- Marketing authorisation of Fovepta® in Germany
- Initial sales of Hepatect® in Brazil
- Continuation of the clinical development of CivacirTM planned for the second half of 2012
DREIEICH, Germany I April 23, 2012 I Biotest AG obtained marketing authorisation from the Paul Ehrlich Institute for Fovepta®, a hepatitis B hyperimmunoglobulin, in late March. Fovepta® provides immunoprophylaxis when administered subcutaneously to the newborn babies of mothers infected with hepatitis B. It was developed specifically for use in newborns and can be applied as subcutaneous injection that is particularly gentle for them. It is much better tolerated than the common intramuscular products. Fovepta® comes in a prefilled syringe, with the choice of needle left to the clinician.
Marketing authorisation in Germany provides a basis for further international regulatory approvals in other countries. Fovepta® was developed particularly for markets with high rates of viral hepatitis B infection. Obtaining marketing authorisation for Fovepta® in Asian and South American markets, e.g. Brazil, is therefore a high priority.
In January this year, the Journal of Perinatal Medicine accepted the article "An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers." (Buxman et al).
This product allows Biotest AG to consistently expand its hepatitis B hyperimmunoglobulin portfolio worldwide.
- Hepatect® given i.v. in the perioperative and early maintenance transplantation period
- Nabi HBTM given i.m. after needlestick injuries, for newborns of hepatitis B-infected mothers and when dealing with hepatitis B virus infection (only for the US market)
- Zutectra® subcutaneous for self-treatment at home following transplantation
- Fovepta® subcutaneous for newborns of hepatitis B-infected mothers
Biotest is today the global market leader with hepatitis B immunoglobulins for prophylaxis of reinfection after liver transplantation. Besides Nabi HBTM in the American market, we are working towards further international expansion of the hepatitis B portfolio. Zutectra® is coming onto the market in France, Switzerland and Spain in the first half of 2012.
After setting up Biotest Farmacia in Brazil, we have now achieved initial sales of Hepatect® and will now devote all our efforts to obtaining marketing authorisation in this country for Zutectra® and Fovepta® to gain the hepatitis B market for Biotest.
The hyperimmunoglobulin CivacirTM is being developed at Biotest for the much more common hepatitis C reinfection prophylaxis following liver transplantation. Continuation of clinical development is planned in the USA in the second half of the year following reformulation of the product.
SOURCE: Biotest
Post Views: 59
- Marketing authorisation of Fovepta® in Germany
- Initial sales of Hepatect® in Brazil
- Continuation of the clinical development of CivacirTM planned for the second half of 2012
DREIEICH, Germany I April 23, 2012 I Biotest AG obtained marketing authorisation from the Paul Ehrlich Institute for Fovepta®, a hepatitis B hyperimmunoglobulin, in late March. Fovepta® provides immunoprophylaxis when administered subcutaneously to the newborn babies of mothers infected with hepatitis B. It was developed specifically for use in newborns and can be applied as subcutaneous injection that is particularly gentle for them. It is much better tolerated than the common intramuscular products. Fovepta® comes in a prefilled syringe, with the choice of needle left to the clinician.
Marketing authorisation in Germany provides a basis for further international regulatory approvals in other countries. Fovepta® was developed particularly for markets with high rates of viral hepatitis B infection. Obtaining marketing authorisation for Fovepta® in Asian and South American markets, e.g. Brazil, is therefore a high priority.
In January this year, the Journal of Perinatal Medicine accepted the article "An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers." (Buxman et al).
This product allows Biotest AG to consistently expand its hepatitis B hyperimmunoglobulin portfolio worldwide.
- Hepatect® given i.v. in the perioperative and early maintenance transplantation period
- Nabi HBTM given i.m. after needlestick injuries, for newborns of hepatitis B-infected mothers and when dealing with hepatitis B virus infection (only for the US market)
- Zutectra® subcutaneous for self-treatment at home following transplantation
- Fovepta® subcutaneous for newborns of hepatitis B-infected mothers
Biotest is today the global market leader with hepatitis B immunoglobulins for prophylaxis of reinfection after liver transplantation. Besides Nabi HBTM in the American market, we are working towards further international expansion of the hepatitis B portfolio. Zutectra® is coming onto the market in France, Switzerland and Spain in the first half of 2012.
After setting up Biotest Farmacia in Brazil, we have now achieved initial sales of Hepatect® and will now devote all our efforts to obtaining marketing authorisation in this country for Zutectra® and Fovepta® to gain the hepatitis B market for Biotest.
The hyperimmunoglobulin CivacirTM is being developed at Biotest for the much more common hepatitis C reinfection prophylaxis following liver transplantation. Continuation of clinical development is planned in the USA in the second half of the year following reformulation of the product.
SOURCE: Biotest
Post Views: 59
