Biodel receives notice of issuance for United States patent covering lead product candidates.Biodel, Inc. (Danbury, CT) announced the receipt of a notice of issuance from the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property for the company's patent encompassing VIAject and VIAtab, Biodel's two product candidates in clinical trials. The notice of issuance provides that United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Patent 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 technology and will protect our company's current clinical stage product candidates, VIAject and VIAtab," stated Dr. Solomon S. Steiner, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Biodel. "In addition, this patent represents a significant milestone in our strategy to build our intellectual property portfolio." VIAject is a rapid-acting injectable human insulin human insulin n. A protein that has the normal structure of insulin produced by the human pancreas but that is prepared by recombinant DNA techniques and by semisynthetic processes. intended for meal- time use by patients with Type 1 or Type 2 diabetes type 2 diabetes n. See diabetes mellitus. . In Phase I and Phase II clinical trials, VIAject 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 may be safer, require a lower dose and promote weight loss when compared to currently marketed meal-time insulins. VIAject is currently being tested in two pivotal Phase III clinical trials, which are comparing the effects of VIAject to Humulin R, the leading recombinant human insulin Noun 1. recombinant human insulin - a form of insulin (trade name Humulin) made from recombinant DNA that is identical to human insulin; used to treat diabetics who are allergic to preparations made from beef or pork insulin Humulin . VIAtab is a sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. tablet formulation of insulin, currently in Phase I clinical trials. VIAtab demonstrated encouraging safety and pharmacokinetic profiles in Phase I clinical testing. VIAdel technology allows for a more effective delivery of endocrine therapeutics as well as increased efficacy and safety. This patented technology is applicable to a wide range of peptides, proteins and other macromolecules Macromolecules A large molecule composed of thousands of atoms. Mentioned in: Gene Therapy macromolecules . Biodel's lead product candidates, VIAject and VIAtab for diabetes, utilize VIAdel technology. Additionally, Biodel is developing other therapies, such as VIAmass and VIAcal, to treat osteoporosis. All of Biodel's proprietary technologies and products have been developed in-house. Biodel is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel technology, which reformulates existing FDA-approved peptide drugs. The company's lead product candidate, VIAject, is a rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject is currently being tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab, a sublingual tablet formulation of insulin in Phase I clinical trials and two osteoporosis product candidates in pre-clinical studies. Biodel, Inc. +1-212-213-0006, www.biodel.com |
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