Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, and Tarix Pharmaceuticals, a clinical stage biopharmaceutical company, have entered into a definitive licensing agreement to develop an oral formulation of TXA127, Tarix’s lead peptide drug candidate.

The oral formulation of TXA127 is being developed jointly by Unigene and Tarix under a previously agreed upon feasibility program whereby the companies leveraged Unigene’s Peptelligence technology platform to enable enhanced oral delivery of TXA127.

According to terms of the licensing agreement, Tarix will have an exclusive worldwide license to Unigene’s Peptelligence technology covering the use of that technology with Angiotensin (1-7), the pharmaceutical ingredient in TXA127, as well as its functional equivalents, analogues or derivatives. In return for the license, Tarix will pay Unigene a percentage of revenues, if any, derived from the direct sales of any oral dose form of an approved Angiotensin (1-7) product by Tarix or from any up-front, milestone or royalties received by Tarix from a third-party sub-licensee of Unigene’s Peptelligence technology with respect to any Angiotensin (1-7) product. There is no upfront payment being made by Tarix to Unigene in connection with the execution of the license.

Ashleigh Palmer, Unigene’s chief executive officer, commented, “Our licensing agreement with Tarix is further validation of the strength of Unigene’s Peptelligence platform and the tremendous value that our feasibility programme offers to innovators in the therapeutic peptide field. We are very excited to extend our feasibility partnership with Tarix into a fully-fledged licensing agreement and to work with Dr. Franklin and his company’s scientific team to advance the development of what we all agree is a potentially groundbreaking drug.”

Rick Franklin, chief executive officer of Tarix, commented, “TXA127 has always been a high-value opportunity, given its potential to treat multiple therapeutic conditions. However, our ability to potentially deliver TXA127 orally will significantly enhance its transactability with prospective advanced-stage development partners and serves to greatly differentiate it from other peptide-based drugs. Based on our experience, Unigene’s Peptelligence technology and feasibility program offer the potential to truly transform the therapeutic peptide market.”

In September, data from a feasibility study of TXA127 demonstrated that the oral formulation produced extremely high exposure in the blood that resulted in a several-fold increase in bioavailability as compared to the oral delivery of the unformulated drug, and was equal to or greater than that achieved by the current subcutaneous formulation.

TXA127 is a pharmaceutical formulation of the naturally occurring peptide, Angiotensin (1-7). Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation, stroke recovery, peripheral vascular disease and diabetes. TXA127 has been granted orphan drug status by the US Food and Drug Administration (FDA) as a treatment for pulmonary arterial hypertension, to enhance engraftment in patients receiving a stem cell transplant, and for Myelodysplastic Syndrome (MDS). Tarix is developing a related peptide, PanCyte, for stroke and diabetes.