Download SALIX PHARMACEUTICALS LTD (Form: 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 11, 2014
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
Delaware
000-23265
94-3267443
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
8510 Colonnade Center Drive
Raleigh, North Carolina
27615
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (919) 862-1000
Not Applicable
(Former name or former address, if changed since last report)
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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
Relistor ® Supplemental New Drug Application (sNDA)
On August 11, 2014, Salix Pharmaceuticals, Ltd. (the “Company”) and Progenics Pharmaceuticals (“Progenics”) announced that
the Food and Drug Administration had informed Salix that the sNDA for Relistor (methylnaltrexone bromide) Subcutaneous Injection, 20
mg/ml, for the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain had been assigned a user fee goal
date of September 29, 2014. A copy of the joint press release is attached hereto as Exhibit 99.1.
Topline Retreatment Study Results for Rifaximin in Subjects with Irritable Bowel Syndrome with Diarrhea (“IBS-D”)
On August 11, 2014, the Company announced the topline results from the analysis of the microbiome, culture and susceptibility,
and two key secondary efficacy endpoints from data collected in TARGET 3 – a Phase 3 randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with IBS-D who
respond to an initial treatment course with rifaximin 550 mg TID for 14 days. A copy of the press release is attached hereto as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No.
Description
99.1
Joint press release with Progenics dated August 11, 2014.
99.2
Press release dated August 11, 2014.
SIGNATURES
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.
August 12, 2014
SALIX PHARMACEUTICALS, LTD.
By:
/s/ William C. Bertrand
William C. Bertrand
Senior Vice President and General Counsel
EXHIBIT INDEX
Exhibit
No.
Description
99.1
Joint press release with Progenics dated August 11, 2014.
99.2
Press release dated August 11, 2014.
Exhibit 99.1
Salix Contact:
Progenics Contact:
Adam C. Derbyshire
Executive Vice President
and Chief Financial Officer
919-862-1000
G. Michael Freeman
Associate Vice President, Investor Relations
and Corporate Communications
919-862-1000
Melissa Downs
Corporate Development
914-789-2800
FDA Assigns September 29, 2014 Prescription Drug User Fee Act Goal Date for RELISTOR ® Subcutaneous Injection sNDA for the
Treatment of Opioid-induced Constipation in Patients with Chronic Non-cancer Pain
FDA Approval Will Expand Treatment of Opioid-induced Constipation to Include Patients Taking Opioids for Chronic Non-Cancer Pain
RALEIGH, NC and TARRYTOWN, NY, August 11, 2014 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals
(NASDAQ:PGNX) today announced that the Food and Drug Administration (FDA or Agency) has informed Salix that the supplemental New
Drug Application (sNDA) for RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of
opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain has been assigned a user fee goal date of
September 29, 2014.
On July 10, 2014 the FDA Office of Drug Evaluation III responded to the Company’s formal appeal filed in response to the Complete
Response Letter (CRL) of July 27, 2012 to the supplemental NDA (sNDA) for RELISTOR. The Agency’s letter stated that, “Salix’s request
that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients
with chronic non-cancer pain based on the submitted data is granted.” In regard to the RELISTOR sNDA the Agency directed Salix to work
with and submit certain information to the Division of Gastroenterology and Inborn Errors Products (DGIEP). On July 29, 2014 the FDA
accepted Salix’s resubmission. On August 8, 2014 the FDA communicated to Salix that the Company’s resubmission is a complete, class 1
response to the FDA’s action letter and assigned the user fee goal date.
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“The approval and availability of RELISTOR for this expanded use will be an important and welcomed advancement for treating the
underlying cause of OIC experienced by many patients taking opioids for chronic non-cancer pain,” stated Bill Forbes, Executive Vice
President, Medical, Research and Development and Chief Development Officer, Salix. “Frequently, opioid analgesics are prescribed to manage
pain in patients suffering from chronic conditions. Unfortunately, the use of an opioid can result in debilitating constipation for a significant
number of these patients. RELISTOR is a peripherally acting mu-opioid receptor antagonist (PAMORA) designed to counteract the
constipating effects of opioid pain medications without affecting their ability to relieve pain.”
