PharmaJet® Receives Grand Challenges Explorations Funding

Golden, Colorado, USA – November 14, 2011 – PharmaJet Inc. announced today that it will receive funding through Grand Challenges Explorations, an initiative created by the Bill & Melinda Gates Foundation that enables researchers worldwide to pursue innovations that address persistent health and development challenges.

Dr. Linda McAllister, MD, PhD, Chief Medical Officer, Vice President of Research and Development, will pursue an innovative global health research project, titled "Elucidating the Mechanism of Intradermal Delivery."

Grand Challenges Explorations funds scientists and researchers worldwide to explore ideas that can break the mold in how we solve persistent global health and development challenges. Dr. McAllister's project is one of 110 Grand Challenges Explorations grants announced this week.

"We believe in the power of innovation—that a single bold idea can pioneer solutions to our greatest health and development challenges," said Chris Wilson, Director of Global Health Discovery for the Bill & Melinda Gates Foundation. "Grand Challenges Explorations seeks to identify and fund these new ideas wherever they come from, allowing scientists, innovators and entrepreneurs to pursue the kinds of creative ideas and novel approaches that could help to accelerate the end of polio, cure HIV infection or improve sanitation."

Projects that are receiving funding show promise in tackling priority global health issues where solutions do not yet exist. This includes finding effective methods to eliminate or control infectious diseases such as polio and HIV as well as discovering new sanitation technologies.

To learn more about Grand Challenges Explorations, visit www.grandchallenges.org.

Global polio eradication is within reach. The oral polio vaccine (OPV) currently in use leads to vaccine- associated poliomyelitis at a rate of 1 to 2 cases per million vaccine doses delivered. A global switch to inactivated polio vaccine (IPV) is critical and long overdue, however this transition is challenged by the increased cost of IPV, as well as the requirement for a needle to deliver IPV. PharmaJet plans to address these challenges by delivery of a reduced dose IPV vaccine into the skin (dermis) with an easy-to-use needle-free jet injection technology.

In contrast to muscle, the dermis is more immunologically active, allowing for dose reduction with a variety of vaccines however, it is unknown what drives the efficacy of intradermal (ID) delivery. With this funding PharmaJet hopes to elucidate the specific drivers of intradermal effectiveness, enabling further optimization of the needle-free technology and vaccine formulation to deliver the most cost effective strategies for global polio eradication.

About Grand Challenges Explorations
Grand Challenges Explorations is a US$100 million initiative funded by the Bill & Melinda Gates Foundation. Launched in 2008, Grand Challenge Explorations grants have already been awarded to nearly 500 researchers from over 40 countries. The grant program is open to anyone from any discipline and from any organization. The initiative uses an agile, accelerated grant-making process with short, two-page online applications and no preliminary data required. Initial grants of $100,000 are awarded two times a year. Successful projects have an opportunity to receive a follow-on grant of up to US$1 million.

About PharmaJet Inc. and Needle-free Injection Technology
PharmaJet's needle-free injection technology delivers liquid drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick risk and the burden of sharps waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. The PharmaJet system has been well received in the developed world, and is also extremely advantageous in the developing world due to its usability, affordability and inherent safety features.

PharmaJet Responds to the FDA Statement Issued by the Vaccines Blood and Biologics Division (CBER) on 21 October 2011

This information letter is in response to a statement published on the FDA website today by FDA regarding Flu Vaccines and Jet Injectors. We also are providing you with information about the FDA's Center for Devices and Radiological Health division's (CDRH) documented clearance of the PharmaJet devices for vaccine delivery.

We were provided no notice by FDA of any concerns about Jet Injectors or FDA's statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA.

Below is one the FDA 510k marketing clearance statements provided to PharmaJet, related to its 0.5 ml injection devices (2009 and 2011 clearances) for vaccine delivery. We would be pleased to provide you with our complete FDA 510(k) clearance documents on request.

Indications for Use
510(k) Number (if known):		K081532
Device Name:		PharmaJet, Inc., PharmaJet Needle-free Injection System
Indications for Use		The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.

PharmaJet is now engaged with the FDA on this matter, and will be continuing this dialogue when the FDA resumes its business activity on Monday the 24th of October. We will keep you informed of progress with our discussions. We continue to stand behind our products and appreciate your continued support.

PharmaJet® FDA Regulatory Clearances on its Needle-free Injection Devices

Golden, CO – October 21, 2011 – PharmaJet has received two FDA 510(k) marketing clearances for its IM/SC injection technology. Below are the INDICATIONS FOR USE, cleared by the FDA.

FDA 510(k) Number K111517: PharmaJet Stratis Needle-free Injection System

"The PharmaJet Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication."

