Merck & Co Inc: Key Developments
Merck & Co., Inc. Wins Summary Judgment In Texas Attorney General's Lawsuit Involving VIOXX
November 23, 2009 |
| Merck & Co., Inc. announced that Travis County, Texas District Court Judge Scott H. Jenkins granted Merck's motion for summary judgment, dismissing all claims in a VIOXX-related lawsuit filed on behalf of the State of Texas. In that case, which was filed in 2005 by the Texas Attorney General's Office, the state sought damages and penalties from Merck for alleged violations of the Texas Medicaid Fraud Prevention Act (TMFPA), including a refund of all monies that the state had spent on VIOXX. In its motion for summary judgment, Merck maintained, among other things, that the evidence showed that the Company acted responsibly and truthfully in its communications about VIOXX with the State of Texas, doctors in the state and the U.S. Food and Drug Administration. Merck further pointed out that the TMFPA was not designed to apply to claims such as those brought by the state, and that the state had failed to elicit any evidence demonstrating that Merck had caused the state damages. After reviewing the briefs of the parties and hearing oral argument, the court rejected the state's claims, dismissing each of them with prejudice. Merck vigorously defended the lawsuit for over four years in Texas state court in Austin. By dismissing the claims, the court concluded that a trial of the state's claims was not necessary. A trial in the case filed against Merck by the Louisiana Attorney General is scheduled to begin in federal court in New Orleans on April 12, 2010. |
Merck & Co., Inc. Receives CHMP Positive Opinion For New Fertility Treatment, ELONVA
November 20, 2009 |
| Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. If approved by the European Commission, Merck would receive marketing authorization for ELONVA with unified labeling valid in all European Union Member States. ELONVA is the first in the class of sustained follicle stimulants (SFS). Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle. |
Merck & Co., Inc. Announces Higher Dose Of Merck`s COZAAR Significantly Reduced Deaths And Hospitalizations Due To Heart Failure In Investigational Study
November 17, 2009 |
| Merck & Co., Inc. announced that In an investigational study, Merck's medicine COZAAR (losartan potassium tablets) 150 mg, administered once daily, significantly reduced the risk of all cause death or hospitalization due to heart failure compared to a lower 50 mg once daily dose of COZAAR. The Merck-sponsored study compared the safety and efficacy of two doses of COZAAR in patients with chronic heart failure and reduced cardiac function who were intolerant of angiotensin converting enzyme (ACE) inhibitors. The results of the study, called HEAAL Heart failure Endpoint evaluation of the A-II-Antagonist Losartan. COZAAR is not indicated in the U.S. for the treatment of patients with chronic heart failure and is not approved for use, for any indication, at the 150 mg dose used in the HEAAL study. COZAAR is an angiotensin II antagonist (AIIA), cardiovascular medicine approved for three indications: Study results demonstrated COZAAR administered in a 150 mg once daily dose, when compared with COZAAR 50 mg per day, significantly reduced the risk of the primary composite endpoint in patients with reduced left ventricular ejection fraction (LVEF); and reduced ACE inhibitor intolerance (p=0.027). |
Opko Health Inc. Completes Acquisition of NK-1 Compounds from Merck & Co., Inc.'s Schering Corporation
November 11, 2009 |
| Opko Health Inc. announced that it has completed the acquisition of rolapitant and a related compound from Schering Corporation, a subsidiary of Merck & Co., Inc. |
Merck & Co., Inc. Comments On Long Term EPS Outlook
November 4, 2009 |
| Merck & Co., Inc. announced that it is targeting a high single digit non-GAAP earnings per share (EPS) compound annual growth rate from fiscal 2009 to fiscal 2013 (with the fiscal 2009 base representing the Company's previous stand-alone non-GAAP EPS outlook of $3.20-$3.30). According to Reuters Estimates, analysts were expecting the Company to report non-GAAP EPS of $3.25 for fiscal 2009; non-GAAP EPS of $3.44 for fiscal 2010; non-GAAP EPS of $3.79 for fiscal 2011; non-GAAP EPS of $3.65 for fiscal 2012 and non-GAAP EPS of $3.47 for fiscal 2013. |
