SAN DIEGO, March 7 /PRNewswire/ -- Verus Pharmaceuticals, Inc., a pediatric-oriented specialty pharmaceutical company, today announced study results supporting the potential need for two doses of epinephrine to treat anaphylaxis, a severe, life-threatening systemic allergic reaction. The study, “Factors Affecting the Use of Automatic Epinephrine Injectors,” was presented today as a poster session at the 2006 American Academy of Allergy, Asthma & Immunology Annual Meeting. According to the 100-person study, one third of patients experiencing an anaphylactic episode in the field required two epinephrine injections and 50% treated in an urgent care facility required two injections. Importantly, only 16% carried two epinephrine auto-injectors (two doses in total) at all times. Twinject(R), a novel epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions, is the only available product approved by the FDA that contains two doses of epinephrine in a single, compact device. Twinject was launched in the U.S. in August, 2005 after the study was completed.
“The need for two injections of epinephrine ranged from 33 to 50%, depending on the setting in which treatment was given,” said Phillip L. Lieberman, M.D., Clinical Professor of Medicine and Pediatrics in the Department of Medicine and Pediatrics, Divisions of Allergy and Immunology at the University of Tennessee Center for the Health Sciences, and co-author of the study. “We were surprised that only 16% of subjects always carried two doses of epinephrine. Other studies have demonstrated that more than one dose of epinephrine may be required in many situations to properly address the allergic reaction, with the second dose often needed within 5-10 minutes after the first. We hope that these findings will encourage all severe allergy sufferers to carry two doses of epinephrine at all times.”
The study was designed to assess the incidence of anaphylactic episodes requiring more than one injection of epinephrine and to assess the differences in perspective between adults experiencing anaphylactic episodes and the caregivers of children who suffer episodes. When asked about the overall level of concern in dealing with a potential episode, over 25% of caregivers were “very concerned” versus 9% of adults. Only 24% of adults had more than one epinephrine auto-injector potentially available for use, whereas 48% of caregivers had more than one; 84% of the respondents, however, did not carry a second auto-injector (with a second dose) with them at all times.
“This study adds to the rapidly growing body of evidence on the potential need for two doses to properly address this life-threatening condition,” said Robert W. Keith, President and Chief Operating Officer, Verus Pharmaceuticals. “It also clearly illustrates that most at-risk patients are not fully prepared at all times. As such, we are excited to be able to offer patients and caregivers a new option in Twinject, the only dual-dose epinephrine auto-injector available today.”
About Anaphylaxis
Anaphylaxis is a severe, life-threatening systemic allergic reaction triggered by exposure to one or more various antigens, including foods, insect stings, drugs, and latex products. Up to 43 million people in the U.S. alone are at risk for anaphylactic episodes, and underlying incidence rates are expected to continue increasing in future years. Up to eight percent of children have food allergies, with allergies to peanuts and tree nuts among children having doubled in the past five years. The timing, location, pattern (including onset, severity and length) and specific treatment requirements for each future episode cannot be predicted in advance. As such, all at-risk patients need to be fully prepared at all times for these unpredictable episodes.
About Twinject
Twinject Auto-Injector (epinephrine injection, USP 1:1000) is the only available product approved by the FDA that contains two doses of epinephrine in a single, compact device. This is an important feature, as published studies indicate that more than one dose of epinephrine may be required for one in three patients to properly address the allergic reaction, with the second dose often needed within 5-10 minutes after the first. More information about anaphylaxis and Twinject is available on the company’s Twinject website at www.twinject.com.
About Verus
Verus Pharmaceuticals is dedicated to improving the lives of children and those who care for them. Verus is building a portfolio of products for the unmet medical needs of children through acquisitions and alliances, with an initial focus on the treatment of asthma, allergies, and related diseases and conditions. Verus is differentiated by its pediatric orientation and its strong financial position and experienced management team, which allows the company to capitalize on an extensive network to build its product portfolio and pursue complementary transactions. The company’s rigorous, disciplined approach to strategic decision-making and core competencies in development and commercialization is expected to provide significant value to its partners. More information about Verus is available on the company’s corporate website at www.veruspharm.com.
Verus(TM) and Twinject(R) are trademarks of Verus Pharmaceuticals, Inc.
Forward-Looking Statements
Verus Pharmaceuticals cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Verus that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Verus’ business including, without limitation, statements about: its ability to identify appropriate acquisition, licensing, or co-development and/or promotion candidates in the future or be able to take advantage of the opportunities it identifies; difficulties or delays in developing, obtaining regulatory approval, manufacturing and commercializing its products; unexpected performance or side effects of its products that could delay or prevent development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and Verus undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Company Contact: Media Contact: Robert W. Keith Kathy W. Sweeney President and Chief Operating Officer Mentus Verus Pharmaceuticals, Inc. 858-455-5500, x230 858-436-1615 kwitz@mentus.comrkeith@veruspharm.com
Verus Pharmaceuticals, Inc.
CONTACT: Robert W. Keith, President and Chief Operating Officer of VerusPharmaceuticals, Inc., +1-858-436-1615, rkeith@veruspharm.com; or Media,Kathy W. Sweeney of Mentus, +1-858-455-5500, ext. 230, kwitz@mentus.com,for Verus Pharmaceuticals, Inc.
