RedHill Biopharma Announces Patent Notice of Allowance from the United States Patent and Trademark Office for Its Leading RHB-104 (Crohn's) Drug, to Expire No Earlier Than in 2029

RHB-104 is planned to begin a Phase III clinical trial in Crohn's disease in the first half of 2013 and a Phase IIa trial in Multiple Sclerosis in January 2013

TEL AVIV, Israel--()--RedHill Biopharma Ltd. (TASE:RDHL), an Israeli biopharmaceutical company focusing primarily on acquisition and development of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported today that the United States Patent and Trademark Office ("USPTO") has published notification of a Notice of Allowance for U.S. Patent Application Serial Number 12/918,310 entitled "Methods and Compositions for Treating Inflammatory Bowel Disease", directed to RedHill’s RHB-104 indicated for the treatment of Crohn's disease.

The Notice of Allowance has been issued following the determination of the USPTO that a new patent will be granted based on the Company's application. The issued patent would have a term that expires no earlier than in 2029.

The Company is in advanced preparations for a Phase III clinical trial in the US, Canada and Israel with RHB-104 to treat Crohn’s disease, currently scheduled to commence during the first half of 2013. In addition, the Company is in advanced preparations for a Phase IIa Proof of Concept trial in Israel, scheduled to commence in January, 2013, to assess the efficacy and safety of RHB-104 as an add-on therapy for the treatment of Multiple Sclerosis.

The market for diagnosis and drug treatment of Crohn’s disease is estimated at approximately $3 billion worldwide in 2011.

“This Notice of Allowance represents another step forward in RedHill’s effort to protect the commercial potential of RHB-104, aimed to offer an attractive and novel treatment option for patients suffering from Crohn’s disease,” said Guy Goldberg, RedHill's Chief Business Officer. "Intellectual property protection is a critical part of our strategy and we believe that the issuance of the new patent will enable RHB-104, if approved, to be a key growth driver in our business for many years."

About RedHill Biopharma Ltd.:

RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development of late clinical-stage, patent protected, new formulations and combinations of existing drugs. The Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a once-daily formulation of a leading radiotherapy-induced nausea and vomiting prevention drug, an oral thin film formulation of Rizatriptan for the treatment of acute migraine, a combination therapy for the treatment of Crohn's disease as well as Multiple Sclerosis (MS) disease, and companion diagnostic test for detection of the MAP bacteria, a combination therapy for the treatment of resistant H. pylori bacteria causing ulcers, and an encapsulated formulation for bowel preparation ahead of certain gastro procedures. The Company's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.

This Press Release does not constitute an offer or solicitation to acquire and/or sell the Company's securities or to participate in any investment in the Company. Statements in this Press Release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All of these forward-looking statements are subject to risks and uncertainties that may change at any time, and, therefore, actual results may differ materially from those expected. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors.

Contacts

PR contact:
Gelbert-Kahana
Senior Financial PR Account Manager
Hagai Schwartz, +972 (0)54-4569-120
hagais@gk-biz.com
or
Company contact:
RedHill Biopharma
VP Business Development & Licensing
Adi Frish, +972 (0)54-6543-112
adi@redhillbio.com

Contacts

PR contact:
Gelbert-Kahana
Senior Financial PR Account Manager
Hagai Schwartz, +972 (0)54-4569-120
hagais@gk-biz.com
or
Company contact:
RedHill Biopharma
VP Business Development & Licensing
Adi Frish, +972 (0)54-6543-112
adi@redhillbio.com