Ixogel® is Granted QIDP Status by the US Food and Drug Administration
Ixodes AG, a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention of Lyme Disease, today announced that the U.S. Food and Drug Administration (FDA) has designated the company's lead product candidate, Ixogel®, as a Qualified Infectious Disease Product (QIDP) for the prevention of Lyme Disease after a tick bite and is working with the company on the phase III protocol. Special Protocol Assessment (SPA) confirmation expected soon.
Zürich, Switzerland, September 29, 2015 --(PR.com)-- Ixodes AG, a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention of Lyme Disease, today announced that the U.S. Food and Drug Administration (FDA) has designated the company's lead product candidate, Ixogel®, as a Qualified Infectious Disease Product (QIDP) for the prevention of Lyme Disease after a tick bite and is working with the company on the phase III protocol. Special Protocol Assessment (SPA) confirmation expected soon.
The QIDP designation will make Ixogel® eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review and eligibility for fast-track status and – providing that FDA approval is obtained - , Ixogel® would be eligible for an additional five-year extension of Hatch-Waxman patent exclusivity.
Ixogel® is a novel topical formulation of Azithromycin applied at the site of the tick bite within 3 days after the bite. Ixogel® provides a preventative solution by eradicating Borrelia in the skin before they disseminate and can lead to Lyme Disease. Ixogel® demonstrated an excellent safety profile and a trend to prevent symptoms of Lyme Disease in a European human clinical trial. Agreement with the FDA after Special Protocol Assessment (SPA) of the US phase III protocol is expected soon and the European clinical design has been agreed with the German Health Authority BfArM.
"Ixodes AG is delighted that the FDA is working on our phase III protocol for Special Protocol Assessment (SPA) and has given Ixogel® the QIDP designation. This affirms the importance of addressing the serious medical need related to Lyme Disease due to tick bites," said Gustave Huber, Ixodes Chief Executive Officer. "The QIDP designation and the expected SPA agreement with the FDA on the Phase 3 protocol will strongly support our goal to bring Ixogel® to the U.S. and European market as fast as possible."
In order to achieve QIDP designation, a drug product must be intended to treat serious or life-threatening infections, particularly those infections caused by "qualified pathogens," as determined by the FDA. These pathogens include Borrelia burgdorferi, the pathogen causal for Lyme Disease.
Ixogel's accelerated approval designation provides Ixodes AG with the opportunity to meet with the FDA on a more frequent basis during the review process, and provides eligibility for priority review of the marketing application.
About Ixodes AG / Ixogel®
Ixodes AG is a privately held company in Zürich, Switzerland. Its main focus is on the development of Ixogel® a novel topical application of Azithromycin to prevent Lyme Disease. After a tick bite, the causal pathogen leading to Lyme Disease - Borrelia burgdorferi - remains at the site of the bite in the skin for some time. Ixogel® uses this time window to eradicate the pathogen locally, thereby preventing its dissemination and thus the development of Lyme Disease. Ixodes has an approved clinical protocol with the FDA as well as the clinical design with the German BfArM.
About Lyme Disease:
Lyme disease in North America is caused by the bacterium Borrelia burgdorferi and is transmitted to humans via the skin through the bite of infected blacklegged Ixodes scapularis ticks. In Europe, Lyme Disease can also be the result of B. afzelii and B. garinii infections which are typically transmitted by Ixodes ricinus. Symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can affect joints, the heart, and the nervous system.
Lyme Disease is a Disease associated with morbidity that has substantial impact on day-to-day functioning. It concentrates in the northeast and upper Midwest of the US and is the most commonly reported vector-borne Disease in the United States. The Centre of Disease Control (CDC) recently reported > 300,000 new cases of Lyme Disease in the US. Ixodes AG estimates the same number of cases in Central and Northern Europe per year.
For further information, contact:
Luzi Andreas von Bidder
Ixodes@bluewin.ch
Phone +41 79 507 34 69
The QIDP designation will make Ixogel® eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review and eligibility for fast-track status and – providing that FDA approval is obtained - , Ixogel® would be eligible for an additional five-year extension of Hatch-Waxman patent exclusivity.
Ixogel® is a novel topical formulation of Azithromycin applied at the site of the tick bite within 3 days after the bite. Ixogel® provides a preventative solution by eradicating Borrelia in the skin before they disseminate and can lead to Lyme Disease. Ixogel® demonstrated an excellent safety profile and a trend to prevent symptoms of Lyme Disease in a European human clinical trial. Agreement with the FDA after Special Protocol Assessment (SPA) of the US phase III protocol is expected soon and the European clinical design has been agreed with the German Health Authority BfArM.
"Ixodes AG is delighted that the FDA is working on our phase III protocol for Special Protocol Assessment (SPA) and has given Ixogel® the QIDP designation. This affirms the importance of addressing the serious medical need related to Lyme Disease due to tick bites," said Gustave Huber, Ixodes Chief Executive Officer. "The QIDP designation and the expected SPA agreement with the FDA on the Phase 3 protocol will strongly support our goal to bring Ixogel® to the U.S. and European market as fast as possible."
In order to achieve QIDP designation, a drug product must be intended to treat serious or life-threatening infections, particularly those infections caused by "qualified pathogens," as determined by the FDA. These pathogens include Borrelia burgdorferi, the pathogen causal for Lyme Disease.
Ixogel's accelerated approval designation provides Ixodes AG with the opportunity to meet with the FDA on a more frequent basis during the review process, and provides eligibility for priority review of the marketing application.
About Ixodes AG / Ixogel®
Ixodes AG is a privately held company in Zürich, Switzerland. Its main focus is on the development of Ixogel® a novel topical application of Azithromycin to prevent Lyme Disease. After a tick bite, the causal pathogen leading to Lyme Disease - Borrelia burgdorferi - remains at the site of the bite in the skin for some time. Ixogel® uses this time window to eradicate the pathogen locally, thereby preventing its dissemination and thus the development of Lyme Disease. Ixodes has an approved clinical protocol with the FDA as well as the clinical design with the German BfArM.
About Lyme Disease:
Lyme disease in North America is caused by the bacterium Borrelia burgdorferi and is transmitted to humans via the skin through the bite of infected blacklegged Ixodes scapularis ticks. In Europe, Lyme Disease can also be the result of B. afzelii and B. garinii infections which are typically transmitted by Ixodes ricinus. Symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can affect joints, the heart, and the nervous system.
Lyme Disease is a Disease associated with morbidity that has substantial impact on day-to-day functioning. It concentrates in the northeast and upper Midwest of the US and is the most commonly reported vector-borne Disease in the United States. The Centre of Disease Control (CDC) recently reported > 300,000 new cases of Lyme Disease in the US. Ixodes AG estimates the same number of cases in Central and Northern Europe per year.
For further information, contact:
Luzi Andreas von Bidder
Ixodes@bluewin.ch
Phone +41 79 507 34 69
Contact
Ixodes AG
Luzi Andreas von Bidder
+41 79 507 34 69
ixogel.com
Luzi Andreas von Bidder
+41 79 507 34 69
ixogel.com
Contact
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