Markley H.G.,New England Regional Headache Center |
Dunteman E.D.,Aanda Pain Institute Of St Louis |
Kareht S.,Depomed Inc. |
Sweeney M.,Depomed Inc.
Clinical Journal of Pain | Year: 2015
Objectives: To evaluate the safety and effectiveness of once-daily gastroretentive gabapentin (G-GR) for the treatment of postherpetic neuralgia in real-world clinical practice.Materials and Methods: Patients aged 18 years and above were divided into 2 cohorts: patients aged 70 years and below and patients above 70 years. All patients were titrated to 1800mg GGR/ d over 2 weeks and maintained at that dosage for 6 weeks, for 8 weeks total treatment. To reflect clinical practice, exclusion criteria were limited to those in the product label. Efficacy was assessed using a visual analog scale (VAS) and the Brief Pain Inventory. Patient/Clinician Global Impression of Change scales were completed at week 8. Adverse events (AEs) were assessed.Results: The efficacy population included 190 patients (110, 70 y and below; 80, above 70 y). The mean percent change in VAS score at week 8 from baseline was -21.3%/-20.4% (70 y and below/ above 70 y). The proportion of patients with a ≥30% reduction in VAS score from baseline was 51.8%/55.0% (70 y and below/above 70 y) and was 42.7%/37.5% for a ≥50% reduction. Brief Pain Inventory scores were all significantly reduced by week 8. On the Patient Global Impression of Change instrument, more patients aged 70 years and below reported feeling much or very much improved from baseline (59.0% vs. 40.3%). G-GR was generally well tolerated. Thirty-seven (18.8%) patients experienced AEs that led to discontinuation. No patients died and 5 (2.5%) patients experienced serious AEs. The most common G-GR-related AEs (70 y and below/above 70 y) were dizziness (11.7%/16.3%) and somnolence (3.6%/8.1%).Discussion: In real-world clinical practice, G-GR seems to be an effective, well-tolerated treatment option for patients with postherpetic neuralgia, regardless of age. © 2014 by Lippincott Williams and Wilkins.
News Article | November 4, 2016
NEWARK, Calif., Nov. 04, 2016 (GLOBE NEWSWIRE) -- Depomed Inc. (NASDAQ:DEPO) today announced the introduction of a new formulation of CAMBIA® (diclofenac potassium) for oral solution, that contains the sweetener sucralose, replacing the sweeteners saccharin sodium and aspartame. The new formulation, which was approved by the U.S. Food and Drug Administration, addresses some patient sensitivities towards certain sweeteners and is not as a result of any product safety concerns nor does it alter the efficacy profile of the product. CAMBIA® with sucralose will be available following the dispensing of current inventories containing aspartame. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). “Recognizing that some patients may have sensitivities to aspartame, CAMBIA’s new formulation is a welcome addition to the migraine treatment arsenal,” said Alan Rapoport, M.D., Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA, Los Angeles, California, and Immediate Past-President of the International Headache Society. “With this proactive step, Depomed continues their commitment to partnering with the medical community.” “CAMBIA’s new formulation is aimed at improving the patient experience,” said Srinivas Rao, M.D., Ph.D., Chief Medical Officer of Depomed. “We are pleased to be offering this new formulation as it exemplifies Depomed’s collaborative approach with physicians who are on the front line of treating patients with pain.” With this reformulation, item 5.14 from the CAMBIA label titled Phenylketonurics which states “CAMBIA contains aspartame equivalent to phenylalanine 25 mg per packet.” is removed. Phenylketonuria (PKU) is an inherited metabolic disorder in which a person does not have the liver enzyme needed to break down phenylalanine. INDICATIONS AND USAGE CAMBIA® (diclofenac potassium) for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established. Non-Interchangeability with Other Formulations of Diclofenac Different formulations of oral diclofenac are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulation of diclofenac to CAMBIA. CONTRAINDICATIONS CAMBIA is contraindicated in the following patients: Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Avoid the use of CAMBIA in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CAMBIA is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. See full Prescribing Information for more information. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue CAMBIA immediately, and perform a clinical evaluation of the patient. To minimize the potential risk for an adverse liver-related event in patients treated with CAMBIA, use the lowest effective dose for the shortest duration possible. NSAIDs, including CAMBIA, can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use NSAIDs, including CAMBIA, with caution in patients with hypertension. Monitor blood pressure closely during the initiation of NSAID treatment and throughout the course of therapy. