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Lipocine issued several patents covering core technology platforms PDF Print E-mail


March 13, 2002

LIPOCINE ISSUED SEVERAL PATENTS COVERING CORE TECHNOLOGY PLATFORMS. SALT LAKE CITY, UT. MARCH 13, 2002.

Lipocine Inc. ("Lipocine") today announced that the United States Patent & Trademark Office has issued four patents covering its core technology platforms. These include Lipocine's two lead oral drug delivery platforms - Lip'ral for the optimal delivery of drugs with solubility problems and Hydroance for the enhanced absorption of drugs with permeability problems.

US 6,267,985 relates to compositions and methods for the improved delivery of hydrophobic and hydrophilic therapeutic agents; US 6,309,663 relates to compositions, systems, and methods for enhanced absorption of hydrophilic agents, such as peptides, proteins, cytokines, genetic material, oligonucleotides, polysaccharides; US 6,294,192 relates to compositions and methods for the improved delivery of hydrophobic agents; US 6,248,363 relates to solid compositions for the improved delivery of active ingredients. The series of patents entails more than 500 claims for respective composition and methods of use of Lipocine's core drug delivery technology platforms.

"This is both an exciting and an extraordinary milestone for Lipocine," said Dr. William I. Higuchi, Chairman of Lipocine's Board of Directors. "Using mostly safe lipid excipients already in the domain of commercially available products, Lipocine addresses solubility and absorption drug delivery challenges using systematic methodologies that optimally design disperse systems to achieve superior therapeutic objectives," Dr. Higuchi said.

"These are broad technology patents that address critical unmet drug delivery needs in the pharmaceutical and biotechnology industries," said Dr. Mahesh V. Patel, CEO and President of Lipocine. "This positions our technology platforms as key elements of proprietary product development for licensing/commercialization and partnering for product life cycle management. We now are a viable option for emerging companies with discovery focuses seeking to gain more formulation control' in product development," Dr. Patel said.

Lip'ral pertains to lipidic compositions for the optimal delivery of poorly water-soluble drugs. Low absorption/bioavailability and high variability typically seen with hydrophobic drugs are generally attributed to a combination of poor solubility/dissolution of drugs in the gastro-intestinal (GI) tract, inefficient presentation of the drug to the absorption site and the profound and highly variable influence of physiological factors such as food intake and GI pH on drug absorption. Unlike competing technologies, Lip'ral comprehensively addresses all challenges/aspects of poor absorption with respect to hydrophobic drugs.

Hydroance pertains to lipidic compositions for the optimal presentation of absorption promoters, in concert with the drug, to the absorption site for the optimal delivery of hydrophilic drugs. Unlike competing technologies, Hydroance uses bioacceptable (non NCE) materials and uses absorption promoters at levels in the domain of currently available products. NanosplodeTM pertains to compositions, dosage forms and processes for solids and rapid dispersion applications. LiIV (parenteral) pertains to lipidic compositions for superior drug loading and targeting of polyfunctional actives. MistocineTM pertains to fine lipidic sprayable compositions for transmucosal and other delivery routes.

About Lipocine

Lipocine Inc. is a leader in the design and development of oral, parenteral, inhalation, transmucosal and other innovative lipid-based products and technologies that address challenging drug delivery problems. These problems might include but are not limited to: solubility, stability, absorption, side effect, targeting, patient compliance, safety, interpatient variability, and bioacceptability of difficult to deliver, high-selling therapeutic compounds, including hydrophilic macromolecular, poorly water-soluble and/or biotechnology-based drugs.

Lipocine has several U.S. patents issued and numerous pending along with several product development partnerships with major multinational pharmaceutical companies. Lipocine has value-added products in the therapeutic areas of hormone replacement, cardiovascular/lipid management, immunomodulation and anti-thrombosis therapies under development and they are available for out-licensing or co-development partnering opportunities. Lipocine's unique technology platforms are Lip'ral, Hydroance, Nanosplode™, LiIV and Mistocine™. Lipocine is one of the leading drug delivery solution providers to the biotechnology industry. More information can be found at Lipocine's home page at: http://www.lipocine.com.

Source: Lipocine Inc. 350 W. 800 N., Suite 314 Salt Lake City, UT 84103 Phone: (801) 994-7383 Fax: (801) 994-7388

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