Oral Bioavailability of Octreotide Using Aegis Therapeutics, LLC’ Intravail(R) Formulation Technology Surpasses That Obtained by Injection

SAN DIEGO, CA--(Marketwire - April 13, 2011) -

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Scientists at Albany Medical College and Aegis Therapeutics report that oral delivery of the peptide drug octreotide, in the presence of the absorption enhancer Intravail®, achieves systemic bioavailability that exceeds that achieved by subcutaneous injection. This second example of unsurpassed oral bioavailability of a peptide drug is reported in the scientific journal Regulatory Peptides*. In an earlier study published in June, 2010, scientists at Albany Medical College reported that oral administration of the novel anti-obesity/anti-diabetic peptide D-Leu-OB3, developed and patented by Albany Medical College, resulted in systemic bioavailability in excess of 50% compared to subcutaneous injection when administered using Aegis' Intravail® formulation technology. In contrast, published studies using alternative oral absorption enhancers typically report less than 5%, and often less than 1%, systemic bioavailability compared to injection.

Octreotide is a peptide drug currently administered by injection for treatment of acromegaly and serious symptoms of carcinoid and VIP-secreting tumors. The results of this latest study indicate that oral delivery of octreotide in Intravail® may have significant potential as a novel, non-invasive treatment alternative to both short-acting and depot injectable formulations of octreotide, providing greater patient comfort and convenience and elimination of needle-stick injuries and associated medical waste disposal concerns. Octreotide is currently marketed as an injectable product by a number of companies and aggregate sales exceed $ 1 billion annually.

This study highlights the extension of the use of Intravail® beyond earlier published studies describing non-invasive delivery of peptides via metered nasal spray delivery where Intravail® has been shown to be highly effective for non-invasive delivery of a number of peptides including insulin, PTH (parathyroid hormone) 1-34, calcitonin, beta interferon (both Rebif® and Betaseron®), human growth hormone, and GLP-1 analogs such as exendin-4 (Byetta®) and liraglutide (Victoza®), and [DLeu-4]-OB3, as well as a number of poorly absorbed small molecule drugs. To date, nine human trials have been conducted or are currently underway for these or other undisclosed applications.

About Aegis Therapeutics
Aegis Therapeutics commercializes its patented drug delivery and drug formulation technologies through product specific licenses. Our Intravail® technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection with exceptionally high and unmatched bioavailability. Our ProTek® technology provides proprietary, easily manufacturable, aqueous dosage forms that are stable at elevated temperature and that reduce unwanted immunogenicity of many protein and peptide therapeutics. http://www.aegisthera.com/

About Albany Medical College
Albany Medical College, one of the nation's oldest medical schools, is part of Albany Medical Center, which also includes the Albany Medical Center Hospital, one of upstate New York's largest teaching hospitals, and the Albany Medical Center Foundation, Inc., one of the Capital Region's most active fundraising organizations. The institution has a three-fold mission of patient care, biomedical research and medical education.

*Maggio, E and Grasso, P, Regulatory Peptides 167 (2011) 233-238, Oral delivery of octreotide acetate in Intravail® improves uptake, half-life, and bioavailability over subcutaneous administration in male Swiss Webster mice

Rebif®, Betaseron®, Byetta®, Victoza® and Intravail® are registered trademarks of Serono, Inc., Bayer Healthcare, Amylin Corp. Novartis Corp. and Aegis Therapeutics LLC, respectively.