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. A meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]). Avoid the use of CAMBIA in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If CAMBIA is used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CAMBIA in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs. CAMBIA is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). NSAIDs, including diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events can occur without warning. CAMBIA should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. CAMBIA is contraindicated in patients with previous serious skin reactions to NSAIDs. Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with CAMBIA has any signs or symptoms of anemia, monitor hemoglobin or hematocrit. NSAIDs, including CAMBIA, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), and serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients and any patient who may be adversely affected by alterations in platelet function for signs of bleeding. ADVERSE REACTIONS The most common adverse events (≥1% and greater than placebo) in clinical trials with CAMBIA were nausea and dizziness. Drugs That Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking CAMBIA with drugs that interfere with hemostasis. Concomitant use of CAMBIA and analgesic doses of aspirin is not generally recommended. Concomitant use with CAMBIA in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. Concomitant use with CAMBIA can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. Please see full Prescribing Information for complete information about Drug Interactions. Use in Pregnancy Based on animal data, may cause fetal harm. Based on human data, starting at 30 weeks gestation, CAMBIA should be avoided as premature closure of the ductus arteriosus in the fetus may occur. Prior to 30 weeks gestation, CAMBIA should be used in pregnancy only if the potential benefit outweighs the risk to the fetus (Category C). Starting at 30 weeks, CAMBIA can cause fetal harm (Category D). Nursing Mothers: Use with caution, as it is not known if diclofenac is excreted in human milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects Hepatic Impairment Because hepatic metabolism accounts for almost 100% of diclofenac elimination, patients with hepatic impairment should be considered for treatment with CAMBIA only if the benefits outweigh the risks. Renal Impairment Treatment with CAMBIA is not recommended in patients with advanced renal disease. Please see accompanying full Prescribing Information and Medication Guide for more information about CAMBIA. Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit www.depomed.com. “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to risks detailed in the Company’s Securities and Exchange Commission filings, including the Company’s most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the Company’s plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
News Article | November 18, 2016
Global Pain Management Drugs and Devices market is expected to grow from $39.48 billion in 2015 to reach $58.2 billion by 2022 with a CAGR of 5.7%. Growing various pain disorders coupled with increasing global geriatric people is the major factor propelling the pain management drugs and devices market. Furthermore, rapid technological developments, growing healthcare industry across the globe are some of the factors boosting the market growth. However, intensified competition between companies and lack of skilled professionals are the factors inhibiting the market growth. The Neuromodulation device leads the market globally with the biggest market share and is expected to grow with a high CAGR during the forecast period. The growth of this segment is attributed to increasing chronic back pain. By drugs, opiods segment commands the market accounting for more than 42% of the total market. North America is anticipated to hold the largest share in global pain management drugs and devices market due to increasing demand from U.S. and Asia Pacific is likely to grow at a fastest rate during the forecast period. Some of the key players in global pain management drugs and devices market include Abbvie Inc., Astrazeneca Depomed Inc., B. Braun Melsungen AG, Becton, Dickinson and Company, Boston Scientific Corporation, Eli Lilly & Co., Glaxosmithkline, Halyard Health, Inc., Hisamitsu Pharmaceutical Co. Inc, Johnson & Johnson, Medtronic Inc., Medtronic PLC, Neurotech Na, Inc. (A Subsidiary of Theragen LLC), Nevro Corp., Novartis International Ag, Pfizer, Purdue Pharmaceuticals Lp, Smiths Medical, and ST. Jude Medical, Inc. Applications Covered: • Cancer Pain • Facial Pain and Migraine • Musculoskeletal Pain • Neuropathic Pain • Other Applications o Post-operative Pain o Pregnancy/Labor and Menstrual Pain o Sports Injuries o Trauma Pain Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements About Us Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports understand how essential statistical surveying information is for your organization or association. Therefore, we have associated with the top publishers and research firms all specialized in specific domains, ensuring you will receive the most reliable and up to date research data available.