FDA 510(k) Number K081532: PharmaJet Needle-free Injection System

"The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication."

The concurrence of CDRH, Office of Device Evaluation (ODE) is attached for both of PharmaJet's 510(k) clearances.

About PharmaJet Inc. and Needle-free Injection Technology:
PharmaJet's needle-free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick risk and the burden of sharps waste management.

PharmaJet's Heather Callender-Potters Named Ernst & Young Entrepreneur Of The Year® 2011 Mountain Desert Region Award Finalist

Golden, CO – May 23, 2011 – PharmaJet® today announced that Chairman, Heather Callender-Potters is an Ernst & Young Entrepreneur Of The Year® 2011 finalist. The Ernst & Young award program recognizes entrepreneurs who demonstrate excellence and extraordinary success in such areas as innovation, financial performance and personal commitment to their businesses and communities. Heather Callender-Potters was selected by a panel of independent judges. Award winners will be announced at a special gala event on Thursday, June 16th at the Seawell Ballroom in the Denver Center for the Performing Arts.

"I am honored to be among the finalists for the E&Y award and to share the PharmaJet® story of our innovative, needle-free injection device, optimized for safe vaccine delivery—the most effective form of preventative healthcare," says Heather Callender-Potters, Chairman of PharmaJet®. "To be included with a group of entrepreneurs, who are each impressive within their industries, is inspiring. Success is not only about passion and vision, but it is also about commitment. This strengthens my own commitment to PharmaJet's global plans and our vision, and allows me to reconfirm publicly my convictions about working tirelessly to accomplish them."

The Ernst & Young Entrepreneur Of The Year Program celebrates its 25th anniversary this year. The program has expanded to recognize business leaders in more than 140 cities and more than 50 countries throughout the world.

Regional award winners are eligible for consideration for the Entrepreneur Of The Year National Award. Award winners in several national categories, as well as the Entrepreneur Of The Year overall National Award winner, will be announced at the annual awards gala in Palm Springs, California, on November 12, 2011. The awards are the culminating event of the Ernst & Young Strategic Growth Forum®, the nation's most prestigious gathering of high-growth, market-leading companies, which will be held November 9–13, 2011.

About PharmaJet® Inc. and Needle-free Injection Technology:
PharmaJet's needle‐free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet® injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle‐stick risk and the burden of sharps waste management. Further benefits of PharmaJet® injectors include the potential for dose‐sparing of vaccines, reducing the overall cost of vaccine delivery.

About Ernst & Young Entrepreneur Of The Year®
Ernst & Young Entrepreneur Of The Year® is the world's most prestigious business award for entrepreneurs. The unique award makes a difference through the way it encourages entrepreneurial activity among those with potential, and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, Entrepreneur Of The Year celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 140 cities in more than 50 countries.

Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards are pleased to have the Ewing Marion Kauffman Foundation as a national sponsor. In the Mountain Desert region sponsors include Faegre & Benson, Clifton Gunderson, ADP, Scherzer International, The Denver Business Journal and JohnstonWells Public Relations.

About the Ernst & Young
Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide, our 141,000 people are united by our shared values and an unwavering commitment to quality. We make a difference by helping our people, our clients and our wider communities achieve their potential.
Ernst & Young LLP is a client-serving member firm of Ernst & Young Global Limited operating in the US. For more information about our organization, please visit www.ey.com.

PharmaJet is honored to be officially named as a 2011 Colorado Companies to Watch award winner!

Now in its third year, Colorado Companies to Watch attracted over 360 nominees. With nearly 100 companies selected as finalists, PharmaJet prevailed along with forty-nine others to receive the distinction of being named to the Colorado Companies to Watch class of 2011. Colorado Companies to Watch is hosted by the Colorado Office of Economic Development and International Trade in partnership with the Edward Lowe Foundation.

FDA Grants PharmaJet® 510(k) Clearance on Intradermal Needle-free Injection Device

First FDA-cleared needle-free injection alternative to needle-based "Mantoux" method.

GOLDEN, CO, USA - March 22, 2011 – The U.S. Food and Drug Administration (FDA) has awarded PharmaJet 510(k) clearance to market a 0.1mL Intradermal (ID) Needle-free Injection System. Delivery to the intradermal tissue layer is the approach used for many vaccines, such as tuberculosis and rabies, for which ID delivery has proven efficacious. In addition, ID delivery is being explored for vaccines such as polio, and many others in development. PharmaJet will now market the first FDA-cleared intradermal, needle-free alternative to the current needle-based "Mantoux" technique, which is time consuming, difficult for the healthcare provider to administer and painful for the patient to receive.

