NanoViricides Inc. (NNVC)

[changes_iv]

June 10, 2013 Janssen, Johnson & Johnson Innovation, Announce Collaboration With Belgian Scientists To Pursue New Research In Neurodegenerative Diseases

Janssen Research & Development will collaborate initially with KU Leuven, University Hospitals Leuven and VIB( Vlaams Instituut voor Biotechnologie) to create opportunities for collaborative research, and will invite other academic institutions to join the project as its next phase begins later this year.

Today Sep 03, 2013

Interest in a treatment for dengue fever in Europe was confirmed today by the announcement that J&J has signed a collaboration with the Wellcome Trust and the University of Leuven in Belgium. http://www.wellcome.ac.uk/News/Media-office/Press-releases/2013/WTP053792.htm

No doubt tha Big Pharma seeks creative and mutually beneficial pharmaceutical collaborations that as they say, "provide the best value in medicines to patients and to the healthcare industry".

The approach of some includes early stage option-based deals, late stage licensing deals, and acquisitions.

Geographically speaking they may be talking, dealing, collaborating on the other side of the world. However, it could also be a diversion while talks are going on closer to home. Just speculating.

DengueCide is "the only game in town" ~ Dr. Anil Diwan. Other Dengue drugs have failed in clinical trials. Once DengueCide is US FDA approved it will gain extension for patent life (7 years) and be a candidate to earn a Priority Review Voucher (minimum $200 million).

"As I’ve pointed out before, Forbes magazine estimates that the pharmaceutical industry spends $4 billion per new drug approval. Even the low estimates have a total cost of over a billion dollars. So it simply doesn’t make much business sense in this regulatory environment to try to tackle many tropical diseases.

The cost for individual approval is, of course, considerably less. But the total cost figure is a reliable proxy for the risk involved in drug development. It is not much of a surprise, therefore, that startups and established pharma alike are unwilling to spend tens of million on medicines that probably won’t provide a return on investment.

Those Duke economists I mentioned above who designed the PRVs were clever enough to recognize that delays associated with regulatory approval could be exploited to encourage orphan drug development. Any real reform of the FDA would, of course, be a superior solution, but that doesn’t look like it’s happening anytime soon.

Why?

Because it can take years to get through the regulatory maze, a shortcut to the front of the line is immensely valuable to Big Pharma. Not only would it reduce financing costs, it could also be used to get a drug to market before the competition. In lucrative, although often competitive areas, this advantage can be worth billions.

As you may know, most drug development companies depend on partnerships with Big Pharma to fund extremely expensive Phase 3 trials that precede drug approval. If a company that won approval for an orphan drug were to be awarded a PRV, however, it would change the entire risk/reward picture. At the very least, it could lead to a much bigger cash payout for the developing company in a Big Pharma drug deal".

` Patrick Cox

The efficacy of DengueCide™ *** is unprecedented ~ Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley.

The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation.

Once a compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%).