<SEC-DOCUMENT>0001477932-16-008388.txt : 20160203
<SEC-HEADER>0001477932-16-008388.hdr.sgml : 20160203
<ACCEPTANCE-DATETIME>20160202185620
ACCESSION NUMBER:		0001477932-16-008388
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160201
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160203
DATE AS OF CHANGE:		20160202

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Citius Pharmaceuticals, Inc.
		CENTRAL INDEX KEY:			0001506251
		STANDARD INDUSTRIAL CLASSIFICATION:	MOTOR VEHICLE PARTS & ACCESSORIES [3714]
		IRS NUMBER:				273425913
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			0930

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-55532
		FILM NUMBER:		161382533

	BUSINESS ADDRESS:	
		STREET 1:		63 GREAT ROAD
		CITY:			MAYNARD
		STATE:			MA
		ZIP:			01754
		BUSINESS PHONE:		(978) 938-0338

	MAIL ADDRESS:	
		STREET 1:		63 GREAT ROAD
		CITY:			MAYNARD
		STATE:			MA
		ZIP:			01754

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Trail One, Inc.
		DATE OF NAME CHANGE:	20110314

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	TrailOne, Inc.
		DATE OF NAME CHANGE:	20101119
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>ctxr_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<html><head><title> ctxr_8k.htm </title><!--Document Created by EDGARMaster--></head><BODY style="TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: 0px 7%" scroll="yes"><p style="MARGIN: 0px">&nbsp; </p><p style="MARGIN: 0px"><div style="FONT-SIZE: 1px; WIDTH: 100%; BORDER-BOTTOM: #000000 4px solid; MARGIN: 0px"></div><p style="MARGIN: 0px"><div style="FONT-SIZE: 1pt; WIDTH: 100%; BORDER-BOTTOM: #000000 1px solid; MARGIN-TOP: 2px"></div><p style="MARGIN: 0px"><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center"><b><font size="3">UNITED STATES</font></b></p><p style="MARGIN: 0px" align="center"><b><font size="3">SECURITIES AND EXCHANGE COMMISSION</font></b></p><p style="MARGIN: 0px" align="center"><b><font size="3">Washington, D.C. 20549</font></b><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center"><b><font size="6">FORM 8-K</font></b><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center"><b><font size="2">CURRENT REPORT</font></b></p><p style="MARGIN: 0px" align="center"><font size="2"><strong>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</strong></font><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;&nbsp;</p><p style="MARGIN: 0px" align="center"><font size="2">Date of Report (Date of earliest event reported): <strong>February 1, 2016</strong></font><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="6478ec96-63b3-4118-bf5e-72f69dbcdd89" style="TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: auto" cellspacing="0" cols="1" cellpadding="0" width="55%" align="center" border="0">    <tr><td style="BORDER-BOTTOM: black 1px solid"><p style="MARGIN: 0px" align="center"><font size="6"><strong>Citius Pharmaceuticals, Inc.</strong></font></p></td></tr><tr><td><p style="MARGIN: 0px" align="center"><font size="2">(Exact Name of Registrant as Specified in Charter)</font><font size="2"></font></p></td></tr></table></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="046efc2a-13c7-4580-a750-2b25be2823e6" style="WIDTH: 85%; TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: auto" cellspacing="0" cols="5" cellpadding="0" width="85%" align="center" border="0">    <tr height="15"><td style="BORDER-BOTTOM: black 1px solid" valign="top" width="30%" =""=""><p style="MARGIN: 0px" align="center"><font size="2"><strong>Nevada</strong></font></p></td><td valign="top" width="5%"></td><td style="BORDER-BOTTOM: black 1px solid" valign="top" width="30%" =""=""><p style="MARGIN: 0px" align="center"><font size="2"><strong>333-206903</strong></font></p></td><td valign="top" width="5%"></td><td style="BORDER-BOTTOM: black 1px solid" valign="top" width="30%" =""=""><p style="MARGIN: 0px" align="center"><strong><font size="2">27-3425913</font><font size="2"></font></strong></p></td></tr><tr height="15"><td valign="top"><p style="MARGIN: 0px" align="center"><font size="2">(State or other jurisdiction<br></font><font size="2">of incorporation)</font></p></td><td valign="top"></td><td valign="top"><p style="MARGIN: 0px" align="center"><font size="2">(Commission<br>File Number)</font></p></td><td valign="top"></td><td valign="top"><p style="MARGIN: 0px" align="center"><font size="2">(IRS Employer<br>Identification No.)