US Food and Drug Administration (FDA) has granted orphan drug status for Vicore Pharma's lead compound C21 for the treatment of idiopathic pulmonary fibrosis (IPF).
FDA has granted orphan drug designation for Vicore Pharma's drug candidates C21 for the treatment of IPF. C21 is thereby approved as an orphan drug in the USA. The approval brings C21 exclusivity on the US market from when the drug will be approved and for 7 years thereafter. Other benefits related to orphan drug designation include tax relief on the costs for clinical trials executed in the USA and support from the authorities with scientific advice relating to the design of forthcoming clinical trials.
C21 holds the corresponding orphan drug status in the EU since august 2016.
Orphan drug designation provides us safety and support by the authorities during the continued clinical development process for C21 as a new therapy for IPF, an encouraging circumstance as we go forward. We can also note that the interest for our technology among the pharmaceutical companies is increasing the regulatory achievement says Per Jansson, CEO Vicore Pharma.
For more information, please contact:
Per Jansson, CEO
Tel: +46 70917 47 46
Johanna Gräns, Regulatory affairs manager
About Orphan drugs
In the United States, a drug can receive orphan drug designation if it is intended for the treatment of a rare disease that affects fewer than 200,000 people in the United States. Around 60 million people in the US and Europe suffer from a rare disease and there are 7,000 identified rare diseases. As the pharmaceutical industry under normal circumstances does not find it worthwhile to invest in developing a drug that only will be used for limited group of patients, different forms of regulations have been introduced to enhance the industry's attraction to neglected patient groups also driving forces. Despite the limited patient groups several large companies exclusively focuse on orphan drugs, including Shire, Genzyme, Celgene and Alexion Pharmaceuticals. The value of the global orphan drug market amounts to about 20% of the total pharmaceutical market.
About Idiopatic pulmonary fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive decline in lung function. The term pulmonary fibrosis means scarring of lung tissue and is the cause of worsening dyspnea (shortness of breath). Fibrosis is usually associated with a poor prognosis. IPF usually occurs in individuals of between 50 and 70 years of age.
About Vicore Pharma Holding (publ)
Vicore Pharma develops drugs targeting stimulation of the AT2 Receptor (AT2R) in the Renin-Angiotensin-System (RAS). The company vision is to establish a new class of small molecule drugs to allieviate chronic inflammatory and fibrotic diseases through selective agonism with AT2R. The company’s lead compound, C21, has undergone clinical Phase I studies following numerous peer review publications with positive outcome in preclinical efficacy studies. For further information, please refer to www.vicorepharma.com
This is information which Vicore Pharma Holding AB is required to disclose under the EU Market Abuse Regulation and the Securities Market Act. The information was provided by the above contact person's auspices, for publication January 27, 2017 at. 11:30 CET.
Vicore Pharmas affärsstrategi är att leda utvecklingen av nya molekyler med agonistisk verkan på AT2 receptorn för att utveckla framgångsrika läkemedel.