August 1, 2011
FDA Tentatively Approves Intelliject’s Lead Product, E-CUE™
RICHMOND, Va. — August 1, 2011 — Intelliject, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company’s New Drug Application (NDA) for a novel epinephrine auto-injector, E-CUE™, for emergency treatment of allergic reactions including anaphylaxis.
The tentative approval of E-CUE™ following a first cycle, 10 month review by the FDA provides validation of Intelliject’s vision of developing patient-centric products and of the company’s ability to execute. According to Spencer Williamson, President and CEO of Intelliject, “E-CUE™’s tentative approval is another important step along our journey to empower patients living with serious medical conditions.”
Obtaining a tentative approval means that the product review is complete and the submission met the FDA’s requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved, specifically the current patent litigation brought against Intelliject by King Pharmaceuticals, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian). Final FDA approval is required before a product can be marketed in the United States.
Intelliject is confident that the pending patent disputes with King and Meridian will be favorably resolved and looks forward to obtaining final FDA approval and to E-CUE™’s subsequent availability.
Intelliject is a specialty pharmaceutical company dedicated to developing drug/device combination products that empower patients to gain freedom from their medical conditions. Each Intelliject product combines an established drug with an innovative delivery platform with the goal of achieving superiority, patient preference and cost effectiveness.
Intelliject applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable.
Intelliject is a privately-held company headquartered in Richmond, Virginia.
For online information please visit www.intelliject.com.
Anaphylaxis is a severe allergic reaction that involves a number of body systems and can be fatal within minutes. The American College of Allergy, Asthma and Immunology estimates there are up to 2,000 episodes of anaphylaxis per every 100,000 people in the U.S. each year, although the precise incidence of anaphylaxis is unknown and is likely underreported.
Anaphylaxis can occur in people with allergies to certain foods, insect stings, medications, latex or other allergens. All published national anaphylaxis guidelines recommend epinephrine as the first choice treatment in an acute episode. The vast majority of deaths from anaphylaxis occur in individuals who do not receive epinephrine in a timely manner.
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In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Intelliject’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. Some of these forward-looking statements may be identified by the use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Intelliject cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Intelliject undertakes no obligations to update or revise these statements, except as may be required by law.