimmune diseases.
-- Journal of Leukocyte Biology published a paper in January 2007
describing a method, the ELISPOT, that provides a novel tool to
study pathways promoting or inhibiting HMGB1 secretion.
Financial Results for the Three Months Ended March 31, 2007 and 2006 Total revenue for the three months ended March 31, 2007 was $3.5 million, compared with $2.3 million for the same period in 2006, an increase of 54 percent. Revenue for the first quarter of 2007 included: * Sales of ZYFLO that accounted for $2.9 million in revenue, compared with $1.0 million in the first quarter of 2006 and $1.9 million in the fourth quarter of 2006. Through the end of 2006, revenue from ZYFLO was recognized when the product was dispensed through patient prescriptions rather than when the product was shipped to third parties. Beginning in the first quarter of 2007, the Company converted to recognizing revenue from sales of ZYFLO when the product is shipped to third parties, less an estimate of expected product returns. * Collaboration revenue of $601,000 from Critical Therapeutics' HMGB1 collaboration with MedImmune, Inc. and its license agreement with Beckman Coulter, Inc. to develop HMGB1 diagnostic assays Noun 1. diagnostic assay - an assay conducted for diagnostic purposes diagnostic test assay - a quantitative or qualitative test of a substance (especially an ore or a drug) to determine its components; frequently used to test for the presence or . This compares with collaboration revenue of $1.3 million in the first quarter of 2006. The decrease in the revenue under collaboration agreements resulted from a decline in the Company's obligations associated with the HMGB1 program. As the HMGB1 program advances into later stages of preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development, a larger portion of the costs and activities are being assumed by MedImmune resulting in lower revenue recognized by the Company under its collaboration agreement. In future periods, the Company's collaboration revenue under the MedImmune agreement will increase in periods when milestones are achieved. As of March 31, 2007, the Company has $105,000 of revenue deferred under its collaboration agreement with MedImmune. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the three months ended March 31, 2007 decreased $11.0 million, or 56 percent, to $8.7 million, compared with $19.7 million for the same period in 2006. Total operating expenses for the first quarter of 2007 included: * Cost of products sold that totaled $741,000, including $166,000 related to previously deferred revenue, resulting in gross margins on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of ZYFLO of approximately $2.2 million, or 74 percent. This compares to cost of products sold of $504,000 and gross margins of 51 percent in the first quarter of 2006. * Research and development (R&D) expenses that decreased $6.5 million, or 69 percent, to $2.9 million in the first quarter of 2007, compared with $9.4 million for the first quarter of 2006. This decrease was primarily due to lower expenses associated with the Company's clinical trials, as well as the reduction in the number of employees performing R&D activities following the Company's 2006 restructurings. * Sales and marketing expenses that decreased $4.9 million, or 71 percent, to $2.0 million in the first quarter of 2007, compared with $6.9 million in the first quarter of 2006. This decrease was primarily associated with the 2006 reduction in the sales force. * General and administrative (G&A) expenses that increased slightly to $3.1 million, compared with $2.9 million in the first quarter of 2006. Cost savings in G&A expenses resulting from the 2006 restructurings were offset by consulting, legal and advisory fees associated with the Company's co-promotion agreement with DEY. * Stock-based compensation expense, as calculated under SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 123(R), totaled $1.0 million for the quarter ended March 31, 2007, compared with $1.4 million in the first quarter of 2006. Research & Development Update Critical Therapeutics is progressing its preclinical and development programs and expects to initiate three clinical trials during 2007. Zileuton CR Clinical Trial The Company currently plans to conduct a clinical trial evaluating zileuton CR as an add-on therapy to moderate doses of inhaled corticosteroids Corticosteroids, Inhaled Definition Inhaled corticosteroids are glucocorticoids (a class of steroid hormones that are synthesized by the adrenal cortex and have anti-inflammatory activity) formulated to be used in the respiratory tract and lungs. in asthma patients to support the sales and marketing of zileuton CR, pending regulatory approval. The Company expects to begin enrolling patients in this trial in the second quarter of 2007. Injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. Formulation of Zileuton (zileuton injection) The Company is developing an injectable formulation of zileuton for use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma and other acute hospital-based pulmonary conditions. The Company expects to initiate a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in the second half of 2007 following favorable results from an earlier clinical trial in asthma patients. This Phase II trial will be focused on identifying the optimal dose to be tested in Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the . Zileuton Life Cycle Extension Program The Company is currently pursuing life cycle extension strategies to enhance the intellectual property position of zileuton for the treatment of asthma and provide for possible development opportunities in other inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; , including COPD and nasal