Merck & Co., Inc. And Schering-Plough Corporation to Complete Merger On November 3, 2009
November 3, 2009 |
| Merck & Co., Inc. and Schering-Plough Corporation announced that they will complete their merger on November 3, 2009. The companies will begin combined operations from November 4, 2009. As previously announced, Schering-Plough will change its name to Merck and its common stock will trade under the ticker symbol MRK on the New York Stock Exchange. Under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 shares of the newly combined company and $10.50 in cash for each share of Schering-Plough. Each Merck common share will automatically become a common share of the newly combined company. This announcement follows clearance from regulatory authorities in China and Mexico. The merger of local Merck and Schering-Plough entities may be pending in other jurisdictions and integration is subject to completion of various local legal and regulatory obligations. |
Merck & Co., Inc. And Schering-Plough Corporation Receive Approval From European Commission For Merger-Complete Story
October 23, 2009 |
| Merck & Co., Inc. and Schering-Plough Corporation announced that they have received clearance from the European Commission (EC) under the EC Merger Regulation for their proposed merger. Integration planning teams from Merck and Schering-Plough are working together to ensure that the combined company will be well equipped to begin its first day of business as soon as the merger is completed. Merck & Co., Inc. and Schering-Plough Corporation continue to expect the transaction to close in the fourth quarter of 2009. |
Merck & Co., Inc. Raises Low End Of Prior FY 2009 EPS Guidance; Reaffirms FY 2009 Revenue Guidance
October 22, 2009 |
| Merck & Co., Inc. updated fiscal 2009 non-GAAP earnings per share (EPS) guidance to be between $3.20 to $3.30, excluding certain items, and its fiscal 2009 GAAP EPS to be in the range of $3.69-$3.89. The 2009 GAAP guidance includes a pretax charge of approximately $400-$600 million associated with the Company's 2008 global restructuring program and $250-$350 million of pre-closing costs related to the Schering-Plough merger. Merck said it is reaffirming its guidance for fiscal 2009 revenue of $23.2-$23.7 billion. All of the 2009 guidance provided by the company excludes contributions from Schering-Plough that would result from the merger and any costs incurred upon closing of the merger, which is expected to occur in the fourth quarter. According to Reuters Estimates, analysts were expecting the Company to report revenues of $23.5 billion and EPS of $3.23 for the same period. |
CDC Advisory Committee On Immunization Practices Votes For Permissive Use And For Vaccines For Children Funding For Merck & Co., Inc.'s GARDASIL For Boys And Young Men
October 21, 2009 |
| Merck & Co., Inc. announced that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) supports the permissive use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and young men ages nine to 26, which means that GARDASIL may be given to males ages nine to 26 to reduce the likelihood of acquiring genital warts at the discretion of the patient's health care provider. The ACIP also voted to recommend that funding be provided for the use of GARDASIL in males through the Vaccines for Children (VFC) program. On October 16, the Food and Drug Administration (FDA) approved GARDASIL for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11, making GARDASIL the only HPV vaccine approved for use in males. GARDASIL is also the only HPV vaccine that protects against HPV types six and 11 which cause approximately 90% of all genital warts cases. For females, the ACIP also voted to recommend vaccination with either the bivalent or the quadrivalent HPV vaccine for the prevention of HPV 16 and -18 related cervical cancers, precancers and dysplastic lesions, and recommended vaccination with the quadrivalent HPV vaccine, GARDASIL, for the prevention of cervical, vulvar and vaginal cancers, precancers and dysplastic lesions due to HPV types 16 or 18, and for prevention of genital warts due to HPV types six or 11. |
FDA Approves Merck & Co., Inc.'s GARDASIL for Use in Boys and Young Men
October 16, 2009 |
| Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. |
Galapagos NV Expands Strategic Alliance In Metabolic Disease With Merck & Co., Inc.