</font></p></td></tr></table><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="4804dc93-3269-4a96-9a43-977cdc64ca55" style="WIDTH: 85%; TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: auto" cellspacing="0" cols="3" cellpadding="0" width="85%" align="center" border="0">    <tr height="15"><td style="BORDER-BOTTOM: black 1px solid" valign="top" width="45%"><p style="MARGIN: 0px" align="center"><font size="2"><strong>63 Great Road</strong></font></p><p style="MARGIN: 0px" align="center"><font size="2"><strong>Maynard, MA 01754</strong></font></p></td><td valign="top" width="10%"><strong></strong></td><td style="BORDER-BOTTOM: black 1px solid" valign="bottom" width="45%"><p style="MARGIN: 0px" align="center"><font size="2"><strong>01754</strong></font></p></td></tr><tr height="15"><td valign="top"><p style="MARGIN: 0px" align="center"><font size="2">(Address of principal executive offices)</font></p></td><td valign="top"></td><td valign="top"><p style="MARGIN: 0px" align="center"><font size="2">(Zip Code)</font></p></td></tr></table><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center"><font size="2">Registrant's telephone number, including area code:<strong> (978) 938-0338</strong></font><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center">_______________________________________________</p><p style="MARGIN: 0px" align="center"><font size="2">(Former name or former address, if changed since last report)</font><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><font size="2">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</font><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><font size="2"><table id="788c74eb-203e-49bc-84de-1deddc549b15" style="TEXT-ALIGN: justify; FONT: 10pt times new roman" cellspacing="0" cellpadding="0" width="100%" border="0">    <tr><td valign="top" width="4%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">&#168;</font></td><td valign="top" width="96%"><p style="MARGIN: 0px">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p></td></tr><tr height="15"><td valign="top"></td><td valign="top"></td></tr><tr><td valign="top"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">&#168;</font></td><td valign="top"><p style="MARGIN: 0px">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</p></td></tr><tr height="15"><td valign="top"></td><td valign="top"></td></tr><tr><td valign="top"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">&#168;</font></td><td valign="top"><p style="MARGIN: 0px">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</p></td></tr><tr height="15"><td valign="top"></td><td valign="top"></td></tr><tr><td valign="top"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Wingdings">&#168;</font></td><td valign="top"><p style="MARGIN: 0px">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p></td></tr></table></font>&nbsp;&nbsp;</p><p style="MARGIN: 0px"><div style="FONT-SIZE: 1pt; WIDTH: 100%; BORDER-BOTTOM: #000000 1px solid; MARGIN: 0px"></div><p style="MARGIN: 0px"><div style="FONT-SIZE: 1pt; WIDTH: 100%; BORDER-BOTTOM: #000000 4px solid; PAGE-BREAK-AFTER: always; MARGIN-TOP: 2px"></div><p style="MARGIN: 0px"><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><font size="2">Item 7.01 Regulation FD Disclosure.</font></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><font size="2">On February 1, 2016, Citius Pharmaceuticals, Inc. (the "Company") issued a press release announcing top-line data collected from the first Phase 2a clinical trial of hydrocortisone acetate ("HC") and lidocaine hydrochloride ("L"), as single agents, and in combination ("HC+L") in patients with Grade I and II hemorrhoids. </font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><font size="2">A copy of the press release that discusses this matter is filed as Exhibit 99.1 to, and incorporated by reference in, this report. The information in this Current Report is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in any such filing.</font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><font size="2">Item 9.01 Financial Statements and Exhibits.</font></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><i><font size="2">(d) Exhibits.</font></i></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="61fc4f57-2a05-484b-9607-975e4a4f7bd1" style="WIDTH: 100%; TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: auto" cellspacing="0" cellpadding="0" width="100%" border="0">    <tr><td style="BORDER-BOTTOM: black 1px solid" valign="bottom" width="8%"><p style="MARGIN: 0px"><font size="2"><strong>Exhibit No.</strong></font></p></td><td valign="bottom" width="2%"><p style="MARGIN: 0px"><strong>&nbsp;</strong></p></td><td id="hdcell" style="BORDER-BOTTOM: black 1px solid" valign="bottom" width="90%" align="center"><p style="MARGIN: 0px" align="left"><font size="2"><strong>Description of Exhibit</strong></font><font size="2"></font></p></td></tr><tr><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td><td id="hdcell"><p style="MARGIN: 0px">&nbsp;</p></td></tr><tr bgcolor="#cceeff"><td>99.1</td><td valign="bottom"><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px"><font size="2">Press Release dated February 1, 2016.</font><font size="2"></font></p></td></tr></table><p style="MARGIN: 0px">&nbsp;<b><font size="2">   <p><p style="MARGIN: 0px"><table id="pagebreak98a30ca3-6874-42aa-8c7c-2f157409c39e" class="pagebreak" style="WIDTH: 100%; FONT: 10pt TIMES NEW ROMAN" cellspacing="0" cellpadding="0" border="0">    <tr><td class="hpbhr">&nbsp;</td></tr><tr><td style="BORDER-BOTTOM: black 1px solid; TEXT-ALIGN: center">2</td></tr><tr></tr><tr><td><div style="WIDTH: 100%; PAGE-BREAK-AFTER: always; LINE-HEIGHT: 0px"></div></td></tr><tr><td>&nbsp;</td></tr></table></p><p style="MARGIN: 0px" align="center">&nbsp;<br>SIGNATURE</font></b><font size="2"></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><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 hereunto duly authorized.