<SEC-DOCUMENT>0001171843-14-001832.txt : 20140424
<SEC-HEADER>0001171843-14-001832.hdr.sgml : 20140424
<ACCEPTANCE-DATETIME>20140424080057
ACCESSION NUMBER:		0001171843-14-001832
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20140424
FILED AS OF DATE:		20140424
DATE AS OF CHANGE:		20140424

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			RedHill Biopharma Ltd.
		CENTRAL INDEX KEY:			0001553846
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35773
		FILM NUMBER:		14780175

	BUSINESS ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
		BUSINESS PHONE:		972-3-541-3131

	MAIL ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>document.htm
<DESCRIPTION>FORM 6-K FILING DOCUMENT
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		<title>Form 6-K Filing</title>
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			<b><font size="4">UNITED STATES<br>
					SECURITIES AND EXCHANGE COMMISSION</font><br>
				Washington, D.C. 20549</b>
			<p><b><font size="4">FORM 6-K</font></b></p>
			<p><b>Report of Foreign Private Issuer<br>
					Pursuant to Rule 13a-16 or 15d-16<br>
					of the Securities Exchange Act of 1934 </b></p>
			<p><font size="2">For the month of <b>April 2014</b>.</font><br>
				<font size="2">Commission File No.:001-35773</font></p>
			<p><font size="4"><b>REDHILL BIOPHARMA LTD.</b></font><br>
				<font size="2">(Translation of registrant's name into English)</font></p>
			<p><b>21 Ha'arba'a Street, Tel Aviv, 64739, Israel</b><br>
				<font size="2">(Address of principal executive office)</font></p>
			</p></div>
		<p><font size="2">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</font></p>
		<p align="center">Form 20-F [ x] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form 40-F [ &nbsp;]</font></p>
		<p><font size="2">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): <u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u></font></p>
		<p><font size="2">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): <u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u></font></p>
		<!--<p><font size="2">Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes [ &nbsp;&nbsp;] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;No [  x ]</font></p>
		<p><font size="2">If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-<u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u>.</font></p>-->

		<p><font size="2"><P >
	Attached hereto and incorporated by reference herein is a press release issued by the Registrant and entitled: <i>&quot;RedHill Biopharma and IntelGenx Provide an Update on FDA&#39;s Ongoing Review of the NDA for RHB-103 Oral Migraine Film&quot;</i></P>
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<P >
	This Form 6-K is incorporated by reference into the Company&#39;s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286) and its Registration Statement on Form F-3 filed with the Securities and Exchange Commission on January 23, 2014 (Registration No. 333-193503). </P>
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			<b><font size="2">SIGNATURES</font></b></div>
		<p><font size="2">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</font></p>
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				<td width="47%">&nbsp;</td>
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				<td width="47%">REDHILL BIOPHARMA LTD.<br>
					<font size="2">(Registrant)</font><br>
					<br>
				</td>
			</tr>
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				<td width="47%"><font size="2">Date: April 24, 2014</font></td>
				<td width="6%">&nbsp;</td>
				<td width="47%"><font size="2">By: <u>/s/ DROR BEN-ASHER</u><br>
					Dror Ben-Asher<br>
					Chief Executive Officer</font></td>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>newsrelease.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<html><head><title>RedHill Biopharma and IntelGenx Provide an Update on FDA's Ongoing Review of the NDA for RHB-103 Oral Migraine Film</title></head><body><p align="right">EXHIBIT 99.1</p><h3 align="center">RedHill Biopharma and IntelGenx Provide an Update on FDA's Ongoing Review of the NDA for RHB-103 Oral Migraine Film</h3><p>TEL-AVIV, Israel, April 24, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the RHB-103 New Drug Application ("NDA") and has requested further clarifications. RHB-103 is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.</p><p>
	RedHill and IntelGenx (the "Companies") reported on March 3, 2014 that they had submitted their response to the FDA's CRL for the RHB-103 NDA, which had raised questions primarily related to Chemistry, Manufacturing and Controls (CMC). In response, the FDA has requested from the Companies additional CMC data, which the Companies believe they can supply within several weeks based on available information.</p><p>
	The Companies further report that a supplier of raw material for RHB-103 is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to RHB-103. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions.</p><p>
	The Companies believe that FDA approval of the RHB-103 NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, RedHill and IntelGenx continue to work with the FDA in order to submit all the data requested and will provide an update as and when applicable.</p><p>
	<strong>About RHB-103:</strong></p><p>
	RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT<sub>1</sub> receptor agonist and the active drug in Merck &amp; Co.'s Maxalt&#174;. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 2013<sup>1</sup>.</p><p>
	RHB-103 is based on IntelGenx' proprietary "<i>VersaFilm</i>&#8482;" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the RHB-103 oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population<sup>2</sup>.</p><p>
	<strong>About RedHill Biopharma Ltd.:</strong></p><p>
	RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill's current pipeline of proprietary products includes: (i) <strong>RHB-104</strong> <strong>-</strong> an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study; (ii) <strong>RHB-105</strong> <strong>-</strong> an oral combination therapy for <i>Helicobacter pylori</i> infection, with an ongoing Phase III study; (iii) <strong>RHB-106</strong> <strong>-</strong> an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.;<strong>(iv) RHB-103</strong> <strong>-</strong> an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; (v) <strong>RHB-102</strong> <strong>-</strong> a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) <strong>RHB-101</strong> <strong>-</strong> a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit: www.redhillbio.com.</p><p>
	<strong>About IntelGenx:</strong></p><p>
	IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.</p><p>
	<i>This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; (iv) the clinical development, commercialization, and market acceptance of the Company's therapeutic candidates; (v) the Company's ability to establish and maintain corporate collaborations; (vi) the interpretation of the properties and characteristics of the Company's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; (vii) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (ix) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (x) estimates of the Company's expenses, future revenues capital requirements and the Company's needs for additional financing; and (xi) competitive companies, technologies and the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC </i><i>on February 25, 2014. 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 unless required by law.</i></p><p>
	1 EvaluatePharma, 2013 WW annual sales by pharmacological class, 5-HT1B (serotonin) &amp; 5HT1D (serotonin) agonist.</p><p>
	<sup>2 </sup>Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-&#160;related&#160;nausea: results from the American&#160;Migraine&#160;Prevalence and Prevention (AMPP) study, Headache.&#160;2013&#160;Jan;53(1):93-103. doi: 10.1111/j.1526-4610.2012.02292.x. Epub 2012 Nov 13.</p><pre>CONTACT: Company contact:
         Adi Frish
         Senior VP Business Development &amp; Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com

         PR contact (U.S.):
         Lauren Glaser
         Vice President
         The Trout Group
         +1-646-378-2972
         lglaser@troutgroup.com</pre></body></html>
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