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) December 20, 2011
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) |
(IRS Employer ID Number) |
| 8510 Colonnade Center Drive Suite 501, Raleigh, North Carolina 27615 | ||||
| (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 2.01 | Completion of Acquisition or Disposition of Assets. |
On December 20, 2011, Salix Pharmaceuticals Inc., a wholly-owned subsidiary of Salix, completed its acquisition of all issued and outstanding capital stock of Oceana Therapeutics, Inc., a Delaware corporation and wholly-owned subsidiary of Oceana Therapeutics LLC (“Oceana”), pursuant to the Stock Purchase Agreement, dated as of November 8, 2011, by and between Salix and Oceana. Pursuant to the agreement, Salix paid $300 million in cash for the stock of Oceana Therapeutics, Inc. subject to certain working capital adjustments. A portion of the purchase price will be held in an escrow account from which Salix may receive payments in respect of post-closing indemnification or working capital adjustment claims that it may have. There is no prior relationship between Salix and its affiliates and Oceana and its affiliates.
We will file a copy of the Stock Purchase Agreement with our Annual Report on Form 10-K for the year ending December 31, 2011.
| Item 8.01. | Other Events. |
On December 20, 2011, Salix issued a press release announcing that it had completed the acquisition of all the outstanding stock of Oceana Therapeutics, Inc. A copy of this press release is being filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference into this Current Report on Form 8-K.
Also, on December 20, 2011, Salix issued a press release announcing the successful outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation in subjects with chronic, non-cancer pain. A copy of this press release is filed herewith as Exhibit 99.2 and the information contained therein is incorporated by reference into this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
| (a) | Financial Statements of Businesses Acquired. |
If and to the extent required, the financial statements provided for by Item 9.01(a) of Form 8-K will be filed by amendment no later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.
| (b) | Pro Forma Financial Information. |
If and to the extent required, the financial statements provided for by Item 9.01(b) of Form 8-K will be filed by amendment no later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.
| (d) | Exhibits |
| Exhibit |
Description | |
| 99.1 | Press release dated December 20, 2011, announcing completion of its acquisition of Ocean Therapeutics, Inc. | |
| 99.2 | Press release dated December 20, 2011, announcing positive study results for RELISTOR®. | |
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: December 27, 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 COMPLETES ACQUISITION OF OCEANA THERAPEUTICS
SOLESTA® and DEFLUX ® Expand Salix’s Product Portfolio
RALEIGH, NC, December 20, 2011 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Oceana Therapeutics, LLC today closed a transaction whereby Salix acquired all of the outstanding stock of Oceana Therapeutics, Inc., a privately-held global provider of gastroenterology and urology therapeutics.
“The acquisition of Oceana expands our product portfolio of innovative products, furthers the diversification of Salix’s base business and provides immediate added revenue,” stated Carolyn Logan, President and Chief Executive Officer, Salix. “By means of this transaction Salix is positioned to provide physicians and patients two additional products - SOLESTA®; a first-in-class, biocompatible tissue bulking agent for the treatment of fecal incontinence; and DEFLUX®, the only FDA-approved alternative to major ureteral reimplantation surgery for the treatment of vesicoureteral reflux.
“SOLESTA is the only nonsurgical FDA-approved treatment for fecal incontinence in adult patients who fail conservative therapy. Fecal incontinence is a significant unmet medical need that affects approximately 15% of people in the United States over the age of 50, and is the leading reason for admission to assisted living facilities in the United States. For patients who have not responded to conservative therapy, SOLESTA, an injectable gel containing dextranomer microspheres and hyaluronic acid, may serve as a much-welcomed solution that does not involve surgery and can be performed without anesthesia. SOLESTA is a highly synergistic addition to our product portfolio. We believe our specialty sales force, calling on gastroenterologists and colorectal surgeons, should be able to maximize the commercial potential of this asset. SOLESTA was approved by the FDA through the premarket approval process as a Class III Medical Device in May 2011 and launched in September 2011. SOLESTA also is CE Mark-approved and marketed in Europe.
