A Patent for Mixing a Dry Reagent, Including Lyophilized Drugs, in a Needle-Free Injector Awarded to PenJet Corporation.

Business Editors & Health/Medical Writers

SANTA MONICA, Calif.--(BUSINESS WIRE)--Nov. 14, 2002

A U.S. Patent for devices and methods for delivering a lyophilized drug with a needle-free injector has been granted to PenJet(R) Corporation, a Santa Monica-based medical device company, it was announced today. Foreign patents are pending.

This is the third patent PenJet(R) has been awarded for its mixing and filling technology that enables needle-free injections of multi-component drugs. These drugs include both a pharmaceutical reagent and a diluent, which may be combined immediately prior to injection.

Multi-component drugs are frequently stored in separate vessels because they are not stable for long periods of time after being mixed. This makes it difficult to store them in either conventional, pre-filled syringes or needle-free injectors. PenJet's(R) patented filling and mixing technology provides a safe and cost-effective solution to this problem, and is applicable to a host of pharmaceutical products. Its family of patents includes: U.S. Patent No. 6,223,786; U.S. Patent No. 6,302,160; and the latest, U.S. Patent No. 6,474,369.

"Pharmaceutical manufacturers will now be able to package their innovative lyophilized drugs in a needle-less, single use, inexpensive jet injector," said Thomas P. Castellano, PenJet(R) Corporation's CEO. "Although it has wide applicability for the needle-free delivery of a great many drugs in dry or solid form, it is particularly relevant to the increasing number of highly potent, biotechnologically derived proteins that require lyophilization to maintain their required shelf life."

The patented devices include a variety of shuttle configurations that allow a reagent and a diluent to be contained in separate chambers and mixed immediately prior to injection. To give a needle-free injection with a PenJet(R) once the reagent and diluent are combined, a safety ring that avoids accidental triggering is removed, the nozzle is placed against a suitable injection site, such as the upper arm, thigh or stomach, and the PenJet(R) administers the injection when gently pressed. After use, the PenJet(R) can be safely discarded in any trash receptacle, or recycled into non-medical devices, since it has no needle and has injected all the medication or vaccine it contained.

Half the size of a conventional fountain pen, the PenJet(R), uses a patented self-contained, compressed inert gas system to inject drugs into the skin surface without a needle. The patient experiences minimal sensation and no noise when the injection is given. This eliminates the pain and fear associated with needles, as well as the risk of accidental needle sticks and improper dosages. Compared to prior jet injectors, which are expensive, noisy, awkward to fill and inject with, the small PenJet(R) is easy to store, carry and use.

PenJets can administer a wide range of subcutaneous, intradermal and some intermuscular injections and will be shipped from a pharmaceutical company, pre-filled with a drug dose ready to inject.

PenJets(R) are safe and simple enough for most people to instantly administer an injection to themselves or others without any prior experience. Coupled with its low cost, PenJets(R) are applicable for usages ranging from mass inoculations of entire populations for diseases such as influenza and smallpox, to home administration of pharmaceuticals by patients or their caregivers. It should prove useful in underdeveloped nations where vaccines can be distributed and safely administered to people who have little or no access to health care professionals.

PenJet(R) Corporation is a private company specializing in drug delivery systems that encompass drug delivery devices, and fully automated aseptic assembly and filling equipment. Its website is at http://www.penjet.com.