--DiaPep277 ®, a First-in-Class Immune Intervention Therapy in Phase 3 Testing for New Onset Type 1 Diabetes--
--Hyperion to Host Analyst/Investor Teleconference Today at 8:45 a.m. EDT (5:45 a.m. PDT)--
BRISBANE, Calif., April 24, 2014 (GLOBE NEWSWIRE) -- Hyperion Therapeutics (Nasdaq:HPTX) announced today that it has entered into a definitive agreement under which it will acquire Andromeda Biotech Ltd., an Israel-based subsidiary of Clal Biotechnology Industries Ltd. (TASE:CBI). Andromeda is focused on the development of DiaPep277 ®, a first-in-class immune intervention therapy for new onset Type 1 diabetes, an orphan indication with approximately 35,000 adults diagnosed annually across the U.S. and Europe. DiaPep277 is currently being evaluated in a confirmatory Phase 3 clinical study in adult patients with new onset Type 1 diabetes. The Phase 3 study is fully enrolled and results are anticipated in the first quarter of 2015.In its first Phase 3 study, a randomized, double-blind, placebo-controlled, multinational trial, DiaPep277 demonstrated a significant reduction in beta cell loss as reflected by preservation of glucagon-stimulated C-peptide secretion relative to placebo. In addition, a significantly higher proportion of patients treated with DiaPep277 maintained target levels of glycated hemoglobin (HbA1c, a measure of metabolic control) and had a lower rate of hypoglycemic events versus placebo. Similar results in the ongoing confirmatory Phase 3 study could position DiaPep277 as the first disease-modifying therapy approved for Type 1 diabetes. "The acquisition of Andromeda Biotech is a transformative event for Hyperion," said Donald J. Santel, president and chief executive officer of Hyperion. "We believe DiaPep277 has the potential to become a highly differentiated, first-in-class medicine for an orphan indication with a significant unmet need. With the successful commercialization of RAVICTI ® well under way, DiaPep277 adds an attractive late-stage asset to our portfolio, while we continue development of glycerol phenylbutyrate for hepatic encephalopathy." At the closing of the transaction, Hyperion will pay $12.5 million in cash, less adjustments for expenses incurred in connection with the transaction, and 312,869 shares of Hyperion common stock (valued at approximately $7.85 million based on the average closing price of $25.09 per share for the 15 consecutive trading days ending April 17, 2014). Hyperion will potentially make contingent payments to Andromeda security holders, as follows:
- potential global regulatory and approval milestones payments that total $120 million, the first of which would not be made until acceptance of the first marketing application filing for review in either the U.S. or Europe, whichever occurs first;
- up to $430 million in commercial milestones, the first of which would be due upon achievement of annual worldwide net sales of $450 million; and
- tiered contingent sales payments ranging from 10% on annual worldwide net sales up to $300 million to 17% for annual worldwide net sales that exceed $1.2 billion, with the exception of sales by distributors in certain territories, for which the rate is 25%.