The notice of issuance provides that U.S. Patent No. 7,279,457 will issue on October 9, 2007. The patent will expire in January 2026.
"This patent validates Biodel's proprietary rights in our VIAdel(TM) technology and will protect our company's current clinical stage product candidates, VIAject(TM) and VIAtab(TM)," stated Dr. Solomon S. Steiner, Chairman and CEO of Biodel. "In addition, this patent represents a significant milestone in our strategy to build our intellectual property portfolio."
VIAject(TM) is a rapid-acting injectable human insulin intended for meal- time use by patients with Type 1 or Type 2 diabetes. In Phase I and Phase II clinical trials, VIAject(TM) has been shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs. As a result, VIAject(TM) may be safer, require a lower dose and promote weight loss when compared to currently marketed meal-time insulins. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials, which are comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.
VIAtab(TM) is a sublingual tablet formulation of insulin, currently in Phase I clinical trials. VIAtab(TM) demonstrated encouraging safety and pharmacokinetic profiles in Phase I clinical testing.
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The medical community should insist that we invest the resources needed to do trials that ascertain the effect of interventions on patient-important outcomes, the authors state. This policy will prevent the premature dissemination of therapies that ultimately prove harmful, facilitate patients' participation in decision making, and speed the day when we can confidently offer safe treatments that can provide important benefit to patients with diabetes.
In summary, the authors say:
Diabetes medications have been approved without requiring proof of reducing the risk of complications associated with diabetes, such as heart attack, stroke, amputation, blindness and kidney dialysis. The majority of diabetes trials focus on the ability of medications to reduce blood sugar, not on outcomes that matter to patients. Diabetes medications may reduce the risk of complications, but we do not know this with confidence. The focus should shift from getting new drugs to market to testing the effect of diabetes medications against outcomes important to patients.
Dr. Montori is a lead investigator with the Knowledge and Encounter Research Unit at Mayo Clinic. His research team seeks to improve the care and outcomes of patients with diabetes by studying ways to promote health care decisions that are more consistent with research findings and the values and preferences of informed patients.
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