October 14, 2009 |
| Galapagos NV announced that it has expanded its global strategic alliance in metabolic diseases with an affiliate of Merck & Co., Inc to incorporate the development of new therapies for atherosclerosis. Galapagos will be responsible for the discovery and pre-clinical development of new small molecule candidate drugs based on novel Galapagos targets. The alliance will make use of Galapagos' proprietary target discovery platform for identification of novel targets in atherosclerosis, as well as in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck will have an exclusive option to license in each candidate for clinical development and commercialization on a worldwide basis. Upon exercise of such option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute Phase I clinical studies and will have the right to further develop and commercialize certain compounds for which Merck does not exercise its exclusive option. |
Merck & Co., Inc. Announces New Analysis Of Pooled Clinical Data Shows Januvia (sitagliptin) From MSD Provided Significant Blood Sugar Lowering Over Two Years
September 29, 2009 |
| Merck & Co., Inc. announced that post-hoc analysis, presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed Januvia (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two years. In a post-hoc pooled analysis of data from two clinical trials evaluating sitagliptin as monotherapy, HbA1c over time was examined in 147 patients with a baseline HbA1c of 7.5 to 10.0% who were not taking any diabetes medications upon entry. The mean HbA1c in the patients (n=32) completing two years of sitagliptin monotherapy decreased from a baseline of 8.3 to 6.9%- into target guideline ranges. The studies had established criteria to specify when patients should start additional antihyperglycaemic therapy or discontinue from the studies, and these criteria, including either measurements of fasting plasma glucose (FPG) or HbA1c, became stricter over time. The analyses excluded data obtained after patients had started additional medicines. Overall, 67 out of 147 patients (46%) in the monotherapy group received glycaemic rescue medication or discontinued treatment because patients did not meet the progressively stricter glycaemic criteria and/or did not meet the investigator's expectations of glycaemic improvement over the two years of study. |
Merck & Co., Inc. Receives Positive CHMP Opinion for Januvia and Janumet As Add-On To Insulin In European Union
September 28, 2009 |
| Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), announced that it has received a positive opinion from the European Medicines Agency`s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for Januvia (sitagliptin) and Janumet (fixed-dose combination of sitagliptin and metformin)recommending their useas add-on toinsulin for the treatment of type 2 diabetes. If adopted by the European Commission, sitagliptin will be the only diabetes treatment in the DPP-4 inhibitor class to have an indication for use as add-on to insulin in the EU. The fixed dose combination of sitagliptin and metformin is not available in some EU countries, including the UK. With this positive opinion, the CHMP recommends that sitagliptin alone or in combination with metformin be indicated as add-on to insulin when diet and exercise plus stable dosage of insulin and metformin alone do not provide adequate glycemic control. |
Merck & Co., Inc. Receives Exclusive U.S. Marketing Rights For AFLURIA, Seasonal Influenza Vaccine From CSL Biotherapies
September 28, 2009 |
| Merck & Co., Inc. announced that it has entered into an exclusive agreement with CSL Biotherapies, a subsidiary of CSL Limited, to market and distribute AFLURIA (Influenza Virus Vaccine), CSL's seasonal influenza (flu) vaccine, in the U.S., for the 2010/2011-2015/2016 flu seasons. Under the terms of the agreement, the Company will assume responsibility for all aspects of commercialization of AFLURIA in the U.S. CSL will supply AFLURIA to the Company and will retain responsibility for marketing the vaccine outside the U.S. Specific financial details of the agreement were not disclosed. |
US FDA Sees Pancreatitis Link With Merck & Co., Inc.'s Januvia-Reuters
September 25, 2009 |
| Reuters reported that U.S. health officials said they suspect Merck & Co., Inc.'s diabetes drug Januvia may be linked to serious cases of inflamed pancreas, but Company officials disputed the connection. The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009. The FDA said it was working with Merck to add information about the cases to the drugs' labels and that doctors should closely monitor their patients. |
