Key Developments: Alimera Sciences Inc (ALIM.O)

ALIM.O on Consolidated Issue listed on NASDAQ Global Market

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25 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Alimera Sciences Inc receives positive outcome of repeat-use procedure for 10 additional european countries
Monday, 30 Jun 2014 07:30am EDT 

Alimera Sciences Inc:Positive outcome of Repeat-Use Procedure for ILUVIEN for treatment of chronic diabetic macular edema (DME) in additional 10 European Union countries.Alimera submitted application through Mutual Recognition Procedure (MRP) with Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) serving as Reference Member State.Regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland and the Czech Republic, will now enter the national phase in which each country grants marketing authorization.ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.  Full Article

Alimera Sciences Inc's ILUVIEN receives marketing authorization in Italy for treatment of chronic diabetic macular edema
Monday, 23 Jun 2014 07:00am EDT 

Alimera Sciences Inc:Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN for treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.ILUVIEN marketing authorization notice was published on June 18 in Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government.Designated a C Class product in Italy, ILUVIEN will be available initially to private paying patients. Alimera is pursuing H Class designation for ILUVIEN with the Italian regulatory authorities, which, if granted, would expand patient access to product.  Full Article

Specialised Therapeutics Australia announces license deal with Alimera Sciences Inc
Monday, 28 Apr 2014 07:00am EDT 

Alimera Sciences Inc:Australian and New Zealand patients suffering from vision impairment due to a type of diabetes-induced eye disease will have access to a new treatment, following a license deal between Australian biopharmaceutical company Specialised Therapeutics Australia (STA) and Alimera Sciences.Under the terms of the license arrangement, STA will be responsible for all regulatory and commercial activities for ILUVIEN in Australia and New Zealand.The agreement includes a milestone payment to Alimera Sciences on achievement of a Pharmaceutical Benefits Scheme (PBS) listing, as well as an increasing royalty payment based upon a specific sales target.  Full Article

Alimera Sciences Inc secures $35 mln debt facility
Friday, 25 Apr 2014 07:00am EDT 

Alimera Sciences Inc:United Kingdom subsidiary, Alimera Sciences Limited (Limited) enters into loan and security agreement with Hercules Technology Growth Capital, Inc. for term loan in principal amount of up to $35 mln.Hercules is advancing $10 mln to Limited and will advance remaining $25 mln in event U.S. Food and Drug Administration (FDA) approves ILUVIEN on or before Oct. 31 and certain other conditions are satisfied.Proceeds for initial funding of $10 mln under term loan will be used to pay off existing term loan payable to Silicon Valley Bank (SVB) and to provide additional working capital for general corporate purposes.  Full Article

Alimera Sciences Inc announces resubmission of ILUVIEN NDA to FDA
Thursday, 27 Mar 2014 07:00am EDT 

Alimera Sciences Inc:Resubmitted NDA for ILUVIEN to U.S. FDA.ILUVIEN is injected in back of patient's eye to a position that takes advantage of eye's natural fluid dynamics.Most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.ILUVIEN received marketing authorizations in Austria, UK , Portugal, France, Germany and Spain and is commercially available in UK and Germany.ILUVIEN has not been approved for sale in US.  Full Article

Alimera Sciences Inc closes $37.5 mln private placement of common stock
Monday, 3 Feb 2014 08:20am EST 

Alimera Sciences Inc:Says it closed its previously announced private placement of common stock on Jan. 31.Says gross proceeds from the offering were about $37.5 mln.Says proceeds from the private placement are expected to be used for general corporate and working capital purposes.Says Cowen and Company, LLC served as sole placement agent for the transaction.  Full Article

Alimera Sciences Inc announces $37.5 mln private placement
Tuesday, 28 Jan 2014 06:45am EST 

Alimera Sciences Inc:Says it has obtained commitments from certain non-affiliated institutional investors to purchase about $37.5 mln of its common stock in a private placement.Says proceeds from the private placement are expected to be used for general corporate and working capital purposes.Says it has entered into a securities purchase agreement with the investors pursuant to which Alimera will sell an aggregate of 6,250,000 shares of its common stock at a purchase price of $6.00 per share.Says Cowen and Company, LLC served as sole placement agent for the transaction.  Full Article

FDA Denies Approval For Alimera Sciences Inc's Eye Implant-Reuters
Friday, 18 Oct 2013 07:21am EDT 

Reuters reported that Alimera Sciences Inc said U.S. health regulators declined to approve its eye implant for retinal swelling and indicated the need for a new clinical trial. The Company said the U.S. Food and Drug Administration identified concerns regarding the benefit to risk and safety profiles of Iluvien in its complete response letter. Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular oedema. The FDA also referenced deficiencies at the facility where Iluvien is manufactured, Alimera said.  Full Article

Alimera Sciences Inc Secures $20 Million Debt Facility
Wednesday, 8 May 2013 08:00am EDT 

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
Monday, 1 Apr 2013 05:33pm EDT 

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

Alimera makes fourth bid for eye treatment approval from FDA

- Alimera Sciences Inc said it has applied a fourth time for U.S. regulatory approval to start selling an eye implant that delivers a drug to treat a form of blindess in diabetes patients.

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