pSivida news
pSivida hat gleich mehrere heisse Eisen im Feuer:
Neben der Eigenentwicklung von Wirkstoffen inkl. Dosierungstechnologie in der Ophthalmologie arbeiten sie mit Alimera (Illuvien Lancierung dieses Jahr in UK und DE, resubsmission in US auch diese Woche) sowie Pfizer zusammen.
Und nun kommt eine weitere Zusammenarbeit zustande mit einem Global Player aus der Pharmabranche --> siehe news von heute.
Meldung vom 04.04.2013:
WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that it has signed a funded technology evaluation agreement with a leading global pharmaceutical company. The agreement will evaluate pSivida’s proprietary Durasert™ and Tethadur™ technologies for this pharmaceutical company’s select products in ophthalmology. The Durasert technology system delivers specific quantities of drugs directly to a target site in the body at controlled rates for predetermined periods of time ranging from weeks to months. Tethadur is pSivida’s proprietary technology for the delivery of proteins, peptides and antibodies.
“We are extremely pleased to be working with another global pharmaceutical company to apply our unique technologies to develop transformational products in ophthalmology,” said Dr. Paul Ashton, pSivida president and CEO.
pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN®, partnered with Alimera and approved in multiple EU countries. Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.
Meldung vom 01.04.2013
WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (PSDV)(PVA.AX), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).
Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.
“We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”
pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.
