Registration of SUBLIVAC® Birch and SUBLIVAC® Trees 40.000 AUN/ml in Germany accomplished
Leiden, the Netherlands (14 August 2018) – HAL Allergy B.V. today announced the registration of SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml in Germany. These are the first marketing authorisations granted by the Paul Ehrlich Institute following the German Therapieallergene‑Verordnung (TAV).
The TAV was initiated by the German Federal Ministry of Health on 14 November, 2008, and regulates the marketing authorisation requirements for frequent therapeutic allergens, in order to guarantee quality, effectiveness and safety.
“We are proud to be the first company that registers two products in line with the German Therapieallergene‑Verordnung”, says Harry Flore, CEO of HAL Allergy Group. “We acknowledge that the regulations set by the German authorities, are important for allergic patients in Germany, the largest European allergy market. Therefore, we were determined to register our sublingual birch and trees products. The studies to obtain these marketing authorisations are part of our extensive clinical development program and follow the new EMA requirements.”
The studies confirm that SUBLIVAC® Birch 40.000 AUN/ml shows significant and clinically relevant improvement for adults in all primary and secondary endpoints versus placebo.
Principal investigator Prof. Dr. Oliver Pfaar, Scientific Head at the Allergy Center Wiesbaden and Professor at the Medical Faculty Mannheim, University Heidelberg, Germany, also member of the Scientific Advisory Board of HAL Allergy Group explains: “In the phase II study we identified the optimal dose of allergen. Phase III demonstrated a strong clinical efficacy of 32% in the combined symptom and medication score, compared to placebo. There was a significant improvement in quality of life scores as well as important changes in immunoglobulins.”
SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml
HAL Allergy has developed SUBLIVAC®, which is a liquid preparation for sublingual administration, containing allergen extracts in a glycerinated phosphate buffer. SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml is indicated for the treatment of allergic rhinitis and rhino-conjunctivitis in adults with or without asthma, caused by sensitisation to birch or tree pollen. The recommended dose schedule starts with one drop, increased by one drop per day until the daily maintenance dose of five drops per day is reached. The administration of drops allows flexibility in dosage regime as may be required by individual need. SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml consist of one concentration, containing 24 ml of allergen extract. The product should be stored in the refrigerator between 2 0C and 8 0C. After first opening of the vial, the product can be stored for a period of six months at room temperature, below 25 0C.
About HAL Allergy
HAL Allergy specializes in immunotherapy, desensitization and therapeutic treatment of all allergies mainly caused by tree and grass pollens and mites with the help of preparations that can be administered orally or subcutaneously. The company works intensively in collaboration with its sales organizations, distributors and internationally acclaimed research institutes to bring out the best possible combination of knowledge and experience. The company focuses on the core group of allergy experts from the specialties of Ear Nose & Throat, Dermatology, Pediatrics and Pulmonology. HAL Allergy has the most modern and state‑of‑the‑art production facility at its main site in the Leiden Bio Science Park in the Netherlands. Currently their products are marketed in sixteen countries. Moreover this leading manufacturer of therapeutic and diagnostic agents for allergies has sales organizations in all the major European markets including Germany, Poland, Austria, Italy and Spain. More information is available on: www.hal‑allergy.com.
The main shareholder of HAL Allergy Group is Droege Group AG, based in Düsseldorf, Germany.
About Droege Group
Droege Group (founded in 1988) is an independent advisory and investment company under full family ownership. The company acts as a specialist for tailor-made transformation programs aiming to enhance corporate value. Droege Group combines its corporate family-run structure and capital strength into a family-equity business model. The group carries out direct investments with its own equity in corporate spin-offs and medium-sized companies in “special situations”. With the guiding principle “execution – following the rules of art”, the group is a pioneer in execution-oriented corporate development. Droege Group follows a focused investment strategy based on current megatrends (knowledge, connectivity, prevention, demography, specialization, future work, shopping 4.0). Enthusiasm for quality, innovation and speed determines the company’s actions. In recent years Droege Group has successfully positioned itself in domestic and international markets and operates in 30 countries. More information is available on www.droege‑group.com.
HAL Allergy B.V.
Mildred van Vrijberghe
Project Coordinator Marketing
Tel. + 31 (0)88 1959192