PHILADELPHIA, Aug. 18 /PRNewswire/ -- United Research Laboratories and Mutual Pharmaceutical Company today announce that Mutual has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), seeking approval to market Mutual’s guaifenesin extended-release tablets, 600 mg and 1200 mg. Guaifenesin extended-release tablets are currently marketed over-the-counter by Adams Respiratory Therapeutics under the brand name Mucinex(R). According to Adams, Mucinex(R) is one of the most widely recommended OTC products to treat chest congestion and related coughs.
On August 9, 2006, FDA determined that Mutual’s guaifenesin extended-release ANDA passed FDA’s rigorous criteria for accepting an ANDA for filing, which includes a determination that Mutual has submitted thorough bioequivalence and stability studies. A copy of FDA’s communication regarding this matter is available at http://www.urlmutual.com/guaifenesin.pdf. Mutual provided a copy of this communication and other related materials to Adams on August 11, 2006.
Mutual firmly believes that its guaifenesin extended-release tablets are bioequivalent to Mucinex(R) under the applicable standards set forth in the Hatch-Waxman regulatory provisions. During an investor conference call this morning, Adams claimed that its New Drug Application for Mucinex(R) was required to meet a more rigorous bioequivalence standard but provided no support for this assertion. Even if a higher standard was applied to Adams’ product, however, the only reason for doing so would be because Adams was required to demonstrate that its new product was safe and effective. Because it is seeking approval for a generic product, Mutual is only required to demonstrate that its tablets are bioequivalent and pharmaceutically equivalent to Mucinex(R) under the typical standards employed under the Hatch-Waxman provisions. FDA applies the Hatch-Waxman standard to generic products and has rejected attempts by brand companies to apply new bioequivalency requirements to generic products. There is no reason to believe that the same generic standards will not be applied to guaifenesin extended-release tablets, which are safe enough for patients to use without a doctor’s prescription.
Adams’ patents unquestionably do not prohibit Mutual from marketing its guaifenesin extended-release tablets. In fact, Mutual was marketing an identical formulation to its proposed 600 mg product more than one year before the filing of the first Adams patent, on April 28, 2000. Mutual’s proposed 1200 mg tablets are dose-proportional to these 600 mg tablets. As such, either Adams’ patents do not cover Mutual’s guaifenesin extended-release tablets or those patents are invalid. In fact, on August 11, 2006, Mutual shared this information with Adams and provided documentary proof of these prior sales in a good faith effort to demonstrate that Adams’ patent claims were baseless and that Adams should not attempt to delay Mutual’s market entry with frivolous actions. Mutual supplied Adams with the manufacturing records for the ANDA and the manufacturing and sales records for its earlier product, which demonstrate that this product was manufactured and sold years before Adams’ patent filing date. In the investor conference call today, Adams’ CEO acknowledged that Mutual’s guaifenesin extended-release tablets employed “older, well-known matrix technology” and effectively conceded that Adams’ patents could not cover Mutual’s guaifenesin extended-release tablets.
Moreover, Adams’ patents are solely directed towards a bi-layer tablet. Mutual’s guaifenesin extended-release tablets, however, contain a homogenous mixture of guaifenesin and certain excipients. There are no layers in Mutual’s tablet and certainly not two layers as required in the patent. Mutual provided copies of its master formula to Adams showing that there are not two layers. Mutual’s guaifenesin tablets cannot, therefore, infringe Adams’ patents. Should Adams file a patent infringement suit against Mutual, Mutual expects to prevail in such a lawsuit on a summary judgment motion.
During today’s conference call, Adams’ CEO further stated that an unspecified company has petitioned the Patent & Trademark Office to reexamine the validity of one of Adams’ patents. Mutual did not file this petition because Adams’ patents clearly do not cover Mutual’s guaifenesin extended-release tablets and, accordingly, Mutual had no reason to pursue such a strategy.
Any patent litigation initiated by Adams against Mutual would be objectively baseless and would merely constitute an attempt to delay the market entry of Mutual’s product. Such delay would result in considerable harm to competition, to consumers and to Mutual, and would violate federal and state antitrust and unfair competition laws. Mutual will aggressively defend against any patent claims filed by Adams, and will also vigorously pursue all available remedies under the antitrust and unfair competition laws, including treble damages potentially amounting to tens of millions of dollars or more. Because a lawsuit against Mutual would be anticompetitive, Mutual will immediately bring such litigation to the attention of the Federal Trade Commission and state attorneys general and request a full investigation of Adams’ conduct.
Mutual is pursuing a broad-based guaifenesin strategy that will result in either extremely low-priced generic entry or a deal with a large OTC pharma company. Mutual can launch its guaifenesin extended-release tablets as generic products and price these products aggressively in order to obtain a significant market share. On the other hand, Mutual is in discussions with several of the largest OTC pharma companies in the country about their possible interest in launching guaifenesin extended-release tablets as branded products. Mutual also is aggressively pursuing the development of a line of guaifenesin combination products (such as with pseudoephedrine or dextromethorphan). Like its guaifenesin extended-release tablets, Mutual is highly optimistic about the prospects for expeditious filings with FDA and prompt FDA approval.
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, it has accumulated 250 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. The company is privately-held and headquartered in Philadelphia. URL/Mutual is a privately held 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. 25th to 28th.
United Research Laboratories and Mutual Pharmaceutical Company
CONTACT: Richard P. Foster, Vice President, Marketing and StrategicAnalysis of United Research Laboratories and Mutual Pharmaceutical Company,+1-215-697-1900
