LAKE FOREST, Ill., June 28, 2019 (GLOBE NEWSWIRE) -- Akorn, Inc. (AKRX), a leading specialty generic pharmaceutical company, today announced that it has launched its first-to-market generic of Loteprednol Etabonate Ophthalmic Suspension, 0.5%.
Douglas Boothe, Akorn’s President and Chief Executive Officer, stated, “This launch underscores our ability to execute on development and manufacturing of complex ophthalmic suspensions. With the launch of this first-to-market generic, we are pleased to offer patients additional treatment options for ocular inflammation.”
According to IQVIA, U.S. sales of Loteprednol Etabonate Ophthalmic Suspension, 0.5% were approximately $90 million for the twelve months ended April 2019.
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
Akorn, Inc. is a specialty generic 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 that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com.
Cautionary Note Regarding Forward-Looking Statements
This press release includes statements that may constitute "forward-looking statements" about, among other things, Akorn's expectations regarding product offerings, commercial launch timing and other goals and plans that are subject to substantial risks and uncertainties which could cause actual results to differ materially from those expressed or implied by such statements. Such risk factors include, but are not limited to: (i) the effect of the Delaware court’s recent decision against Akorn on Akorn’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally, (ii) the risk that ongoing or future litigation related to the court’s decision may result in significant costs of defense, indemnification and/or liability, (iii) the outcome of the investigation conducted by Akorn with the assistance of outside consultants, into alleged breaches of FDA data integrity requirements relating to product development at Akorn and any actions taken by Akorn, third parties or the FDA as a result of such investigations, (iv) the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any, (v) the timing and success of product launches, (vi) difficulties or delays in manufacturing, (vii) Akorn’s increased indebtedness and compliance with certain covenants and other obligations under the Standstill Agreement, which create material uncertainties and risks to its growth and business outlook, (viii) Akorn’s obligation under the Standstill Agreement to enter into a Comprehensive Amendment that is satisfactory in form and substance to the Lenders, (ix) Akorn’s obligation under the Standstill Agreement to pay certain fees and expenses and increased interest margin, (x) such other risks and uncertainties outlined in the risk factors detailed in the “Risk Factors” of Akorn’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (as filed with the Securities and Exchange Commission (“SEC”) on March 1, 2019), Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2019 (filed with the SEC on May 7, 2019) and in other subsequent Akorn filings with the SEC. Readers should carefully review these risk factors, and should not place undue reliance on the forward-looking statements. These forward-looking statements are based on information, plans and estimates at the date of this press release. Akorn undertakes no obligation to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes or developments.