NanoViricides Inc. (NNVC)

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Thanks to the consulting firm Cote' Orphan Consulting (COC), headed by Dr. Tim Cote', for assisting with the DengueCide orphan drug applications. NanoViricides, Inc., in consultation with COC, has successfully obtained the award of orphan drug designation to DengueCide, the company's drug candidate for the treatment of dengue and dengue hemorrhagic fever, by the European Medicines Agency (EMA). The Company has recently received Orphan Drug Designation for DengueCide from the US FDA.

FDA's orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the Orphan Drug Act of 1983, a rare disease is defined as any disease affecting fewer than 200,000 individuals in the US in any given year.

The act allows FDA to give the products approved to treat the orphan conditions special marketing protections (7 years of market exclusivity), tax credits to offset some of the costs of development, faster regulatory reviews and additional assistance from FDA reviewers during the development and review process.

http://www.raps.org/focus-online/news/news-article-view/article/3608.aspx

An approved orphan medicine in the European Medicines Agency (EMA) countries is expected to benefit from ten years of marketing exclusivity protection. An additional two years of exclusivity can be obtained if the drug development has complied with an agreed pediatric investigation plan, with a total of twelve years of market exclusivity for a drug that is approved for both adult and pediatric usage.

Applications for orphan designation are examined by the European Medicines Agency's Committee for Orphan Medicinal Products (COMP), using a network of international experts. This designation is recognized by all 27 countries within the European Union.

http://www.barchart.com/headlines/story/1004976/nanoviricides-denguecide-receives-orphan-drug-designation-from-the-european-medicines-agency

Published on Apr 16, 2013

Dr. Coté is the leading national regulatory expert in orphan drug development. With 22 years of Federal service at the FDA, NIH, and CDC, Dr. Coté most recently served as the Director of the FDA Office of Orphan Products Development (OODP) from Sept 2007 -- May 2011. Dr. Coté was instrumental in implementing the Orphan Drug Act and personally signed over 800 orphan drug designations in his time at the Agency.

Currently, Dr. Coté runs a consulting firm in addtion to being the Professor of Regulatory Practice at the Keck Graduate Institute in Claremont, California and co editor of two journals focused on rare diseases (with Dr. M. Ian Phillips).
Cote Orphan Consulting helps companies understand FDA operations as they affect their company and provide advice regarding strategic planning and execution in regulatory affairs for orphan drugs.

In this exclusive interview with Rare Disease Report, Dr. Cote explained the reasons why orphan drugs are currently being well studied and marketed in the United States.

Published on Jun 21, 2013

Megan Hill, Senior Associate at Cote Orphan Consulting, took the time to speak with us at World Orphan Drug Congress USA 2013.

Megan spoke on what Cote Orphan Consulting does, and why they chose to sponsor the World Orphan Drug Congress USA 2013.

World Orphan Drug Congress USA is the largest international, commercially-focused event for the advancement of rare disease research and orphan drug development.

For more information, go to www.terrapinn.com/orphandrug, or to keep up to date with orphan drug industry news visit our blog at http://blogs.terrapinn.com/total-biop....