Antares Pharma, Inc. (ATRS)

[jab91252]

Interesting article in the latest "Drug Development and Delivery" magazine. This article is framed and written around "Unilife's" devices - but it relates to the delivery method(s)via injectors and what the market place and companies are looking for. I've posted the link to the article and also some of the key points.
jab9

http://www.drug-dev.com/ME2/dirmod.asp?sid=&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=8F3A7027421841978F18BE895F87F791&tier=4&id=4522F169ED94482CB202FBA462D63EDC

Issue Date: March 2013, Posted On: 3/13/2013
The New Industry Paradigm for Prefilled Success


INTRODUCTION

The prefilled syringe turns 40 next year. Since the filing of the first patents for a glass ready-to-fill syringe in 1974, this device class has attained an unrivaled position as the preferred choice for the delivery of parenteral drugs and vaccines. After a period of relative industry stability defined by peripheral innovation, a converging series of external and internal forces are set to reshape the prefilled syringe industry so that it will better serve the emerging needs of pharmaceutical companies, patients, and other stakeholders across the continuum of care.
More than 2 billion prefilled syringes are used worldwide each year. At least 60 drugs and vaccines are available in a prefilled format for use across more than a dozen therapeutic classes. These branded, generic, and biosimilar injectable therapies, collectively made by a who’s who of pharmaceutical companies, generate combined annual revenues in excess of $50 billion.

In speaking with many pharmaceutical companies, it is apparent that five trends are now converging together to redefine not only the composition of a prefilled syringe, but the entire industry landscape.

These five emerging or unmet market needs for the delivery of prefilled therapies are 1) Device Customization, 2) Lifecycle Management, 3) Needlestick Safety, 4) Brand Differentiation, and 5) Combination Therapies.

Device Customization

Another key requirement for prefilled customization relates to the growing importance of human factors engineering. With prefilled therapies increasingly being targeted for self-administration by specific patient populations, the external design and functionality of the device must be tailored to specific user needs.

During the clinical development or lifecycle management of injectable therapies, drug and device companies must conduct user studies with the target patient group. Human factors that can be measured for patient acceptability include initiation force, glide force, and the activation force for a safety mechanism, the ergonomic design of finger flange, overall ease-of-use, and convenience of disposal.

Lifecycle Management

Traditionally, a pharmaceutical company would launch its therapy lyophilized in a vial, then transition a few years later into a liquid-stable format with a standard prefilled syringe, and then perhaps later add an auto-injector. The lifecycle management of Copaxone by Teva is an excellent example of lifecycle management in process. Today, however, the launch of an injectable therapy in a standard prefilled syringe is considered to be the absolute bare minimum required to compete.

With the standard prefilled syringe now widely acknowledged as a status-quo device, pharmaceutical companies are seeking access to best-in-class delivery systems that can improve therapy compliance and drive preference rates amongst patients and prescribers.

Potential may also exist for prefilled syringes to extend the commercial lifecycle of mature therapies. The conversion of a drug from a standard prefilled syringe into an enhanced, market-leading delivery system may allow the pharmaceutical company to retain some level of market share that would otherwise be lost to incoming generic or biosimilar rivals.

Needlestick Safety

OSHA, the FDA, and many healthcare associations cite a preference amongst healthcare workers for the selection and use of devices with automatic (passive) and integrated safety features that can minimize the risk of harm and best comply with routine injection procedures. Pharmaceutical companies that select such prefilled devices with automatic, integrated safety features will be in a strong position to leverage these protective and functionality benefits to build user preference rates and optimize market share.

Brand Differentiation

Devices that are differentiated and offer true benefits to the patient can be leveraged by pharmaceutical companies to optimize the commercial value of their injectable therapies.

An elegant, sleek, and attractive device that is devoid of unsightly springs, compact in size, and has an external form factor that can be customized to specific drug brand or patient needs can generate powerful levels of differentiation. User opportunities for differentiation may include a more intuitive device that offers fewer steps of use, an unobstructed view of the drug, or the use of audible, tactile, and visual indicators to signal delivery of the full dose. Pharmaceutical companies that are able to access prefilled devices that can be customized to address the specific therapy needs and create the safest, simplest possible injection experience for the patient will have the best opportunities to generate powerful brand differentiation within competitive markets.

Combination Therapies

Prefilled syringes with dual or multichamber configurations that can efficiently contain a combination of liquid or dry drug combinations in a system that is ready for efficient reconstitution or mixing at the point of delivery have significant potential to transform the treatment of countless chronic or acute conditions. Only a few such dual-chamber prefilled syringes are now available to pharmaceutical companies.

FUTURE OUTLOOK

A number of internal and external forces have led the prefilled syringe industry to a state where it is primed for change. In the future, the prefilled syringe is set to transition from being an off-theshelf commodity device, to one in which component materials, functionality, and branding are fully customizable.
To succeed in this new environment, device manufacturers must follow a new paradigm for market success. They must be committed to serving pharmaceutical companies under long-term partnerships throughout the clinical development and commercial lifecycle of the drug-device combination. They must have the right balance between operational capabilities and business agility to ensure they are responsive and adaptable to emerging customer needs. They must have quality standards that exceed the industry benchmark and instill confidence and reliability into the pharmaceutical supply chain.

Device manufacturers must also possess management depth with strong levels of technical expertise so that their knowledge base can rival, and in some cases exceed, those of pharmaceutical companies. They must have a broad portfolio of flexible, differentiated device technologies that are platform-based instead of being rigid products. And they must be fully committed to working with their customers to enhance or enable the commercial success of their injectable therapies.