Le Lézard
Classified in: Health
Subject: FDA

The U.S. Food and Drug Administration (FDA) Has Granted Orphan Drug Designation to PharmaMar's Lurbinectedin


MADRID, August 3, 2018 /PRNewswire/ --

PharmaMar (MCE: PHM) announces that lurbinectedin has been granted orphan drug status by the FDA for the treatment of small cell lung cancer.

     (Logo: http://mma.prnewswire.com/media/624563/PharmaMar_Logo.jpg )

The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan Drug designation may provide certain benefits, including a 7-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials, and an exemption from FDA application fees.

"We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this cancer, and recognizes the potential benefits that lurbinectedin may provide for patients with small cell lung cancer," said Luis Mora, Managing Director of the Oncology Business Unit of PharmaMar. "Receiving orphan drug designation for the treatment of small cell lung cancer (SCLC) is a significant regulatory milestone in the development of lurbinectedin", has added.

About PharmaMar  

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre® (lurbinectedin, PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.

About lurbinectedin 

Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer  

SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%[i]. About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problem[ii]. After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.

Disclaimer 

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

i. http://www.cancer.gov/types/lung/hp/small-cell-lung-treatment-pdq  

ii. http://www.jnccn.org/content/11/1/78.full.pdf  

Media Contact: 
Alfonso Ortín - Communications Director [email protected] Mobile: +34-609-493-127
Miguel Martínez-Cava - Digital Communication Manager [email protected] Mobile: +34-606-597-464
Phone: +34-918-466-000

Investor Relations: 
Phone: +34-914-444-500
Or please visit our website at http://www.pharmamar.com

SOURCE PharmaMar


These press releases may also interest you

at 00:25
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial...

28 mar 2024
The report titled "Central Lab Market by Service Type (Anatomic Pathology/Histology, Biomarker Services, Genetic Services), Phase (Phase 1, Phase 2, Phase 3), Therapeutic Area, End-use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Personalized Nutrition Market by Measurement Type (Active Measurement, Standard Measurement), Application (Indication-based, Standard Supplements), Distribution Channel, End-Use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Carbon Dioxide Incubator Market by Product (Air Jacketed CO2 Incubators, Direct Heat CO2 Incubators, Water Jacketed CO2 Incubators), Capacity (100-200 Litre, Above 200 Litre, Below 100 Litre), Application, End User - Global...

28 mar 2024
The "Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19"...

28 mar 2024
The "Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Customization 2023 - 2027 " report has been added to  ResearchAndMarkets.com's offering. Infectious disease Dx is...



News published on and distributed by: