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Nasulin is the patented intranasal insulin spray of CPEX which incorporates
CPE-215 as a permeation facilitator that addresses the need for an insulin
product that more closely resembles the body’s normal physiological response
and provides a more patient-friendly delivery method. These potential benefits
could reshape the insulin market. In general, drugs delivered via the nasal
cavity have the potential to be readily absorbed across the highly vascularized
nasal mucosa and directly into the circulatory system, thereby avoiding
first-pass metabolism in the liver. The speed of absorption affords a faster
onset of action compared to the most rapid-acting, injectable insulin
formulations. A series of studies have confirmed that Nasulin delivers insulin
quickly through the nasal mucosa, even more rapidly than subcutaneous injection.
According the 2007 prevalence data released by the United States Centers
for Disease Control and Prevention, or CDC, approximately 24 million people in
the United States, or 8% of the population, suffer from diabetes. A study
published by Diabetes Care in 2006 projects that the number of diagnosed
diabetics in the U.S. will reach 48.3 million by 2050 due to an aging population,
rising obesity rates and poor health habits. Prescription trends show a preference
for combining rapid-acting injections during mealtimes with a once daily basal
insulin injection. Due to the time-action profiles of the rapid-acting mealtime
injectable insulins, patients are at increased risk for hypoglycemic events and
for gaining weight. The ultra-rapid time-action profile of Nasulin has the
potential to reduce the risk of hypoglycemic events and of weight gain. In
addition, because Nasulin delivers needle-free insulin, it has the potential to
improve the acceptability of mealtime insulin among patients with diabetes and
has the potential to improve adherence to insulin treatment regimens.
Nasulin is currently in Phase 2 clinical trials and is being developed for the
treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes. We believe
an intranasal route of administration will yield an ultra-rapid time action profile
which will reduce hyperglycemia with less risk of hypoglycemia and weight gain. In
addition, this needle-free route of delivery avoids the potential pulmonary
disadvantages of competitive candidates that use an inhalation route of
administration. Our expectation is to finish key efficacy Phase 2 trials in patients
with Type 2 diabetes in 2011 while simultaneously seeking a pharmaceutical partner
to support Phase 3 clinical trials and product commercialization upon regulatory
approval. While the terms of any future alliance will be determined through
negotiation, we would look to license the product in return for upfront payments,
milestones and royalties that reflect our research investment, innovation and
potential market size.
For additional information (abstracts, poster
reprints and published articles) relating to Nasulin, CLICK HERE. |
