SAN DIEGO, July 14, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX) announced today the issuance of a new patent, US 8,734,384, from the United States Patent and Trademark Office (USPTO). The patent covers the biphasic pressure profile utilized by the company's proprietary DosePro® Needle-free Delivery System. The specific pressure profile covered is essential for reliable subcutaneous injection by needle-free technology. In addition to covering the current DosePro platform, the patent is also expected to cover a DosePro platform in development intended for delivery of larger dose volumes.
John Turanin, vice president and general manager, Zogenix technologies, commented, "The expansion of our intellectual property covering the DosePro needle-free delivery technology is a key component of our long-term strategy to out-license the technology via our collaboration with Battelle and potentially develop our own DosePro-based products. The new patent covers the fundamental pressure profile required for a successful needle-free injection and is based on the examination of thousands of human subcutaneous injections during the development of the DosePro technology. It adds to the already extensive portfolio of intellectual property covering DosePro, including recently issued patents covering needle-free delivery of viscous pharmaceutical formulations."
Zogenix has a long-term co-marketing agreement with Battelle for the DosePro needle-free drug delivery technology. The agreement is focused on advancing out-licensing opportunities for DosePro with biopharmaceutical clients. This includes the development of DosePro for dose volumes of 1mL and higher to accommodate a greater number of biopharmaceutical drug candidates, such as higher-dose biologic therapies.
Zogenix's DosePro technology is currently utilized in SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, recently acquired from Zogenix by Endo International plc. Zogenix continues to be the manufacturer of the product, having produced nearly 3,000,000 units since launch in 2010. The new DosePro patent will be listed in the United States Food and Drug Administration (FDA) Orange Book for SUMAVEL DosePro and is expected to add five years of coverage to the patents previously covering the product, extending the Orange Book patent expiry through 2032.
About the FDA Orange Book
The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, lists all drug products that have been approved by the FDA for safety and effectiveness. The Orange Book also includes information on patents which claim an approved drug product or method of use of the drug product, to facilitate the legal requirement that generic drug applicants include an appropriate certification to each such patent as part of any Abbreviated New Drug Application (ANDA) for a generic version of a listed drug.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning. More information about Zogenix is available at www.zogenix.com
Forward-Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding the expected expiration of patent number 8,734,384 in 2032 and the scope of potential coverage provided by such patent; and the potential for out-licensing opportunities for DosePro. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this presentation due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates and the ability to operate its business without infringing the intellectual property rights of others; Zogenix's ability to ensure adequate and continued supply of DosePro (including Sumavel DosePro) to successfully meet anticipated market demand; Zogenix may be unable to successfully develop a DosePro platform for delivery of larger dose volumes; Zogenix's dependence on third parties to carry out key aspects of its business, including Battelle with respect to out-licensing DosePro technology and material suppliers and contract manufacturers with respect to Sumavel DosePro; Zogenix's ability to compete within its target markets; and other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SUMAVEL® is a registered trademark of Endo International plc.
DosePro® is a registered trademark of Zogenix, Inc.