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) March 31, 2011
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 1.01. | Entry into a Material Definitive Agreement. |
Amended and Restated Development, Commercialization and License Agreement
On March 31, 2011, Salix’s subsidiary Salix Pharmaceuticals, Inc. entered into an Amended and Restated Development, Commercialization and License Agreement (the “License Agreement”) with Lupin Ltd. The License Agreement replaces in its entirety the original agreement between the parties dated as of September 30, 2009 (the “Original License Agreement”). Under the Original License Agreement, Salix and Lupin are collaborating with respect to the development of a product incorporating rifaximin and utilizing Lupin’s proprietary bioadhesive drug delivery technology, or any other bioadhesive for purposes of gastrointestinal drug delivery (the “Licensed Bioadhesive Product”), for commercialization in the United States for human use. The License Agreement expands the collaboration between Salix and Lupin to extend worldwide (other than India) and to include not only the Licensed Bioadhesive Product but all rifaximin products covered by Lupin technology or technology jointly developed by Lupin and Salix (“Licensed Products”).
Under the License Agreement, Lupin has granted Salix exclusive worldwide rights (except for India) to exploit Licensed Products for human use. Lupin also has agreed to certain specific limitations on its right to sell or distribute rifaximin to persons other than Salix and its Affiliates. Such limitations continue in effect for so long as any one of the License Agreement, the API Supply Agreement or the Finished Product Supply Agreement continues in force.
In connection with the signing of the License Agreement, Salix must pay Lupin an upfront fee of $10 million. Salix is also obligated to pay up to $53 million in respect of U.S. regulatory milestones relating to Licensed Products covered by Lupin or jointly-held patents, as well as royalties in a percentage in the low teens of net sales of Licensed Products covered by Lupin or jointly-held patents during the royalty term. Royalty rates are subject to reduction and set-offs in certain circumstances. If Salix intends to commercialize a Licensed Product that is covered by Lupin or jointly-held patents outside the United States, then Salix and Lupin are required to negotiate to establish terms and conditions in respect of the consideration to be paid to Lupin in connection with such commercialization.
During the first three years of the License Agreement, Salix must pay Lupin a minimum quarterly payment unless specified payments by Salix to Lupin during that quarter exceed that amount. The payments that are credited against the minimum quarterly consideration target consist of milestone payments, royalties, markups under the Finished Product Supply Agreement (described below), amounts paid by Salix to Lupin for development services less Lupin’s cost of providing such services, and markups above manufacturing cost payable by Salix to Lupin pursuant to subsequently agreed supply arrangements, but exclude the up-front fee and payments under the API Supply Agreement (described below). Payments made by Salix and received by Lupin in respect of shortfalls in quarterly consideration targets are to be trued up on an annual basis.
The term of the License Agreement continues until the later of the expiration of Salix’s obligations to pay royalties in respect of Licensed Products covered by Lupin or jointly-held patents and the tenth anniversary of the License Agreement. The royalty terms with respect to any Licensed Bioadhesive Product in a particular country other than India will end upon the commercial introduction by a third party of an approved prescription product in that country containing rifaximin and utilizing bioadhesive technology or, if earlier, the later of (1) the 10th anniversary of the first commercial sale of the Bioadhesive Rifaximin Product in that country and (2) the first date on which there is no longer (i) a valid relevant patent claim in that country or (ii) any data exclusivity with respect to the bioadhesive rifaximin product in that country. The royalty terms with respect to any non-bioadhesive products in a particular country terminate upon the earlier of the first commercial sale in that country of a competitive prescription product containing rifaximin or the first date on which the exploitation of the product would no longer infringe a relevant Lupin patent.
