Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in Chronic Constipation and Irr... Page 1 of 3
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`Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in
`Chronic Constipation and Irritable Bowel Syndrome
`
`April 07, 2008 07:00 AM Eastern Daylight Time
`
`NEW YORK--(BUSINESS WIRE)--Callisto Pharmaceuticals, Inc. (AMEX: KAL; FWB: CA4) announced
`today that through its wholly-owned subsidiary, Synergy Pharmaceuticals, Inc. it filed an IND on April
`2, 2008 with the FDA for SP-304 (also called Guanilib) for the treatment of chronic constipation and
`constipation-predominant irritable bowel syndrome.
`
`SP-304 is an analog of uroguanylin, a natural hormone produced in the gastro-intestinal (GI) tract that
`is a key regulator of intestinal function. SP-304 works by activating a unique receptor, the GC-C
`receptor, on intestinal epithelial cells, promoting fluid and ion transport. The drug is administered
`orally. Nonclinical animal studies have shown SP-304 to be well tolerated. Importantly, SP-304 shows
`almost no absorption systemically into the body, exerting its effect locally on GC-C receptors within the
`gut.
`
`"Callisto is pleased that SP-304 is moving forward on schedule into clinical studies. There is strong
`clinical evidence of efficacy and safety for this class of compounds and we are hopeful that this
`product may address the significant unmet medical need of patients suffering from chronic
`constipation and IBS," said Gary S. Jacob, Ph.D., CEO of Callisto, and Chairman of Synergy
`Pharmaceuticals. 'There are only two compounds presently in this class, our drug, and linaclotide, a
`drug that is currently being developed by Microbia and Forest Laboratories to treat GI disorders. We
`believe that SP-304 has the potential to be the best in class."
`
`In animal models SP-304 has been shown to produce responses supporting its potential to reduce
`symptoms of chronic constipation and constipation-predominant irritable bowel syndrome. Pending
`clearance by the FDA, Callisto intends to initiate an SP-304 Phase I clinical trial in 2Q2008 to evaluate
`safety, pharmacokinetic, and pharmacodynamic properties.
`
`About Chronic Constipation
`
`Chronic constipation is a very common gastrointestinal disorder. Up to 26 million Americans suffer
`from the disorder, and of this population about 5 million have a severe condition necessitating relief.
`The prevalence of the disorder is similar in other developed countries. Patients with chronic
`constipation often experience hard stools, straining during bowel movements and not enough bowel
`movements during the week. People with chronic constipation can experience serious discomfort
`which adversely affects their ability to work and their quality of life.
`
`Irritable Bowel Syndrome
`
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`Bausch Health Ireland Exhibit 2014, Page 1 of 3
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`Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in Chronic Constipation and Irr... Page 2 of 3
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`Up to one sixth of adults experience inflammatory bowel syndrome (IBS), a condition marked by
`disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms;
`diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder
`(IBS-M). The split in prevalence between the forms is about 113rd each. In addition, most patients
`suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated
`10 M people in the US and an additional 10 M people in the EU suffer from IBS-C. IBS (all forms)
`accounts for 12% of adult visits to primary care physicians in the US.
`
`About Callisto Pharmaceuticals, Inc.
`
`Callisto is a biopharmaceutical company focused on the development of new drugs to treat various
`forms of gastrointestinal diseases and cancer. Callisto's drug candidates include SP-304, a proprietary
`drug for gastrointestinal disorders that is currently being developed by its wholly-owned subsidiary,
`Synergy Pharmaceuticals, as well as two anti-cancer agents. Synergy's proprietary drug SP-304
`(Guanilib) is planned to begin clinical development in 2Q2008 for gastro-intestinal disorders. SP-304 is
`a synthetic analog of the human gastrointestinal hormone uroguanylin, and acts by activating the
`guanylate cyclase C (GC-C) receptor on epithelial cells of the colon. The Company's lead drug in the
`clinic, Atiprimod, is presently in a Phase II clinical trial in advanced carcinoid cancer, a neuroendocrine
`tumor, and in a Phase II extension trial in advanced carcinoid cancer patients. Callisto's second
`cancer drug in the clinic, L-Annamycin, is currently in a Phase 1/11 clinical trial in adult relapsed or
`refractory acute lymphocytic leukemia, and in a Phase I clinical trial in children and young adults with
`refractory or relapsed acute lymphocytic leukemia or acute myelogenous leukemia. Callisto has
`exclusive worldwide licenses from Genzyme Inc. and M.D. Anderson Cancer Center to develop,
`manufacture, use and sell Atiprimod and L-Annamycin, respectively. Callisto is also listed on the
`Frankfurt Stock Exchange under the ticker symbol CA4. More information is available at
`http://www.callistopharma.com.
`
`Forward-Looking Statements
`
`Certain statements made in this press release are forward-looking. Such statements are indicated by
`words such as "expect," "should," "anticipate" and similar words indicating uncertainty in facts and
`figures. Although Callisto believes that the expectations reflected in such forward-looking statements
`are reasonable, it can give no assurance that such expectations reflected in such forward-looking
`statements will prove to be correct. As discussed in the Callisto Pharmaceuticals Annual Report on
`Form 10-K for the year ended December 31, 2007, and other periodic reports, as filed with the
`Securities and Exchange Commission, actual results could differ materially from those projected in the
`forward-looking statements as a result of the following factors, among others: uncertainties associated
`with product development, the risk that products that appeared promising in early clinical trials do not
`demonstrate efficacy in larger-scale clinical trials, the risk that Callisto will not obtain approval to
`market its products, the risks associated with dependence upon key personnel and the need for
`additional financing.
`
`Web site: http://www.callistopharma.com
`
`Contacts
`Callisto Pharmaceuticals, Inc.
`Gary S. Jacob, Ph.D.
`CEO, Callisto Pharmaceuticals, Inc.,
`+1-212-297-0010, jacob@callistopharma.com
`
`http ://www.businesswire.com/news/home/200804070053 83/ en/Callisto-Pharmaceuticals-F... 1/15/2016
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`Bausch Health Ireland Exhibit 2014, Page 2 of 3
`Mylan v. Bausch Health Ireland - IPR2022-01104
`
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`Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in Chronic Constipation and Irr... Page 3 of 3
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`or
`Russo Partners
`Tony Russo, +1-212-845-4251
`tony.russo@russopartnersllc.com
`or
`Steve Suriano, +1-212-845-4235
`steve.suriano@russopartnersllc.com
`
`http ://www.businesswire.com/news/home/200804070053 83/ en/Callisto-Pharmaceuticals-F... 1/15/2016
`
`Bausch Health Ireland Exhibit 2014, Page 3 of 3
`Mylan v. Bausch Health Ireland - IPR2022-01104
`
`