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)
June 28, 2010
VIVUS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-33389 |
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94-3136179 |
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(State
or other jurisdiction of |
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(Commission File Number) |
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(IRS
Employer |
1172 CASTRO STREET
MOUNTAIN VIEW, CA 94040
(Address of principal executive offices, including zip code)
(650) 934-5200
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure
On June 29, 2010, Dr. Kishore Gadde will deliver an oral presentation entitled: “A Low-Dose, Controlled-Release Formulation of Phentermine/Topiramate Demonstrates Significant Weight Loss, Clinical Improvement in Overweight/Obese Patients With Type 2 Diabetes Mellitus or Prediabetes: the CONQUER Trial” beginning at 5:45 p.m. at the 70th Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Florida.
A copy of the slides to be presented by Dr. Gadde is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference into any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Slide presentation dated June 28, 2010, entitled “A Low-Dose, Controlled-Release Formulation of Phentermine/Topiramate Demonstrates Significant Weight Loss, Clinical Improvement in Overweight/Obese Patients With Type 2 Diabetes Mellitus or Prediabetes: the CONQUER Trial” |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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VIVUS, INC. |
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By: |
/s/ Lee B. Perry |
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Lee B. Perry Vice President and Chief Accounting Officer |
Date: June 28, 2010
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Slide presentation dated June 28, 2010, entitled “A Low-Dose, Controlled-Release Formulation of Phentermine/Topiramate Demonstrates Significant Weight Loss, Clinical Improvement in Overweight/Obese Patients With Type 2 Diabetes Mellitus or Prediabetes: the CONQUER Trial” |
Exhibit 99.1
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Kishore M. Gadde, MD Duke University Medical Center Thomas Najarian, MD Wesley W. Day, PhD VIVUS A Low-Dose, Controlled-Release Formulation of Phentermine/Topiramate Demonstrates Significant Weight Loss, Clinical Improvement in Overweight/Obese Patients With Type 2 Diabetes Mellitus or Prediabetes: the CONQUER Trial |
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Author Disclosure Past 2 years Kishore M. Gadde Research support: BMS, Forest Labs, NIDDK, Pfizer, VIVUS Stock/shareholder: Orexigen Thomas Najarian Employee of Vivus, Inc. Wesley W. Day Employee of Vivus, Inc. |
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Background Phentermine (PHEN) is a sympathomimetic drug approved for short-term treatment of obesity1 Topiramate (TPM), indicated for treatment of epilepsy and prevention of migraine headache, has demonstrated weight loss, cardiometabolic benefits in clinical trials2-8 A novel low-dose, controlled-release (CR) combination of these two drugs – PHEN/TPM CR – has been developed with the aim of maximizing weight loss with a potential to reduce adverse events9 1. Adipex-P [package insert]. Sellersville, PA: Teva Pharmaceuticals USA; 2005. 2. Topamax [package insert]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2009. 3. Bray GA, et al. Obes Res. 2003;11:722-733. 4. Wilding J, et al. Int J Obes. 2004;28:1399-1410. 5. Tonstad S, et al. Am J Cardiol. 2005;96:243-251. 6. Stenlöf K, et al. Diabetes Obes Metab. 2007;9:360-368. 7. Toplak H, et al. Int J Obes (Lond). 2007;31:138-146. 8. Rosenstock J, et al. Diabetes Care. 2007;30:1480-1486. 9. Data on file. Vivus, Inc. |
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CONQUER Trial Objectives To examine weight loss and improvement in glycemic measures in the entire sample of overweight and obese subjects with related comorbidities (type 2 diabetes mellitus [T2DM] or prediabetes [impaired fasting glucose/impaired glucose tolerance, IFG/IGT], hypertension [HTN], hypertriglyceridemia) To examine improvement in glycemic measures in the subset of overweight and obese subjects with T2DM or prediabetes |
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CONQUER Trial Methods Design: Phase 3 RCT of 56 weeks duration Subjects: 2487 overweight or obese subjects with >2 weight-related comorbidities (T2DM or prediabetes, HTN, hypertriglyceridemia, abdominal obesity) Lifestyle modification counseling for all subjects Randomization to treatment: Placebo (n=994) PHEN/TPM CR 7.5/46 (n=498) PHEN/TPM CR 15/92 (n=995) |
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Proportions of Subjects With Comorbidities HTN (or >2 antihypertensive medications) – 53% Hypertriglyceridemia (or >2 lipid-lowering medications) – 36% Abdominal obesity – 99% T2DM or prediabetes – 68% T2DM diagnosis – 16% Prediabetes (IFG/IGT) – 67% >3 comorbidities – 51% |