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics are frequently prescribed for patients with chronic pain, including patients with advanced illness. An estimated 27 million
patients in the US are on opioids for chronic pain. Constipation is one of the most common and distressing side effects in patients receiving
chronic opioid therapy. Approximately 40% of chronic pain patients, or nearly 11 million patients, on opioid therapy will experience OIC.
RELISTOR is the first approved medication that specifically targets the underlying cause of OIC.
RELISTOR is a Peripherally Acting Mu Opioid Receptor Antagonist (PAMORA) specifically designed to block the constipating effects of
opioids in the gastrointestinal tract. The unique molecular structure of RELISTOR restricts it from crossing the blood brain barrier and
interfering with the analgesic effect of opioids. In clinical trials, approximately 50% of patients experienced relief of OIC in as little as 4 hours.
RELISTOR is the only PAMORA currently approved by the FDA for the treatment of OIC in patients with advanced illness receiving
palliative care when the response to laxatives has been insufficient.
RELISTOR Subcutaneous Injection was approved in the United States in 2008 for the treatment of OIC in patients with advanced illness who
are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not
been studied in the advanced illness population. The drug is also approved for use in over 50 countries worldwide, including the European
Union, Canada, and Australia. In the 28 member countries of the E.U., as well as Iceland, Norway and Liechtenstein, RELISTOR is approved
for the treatment of OIC in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been
sufficient. In Canada, the
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drug is approved for the treatment of OIC in patients with advanced illness, receiving palliative care. When response to laxatives has been
insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Applications in additional countries are
pending. RELISTOR is under license to Salix Pharmaceuticals, Inc. from Progenics Pharmaceuticals, Inc.
For more information about RELISTOR, please visit www.RELISTOR.com
Important Safety Information about RELISTOR
RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical
gastrointestinal obstruction.
Cases of gastrointestinal (GI) perforation have been reported in adult patients with opioid-induced constipation and advanced illness with
conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer,
Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, or colon). Use RELISTOR with
caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly
notify their physician if they develop severe, persistent, or worsening abdominal symptoms.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.
Use of RELISTOR beyond four months has not been studied.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5%),
flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and hyperhidrosis (6.7%).
RELISTOR full Prescribing Information for the U.S. is available at www.RELISTOR.com .
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical
devices for the prevention and treatment of gastrointestinal diseases.
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Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory
submission of these products, and commercialize them through the Company’s 500-member specialty sales force.
Salix markets XIFAXAN ® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP ® (PEG 3350, sodium sulfate, sodium chloride, potassium
chloride, sodium ascorbate and ascorbic acid for oral solution, 100 g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g), OSMOPREP ® (sodium phosphate
monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO ® (mesalamine) extended-release capsules
0.375 g, UCERIS ® (budesonide) extended release tablets, for oral use, GIAZO ® (balsalazide disodium) tablets, COLAZAL ® (balsalazide
disodium) Capsules, GLUMETZA ® (metformin hydrochloride extended-release tablets) 500 mg and 1000 mg, ZEGERID ®
(omeprazole/sodium bicarbonate) Powder for Oral Suspension, ZEGERID ® (omeprazole/sodium bicarbonate) Capsules, METOZOLV ® ODT
(metoclopramide hydrochloride), RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ ® (crofelemer)
delayed-release tablets, SOLESTA ® , DEFLUX ® , PEPCID ® (famotidine) for Oral Suspension, DIURIL ® (chlorothiazide) Oral Suspension,
AZASAN ® (azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC ® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC ® 25 mg
Suppository (Hydrocortisone Acetate), PROCTOCORT ® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT ® Suppository
(Hydrocortisone Acetate Rectal Suppositories) 30 mg , CYCLOSET ® (bromocriptine mesylate) tablets, FENOGLIDE® (fenofibrate) tablets.
UCERIS (budesonide) rectal foam, RELISTOR ® , LUMACAN ™ , RUCONEST®, RHB-106 and rifaximin for additional indications are
under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP,
AZASAN, GLUMETZA and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and
other important information or contact the Company at 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.