polyps Nasal Polyps Definition A polyp is the medical term for any overgrowth of tissue from the surface of a body organ. Polyps come in all shapes—round, droplet, and irregular being the most common. . Critical Therapeutics plans to initiate a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in the second half of 2007 examining the pharmacokinetic profile of the R isomer isomer (ī`səmər), in chemistry, one of two or more compounds having the same molecular formula but different structures (arrangements of atoms in the molecule). Isomerism is the occurrence of such compounds. of zileuton. Development of the R isomer may lead to potential dosing improvements for patients. Alpha-7 The Company's alpha-7 program, which is directed at the discovery and development of novel small molecule drugs for the treatment of inflammation, has selected two exploratory development candidates from a series of proprietary lead molecules. The Company is conducting non-GLP (Good Laboratory Practice) toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. studies with these candidates before selecting a lead clinical candidate to take into GLP See gateway location protocol. toxicology studies. The Company believes that this innovative anti-inflammatory approach will have potential for broad applications in both acute and chronic inflammatory diseases and is exploring possible collaborations with larger pharmaceutical companies to leverage the broad potential of this pathway. HMGB1 The Company's HMGB1 program, which is partnered with MedImmune, Inc., continues to make progress toward the identification of a first clinical candidate. The collaboration has narrowed down potential clinical candidates to a few fully human antibodies that have shown efficacy in pre-clinical models of arthritis. The joint development team expects to select a clinical candidate for the development of HMGB1 antibodies for chronic inflammatory disease, such as rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. or Lupus lupus (l  `pəs), noninfectious chronic disease in which antibodies in an individual's immune system attack the body's own substances. , in 2007. The collaboration also is
making progress with the development of HMGB1 antibodies for acute
inflammatory diseases, such as sepsis Sepsis DefinitionSepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms. . According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the terms of the Company's collaboration agreement with MedImmune, the obligations of both companies remain unchanged as a result of MedImmune's recently announced sale to AstraZeneca PLC, and the two companies expect to continue to move forward with the HMGB1 program. Financial Guidance For the year ending December 31, 2007, the Company is projecting net cash expenditures to be between $19 million and $23 million. These projections include the anticipated receipt of an additional $9 million in milestone payments in 2007 from DEY related to the approval and launch of zileuton CR, but exclude the impact of any future business development agreements, such as co-development deals for alpha-7, zileuton life cycle extension or zileuton injection. Under the DEY co-promotion agreement signed in the first quarter of 2007, Critical Therapeutics has deferred the $3 million payment received upon signing. The $3 million payment will be amortized over the term of the agreement, along with any future milestone payments received from DEY. The Company expects to record all ZYFLO sales generated by the combined sales force and record any co-promotion fees paid to DEY as an operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. . Because the milestone payments are being amortized in future years, the Years, The the seven decades of Eleanor Pargiter’s life. [Br. Lit.: Benét, 1109] See : Time Company expects a net loss for 2007 of between $31 million and $35 million, or between $0.72 and $0.81 per share, assuming 43 million shares outstanding. Research and development expenses for 2007 are expected to be between $16 million and $20 million, including approximately $3.1 million in milestone payments that would be due to third parties upon the approval of zileuton CR. Sales and marketing expenses are expected to increase in the second half of 2007 as the Company prepares for the commercial launch of zileuton CR and increases the size of its sales force to approximately 40 sales representatives. These estimates for 2007 include the impact of non-cash charges Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. related to stock-based compensation expense for employees and non-employees of approximately $3.0 million. Critical Therapeutics expects net cash expenditures to be between $4 million and $6 million in the second quarter of 2007, based on a net loss of between $9 million and $11 million, or $0.21 to $0.26 per share. These projections assume that zileuton CR is approved during the second quarter of 2007 and the Company receives a $4 million milestone payment from DEY. Conference Call Information Critical Therapeutics will hold an audio webcast and conference call today to discuss the Company's first quarter 2007 financial results, strategy, upcoming milestones and financial guidance. Investors and other interested parties can access the call as follows:
Date: Tuesday, May 8, 2007
Time: 9:00 A.M. Eastern Time
Dial-in: (800) 475-3716 (U.S. and Canada)
(719) 457-2728 (International)
Webcast Information: www.crtx.com
A live and archived audio webcast of the conference call also will be available on the "Investors" section of the Critical Therapeutics website. From the home page, click on "Investors" and then on "Webcasts & Presentations." About ZYFLO([R])/Zileuton ZYFLO([R]) (zileuton tablets) is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes Leukotrienes A class of small molecules produced by cells in response to allergen exposure; they contribute to allergy and asthma symptoms. Mentioned in: Leukotriene Inhibitors leukotrienes from arachidonic acid arachidonic acid /arach·i·don·ic acid/ (ah-rak?i-don´ik) a polyunsaturated 20-carbon essential fatty acid occurring in animal fats and formed by biosynthesis from linoleic acid; it is a precursor to leukotrienes, prostaglandins, and . 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus mucus /mu·cus/ (mu´kus) the free slime of the mucous membranes, composed of secretion of the glands, various salts, desquamated cells, and leukocytes. mu·cus n. secretion. ZYFLO is the only 5-LO inhibitor approved for marketing by the U.S. Food and Drug Administration. ZYFLO is not indicated for use in the reversal of broncospasm in acute asthma attacks, including status asthmaticus status asth·mat·i·cus n. A condition of severe, prolonged asthma. status asthmaticus Pulmonology A condition characterized by ↓ response in asthmatics to drugs for which they had previously been sensitive; . Mild to moderate side effects Side effects Effects of a proposed project on other parts of the firm. associated with the use of ZYFLO are abdominal pain Abdominal pain can be one of the symptoms associated with transient disorders or serious disease. Making a definitive diagnosis of the cause of abdominal pain can be difficult, because many diseases can result in this symptom. Abdominal pain is a common problem. , upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT (character) alt - /awlt/ 1. The alt modifier key on many keyboards, including the IBM PC. On some keyboards and operating systems, (but not the IBM PC) the alt key sets bit 7 of the character generated. See bucky bits. 2. . As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease Liver Disease Definition Liver disease is a general term for any damage that reduces the functioning of the liver. Description The liver is a large, solid organ located in the upper right-hand side of the abdomen. or transaminase transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase. trans·am·i·nase n. See aminotransferase. elevations greater than or equal to three times the-more-upper limit of normal. For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information. About Critical Therapeutics Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO[R] (zileuton tablets), which is marketed in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics is working to expand its zileuton franchise by developing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an injectable formulation for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is collaborating with MedImmune, Inc. to design antibody therapies antibody therapy Clinical immunology Any therapeutic intervention in which a monoclonal or other concentrated antibody is used to manage a condition–eg, cancer or severe infection that treat acute and chronic diseases triggered by the inflammatory cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). HMGB1. Research pipeline programs include lifecycle management to extend the zileuton franchise and an alpha-7 project for the treatment of inflammation. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding possible therapeutic benefits, market acceptance and future sales of ZYFLO and, if approved, zileuton CR; the anticipated success of the co-promotion arrangement with DEY; the progress, timing and success of our regulatory filings, regulatory approvals and product launches, including for zileuton CR; the progress and timing of our drug development programs and related trials; our strategy, future operations, financial position, future revenues, and projected costs, including net cash expenditures, net loss and research and development expenses for 2007; the receipt of milestone payments in 2007 from the co-promotion agreement with DEY and net cash expenditures and net loss for the second quarter of 2007; prospects, plans and objectives of management; and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: the expected timing and outcome of the new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for zileuton CR and related discussions with the FDA, including our ability to rely on historical data in the NDA, and the sufficiency and acceptability of the results of pharmacokinetic studies of zileuton CR for FDA purposes; our ability to successfully market an sell ZYFLO and, if approved, zileuton CR, including the success of our co-promotion arrangement with DEY; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO, and, if approved, zileuton CR; patient physician and third-party payor acceptance of ZYFLO and, if approved, zileuton CR, as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO and, if approved, zileuton CR; our heavy dependence on the commercial success of ZYFLO and, if approved, zileuton CR; our ability to maintain regulatory approvals to market and sell ZYFLO and, if approved, zileuton CR; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO, zileuton CR, our discoveries and our drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our 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. and other filings that we make with the Securities and Exchange Commission (SEC). If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim dis·claim v. dis·claimed, dis·claim·ing, dis·claims v.tr. 1. To deny or renounce any claim to or connection with; disown. 2. To deny the validity of; repudiate. 3. any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release. ZYFLO([R]) is a registered trademark of Critical Therapeutics, Inc. Financial Tables Follow [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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