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Twinject Press Release
Company Contact:    
Robert W. Keith    
President and Chief Operating Officer    
Verus Pharmaceuticals, Inc.    
858-436-1615    
rkeith@veruspharm.com    
     
Media Contact:    
Kathy W. Sweeney    
Mentus    
858-455-5500, x230    
kwitz@mentus.com    

 

 
Verus Pharmaceuticals Announces Acquisition of Twinject for Anaphylaxis

SAN DIEGO – July 6, 2005 – Verus Pharmaceuticals, Inc., a pediatric-oriented company dedicated to identifying, developing and delivering solutions to address the unmet medical needs of children and those who care for them, today announced it has acquired exclusive, worldwide rights to Twinject® from Hollister-Stier Laboratories LLC. Twinject, a novel epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis), was approved by the U.S. Food and Drug Administration (FDA) in 2003; two dosages are now approved for self-administration (0.3 mg and 0.15 mg). In addition to Twinject, Verus has acquired rights to other intellectual property and assets, including complementary and next generation device designs and on-going development programs.

“There are significant unmet medical needs for those individuals at risk for anaphylaxis and, unfortunately, no advancements in self-administered treatment options have been commercialized in the U.S. since the early 1980s,” said Robert W. Keith, President and Chief Operating Officer of Verus. “Twinject is the first and only product approved by the FDA that contains two doses of epinephrine in a single device. This is an important feature of Twinject, as published 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 dose. As such, we are eager to bring this novel product line to market and are committed to working closely with patients, caregivers, and advocacy groups to develop additional products that address other unmet medical needs for those at risk.”

“The acquisition of Twinject allows Verus the opportunity to establish a leadership position in an attractive, high growth market,” said Todd C. Davis of Paul Royalty Fund. “We look forward to working with the Verus management team to launch Twinject and to build a comprehensive anaphylaxis franchise on a global basis.”

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 anaphylactic episode cannot be predicted in advance.

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 website at www.veruspharm.com

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.

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IMPORTANT SAFETY INFORMATION ABOUT TWINJECT: Twinject is indicated in the emergency treatment of severe allergic reaction (type I) including anaphylaxis to stinging insects and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substance or exercise-induced anaphylaxis.

Since the dose of epinephrine delivered from Twinject 0.15 mg is fixed at 0.15 mg, the physician should consider other forms of injectable epinephrine if doses lower than 0.15 mg are felt to be necessary (eg, patients who weigh less than 15 kilograms [approximately 33 pounds]).

Twinject should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. DO NOT INJECT INTRAVENOUSLY.

Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute life-threatening situation. Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.

Twinject is designed as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care. Please see complete prescribing information for more details.