For more information, please visit our website at www.salix.com or contact Salix at 919-862-1000. Follow us on Twitter (@SalixPharma) and
Facebook ( www.facebook.com/SalixPharma ). Information on our Twitter feed, Facebook page and website is not incorporated in our filings
with the SEC.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in
late-stage clinical development. Progenics’ first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic
and a small molecule targeted imaging agent, both in phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and
molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics’ first
commercial product, Relistor ® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix
Pharmaceuticals, Inc. For additional information, please visit www.progenics.com .
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Additional information concerning Progenics and its business may be available in press releases or other public announcements and public
filings made after this release.
Information on or accessed through our website is not included in the company’s SEC filings.
Salix Disclosure Notice
As previously announced on July 8, 2014, Salix, Cosmo Pharmaceuticals S.p.A. and Irish domiciled Cosmo Technologies Limited entered into
an Agreement and Plan of Merger and Reorganization, pursuant to which a subsidiary of Cosmo Technologies Limited will merge with and
into Salix, with Salix as the surviving entity, and Salix will become an indirect, wholly-owned subsidiary of Cosmo Technologies Limited,
which will change its name to Salix Pharmaceuticals, plc.
Please Note: The statements provided herein that are not historical facts are or might constitute projections and other forward-looking
statements regarding future events. Although we believe the expectations reflected in such forward-looking statements are based on reasonable
assumptions, our expectations might not be attained. Forward-looking statements are just predictions and are subject to known and unknown
risks and uncertainties that could cause actual events or results to differ materially from expected results. Factors that could cause actual
events or results to differ materially from those described herein include, among others: uncertainties as to the ability to successfully complete
the proposed transaction in accordance with its terms and in accordance with the expected schedule; the possibility that competing offers will
be made; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived, including that a
governmental entity may prohibit or refuse to grant any approval required for the consummation of the proposed transaction; the
unpredictability of the duration and results of regulatory review of New Drug Applications, Biologics License Agreements, and Investigational
NDAs; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and
results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation, including the
ongoing Department of Justice investigation of Salix’s marketing practices; market acceptance for approved products; revenue recognition
and other critical accounting policies; the need to acquire new products; changes in tax laws or interpretations thereof; general economic and
business conditions; and other factors. Readers are cautioned not to place undue reliance on the forward-looking statements included herein,
which speak only as of the date hereof. Salix does not undertake to update any of these statements in light of new information or future events,
except as required by law. The reader is referred to the documents that Salix files from time to time with the SEC.
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Progenics Disclosure Notice
This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions
only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties
include, among others: market acceptance for approved products; generic and other competition; the possible impairment of, inability to
obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting
matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in
its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press
release as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or
circumstances or otherwise.
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Exhibit 99.2
Contact:
Adam C. Derbyshire
Executive Vice President
and Chief Financial Officer
919-862-1000
G. Michael Freeman
Associate Vice President, Investor Relations
and Corporate Communications
919-862-1000
SALIX ANNOUNCES IMPORTANT TOPLINE RESULTS FOR MICROBIOME, CULTURE & SUSCEPTIBILITY, AND KEY
SECONDARY EFFICACY RESULTS FOR TARGET 3, RIFAXIMIN IBS-D REPEAT TREATMENT STUDY
Most Comprehensive Microbiome Data Set in IBS Patients to Date with More than Two Billion Data Points Collected
Longitudinal Samples Demonstrate Microbiome Stability with Repeat Rifaximin Dosing
Alterations in Antibiotic Susceptibility for Potential Major Pathogens were not Apparent with Repeat Rifaximin Use
Key Secondary Efficacy Endpoints Support Positive Top-Line Primary Efficacy Results
RALEIGH, NC, August 11, 2014 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the topline results from the analysis of
the microbiome, culture and susceptibility, and two key secondary efficacy endpoints from data collected in TARGET 3 – a Phase 3
randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three
times daily) for 14 days in subjects with irritable bowel syndrome with diarrhea, or IBS-D, who respond to an initial treatment course with
rifaximin 550 mg TID for 14 days.
