-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, TVscJP7wP0TOgNAtknu0hYiCsfomRnIpdGIXJbFo+7FVlhSvwPm1jzn7YmmaZgqf Qmm8FYL+L3FmtlAH5foDHA== 0001193125-07-213485.txt : 20071005 0001193125-07-213485.hdr.sgml : 20071005 20071004173113 ACCESSION NUMBER: 0001193125-07-213485 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071004 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071005 DATE AS OF CHANGE: 20071004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SALIX PHARMACEUTICALS LTD CENTRAL INDEX KEY: 0001009356 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943267443 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23265 FILM NUMBER: 071157519 BUSINESS ADDRESS: STREET 1: 1700 PERIMETER PARK DRIVE CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: (919) 862-1000 MAIL ADDRESS: STREET 1: 1700 PERIMETER PARK DRIVE CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: SALIX HOLDINGS LTD DATE OF NAME CHANGE: 19970807 8-K 1 d8k.htm FORM 8-K Form 8-K

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) October 4, 2007

 


SALIX PHARMACEUTICALS, LTD.

(Exact name of registrant as specified in its charter)

 


Delaware

(State or other jurisdiction of incorporation)

 

000-23265   94-3267443
(Commission File Number)   (IRS Employer ID Number)

1700 Perimeter Park Drive, Morrisville, North Carolina 27560

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (919) 862-1000

 


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.

On October 4, 2007, Salix Pharmaceuticals, Ltd. issued a press release announcing that it has licensed OsmoPrep™ to Mayoly-Spindler in France. A copy of this press release is attached as Exhibit 99.1.

Also, on October 4, 2007, Salix Pharmaceuticals, Ltd. issued a press release announcing the successful completion and outcome of the second of two Phase III registration trials to evaluate the safety and efficacy of the Company’s new granulated mesalamine product currently under development for the indication of maintenance of remission in patients with ulcerative colitis. A copy of this press release is attached as Exhibit 99.2.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit No.

  

Description

99.1

   Press release dated October 4, 2007 regarding licensing agreement with Mayoly-Spindler.

99.2

   Press release dated October 4, 2007 regarding Phase III registration trials results.


SIGNATURE

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.

 

    SALIX PHARMACEUTICALS, LTD.

Date: October 4, 2007

   
   

/s/ Adam C. Derbyshire

    Adam C. Derbyshire
    Senior Vice President and Chief Financial Officer
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

FOR IMMEDIATE RELEASE

 

Contact:   Adam C. Derbyshire   Mike Freeman
  Senior Vice President and   Executive Director, Investor Relations and
  Chief Financial Officer   Corporate Communications
  919-862-1000   919-862-1000

SALIX PHARMACEUTICALS LICENSES OSMOPREP™

TO MAYOLY-SPINDLER IN FRANCE

Tablet Bowel Cleanser Patented In Europe to 2016

RALEIGH, NC, October 4, 2007 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that it has licensed exclusive rights to market OSMOPREP™ (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets in France to Mayoly-Spindler S.A.S of Chatou, France. Under the terms of the agreement, Salix may receive up to $1 million in milestone payments, as well as royalty payments based on product sales. Mayoly-Spindler will join the current mutual recognition process being conducted by Dr. Falk Pharma to obtain Marketing Authorization in Europe.

Commenting on the agreement, Carolyn Logan, President and Chief Executive Officer, Salix, stated, “We are pleased to initiate a relationship with the highly-regarded company, Mayoly-Spindler. In keeping with our strategy, this agreement allows Salix to focus its commercial efforts on the U.S. market and our partner, Mayoly-Spindler, to focus on developing the commercial potential of OSMOPREP in France, its core market.” Speaking on behalf of Mayoly-Spindler, President Jean-Gilles Vernin stated, “We are pleased with the opportunity to work with Salix, a leading U.S. gastroenterology company. The acquisition of this product reinforces our portfolio and confirms our effort to better support the French gastroenterology community. We anticipate marketing approval for the product in the first half of 2009.”

