October 15, 2008
Akorn, Inc. Announces the Launch of Akten(TM) Gel 3.5%
Akorn, Inc. (NASDAQ: AKRX) today announced the commercial launch of Akten(TM) Gel 3.5%, a topical ocular anesthetic ophthalmic drug product. Akten(TM) represents the first FDA approved drug product indicated for use as an ocular anesthetic in four decades. Akten(TM) is the only approved ocular gel formulation that also contains the highest concentration of lidocaine. Akten(TM) has several unique features: it is preservative free, non toxic to the cornea, does not sting due to its physiological pH and can be stored at room temperature. Akten(TM) can be used as a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. Examples of these procedures include cataract/glaucoma surgery, intravitreal injections for retinal disorders, retina surgery, and miscellaneous ocular procedures both in hospital/clinics and office based practices.
The results of a phase III clinical trial for Akten(TM) have been published as a manuscript in a peer reviewed journal, Ophthalmic Surgery, Lasers & Imaging (OSLI); September/October 2008, "Lidocaine Hydrochloride Gel For Ocular Anesthesia: Results of a Prospective Randomized Study." The study findings include safety, efficacy and tolerability of Akten(TM), and will be presented by Drs. B. Busbee, A. Alam and E. Reichel at the upcoming American Academy of Ophthalmology (AAO) meeting in Atlanta on November 8 and 9, 2008 at the Akorn booth #3421.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "I believe that Akten(TM) will become the standard of care whenever an ocular anesthetic is required. Akten(TM) represents a new horizon in ocular anesthesia. The benefits of Akten(TM) are important to consider whenever an ocular procedure is necessary."
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate,""estimate,""expect,""project,""intend,""plan,""believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.