Merck & Co., Inc. and Qiagen N.V. Collaborate To Accelerate Access To Cervical Cancer Vaccination and Screening In Developing Countries
September 23, 2009 |
| Merck & Co., Inc. and Qiagen N.V. announced their intent to collaborate on a new program to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world. Merck and QIAGEN plan to reach out to select GAVI-eligible countries to explore the feasibility of implementing cervical cancer reduction programs. These programs are expected to be national in scope, all girls within a defined age range in the selected countries would be offered vaccination, and the program would work towards implementation of screening, and treatment as needed, for all women of a defined age group. |
sanofi-aventis Completes Acquisition of Merck & Co., Inc.'s Interest in Merial Limited
September 18, 2009 |
| sanofi-aventis and Merck & Co., Inc. announced that the acquisition by sanofi-aventis of Merck`s 50% interest in Merial Limited has been completed. Sanofi-aventis acquired Merck`s interest in Merial for a cash consideration of $4 billion. Merial is a 50/50 joint venture between Merck and sanofi-aventis and is now a wholly owned subsidiary of sanofi-aventis. As per the terms of the agreement, sanofi-aventis also has an option, following the closing of the Merck/Schering-Plough merger, to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and sanofi-aventis. If the option is exercised by sanofi-aventis, the formation of the new animal health joint venture would be subject to approval by the relevant competition authorities. The acquisition of Merial is expected to be accretive to sanofi-aventis' adjusted net income from the first year. |
Wellcome Trust And Merck & Co., Inc. Launch Joint Venture To Develop Affordable Vaccines For Low-Income Countries
September 17, 2009 |
| The Wellcome Trust and Merck & Co., Inc. announced the creation of the MSD Wellcome Trust Hilleman Laboratories, the research and development joint venture with a not-for-profit mission to focus on developing affordable vaccines to prevent diseases that commonly affect low-income countries. |
sanofi-aventis EU Clears Sanofi-Aventis To Buy Merck & Co., Inc.'s Stake In Merial Joint Venture-DJ
September 16, 2009 |
| Dow Jones reported that the European Commission (EU) approved sanofi-aventis to buy the remaining 50% of its animal health joint venture Merial. Merial was formed as a 50-50 joint venture with Merck & Co., Inc. |
EU Approves Merck & Co., Inc.'s Isentress For New HIV Patients-AP
September 15, 2009 |
| The Associated Press reported that European Union regulators expanded the approval of Merck & Co., Inc.'s HIV drug Isentress, the Company said. Merck said the drug is now approved for adult patients who are starting treatment for the first time. Previously it was only approved for patients who had not been helped by other drugs. The ruling was made by the European Union Commission and announced by the Company's Merck Sharp & Dohme unit. The approval applies to 27 EU member countries. Isentress, or raltegravir, is approved in combination with other antiretroviral drugs. |
Merck & Co., Inc.'s ISENTRESS (raltegravir) Tablets Studied in Comparison to Efavirenz in Combination Therapy Through 96 Weeks in HIV-1 Treatment-Na ve Patients
September 13, 2009 |
| Merck & Co., Inc.'s ISENTRESS was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-nave) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK. In STARTMRK, ISENTRESS patients received either ISENTRESS or efavirenz in combination therapy. In this ongoing, multi-center, double-blind, randomized, active-controlled Phase III STARTMRK trial, 563 treatment-nave adult patients received either 400 mg ISENTRESS administered orally twice daily in combination with tenofovir/emtricitabine or 600 mg efavirenz administered orally once daily in combination with the same agents. The primary endpoints were reductions in HIV-1 viral load to less than 50 copies/mL and an evaluation of safety and tolerability at Week 48. Secondary endpoints included ARV activity as measured by the proportion of patients achieving HIV viral load to less than 50 copies/mL, less than 400 copies/mL and change from baseline in CD4 count at Week 96, as well as tolerability and safety at Week 96. After 96 weeks of treatment, the ISENTRESS-based regimen suppressed HIV RNA levels below 50 copies/mL at a rate comparable to the regimen containing efavirenz (81% versus 79%, respectively); the treatment difference was two percent favoring ISENTRESS with an associated 95% confidence interval (CI) of (-4.3, 9.0). |
