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Home  /   Forum   /   BioPharma   /   CRTX

BioPharma« Terug naar discussie overzicht

CRTX

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798 Posts
Pagina: 1 2 3 4 5 6 ... 40 »» | Laatste | Omlaag ↓
  5. [verwijderd] 14 maart 2007 15:22
    +33% RT 2.39

    Critical Therapeutics, Merck KGaA Affiliate Dey Sign Co-Promotion Pact for Respiratory Drugs

    NEW YORK (AP) -- Drug developer Critical Therapeutics Inc. said Wednesday it signed a co-promotion agreement with Dey LP, an affiliate of German drug maker Merck KGaA, to sell each others' respiratory products.
    Financial terms of the agreement were not disclosed.

    Under the agreement, the two companies will use a combined sales force of 240 reps to sell Critical Therapeutics' Zyflo asthma drug and Dey's chronic obstructive pulmonary disease drug, both of which are currently under review by the Food and Drug Administration.

    Critical Therapeutics said the FDA will make a decision on its drug by May 31, and expects a product launch by the second half of the year pending approval.

    biz.yahoo.com/ap/070314/critical_ther...
  9. [verwijderd] 14 mei 2007 17:59
    RT 2.72 +65%

    Monday May 14, 10:45 am ET
    Critical Therapeutics Shares Rise As FDA Approves Chronic Respiratory Disorder Treatment

    LEXINGTON, Mass. (AP) -- Shares of Critical Therapeutics Inc. jumped Monday after the small drug developer received Food and Drug Administration approval for a respiratory treatment it will market with Dey LP, an affiliate of German drug maker Merck KGaA.
    Critical Therapeutics shares jumped 59 cents, or 36.2 percent, to $2.23 in morning trading at more than 27 times average volume. Shares have traded between $1.44 and $4.79 over the past 52 weeks.

    The approval covers Perforomist, an inhalable twice-a-day treatment for the respiratory ailments emphysema and chronic bronchitis -- the most common forms of Chronic Obstructive Pulmonary Disease (COPD). Critical Therapeutics applied under an FDA process that allowed the use of data on a similar product Foradil, sold by Schering-Plough Corp. and Novartis AG.

    Data from two late-stage clinical trials on Perforomist found the medication significantly improved symptoms of emphysema and chronic bronchitis, and was similar in safety and effectiveness to Foradil.

    Critical Therapeutics plans to increase its sales force to at least 40 reps, which it will do when another product it collaborates on with Dey, the asthma treatment Zyflo, gets FDA approval.

    COPD covers a number of chronic lung ailments where the airways to the lungs narrow and breathing becomes difficult. About 12 million in the U.S. suffer from COPD, and another 12 million have symptoms but have not been diagnosed. The company said COPD is the fourth leading cause of death in the U.S., behind heart disease, cancer and stroke.

    biz.yahoo.com/ap/070514/critical_ther...
  13. [verwijderd] 15 mei 2007 14:35
    The FDA has told CRTX that it expects to reach a decision on the controlled release form by May 31.

    Critical Therapeutics Awaits FDA Decision on New Zyflo Formulation
    Tuesday May 15, 4:02 am ET

    Andrew Vaino submits: Nothing really beats finding a tiny company with great potential that not too many people seem interested in. Halozyme (NasdaqGM: HALO) was trading at $2.48 last August and is now over $10. Biosante (AMEX: BPA - News) is another excellent example, and is up over 100% since I mentioned it in February.
    A perceptive reader emailed me about Critical Therapeutics (NasdaqGM: CRTX). It is a small company that sells Zyflo, a pill that inhibits 5-lipoxygenase inhibitor (5-LO). 5-lipooxygenase is responsible for the conversion of arachidonic acid to leukotrienes, which can cause constriction in the lungs. Other potential applications of a 5-LO inhibitor include vascular disease, stroke, and even pancreatic cancer. Zyflo is sold as a treatment for asthma. Seventeen million Americans have asthma, and this number is increasing.

    Now, one of the problems with Zyflo is that is has to be taken four times a day. Ideally this means every six hours, and since people generally like to sleep at least eight hours, this is a drawback. To improve on this, CRTX adjusted the formulation of Zyflo so that it can be dosed only twice a day. It used technology that was developed by Skyepharma’s Geomatrix technology.

    This technology uses solid forms of the pill that erode at different rates in order to control the release of the drug over different periods of time. CRTX is also evaluating an injectable form that could be used in emergency settings. This treatment is not perfect. In a clinical trial of 5000 patients, just over 3% developed increased levels of the liver enzyme alanine transaminase. This is not ideal, but it is something that can be tested for, and monitored. Potential difficulties with liver enzymes has not derailed the sales of Lipitor.

    CRTX has been selling Zyflo since Q4 of 2005 and quarter over quarter sales of Zyflo have been increasing steadily since its launch. The more convenient controlled release version should provide a boost to sales. The FDA has told CRTX that it expects to reach a decision on the controlled release form by May 31.

    The stock is currently trading at less than $1.75. Approval, which I consider highly likely, should give this stock a boost. The company just released the 10-Q and, while not rock solid, it isn't in bad shape. Sales have been increasing steadily and the long release form, if approved. will improve this even more. My take is that this is a low price, low volume (avg volume is 229K) stock with a substantial near term potential.

    biz.yahoo.com/seekingalpha/070515/354...
798 Posts
Pagina: 1 2 3 4 5 6 ... 40 »» | Laatste |Omhoog ↑

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