Alan Shortall, the Founder, CEO and Executive Director of Unilife Corporation (UNIS), Interviews with The Wall Street Transcript

Wall Street Transcript


Topics covered: Orthopedics and Cardiovascular Medical Devices - Medical Device Innovation and Consolidation Trends - Cardiac - Health Care - Affordable Care Act - Continued Pricing Pressure - Aging U.S. Population

Companies include: Unilife Corporation (UNIS) and many more.

In the following excerpt from the Medical Devices Report, the Founder, CEO and Executive Director of Unilife Corporation (UNIS) discusses company strategy and the outlook for this vital industry:

Now to put this into context, there are over 1,000 biologic drugs coming through the R&D pipeline from U.S. pharmaceutical companies alone. These are very high-performance and very high-value drugs, oftentimes selling for anywhere from $2,000 to up to $8,000 or more per dose. The pharmaceutical companies love them, because they don't have to sell many to have a blockbuster, which is over $1 billion a year. It's also more difficult when they go off-patent for a bio-similar company to try to replicate them without having to do clinical trials, so there's a lot of value in biologics for pharmaceutical companies. Those which ultimately get approved will have cost an average of $1 billion to get to market, but with so many coming through the pipeline, it's reasonable to assume, as they're chasing similar disease states, chronic disease in particular, they're going to end up entering into competitive market spaces.

With more patients self-injecting, the injectable drug delivery system becomes very important as a differentiator and also as an enabler for delivery, so you look out five, six years when a physician goes to write a prescription, then the physician might have a choice of three or four high-performance biologics. With all other things being equal, chances are the physician will write the prescription for the drug that's the easiest, safest and most convenient for the patient to just self-inject - not only just for convenience, but because the patient's adherence or nonadherence to a drug regimen can become a big cost to the health care system. So the easier it is for the patient to use it, the better the chances are that the patient is going to continue on that drug regimen.

Now this is where the EZMix comes into play. Over a third of the biologics are expected to be delivered into the market in what's known as a lyophilized format. That's like a dry or powdered drug. There are many reasons for that, but the main reason is because of the complexity of the biologics. The pharmaceutical companies are challenged in being able to keep them in a liquid-stable state to meet the shelf-life requirement, so what they'll do is dry-freeze the liquid into a powder format that has to then be reconstituted with diluent at the time of injection.

Currently, the only real way to reconstitute a lyophilized drug is through a complex process consisting of around 14 or more steps, where the user has to draw up the liquid, inject it into the vial with the powder, shake it up, use another syringe to draw up to inject, etc. It's a long process, and it's also a process that's prone to patient error. If a patient makes an error in reconstitution, they may have to discard the dose, which could mean throwing away thousands of dollars. Additionally, it could be a risk to the patient if it's not done properly. Physicians are not generally inclined to write a prescription for a patient to self-inject when the patient may have to reconstitute a lyophilized drug.

So what we've done to remedy this is create the EZMix. The core of the EZMix is our Unifill syringe; however, EZMix contains the drug powder and the diluent together in two separate chambers. With one single step, the patient pushes on the flange; it reconstitutes the drug through fluid mechanics, mixing the diluent and the powder together, and then when the patient injects, they have built-in safety with automatic and controlled needle retraction, so when the syringe is taken away from the body the needle has disappeared. There is no risk of needlestick injuries. We've been able to take a very complex process down to a very simple one-step process.

You will never give an EZMix or a Unifill to a health care worker or a doctor, or even a pharmaceutical company executive, and fail to receive a very enthusiastic "wow." The EZMix is ...


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