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Summit Corporation Plc (LSE:SUMM) shares were up 4.3% by 9:44 am GMT on Thursday following a press release by the company.
According to the announcement, the drug discovery company’s SMT C1100 product, manufactured to treat Duchenne Muscular Dystrophy, was granted orphan drug status by the United States Food and Drug Administration.
The SMT C1100 was granted orphan drug status in December 2008 by the European Medicines Agency.
Executive Chairman Comments
Barry Price, PhD, the Executive Chairman of Summit said:
“We are pleased the US FDA has designated SMT C1100 as an orphan drug for DMD as this recognises its potential to treat a major unmet medical need. Our clinical candidate has now been granted orphan drug status both in Europe and the US, and this status will provide additional regulatory support and various commercial benefits including extended periods of market exclusivity.
Summit believes that SMT C1100 can become a first-in-class treatment for DMD and it is our intention to commence a clinical study that will evaluate a new formulation of this drug that will benefit all patients with this fatal disease.”
About Orphan Drug Designation
Orphan drugs are medicines that have been created to treat a rare medical condition, known as an orphan disease. The US Orphan Drug Act and European Orphan legislation represent governmental efforts to encourage investment in, and development of, these types of drugs. When a drug is designated as an orphan drug, it is given a seven year period of market exclusivity in the US once it is approved. In Europe it is given ten years of exclusivity. Other benefits of orphan drug designation include additional regulatory support, accelerated approval, and reduced fees.
About the Disease and the Medicine
Duchenne Muscular Dystrophy is caused by the absence of the protein dystrophin, causing degeneration of vital and skeletal muscles, including the heart. The only drugs currently in use are steroids to reduce the symptoms, however no treatments are available for the disease.
SMT C1100 responds to the disease by increasing production of a similar protein in the body called utrophin, which can work to replace the missing dystrophin. According to the statement, the company recently released compelling preclinical data showing that SMT C1100 can increase utrophin production and restore healthy muscle function. With the upregulation of the drug, all patients with DMD will benefit, as the drug is expected to be complimentary with other treatments.
Company Spotlight
Summit Corporation Plc is a drug discovery company based in Oxford, UK with an innovative technology platform known as Seglins for the discovery of new drugs. Summit’s research is focused on high value therapies, with a strategy of signing early-stage drug technology deals that generate upfront cash, transfer development costs, and retain upside potential. The company is listed on the AIM under the symbol SUMM.
