According to Alan Shortall, CEO of Unilife, one of the fastest growing sectors of the $200 billion pharmaceutical market is lyophilized drugs and vaccines that require reconstitution at the point of delivery. The supply of therapies in a lyophilized, or dry drug powder form, says Alan Shortall, is common where the molecule is either not suitable for liquid stable form or the pharmaceutical company is seeking to fast-track time to market.
With macromolecule biologics comprising an increasingly large part of the development pipelines of pharmaceutical companies, one in every three novel drugs approved by the FDA since 2008 has been launched in a lyophilized form, reports Alan Shortall.
In this interview, Alan Shortall, Unilife’s CEO, discusses some of the unmet needs and potential solutions for this fast-growing market for drug reconstitution.
Question: Welcome, Alan Shortall. Would you please explain how lyophilized drugs are typically delivered into the market?
Alan Shortall: “Traditional methods for drug reconstitution are extremely time intensive, making them largely unsuitable for use by patients. You need several pieces of equipment including a vial for the lyophilized drug, a vial for the diluent, two needles and a syringe. It can require ten distinct steps just to reconstitute the drug, let alone its delivery to the patient.
Question: Does this explain the growing popularity of dual chamber prefilled syringes?
Alan Shortall: “Dual chamber prefilled syringes represent a far more convenient delivery system for lyophilized drugs and vaccines. In one chamber, you have the lyophilized drug. And in another chamber is the diluent. But there are still problems with conventional dual chamber technologies”.
Question: Alan Shortall, can you describe some of these unmet market needs?
Alan Shortall: A dual chamber prefilled syringe should ideally be as simple as two key steps…Reconstitute the drug, and inject the dose. But conventional dual chamber prefilled syringes can involve multiple steps that make them non-intuitive for use by either trained clinicians or patients. Another problem is that conventional dual chamber prefilled technologies requiring vents that can….
Finally, there is no dual chamber prefilled syringe with integrated safety features.
Question: How are Alan Shortall and the Unilife team looking to make a difference?
Alan Shortall: “We are very much driven to address unmet market needs. You see an increasing number of biotech molecules that are not liquid stable. We have developed a unique technology platform of drug reconstitution delivery systems that can address the needs of pharmaceutical customers, healthcare workers and their patients. We are now bringing these technologies to market in conjunction with interested pharmaceutical partners.”
Question: What are the key points of differentiation between Unilife’s technology and the status quo for dual chamber prefilled syringes?
Alan Shortall: The EZMix is the only prefilled syringe that combines efficient drug reconstitution with integrated safety features. It features two drug chambers in a single delivery system that is easy for either healthcare workers or patients to use. It can store either liquid-liquid or liquid-powder combinations. There are really only two key steps of use…reconstitution and injection. And at the completion of the full dose, a retraction mechanism is automatically activated that allows the operator to control the speed at which the needle is withdrawn directly from the body into the barrel where it’s locked in place. So EZMix is a drug reconstitution system, a primary drug container, a safety device and a needle containment system all rolled into one.
Question: What stage of development is the EZMix?
Alan Shortall: We have developed the EZMix in direct response to the unmet needs of some of the pharmaceutical companies we regularly collaborate with. And since we announced the initial development of the EZMix in 2011, we’ve been flooded with additional pharmaceutical companies seeking further information. As with all of our products, the device can also be customized to address any specific requirements the customer may have.
Question: What types of drugs do you see being administered by EZMix?
Alan Shortall: The EZMix offers a revolutionary solution to the reconstitution and injection of a wide variety of lyophilized drugs and vaccines. The devices can be supplied either with a staked (fixed) needle for subcutaneous injections, or with interchangeable needles of up to 1.5 inches in length. The current technology can accommodate up to 1mL of diluent volume. With so many emerging therapies being developed that can be enabled or enhanced by delivery in the EZMix, we see a very big future for this technology.
Alan Shortall can be contacted at firstname.lastname@example.org or www.unilife.com.
Although Unilife recently moved their offices to the United States from Australia, the firm is still publicly traded in its country of origin. Unilife may be found on both the NASDAQ as well as the Australian Stock exchange. Founder and CEO of Unilife Alan Shortall says that the transition from Australia to the United States happened between 2008 and 2010; the firm has offices in both countries.
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