The effects of rifaximin on the gut microbiota in the IBS-D repeat treatment study, TARGET 3, were evaluated by two methods: traditional
culture techniques and next-generation gene sequencing of stool samples collected from approximately 100 randomly selected subjects in the
trial. Skin swabs were also obtained from an additional 113 randomly selected subjects and cultured for Staphylococcus bacteria.
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Using next-generation 16S rRNA gene sequencing methods, we generated approximately 2.2 billion base pairs from stool samples collected
over the course of the study from approximately 100 randomly selected subjects. Our data reveal no disturbance of fecal microbiota, based on
both diversity and Bray-Curtis similarity measures, in subjects taking repeat courses of rifaximin as compared to subjects taking a single course
of rifaximin followed by placebo for the remainder of the trial.
Results of the culture and susceptibility testing demonstrate no evidence of cross-resistance to non-rifamycin antibiotics in isolates grown from
either stool or skin swab cultures. Importantly, repeat treatment courses of rifaximin do not appear to predispose patients to the emergence of
potentially pathogenic bacteria (e.g., C. difficile, Enterococcus, or Staphylococcus) in the stool or on the skin. As would be expected, given the
high concentration of rifaximin achieved in the stool, transient changes in the rifaximin minimum inhibitory concentrations (MICs), a measure
of microbial sensitivity to an antibiotic, were observed in some of the normal flora but these changes were reversible over time. A very small
number of C. difficile isolates were identified in stool samples at a rate consistent with literature reports of asymptomatic carriers in the general
population, and none of these isolates demonstrated rifaximin resistance.
Efficacy: The company previously disclosed topline efficacy results in both the July 1, 2014 press release as well as the July 9, 2014 Investor
Day. Today’s press release discloses the results of two of the Key Secondary Efficacy Endpoints included in TARGET 3 in support of the
Primary Efficacy Endpoint.
These Key Secondary Endpoints evaluated relief of symptoms during the Primary Evaluation Period (PEP) in the first repeat treatment phase
and the avoidance of subsequent symptom recurrence (in subjects with symptom relief) during the:
•
Double-Blind Phase of the Study (Key Secondary Efficacy Endpoint Number 1: Response type – durable and maintained):
Proportion that responded to the composite FDA Endpoint of relief in both IBS-related Abdominal Pain AND Stool Consistency
during the PEP in the first repeat double-blind, placebo controlled treatment phase AND continued to respond without recurrence
through the end of Week 6 following the second repeat double-blind, placebo controlled treatment. The results indicate a
significantly greater proportion of rifaximin-treated subjects met this endpoint as compared to placebo-treated subjects (p=0.0068).
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•
First Double-Blind Repeat Treatment and follow-up (Key Secondary Efficacy Endpoint Number 2: Response type – durable):
Proportion that responded to the composite FDA Endpoint of relief in both IBS-related Abdominal Pain AND Stool Consistency
during the PEP in the first repeat double-blind, placebo controlled treatment phase AND continued to respond without recurrence
through the end of Week 12, independent of any additional treatment. The results indicate a significantly greater proportion of
rifaximin-treated subjects met this endpoint as compared to placebo-treated subjects (p-value=0.0419)
Overall, the data demonstrate that efficacy is maintained following repeat treatment with rifaximin for up to 3 treatment cycles in subjects with
IBS-D, with no evidence of significant effects on pathogen emergence, pathogen susceptibility or the general microbial population in stool or
skin swab samples.
About XIFAXAN 550 mg
Indication:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients  18
years of age.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial
agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and
anaphylaxis.
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may
range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to
overgrowth of C. difficile . If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be
discontinued.
There is increased systemic exposure in patients with more severe hepatic dysfunction. The clinical trials were limited to patients with MELD
scores < 25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
Concomitant administration of drugs that are P-glycoprotein (P-gp) inhibitors with XIFAXAN can substantially increase the systemic exposure
to XIFAXAN. Caution should be exercised when concomitant use of XIFAXAN and a P-gp inhibitor such as cyclosporine is needed. In
patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the
systemic exposure to XIFAXAN.
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Based on animal data, XIFAXAN may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to
the mother.
