PSDV and Pfizer start P1 glaucoma trials ...
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At that point, Pfizer has an option to take an exclusive, world-wide license to develop and commercialize the product candidate in return for a
$20 million option exercise payment,
double-digit royalty payments on sales of the product and additional development, regulatory
and any sales performance milestone payments of up to $146.5 million.
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pSivida Announces Phase I/II Clinical Study Evaluating Bioerodible, Sustained Release Latanoprost Device in Ocular Hypertension and Glaucoma
WATERTOWN, Mass.--(BUSINESS WIRE)-- Drug delivery company pSivida Corp. (NASDAQ:PSDV - News) (ASX:PVA.ax - News) today announced the commencement of a Phase I/II clinical trial studying a new bioerodible drug delivery implant for the treatment of glaucoma and ocular hypertension. The implant is designed to provide long-term, sustained release of latanoprost, the most commonly prescribed agent for reduction of intraocular pressure in patients with ocular hypertension and glaucoma worldwide.
The product candidate is a new, compact drug-delivery implant based on the Company’s DurasertTM technology system. The implant is designed to be administered by an eye care professional in a minimally invasive, outpatient procedure; it is also designed to be injected into the subconjunctival space of the eye and to be bioerodible.
The new study is a dose-escalating study designed to assess the safety and efficacy of the implant in patients with elevated intraocular pressure. If successful, pSivida plans to advance the product into a multi-center Phase II trial.
Dr Paul Ashton, President and CEO of pSivida Corp., said, “We are extremely pleased that this first application of our new bioerodible drug-delivery technology has entered clinical trials. We look forward to advancing this new delivery system both in glaucoma and potentially in other applications as well.”
The insert is being developed under the recently amended Research and Collaboration Agreement with Pfizer Inc. Under the revised agreement, Pfizer will make an initial payment of $2.3 million. pSivida will, with technical assistance from Pfizer, have the right to develop this candidate for the reduction of intraocular pressure in patients with ocular hypertension or glaucoma through Phase II clinical trials.
At that point, Pfizer has an option to take an exclusive, world-wide license to develop and commercialize the product candidate in return for a $20 million option exercise payment, double-digit royalty payments on sales of the product and additional development, regulatory and any sales performance milestone payments of up to $146.5 million.
If Pfizer does not exercise its option, pSivida will retain the right to develop and commercialize the glaucoma product on its own or with a partner. As part of the amended agreement, pSivida regains all rights to its intellectual property in ophthalmic applications previously included in the original Research and Collaboration Agreement, other than those related to the latanoprost product.
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