Oral Human Growth Hormone
In September 2004, Emisphere entered into a licensing agreement with Novartis AG to develop an oral formulation of recombinant human growth hormone (rhGH), a hormone which stimulates muscle and bone growth in children and maintains muscle and bone quality in adults.
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.
Under the terms of the agreement, Emisphere will work with Novartis to initiate clinical trials of a convenient, oral growth hormone product using its eligen® technology. Novartis will fully fund the program including clinical studies. Emisphere will receive up to $34 million during the course of product development, and a royalty increasing to double-digit rates based upon sales. During the first year, Emisphere could receive up to $6 million.
In May 2006, Novartis Pharma AG has notified
Emisphere that Novartis Pharma AG will initiate the
development of an oral human growth hormone (rhGH)
product using Emisphere's eligen®
delivery technology. Emisphere is entitled to a $5
million development commencement milestone payment
as a result of the Novartis Pharma AG decision to
proceed with product development.
Novartis Pharma AG notified Emisphere that it had
initiated a multidose study in growth
hormone-deficient adults with the oral formulation
of rhGH in Q1 this year. Once finished, the results
of the trial will be communicated in an appropriate
and timely manner.
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