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pSivida Corp. (PSDV)
Q3 2014 Earnings Conference Call
May 13, 2014 04:30 PM ET
Lori Freedman - VP of Corporate Affairs and General Council
Dr. Paul Ashton - President and CEO
Len Ross - VP, Finance
Suraj Kalia - Northland Securities
Graig Suvannavejh - MLV
Previous Statements by PSDV
» pSivida (PSDV) Q3 2014 Results - Earnings Call Webcast
» pSivida Corp's CEO Discusses F2Q 2014 Results - Earnings Call Transcript
» Q2 2014 P Sivida Corp Earnings Conference call (Webcast)
» pSivida's CEO Discusses F1Q 2014 Results - Earnings Call Transcript
I would now like to turn the conference over to Ms. Lori Freedman, Vice President of Corporate Affairs and General Council. Ma'am you may begin.
Good afternoon everyone and thank you for joining us. After the market closed today, we released our third quarter financial results for fiscal 2014. A copy of the release is available on the Investor section of our website at www.psivida.com. On the call with me today is Dr. Paul Ashton, President and Chief Executive Officer; and Len Ross, Vice President, Finance.
Before I hand the call over to Paul, I need to remind everyone that some of our prepared remarks are and answers to your questions may be forward-looking in nature. Forward-looking statements are inherently subject to risks and uncertainties. All statements other than statements of historical facts are forward-looking statements and we cannot guarantee that the results and other expectations expressed, anticipated, or implied will be realized. Actual results could differ materially from those anticipated, estimated or projected in the forward-looking statements. For a more detailed discussion of risk factors that could impact our future results and financial condition, I refer you to our filings with the SEC including our Annual Report on Form 10-K for the fiscal year ended June 30, 2013. We undertake no obligation to update any forward-looking statements in order to reflect events or circumstances that may arise after this conference call.
With that, I’d like to turn the call over to Paul.
All right. Thank you, Lori. And welcome everyone as we discuss the results of our third quarter of fiscal 2014. This was another very good quarter for us, with good news for Medidur, our lead development product, ILUVIEN for chronic DME lead licensed product and Tethadur, our technology for sustain delivery of biologics.
Now first, as you know we’re conducting a phase III clinical trial for Medidur, our injectable sustained release micro-insert for the treatments of posterior uveitis. This is a serious disease to the back of the eye and the third largest cause of blindness in the U.S.
The micro-insert used on Medidur is the same one used on ILUVIEN for chronic DME with the same drug [Indiscernible]. We’d be able to the data in the ILUVIEN filing to support the filings for the approval of Medidur in posterior uveitis.
We now plan to seek approval of Medidur in the U.S. for safety and efficacy data, file only the current phase III clinical trial rather than a two phase II trials we have previously planned, ILUVIEN has approved. This would save money and more importantly time in the Medidur approval process.
We've modified the Medidur in silicon, to use a small gauge needles in ILUVIEN to make Medidur easy to inject. We also plan to provide additional clinical data about the utilization and safety of the new proprietary in silicon. If ILUVIEN is not approved, we would revert back to our original plan.
We expect to complete the [Indiscernible] of our current phase III trial in late calendar 2014 or early 2015, with a primary end points of progression of uveitis at one year. We’re anticipating having data from the trial in the first half of calendar 2016 and potentially filing for U.S approval later that year. We'll be meeting with the FDA to confirm our regulatory strategy, as well as our pay to become avail.
Now, we have a higher level of confidence by the expected results from our Medidur trial based on early clinical trial results for ILUVIEN and DME and Retisert an FDA approved product for posterior uveitis that we developed and incensed to Bausch & Lomb.
Because ILUVIEN is the same insert delivering the same dose of the same drug as Medidur and Retisert is an implant that delivers a larger dose of the same drug for posterior uveitis. We’re very optimistic on our Phase III trial, which use a Medidur as anti effective as Retisert in treating posterior uveitis or with more favorable risk benefit profile and fewer side effects. Comfortable in fact to ILUVIEN but may be even easy to administer. We’re developing Medidur independently.
So let’s turn to ILUVIEN for chronic DME. We are really pleased with the favorable developments in the regulatory process in the U.S. As you recall, ILUVIEN has yet to win U.S. approval. It has been approved in multiple EU countries and it’s being sold by our licensee Alimera in the U.K and Germany.
In March, Alimera re-filed the NDA with the FDA, before the issues raised in the last complete response letter and providing additional safety data. The FDA has issued a PDUFA date of September 26. That’s the date by which the FDA plans to complete its review. And as indicated, further clinical trials will not be required for this decision.