“DEFLUX is indicated for children affected by vesicoureteral reflux (Grades II-IV), a malformation of the urinary bladder that can result in severe infections of the kidneys and irreversible kidney damage. DEFLUX has been on the market in the United States since 2001. We look forward to adding DEFLUX to the line of products sold by our institutional sales force. DEFLUX also is approved and marketed outside the United States in over 40 countries. Worldwide net sales of DEFLUX through the first nine months of 2011 were approximately $26 million.”
“This transaction should accelerate Salix’s strategic initiatives,” stated Adam Derbyshire, Executive Vice President and Chief Financial Officer, Salix. “The addition of SOLESTA and DEFLUX represents an opportunity for Salix to create stockholder value by leveraging its primary asset - its top-performing specialty sales force. We believe peak-year sales for SOLESTA could exceed $500 million. We expect the transaction to be modestly accretive in 2012 and highly accretive thereafter.”
Wells Fargo Securities, LLC is acting as exclusive financial advisor to Salix and Covington & Burling LLP is acting as legal counsel to Salix in the transaction. Jefferies & Company, Inc. is acting as exclusive financial advisor to the seller, and Debevoise & Plimpton LLP is acting as legal counsel to the seller in the transaction.
About Solesta®
Solesta® is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (e.g., diet, fiber therapy, anti-motility medications). It is the only injectable gel to be administered in an outpatient setting without the need for surgery or anesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allow for better sphincter control.
Solesta should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products. The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.
Additional information about Solesta, including important safety information, is available at: http://www.solestainfo.com/pdf/solesta_label.pdf
About Fecal Incontinence
Fecal incontinence is a common condition that is the impaired ability to control bowel movements, and is one of the most psychologically and socially debilitating conditions in an otherwise healthy individual. It is estimated that approximately 2% of the population are affected by it. Common causes of fecal incontinence include constipation, diarrhea, and muscle or nerve damage that can lead to common occurrences of involuntary excretion and leaking for those affected. Many do not seek medical help and instead attempt to self-manage the problem. In one study, only one-third of individuals with fecal incontinence had ever discussed the problem with a physician.
About Deflux®
Deflux® is used for the treatment of Vesicoureteral reflux (VUR) - a malformation of the urinary bladder which affects children and can result in severe infections of the kidney and even irreversible kidney damage. Deflux is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV and is the only FDA approved bulking agent for endoscopic treatment of VUR (grades II-IV). Deflux endoscopic injection is an effective treatment alternative to ureteral reimplantation.
Deflux should not be used in patients with non-functional kidney(s), hutch diverticulum, ureterocele, active voiding dysfunction, and ongoing urinary tract infection (UTI). Side effects associated with Deflux include UTI, ureteral dilatation, and nausea/vomiting/abdominal pain. Although vascular occlusion, ureteral obstruction, dysuria, hematuria/bleeding, urgency, and urinary frequency have not been observed in any of the clinical studies, they are potential adverse events associated with subureteral injection procedures. Following approval, rare cases of postoperative dilatation of the upper urinary tract with or without hydronephrosis leading to temporary placement of a ureteric stent have been reported.
Additional information about Deflux, including important safety information, is available at: http://www.deflux.com/sites/default/files/Deflux_PI.pdf
About Vesicoureteral reflux (VUR)
Vesicoureteral reflux (VUR) is the abnormal movement of urine from the bladder into ureters or kidneys. Urine normally travels from the kidneys via the ureters to the bladder. In vesicoureteral reflux the direction of urine flow is reversed (retrograde). Younger children are more prone to VUR because of the
relative shortness of the submucosal ureters. This susceptibility decreases with age as the length of the ureters increases as the children grow. VUR becomes a serious condition when infected urine enters the kidneys, leading to the possibility of kidney infection (Pylonephritis) and permanent kidney damage (scarring) in young children.
About Salix Pharmaceuticals
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 gastroenterology specialty sales and marketing team.