Either party may terminate the License Agreement due to the insolvency of, or a material breach of the agreement by, the other. Lupin may terminate the License Agreement upon termination of the API Supply Agreement (other than by Salix due to Lupin’s breach). Salix may terminate the agreement if any regulatory authority in the United States requires or causes the withdrawal of a Salix prescription rifaximin product, upon the commercial sale or distribution in the United States of a third party of an unauthorized generic version of any Salix prescription rifaximin product, or if Salix determines that it is not feasible or desirable to pursue the development and commercialization of the licensed product for reasons relating to the identity of any successor to Lupin. In addition, Salix may terminate the License Agreement for convenience, but must in connection with any such termination occurring prior to the third anniversary of the License Agreement pay Lupin an amount equal to the aggregate quarterly Lupin quarterly consideration targets for the full initial three-year period less
any amounts paid or payable by Salix prior to termination by way of creditable consideration realized by Lupin or payments made by Salix to Lupin in respect of any consideration shortfalls. If a Licensed Product that has been designated for development in connection with the collaboration receives regulatory approval in the U.S., then Salix is entitled to royalties of a mid-single digits percentage of net sales of such Licensed Product worldwide (other than India) by Lupin and its licensees for ten years following the date of termination of the License Agreement.
Under the License Agreement, Salix and Lupin will continue in effect the joint steering committee established under the Original License Agreement to oversee and coordinate the development and other exploitation of Licensed Products for human uses worldwide (other than India). Salix has the sole responsibility and authority for clinical trials, regulatory approvals and commercialization of Licensed Products worldwide (other than India), and must engage in defined minimum development and commercialization efforts.
Pursuant to the License Agreement, Salix has granted to Lupin an exclusive license to Salix technology arising from the collaboration and a non-exclusive right of reference to Salix regulatory documentation for the development and commercialization of the Licensed Bioadhesive Product in India for all uses and worldwide for non-human use.
Salix and Lupin will jointly own all improvements jointly developed under the License Agreement, with Salix having the right to exploit such improvements in respect of Licensed Products for human use worldwide (other than India) and Lupin having the right to exploit such improvements in respect of Licensed Products in India for all uses and worldwide for non-human use. Salix will own and retain all right and title to the product trademarks.
First Amendment to Rifaximin Manufacturing and Supply Agreement
Simultaneously with the execution of the License Agreement, Salix and Lupin entered into an amendment to the Rifaximin Manufacturing and Supply Agreement, dated September 30, 2009 (the “Original API Supply Agreement”). We refer to the Original API Supply Agreement as amended by such amendment as the API Supply Agreement. The amendment updates invention-related provisions in the Original API Supply Agreement so as to coordinate them with the expanded scope of the collaboration established by the License Agreement.
Finished Product Manufacturing and Supply Agreement
Simultaneously with the execution of the License Agreement, Salix and Lupin entered into a Finished Product Manufacturing and Supply Agreement, which we refer to herein as the Finished Product Supply Agreement. Under the agreement, Salix will exclusively purchase from Lupin, and Lupin will supply to Salix, all of Salix’s requirements of Licensed Products covered by Lupin or jointly-held patents for marketing, sale and distribution by Salix under the License Agreement. However, Salix may source a portion of its requirements of relevant products from a source other than Lupin as necessary to secure and maintain, as it determines in consultation with Lupin, a viable second source.
The purchase price for each product covered by the Finished Product Supply Agreement will be Lupin’s manufacturing cost for such product, increased by a specified markup.
The Finished Product Supply Agreement expires on the first date following the first date on which Salix expects to require commercial supply of a product thereunder when there is no longer a product to which the Finished Product Supply Agreement applies. The agreement will cease to apply in respect of each product on a product-by-product basis on the earlier of (i) the fifth anniversary of the first date on which Salix expect to require commercial supply for such product and (b) the third anniversary of the commercial sale in the United States of an unauthorized generic version of such product.
Either party may terminate the Finished Product Supply Agreement due to the insolvency of, or a material breach of the agreement by, the other party, if the continued operation of the agreement is prohibited, prevented or delayed as a result of a governmental order, or upon the occurrence of an uncured force majeure event. Salix may terminate the agreement if regulatory authorities require or cause the withdrawal of any product or upon the termination of the License Agreement. Lupin may terminate the agreement following its termination of the License Agreement pursuant to specified provisions of the License Agreement. Lupin may also terminate the agreement should the quantity of Salix’s purchase orders, in the aggregate, drop below specified thresholds for a specified period.
