Anaheim, Calif., February 14, 2012 — With the goal of becoming the safest, most portable and user-friendly auto-injector on the market, an innovative epinephrine auto-injector in development for patients at risk for anaphylaxis, or severe allergic reaction, is utilizing Bayer MaterialScience LLC plastics. It combines a well-known medicine with a customized delivery system, resulting in a unique solution for patients.
Intelliject, Inc., a specialty pharmaceutical company, created the product, which has recently been granted tentative approval by the United States Food and Drug Administration (FDA) as e-cue™. The need for a product that empowers people to be in control of their medical conditions hits close to home for the founders of Intelliject – identical twin brothers who, themselves, have severe food allergies.
The Intelliject auto-injector, the size of a credit card and thinner than a typical cell phone, is being developed to be carried by at-risk individuals at all times. In the event of a severe allergic reaction, a patient would remove it from its outer case, activating the device's voice-guided PromptSystem™ that walks the person through how to use the product.
Several parts of the device are molded from Bayer plastics.
The outer cover of the device needed to be very thin, according to Mark Licata, vice president, industrialization and quality, Intelliject, Inc. "Makrolon® 2458 medical grade polycarbonate is the ideal material for molding the thin walls of this part because it is a high-flow resin," said Licata.
The electrical cover, white housing and top and the red safety guard of the device are injection molded using two medical grades of Bayblend® polycarbonate/acrylonitrile butadiene styrene (PC/ABS) blend plastic, Bayblend M850 and Bayblend M850XF. Additionally, the piece of the device that touches the patient during injection is molded from Bayblend M850XF. The medical grades of Bayblend PC/ABS blend plastic meet the requirements of the FDA-modified ISO 109931 tests for biocompatibility while offering impact resistance and rigidity, as well as dimensional and color stability.
"As someone who has suffered severe allergic reactions myself, I know it is critical to have an epinephrine auto-injector that can be taken anywhere and that can cope with rough and tumble situations and still perform," said Evan Edwards, co-founder and vice president of product development, Intelliject, Inc. "People often talk about a product as 'tough enough to be run over by a car' as a figure of speech, but we set that as our standard for the e-cueTM. When we received the first batch of devices we took one outside and drove back and forth over it with a car. It was undamaged, which speaks volumes about both its design and the constituent materials."
"The design of the Intelliject auto-injector is what we believe will make it unique in the market," Edwards continued. "Bayer's engineered plastics made it possible to achieve a novel, patient-centric design. But beyond supplying its materials, the Bayer team also provided technical support throughout the device's development, conducting finite element analysis and mold-flow analysis of the materials, which was a great help in the process."
"We worked with Intelliject for several years to advance this device," said Bruce Fine, market segment leader, Medical and Consumer Products - Polycarbonates, Bayer MaterialScience LLC. "We were able to offer the most appropriate medical-grade and general-purpose plastics that met the requirements of several components. We are glad that we were able to provide the materials and technical support that played a role in the design and continued development of this innovative product."
e-cue™ was granted tentative approval by the FDA in August 2011. Tentative approval means that the product review is complete and the submission met the FDA's requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved.
For more information about this application and other medical advances from Bayer, stop by Bayer's booth, #2021, at MD&M West, February 14-16, in Anaheim, Calif.
About Bayer MaterialScience LLC:
Bayer MaterialScience LLC is one of the leading producers of polymers and high-performance plastics in North America and is part of the global Bayer MaterialScience business with approximately 14,700 employees at 30 production sites around the world and 2010 sales of 10.2 billion euros. The company manufactures high-tech polymer materials and develops innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction, medical, and sports and leisure industries. Sustainability is central to Bayer MaterialScience LLC's business and is based around the key areas of innovation, product stewardship, excellence in corporate management, social responsibility and respect for the environment.
Intelliject is a specialty pharmaceutical company dedicated to developing drug/device combination products that empower patients to gain freedom from their medical conditions. Each Intelliject product combines an established drug with an innovative delivery platform with the goal of achieving superiority, patient preference and cost effectiveness.
Intelliject applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable.
Intelliject is a privately held company headquartered in Richmond, Virginia. For online information please visit www.intelliject.com.
Sean Kelly, Phone: 412-777-5200
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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