LAKE FOREST, Ill., March 20, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has launched Phenylephrine HCl Ophthalmic Solution, USP, 2.5% and 10%. The launch follows an approval of a New Drug Application (NDA) for the product from the U.S. Food and Drug Administration (FDA) on January 15, 2015. This launch further expands Akorn's leading generic and branded ophthalmic portfolio and brings a shelf-stable formulation of phenylephrine back to the market.
According to IMS Health, sales of Phenylephrine Ophthalmic Solution, USP, 2.5% and 10% were $24 million for the twelve months ended January 31, 2015. However, from prior market experience, Akorn estimates the total market for the product to be larger than $24 million due to direct sales to physicians and hospital systems that may not be fully captured by IMS.
About Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%
Akorn's Phenylephrine Hydrochloride Ophthalmic Solution, USP, is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil. Phenylephrine is commonly used by optometrists, ophthalmologists and other physicians to dilate patients' pupils before ocular examinations. Akorn's approval represents the second NDA approval for an ophthalmic phenylephrine product following the approval of a competing NDA product and the subsequent withdrawal of grandfathered products from the market in 2013.
Akorn's Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%, available in 2 mL and 15 mL fill sizes and Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%, available as a 5 mL fill size, is shelf-stable and therefore does not require refrigeration, which is an advantage over the competitor's refrigerated product.
Akorn, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India where the company manufactures ophthalmic, injectable and specialty non-sterile pharmaceuticals. Additional information is available on the company's website at www.akorn.com.
Forward Looking Statements
This press release includes statements that may constitute "forward looking statements", including projections of sales and other statements regarding Akorn's launches, regulatory approvals, goals and strategy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Factors that could cause or contribute to such differences include, but are not limited to: the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's periodic public filings with the Securities and Exchange Commission and in other written or oral investor communications. Other factors besides those listed there could also adversely affect our results. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward-looking statements.
The addressable IMS market size figures presented in this press release outline the approximate aggregate size of the potential market and are not forecasts of our future sales.
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