</font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="e0f28641-a9d0-4a26-81dc-0c248a4fe95d" style="TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: auto" cellspacing="0" cellpadding="0" width="100%" border="0">    <tr height="15"><td valign="top"></td><td valign="top" colspan="2"><p style="MARGIN: 0px"><b><font size="2">CITIUS PHARMACEUTICALS, INC.</font></b><font size="2"></font></p></td><td></td></tr><tr height="15"><td valign="top" width="50%"></td><td valign="top" width="3%"></td><td valign="top" width="35%"></td><td valign="top" width="12%"></td></tr><tr height="15"><td valign="top"><p style="MARGIN: 0px"><font size="2">Date: February 3, 2016</font></p></td><td valign="top"><p style="MARGIN: 0px"><font size="2">By:</font></p></td><td style="BORDER-BOTTOM: black 1px solid" valign="top" =""=""><p style="MARGIN: 0px"><i><font size="2">/s/ Leonard Mazur</font></i><font size="2"></font></p></td><td valign="top"></td></tr><tr height="15"><td valign="top"></td><td valign="top"></td><td valign="top"><p style="MARGIN: 0px"><font size="2">Leonard Mazur</font></p><p style="MARGIN: 0px"><font size="2">President and Chief Executive Officer</font></p></td><td></td></tr></table><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center">&nbsp;</p><p style="MARGIN: 0px" align="center">3</p><hr style="COLOR: #000000" noshade=""></BODY></html>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ctxr_ex991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<html><head><title> ctxr_ex991.htm </title><!--Document Created by EDGARMaster--></head><BODY style="TEXT-ALIGN: justify; FONT: 10pt TIMES NEW ROMAN; MARGIN: 0px 7%" scroll="yes"><p style="MARGIN: 0px" align="right"><strong>EXHIBIT 99.1</strong></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center"><strong>Citius Pharmaceuticals Announces Results from Phase 2a Trial of Hydrocortisone and Lidocaine Combination Cream in Patients with Grade I and II Hemorrhoids</strong></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><font size="2"><font face="Symbol"><table id="e0e31512-f87b-4a5d-b69c-7d6d99e31d36" style="WIDTH: 100%; FONT: 10pt times new roman" cellspacing="0" cols="3" cellpadding="0" width="100%" align="center" border="0">    <tr><td valign="top" width="45"><p style="MARGIN: 0px">&nbsp;</p></td><td valign="top" width="45"><p style="MARGIN: 0px"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Symbol">&#183;</font></p></td><td><p style="MARGIN: 0px">Company advances commercialization of product into $1 billion industry</p></td></tr><tr><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td></tr><tr><td valign="top" width="45"><p style="MARGIN: 0px">&nbsp;</p></td><td valign="top" width="45"><p style="MARGIN: 0px"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Symbol">&#183;</font></p></td><td><p style="MARGIN: 0px">Combination product demonstrates positive directional improvement compared to placebo in Global Score of Disease Severity and the onset of symptom relief</p></td></tr><tr><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td></tr><tr><td valign="top" width="45"><p style="MARGIN: 0px">&nbsp;</p></td><td valign="top" width="45"><p style="MARGIN: 0px"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Symbol">&#183;</font></p></td><td><p style="MARGIN: 0px">Data demonstrate an excellent safety profile</p></td></tr><tr><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td><td><p style="MARGIN: 0px">&nbsp;</p></td></tr><tr><td valign="top" width="45"><p style="MARGIN: 0px">&nbsp;</p></td><td valign="top" width="45"><p style="MARGIN: 0px"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Symbol">&#183;</font></p></td><td><p style="MARGIN: 0px">Company plans to conduct future studies</p></td></tr></table></font></font></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Maynard, MA; February 1, <sup></sup>2016 (PR NEWSWIRE) &#8211; Citius Pharmaceuticals, Inc. (OTCQB:CTXR) today announced top line data from the first Phase 2a clinical trial of hydrocortisone acetate (HC) and lidocaine hydrochloride (L) as single agents and in combination (HC+L) in patients with grade I and II hemorrhoids. Citius' hydrocortisone and lidocaine cream is targeting to become the first FDA &#8211;approved prescription product to treat hemorrhoids in the U.S.</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">In this randomized, double blind study of topical formulations of hydrocortisone, lidocaine and hydrocortisone + lidocaine were tested in patients with Grade I and II hemorrhoids. There have been no historical randomized, placebo-controlled studies of these two drugs used either individually or in combination to treat hemorrhoids. Therefore, this study's objective was to obtain data to inform the design of future studies. In this study, 210 patients were treated twice daily for 14-days with either placebo or one of the six active drug treatments (i.e., two concentrations of each HC, L and HC+L). Patients kept a diary of their symptoms. Additionally, there were 4 physician assessments during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids such as bleeding, pruritus and overall pain and discomfort, and time to the onset of symptom