AktenTreatment for Ocular Anesthesia
Update: Akten Now FDA Approved - October 7, 2008
Akorn, Inc. Announces the New Drug Application Filing for Akten
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jun 29, 2007 - Akorn, Inc. today announced the filing of NDA 22-221 for Akten Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. Based on the pre-NDA meeting April 25, 2007 with the U.S. Food and Drug Administration (FDA), the dose and the overall structure of the NDA submission was finalized. The NDA was filed after a 209 randomized patient, placebo controlled clinical trial was conducted, which subsequently met the primary endpoints in all three dosing arms. Akten is projected to be launched in the first half of 2008.
Akten is a novel, unit dose, preservative free gel formulation intended to be used in any ocular procedure that requires a topical anesthetic agent. The estimated market size for Akten is approximately six million procedures annually. These procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injections. Akorn has filed two United States patents and one International patent on the formulation and method of use of Akten.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "This is a very important milestone in our Company's history. Akten is our first internally developed NDA drug product, and is manufactured at our Somerset, NJ facility. Akten will be marketed directly to ophthalmologists with a targeted detail sales team."
Abu Alam, Ph.D., Akorn's Senior Vice President of New Business Development and Akten's Clinical Study Director stated, "The filed indication for Akten is for ocular surface anesthesia during ophthalmologic procedures and is based on the results of our clinical trial and discussions with the FDA. We would like to thank Drs. Elias Reichel and Brandon Busbee, who collaborated with Akorn on Akten's clinical trial design and patent filings."
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. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.
Arthur S. Przybyl
President and CEO
Posted: June 2007
- Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5% - October 8, 2008
- Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5% - June 4, 2008