In my last blog I talked about how products providing Transformational Change can be developed at fractions of the usual cost, risk and time by Strategic Drug Delivery: i.e. by combining existing drugs with delivery technologies to fill existing “Therapy Gaps.” The eye space is a fertile ground for this model as there are many poorly treated diseases, many drugs that could work and very few effective ways to get them to the back of the eye. Hence a lot of therapy gaps.
Our most recent product ILUVIEN® (developed with our partner Alimera Sciences) may fill some of those gaps– it provides 3 years of therapy for chronic Diabetic Macular Edema from a single injection and has been approved in multiple EU countries with first sales expected in Germany later this quarter. People following Alimera carefully may have seen that a price in Germany of €7,975 has been published. This is obviously great news. Now, the published price is essentially the “list price” and the ultimate sales price will likely be subject to various discounts to the list price. So this is consistent with Alimera’s statement that the Germany price will be comparable with the UK price of £5,500 (accepted by UK private insurers). In another positive development, Alimera recently stated that they had “submitted a response to the FDA’s CRL.” This is regulation speak for re-filing the NDA for ILUVIEN. The next development will hopefully be the acceptance of the re-filing for review and the issuance of a PDUFA date. This won’t mean that the FDA has accepted the product, only that it will review the application within a certain time period (the PFUFA date).
Another positive development for pSivida has been the signing of a technology evaluation agreement with an un-named “International Pharma company.” Under these kinds of agreements, researchers from pSivida and the partner typically work together to come up with potential products, typically with pSivida providing the delivery technology and the partner providing the drug molecule (and the money). If successful, the companies typically negotiate a full license and collaboration agreement. These negotiations occur with the knowledge that the drug and technology “work” together and the value of the deal typically increases (as the risk to both sides decreases). This is truly a ”win-win” as the downsides are reduced, the partner hasn’t paid a lot of money for a license to something that doesn’t work with their drug and our technology is not locked up in a program that isn’t going anywhere.
If you remember the equation from my last blog post:
Therapy Gap + (Current Drug X Technology) = Transformational Change
These agreements increase the “Current Drug” part of the equation. “Therapy Gaps” and “Technology” are already there. So these agreements increase our chances of hitting Transformational Change, and at no cost to us. In fact our tech evaluation agreements are expected to bring in more than $2m over the next year or so; helps our burn rate AND gives real upside.
Next time I look forward to discussing the impact of Biologics on drug delivery space and providing more color on our development programs.