Positive outcome of the phase II dose range finding study with SUBLIVAC® FIX Birch


Leiden, the Netherlands – HAL Allergy B.V. today announced a positive outcome of the dose range finding study with its sublingual immunotherapy product, SUBLIVAC® FIX Birch.

In this study, patients with birch pollen induced allergic rhinitis were treated for 5 months with either one of four active doses or placebo. After 5 months of treatment, the primary outcome measure, the composite nasal symptom score following the nasal provocation test, decreased in all active dose groups compared to placebo whereby a clear and significant (p<0.001) dose response relationship was observed. In addition nasal flow was also improved in a dose dependent manner and a significant immunological response was seen in the active dose groups. All active dose groups were well tolerated and no serious adverse events related to treatment were reported.

This study confirms the potential of HAL Allergy’s sublingual birch product and demonstrates a dose response relationship for a sublingual drops birch immunotherapy product. In addition, the consistent clinical data clearly identifies the optimal dose for the upcoming phase III efficacy study.

About allergic rhinitis

Allergic rhinitis is a common chronic inflammatory disease of the upper airways characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. The prevalence is estimated to be as high as 25% in developed countries. The disease has an impact on the quality of life of patients and is associated with considerable direct and indirect costs. The most recent estimate of the annual costs of allergic rhinitis range from $2 to 5 billion in the USA (2003 values).


SUBLIVAC® FIX Birch is an allergen extract of birch pollen for sublingual use. The product is in commercial use and is primarily prescribed for patients suffering from severe allergic respiratory diseases inadequately controlled despite the use of symptomatic medication.

About HAL Allergy 

The HAL Allergy Group was established in 1959 and is an important European manufacturer of allergy vaccines and diagnostics. The Group's products are distributed through subsidiaries in Germany, Spain, Italy, Poland, Austria and the Benelux as well as a network of distribution partners around Europe. Currently HAL Allergy employs over 270 people throughout Europe with more than 160 situated in the Netherlands HQ. The German subsidiary in Düsseldorf, in operation since 1977 and one of the top three players in the largest allergy market, employs 60 people and is the main sales and marketing operation for the HAL Allergy Group. The main shareholder of HAL Allergy GmbH is Droege International Group AG, headquartered in Düsseldorf, Germany. More information is available on:

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About HAL Allergy

HAL Allergy Group is active in the field of biopharmaceuticals and is located at the Bio Science Park in Leiden, The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases. In addition, we offer contract manufacturing services focusing on the production of biopharmaceutical products for (pre-) clinical studies. With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect causing a reduction in symptoms and long-term disease suppression. The allergy therapies are used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings. More information is available on:   

The main shareholder of HAL Allergy GmbH is Droege International Group AG, which is an independent Advisory and Investment Company, based in Düsseldorf, Germany. More information is available on: 

HAL Allergy Group

Monique Lutgens
Manager Corporate Communications
Tel. + 31 (0)88 1959010