Key Developments: pSivida Corp (PSDV.W)
3.10USD
23 May 2013
$0.11 (+3.68%)
$2.99
$3.06
$3.10
$3.06
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Latest Key Developments (Source: Significant Developments)
pSivida Corp's licensee Alimera Sciences, Inc Reports On Resubmission To FDA Of NDA For ILUVIEN For Chronic Diabetic Macular Edema
pSivida Corp 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. 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. Full Article
pSivida Corp's Licensee Alimera Sciences, Inc. Reports Updates On ILUVIEN For Chronic Diabetic Macular Edema (DME).
pSivida Corp announced that its licensee Alimera Sciences Inc, Inc. reported a number of updates with respect to ILUVIEN for chronic diabetic macular edema (DME). Alimera announced that it intends to resubmit its New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of March 2013. Using data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME Study), the resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, the same group for which marketing approval for ILUVIEN has been granted in various EU countries, according to Alimera. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera. Alimera also announced that shipments of ILUVIEN to the German market are expected to begin in the second quarter of 2013 upon acceptance from the Medicine and Health products Regulatory Agency of the intended commercial batch size, a delay from Alimera’s previous expectation that this would occur in the first quarter of 2013. Full Article
pSivida Corp Not To Pay H1 2013 Interim Dividend
pSivida Corp announced that the Company does not propose to pay any dividends for the half year ended December 31, 2012. Full Article
pSivida Corp Announces Spain Grants ILUVIEN Marketing Approval for Chronic Diabetic Macular Edema
pSivida Corp announced that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Full Article
pSivida Corp Reports Patient Access Scheme Being Developed by Alimera to Address Cost Concerns Following Negative Final Draft Guidance by U.K.’s NICE for ILUVIEN for DME
pSivida Corp announced that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. While ILUVIEN has received marketing authorization in the U.K., the independent Appraisal Committee concluded that the evidence provided did not show that the benefits ILUVIEN provides to patients justify the proposed price. pSivida’s licensee, Alimera Sciences, reported that in response to the final draft guidance, it has immediately begun to develop a Patient Access Scheme (PAS) to address NICE’s cost concerns. According to Alimera, the PAS being developed, if accepted, will make ILUVIEN available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies. Full Article
pSivida Corp. Announces Closing Of $5.36 Million Registered Direct Financing
pSivida Corp. announced that it closed the previously-announced securities purchase agreement with institutional investors to raise gross proceeds of approximately $5.36 million in a registered direct offering through the sale of 2,494,419 shares of the Company’s common stock and warrants to purchase 623,605 shares of its common stock. The common stock and warrants were sold in units, with each unit consisting of one share of common stock and the equivalent of a warrant to purchase 0.25 shares of common stock. Each purchaser received warrants to purchase a number of whole shares of common stock equal to 25% of the number of shares of common stock purchased by such purchaser. Each unit was sold at a negotiated price of $2.15 per unit. Each warrant is exercisable for one share of common stock, has an exercise price of $2.50 per share and is exercisable commencing six months after date of issuance until the date five years from the issuance date. The Company intends to use the proceeds from this offering for general corporate purposes, which may include funding its clinical trials for posterior uveitis and other business operations. Rodman & Renshaw, LLC acted as sole placement agent for the offering. Full Article
pSivida Corp. Announces $5.36 Million Registered Direct Financing
pSivida Corp. announced that it has entered into a securities purchase agreement with institutional investors to raise gross proceeds of approximately $5.36 million in a registered direct offering through the sale of a total of 2,494,419 shares of the Company’s common stock and warrants to purchase 623,605 shares of its common stock. The common stock and warrants will be sold in units, with each unit consisting of one share of common stock and the equivalent of a warrant to purchase 0.25 shares of common stock. Each purchaser will receive warrants to purchase a number of whole shares of common stock equal to 25% of the number of shares of common stock purchased by such purchaser. Each unit will be sold at a negotiated price of $2.15 per unit. Each warrant will be exercisable for one share of common stock, has an exercise price of $2.50 per share and will be exercisable during the period commencing six months after the date of its original issuance and ending five years from date of its issuance. These securities are being offered through an effective registration statement. The offering is expected to close on or about August 7, 2012. The Company intends to use the proceeds from this offering for general corporate purposes, which may include funding its clinical trials for posterior uveitis and other business operations. Rodman & Renshaw, LLC acted as sole placement agent for the offering. Full Article
Federal Ministry Of Health Of Germany Grants pSivida Corp.'s ILUVIEN Marketing Authorization For Treatment Of Chronic Diabetic Macular Edema
pSivida Corp. announced that the Federal Ministry of Health of Germany (Bundesministerium fur Gesundheit, BfArM) has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Full Article
pSivida Corp. Receives FDA Clearance For Pivotal Trials For Injectable Sustained-release Micro-Insert To Treat Uveitis
pSivida Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to treat posterior uveitis with pSivida’s injectable sustained-release micro-insert. pSivida is now permitted to move directly to two Phase III trials to treat patients with posterior uveitis. These trials, which pSivida expects would enroll a total of 300 patients, would be in addition to the investigator-sponsored trial studying the same device for posterior uveitis announced last month. Posterior uveitis is an inflammatory disease of one of the layers of the eye. pSivida’s injectable micro-insert to treat posterior uveitis is a tiny tube about the size of an eyelash. It releases the off-patent steroid fluocinolone acetonide at a consistent rate over a period of approximately 36 months. The micro-insert is injected into the back of the eye during an office visit through the use of a fine gauge needle. Full Article
pSivida Corp. Announces Grant Of Marketing Authorization In France For ILUVIEN
pSivida Corp. announced that the National Security Agency of Medicines and Health Products (L'Agence Nationale de Securite du Medicament et des Produits de Sante) has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. ILUVIEN is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. Full Article
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