News Article | November 22, 2016
According to Stratistics MRC, the Global Pain Management Drugs and Devices market is expected to grow from $39.48 billion in 2015 to reach $58.2 billion by 2022 with a CAGR of 5.7%. Growing various pain disorders coupled with increasing global geriatric people is the major factor propelling the pain management drugs and devices market. Furthermore, rapid technological developments, growing healthcare industry across the globe are some of the factors boosting the market growth. However, intensified competition between companies and lack of skilled professionals are the factors inhibiting the market growth. Access the complete report at: http://www.strategymrc.com/report/pain-management-drugs-and-devices-market The Neuromodulation device leads the market globally with the biggest market share and is expected to grow with a high CAGR during the forecast period. The growth of this segment is attributed to increasing chronic back pain. By drugs, opiods segment commands the market accounting for more than 42% of the total market. North America is anticipated to hold the largest share in global pain management drugs and devices market due to increasing demand from U.S. and Asia Pacific is likely to grow at a fastest rate during the forecast period. Some of the key players in global pain management drugs and devices market include Abbvie Inc., Astrazeneca Depomed Inc., B. Braun Melsungen AG, Becton, Dickinson and Company, Boston Scientific Corporation, Eli Lilly & Co., Glaxosmithkline, Halyard Health, Inc., Hisamitsu Pharmaceutical Co. Inc, Johnson & Johnson, Medtronic PLC, Neurotech Na, Inc. (A Subsidiary of Theragen LLC), Nevro Corp., Novartis International Ag, Pfizer, Purdue Pharmaceuticals Lp, Smiths Medical, and ST. Jude Medical, Inc Request for a sample at: http://www.strategymrc.com/report/pain-management-drugs-and-devices-market Drug Classes Covered: • Anti-Migraine Agents • Non-Narcotic Analgesics • Opioids • NSAIDS • Anesthetics • Anticovulsants • Antidepressent Device Types Covered: • Analgesic Infusion Pumps o External Infusion Pumps o Intrathecal Infusion Pumps • Ablation Devices o Cryoablation Devices o Radiofrequency Ablation Devices • Electrical stimulation devices o Neuromuscular Electrical Stimulation (NMES/EMS) Devices o Transcutaneous Electrical Nerve Stimulation (TENS) Devices o Other Electrical Stimulation Devices • Neuromodulation Devices o Sacral Nerve Stimulation Devices o Deep Brain Stimulation Devices o Vagus Nerve Stimulation Devices o Spinal Cord Stimulation (SCS) Devices Indications Covered: • Arthritic pain • Cancer pain • Migraine • Fibromyalgia • Chronic back pain • Neuropathic pain • Post-operative pain Applications Covered: • Cancer Pain • Facial Pain and Migraine • Musculoskeletal Pain • Neuropathic Pain • Other Applications o Post-operative Pain o Pregnancy/Labor and Menstrual Pain o Sports Injuries o Trauma Pain Mode of Purchase Covered: • Prescription-based Devices • Over-the-counter Devices Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements
Verhagen Metman L.,Rush University |
Stover N.,University of Alabama at Birmingham |
Chen C.,Depomed Inc. |
Cowles V.E.,Depomed Inc. |
Sweeney M.,Depomed Inc.
