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Adams Laboratories Announces FDA Approval Of Mucinex (Guaifenesin) NDA And Is Awarded Key Patent

- Action by FDA Marks First-Ever Approval of an NDA For Long-Acting Guaifenesin -

- Mucinex™ Will Have 18 Years Exclusivity as Result of Patent -

FORT WORTH, TX -- July 15, 2002 -- Adams Laboratories, Inc., a provider of specialty pharmaceuticals for respiratory care, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Mucinex™, a single-entity, 600 mg long-acting guaifenesin product that will be available without a prescription. Mucinex provides the maximum therapeutic daily dosage of guaifenesin for adults by taking two 600 mg tablets every 12 hours. It is indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Mucinex is the first and only long-acting guaifenesin product to have an NDA approved by the FDA. This FDA approval suggests that Adams Laboratories may achieve market dominance for Mucinex as a result of the Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act. This Amendment stipulates that a drug product cannot be marketed simultaneously both as a prescription and as a nonprescription product at the same strength and same dosage and for the same indication.

Separately, Adams Laboratories announced that the U.S. Patent and Trademark Office has granted the company U.S. Patent 6,372,252 directed to the Mucinex product and its unique bi-layered delivery system technology. The first layer provides immediate release for rapid onset, allowing for rapid absorption of guaifenesin in the patient's bloodstream. The second is an extended release layer for long-acting effect and sustained relief for a full 12 hours. The patent is directed to formulation methodologies and technologies, biopharmaceutical characteristics and methods of use that include the Mucinex product. It will provide Adams Laboratories with patent protection for Mucinex 600 mg tablets until April 2020.

Mucinex will be available "behind the counter" from pharmacists nationwide, with or without a physician's recommendation. It works by loosening phlegm (mucus) and thinning bronchial secretions to rid the bronchial passageways of bothersome mucus -- making coughs more productive. Mucinex combines extended-release and immediate-release features in a single tablet.

Mucinex has the potential to penetrate a sizeable portion of the cough, cold and flu market, which currently totals approximately $2.4 billion a year in U.S. sales. Of that, guaifenesin products -- single and combination products, prescription and nonprescription -- represent approximately $1.1 billion in annual U.S. sales.

John Q. Adams Sr., Chairman and Chief Executive Officer, stated, "The FDA approval of our Mucinex 600 mg tablet is Adams Laboratories' first major drug approval and represents a pivotal step forward in our quest to become the leading specialty provider of pharmaceuticals for respiratory diseases and conditions. With the only approved NDA for long-acting guaifenesin, Adams Laboratories has the potential for significant revenue growth and we will soon embark on an aggressive sales and marketing program to introduce Mucinex to pharmacies nationwide."

Mr. Adams continued, "Our strategy has been to couple a strong regulatory framework with one focused on building the intellectual property assets of the company. The approval of our NDA and granting of our patent for Adams Laboratories' bi-layered product technology is an enormous step forward in the execution of that strategy, by providing us with 18 years of patent protection for Mucinex as a single-entity, long-acting guaifenesin."

The FDA is currently reviewing Adams Laboratories' NDA for a 1200 mg strength tablet of Mucinex, which would be taken once every twelve hours to achieve maximum therapeutic daily dosage.

In summary, Mucinex is the first and only long-acting guaifenesin product to have an NDA approved by the FDA. This FDA approval suggests that Adams Laboratories may achieve a dominant market position for Mucinex for several key reasons:

* Mucinex is the only FDA-approved long-acting guaifenesin product on the market today; no other long-acting guaifenesin products have undergone the rigors of the FDA regulatory process;
* The Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act stipulates that a drug product cannot be marketed simultaneously both as a prescription and as a nonprescription product at the same strength and same dosage and for the same indication;
* Adams Laboratories has developed a completely unique and patented bi-layered delivery system technology that makes Mucinex both fast-acting and long-lasting.

ABOUT ADAMS LABORATORIES:
Based in Fort Worth, Texas, Adams Laboratories, Inc. develops, markets and sells prescription and non-prescription pharmaceuticals for the treatment of respiratory disorders and diseases. In addition to Mucinex, the Adams Laboratories product portfolio includes the Aquatab(R) line of guaifenesin-based cough and cold products and the ALLERx line of products to treat allergic rhinitis. Adams Laboratories seeks to become the leading specialty provider of pharmaceuticals for the treatment of a broad range of respiratory diseases via a business development strategy that combines product development, acquisitions and in-licensing tactics. More information can be found on the company's website at http://www.adamslaboratories.com.


SOURCE: Adams Laboratories, Inc.

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