Autoinjector Technology in Autoimmune

December 22, 2009 – 2:29 pm by Gina Monari

Chronic conditions, such as those within the autoimmune therapeutic category, are being made more manageable by new devices that make home administration more convenient, dosing more effective, and improve patient compliance. Industry predictions are that therapies for treating those patients will continue to be launched with some form of autoinjector technology, according to Graham Reynolds, VP, innovation strategic marketing, West Pharmaceutical Services Inc. The search for better autoinjectors will continue and features such as needle retraction and needle safety will continue to multiply.

“You reach a critical mass in the market where market leaders are using autoinjector technology, so new entrants to the market have to come up with at least equivalent – if not better – technologies to allow them to compete in the marketplace,” Mr. Reynolds says.

In April, Centocor Ortho Biotech Inc.’s Simponi received FDA approval as the first once-monthly anti-TNF for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The drug was the first subcutaneous anti-TNF to launch with three rheumatic indications simultaneously and with the novel SmartJect Autoinjector.

The Simponi SmartJect is a novel autoinjector designed to meet the needs of arthritis patients that has received the Ease-of-Use Commendation by the Arthritis Foundation.

In 2006, Abbott Laboratories launched the Humira Pen to help make self-injecting simpler and less painful for patients. Humira is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The product is also used to treat Crohn’s disease after other drugs have been tried without successful treatment of symptoms.

Drug companies are beginning to consider the use of autoinjectors earlier in the drug-development process than before. Companies are beginning to have the intent to launch the product with the autoinjector, which means that they have to start the evaluation and the development work very early in the drug cycle, typically in Phase II development of that drug. This is important because there is a critical connection between the autoinjector or the delivery device and the drug container. The drug container in most autoinjectors is a prefillable syringe that has to be compatible with the autoinjector and has to function effectively to be able to give the dose every time repeatedly without any adverse effect on the drug or the device.

“What that means is that a pharmaceutical company or a biotech company should be thinking in Phase II studies if they’re going to go to an autoinjector they need to be evaluating the compatibility of the syringe or the autoinjector at an early stage,” Mr. Reynolds says.

For a device to be successful, patient needs with regard to training tools and support must be met. The needs of the end-user will determine the size of a device, how it should look, and how it should feel. This kind of information provides marketers and their partners with good information to train individuals and give support in using the device.

Many pharmaceutical provide online support for patients after the launch of a product. Pharmaceutical companies, their vendors, and advertising agencies are working much closer now than before, and some industry experts believe there is a lot of opportunity for more collaboration between the device manufacturer, the drug manufacturer, the patient population, and the branding people who position the product.

“In an ideal world you’d have a strong collaboration with all the aspects right back from the device manufacturer or the drug manufacturer or the marketers and more importantly, the patient, to figure out how we can all help them to make the injection experience much more compliant, but also easier,” Mr. Reynolds says.

SimponiOne Support is an online support solution developed for people receiving treatment with Simponi and for healthcare professionals. Patients have access to cost support, nurse support, and safe returns for the proper disposal of used SmartJect autoinjectors. Medical practices trying to figure out insurance billing for Simponi can use AccessOne, an integrated service for Simponi benefits.

Abbott’s My Humira provides patient support for the Humira Pen and prefilled syringe. At the Website, patients have access to injection instructions and a video, a kit to get started, the ability to talk to a nurse, information about Humira Pen and syringe disposal, medication reminders, and tips from the myHUMIRA Panel comprising of individuals living with autoimmune conditions. The company provides detailed transcripts and visual guidelines throughout the site, such as this Humira Pen diagram below.

Autoinjector and prefillable syringe technology continues to evolve. West Pharmaceuticals has developed ConfiDose, a disposable autoinjector designed for prefillable syringes, which can be glass or plastic. A patient carries out three steps with ConfiDose, which requires them to first remove the cap, then twist the device to release the safety mechanism, and then place it on their body in the appropriate point of injection and hit the button. During the process, the needle is inserted, the dose delivered, and at the end of the dose the needle retracts.

“The needle is completely hidden both before and after injection, which we find to be a key factor when you’re talking about needle phobia and pain of the patient and also safety in terms of encapsulating the needle after use,” Mr. Reynolds says.

West’s Confidose technology allows more novel high-viscosity drugs to be injected in a reasonable period of time, without the risk of damaging the syringe or incomplete dosing. The drug is prepackaged in the device, which is a barrier to counterfeiting.

Editor’s Note: Watch for the January issue of Med Ad News to read more about marketing and branding in the therapeutic area of autoimmune diseases, and check out the February issue of Pharmaceutical and Medical Packaging News to read more news about the use of autoinjectors in other therapeutic categories.