Movement Disorders | Year: 2015
This study was undertaken to compare efficacy, tolerability, and pharmacokinetics of DM-1992, an extended-release formulation of carbidopa/levodopa (CD/l-dopa) with immediate-release (IR) CD/l-dopa in patients with advanced Parkinson's disease. This randomized, open-label, crossover study included a 3-d baseline and two 10-d treatment periods. Patients with daily OFF time of 2.5 h or more taking 400 mg or more l-dopa/d in four or more divided doses were titrated to stable regimens of DM-1992 2 times per day or CD/l-dopa IR 3 times to 8 times per day. Patients were allowed to take rescue CD/l-dopa as needed. Using home diaries, patients recorded OFF time and ON time with or without troublesome dyskinesia during baseline and treatment days 7 through 9. During 12-h clinic visits on day 10, plasma samples were collected for pharmacokinetics, and motor performance was assessed hourly. Thirty-four patients were enrolled; mean baseline l-dopa dosage was 968 mg/d. After titration, CD/l-dopa IR was dosed 4.8 times per day and DM-1992, 2 times per day. Rescue CD/l-dopa IR was given 1.3 times during the DM-1992 arm and 0.2 times during the CD/l-dopa IR arm. The reduction from baseline in % OFF time was greater for DM-1992 compared with CD/l-dopa IR (-5.52% vs. +1.33%; P=0.0471). At steady-state, compared with CD/l-dopa IR, DM-1992 exhibited a smoother plasma l-dopa concentration profile mostly because of a significantly higher (day 10) predose l-dopa concentration, associated with enhanced motor performance. Although more patients taking DM-1992 had one or more adverse events (AEs) than CD/l-dopa IR patients (35% vs. 15%), no pattern to the AEs was seen, nor any resulting discontinuations. DM-1992 was associated with a reduction in %OFF time compared with CD/l-dopa IR despite a reduced dosing frequency. Although the open-label study design and the greater number of rescue doses during the DM-1992 arm call for caution in interpreting the results, the elevated predose plasma l-dopa concentration (12 h after DM-1992 administration) lends objective support to our findings, suggesting that phase 3 studies are warranted. © 2015 International Parkinson and Movement Disorder Society.
Pinkerton J.V.,University of Virginia |
Kagan R.,East Bay Physicians Medical Group |
Portman D.,Columbus Center for Womens Health Research |
Sathyanarayana R.,Depomed Inc. |
Sweeney M.,Depomed Inc.
Menopause | Year: 2014
OBJECTIVE: The goal of this study was to evaluate the efficacy and safety of gastroretentive gabapentin (G-GR) for the treatment of moderate-to-severe menopausal hot flashes. METHODS: The primary endpoints of this randomized, placebo-controlled study of G-GR (600 mg am/1,200 mg pm) were the mean daily frequency and severity of hot flashes at weeks 4 and 12. Secondary endpoints included Patients' Global Impression of Change, Clinicians' Global Impression of Change, and daily sleep interference at week 24. RESULTS: Six hundred women with 7 or more moderate-to-severe hot flashes/day enrolled; 66.2% completed 24 weeks of treatment. At weeks 4 and 12, G-GR-treated women experienced significantly greater reductions in mean hot flash frequency and severity than placebo-treated women (frequency: week 4,-1.7, P < 0.0001; week 12,-1.14, P = 0.0007; severity: week 4,-0.21, P < 0.0001; week 12,-0.19, P = 0.012). Similar reductions were maintained up to week 24. On the Patient Global Impression of Change, more women receiving G-GR than placebo were "much" or "very much" improved (week 12: 58% vs 44%, P = 0.0008; week 24: 76% vs 55%, P < 0.0001). G-GR significantly reduced sleep interference compared with placebo at week 12 (P = 0.0056) and week 24 (P = 0.0084). Approximately 5% more women taking G-GR withdrew because of adverse events (G-GR/placebo, 16.7%/11.5%). The most common adverse events were dizziness (12.7%/3.4%), headache (9.3%/8.1%), and somnolence (6.0%/2.7%); incidences dropped to sustained low levels after a few weeks. CONCLUSIONS: G-GR is a modestly effective nonhormone therapy option for the treatment of moderate-to-severe hot flashes due to menopause and is well tolerated with titration. © 2014 The North American Menonpause Society.