The intradermal layer is rich with cells that help stimulate the body's immune response. With PharmaJet's needle-free ID delivery into the same location as traditional needle/syringe injection, evidence suggests that the volume of some vaccines may be reduced by as much as 80% and still provide the appropriate immune protection. Intradermal delivery may allow for vaccine dosages to be stretched, providing significant savings in delivery costs and expanded coverage for vaccines in limited supply. This delivery system will enable routine use of lower-cost dose and volume-sparing strategies for mass vaccination and pandemic vaccine stockpile management.

"This is important technology and we are pleased to have the 1st FDA-cleared needle-free ID injection system", stated James A. Bowman, President of PharmaJet Inc. "PharmaJet is proud to be the leader in needle-free injection technology, revolutionizing the way vaccines are delivered."

In addition to this newly cleared ID device, PharmaJet currently markets an FDA-cleared, needle-free system for intramuscular (IM) and subcutaneous (SC) injection that delivers vaccines and liquid medications in a volume of 0.5mL. The PharmaJet single-use, auto-disabling, needle-free system delivers a narrow, high velocity fluid injection, which penetrates the skin in less than 1/3 of a second.

About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet's needle-free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick risk and the burden of sharps waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. The PharmaJet system has been well received in the developed world, and is also extremely advantageous in the developing world due to its usability, affordability and inherent safety features.

CDC Awards Contract to PharmaJet® for Development of Needle‐free Intradermal Vaccine Delivery Device

Funding advances development of needle-free injector that enables reduced doses and antigen‐sparing of vaccines.

GOLDEN, CO, USA - January 27, 2011 – The Centers for Disease Control (CDC) has awarded PharmaJet with a substantial grant to develop needle-free injection devices for intradermal (ID) vaccine delivery. Accurate vaccine delivery into the layers of skin, rather than into muscle, holds the promise of providing protection from disease and doing so with less vaccine, less pain and decreased demand on expensive logistics, such as transportation and cold chain.

Intradermal delivery has the potential to reduce the amount of vaccine required, by as much as 80% in some cases, leading to cost savings and expanded coverage for vaccines in limited supply. The current needle‐based "Mantoux" method of ID delivery is technically difficult, painful for the patient and time consuming. PharmaJet aims to eliminate this barrier by bringing to market a needle‐free injection technology that is:

easy and intuitive to use in individual or mass vaccination settings;
at a competitive cost;
reliable for a broad spectrum of skin types (e.g., infants, children, youth and adults);
used with any vaccine licensed or considered appropriate for ID delivery; and
safe; eliminating needlestick injuries and needle reuse.

A mechanism for reliable, affordable and simple ID delivery could immediately address significant and meaningful public health issues: (a) helping to reduce the cost of vaccine delivery programs worldwide, and (b) facilitating the accurate and consistent intradermal delivery of vaccines, enabling more effective care. The PharmaJet device will enable routine public health use of lower-cost dose-sparing strategies for mass vaccination and pandemic vaccine stockpile management.

"The award of this SBIR Phase II contract will advance development of our technology, permitting dose-sparing stategies for some vaccines, improving the efficacy of others and positioning PharmaJet to play a pivotal role in global vaccine delivery," says Dr. Michael Royals, PharmaJet's Head, Global Technology Development and Chief Science Officer. "A non-needle based solution that enables easy delivery of injectable vaccine will assist initiatives such as the Global Polio Eradication Program, and fits with PharmaJet's core mission to help lower disease transmission and global disease burden."

About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet's needle‐free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick risk and the burden of sharps waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. The PharmaJet® system has been well received in the developed world, and is also extremely advantageous in the developing world due to its usability, affordability and improved safety features.

PharmaJet to appear on "21st Century Healthcare"

Multi-Media Productions (USA), Inc. is pleased to announce that PharmaJet will be featured on 21st Century Health.

(EMAILWIRE.COM, December 23, 2010 ) Boca Raton, FL --- PharmaJet's product delivers vaccines and other liquid medications through the skin. They accomplish this using jet injection technology. They do not use needles – big or small, or patches of any kind.

Their needle-free delivery device is FDA cleared for marketing. The custom-wound spring in the injector provides a unique force that drives the liquid through a tiny hole in the end of the syringe, thus creating a "fluid needle" that is able to penetrate the skin. It can deliver 0.5 ml of a liquid medication through the skin of the arm, the abdomen or the thigh, into the muscle (intramuscular or IM area) where many vaccines are routinely delivered, or into the subcutaneous layer or SC depth between the skin and muscle.