relief. </p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Within the first few days of treatment the highest concentration of the hydrocortisone + lidocaine product was directionally superior to the placebo as measured by the number of subjects experiencing a minimum of 2 levels improvement from baseline according to the GSDS scale. This study was not powered to obtain statistical significance; however the data suggest that the combination product may also perform better than the HC or L alone. The trend of HC+L superiority over placebo was also generally consistent for the treatment of individual signs and symptoms of hemorrhoidal disease &#8211; bleeding, itching, pain and overall discomfort. In addition, no safety signal of note was recorded in the trial. </p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">"We are pleased with the results of this study which was intended to test the hypothesis that a steroid and anesthetic drug combination can be an effective way to reduce the symptoms of hemorrhoids," said Mr. Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, Inc. "As expected, the data provides a positive directional signal and also indicate early reduction of symptoms. We look forward to submitting these results to the FDA as we move toward commercialization of our product within this $1 billion market with unmet need. "</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><table id="pagebreak132a65a0-5a3a-4a7e-8c45-ddfead2d31df" class="pagebreak" style="WIDTH: 100%; FONT: 10pt TIMES NEW ROMAN" cellspacing="0" cellpadding="0" border="0">    <tr><td class="hpbhr">&nbsp;</td></tr><tr><td style="BORDER-BOTTOM: black 1px solid; TEXT-ALIGN: center">1</td></tr><tr></tr><tr><td><div style="WIDTH: 100%; PAGE-BREAK-AFTER: always; LINE-HEIGHT: 0px"></div></td></tr><tr><td>&nbsp;</td></tr></table></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><u><font size="2">About Hemorrhoids </font></u></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Hemorrhoids are a common gastrointestinal disorder, characterized by itching, pain, swelling and tenderness and bleeding. In the U.S., hemorrhoids affect nearly 5% of the population, with approximately 10 million persons annually admitting to having symptoms of hemorrhoidal disease. Of these afflicted persons, approximately one third visit a physician for evaluation and treatment of their hemorrhoids. The data also indicate that for both sexes a peak of prevalence occurs from age 45 to 65 years with a subsequent decrease after age 65. Caucasian populations are affected significantly more frequently than African Americans, and increased prevalence rates are associated with higher socioeconomic status in men but not women. Development of hemorrhoids before age 20 is unusual. In addition, between 50% and 90% of the general U.S., Canadian and European population will experience hemorrhoidal disease at least once in life. Although hemorrhoids and other anorectal diseases are not life-threatening, individual patients can suffer from agonizing symptoms which can limit social activities and have a negative impact on the quality of life. We believe that currently there are no FDA approved products for the treatment of hemorrhoids. </p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><u><font size="2">About Citius Pharmaceuticals, Inc.</font></u></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Citius is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets using innovative, patented or proprietary formulations of previously approved pharmaceutical products. We seek new and expanded indications for previously approved pharmaceutical products as a means to achieving leading market positions or potential market exclusivity. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development. We seek to achieve these objectives by utilizing the U.S. Food and Drug Administration's, or FDA's, 505(b)(2) pathway for our new drug approvals. We believe this pathway is comparatively faster, lower risk and less expensive than the FDA's traditional new drug approval pathway. In addition, we focus on obtaining intellectual property protection with the objective of listing relevant patents in the FDA Orange Book in order to limit generic competition. </p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px"><b><u>Safe Harbor</u></b></p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">This release may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions.</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by use of words "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission.</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, we undertake no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">For additional information, please contact:</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">Robert Haag <br>Managing Partner <br>IRTH Communications <br>CTXR@irthcommunications.com</p><p style="MARGIN: 0px">866-976-4784 </p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px">&nbsp;</p><p style="MARGIN: 0px" align="center">2</p><hr style="COLOR: #000000" noshade="">    <p style="MARGIN: 0px">&nbsp;</p></BODY></html>
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