Alimera Sciences (ALIM) Moves up 130% on Week Due to Positive Results for Decentralized Procedure for ILUVIEN
Tweet
Share
E-mailGet Alerts ALIM Hot Sheet
Join SI Premium – FREE
Shares of Alimera Sciences, Inc., (Nasdaq: ALIM) are trading higher for their second day in a row now after announcing a positive outcome of the Decentralized Procedure for ILUVIEN in Europe today. This news may have been leaked, or investors were buying ahead in anticipation, as shares closed up 35 percent yesterday and are now trading up 70.3 percent in the early hours of trading today.
The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that ILUVIEN is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that, in these seven countries alone, 22.1 million people are currently living with diabetes. By comparison, the Centers for Disease Control and Prevention estimate that Americans with diabetes now number 25.8 million. Alimera estimates that within the seven CMS countries, 1.2 million people suffer from DME.
"Achieving a favorable conclusion for ILUVIEN in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," said Dan Myers, president and chief executive officer, Alimera Sciences. "We will continue to work closely with the UK and the Concerned Member States to ensure that ILUVIEN is made available to patients as soon as possible."
The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that ILUVIEN is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that, in these seven countries alone, 22.1 million people are currently living with diabetes. By comparison, the Centers for Disease Control and Prevention estimate that Americans with diabetes now number 25.8 million. Alimera estimates that within the seven CMS countries, 1.2 million people suffer from DME.
"Achieving a favorable conclusion for ILUVIEN in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," said Dan Myers, president and chief executive officer, Alimera Sciences. "We will continue to work closely with the UK and the Concerned Member States to ensure that ILUVIEN is made available to patients as soon as possible."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Sky Quarry names Heidi Bowman as CFO
- Albemarle names Max Hood as chief accounting officer
- OSR Health faces Nasdaq delisting, plans appeal and $15M put option
Create E-mail Alert Related Categories
Corporate News, FDA, Momentum MoversSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