* * * * *
Detailed descriptions of the Original License Agreement and the Original API Supply Agreement are included in Salix’s Current Report on Form 8-K filed October 5, 2009. Copies of the said agreements were filed on November 9, 2009, as Exhibits 10.67 and 10.68, respectively, to Salix’s Quarterly Report on Form 10-Q.
The descriptions of the License Agreement, the amendment to the Original API Supply Agreement, and the Finished Product Supply Agreement provided above are qualified in their entirety by reference to the full and complete terms contained in the License Agreement, the amendment to Original API Supply Agreement, and the Finished Product Supply Agreement, which will be filed as exhibits to Salix’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2011.
| Item 8.01. | Other Events. |
On April 6, 2011, Salix issued a press release announcing its entry into the License Agreement. A copy of this press release is attached as Exhibit 99.1.
On April 4, 2011, Salix issued a press release announcing the International Liver Congress™ 2011 of the European Association for the Study of the Liver served as the venue for a presentation describing the investigation of rifaximin. A copy of this press release is attached as Exhibit 99.2.
The information in this Item 8.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit |
Description | |
| 99.1 | Press release dated April 6, 2011. | |
| 99.2 | Press release dated April 4, 2011. | |
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: April 6, 2011 | /s/ Adam C. Derbyshire | |
| Adam C. Derbyshire | ||
| Executive Vice President and Chief Financial Officer | ||
Exhibit 99.1
FOR IMMEDIATE RELEASE
| Contact: | Adam C. Derbyshire | G. Michael Freeman | ||
| Executive Vice President and Chief Financial Officer |
Associate Vice President, Investor Relations and Corporate Communications | |||
| 919-862-1000 | 919-862-1000 |
SALIX PHARMACEUTICALS EXPANDS RIFAXIMIN COLLABORATION WITH LUPIN
Collaboration Expanded Worldwide (Other than India) and for All Lupin Rifaximin Technology
RALEIGH, NC, April 6, 2011 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use. This agreement expands the collaboration that Salix and Lupin entered into as of September 30, 2009. The agreement covers the development and commercialization of rifaximin products and provides for Lupin to supply Salix with rifaximin active pharmaceutical ingredient (API) and certain finished rifaximin products. Salix is required to make a $10 million up-front payment to Lupin along with potential U.S. regulatory milestone payments in respect of products covered by Lupin patents or jointly-held patents. Royalties at a percentage rate in the low teens will be payable by Salix to Lupin in respect of sales of products covered by Lupin patents or jointly-held patents. Additionally, Salix will pay Lupin minimum quarterly payments for product development and other activities.
About XIFAXAN® (rifaximin)
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200 mg is approved in over 30 countries worldwide. Alfa Wassermann S.p.A. in Bologna, Italy has marketed rifaximin in Italy under the trade name Normix® for over 30 years. Salix acquired rights to market rifaximin in North America from Alfa Wassermann.
Important Safety Information
XIFAXAN 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients > 18 years of age. In the trials of XIFAXAN 550 mg tablets for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN 550 mg tablets have not been studied in patients with MELD scores > 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN 550 mg tablets to patients with severe hepatic impairment (Child–Pugh C).
XIFAXAN 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 550 mg tablets. 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 550 mg tablets, 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.
The most common adverse reactions occurring in >8 percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (9 percent), pruritus (9 percent), and abdominal pain (9 percent).
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and 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 gastroenterology specialty sales and marketing team.
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), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), RELISTOR® (methylnaltrexone bromide) Subcuataneous Injection, 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. Crofelemer, budesonide foam, RELISTOR®, Lumacan™ and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP 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 the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our web site is not incorporated in our SEC filings.
