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Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment without Competition

Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment without Competition

Written by ι Stock Market Media Group — April 22, 2014

When Nuvilex, Inc. (OTCQB: NVLX) named Clinical Network Services (CNS) as the Contract Research Organization (CRO) for its late phase clinical trials in advanced pancreatic cancer, the company also stated it will apply for “Orphan Drug” status.  This is a designation that will allow Nuvilex to exclusively market its pancreatic cancer treatment using the Cell-in-a-Box® technology combined with the anticancer drug ifosfamide.

Treatments for pancreatic cancer engender an Orphan Drug designation in most countries and that alone enables companies receiving the status to sell their approved treatment without competition for an additional 7 years in the US and 10 years in Europe.

While there are currently long-term patents on Nuvilex’s pancreatic cancer treatment, receiving Orphan Drug status will allow the Maryland biotech firm to exclusively market the Cell-in-a-Box® technology combined with ifosfamide long after those patents expire. 

Nuvilex announced that CNS will immediately provide consulting and management services as part of implementing the company’s global regulatory strategy, including applying for the Orphan Drug designation from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). 

The Orphan Drug designation is given to treatments for “rare” diseases, and the FDA can award the status long before a treatment is approved for use.  In the US, diseases like pancreatic cancer that are diagnosed in less than 200,000 people annually, are eligible for this designation, meanwhile, in Europe, the designation is reserved for diseases occurring in less than 5 out of every 10,000 people, so Nuvilex’s treatment should easily qualify.    

In 2007, both the FDA and EMA moved to reduce the burden on those applying for Orphan Drug status by agreeing to use a common application process for both agencies.