Critical Therapeutics--Günstig und Gut - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Critical eine Interessante Aktie mit potential, seit ende september hat das Unternehmen ein produkt gegen Asthma auf dem Markt .
Anfang nächsten Monat kommen die Quartalzahlen ,dann wird man sehen wie sich Zyflo auf dem markt entwickelt.
Im moment wird an einer verbesserten version von Zyflo gearbeitet(twice a Day) für mitte 2006 wird hierfür sNDA antrag gestellt.
Die meisten Instis.sind im durchschnitt bei 9$ eingestiegen.
Kurrziele liegen zwischen 9-14$.

MarktKap:237mio$
Cash:~100mio$
Kurs:6,95$

www.criticaltherapeutics.com

Critical Therapeutics Announces FDA Approval of ZYFLO(R) for the Prevention and Chronic Treatment of Asthma; Oral Drug Blocks the Production of Mediators That Can Trigger Asthma Symptoms
LEXINGTON, Mass., Sep 28, 2005 (BUSINESS WIRE) -- Critical Therapeutics, Inc. (Nasdaq: CRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company`s supplemental New Drug Application (sNDA) to manufacture and market ZYFLO(R) (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of age and older. There were no material changes to the prescribing information insert for ZYFLO as a result of the FDA review. ZYFLO is expected to be available to patients before the end of October 2005.

ZYFLO is the only FDA approved asthma treatment that inhibits the production of 5-lipoxygenase (5-LO), 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 secretion. ZYFLO has a unique mechanism of action that works early in the inflammatory cascade, thus blocking a broad range of disease mediators.

"This approval of our lead product is a major step forward and positions us to generate top-line revenue growth," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "We have completed the build-out of an 80-person specialty sales force and will be initially calling on a targeted group of approximately 8,000-10,000 allergists, pulmonologists and other respiratory specialists. The message to this audience is simple: ZYFLO`s unique mechanism of action provides another approach to manage severe persistent or difficult-to-treat asthma for patients who are not well controlled on usual care."

ZYFLO was first approved to treat asthma in the United States in 1996. Critical Therapeutics acquired worldwide rights to the drug and other formulations of zileuton in late 2003 and early 2004. In connection with the technology transfer and manufacturing of ZYFLO, Critical Therapeutics submitted an sNDA to the FDA on March 31, 2005 for approval of a new manufacturing process and new production sites.

"The U.S. Surgeon General recently declared that uncontrolled asthma is an under-recognized health problem that impacts millions of people," said Sally Wenzel, M.D., an investigator for ZYFLO and Professor of Medicine at the National Jewish Medical and Research Center in Denver who specializes in more severe forms of asthma. "Statistics suggest that of the approximately 20 million Americans with asthma, more than 11 million, or 55 percent, are not adequately controlling their symptoms. Based on the drug`s pharmacologic profile, I believe ZYFLO may be an effective treatment for patients already taking beta agonists and high-dose steroids that have failed to sufficiently control their asthma symptoms."

About ZYFLO

ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO, which contains the active ingredient zileuton, blocks the formation of leukotrienes that may contribute to asthma symptoms. Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. The recommended dose is one 600mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO can be continued during acute exacerbations of asthma.

Safety Information

Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. 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.

[BrauchGeld]

219$ kostet die behandlung mit Zyflo im Monat pro patient.

Critical Therapeutics Announces Commercial Launch of ZYFLO(R); Studies Showed ZYFLO Reduced the Need for Rescue Medications and Improved Asthma Symptoms
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 10, 2005--Critical Therapeutics, Inc. (NASDAQ: CRTX) today announced details of the commercial launch and price of ZYFLO(R) (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of age and older. On September 28, 2005, the U.S. Food and Drug Administration (FDA) approved the Company`s supplemental New Drug Application (sNDA) to manufacture and market ZYFLO. There were no material changes to the prescribing information for ZYFLO as a result of the FDA review.

ZYFLO is the only drug in the class of 5-lipoxygenase (5-LO) inhibitors approved for marketing by the FDA. ZYFLO interrupts the 5-LO cascade, the products of which trigger the migration and activation of neutrophils and eosinophils, two key white blood cells that contribute to the symptoms of patients with severe persistent or difficult-to-treat asthma.

"The launch of ZYFLO is an important milestone in our efforts to offer innovative medical solutions for the millions of patients in the United States whose asthma symptoms are not adequately controlled with currently available asthma medications," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "According to the American Lung Association, more than half of the estimated 20 million asthma patients in the U.S. do not have their asthma under control despite existing guidelines for the diagnosis and management of the disease. We believe ZYFLO represents a safe and effective treatment option for some of these patients."

Market

The Company has built a specialty sales force that will target a group of approximately 8,000-10,000 allergists, pulmonologists and other respiratory specialists who manage the majority of patients with severe asthma. "Our representatives and sales management team are in place and our field sales support infrastructure is operational. Through our 80-person specialty sales force, we believe we will initially have access to healthcare providers treating approximately 500,000 patients with severe persistent or difficult-to-treat asthma," said Rick Finnegan, senior vice president of sales and marketing.

Critical Therapeutics expects that commercial product will be available in pharmacies throughout the United States the week of October 17, 2005 and patient starter samples for ZYFLO will be available in doctors` offices the week of October 24, 2005.

Clinical Data

Approximately 5,000 patients participated in the development program for ZYFLO. In two pivotal clinical studies, ZYFLO demonstrated the ability to alleviate asthma symptoms, improve lung function, reduce the frequency and severity of exacerbations requiring oral corticosteroid therapy and improve patient quality of life. A post-hoc analysis of 774 patients from the combined pivotal trials for ZYFLO showed that the response to treatment was greater for the severe persistent group. Patients with baseline FEV(1)< or =60% showed statistically significant improvements at the end of the trials in all daily symptoms, overall nocturnal symptoms, rescue medication usage and individual symptoms, such as cough and shortness of breath.

In a 2,947-patient open label Phase IIIb clinical trial comparing patients treated for 12 months with ZYFLO in addition to usual care with those patients on usual care alone, the patients taking ZYFLO showed additional benefit in lung function, reduction in exacerbations requiring beta-agonist or oral corticosteroid use, as well as a reduction in visits to the emergency department. In addition, the Phase IIIb clinical trial of ZYFLO plus usual care provided further data demonstrating that the drug is safe and generally well tolerated.

Price and Patient Assistance

ZYFLO will be priced at a wholesale acquisition cost (WAC) of $7.30 per day, or $219 per month. The drug will be supplied to pharmacies in bottles of 120 tablets, representing a one-month supply for an individual patient. The revenue recognized by the Company will be affected by a number of factors, including patient adherence, discounts, product returns and rebates.

The Company expects that ZYFLO will be available on the majority of managed care formularies, as well through federal and state government programs, within the first two quarters after launch. For uninsured and underinsured patients, Critical Therapeutics is implementing a patient assistance program, which the Company believes will help ensure the broadest and easiest access to ZYFLO for those patients requiring assistance. The Company`s intent is to ensure that all patients who need ZYFLO have affordable access to it.

About Asthma

Asthma is a chronic inflammatory disorder affecting approximately 20 million Americans. Asthma occurs when the walls of the bronchial tubes become inflamed, causing the muscles to constrict and extra mucus to be produced. This can lead to a broad range of symptoms from minor wheezing to severe difficulty in breathing. In some cases, breathing becomes so difficult during a flare-up or "asthma attack" that symptoms can be life-threatening if not properly managed.

About ZYFLO

ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO, which contains the active ingredient zileuton, blocks the formation of leukotrienes that may contribute to asthma symptoms. Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.