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.

Local Company Develops Needle-Free Vaccines

As swine flu season begins, many people aren't worrying about getting sick; they’re dreading the vaccine. Simone Hudson ('12) freely admits that she is terrified of needles. "I just hate needles," she explains. "[They] freak me out... the thought alone makes me wince." The Journal of Family Practice estimates that 10% of the nation is affected by severe needle phobia, including fainting at the sight of needles or refusing necessary medical care if it has to be given through needles. And even those without needle phobia wouldn’t mind avoiding getting stuck in the arm.

And help may be on the way. Kathy Callender, founder of the Colorado-based company PharmaJet, realized years ago that "somebody needs to solve this problem of needles." After five years of work, PharmaJet has just received FDA approval for their needle-free injection system, which is currently being used to administer seasonal flu shots in Colorado and New Jersey.

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PRINCETON: Health officer eyes needle-free flu shots

New device already used in 3 NJ counties

If Health Officer David Henry has his way, Princeton soon may join a handful of New Jersey communities using a newly-approved needle-free injection device to administer flu vaccinations.

The spring-loaded device, developed by PharmaJet, of Golden, Colo., delivers medication by creating a high-velocity stream of medication that can penetrate the skin. The device received clearance from the Food and Drug Administration at the end of February and already has been used in flu vaccination clinics in Sussex, Morris and Burlington counties.

Health officials in those communities have given the device favorable reviews, saying it eliminates the risks and costs associated with disposal of conventional syringes, simplifies the logistics of mass vaccination events and can overcome the apprehensions that may be keeping an uncounted number of needle-phobic persons from getting vaccinated.

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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.

Needle-free flu shots making their point

Trenton Times, October 6th 2009: Belonephobics rejoice. Folks with a fear of needles now have the alternative of "needle-free injections" at some seasonal flu clinics in New Jersey.

Resembling the "hypospray" on the futuristic Star Trek series, the new devices send high-speed jets of fluid into the skin instead of the flesh-piercing long needles that have been the bane of many a doctor visit.

Despite having administered lots of shots over the years, retired nurse Ellen Petrone of Andover Township is no fan of needles when she's on the receiving end. So when she got her seasonal flu shot at a senior center in Sussex County and was given a choice between a regular needle and a needle-free injection, it wasn't a hard decision.

"That wasn't bad at all," Petrone said after receiving the needlefree injection. "I kind of tense up when I know there's a needle coming. This way - needle free - I'm happy."

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NJ Counties and Townships offer PharmaJet as an alternative to Needles in September Flu Campaigns

The abstracts below are all taken from recent publications. Click on the links for more information.

Sussex County to Use High Tech System in Delivering Flu Vaccines

For the 2009-2010 flu season, the Department will also be offering needle-free (no needle) vaccinations using the PharmaJet Needle-free Injection System, as an option for residents at selective clinic sites.
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Morris Regional Public Health Partnership

The Morris Regional Public Health Partnership has been awarded a grant from The New Jersey Health Officers Association to provide Mass Prophylaxis and Public Information Training projects. Both projects intend the development of skills by local health departments to better provide services during a time when large numbers of the general public are required to obtain vaccinations and other public health services. There are two exercises that the Partnership has committed to conduct. One exercise will train personnel in the use of a new system of large scale vaccination delivery. The exercise will evaluate the advantages and disadvantages of using the customary syringes versus the new PharmaJet injector system. This event will be the initial testing of the PharmaJet injector system under conditions requiring mass vaccination.
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Flu vaccine with no needle in Vineland

VINELAND -- Those getting seasonal flu vaccines at the Health Department's clinic Monday afternoon will have to decide, "Needle or no needle."

The city's health department becomes the first in the region to test-drive the new PharmaJet needle-free injection technology. It debuts Monday at the city's most popular vaccine venue -- the drive-through clinic at the U-Sell Flea Market -- said George Sartorio, the city's health officer.

Seasonal flu shots will be given between 3 and 7 p.m. Monday. Immunizations for swine flu -- or H1N1 -- are not yet available.

The PharmaJet device does not use a needle to inject a vaccine into the body. Instead, the immunization penetrates the skin via high-speed pressure in less than 1/3 of a second, according to PharmaJet officials.

Where it is needle-free, it is not necessarily painfree," Sartorio said.

So those who attend the clinics can opt to try to the new device or stick with the traditional injection. Both will be available, Sartorio said.

The city's health department was attracted to PharmaJet because there is less medical waste and less risk of needle sticks to staff.

City health staffers were trained to use the PharmaJet devices Friday.

If there were an H1N1 health emergency declared, Sartorio noted health officials might be able to use the PharmaJet system to administer vast number of shots at a faster pace.

Because it is easy to use, the health department could use medical support staff in addition to full-fledged medical professionals to give Swine Flu vaccinations, he said, noting no such emergency exists at this time.