Independent Expert Confirms View That Adams Has No Legal Basis For Pursuing Legal Action Against Mutual Pharmaceutical Company For Its Guaifenesin Extended-Release Tablets, 600 mg And 1200 mg
PHILADELPHIA, Sept. 29 /PRNewswire/ -- United Research Laboratories, Inc. and Mutual Pharmaceutical Company, Inc. ("Mutual") today announce that pharmaceutical expert Harry G. Brittain, Ph.D., confirms Mutual's assertion that its Abbreviated New Drug Application (ANDA), covering guaifenesin extended-release tablets, 600 mg and 1200 mg, does not violate Adams Respiratory Therapeutics' patents on Mucinex(R). By reviewing the formulation ingredients and manufacturing procedure detailed in the master batch records submitted by Mutual to the U.S. Food and Drug Administration, Dr. Brittain was able to determine with certainty that Mutual's guaifenesin extended-release tablets do not have the characteristics specified in Adams' patents. Mutual's tablets are of uniform composition, whereas Adams' patents are solely directed towards a bi-layer tablet.
"Dr. Brittain's conclusions further reinforce our position that any assertion of Adams' patent claims, against Mutual, would be baseless; they clearly do not cover Mutual's guaifenesin extended-release tablets. We sincerely hope that Adams does not exert efforts to delay the market entry of Mutual's product by initiating baseless anticompetitive litigation," said Richard H. Roberts, M.D., Ph.D., President and Chief Executive Officer of United Research Laboratories/Mutual Pharmaceutical Company.
See link for our letter to Adams: http://www.urlmutual.com/guaifenesin6.pdf See link for the Declaration of Dr. Brittain: http://www.urlmutual.com/guaifenesin7.pdf
A copy of all communications between Mutual and Adams regarding Mutual's ANDA filing for guaifenesin extended-release tablets is available at http://www.urlmutual.com/guaifenesin.htm.
About United Research Laboratories/Mutual Pharmaceutical Company
United Research Laboratories/Mutual Pharmaceutical Company is a leading national supplier of prescription pharmaceutical products. It manufactures and distributes one of the most extensive product lines in the generic industry and has a rapidly growing pipeline of generic and branded products. Since the company's inception in 1946, it has accumulated 274 abbreviated new drug application (ANDA) approvals and four new drug application (NDA) approvals from the U.S. Food & Drug Administration. The company's branded affiliate, AR Scientific, distributes the antibiotics Bactrim and Bactrim DS and the only FDA approved Quinine Sulfate product, Qualaquin(TM). URL/Mutual currently manufactures 2.4 billion tablets and capsules per year and has the capacity to manufacture 4.5 billion. URL/Mutual is a privately held, Philadelphia-based company that has had 6 years of growth in Revenue and EBITDA. 2005 Net Revenue was over $306 million and EBITDA over $100 million.
To learn more about URL/Mutual, they will be presenting at the 2006 UBS Global Lifesciences Conference in NYC on Sept. 28th.
For further information, please call 215-697-1900 for Richard P. Foster, Vice President, Marketing and Strategic Analysis, or visit http://www.urlmutual.com.
URL/Mutual Pharmaceutical Company, Inc.CONTACT: Richard P. Foster, Vice President, Marketing and StrategicAnalysis of URL/Mutual Pharmaceutical Company, Inc., +1-215-697-1900