Regulatory Filings • Oct 13, 2010
Regulatory Filings
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Company release No 21/2010
| Hørsholm 13 October 2010 |
ALK's new and improved adrenaline pen, JEXT®, approved in Europe |
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| Page 1/2 | Summary: The European competent authorities for medicinal products have just approved ALK's new adrenaline pen, JEXT® , for emergency treatment of severe acute allergic reactions. In the months ahead, ALK expects to launch JEXT® on the first European markets as a substitute for the company's existing inlicensed product. |
As announced on 7 October 2010, ALK has developed a new and improved adrenaline auto-injector called JEXT® . The competent authorities for medicinal products in 17 European countries have just approved JEXT® for the emergency treatment of severe acute allergic reactions (anaphylaxis) caused by, for example, foods or bee stings. The approval has been obtained by means of the European authorities' Decentralised Procedure. Following this approval, the national authorities will issue formal marketing authorisations. This is expected to happen in the near future.
JEXT® is expected to be available on the first European markets on 1 January 2011. ALK holds the global product rights and is planning to expand its geographical presence with adrenaline products considerably. Furthermore, with the introduction of JEXT® , ALK expects to improve the company's gross margin and substantially improve earnings from the business area within the next few years.
Jens Bager President and CEO
Contact: Jens Bager, President and CEO, tel. (+45) 4574 7576
Anaphylaxis is a severe allergic reaction that develops rapidly and may lead to death if not treated. The allergic reaction can be triggered by foods or by bee and wasp stings. The symptoms can be itching, rash, swelling of the lips, throat and tongue, wheezing, shortness of breath, coughing and hoarseness, nausea, vomiting, stomach ache, headache, fear of death or unconsciousness.
Treatment of anaphylaxis is by means of adrenaline (epinephrine) injections, or even hospitalisation in some cases, and preventive measures. Patients at risk of developing anaphylaxis are recommended to carry a self-triggering disposable injector containing adrenaline (adrenaline autoinjector), which must be used immediately when symptoms of anaphylaxis appear. It is estimated that in Europe and the USA there are up to four million people carrying an adrenaline auto-injector.
Since anaphylaxis has to be treated quickly and effectively, it is important that such adrenaline injectors are reliable, simple to use and work properly under all circumstances.
JEXT® is a new and improved adrenaline pen that has been developed to meet the requirements of reliability and functionality. Furthermore, JEXT® has a considerably longer shelf-life than existing products. JEXT® has just been approved in Europe for the emergency treatment of severe acute allergic reactions (anaphylaxis). JEXT® has been developed by ALK and is eventually expected to be launched worldwide. Until 31 December 2010, ALK will be retailing another, inlicensed adrenaline pen in a number of European countries.
ALK is a research-driven global pharmaceutical company focusing on allergy treatment, prevention and diagnosis. ALK is the world leader in allergy vaccination (immunotherapy). The company has 1,700 employees with subsidiaries, production facilities and distributors worldwide. ALK is also part of a strategic partnership with Merck on tablet-based allergy vaccination in North America. The company is headquartered in Hørsholm, Denmark, and is listed on NASDAQ OMX Copenhagen A/S. Read more at www.alk-abello.com.
Investor Relations: Per Plotnikof, tel. (+45) 4574 7527, mobile (+45) 2261 2525 Press: Martin Barlebo, tel. (+45) 4574 7901, mobile (+45) 2064 1143
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