Posted on October 6th, 2014
by Paul Ashton, Ph.D.
It’s approved for patients with DME who now have previously been treated with a course of corticosteroids and have not had a clinically significant increase in intraocular pressure (regardless of whether or not they are receiving injections of anti-VEGFs). So this is great news for these patients, they now have an option that provides treatment for 3 years with a single injection and could actually reverse vision loss for many.
It’s great news for our development partner Alimera Sciences, which has invested a lot of time and money in advancing ILUVIEN and is now permitted to market in the U.S. As Alimera’s only product, Alimera can focus its attention on marketing in the U.S. market and the EU, where ILUVIEN’s already approved in 10 countries and marketed in two of them.
And it’s great news for pSivida. The approval of this, our third FDA-approved product, puts us in a very different place as a company and moves us significantly forward on the path to being a stand-alone Specialty Pharma.
First, there is the financial impact–immediate and longer term. We are entitled to a $25m milestone payment from Alimera, and with its payment, we will have enough cash to take us into 2017. Importantly, this payment is non-dilutive – we did not have to issue any stock for this funding. In addition, we could receive more cash from our share of the net profits on ILUVIEN sales. We are entitled to our 20% split of the net profits from each country where Alimera sells ILUVIEN.
Next, there is the impact of ILUVIEN’s approval on the development timeline of our own product, Medidur for posterior uveitis. We believe that the FDA’s approval of ILUVIEN for DME should reduce the risk and shorten the approval path of Medidur, because Medidur is exactly the same micro-insert that’s used in ILUVIEN for DME. It has the same design, the same drug, the same polymers and the same release rate. The only difference is that we have redesigned the inserter to use a smaller gauge needle more commonly used for intravitreal injections, rather than the larger gauge needle used in the ILUVIEN inserter.
Because we have joint ownership of and full reference rights to all ILUVIEN clinical data, we will now be able reference data from an FDA-approved product in the Medidur NDA. We also believe that with ILUVIEN’s approval, we will be able to file for FDA approval of Medidur based on a single Phase III study (together with data from a utilization study we plan to conduct with respect to the new inserter), rather than conducting two Phase III trials. This approach isn’t new. Ozudex for uveitis was approved on the basis of a single Phase III trial after it had already been approved for a
different indication (retinal vein occlusion) with two Phase III trials.
Finally, this approval provides further validation of our business model in ophthalmology: developing new products by improving the effectiveness of already- approved drugs with better delivery systems. The drug in ILUVIEN, fluocinolone acetonide, is an off-patent drug, but when delivered properly, it is highly effective in treating DME andposterior uveitis. With the FDA approval of ILUVIEN, we have validated the latest generation of our Durasert technology; the ILUVIEN micro-insert delivers its drug on a sustained basis for years with a single injection.
There are many ophthalmic diseases where long-term sustained delivery could be key, such as dry-AMD. This disease is about eight times more prevalent than wet-AMD, and currently, there are no treatment options, other than vitamin supplements with inexorable vision loss. We believe a long-term delivery technology coupled with one of several existing drugs could provide a therapeutic breakthrough for these patients. Durasert is currently the only long-term delivery system that has been approved by the FDA for any ophthalmic disease. We believe our Tethadur technology designed to deliver peptides and proteins, including anti-bodies, will be a second such system, achieving the goal of pharmaceutical science for decades to provide long-term delivery of these biologics.
So we have a lot of potential targets and catalysts coming up. Our phase III uveitis study has a one-year primary end-point, and we expect to completed enrollment in about 6 months. (And, as I mentioned above, thanks to the $25 million milestone payment, we believe that we will have more than enough cash to take us through to data, without any net profit payments from ILUVIEN.) In addition, we are continuing to work on our preclinical development programs for both Durasert and Tethadur and look forward to developing new product candidates from that work.
Our strategy going forward will be continue to develop our own products such as Medidur, where the risk, cost and scale of opportunity is appropriate. At the same time, we’ll continue to leverage our technology by working with other companies on products that are outside our internal strategic focus or too expensive to develop ourselves. We have a very exciting future ahead and all of us at pSivida will be working to advance these programs. And we’ll be able to do this from a secure financial position. We have reached an inflection point.
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.