Skinvisible Web Sign Up for Updates         T 702.433.7154
Skinvisible - Polymer Delivery System

The Ultimate Polymer Delivery System.
May 27, 2009

TO OUR VALUED SHAREHOLDERS:

We have received hundreds of calls and emails over the last few weeks in response to the news release about our DermSafe® Hand Sanitizing Lotion that is proven to kill/inactivate the H1N1 virus. If you were one of them we thank you for your positive response and now wish to update you on our progress.

"The only thing certain about influenza viruses is that nothing is certain." (World Health Organization: WHO)

Swine Flu (H1N1) Update:

  • The Center For Disease Control (CDC) reported today there are over 13,300 cases of swine flu around the world with 95 deaths. The United States is reporting over 7,900 cases with Mexico reporting over 367 new cases and 3 deaths just in the last 24 hours.
  • Because the new swine flu virus -- technically called H1N1 -- is a highly unusual genetic mix of bird, flu and human viruses, health officials worry that it could continue to mutate and return in a more virulent form for next winter's flu season. (Center For Disease Control: CDC)
  • H1N1 appears to be more contagious than seasonal influenza. The secondary attack rate of seasonal influenza ranges from 5% to 15%. Current estimates of the secondary attack rate of H1N1 range from 22% to 33%. (The World Health Organisation: WHO)
  • The new H1N1 flu virus could still mutate into a more virulent form and spark an influenza pandemic that could be expected to circle the globe up to three times. (WHO)
  • A distinctive feature of influenza viruses is that mutations occur frequently and unpredictably in the eight gene segments, and especially in the haemagglutinin gene. The emergence of an inherently more virulent virus during the course of a pandemic can never be ruled out. (WHO)
  • The 1918 influenza pandemic - which killed tens of millions of people - began mild and returned within six months in a much more lethal form. The 1968 pandemic began relatively mild, with sporadic cases prior to the first wave, and remained mild in its second wave in most, but not all countries. (WHO)
Skinvisible's DermSafe® Hand Sanitizing Lotion - A Preventive Measure Against H1N1:

DermSafe antimicrobial hand sanitizing lotion is formulated with our patented Invisicare® technology and chlorhexidine as the active ingredient. Chlorhexidine has been safely used in hospitals for over 50 years in pre-surgical soap scrubs. Independent studies verify that DermSafe will stay on the hands for extended periods of time while continuing to kill a host of bacteria and viruses including Influenza A (H1N1).

Skinvisible has conducted numerous bacterial and viral studies at recognized and approved FDA and EU equivalent laboratories. In vitro studies showed a greater than 99% kill on:

  • Type A Influenza viruses that include H1N1 (swine flu), H3N2 and H5N1 (bird flu);
  • Influenza B virus;
  • Hepatitis C virus;
  • Bacteria tested include: enterrococus faecalis, serratia marcescens, staphylococcus aureus (MRSA), e-coli, pseudomonas aeruginosa and clostridium difficile, (c. difficile).
Currently DermSafe is approved for sale/use in Canada by Health Canada and in the US the product has been submitted to the FDA requesting approval under the Emergency Use Authorization plan (see below). Limited regulatory processes are required in other countries to deem DermSafe an approved product, including the United Kingdom, the European Union and a number of Asian countries.

Status of Skinvisible's Progress With DermSafe:

Many of you have asked us what are we doing to make DermSafe available for sale. Below is a summary of the many projects that are underway regarding the licensing of DermSafe worldwide:

Media Coverage: Skinvisible has received excellent media coverage both in newspapers and TV news casts this past few weeks. You can view them on our website www.invisicare.com or www.skinvisible.com.

Canada: We are in discussion for the retail rights to DermSafe for Canada. DermSafe should be on store shevles by this summer, ready for the fall flu season.


United States: We have applied for "Emergency Use Authorization" (EUA) from the FDA. EUA allows the FDA to authorize the use of an unapproved medical product during a declared emergency. Our clinical data has been submitted and an initial review has been conducted by the FDA. We have responded to further questions and now await the review process. We continue to communicate directly with the FDA review team for updates.

Skinvisible continues its discussions and negotiations with a number of multi-national companies regarding the licensing rights for retail, healthcare and the food services industries. While there can be no guarantee that any of these companies will in fact sign a licensing agreement, an approval by the FDA under the EUA plan would be a significant forward step for the product DermSafe and any pending licensee.

Mexico: We have met with the Mexican consulate and they are assisting us in seeking regulatory approval for DermSafe for Mexico. We have also recently engaged a consultant that works closely with the Mexican government and other Latin American countries to assist us in locating distribution for DermSafe.

Afghanistan: This week samples of DermSafe along with our study results, left for Afghanistan to be presented to the US military. We continue to also keep our military contacts informed on our progress both with the EUA status and availability of DermSafe around the globe.

Asia: We have received interest for DermSafe from companies in Asia; primarily China and Hong Kong and are in preliminary discussions now.

We remain steadfast on our pursuit of international licensees both for DermSafe and the other formulations we have developed using our patented Invisicare technology. We have never been in a better position than we are today, with many discussions, negotiations and internal reviews underway for licensing rights. It always seems to take longer than we all would like however some of our potential licensees require global input. We are very encouraged by the positive responses we have had to date. As a Skinvisible shareholder, we appreciate your emails and phone calls on what is happening in your communities - thank you for your continued support and encouragement. As our progress and success stories become available we will provide you with updates.


Terry Howlett President & Chief Executive Officer

Learn more about our company at www.skinvisible.com & www.invisicare.com

Forward-Looking Statements: This document contains 'forward looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on file with the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the quarter ending March 30, 2009.
  Press Release Index


Click here to join our mailing list.
Home    |     About us    |    Technology    |    Products    |    Investors    |    Contact Us    |    Disclaimer & Privacy    |     Sign Up for Updates
© 2008 Skinvisible Pharmaceuticals, Inc.     Note: This website is not intended for Canadian residents.