Merck & Co., Inc. Says Mistrial Declared In First Federal FOSAMAX Trial
September 11, 2009 |
| Merck & Co., Inc. announced that a mistrial was declared by U.S. District Court Judge John F. Keenan in Boles v. Merck, the first FOSAMAX case to go to trial. This case was the Plaintiffs' Steering Committee's first choice to take to trial. The Boles case was tried in New York federal court and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. After several days of deliberations by an eight person jury, Judge Keenan declared a mistrial because the jury did not reach a unanimous verdict. The plaintiff failed to prove her case before this jury, said Paul Strain of Venable LLP, outside counsel for Merck. The jury notes included one presented to Judge Keenan on September 9 signed by seven of the eight jurors, including the jury foreperson, stating that the seven jurors agree that there is no evidence of proof that FOSAMAX caused Mrs. Boles injury. trial, Merck presented evidence that it acted responsibly and that FOSAMAX was not the cause of Shirley Boles' dental and jaw problems. Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX, said Mr. Strain. She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, which can result in poor wound healing. The plaintiff would have experienced dental and jaw-related problems whether she took FOSAMAX or not. |
Merck & Co., Inc. Updates Status of Clinical Development Programs for Investigational CGRP Receptor Antagonist Treatments for Acute Migraine; MK-3207 Clinical Development Discontinued
September 10, 2009 |
| Merck & Co., Inc. updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine. The Company is reviewing available clinical data for telcagepant, which is in Phase III of clinical development, in preparation for discussions that the Company plans to have with regulatory agencies later this year. Separately, Merck is discontinuing the clinical development program for MK-3207, the Company's other investigational CGRP receptor antagonist, and will not start confirmatory Phase IIb/III studies. While efficacy was demonstrated in a Phase II study with MK-3207, some subjects in extended Phase I clinical pharmacology studies were found to have experienced delayed, asymptomatic liver test abnormalities, generally following discontinuation of drug administration. This information led to the decision to discontinue development of MK-3207. |
FDA Advisory Committee Recommends Approval for Use of Merck & Co., Inc.'s GARDASIL in Boys and Men
September 9, 2009 |
| Merck & Co., Inc. announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. The committee's recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008. Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck's application. |
Merck & Co., Inc. Loses Effort To Dismiss 24 Fosamax Cases-Reuters
September 9, 2009 |
| Reuters reported that a Manhattan federal judge has rejected Merck & Co., Inc.'s effort to dismiss 24 cases alleging that its Fosamax drug treatment for osteoporosis causes jaw damage. In an opinion, U.S. District Judge John Keenan ruled that the plaintiffs could introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use. Keenan said the evidence is sufficiently reliable to allow a rational jury to establish such a connection. He said individual plaintiffs will then be allowed to present expert testimony that Fosamax caused them to suffer such damage, and that such testimony could by itself make causation a genuine issue of fact for trial. The Company faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw. A Manhattan jury is deliberating this week over the Merck & Co., Inc.'s potential liability in one such case. |
Merck & Co., Inc. Launches SAFLUTAN (tafluprost) In International Markets
September 3, 2009 |
| Merck & Co., Inc. announced that it has launched SAFLUTAN (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals. |
Merck & Co., Inc.'s Merck Sharp & Dohme Limited Files Marketing Application for Vernakalant Intravenous in Europe
August 26, 2009 |
| Merck & Co., Inc., Whitehouse Station, NJ, USA, which operates in many countries as Merck Sharp & Dohme Limited, announced that the European Medicines Agency (EMEA) accepted for review the company`s Marketing Authorisation Application (MAA) for regulatory approval of vernakalant intravenous (IV). |
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