Akorn Announces Development and Supply Agreement with Hyaluron For Two Injectable ANDA Suspension Drug Products
Monday, July 30, 2007
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ:AKRX - News) today announced the signing of a development and supply agreement with Hyaluron Contract Manufacturing, Inc. (HCM), an innovative leader in aseptic formulation and filling of liquid parenterals located in Burlington, Massachusetts. The Agreement provided for two ANDA injectable suspension products with a 2006 market size of approximately $220 million, according to IMS sales data.
One of the ANDA drug products represents an injectable sustained release pharmaceutical. This product will be available in both prefilled syringe and vial configurations. The second ANDA drug product is indicated as an anti-inflammatory and will be available in multiple packaging configurations. Hyaluron will manufacture both drug products for Akorn, who will be responsible for marketing and distributing them within the United States. Akorn will coordinate the bioequivalency clinical trials, prepare the ANDA Regulatory filings and will own both ANDAs. Financial terms of the agreement were not disclosed. The products are expected to launch in 2010.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated "We are excited to be working with Hyaluron on these two opportunities. Both products will be key growth drivers for our company, similar to our upcoming Vancomycin capsule, Tetanus Diphtheria Vaccine and AktenŽ product launches. The addition of injectable suspensions to Akorn's portfolio complements our line of injectable drug products that includes both proprietary and generic drugs."
Shawn Kinney, Hyaluron's President stated, "Our decision to partner with Akorn is reflective of our commitment to provide our clients--from newly established firms to large-scale commercial enterprises--innovative solutions to all their formulation and filling needs. We look forward to working with Akorn, and to the opportunities this collaboration presents to make a lasting contribution to the market for sterile injectable products."
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.
About Hyaluron Contract Manufacturing, Inc.
Hyaluron Contract Manufacturing, Inc. is a leader in aseptic manufacturing of filled liquid parenterals. Since 1999, HCM has been offering its customers in the pharmaceutical and biotechnology industries innovative and unique solutions to assist them in bringing their products to market. At the core of HCM's business is a commitment to quality, regulatory compliance and on-time delivery, as well as courteous and professional communication. HCM is located in Burlington MA. For further information, visit: www.hyaluron.com.
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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.
Contact:
Akorn, Inc.
Arthur S. Przybyl, 847-279-6100
President and CEO
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