Key Developments: Alimera Sciences Inc (ALIM.W)
5.42USD
18 Jun 2013
$0.06 (+1.12%)
$5.36
$5.42
$5.53
$5.31
3,000
331
$5.58
$1.37
Latest Key Developments (Source: Significant Developments)
Alimera Sciences Inc Secures $20 Million Debt Facility
Alimera Sciences Inc's Alimera Sciences Limited announced that it has entered into a Loan and Security Agreement with Silicon Valley Bank (SVB) providing for a term loan in the principal amount of $5 million and up to an additional $15 million under a working capital line of credit. The proceeds of the term loan will provide additional working capital for general corporate purposes. The line of credit will be utilized to finance accounts receivable in the United Kingdom, Germany and France, and replaces the current $20 million line of credit previously provided by SVB to finance accounts receivable in the United States. Full Article
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
Alimera Sciences Inc's ILUVIEN Receives Marketing Authorization In Spain For Treatment Of Chronic Diabetic Macular Edema
Alimera Sciences Inc announced that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) 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
Alimera Sciences Inc's ILUVIEN Receives Final Draft Guidance From U.K.'s NICE
Alimera Sciences Inc announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has 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 the Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met. In response to the final draft guidance, Alimera is now developing a Patient Access Scheme (PAS) to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from ILUVIEN. The goal of the PAS will be to determine the appropriate pricing for ILUVIEN in order to ensure that treatment decisions are based on patient need, rather than cost. Full Article
Alimera Sciences Inc Closes $40 Million Financing
Alimera Sciences Inc announced that it has completed the sale of $40 million of Series A Convertible Preferred Stock and warrants to purchase Series A Preferred (the Warrants) to a group of institutional investors, including both existing and new investors, in a private placement. On October 1, 2012, the Company held a special stockholders meeting at which the stockholders approved the issuance of Series A Preferred and Warrants pursuant to applicable NASDAQ Listing Rules. At the closing, Alimera sold 1,000,000 units, with each unit consisting of one share of Series A Preferred and a Warrant to purchase .30 shares of Series A Preferred, at a purchase price of $40.00 per unit. The financing resulted in gross proceeds to the Company of approximately $40 million, before deducting expenses payable by the Company of approximately $650,000. Each share of Series A Preferred is convertible into shares of Alimera's common stock, at conversion prices ranging from $2.66 to $3.16 per share based on the occurrence or non-occurrence of certain events. The conversion price is also subject to certain customary price based anti-dilution adjustments. The Warrants are exercisable upon issuance at an exercise price of $44.00 per share of Series A Preferred, provided, however, that the Warrants may be exercised, at the option of the holders, directly for the common stock that would otherwise then be issuable upon conversion of the Series A Preferred covered by such Warrants. Full Article
Alimera Sciences Inc ILUVIEN Receives Marketing Authorization In Germany For Treatment Of Chronic Diabetic Macular Edema
Alimera Sciences Inc announced 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
Alimera Sciences Inc Agrees To Sell $40 Million of Convertible Preferred Stock
Alimera Sciences Inc announced that it has entered into a securities purchase agreement (Purchase Agreement) with a group of institutional investors, including both existing and new investors, for a $40 million Series A Convertible Preferred Stock (Series A Preferred) financing. Alimera intends to use the net proceeds of this offering to fund the development and commercialization of ILUVIEN and for the other working capital purposes permitted under the Purchase Agreement. Palo Alto Investors acted as the lead investor in the offering, with Sofinnova Ventures and New Enterprise Associates also participating. The Purchase Agreement provides for the sale of 1,000,000 shares of the Company's Series A Preferred and warrants to purchase an additional 300,000 shares of Series A Preferred. For each unit consisting of one share of Series A Preferred and a Warrant to purchase .30 of a Share of Series A Preferred, the Investors have agreed to pay $40.00, resulting in gross proceeds to the Company of approximately $40 million, before deducting expenses payable by the Company. Each share of Series A Preferred is initially convertible into approximately 13.75 shares of the Company's common stock, based on an initial conversion price of $2.91 per share. The conversion price is subject to standard broad-based weighted average anti-dilution adjustments, as well as other standard adjustments in the event of changes to the Company's capital structure. Full Article
Alimera Sciences Inc Receives Marketing Authorization In Portugal For The Treatment Of Chronic Diabetic Macular Edema
Alimera Sciences Inc announced the National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) 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. This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The Portuguese authorization is the third national approval in the EU, preceded by Austria and the U.K. ILUVIEN is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. Full Article
Alimera Sciences Inc's ILUVIEN Receives Marketing Authorization In Austria For Treatment Of Chronic Diabetic Macular Edema
Alimera Sciences Inc announced the Austrian Agency for Health and Food Safety (Osterreichische Agentur fur Gesundheit und Ernahrungssicherheit, AGES) 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. This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State, delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), which include Austria, France, Germany, Italy, Spain and Portugal. Full Article
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