Arrowhead Issues a Statement on Intellectual Property Protection for ARC-520
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Research Corporation (NASDAQ:ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today reaffirmed its belief that it has broad access to intellectual property required to develop ARC-520, its clinical candidate against chronic hepatitis B infection. The Company has licenses to relevant patents and patent applications enabling the development and commercialization of ARC-520 in key pharmaceutical markets globally. Arrowhead does not believe there are additional unlicensed patents directed to RNAi therapeutics targeting the hepatitis B virus that affect its freedom to operate.
“The roughly 400 million people world-wide with chronic hepatitis B infection currently have limited options, and we remain committed to them.”
The company signed a license agreement with Alnylam Pharmaceuticals in January 2012, giving it access to intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus. Moreover, Arrowhead holds multiple levels of patent protection on ARC-520 including U.S. Patent Nos. 8,313,772 and 8,501,930 covering the Dynamic Polyconjugate (DPC) delivery system, and U.S. Patent Application number 13/535,454 covering ARC-520’s siRNA component, which was recently allowed by the U.S. Patent and Trademark Office.
Arrowhead and its legal advisors continually review the patent landscape to ensure freedom to operate and the Company believes that development and commercialization of ARC-520 would not infringe patents governing RNAi therapeutics targeting the hepatitis B virus, including U.S. Patent No. 8,618,277 in the McSwiggen patent estate.
“We are moving ARC-520 as quickly as possible to market and do not believe anything limits our ability to do so,” said Christopher Anzalone, Ph.D., Arrowhead’s President and Chief Executive Officer. “The roughly 400 million people world-wide with chronic hepatitis B infection currently have limited options, and we remain committed to them.”
Arrowhead’s RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead’s DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. Arrowhead has completed enrollment in a Phase 1 single ascending dose study in normal volunteers. The company is conducting a single dose Phase 2a study in chronic HBV patients, which it expects to follow with a multi dose, multi national Phase 2b study. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary drug delivery technologies to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead technologies also enable partners to create peptide-drug conjugates that specifically home to cell types of interest while sparing off-target tissues. Arrowhead’s pipeline includes clinical programs in chronic hepatitis B virus and partner-based programs in obesity and oncology.
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Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.