Product
IXIARO
Approval Date
March 30, 2009
Release Date
Second quarter of 2009
Company
Intercell
Class
Vaccines
Indication
A novel vaccine to prevent Japanese Encephalitis.
Active Ingredient
Purified components of inactivated Japanese Encephalitis Virus.
Agency Roster
Global Agencies:
Biolumina, New York.
Huntsworth Health, Maidenhead, UK
Marketing Strategy/Execution
IXIARO will be positioned as the “safe and effective prevention of Japanese Encephalitis, protecting travelers from an unpredictable and potentially devastating illness”. Japanese Encephalitis (JE) is the leading cause of viral neurological disease and disability and the most important viral encephalitis in Asia. JE is an unpredictable threat for travelers. Vaccination is the best protection against JE. IXIARO provides protective antibody titers in up to 98% of subjects. IXIARO provides a protective antibody response that lasts for at least 12 months, as demonstrated in a long-term follow-up study. IXIARO has a similar tolerability profile to placebo.
Globally speaking, Intercell will be targeting health care professionals via sales forces, mailings, the internet, publications, and advisory boards. There is also a direct to consumer program, which will be delivered via clinics in Europe and supplemented by a TV documentary in the US.
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: ChimeriVax
Manufacturer: Acambis
Indication: Encephalitis virus infections
Active ingredient: Japanese encephalitis vaccine
Phase: III
Source: Wolters Kluwer Health
Adverse Reactions
Local reactions (eg, pain, tenderness), headache, myalgia, fatigue, flu-like illness, GI upset, pyrexia.
Adults
≥17yrs: Two doses given 28 days apart. Each dose is 0.5mL IM into deltoid muscle; complete series at least 1 week prior to potential exposure.
Children
<17yrs: not recommended.
Contraindications
Severe allergic reaction (eg, anaphylaxis) after a previous dose.
Precautions
Immunodeficiency. Bleeding disorders. Acute febrile illness. Allergy to protamine sulfate. Have epinephrine inj (1:1000) available. Pregnancy (Cat.B). Nursing mothers.
Interactions
Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
