Approval Of ZYFLO CR the first extended -release leukotriene Synthesis Inhibitor For Asthma

The FDA approved Critical Therapeutics’ New Drug Application (NDA) for twice-daily ZYFLO CR™ (zileuton) extended-release tablets. ZYFLO CR and ZYFLO® (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Critical Therapeutics, together with its co-promotion partner Dey, L.P. (DEY), expects to begin marketing ZYFLO CR in the U.S. in the fall of 2007.

Leukotrienes (whose synthesis the drug inhibits) are inflammatory mediators in asthma. They can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. The drug is preventive and is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO, however, can be continued during acute exacerbations of asthma.

ZYFLO CR uses SkyePharma PLC’s (SKP) proprietary Geomatrix® drug delivery technology, which controls the amount and rate of drug released into the body.

The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.
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What About Exelixis

Biotechnology sector closed mostly higher yesterday and the sentiment towards the sector is increasingly positive. Today is another day, though; it is starting on a negative note. Why? There are always reasons for the ups and the downs and the paralysis.

ASCO is coming.

For the three past years, the prestigious conference has been kidnapped by short-sellers, and the same might repeat this year. Still, the prestigious ASCO conference is the best reminder that the biotech sector should not be underestimated. It has provided the best selling novel biological cancer drugs, which are closing in on the traditional chemotherapies.

Bottom line, regardless of how far the critics go in their game of unfulfilled expectations, the long-lasting effect of ASCO will still be in favor of the firms that put on the market far-reaching cancer drugs such as Rituxan, Avastin, Tarceva, Vectibix, Erbitux, Velcade and all the many other biological products that are taking over the management of cancers.

In other news:

Genzyme (GENZ) decided to buy Bioenvision for $345 million, or $6.50 per share, in cash. Why? Why not? This is the logical question/answer. Genzyme is developing a promising drug, clofarabine, with Bioenvision. Of course buying the partner together with the drug for $345 million is smart.
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Imclone’s (IMCL) stock is being devastated on rumors that the firm’s clinical trials of Erbitux fell short of expectations?! An analyst said he had heard the speculation, but was unable to substantiate it. (Nevertheless he perpetrated it.) The rumors were sufficient to push shareholders to sell the stock. Imclone was unable to confirm the source of information or its validity.
All we personally know about Erbitux’ clinical trial results until now has come from the firm itself. Imclone and its partner stated that data from a phase 3 study of Erbitux and chemotherapy in first-line colon cancer patients is positive. Read More….

Antigen-specific memory T-cell responses to cytomegalovirus (CMV), which may be important in protecting against CMV disease, were detected six months after DNA vaccination in a majority of CMV-seronegative subjects in a previously completed Phase 1 study. Memory T-cells are known to respond quickly upon subsequent infection with virus, transforming into active, effector T-cells that can control disease. Read More….