Innovative Injectors Extend Drug Patent, Marketing Life
Over the next few years, single-use, pre-measured injection systems could change the marketing and patent status of many chronically-administered drugs, according to Meridian Medical Technologies, Inc. "Once a drug is re-formulated and delivered in a novel way, companies may apply for additional patent protection," says Thomas Handel, Executive Director of Business Development at Meridian.
Meridian began as a supplier of single-use injectors for the military. The firm still sells the Department of Defense single-use delivery systems containing antidotes to chemical and biological weapons, but Meridian is now eyeing much broader pharmaceutical markets. Meridian's Auto-Injector, a plastic, self-enclosed, metered single-dose injector, has been the object of "around" five in-house New Drug Applications, according to Handel, "and several others involving pharmaceutical companies. We're looking at delivery of drugs for migraine, AIDS-induced anemia, hormones, and emergency drug delivery."
Handel could not comment on outside NDAs due to confidentiality agreements. However, Meridian's niche markets should provide excellent growth. Meridian is staying away from insulin, the prototypic self-administered injectable drug. "Insulin injections need to be titrated on a daily basis," said company spokeswoman Kathleen Austin, so a metered dose is not appropriate for insulin injection." Rather, the company concentrates on emergency drugs or chronically administered medications such as epinephrine (for anaphylactic shock), human growth hormone, and lyophilized biopharmaceutical preparations.
On Feb. 10 Meridian signed an agreement with Duoject Medical Systems to provide diluent solution and assembly for Duoject's innovative Inter-Vial drug delivery system, which provides rapid, accurate administration of injectable drugs that lack long-term stability in solution. Inter-Vial consists of a syringe that stores powdered medication in a standard vial and sterile diluent in a separate, mechanically connected cartridge. Users mix the wet and dry components quickly in one motion just before injection. The new device, which eliminates preparation time and dosage errors, is designed for the many injectable biotech-derived drugs that cannot be stored in solution.
Duoject will provide mechanical components of the Inter-Vial system and its pharmaceutical company customers will supply dry medication in powder or cake form in vials to Meridian's St. Louis, MO manufacturing facility. Meridian will then prepare cartridges of injectable sterile water and automatically assemble the complete inter-Vial system into a kit that will be ready for market.
Meridian and Duoject are negotiating with pharmaceutical companies which have products requiring this form of delivery. Meridian has worked closely with drug company partners in the past, supporting both NDAs and clinical trials using its Auto-Injector. "Typically a drug company will deliver their active ingredient to us and we'll package it into injectors. We'll then work with our customer on the clinical trials and any regulatory filings that need to be done," Handel said.
For more information, contact: Thomas Handel, Executive Director, Business Development, Meridian Medical Technologies, Inc., 10240 Old Columbia Rd., Columbia, MD 21046. Tel: 410-309-6830.
by Angelo DePalma