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news.Chiasma, a biopharma company, has received FDA's orphan drug designation (ODD) for its investigational new drug, Octreolin.
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Octreolin is an oral form of octreotide acetate that uses the company’s proprietary Transient Permeability Enhancer (TPE) technology for the oral treatment of acromegaly.
Chiasma said that if a new drug application (NDA) is approved, Octreolin should qualify for seven years of market exclusivity, potential tax credits, and a waiver of the prescription drug user fee for the marketing application.
Further, Chiasma is expected to file an application for Orphan Medicinal Product Designation to the European Medicines Agency (EMA) for Octreolin.
Chiasma plans to submit an NDA using the ‘505(b)(2) regulatory pathway’ in the US and its equivalent, the ‘Hybrid Application,’ in Europe.
Chiasma has concluded a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of Octreolin, which demonstrated a PK profile similar to that of subcutaneously injected octreotide acetate.
Chiasma is planning to initiate a pivotal Phase 3 trial by the end of the year for Octreolin in acromegaly.
In addition, Chiasma is developing Octreolin as a potential treatment for patients with portal hypertension (PHT); a clinical trial to evaluate this new indication is expected to start in December of 2010.
Chiasma is expected to evaluate whether Octreolin may improve quality of life, prevent or reduce bleeding events, and lower mortality rates for the estimated 80,000 PHT patients in the US and an equal number in Europe.
Chiasma is planning to request ODD’s for Octreolin for PHT in the US and in Europe. The company also intends to proceed with the aforementioned 505(b)(2) NDA regulatory pathway in the US and its equivalent, the Hybrid Application, in Europe.