Healthcare Industry News:  Novo Nordisk 

Biopharmaceuticals Gastroenterology Surgery Licensing

 News Release - September 19, 2006

Sapphire Therapeutics, Inc. Licenses Ghrelin Mimetic From Novo Nordisk

Ipamorelin to Enter Phase II for Postoperative Ileus

BRIDGEWATER, NJ--(Healthcare Sales & Marketing Network)--Sep 19, 2006 -- Sapphire Therapeutics, Inc., a private biopharmaceutical company that inlicenses compounds acting within the ghrelin pathway and develops them as treatments for metabolic and oncologic diseases, has licensed a highly potent and selective small-molecule ghrelin mimetic, ipamorelin, from Novo Nordisk.

The first indication for which Sapphire is developing ipamorelin is postoperative ileus (POI), the slowing or stopping of intestinal movement that frequently occurs after surgery. Ipamorelin has already demonstrated a good safety and tolerability profile in Phase I clinical studies conducted by Novo Nordisk. No financial terms of the licensing arrangement were disclosed.

"Ipamorelin was the first, and most selective, in an interesting series of peptides our scientists discovered at Novo Nordisk in a medicinal chemistry program exploring growth hormone secretagogues (GHS)," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "Given the extensive research on GHS and ghrelin, the endogenous ligand, as potential therapeutics in the years since, we are delighted that Sapphire will be carrying this promising compound forward, further deepening the ongoing successful collaboration between our companies."

"Licensing such a promising molecule as ipamorelin augments Sapphire's development pipeline of compounds active within the ghrelin pathway," said William J. Polvino, MD, executive vice president for Sapphire. "We are planning a Phase II study in postoperative ileus and believe ipamorelin may also be effective for treating other gastrointestinal motility disorders, such as diabetic gastroparesis."

About Ipamorelin

Ipamorelin is a small-molecule ghrelin mimetic, the first in a class of growth hormone-releasing peptides (GHRP), synthetic growth hormone secretagogues (GHS) that bind to key control points for growth, appetite and gastric motility. Research with GHRPs led to the isolation of the first naturally occurring GHS, ghrelin, a "hunger hormone" secreted by stomach cells.

Exploratory studies in humans demonstrated that ghrelin infusions increased gastric emptying in normal volunteers and in patients with idiopathic or diabetic gastroparesis. However, ghrelin is an unstable lipid-peptide molecule with a pharmacokinetic half-life of about ten minutes, and thus is not an optimal drug candidate.

In contrast, ipamorelin demonstrates a more sustained half-life in humans. Ipamorelin has been shown to be both highly potent and very selective in vivo, and has also demonstrated good safety and tolerability in human clinical studies.

About Postoperative Ileus (POI)

POI is the temporary disruption of gastrointestinal motility experienced by patients following surgery. POI is generally most severe after open abdominal surgery and manipulation of the GI tract, and least severe after minimally invasive procedures. Nevertheless, most patients experience some delay before normal GI function resumes.

Symptoms include slowed or no movement of gas or stool, often accompanied by abdominal pain and distention, nausea or vomiting. In prolonged cases (i.e., three or more days without flatus or bowel movement), POI inhibits oral feeding, putting nutritional stress on an already stressed patient and increasing the risk of complications such as infections and pulmonary distress. Moreover, practices such as administration of opioid analgesics exacerbate POI.

Currently available options for managing POI are considered marginally effective and there is no generally accepted patient management strategy for POI. Ipamorelin may be a new therapeutic to help fill this unmet medical need.

About Sapphire Therapeutics

Sapphire is a private biopharmaceutical company that inlicenses and develops promising small-molecule drug candidates to treat metabolic and oncologic diseases for which existing therapies are limited or marginally effective. Sapphire's pipeline consists of first-in-class, composition-of-matter protected compounds acting within the ghrelin pathway. The furthest advanced is RC-1291, currently in Phase II development, with FDA fast-track designation, in cancer patients with anorexia/cachexia syndrome, a common, life-threatening complication of malignant disease. In addition to ipamorelin, the company has another ghrelin mimetic in preclinical development.

For more information, please visit Sapphire Therapeutics' web site at

Source: Sapphire Therapeutics

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