The Pharma world is all about innovation: new treatments, better treatments and methods that transform the way diseases are treated. Innovations that achieve this transformational change in therapy are what drive research, and can be massively profitable.
Developing new drugs to achieve transformational change, Big Pharma’s traditional path, is very time consuming, risky and expensive. On average it takes over 13 years to develop a new drug, fewer than 1 in 20,000 new drug candidates ever make it to approval and the average cost is well over $1 billion. Fewer than 25% of approved drugs even cover their own development costs. New drug discovery is a daunting undertaking, but when successful the rewards for drugs that provide transformational change can be huge.
There is another way to achieve this: Strategic Drug Delivery.
Strategic Drug Delivery companies can make products that provide transformative change AND make money. They can also do it at fractions of the time, risk and cost of developing a new drug molecule. Strategic Drug Delivery looks for the therapeutic gaps in clinical practice and applies currently available drugs plus new delivery technology to fill those gaps and to create transformational change. You can consider it as a mathematical equation
Therapy Gap + (Current Drug X Technology) = Transformational Change
Take away anything on the left of the equation and it’s hard to achieve the right of the equation.
A great example of Strategic Drug Delivery is Concerta. Before Concerta ADHD therapy wasn’t much good, pills needed to be taken 3 times a day, something children find hard to do when they are at school. A once a day sustained release pill that the parents could give at breakfast was a game changer and a multi-billion dollar product (Concerta). Therapy Gap + (Current Drug X Technology) = Transformational Change. Alza, the maker of Concerta, was subsequently acquired by JNJ for over $10B.
pSivida is a Strategic Drug Delivery Company with a history of not only coming up with products that provide Transformational Change, but also of getting them approved. Our main focus is on ophthalmology and diseases of the back of the eye. That’s where there are a lot of therapy gaps. Many eye diseases, many drugs that potentially work, and no convenient way to get them to the back of the eye. The two leading drugs for eye disease right now (Eylea and Lucentis sharing a $4 billion+ market) have to be injected into the eye every 1-2 months…..indefinitely.
We make sustained delivery systems that provide Transformational Change for the treatment of blinding eye diseases.
Our first product Vitrasert (partnered with Bausch and Lomb) was the first FDA approved drug for a back of the eye disease. This implantable device releases an anti-viral to treat CMV retinitis, a blinding AIDS associate disease.
Our second approved drug Retisert, partnered Bausch and Lomb and approved by the FDA in 2005, was the first approved therapy for posterior uveitis, a blinding autoimmune disease that’s the third or fourth largest cause of blindness in the developed world.
Our most recent product ILUVIEN (partnered with Alimera Sciences and approved in the EU) is the first long term implant approved for Diabetic macular edema, one of the most common causes of vision loss. This implant is a big step forward. It releases medication for three years after a SINGLE injection. It’s scheduled to go on sale (initially in Germany) at the end of this month. There is a lot of focus on this product and rightly so given its importance for patients (one injection per three years versus an injection every 4-6 weeks) the size of the market (about 1 million in the EU) and the very large economic upside for us (we have received $30m from Alimera thus far and will take a sizable piece of profits.
In my next blog I look forward to updating you on the commercial launch of ILUVEIN, EU pricing and the progress towards US approval, and share my own take on developments in the Pharma World.