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Nuvilex Applying For Orphan Drug Status To Market Pancreatic Cancer Treatment Without Competition



4/22/2014 8:37:06 AM

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NEW YORK, NY--(Marketwired - 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.

About Stock Market Media Group
SMMG is a Research and Content Development IR firm that offers a platform for corporate stories to unfold in the media with Reports, Interviews and Articles. SMMG is compensated for Nuvilex articles, reports and interviews by a third party who reserves the right to buy, sell or remain neutral on securities at any time before, during, or after the publication of this article. To date, SMMG has received total compensation of $78,105 for content related to Nuvilex. Additionally, a principal at SMMG currently owns 200,000 total shares of Nuvilex issued by the company through a consulting agreement which has since ended for work unrelated to content development. 100,000 of those shares have been held for the requisite period under Rule 144 as of October 31, 2013, and are eligible to be sold immediately. To date, none of the Rule 144 eligible shares have been sold; however, the principal reserves the right to sell all or part of those shares in Nuvilex at any time without further notice. For more information: www.stockmarketmediagroup.com.


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