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Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such 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, among others: the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
Exhibit 99.2
FOR IMMEDIATE RELEASE
| Contact: | Adam C. Derbyshire | G. Michael Freeman | ||
| Executive Vice President and Chief Financial Officer | Associate Vice President, Investor Relations and Corporate Communications | |||
| 919-862-1000 | 919-862-1000 |
SALIX REVIEWS THE INTERNATIONAL LIVER CONGRESS 2011 OF THE
EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER
Open-Label Maintenance Trial Data Demonstrated Long-Term Efficacy and Survival in Patients
Treated with Rifaximin for the Maintenance of Remission From Overt Hepatic Encephalopathy
RALEIGH, NC, April 4, 2011 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that The International Liver Congress™ 2011 of the European Association for the Study of the Liver (EASL) served as the venue for a presentation describing the investigation of rifaximin, the Company’s gut-selective antibiotic. EASL was held in Berlin, Germany March 30 – April 3.
Long-Term Efficacy and Survival in Patients Treated with the Gut-Selective Antibiotic Rifaximin (550 mg BID) for the Maintenance of Remission from Overt Hepatic Encephalopathy
Oral Presentation, April 2, 2011, 4:15 p.m., Room: Hall 15.2
In an oral presentation, Dr. Kevin Mullen and colleagues presented an update from the data of an open label maintenance trial (OLM) in 128 new patients and 152 rollover patients (70 rifaximin-treated and 82 placebo-treated) from the pivotal Phase 3, multinational, randomized, double-blind, placebo-controlled trial (RCT) of 299 patients with a history of hepatic encephalopathy (HE). Breakthrough HE was defined as an increase to Conn Score (CS) of 2 or greater or CS and asterixis grade increase of 1 each if baseline CS equals 0. Three cohorts comprised the OLM: 1) 128 patients newly exposed to rifaximin (representing 342 Patient Exposure Years [PEY]), 2) 82 placebo-treated patients who crossed over from the RCT (representing 134 PEY), and 3) 70 rifaximin-treated patients who rolled over from the RCT (representing 147 PEY). Placebo patients in the RCT represented 46 PEY. The corresponding rates of HE recurrence for each cohort were significantly lower in the rifaximin treated patients (0.2 to 0.4 events/ PEY) versus placebo patients in RCT (1.6 events/PEY), p<0.0001. Additionally, for all patients treated with rifaximin long term (510 PEY), HE-caused hospitalization rates and All-cause hospitalization rates were significantly lower compared to the hospitalization rates for patients treated with placebo in the RCT (p<0.0001). The event rates were 0.2 rifaximin versus 0.7 placebo (events/PEY); and 0.5 rifaximin versus 1.3 placebo (events/PEY) for the HE-caused and All-cause hospitalizations, respectively. Over the long term, treatment with rifaximin did not adversely affect mortality (38% reduction in risk; p=0.1480) when compared to the historical placebo event rate from the RCT.
About XIFAXAN® (rifaximin)
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200 mg is approved in over 30 countries worldwide. Alfa Wassermann S.p.A. in Bologna, Italy has marketed rifaximin in Italy under the trade name Normix® for over 30 years. Salix acquired rights to market rifaximin in North America from Alfa Wassermann.
Important Safety Information
XIFAXAN 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients > 18 years of age. In the trials of XIFAXAN 550 mg tablets for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN 550 mg tablets have not been studied in patients with MELD scores > 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN 550 mg tablets to patients with severe hepatic impairment (Child–Pugh C).
XIFAXAN 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 550 mg tablets. 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 550 mg tablets, 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.
The most common adverse reactions occurring in >8 percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (9 percent), pruritus (9 percent), and abdominal pain (9 percent).
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and 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 gastroenterology specialty sales and marketing team.
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), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), RELISTOR® (methylnaltrexone bromide) SI, 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. Crofelemer, budesonide foam, RELISTOR®, Lumacan™ and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP 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 the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our web site is not incorporated in our SEC filings.
###
Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such 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, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.