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: market acceptance for approved products; 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; post-marketing approval regulation; 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
| Contacts for Salix Pharmaceuticals: | ||||
| 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 | |||
| Contacts for Progenics Pharmaceuticals: | ||||
| Investors: | Media: | |||
| Amy D. Martini | Aline B. Schimmel | |||
| Corporate Affairs | Scienta Communications | |||
| 914-789-2816 | 312-238-8957 | |||
| amartini@progenics.com | aschimmel@scientapr.com | |||
SALIX AND PROGENICS ANNOUNCE POSITIVE HIGHLY STATISTICALLY SIGNIFICANT RESULTS OF ORAL METHYLNALTREXONE FOR PHASE 3 TRIAL IN CHRONIC, NON-CANCER PAIN SUBJECTS WITH OPIOID-INDUCED CONSTIPATION
NDA Submission Targeted for Mid 2012
RALEIGH, NC, and TARRYTOWN, NY, December 20, 2011 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) today announced the successful outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain. This trial, evaluating three once-daily oral methylnaltrexone dosing regimens (150, 300 and 450mg), demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm. Both the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment. In addition, the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment. Statistically significant efficacy was also seen in both the 300 and 450 mg treatment groups for the two key
secondary efficacy endpoints including one assessing response (responder/non-responder) to study drug during Weeks 1 to 4 where “responder” is defined as having 3 or more RFBMs per week, with an increase of at least one RFBM per week over baseline, for at least 3 out of the first 4 weeks. Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.
“We are extremely pleased with the outcome of this 804-subject Phase 3 trial of oral methylnaltrexone in the treatment of opioid-induced constipation in subjects with chronic, non-cancer pain,” stated Bill Forbes, Pharm.D., Executive Vice President, Medical and R&D, and Chief Development Officer, Salix. “The results of this Phase 3 study show a clear dose response for oral methylnaltrexone. We look forward to presenting detailed data from this study at a medical conference in 2012, as well as submitting the New Drug Application (NDA) for this oral formulation mid-year 2012.”
“Subcutaneous methylnaltrexone, currently marketed as RELISTOR®, is an effective and well-tolerated therapy used to alleviate OIC in advanced illness patients receiving opioids for pain,” said Robert J. Israel, M.D., Progenics’ Senior Vice President for Medical Affairs. “We believe an oral dosage form, if approved, could help patients suffering from OIC resulting from opioid treatment for their chronic pain.”
The study assessed a once-daily oral methylnaltrexone dose of 150, 300 or 450 mg compared to placebo for 84 days. Subjects received oral methylnaltrexone once daily during the first 28 days and on a PRN basis for the remaining 56 days.
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics are frequently prescribed to manage pain in patients with advanced illness. Constipation commonly occurs in palliative-care patients receiving opioid therapy for pain. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC in these patients, when response to laxatives has been insufficient. Opioids relieve pain by specifically interacting with mu-opioid receptors within the brain and spinal cord. However,
opioids also interact with mu-opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR (methylnaltrexone bromide) is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications without affecting their ability to relieve pain. RELISTOR selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. Because of its chemical structure, RELISTOR does not affect the opioid-mediated analgesic effects on the CNS.
About RELISTOR
RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. RELISTOR Subcutaneous Injection is approved in the United States 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. The drug is also approved for use in over 50 countries worldwide, including the European Union, Canada, Australia and Brazil. In the 27 member states of the E.U., as well as Iceland, Norway and Liechtenstein, RELISTOR is approved for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. In Canada, the drug is approved for the treatment of opioid-induced constipation 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 from Progenics Pharmaceuticals, Inc.
Important Safety Information for RELISTOR Subcutaneous Injection
RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to
discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients 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, 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, and/or worsening abdominal symptoms.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhydrosis (6.7% vs 6.5%).
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 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 also 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,), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA®, DEFLUX®, METOZOLV® ODT (metoclopramide HCl, 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.
About Progenics
Progenics Pharmaceuticals, Inc., of Tarrytown, N.Y., is a biopharmaceutical company focused on innovative therapeutics for patients suffering from cancer and related conditions. Progenics’ pipeline candidates include PSMA ADC, a human monoclonal antibody-drug conjugate in phase 1 testing for treatment of prostate cancer, and preclinical stage novel multiplex phosphoinositide 3-kinase (PI3K) inhibitors for the treatment of cancer. Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR®, to Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation. RELISTOR (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness. Regulatory approval is pending for use of RELISTOR in patients with chronic, non-cancer pain.
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 in an increasingly global industry; and revenue recognition and other critical accounting policies. More information concerning Progenics and Salix is available on the companies’ websites, as well as in press releases and reports they file with the U.S. Securities and Exchange Commission.