Posted on April 17th, 2013
by Paul Ashton, Ph.D.
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.
Forward Looking Statements
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this blog are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: Alimera's ability to obtain regulatory approval for ILUVIEN for DME in the U.S. through the advisory committee or otherwise, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, successfully complete pricing and reimbursement discussions for, commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU;; the ability to finance, complete and achieve a successful outcome for Phase III trials for, and file and achieve marketing approvals for, Medidur for posterior uveitis, including efficacy, side effects and risk/benefit profile, as well as uncertainty as to the ultimate results of the investigator-sponsored trial for Medidur for posterior uveitis; initiation, financing and success of Latanoprost Product Phase II trials and exercise by Pfizer of its option; ability to utilize Tethadur and BioSilicon to develop product candidates and products and potential related collaborations; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty income; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.