PSDV : pSivida Corporation Stock Analysis and Research Report

2017-10-20 - by Asif, Contributing Analyst

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pSivida Corporation develop sustained-release drug delivery products that deliver drugs at a controlled and steady rate for months or years. pSivida hss developed three of the four sustained-release ophthalmic products currently approved by the U.S. FDA for treatment of back-of-the-eye diseases. Its product development programs are focused primarily on utilizing its core Durasert technology platform to deliver drugs to treat chronic diseases. Durasert three-year uveitis is its most advanced development-stage product, and is designed to treat chronic non-infectious uveitis affecting the posterior segment of the eye (posterior segment uveitis) for a period of three years. Durasert three-year uveitis met its primary efficacy endpoint of prevention of recurrence of uveitis through six months with a p value of < 0.001 in two ongoing pivotal Phase 3 clinical trials. pSivida anticipate filing an NDA with the FDA in late December 2017 or early January 2018. In July 2017, pSivida amended its collaboration agreement (the Prior Alimera Agreement) with Alimera to, among other things, license distribution, regulatory and reimbursement matters for Durasert three-year uveitis (under the ILUVIEN trademark) for the EMEA to Alimera. Pursuant to the Prior Alimera Agreement, its lead licensed product, ILUVIEN® for DME, is sold by Alimera in the U.S. and multiple EU countries. Its strategy includes developing non-proprietary drugs independently in combination with its Durasert technology platform, while continuing to leverage its technology platform through collaborations and license agreements as appropriate.

Durasert Three-year Uveitis

Injected into the eye in an office visit, Durasert three-year uveitis is a micro-insert that delivers a micro-dose of a corticosteroid to the back of the eye on a sustained basis for approximately three years after a single administration. In Europe, pSivida filed a marketing authorization application (MAA) in June 2017 and subsequently withdrew the application after out-licensing the European rights for Durasert to Alimera. Alimera plans to submit the Durasert three-year uveitis data under its existing ILUVIEN MAA and, if approved, to commercialize the uveitis indication under the ILUVIEN trademark.

pSivida is developing Durasert three-year uveitis independently and the company plan to file an NDA with the FDA by the end of calendar year 2017. Both of its Durasert three-year uveitis Phase 3 clinical trials met their primary efficacy endpoint of prevention of recurrence of uveitis through six months with statistical significance (p < 0.001; intent to treat analysis) and yielded safety profiles consistent with the known effects of ocular corticosteroid use. Similar efficacy and safety results have been observed through 12 months of follow-up in the first pivotal trial and twelve month data from the second pivotal trial is expected in early calendar year 2018. Pending NDA submission and approval by the FDA, pSivida plan to independently commercialize Durasert three-year uveitis in the U.S. given the relatively modest market size and correspondingly limited commercial footprint required to launch on its own.

ILUVIEN

ILUVIEN, an injectable, sustained-release micro-insert delivering 0.19mg of FA to the back of the eye for the treatment of DME, was licensed to and developed with Alimera under the Prior Alimera Agreement. In July 2017, pSivida entered into an amended and restated collaboration agreement with Alimera (the “Amended Alimera Agreement”) pursuant to which pSivida (i) licensed the rights to its three-year uveitis indication to Alimera for the EMEA and (ii) converted its license consideration from a share of Alimera’s net profits for ILUVIEN to a royalty based on Alimera’s net sales for ILUVIEN for DME and, upon an MAA approval, for net sales of ILUVIEN for posterior segment uveitis. Sales-based royalties start at the rate of 2% effective as of July 1, 2017. Commencing January 1, 2019 (or earlier under certain circumstances), the sales-based royalty will increase to 6% (8% on total ILUVIEN net sales in excess of $75 million on a calendar year basis). Alimera's share of contingently recoverable accumulated ILUVIEN commercialization losses under the original net profit share arrangement (as set forth in the Prior Alimera Agreement), was capped at $25 million. Under the Amended Alimera Agreement those recoverable losses will be reduced as follows: (i) $10.0 million was cancelled in lieu of an upfront license fee on the effective date of the Amended Alimera Agreement; (ii) for calendar years 2019 and 2020, 50% of earned sales-based royalties in excess of 2% of net sales will be offset against the quarterly royalty payments otherwise due from Alimera; (iii) on January 1, 2020 (or earlier under certain circumstances), another $5 million will be cancelled, provided, however, that such date of cancellation may be extended under certain circumstances related to Alimera’s regulatory approval process for ILUVIEN for posterior segment uveitis, with such extension, if any, subject to mutual agreement by the parties; and (iv) commencing in calendar year 2021, 20% of earned sales-based royalties in excess of 2% of net sales will be offset against the quarterly royalty payments due from Alimera until such time as the remaining balance of the original $25 million of recoverable commercialization losses has been fully recouped.

pSivida believe that the terms of the Amended Alimera Agreement for ILUVIEN for DME have standardized and simplified the agreement, and improved the potential total value of the agreement for it. ILUVIEN for DME has been sold by Alimera in the U.S. since 2015, where it is indicated for the treatment of DME in patients previously treated with a course of corticosteroids without a clinically significant rise in intraocular pressure (IOP). ILUVIEN for DME has been sold by Alimera in the U.K. and Germany since 2013, in Portugal since 2015 and in Italy, Spain and certain Middle East countries (through sublicense partners) since the second quarter of calendar year 2017. ILUVIEN has marketing approvals in a total of 17 European countries, where it is indicated for the treatment of chronic DME considered insufficiently responsive to available therapies.

Retisert

FDA-approved Retisert® is an implant that provides sustained treatment of posterior segment uveitis for 30 months that was co-developed with and licensed to Bausch & Lomb. Implanted in a surgical procedure, Retisert delivers the same corticosteroid as Durasert but in a larger dose. pSivida receive royalties from Retisert sales.

pSivida is also using its Durasert technology platform to identify potential product candidates that provide sustained treatment of wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis and other diseases. In collaboration with Hospital for Special Surgery (HSS), the company is developing a sustained-release surgical implant to treat pain associated with severe knee OA. This product is currently being evaluated in an investigator-sponsored pilot clinical study that is expected to provide initial results in late calendar year 2017. pSivida is also conducting nonclinical evaluations of various tyrosine kinase inhibitor (TKI) candidates for wet AMD. Finally, pSivida is developing a next-generation Durasert shorter-acting version, initially for the treatment of posterior segment uveitis.

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