BRISBANE, Calif. and RAMAT GAN, Israel, Oct. 7, 2014 -- Hyperion Therapeutics, Inc. (HPTX) ("Hyperion") and Clal Biotechnology Industries Ltd. (CBI.TA) ("CBI") today announced that they have entered into an interim agreement in order to attempt to resolve the disputes between them and to allow CBI to evaluate whether there is any clinical efficacy to, and whether there is a potential regulatory path forward for, DiaPep277 that a party other than Hyperion may wish to pursue.
Under the terms of the interim agreement, and consistent with Hyperion's statement of September 8, 2014, Hyperion will complete the current DIA-AID 2 study of DiaPep277, at its expense. An independent party or parties will be appointed by CBI, at CBI's expense, and will be permitted to have access to relevant non-privileged documentary materials including, the statistical analysis plans, the study dataset after unblinding, and any correspondence with the FDA and other medical/clinical regulatory entities. The independent party is expected to assess, for CBI's benefit, the ongoing conduct of the DIA-AID 2 study, the conduct of the completed DIA-AID 1 study, the integrity of the studies' readouts, and any potential regulatory path forward for DiaPep277. The assessment shall be conducted during the DIA-AID 2 study and thereafter for as long as reasonably required to complete the review. Hyperion will not be obligated to take any action in response to the independent party's observations.
During the interim period (until October 31, 2014, which may be extended by either party for an additional period of 3 weeks), Hyperion and CBI have agreed to not take any additional steps to prosecute any lawsuit, claim, or other litigation against the other party relating to the development of DiaPep277 or the Share Purchase Agreement regarding Andromeda Biotech, Ltd., which Hyperion acquired from CBI in June 2014. Hyperion and CBI have further agreed that by virtue of the interim agreement, neither party has waived any right, claim or defense relating to the above-mentioned Share Purchase Agreement.
About Hyperion Therapeutics
Hyperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases. The company's first commercial product, RAVICTI (glycerol phenylbutyrate) Oral Liquid, was approved in February 2013 and is currently being marketed in the United States. The company also owns worldwide rights to BUPHENYL (sodium phenylbutyrate) Tablets and Powder, which it markets in the U.S. The compound is also marketed internationally through business partners. In addition, the company is developing glycerol phenylbutyrate for the potential treatment of hepatic encephalopathy. For more information, please visit www.hyperiontx.com.
About Clal Biotechnology Industries Ltd.
Clal Biotechnology Industries Ltd. is a specialized holding company, which identifies and supports promising biotechnology companies with proprietary biopharmaceutical solutions to unmet medical needs, approaching large potential markets. Main portfolio companies include MediWound Ltd., CureTech Ltd. and Gamida Cell Ltd.
For more information, please visit www.cbi.co.il.
Forward-Looking Statements for Hyperion Therapeutics
To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
Forward-looking statements contained in this press release include, among others, the appointment and any assessment of the independent party or parties, and the possibility of resolving all disputes with CBI. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of the company in general, see the "Risk Factors" section of Hyperion's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 7, 2014, and in any subsequent filings with the Securities and Exchange Commission.
Hyperion: Myesha Edwards Corporate Communications and Investor Relations (650) 745-7829 Todd Fogarty / Nathan Riggs Kekst and Company 212-521-4800 CBI: Brunswick Group Michael France / Shahed Larson / Brendan Riley 212-333-3810