PharmaJet is developing a 0.1 ml device for intra-dermal delivery into the 2 mm upper layer of the skin where the immune system is very active. For some vaccines, intra-dermal delivery has the potential to reduce the amount of vaccine required, in some cases by as much as 80%, leading to cost savings and expanded coverage for vaccines in limited supply. It may also enable vaccines to work, which may not otherwise work with traditional needle-syringe delivery. JL Haber, Vice President of Programming at Multi Media Productions, added,

"With a unique approach to the needs of the medical industry, PharmaJet was a natural fit for our show. We are excited to have them as a guest on our program."

About PharmaJet

PharmaJet's needle-free injector utilizes a sterile, single-use, auto-disable syringe, which creates a safer work place for healthcare workers, eliminating the possibility of needle-stick injuries. The syringe can only be used one time, which greatly controls the spread of deadly blood-borne pathogens and eliminates the possibility of cross-contamination between patients from needle reuse. Also, the reduction in hazardous needle sharps waste will provide a great cost savings while benefiting the environment. The PharmaJet needle-free injection system is helping to alleviate the fear and anxiety that goes along with getting a needle injection for many children and tens of millions of "belenophobics," who until now have had no practical recourse to their fear of needles.

We are an early stage business that has developed a better method of using jet injection technology. Our mission to serve the global community is shared by both our employees and our investors, and our opportunity to serve individual patients and also public health needs worldwide is enormous.

If you share our mission and are interested in learning more about PharmaJet, then please contact us. We are located in Golden, Colorado, San Francisco, California and Baltimore, Maryland.

About 21st Century Health

21st Century Health is an award winning targeted business show that is independently produced by Multi-Media Productions. The show provides its business viewers an in depth opportunity to find solutions to the industry problems from some of the top business leaders from across the world. Each exclusive segment is taped in our state of the art South Florida Studio.

Once selected, companies are able to present their story and solutions to industry problems in an exclusive way that sets their company apart from the others. With more than 6,000 companies participating on over 600 shows, 21st Century Health continues to be the premier and targeted outlet for the latest business stories. 21st Century Health airs on various national cable networks that are viewed by over 100 million viewers nationwide as well as internationally via DirecTV and Dish Network.

The show can also be viewed through video on demand via http://www.21chtv.com. The 21CHTV Series is also available at more than 27 prestigious college universities, including Carnegie Mellon University, Howard University, Dartmouth College and Georgetown University.

For specific market-by-market air dates and times, please e-mail Moniqueh@mmpusa.com. For more information, please visit http://www.21chtv.com.

PharmaJet and USAMRIID Enter Collaboration on Continued Development of Future-generation Smallpox Vaccine Combined with Needle-free Delivery Technology

Searching for more effective methods to deliver DNA vaccines, USAMRIID's experimental vaccine against smallpox will be evaluated in pre-clinical studies utilizing PharmaJet's needle-free injection technology

(Golden, Colorado, USA) December 6, 2010 – A Cooperative Research and Development Agreement (CRADA) has been signed between PharmaJet, Inc. and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to utilize the PharmaJet needle-free jet injection delivery technology in conjunction with USAMRIID's candidate gene-based smallpox vaccine.

Patented under the name 4pox, the USAMRIID vaccine consists of a combination of genes that, when delivered together, provides protection from orthopoxviruses (e.g., vaccinia virus, monkeypox virus) in animal models. Under the guidance of USAMRIID's Dr. Jay Hooper, immune responses to four different co-delivered immunogens will be evaluated using the PharmaJet needle-free system for intradermal delivery and compared with existing data produced with both PharmaJet and alternative devices.

"PharmaJet is very pleased to continue to work with USAMRIID," said Linda McAllister, acting CEO for PharmaJet. "We are very excited about the potential for our needle-free, jet injection, intradermal technology to contribute to the efficacy of this important new class of DNA-based vaccines."

The gene-based molecular vaccine field continually searches for safe, effective and practical delivery technologies, as well as adjuvant technologies. The 4pox gene-based vaccine has already been evaluated in preclinical models using skin and muscle electroporation and gene gun technology, among other means of delivery. The use of PharmaJet needle-free technology to deliver other DNA vaccines of military importance may be evaluated and added under addendums to this agreement.

About PharmaJet, Inc. and Needle-free Injections:

PharmaJet's needle-free technology delivers vaccines to intramuscular, subcutaneous, and intradermal tissue depths. "Jet" injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses of medications and vaccines while reducing the burden of hazardous waste management. The potential benefits of jet injectors include more consistent delivery, reduced vaccine wastage, elimination of the need to transport large volumes of sharps, and reduction of the risk of needle sticks and of the costs associated with sharps waste. For some vaccines, intradermal delivery has the potential to reduce the amount of vaccine required, in some cases by as much as 80%, leading to cost savings and expanded coverage for vaccines in limited supply.