The most common adverse reactions occurring in  10% of patients and at a higher incidence than placebo in the clinical study were peripheral
edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%).
Xifaxan 550 mg is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
Please see complete Prescribing Information for XIFAXAN.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical
devices for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary
therapeutic products, complete any required development and regulatory submission of these products, and commercialize them through the
Company’s 500-member specialty sales force.
Salix markets XIFAXAN ® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP ® (PEG 3350, sodium sulfate, sodium chloride, potassium
chloride, sodium ascorbate and ascorbic acid for oral solution, 100 g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g), OSMOPREP ® (sodium phosphate
monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO ® (mesalamine) extended-release capsules
0.375 g, UCERIS ® (budesonide) extended release tablets, for oral use, GIAZO ® (balsalazide disodium) tablets, COLAZAL ® (balsalazide
disodium) Capsules, GLUMETZA ® (metformin hydrochloride extended-release tablets) 500 mg and 1000 mg, ZEGERID ®
(omeprazole/sodium bicarbonate) Powder for Oral Suspension, ZEGERID ® (omeprazole/sodium bicarbonate) Capsules, METOZOLV ® ODT
(metoclopramide hydrochloride), RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ ® (crofelemer)
delayed-release tablets, SOLESTA ® , DEFLUX ® , PEPCID ® (famotidine) for Oral Suspension, DIURIL ® (chlorothiazide) Oral Suspension,
AZASAN ® (azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC ® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC ® 25 mg
Suppository (Hydrocortisone Acetate), PROCTOCORT ® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT ® Suppository
(Hydrocortisone Acetate Rectal Suppositories) 30 mg , CYCLOSET ® (bromocriptine mesylate) tablets, FENOGLIDE ® (fenofibrate) tablets.
UCERIS (budesonide) rectal foam, RELISTOR ® , RUCONEST ® , encapsulated bowel preparation and rifaximin for additional indications
are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP,
AZASAN, GLUMETZA and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and
other important information or contact the Company at 919 862-1000.
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Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.
For more information, please visit our website at www.salix.com or contact Salix at 919-862-1000. Follow us on Twitter (@SalixPharma) and
Facebook ( www.facebook.com/SalixPharma ). Information on our Twitter feed, Facebook page and website is not incorporated in our filings
with the SEC.
Salix Disclosure Notice
As previously announced on July 8, 2014, Salix, Cosmo Pharmaceuticals S.p.A. and Irish domiciled Cosmo Technologies Limited entered into
an Agreement and Plan of Merger and Reorganization, pursuant to which a subsidiary of Cosmo Technologies Limited will merge with and
into Salix, with Salix as the surviving entity, and Salix will become an indirect, wholly-owned subsidiary of Cosmo Technologies Limited,
which will change its name to Salix Pharmaceuticals, plc.
Please Note: The statements provided herein that are not historical facts are or might constitute projections and other forward-looking
statements regarding future events. Although we believe the expectations reflected in such forward-looking statements are based on reasonable
assumptions, our expectations might not be attained. Forward-looking statements are just predictions and are subject to known and unknown
risks and uncertainties that could cause actual events or results to differ materially from expected results. Factors that could cause actual
events or results to differ materially from those described herein include, among others: uncertainties as to the ability to successfully complete
the proposed transaction in accordance with its terms and in accordance with the expected schedule; the possibility that competing offers will
be made; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived, including that a
governmental entity may prohibit or refuse to grant any approval required for the consummation of the proposed transaction; the
unpredictability of the duration and results of regulatory review of New Drug Applications, Biologics License Agreements, and Investigational
NDAs; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and
results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation, including the
ongoing Department of Justice investigation of Salix’s marketing practices; market acceptance for approved products; revenue recognition
and other critical accounting policies; the need to acquire new products; changes in tax laws or interpretations thereof; general economic and
business conditions; and other factors. Readers are cautioned not to place undue reliance on the forward-looking statements included herein,
which speak only as of the date hereof. Salix does not undertake to update any of these statements in light of new information or future events,
except as required by law. The reader is referred to the documents that Salix files from time to time with the SEC.
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