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Glycemic Parameters at Baseline (ITT) Measure Overall Sample Prediabetes Sample T2DM Sample Upper Quartile HbA1c (%) 5.9 6.0 6.8 6.9 Fasting glucose (mg/dL) 106.2 113.4 133.9 135.3 Fasting insulin (µIU/mL) 18.1 19.3 21.5 35.3 |
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Weight Loss at Week 56 Overall Sample (ITT-LOCF) Shown on Y-axis is change in LS means. ITT data set consisted of subjects who took >1 dose of the study drug and had >1 post-baseline assessment. *P<0.0001 vs placebo (n=979) (n=488) (n=981) |
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Weight Loss at Week 56 T2DM Sample (LOCF) Shown on Y-axis is change in LS means. *P<0.0001 vs placebo (n=157) (n=67) (n=164) |
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Change in Glycemic Measures at Week 56 Overall Sample (LOCF) Measure Baseline Mean Change at Week 56 Placebo PHEN/TPM CR 7.5/46 PHEN/TPM CR 15/92 HbA1c (%) 5.9 0.1 -0.0* -0.1* Fasting glucose (mg/dL) 106.2 2.3 -0.1† -1.3* Fasting insulin (µIU/mL) 18.1 0.7 -3.5‡ -4.0* Included in the analysis are subjects with baseline value and >1 post-baseline observation. Changes over time are depicted with changes in LS mean values. *P<0.0001 vs placebo; †P<0.005 vs placebo; ‡P< 0.0005 vs placebo |
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Change in Glycemic Measures at Week 56 Prediabetes Sample (LOCF) Included in the analysis are subjects with baseline value and >1 post-baseline observation. Changes over time are depicted with changes in LS mean values. *P<0.0001 vs placebo; †P<0.005 vs placebo Measure Baseline Mean Change at Week 56 Placebo PHEN/TPM CR 7.5/46 PHEN/TPM CR 15/92 HbA1c (%) 6.0 0.0 -0.1* -0.2* Fasting glucose (mg/dL) 113.4 -2.8 -6.2† -7.5* Fasting insulin (µIU/mL) 19.3 1.7 -3.7† -4.8* |
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Change in Glycemic Measures at Week 56 T2DM Sample (LOCF) Included in the analysis are subjects with baseline value and >1 post-baseline observation. Changes over time are depicted with changes in LS mean values. *P<0.05 vs placebo; †P<0.005 vs placebo At study entry, T2DM subjects were being managed with metformin only and/or with lifestyle modification counseling. Measure Baseline Mean Change at Week 56 Placebo PHEN/TPM CR 7.5/46 PHEN/TPM CR 15/92 HbA1c (%) 6.8 -0.1 -0.4* -0.4† Fasting glucose (mg/dL) 133.9 -5.6 -9.7 -11.9 Fasting insulin (µIU/mL) 21.5 -4.5 -3.9 -5.3 |
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Change in Glycemic Measures at Week 56 Upper Quartile (LOCF) Included in the analysis are subjects with baseline value and >1 post-baseline observation. Changes over time are depicted with changes in LS mean values. *P=0.0005 vs placebo; † P<0.0001 vs placebo; ‡ P<0.001 vs placebo; §P<0.05 vs placebo Measure Baseline Mean Change at Week 56 Placebo PHEN/TPM CR 7.5/46 PHEN/TPM CR 15/92 HbA1c (%) 6.9 -0.2 -0.5* -0.5† Fasting glucose (mg/dL) 135.3 -8.2 -12.5 -16.3‡ Fasting insulin (µIU/mL) 35.3 -3.3 -11.7§ -13.9§ |
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Percentage of Subjects With Net* Change in Number of Concomitant Antidiabetic Medications at Week 56: T2DM Sample (ITT) Increased Meds Percentage of Subjects (n=157) Placebo (n=67) PHEN/TPM CR 7.5/46 (n=164) PHEN/TPM CR 15/92 *Percent increase minus percent decrease |
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Treatment-Emergent Adverse Events (AEs) Reported in >5% of CONQUER Subjects: Safety Set Adverse Event (Preferred Term) Placebo (n=993) (%) 7.5/46 (n=498) (%) 15/92 (n=994) (%) Dry mouth 2.4 13.5 20.8 Paresthesia 2.0 13.7 20.5 Constipation 5.9 15.1 17.4 Upper respiratory tract infection 12.9 12.2 13.4 Dysgeusia 1.1 7.4 10.4 Insomnia 4.7 5.8 10.3 Headache 9.1 7.0 10.2 Dizziness 3.1 7.2 10.0 Nasopharyngitis 8.7 10.6 9.9 Sinusitis 6.7 6.8 8.6 Back pain 4.9 5.6 7.2 Nausea 4.2 3.6 6.8 Fatigue 5.0 4.4 6.7 Vision blurred 3.6 4.0 6.0 Diarrhea 4.8 6.4 5.8 Urinary tract infection 3.7 5.2 5.4 Bronchitis 4.3 4.4 5.2 Arthralgia 5.4 4.6 4.4 |
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CONQUER Safety Overview Most AEs were mild/moderate in severity Treatment-emergent serious AEs in the placebo, 7.5/46, and 15/92 groups were 3.8%, 2.8%, and 4.3%, respectively Overall completion rates on study drug were 57%, 69%, and 64% for placebo, 7.5/46, and 15/92, respectively Discontinuations due to adverse events: Placebo – 8.9% PHEN/TPM CR 7.5/46 – 11.6% PHEN/TPM CR 15/92 – 19.2% Reasons for discontinuations (occurring at >1% frequency) included paresthesia, dizziness, insomnia, depression, and nephrolithiasis 1 death occurred in a placebo subject |
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CONQUER Conclusions Both doses of PHEN/TPM CR achieved robust weight loss in overweight/obese patients 7.8% to 9.8% vs 1.2% in placebo in overall sample (ITT-LOCF) 6.8% to 8.8% vs 1.9% in placebo in T2DM sample (LOCF) Weight loss with PHEN/TPM CR was associated with clinically meaningful improvements in glycemic parameters in patients with – or at risk for – T2DM Treatment with PHEN/TPM CR was generally well tolerated with dose-related AE profile |
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