Previous generations of jet injectors delivered billions of doses of vaccines over the last 60 years, but the multiple-use nozzles enabled cross-contamination between patients. Newer devices, such as the PharmaJet system, have been well received in the developed world, but are also extremely advantageous in the developing world because of their usability, affordability, and improved safety features (by design, PharmaJet's "needle-free" syringe cannot be reused). Needle-free jet injection also has the potential to improve safety by eliminating needles from the process of administering vaccines, and eliminating sharps (used metal needles) from the environment. For more information on PharmaJet or needle-free jet injection technology, please visit http://www.pharmajet.com.

About USAMRIID:

USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Department of Defense's Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. While USAMRIID's primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil

[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]

Inviragen and PharmaJet Receive $15.5 Million NIAID Contract to Develop a Needle-free Dengue Vaccine

(Fort Collins, Colorado and Golden, Colorado) Oct. 12, 2010 – Inviragen and PharmaJet announced the award of a five year, $15.5 million dollar contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance the development of a needle-free, easy to administer dengue vaccine. The award will fund preclinical studies, regulatory filings, manufacturing and clinical testing of Inviragen's tetravalent dengue vaccine, DENVax™ delivered with PharmaJet's convenient needle-free injection device.

"This NIAID contract will allow Inviragen and PharmaJet to continue our pioneering development of a needleless dengue vaccine," commented Dr. Dan Stinchcomb, Inviragen's Chief Executive Officer. "The PharmaJet injector has many properties that make it ideal for administering a dengue vaccine worldwide, potentially saving lives in affected countries and reducing the spread of the disease to new regions."

Over 3.5 billion people live in countries that have frequent dengue outbreaks. The four dengue viruses are spread amongst humans by mosquitoes and cause an estimated 30 - 50 million cases of debilitating dengue fever and 0.5 to 2 million cases of life-threatening dengue hemorrhagic fever every year. A recent dengue outbreak in Florida highlights the continuing global spread of the disease.

"People of all ages fear needles and safe disposal of needle waste is a constant problem for health care providers. A needle-free dengue vaccine would be welcomed by patients in endemic countries and by travelers worldwide and could protect them from this devastating disease," said Dr. Linda McAllister, PharmaJet's interim Chief Executive Officer. "In this collaboration, PharmaJet will develop 'needle-free' syringes compatible with our jet injection technology for pre-filling with Inviragen's novel dengue vaccine."

Inviragen's DENVax vaccine, developed by researchers at the CDC's Division of Vector-Borne Diseases, is based on an attenuated DEN-2 virus that generates long-lasting anti-dengue immune responses. CDC scientists engineered this clinically tested, weakened DEN-2 virus to express DEN-1, DEN-3 or DEN-4 structural genes. DENVax is a four-way mixture of the three engineered viruses and the original DEN-2 strain. Inviragen has completed preclinical testing, formulation, and manufacturing of DENVax. Phase 1 clinical safety testing of DENVax, delivered by traditional needle and syringe, began earlier this year. Other dengue vaccine technologies in clinical testing require multiple injections with long intervals between doses. The goal of the Inviragen/PharmaJet collaboration is to develop a needle-free dengue vaccine delivery platform that can rapidly induce neutralizing antibody response after one or two easily administered doses.

PharmaJet's jet injector creates a fine stream of pressurized liquid that penetrates the skin, quickly and effectively delivering doses of medicines and vaccines into different tissues. Jet injection eliminates needles from the process of administering vaccines and eliminates the costs and dangers associated with sharp needle waste. PharmaJet's technology is FDA-cleared for delivery into the muscle (intramuscular) and under the skin (subcutaneous). PharmaJet is developing jet injectors for delivery between the skin layers (intradermal). For some vaccines, intradermal delivery has the potential to reduce the amount of vaccine required, leading to cost savings and expanded coverage for vaccines in limited supply.

"In preliminary animal model studies, we used PharmaJet technology to deliver DENVax intradermally. The combination was safe, induced neutralizing antibodies to all four dengue serotypes and protected against dengue infection," noted Dr. Jorge Osorio, Inviragen's Chief Scientific Officer. "Our ongoing Phase 1 clinical trial is assessing the safety and immune responses after both subcutaneous and intradermal delivery of DENVax by needle. Under this NIAID contract, we aim to test DENVax delivery with the PharmaJet device in children and adults in South America and Southeast Asia, regions that are significantly impacted by dengue disease."

About Inviragen, Inc.