News Article | February 27, 2017
-- Fourth-Quarter 2016 Net Sales of $310.3 Million; Up 27 Percent -- -- Fourth-Quarter 2016 Net Loss of $130.5 Million(1); Adjusted EBITDA of $136.4 Million -- -- Full-Year 2016 Operating Cash Flow of $369.5 Million; Full-Year 2016 Non-GAAP Operating Cash Flow of $452.9 Million; Year-End 2016 Cash Balance of $509.1 Million -- -- Full-Year 2017 Net Sales Guidance of $1.24 Billion to $1.29 Billion; Full-Year 2017 Adjusted EBITDA Guidance of $525 Million to $575 Million -- DUBLIN, Ireland, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced its fourth-quarter and full-year 2016 financial results today and provided its full-year 2017 net sales and adjusted EBITDA guidance. “We delivered a strong fourth quarter and another exceptional year of performance driven by continued commercial execution and the completion of two transformative acquisitions that bolster our rapidly expanding rare disease business,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. “Our performance and continued strategic acquisitions have strengthened and diversified the Company and positioned us well to deliver on our growth objectives over the long term.” (1) The fourth-quarter and full-year 2016 net losses were primarily impacted by the impairment of in-process research and development and other wind- down costs and charges related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia and acquisition-related costs primarily related to the acquisition of Raptor Pharmaceutical Corp. (2) On Sept. 26, 2016, Horizon Pharma agreed to pay Express Scripts $65 million as part of a litigation settlement, which was recorded as a one-time reduction to GAAP net sales for the three months ended Sept. 30, 2016, in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The exclusion of the $65 million settlement from GAAP net sales is the only adjustment reflected in year-to-date 2016 non-GAAP adjusted net sales. Fourth-Quarter 2016 Financial Results Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release. At 8 a.m. EST / 1 p.m. IST today, the Company will host a live conference call and webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed by visiting Horizon's website at http://ir.horizon-pharma.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the conference call will be available approximately two hours after the call and accessible through one of the following telephone numbers, using the passcode below: About Horizon Pharma plc Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets 11 medicines through its orphan, rheumatology and primary care business units. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page. Note Regarding Use of Non-GAAP Financial Measures EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon Pharma as non-GAAP financial measures. Horizon Pharma provides certain other financial measures such as non-GAAP adjusted net sales and net income, non-GAAP diluted earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating expenses, non-GAAP tax rate, non-GAAP operating cash flow and PROCYSBI and QUINSAIR net sales on a combined and adjusted basis, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on Horizon Pharma’s performance, operations, expenses, profitability and cash flows. Adjustments to Horizon Pharma's GAAP figures as well as EBITDA exclude acquisition-related expenses, charges related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia, an upfront fee for a license of a patent, a litigation settlement, loss on debt extinguishment and loss on sale of long-term investments, as well as non-cash items such as share-based compensation, depreciation and amortization, royalty accretion, non-cash interest expense, intangible and other non-current asset impairment charges, and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon's financial and operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected 2017 financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators Horizon's management uses for planning and forecasting purposes and measuring the Company's performance. For example, adjusted EBITDA is used by Horizon as one measure of management performance under certain incentive compensation arrangements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Horizon Pharma has not provided a reconciliation of its full-year or quarterly 2017 adjusted EBITDA outlook to an expected net income (loss) outlook because certain items such as acquisition-related expenses and share-based compensation that are a component of net income (loss) cannot be reasonably projected due to the significant impact of changes in Horizon Pharma's stock price, the variability associated with the size or timing of acquisitions and other factors. These components of net income (loss) could significantly impact Horizon Pharma’s actual net income (loss). Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to Horizon Pharma's full-year and quarterly 2017 net sales and adjusted EBITDA guidance, expected financial performance in future periods, expected timing of clinical, regulatory and commercial events, the expected launch of RAVICTI in Europe, anticipated additional clinical trials of ACTIMMUNE in cancer indications, potential market opportunity for Horizon Pharma’s medicines in approved and potential additional indications, potential growth of Horizon Pharma’s medicines and business and other statements that are not historical facts. These forward-looking statements are based on Horizon Pharma's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon’s actual future financial and operating results may differ from its expectations or goals; Horizon Pharma’s ability to grow net sales from existing products; the availability of coverage and adequate reimbursement and pricing from government and third-party payers and risks relating to the success of Horizon Pharma’s business strategies; whether Horizon Pharma is unable to enter into additional business arrangements with pharmacy benefit managers and payers on favorable terms or at all or unable to realize the expected benefits from such arrangements; risks related to acquisition integration and achieving projected cost savings and benefits; risks associated with clinical development and regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon Pharma operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon Pharma's filings and reports with the SEC. Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information. The Company acquired Raptor Pharmaceutical Corp. on October 25, 2016, including PROCYSBI and QUINSAIR. PROCYSBI and QUINSAIR net sales for the partial fourth quarter of 2016 were $25.3 million and $1.0 million, respectively. The following tables reflect sales for full-year 2015, first, second and third quarter under Raptor Pharmaceutical Corp. ownership and partial fourth-quarter 2016 net sales of Raptor and Horizon on a combined basis. (1) Expenses, including legal and consulting fees, incurred in connection with the Company’s acquisitions of Vidara Therapeutics International Public Limited Company (“Vidara”), Hyperion Therapeutics, Inc. (“Hyperion”), Crealta Holdings LLC (“Crealta”), Raptor Pharmaceutical Corp. (“Raptor”), its agreement to acquire the worldwide rights to interferon gamma-1b and its withdrawn offer to acquire Depomed Inc. have been excluded. (2) Intangible amortization expenses are associated with the Company’s intellectual property rights, developed technology and customer relationships of ACTIMMUNE, BUPHENYL, KRYSTEXXA, LODOTRA, MIGERGOT, PENNSAID 2%, PROCYSBI, RAVICTI, RAYOS and VIMOVO. (3) Represents amortization of debt discount and deferred financing costs associated with the Company's debt. (4) Represents accretion expense associated with the ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO royalties for the three and twelve months ended December 31, 2016, and represents accretion expense associated with the ACTIMMUNE, BUPHENYL, RAVICTI and VIMOVO royalties for the three and twelve months ended December 31, 2015. (5) In connection with the Crealta acquisition, the KRYSTEXXA and MIGERGOT inventory was stepped up in value by $144,289 and during the three months ended December 31, 2016, the Company recognized in cost of goods sold, $20,889 for step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. During the twelve months ended December 31, 2016, the Company recognized in cost of goods sold, $48,758 for step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. In connection with the Raptor acquisition, the PROCYSBI and QUINSAIR inventory was stepped up in value by $66,950 and during the three months ended December 31, 2016, the Company recognized in cost of goods sold $22,379 of step-up inventory costs related to PROCYSBI and QUINSAIR inventory sold. In connection with the Hyperion acquisition, the BUPHENYL and RAVICTI inventory was stepped up in value by $8,682 and during the three months and twelve months ended December 31, 2015, the Company recognized in cost of goods sold $860 and $8,341, respectively, of step-up inventory costs related to BUPHENYL and RAVICTI inventory sold. In connection with the Vidara acquisition, the ACTIMMUNE inventory was stepped up in value by $14,218 and during the first quarter of 2015, the Company