OSMOPREP™ Tablets were granted Marketing Authorization in the United Kingdom in December 2006, where it is indicated for cleansing of the bowel when required as a preparation


for certain diagnostic procedures such as colonoscopy. OSMOPREP has patent protection in Europe to May 2016.

Laboratories Mayoly-Spindler is a privately-owned pharmaceutical company that develops and markets products in the therapeutic areas of gastroenterology, rheumatology and dermatology.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them in the United States through the Company’s 150-member gastroenterology specialty sales and marketing team.

Salix markets COLAZAL® (balsalazide disodium) Capsules 750 mg, XIFAXAN® (rifaximin) tablets 200 mg , OSMOPREP™ (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), 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. SANVAR® IR (vapreotide acetate), balsalazide tablet, encapsulated mesalamine granules and rifaximin for additional indications are under development.

In the U.S., OSMOPREP Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep Tablets are used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute obstruction or pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric


bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep Tablets. OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were transient and self-limited abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OsmoPrep Tablets be advised to adequately hydrate before, during, and after the use of OsmoPrep.

For full prescribing information on Salix products, please visit www.salix.com.

Salix trades on the NASDAQ Global Market under the ticker symbol “SLXP”.

For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include: reliance on third parties for international sales; risks of regulatory review and clinical trials; intellectual property risks; market acceptance for approved products; competition, including from potential generic or over-the-counter products; management of rapid growth; and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

EX-99.2 3 dex992.htm PRESS RELEASE Press release

EXHIBIT 99.2

FOR IMMEDIATE RELEASE

 

Contact:

      Adam C. Derbyshire    Mike Freeman
      Senior Vice President and    Executive Director, Investor Relations and
      Chief Financial Officer    Corporate Communications
      919-862-1000    919-862-1000

SALIX ANNOUNCES STATISTICALLY SIGNIFICANT TOP-

LINE RESULTS FOR SECOND PRODUCT REGISTRATION

STUDY OF GRANULATED MESALAMINE IN ULCERATIVE

COLITIS

- December 2007 NDA Submission Targeted -

RALEIGH, NC, October 4, 2007 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful completion and outcome of the second of two Phase III registration trials to evaluate the safety and efficacy of the Company’s new granulated mesalamine product currently under development for the maintenance of remission in patients with ulcerative colitis. Results from the study indicate that a statistically significantly greater proportion of subjects dosed once-a-day with 1.5 grams of granulated mesalamine remained relapse-free over 6 months of treatment than patients dosed with placebo.

Commenting on the study, Bill Forbes, Pharm.D., Vice President, Research and Development, Salix Pharmaceuticals, stated, “The outcome of this second, 300-subject, multicenter, 6-month, double-blind, randomized, placebo-controlled study confirms the results of the study we reported in September 2007. The results of this second study again demonstrate the utility of our novel delayed and extended release formulation of mesalamine, dosed once a day in this study, to successfully maintain remission in ulcerative colitis patients. We continue to anticipate a December 2007 NDA submission for this product.”

Salix acquired rights to market granulated mesalamine in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Dr. Falk Pharma markets granulated mesalamine in Germany and other


European countries, as well as Australia, under the trade name Salofalk Granu-Stix®. The application to market Salofalk Granu-Stix is currently under regulatory review for additional non-EU countries.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s 150-member gastroenterology specialty sales and marketing team.

Salix markets COLAZAL® (balsalazide disodium) Capsules 750 mg, XIFAXAN® (rifaximin) tablets 200 mg , OSMOPREP™ (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), 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. SANVAR® IR (vapreotide acetate), balsalazide tablet, encapsulated mesalamine granules and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com.

Salix trades on the NASDAQ Global Market under the ticker symbol “SLXP”.

For more information please visit our web site at www.salix.com or contact the Company at 919-862-1000. Information on our web site is not incorporated in our SEC filings.

###

 

2


Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks of regulatory review and clinical trials, potential generic and other competition, market acceptance for approved products, intellectual property risks, the need to acquire additional products and management of rapid growth. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

 

3

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