Inviragen is focused on developing vaccines to protect against infectious diseases worldwide. Inviragen's lead product candidate is a vaccine to protect against dengue fever. Inviragen is also developing vaccines to protect against hand, foot and mouth disease and Japanese encephalitis, both of which affect millions of children in Asia. Vaccines in preclinical research stages include a chikungunya vaccine, a low-cost human papilloma virus vaccine, vaccines to protect against new forms of influenza, a vaccine to protect against West Nile and a combination plague/smallpox vaccine for biodefense. Inviragen has offices in Colorado, Wisconsin and Singapore. Please see www.inviragen.com for more details.

About PharmaJet, Inc.

PharmaJet, Inc. is a privately held company located in Denver, Colorado, with offices and representatives also in San Francisco, California, Baltimore, Maryland, Chicago, Illinois, and Sao Paulo, Brazil. PharmaJet develops, manufactures and markets vaccine and drug delivery products based on its proprietary needle free jet injection technology. PharmaJet's US FDA 510(k) clearance relates to its 0.5 ml volume syringe, cleared for use with any liquid medicine. This technology is also cleared for use in the EU (CE Mark) and Brazil. The company meets GMP and ISO compliant standards for sterile single use products: 10993, 11737, 11607, and 11137. It is compliant with the ISO Quality Management System of 13485:2003, and the Needle Free Worldwide Standard of ISO 21649:2006.

Editor's note: for more information dengue fever, please the WHO website at www.who.int/topics/dengue/en or the Pediatric Dengue Vaccine Initiative (PDVI) website at www.pdvi.org/about_dengue/DF.asp.

Co-Founders of PharmaJet® Honored as Laureate of The Tech Museum's Tech Awards in 2010

(Laureate) is One of 15 Innovators From Around the World Recognized for Applying Technology to Benefit Humanity

(Golden, Colorado, USA) Sept. 22, 2010 – Kathleen Callender and Heather Callender-Potters, founders of PharmaJet, Inc. (proprietary needle-free jet injection technology used to deliver vaccines) were this week named to The Tech Awards Laureates 2010, as one of 15 global innovators recognized each year for applying technology to benefit humanity and spark global change. The Tech Awards, a signature program of The Tech Museum, and presented by Applied Materials, Inc., selected them from among hundreds of nominations representing more than 50 countries.

About the Tech Awards

Technology Benefiting Humanity is one of the premier annual humanitarian awards programs in the world, recognizing technical solutions that address the most critical issues facing our planet and its people. The awards program honors 15 scientists and innovators annually alongside the recipient of the Global Humanitarian Award, which will be presented this year to Queen Rania Al Abdullah of Jordan. Laureates are selected by a prestigious panel of international judges organized by the Center for Science, Technology, and Society at Santa Clara University, and made up of Santa Clara University faculty as well as leaders from educational and research institutions, industry and the public sector around the world.

Established in 2000, The Tech Awards recognizes 15 laureates, three in each of five universal categories: education, equality, environment, economic development and health. These laureates have developed new technological solutions or innovative ways to use existing technologies to significantly improve the lives of people around the world. This year, the laureate list represents the truly global vision of the program, including individuals from Brazil, Bangladesh, the Philippines and the San Francisco Bay Area. The laureates work impacts people in many more countries worldwide. One laureate in each category will receive a $50,000 cash prize during the annual Awards Gala in Santa Clara, California on November 6.

About the Founders

With her hands-on healthcare and practice management background, Ms. Callender has participated in medical group missions work in the developing world, which is where she witnessed first-hand the profound problems of needle re-use and needle-stick injuries. A dirty needle can transmit up to 20 blood borne pathogens, most commonly HIV, Hepatitis B, and Hepatitis C. There are an estimated 22 million needle-stick injuries world-wide per year; and the WHO estimates that up to 40-70% of needles are re-used in some countries. PharmaJet's technology has been propelled by Kathy's passion to make a difference in global world health by increasing the vaccination of the worlds children while at the same time limiting the source of needle re-use related diseases that plague the developing world and negatively impact the livelihood of so many individuals, their families and communities.

A private equity fund manager and active angel investor, Ms. Callender-Potters is also passionate about the advancement of technologies that can create a paradigm shift in thinking and application. Heather spent 19 years investing in early stage businesses in Central and Eastern European countries, helping to introduce novel technologies that can flourish and contribute to the health of emerging economies. She has worked to advance PharmaJet's collaborations that will have a great impact on both the developed and the developing world. In particular, her focus has been on the company's intra-dermal injection technology that has the ability to positively impact the body's immune response several fold versus standard depth of injection used by traditional needle-syringe.

