The study analysed that the hemophilia pipeline comprises of 53 drug candidates, of which one drug candidate has been filed by LFB SA as biologics license application, four drug candidates are in Phase III stage, four drug candidates are in Phase II stage, 11 drug candidates are in Phase I stage, 27 drug candidates are in the Pre-Clinical stage and six drug candidates are in the Discovery stage of development. Hemophilia is a genetic disorder characterized by excessive bleeding and delayed blood clotting. There is broadly two type of hemophilia that have been identified namely, hemophilia A and hemophilia B. The prevalence of hemophilia A is about four times more as compared to the prevalence of hemophilia B. People of all races and ethnic groups are affected by hemophilia. It has been observed that the male population is more commonly affected by the disease as compared to the female population, since hemophilia is inherited in an X-linked recessive genetic pattern, where females are generally carriers of the disease. Presently, many new methods are under investigation as possible treatments for bleeding disorders. Scientists are focusing on factor VIII or factor IX genes with superior functioning, that are intended to be inserted into the cells of people with hemophilia. Gene therapy is also expected to show effective results in the treatment of hemophilia, as it might help the patients start synthesizing their own clotting factor, thereby completely eliminating or reducing the need for infusions per week.
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The pipeline analysis based on route of administration of active drug candidates showed , that around 19.0% of drug candidates of hemophilia therapeutics pipeline are being developed for administration through intravenous route, 15.0% are being developed to be administered by parenteral route, 13.0% are being developed to be administered by subcutaneous route, 6.0% are being developed to be administered by other route such as intravenous infusion. Route of administration of 47.0% active drug candidates is not disclosed.
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Many drug candidates received USFDA designations namely Orphan, Fast Track or Breakthrough designations in their clinical stages for the treatment of hemophilia. In August 2016, orphan drug designation was granted to emicizumab, a Phase III drug candidate of Chugai Pharmaceuticals, by Ministry of Health, Labour and Welfare, Japan. In November 2012, USFDA granted orphan drug designation to PF-05280602, a Phase II drug candidate of Pfizer, Inc.
Some of the key players developing drugs for the treatment of hemophilia include Sangamo BioSciences, Inc., Caisson Biotech, Inc., XL-protein GmbH, mAbxience SA, Prothix BV, Immusoft Corporation, 3B Pharmaceuticals GmbH, GeneOne Life Science, Inc., Sernova Corp., Arcturus Therapeutics, Inc., REGiMMUNE Corporation, Alteogen, Inc., Glycotope GmbH.