Lithera Receives Patent From the USPTO Protecting Methods of Use and Formulations for LIPO-202

SAN DIEGO, April 2, 2013 /PRNewswire/ -- Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, today announced significant advances in the patent estate covering LIPO-202 (Salmeterol Xinafoate for Injection), the company’s lead product candidate under development for localized, non-ablative reduction of subcutaneous fat.

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On March 26, 2013, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,404,750 to Lithera, Inc. for its patent application entitled, “Methods for Administration and Formulations for the Treatment of Regional Adipose Tissue.” The patent, which extends through at least 2030, provides broad method of use and formulation protection directed to the subcutaneous administration of long-acting beta2-adrenergic receptor agonists, including salmeterol xinafoate, alone and in combination with other agents, including glucocorticoids, when used for local fat reduction.

Separately, on February 27, 2013, Lithera received a Notice of Allowance from the USPTO for a patent application covering methods of use for long-acting beta2-adrenergic receptor agonists as a monotherapy or in combination with other agents in the treatment of fat accumulation and the reduction of adipose tissue in humans. This Notice of Allowance enhances a previously issued patent (U.S. Patent No. 7,829,554) directed to the use of a long-acting beta2-adrenergic receptor agonist and a glucocorticoid in combination for local fat reduction.

“Receiving these notices from the USPTO protecting LIPO-202 is a significant achievement for Lithera as it affirms the uniqueness of the drug’s use as we advance its clinical and eventual commercial development,” remarked George W. Mahaffey, President and CEO of Lithera. “Importantly, Lithera’s intellectual property now specifically protects the use of salmeterol and similar beta agonists as single agents for the aesthetic reduction of subcutaneous abdominal fat.”

LIPO-202 is currently the subject of a 500-patient, multi-center, randomized, placebo-controlled Phase 2b clinical trial (RESET) designed to measure the effects of three different doses of LIPO-202 on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects compared to placebo. Lithera expects to report top-line results from this study in the third quarter of 2013.

About Lithera:
Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both lifestyle and medical indications in aesthetic medicine and ophthalmology. Using FDA-registered drugs approved for use in other indications, Lithera’s products target and stimulate natural fat tissue metabolism to achieve non-ablative, non-surgical fat tissue reduction in specific locations. Our lead product candidate, LIPO-202 (Salmeterol Xinafoate for Injection), is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). LIPO-202 is currently under development for the aesthetic reduction of subcutaneous fat in the periumbilical area. LIPO-102 (Salmeterol Xinafoate and Fluticasone Propionate for Injection) is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (the thyroid condition is also known as Graves’ Disease). Founded in 2007, the Company has assembled an exceptional team of senior executives, employees and advisors and has been financed by top-tier venture capital firms. For more information on Lithera, Inc., please visit www.lithera.com.

Lithera, LIPO-102, LIPO-202 and the Lithera logo are trademarks or registered trademarks of Lithera, Inc. Other names and brands may be claimed as the property of others.

SOURCE Lithera, Inc.