"We are extremely honored to be among the Tech Awards recipients, and are so pleased that the award festivities and community of contributors will allow us a unique avenue for further advancing our dream to make a positive change in world health," said Heather Callender-Potters, Chairman of PharmaJet. Kathleen Callender added, "each time I find a kindred spirit who shares my passion for making a difference, especially for the young children of the developing world, I am inspired to work harder toward my goal of contributing to world health. Being included in the Tech Awards organization is not only rewarding, but constitutes an obligation for me to continue my efforts toward having PharmaJet's needle-free technology widely used as a solution to improve the overall well being of people worldwide."

VIDEO: Nokia Health Award Laureate 2010: PharmaJet
AUDIO: PharmaJet wins Tech Award: Kathleen Callender

PharmaJet and Netherlands Vaccine Institute (NVI) Partner for Needle-free Intra-dermal Delivery of Polio Vaccine

Lower cost of using smaller doses, and acceptance by healthcare workers, children and parents are benefits that may speed polio eradication

Bilthoven, Netherlands. March 2, 2010. The Netherlands Vaccine Institute (NVI) and PharmaJet, Inc. have entered into a collaboration aimed at helping speed the eradication of polio. The parties have been working together to evaluate PharmaJet's intra-dermal needle-free delivery technology with NVI's Salk inactivated polio vaccine (IPV). The collaboration aims to demonstrate that the immune response from a fractional dose of 0.1 ml vaccine delivered needle-free into the intra-dermal region of the skin is equivalent to the standard dose of 0.5 ml vaccine delivered with a needle and syringe into the muscle.

"Eradication of Polio is a major global health goal for governments around the world, the WHO and NGOs such as Rotary International and the Bill and Melinda Gates Foundation", said Lucas Elting, Chief Executive Officer of the Netherlands Vaccine Institute. "NVI has been at the forefront of innovation in development, manufacturing and/or supplying Salk and Sabin IPV vaccines worldwide. Our capability will play a major role in preventing the reemergence of polio, and as a public Dutch institution we are committed to adding polio to the list of eradicated infectious diseases."

Based on WHO guidance that has been substantially adopted throughout the world, there is a migration from the use of oral polio vaccine (OPV) delivered by drops, to IPV that is injected into the body. IPV is more effective against re-emergent strains of the virus. For full eradication, IPV must be universally adopted. In countries where the disease is still prevalent e.g., in regions of India, Pakistan, Afghanistan, and Nigeria, the hurdles to implementing the Salk and Sabin IPV strategy are still considerable.

"The cost of scale up, manufacturing and logistics of supplying and administering injected polio vaccine are high, however it can be reduced substantially if instead of the traditional 0.5 ml intra-muscular injection we can switch to 0.1 ml injected intra-dermally", said Rajen Dalal, PharmaJet's CEO and President. "PharmaJet's intra-dermal injection technology can reduce the cost. At the same time, the needle free device can be used by the large network of hundreds of thousands of community healthcare workers who deliver OPV drops door to door, without having to retrain them to inject IPV with needles and syringes. Needle free will also eliminate the risk of needle stick injuries and reuse of spent sharps, which cause the spread of blood borne diseases such as AIDS and hepatitis."

Polio News reported that major funding had been announced last year to boost the polio eradication effort. The Bill and Melinda Gates Foundation, Rotary International, and the British and German governments have committed more than US$630 million in funding to stop polio. On January 21, 2009 the Gates Foundation announced it was awarding a $255 million challenge grant to Rotary, which Rotary will match with $100 million from its members over the next three years. In addition, the United Kingdom and Germany are committing $150 million and $130 million, respectively, over the next five years.

The demand for IPV could be high as 400 million doses per annum, for decades until the disease is fully eradicated. The WHO has conducted three human clinical trials to date, to optimize fractional dose, intra-dermal delivery of IPV. Additional studies are planned to start this year.

About the Netherlands Vaccine Institute (NVI) and IPV

NVI is a governmental organization with the primary task to make state of the art vaccines available for the Dutch National Immunization Program. However, it has an extensive research and development program for vaccines, including production and control of vaccines for human use. NVI is the owner of proprietary polio (Salk IPV) strains and is a manufacturer of IPV vaccine, which it sells and provides related technology transfer to various customers, but particularly developing country manufacturers in Asia. NVI is involved in a WHO sponsored project, part of the Eradication Initiative, and is establishing a Sabin IPV production process on a pilot scale to transfer such technology to developing countries in order to enable them to produce a vaccine against polio in their own country. www.nvi-vaccin.nl

About PharmaJet, Inc and Needle Free Injections

PharmaJet, Inc. is a privately held company located in Denver, Colorado; San Francisco, California; and Baltimore, Maryland. It develops, manufactures and markets vaccine and drug delivery products based on its proprietary needle free jet injection technology.

