Aegis Therapeutics, LLC and Dr. Reddy’s Laboratories recently announced a partnership providing Dr. Reddy’s access to Aegis’ Intravail drug delivery technology for certain undisclosed therapeutics currently being marketed with annual worldwide sales in excess of US $1 billion. Financial terms were not disclosed.

“We are extremely pleased to be working with Aegis and gaining access to their patented Intravail drug delivery technologies,” said Raghav Chari, Senior Vice President, Proprietary Products business, Dr. Reddy’s. “The results of successful human studies completed to date will provide a unique product offering, satisfying a significant unmet need in the market. We hope this will continue to provide affordable and innovative medicines to a much wider population.”

“Dr. Reddy’s has a worldwide reputation for developing innovative, high-quality branded pharmaceuticals,” added Edward T. Maggio, Chief Executive Office, Aegis Therapeutics. “We are pleased to be working with Dr. Reddy’s on this exciting application of our technology, another significant milestone in Aegis’ commercialization strategy.”

The products under the exclusive license agreement will be developed, manufactured, and marketed worldwide by Dr. Reddy’s.

Aegis also recently announced that Zelos Therapeutics, Inc. has initiated dosing in a 7-day clinical study of a nasal spray formulation of ZT-034 (teriparatide) that is being developed in collaboration. 

Nasal spray ZT-034 is being developed as an alternative to Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]), which generated approximately $800 million in annual sales in 2009 for the treatment of osteoporosis and is administered by daily injection. Non-injectable formulations, such as nasal spray ZT-034 could expand the market for parathyroid hormone (PTH) analogs to considerably more than $1 billion.  The study design will include a Forteo treatment arm to provide an initial comparison with the marketed product.

“PTH analogs, such as teriparatide, are an important but underutilized therapeutic option for osteoporotic patients at high risk of fracture,” said Dr. Brian MacDonald, CEO of Zelos Therapeutics. “We believe that formulation of teriparatide as a nasal spray with comparable efficacy and safety to Forteo represents a simple, convenient approach to dosing that will make PTH therapy a better option for many more patients.”

Nasal spray ZT-034 is formulated with Aegis Therapeutics’ proprietary agent Intravail to create a stable solution of teriparatide and enhance absorption of the peptide across the nasal mucosal surface. 

“We are pleased to be working with Zelos on this important application of our drug delivery technology,” commented Dr. Maggio. “Intravail has produced dramatic increases in intranasal bioavailability for many peptides and other difficult-to-deliver therapeutics in a simple, well-tolerated method of delivering peptides without an injection.”

Zelos Therapeutics plans to develop nasal spray ZT-034 under the 505(b)(2) regulatory pathway that was included in the Federal Food, Drug and Cosmetic Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).  

Zelos Therapeutics specializes in the development of innovative treatments for bone disorders and related indications in large, underserved markets. Led by an experienced team of biopharmaceutical executives and funded by leading healthcare investors, Zelos Therapeutics is advancing a portfolio of product opportunities into late-stage clinical development. 

Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses to pharmaceutical and biotechnology companies, including F. Hoffmann-La Roche, Dr. Reddy’s Laboratories, Nerveda, and Zelos Therapeutics, in addition to a number of undisclosed pharmaceutical and biotechnology partners. Its patented Intravail drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide, and non-peptide macromolecular and small molecule therapeutics via the intranasal administration route with exceptionally high and unmatched bioavailability that can currently only be achieved by injection.

Intravail has also been successfully applied to buccal, oral, and rectal administration of both small molecule and peptidic drugs. The company’s patented ProTek technology allows creation of proprietary, easily manufacturable, and stable aqueous or lyophilized dosage forms that maintain the integrity and physiological activity of many protein and peptide therapeutics. ProTek technology is applicable to injectable, intranasal, and other dosage forms.