recognized in cost of goods sold the remaining $3,154 of step-up inventory costs related to ACTIMMUNE. (6) At the time of the Company's acquisition of the rights to ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO, the Company estimated the fair value of contingent royalties payable to third parties using an income approach under the discounted cash flow method, which included revenue projections and other assumptions the Company made to determine the fair value. If the Company significantly over-performs or underperforms against its original revenue projections or it becomes necessary to make changes to assumptions as a result of a triggering event, the Company is required to reassess the fair value of the contingent royalties payable. Any subsequent adjustment to fair value is recorded in the period such adjustment is made as either an increase or decrease to royalties payable, with a corresponding increase or decrease in cost of goods sold, in accordance with established accounting policies. During the three and twelve months ended December 31, 2016, the Company recorded a net charge of $386, to cost of goods sold to adjust the amount of the contingent royalty liabilities relating to ACTIMMUNE, KRYSTEXXA, RAVICTI and VIMOVO. During the three and twelve months ended December 31, 2015, the Company recorded a net charge of $6,874 and $21,151, respectively, to cost of goods sold to adjust the amount of the contingent royalty liabilities relating to ACTIMMUNE, RAVICTI and VIMOVO. (7) Represents share-based compensation expense associated with the Company's stock option, restricted stock unit, and performance stock unit grants to its employees and non-employees, its cash-settled long-term incentive program and its employee stock purchase plan. (8) Represents depreciation expense related to the Company’s property, equipment, software and leasehold improvements. (9) Represents a charge for the impairment of in-process R&D related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia. (10) Represents charges for wind-down costs related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia. (11) Royalties of $10,434 and $37,593 were incurred during the three and twelve months ended December 31, 2016, respectively, based on the periods’ net sales for ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO. Royalties of $8,944 and $29,834 were incurred during the three and twelve months ended December 31, 2015, respectively, based on the periods’ net sales for ACTIMMUNE, BUPHENYL, RAVICTI and VIMOVO. (12) Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the statutory income tax rate of the applicable jurisdictions for each non-GAAP adjustment. (13) During the three months ended September 30, 2015, the Company purchased 2,250,000 shares of common stock of Depomed, Inc. ("Depomed") representing 3.75 percent of Depomed's then outstanding common stock. The shares were acquired at a cost of $71,813. During the three months ended December 31, 2015, following the Company's decision to withdraw its offer to acquire Depomed, the Company sold all of its shares in Depomed, receiving sales proceeds of $42,781. Following this sale, the Company recognized a loss of $29,032 in the consolidated statement of comprehensive income (loss). (14) Represents an upfront fee paid for a license of a global patent. (15) On September 26, 2016, the Company agreed to pay Express Scripts $65 million as part of a litigation settlement, which was recorded as a one-time reduction to GAAP net sales for the twelve months ended December 31, 2016, in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The exclusion of the $65 million settlement from GAAP net sales is the only adjustment reflected in the non-GAAP adjusted net sales for the twelve months ended December 31, 2016. (16) During the third quarter of 2016, the Company released a contingent liability of $6.9 million that was recorded as part of acquisition accounting for Crealta. (17) During the twelve months ended December 31, 2015, the Company recorded a loss on induced debt conversions of $77,624, which represented an early redemption payment of $45,366, the write-down of $21,581 in debt discount and deferred financing costs, $10,005 in additional exchange consideration to debt holders and $672 in expenses incurred in connection with the induced debt conversions. (18) Other non-GAAP income tax adjustments in the twelve months ended December 31, 2015 of $105,133 related to the release of certain valuation allowances in connection with the Hyperion acquisition.
Sang C.N.,Harvard University |
Sathyanarayana R.,Depomed Inc. |
Sweeney M.,Depomed Inc.