Jet injectors can deliver vaccines intra-dermally. For some vaccines, intra-dermal delivery has the potential to reduce the amount of vaccine required, leading to cost savings and expanded coverage for vaccines in limited supply. Although previous generations of jet injectors delivered billions of doses of vaccines over the last 60 years, newer devices, like PharmaJet's system, are more appropriate for the developing world because of their usability, affordability of materials, and improved safety features.

Needle-free jet injection also has the potential to improve safety by eliminating needles from the process of administering vaccines. Jet injectors create a fine stream of pressurized liquid that penetrates the skin, delivering doses of medications and vaccines while reducing the burden of hazardous waste management. The potential benefits of jet injectors include more consistent delivery, reduced vaccine wastage, elimination of the need to transport large volumes of sharps, and reduction of the risk of needle sticks and of the costs associated with sharps waste.

New collaboration with PATH will evaluate needle-free injections for developing-country immunization programs

Vaccine injections without needles may reduce health risks and lower costs

Seattle, WA, November 3, 2009—PATH and a drug-delivery technology company are collaborating to bring developing countries safe, effective, and affordable injections without using needles. The new partnership between PATH and PharmaJet, a privately held company, will evaluate a new generation of needle-free injection technologies, including PharmaJet's needle-free, disposable-syringe jet injectors. These vaccine delivery technologies could reduce health risks and costs associated with traditional needle injections.

The collaboration is part of a PATH-led effort to advance needle-free injection technologies for developing-country immunization programs. PATH is engaging with device developers interested in supplying their devices to low-income countries. Starting in Brazil, where clinical studies are scheduled to begin in early 2010, PATH will evaluate needle-free delivery of a variety of vaccines compared to delivery by needle and syringe. Vaccines to be tested include those to prevent measles-mumps-rubella and yellow fever. PATH and its Brazilian partners also plan to conduct pilot introduction studies and other activities to facilitate adoption of needle-free technologies like the PharmaJet system.

"Disposable-syringe jet injector technology has the potential to provide safer and more affordable vaccines to millions of people around the world," said Darin Zehrung, team leader for vaccine delivery technologies at PATH. "This collaboration is an important step in our work to explore the regulatory pathway, commercial viability, and sustainability of this class of jet injectors in the developing world and share that knowledge with the entire global health community."

"Efficient design and use of recyclable materials already ensure very low costs, and now with the help of PATH, we will evaluate strategies to serve a larger base, which could further improve the cost and benefits of needle-free injections," said Rajen K. Dalal, president and CEO of PharmaJet. "Our business goals are in complete alignment with our ambition to serve the public health needs of three billion people living in low-resource settings around the world."

The need for safe injections

The World Health Organization estimates that at least 16 billion injections are given in developing and transitional countries each year. Prior to the introduction of autodisable syringes and a worldwide emphasis on injection safety, health officials estimated that at least 50 percent of injections in developing countries were considered to be unsafe. Unsafe injections can expose individuals to the risk of infections such as HIV, hepatitis B, or hepatitis C. Infection can occur when health workers or patients reuse syringes, contaminate medications with used syringes, or accidentally injure the patient or themselves with a used needle.

While developing countries have begun extensive efforts to improve injection safety, the costs and difficulty of managing ever-growing volumes of vaccine and sharps waste remain an obstacle to safety.

The potential of needle-free jet injectors

Needle-free jet injection has the potential to improve safety by eliminating needles from the process of administering vaccines. Jet injectors create a fine stream of pressurized liquid that penetrates the skin, delivering doses of medications and vaccines while reducing the burden of hazardous waste management. The potential benefits of jet injectors include more consistent delivery, reduced vaccine wastage, elimination of the need to transport large volumes of sharps, and reduction of the risk of needle sticks and of the costs associated with sharps waste.

Jet injectors can also deliver vaccines intradermally. For some vaccines, intradermal delivery has the potential to reduce the amount of vaccine required, leading to cost savings and expanded coverage for vaccines in limited supply. Although previous generations of jet injectors delivered billions of doses of vaccines over the last 60 years, newer devices, like PharmaJet's system, are more appropriate for the developing world because of their usability, affordability of materials, and improved safety features.

About PATH

PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being. For more information, please visit www.path.org.

Read the PATH press release here.

Regulatory Clearance in Brazil

Sao Paulo, Brazil October 30, 2009: ANVISA, the National Agency of Health Surveillance, has approved the registration of PharmJet's 0.5 ml Needle Free Jet Delivery System for sale in Brazil. The approval was made official with the publication of the registration in the newspaper "Diario Oficial da Uniao – DOU", on October 29th, 2009.