IDEV » Topics » OCTREOTIDE IMPLANT

This excerpt taken from the IDEV 10-K filed Dec 11, 2008.

OCTREOTIDE IMPLANT

General. We obtained the octreotide implant through our acquisition of Valera. Our octreotide implant is a soft, flexible 6-month hydrogel implant based on our patented HYDRON Polymer Technology that delivers octreotide, a somatostatin analogue, to reduce growth hormone (“GH”) and insulin-like growth factor (“IGF-1”) levels in patients with acromegaly.

Acromegaly is a chronic hormonal disorder that occurs when a pituitary tumor produces excess growth hormone. It most commonly affects middle-aged adults, and if untreated, causes enlargement of certain bones, cartilage, muscles, organs and other tissue, leading to serious illness and potential premature death.

Octreotide is also approved to treat the symptoms associated with metastatic carcinoid tumors and vasoactive intestinal peptide secreting adenomas, which are gastrointestinal tumors.

 

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Development and Commercialization. In 2004, Valera initiated and completed a Phase I/II pharmacokinetic clinical trial with eleven patients with acromegaly. The trial was designed to evaluate the release characteristics of the octreotide implant and to examine safety and efficacy parameters. The endpoints achieved in the trial were the reductions in GH and IGF-1 levels in the blood in these patients. During the trial, side effects included diarrhea, low blood sugar and implant site reactions.

In November 2007, we announced positive results from a Phase II clinical trial of the octreotide implant. The trial was an open-label study designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre-hydrated and non-hydrated octreotide implants and evaluated the suppression of growth hormones (“GH”) and insulin-like growth factor 1 (“IGF-1”). The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5 ng/mL on entry into the study indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH in 94% of patients. Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achieved suppression to <2.5 ng/mL. The trial also confirmed by pharmacokinetic analysis that there was no difference in the predictable, steady release of octreotide from either the pre-hydrated or non-hydrated octreotide implant. All patients enrolled completed the six month trial and there were no serious or severe adverse events reported. We announced the initiation of a Phase III trial on September 30, 2008. Approximately 34 clinical sites in six countries are participating in this trial. Participants in the open-label trial will be randomized in a 3:1 ratio to either the octreotide implant or month injections of Sandosatatin® LAR® (“S-LAR”). The trial is expected to recruit approximately 140 patients in the U.S. and Europe. Patients must be known responders, having well-maintained GH and IGF-1 levels, to somatostatin analogues. The primary efficacy endpoint of this trial is the suppression of GH and IGF-1. If approved, we intend to commercialize the octreotide implant in the U.S. utilizing our specialty sales force primarily to endocrinologists and medical oncologists. We are seeking partners for commercialization in territories outside the United States.

This excerpt taken from the IDEV 10-K filed Dec 12, 2007.

OCTREOTIDE IMPLANT

General. We obtained the octreotide implant through our acquisition of Valera. Our octreotide implant is a soft, flexible 6-month hydrogel implant based on our patented Hydron Technology that delivers octreotide, a somatostatin analogue, to reduce growth hormone (GH) and insulin-like growth factor (IGF-1) levels in patients with acromegaly.

Acromegaly is a chronic hormonal disorder that occurs when a pituitary tumor produces excess growth hormone. It most commonly affects middle-aged adults, and if untreated, causes enlargement of certain bones, cartilage, muscles, organs and other tissue, leading to serious illness and potential premature death.

Octreotide is also approved to treat the symptoms associated with metastatic carcinoid tumors and vasoactive intestinal peptide secreting adenomas, which are gastrointestinal tumors.

Development Program. In November 2007, we announced positive results from a Phase II clinical trial of the octreotide implant. The trial was an open-label study designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre-hydrated and non-hydrated octreotide implants and evaluated the suppression of growth hormones (GH) and insulin-like growth factor 1 (IGF-1). The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5 ng/mL on entry into the study indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH in 94% of patients. Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achieved suppression to <2.5 ng/mL. The trial also confirmed by pharmacokinetic analysis that there was no difference in the predictable, steady release of octreotide from either the pre-hydrated or non-hydrated octreotide implant. All patients enrolled completed the six month trial and there were no serious or severe adverse events reported.

In 2004, Valera initiated and completed a Phase I/II pharmacokinetic clinical trial with eleven patients with acromegaly. The trial was designed to evaluate the release characteristics of the octreotide implant and to examine safety and efficacy parameters. The endpoints achieved in the trial were the reductions in GH and IGF-1 levels in the blood in these patients. During the trial, side effects included diarrhea, low blood sugar and implant site reactions.

We anticipate initiating our Phase III program in 2008 utilizing the non-hydrated octreotide implant. If approved, we intend to commercialize the octreotide implant in the U.S. utilizing our specialty sales force primarily to endocrinologists. We intend to seek partners for commercialization in territories outside the U.S.

 

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EXCERPTS ON THIS PAGE:

10-K
Dec 11, 2008
10-K
Dec 12, 2007
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