Clinical Journal of Pain | Year: 2013
OBJECTIVE:: To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg). METHODS:: This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation. RESULTS:: Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (-2.1 vs. -1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported "much" or "very much" improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (-2.3 vs. -1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%). CONCLUSION:: Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia. Copyright © 2012 by Lippincott Williams & Wilkins.
Wallace M.S.,University of California at San Diego |
Irving G.,Swedish Pain and Headache Center Washington |
Cowles V.E.,Depomed Inc.
Clinical Drug Investigation | Year: 2010
Background: Postherpetic neuralgia (PHN) is a neuropathic pain syndrome that may develop subsequent to healing of herpes zoster rash. Objectives: This study aimed to determine the efficacy and safety of gabapentin extended-release (gabapentin ER) tablets for the treatment of patients with PHN and to determine whether optimal benefits might be achieved with once-daily (QD) or divided-dose (DD) administration.Methods: This was a 10-week, randomized, double-blind, placebo-controlled, multicentre trial comparing gabapentin ER (total daily dose 1800 mg) either QD or as an asymmetrical DD with placebo in 407 patients with post-zoster pain for ≥3 months and a baseline average daily pain score (ADP) ≥4 on a 010 Likert numerical rating scale. The primary efficacy outcome was the ADP score mean change from baseline to week 10 using baseline observation carried forward (BOCF). Secondary efficacy outcomes included changes to week 10 in last observation carried forward (LOCF) ADP score, LOCF average daily sleep interference score, Short-Form McGill Pain Questionnaire score, Neuropathic Pain Scale score, and Brief Pain Inventory score. Results: Of 407 randomized patients, 400 were included in the intent-to-treat population (gabapentin ER QD, n = 134; gabapentin ERDD, n = 135; placebo, n = 131). Between-group differences in the least squares (LS) mean changes in BOCF ADP scores did not reach statistical significance (gabapentin ER QD -1.85 [p = 0.110 vs placebo]; gabapentin ER DD -1.72 [p = 0.255 vs placebo]; placebo -1.42). In the LOCF analysis, the LS mean ADP score for the gabapentin ER QD group, but not for the DD group, improved compared with placebo (gabapentin ER QD, -2.28; p = 0.032 vs placebo). Improvements compared with placebo were also observed in the gabapentin ER QD group, but not for the DD group, for mean daily sleep interference scores (gabapentin ER QD, -2.49; placebo, -1.63; p < 0.001). Most adverse events (AEs) were mild or moderate. Among gabapentin-treated patients, 12% and 11% withdrew due to AEs, most commonly for dizziness (2% and 3%), in the gabapentin ER QD and DD groups, respectively. Treatment-related AEs in the gabapentin ER-treated groups occurred in 31% of patients. The most common AEs in the gabapentin ER QD and DD groups included dizziness (10% and 15%), headache (4% and 7%), somnolence (3% and 7%) and peripheral oedema (5% and 5%), respectively. Conclusion: The primary efficacy endpoint for this study of gabapentin ER was not met, most likely due to the unexpectedly large placebo response. Outcomes on secondary endpoints suggest the potential efficacy of gabapentin ER QD. Gabapentin ER was well tolerated in this study. © 2010 Adis Data Information BV. All rights reserved.
Chen C.,Depomed Inc. |
Gupta A.,Depomed Inc.
Pain management | Year: 2014
This review will provide an overview of pharmacokinetics and clinical practice considerations of the novel formulations of fentanyl for the treatment of breakthrough cancer pain. First, we provide a brief description of the physicochemical properties of fentanyl. Second, we describe the basic pharmacokinetics of fentanyl, the specifics of various formulations and how they affect pharmacokinetics of fentanyl. Finally, we offer the perspectives on clinical practices in the proper uses of these products. Advancements in the formulations and delivery of fentanyl have provided a safer and more effective treatment for breakthrough cancer pain. These dosage forms offer overlapping yet distinct pharmacokinetic advantages to allow more choices for physicians and patients in the management of breakthrough cancer pain.