Akorn Announces Launch of Loteprednol Etabonate Ophthalmic Suspension, 0.5%
June 28 2019 - 7:00AM
Akorn, Inc. (Nasdaq: 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.
About AkornAkorn, 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
StatementsThis 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.
Investors/Media:(847)
279-6162Investor.relations@akorn.com
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