Emisphere Technologies Inc has entered into a licensing agreement with Novartis Pharma AG to develop an oral formulation of recombinant human growth hormone (rhGH).

The companies formed the agreement following successful completion of pre-clinical feasibility studies for rhGH with Emisphere's eligen technology. Emisphere has identified delivery agents that can deliver therapeutically sufficient levels of rhGH to the blood stream when administered orally. The lead carrier for rhGH has completed extensive formulation and preclinical safety studies.

Under the terms of the new agreement, Novartis will pay Emisphere up to $34 million during the course of product development, and a royalty increasing to double-digit rates based upon sales. Including the initial payment, Emisphere could receive up to $6 million over the course of the next year.

Emisphere will work with Novartis to initiate clinical trials of a convenient, oral human growth hormone product using its eligen technology. Novartis will fully fund the program including all clinical studies, a company release says.

This collaboration marks the second between the two companies. In 2000 Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoporosis.

Michael M Goldberg, chairman and CEO, Emisphere Technologies Inc, commented, "We are extremely pleased to expand on our successful relationship with Novartis. This new agreement again demonstrates the technical expertise contained within Emisphere and the value of our eligen technology."

Emisphere's oral drug delivery technology platform, known as the eligen technology, is based on the use of proprietary, synthetic chemical compounds, known as Emisphere delivery agents, or "carriers". These molecules facilitate or enable the transport of the therapeutic macromolecules across biological membranes such as those of the gastrointestinal tract, and exert their desired pharmacological effect. Emisphere's eligen technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity, the release added.