One for your Portfolio: Hot Healthcare Stock under $10

Posted by on Sep 01, 2010 | No comment

Alimera Sciences’ Shares Boosted on FDA Priority Review for Iluvien

Alimera Sciences Inc. (NASDAQ: ALIM) is an Alpharetta, Georgia-based bioharmaceutical company specializing in the research, development and commercialization of prescription ophthalmic pharmaceuticals.  Shares of the company soared Tuesday after U.S. regulators accepted the New Drug Application (NDA) for its lead candidate, Iluvien.  In addition, the agency granted the drug candidate a priority review status, which means the agency will decide on whether to approve the drug within six months, instead of the usual ten months.

FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. The eye drug maker filed the NDA with the FDA in late June 2010.

In a release, Dan Myers, president and CEO of Alimera Sciences, stated that receiving priority review status from the FDA marks another important milestone in the company’s efforts to provide an approved therapeutic option for patients with diabetic macular edema, or DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.

If Iluvien is approved, the company believes the drug will be the first pharmaceutical in the United States indicated to treat DME, and the first long-term treatment with the potential to be therapeutically effective for up to 36 months.

According to findings from the Wisconsin Epidemiologic Study of Diabetic Retinopathy, 13% to 25% of patients with diabetes mellitus develop DME in 10 years.  As the number of diabetic patients increases, Alimera Sciences projects the annual incidence of diagnosed DME to rise .

Overseas, Alimera Sciences is also seeking to have the DME drug approved in the UK. The company submitted the Marketing Authorization Application (MAA) for Iluvien to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK in July 2010.  Furthermore, it is seeking approval in Austria, France, Germany, Italy, Portugal and Spain. In Canada, the company intends to file in September this year.

Currently, Alimera Sciences is conducting two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients at multiple sites across the United States, Canada, Europe and India, aimed to test the efficacy and safety of Iluvien with two doses, a high and low dose, for the treatment of DME.

On Tuesday, shares of Alimera Sciences extended 5.56% and closed at $8.55 on over four times the average trading volume, climbing again in Wednesday’s trading, up nearly 2% to $8.71 mid-day.  So far the stock has reached a 52-week low of $6.30 and a 52-week high of $11.30.

Citi analyst Amit Bhalla recently reaffirmed a Buy rating and $15 price target on Alimera Sciences, on the back of positive regulatory outlook for Iluvien.

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