Merck to pay $830 mn to resolve class action case over Vioxx

Merck, known as MSD outside the United States and Canada, announced that it has reached an agreement with plaintiffs to resolve In re Merck & Co., Inc. Securities Litigation, a multi-district class action lawsuit pending in New Jersey federal court. The settlement class consists of persons who purchased Merck securities during the period from May 21, 1999, through October 29, 2004, inclusive, and who seek to recover damages under the federal securities laws for certain Merck statements regarding Vioxx.

Under the agreement, Merck will pay $830 million to resolve the settlement class members’ claims, plus an additional amount for approved attorneys’ fees and expenses. After available funds under certain insurance policies, Merck’s cash payment for the settlement and fees will be approximately $680 million, for which the company will record a charge in the fourth quarter of 2015, which will be excluded from non-GAAP results. The agreement is subject to court approval.

The settlement does not constitute any admission by Merck or any of the individual defendants of any liability or wrongdoing.

Merck still faces previously disclosed individual securities lawsuits related to Vioxx.

Merck net profit dips by 66% to $688 million in Q2

Merck has received major setback during the second quarter ended June 2015 due to acquisitions, divestitures and foreign exchange. Its net profit declined sharply by 66 per cent to $687 million from $2,004 million in the corresponding period of last year. Its sales also declined by 11 per cent to $9,785 million from $10,934 million on account of lower sales in cardiovascular and hepatitis C portfolios. With lower profit, its EPS declined to $0.24 from $0.68 in the last period. R&D expenditure increased slightly to $1,670 million from $1,664 million.

Kenneth C Frazier, chairman and chief executive officer, said, “We're investing resources to grow our strongest brands and to support the most promising assets in our pipeline, while at the same time lowering our cost base and delivering operation leverage. We have made significant progress this quarter in two of our most important assets, the Keytruda and hepatitis C programmes, and will be fully prepared to take advantage of these potentially breakthrough opportunities. We are witnessing the introduction of breakthrough therapies for some of the most difficult-to-treat diseases.”

Its pharmaceutical sales declined by 6 per cent to $8,564 million from $9,098 million and that of animal health by 4 per cent to $840 million from $872 million. The company divested its consumer care business. The sales of cardiovascular portfolio of Zetia and Vytorin in US declined due to loss of exclusivity and that of Remicade, a treatment for inflammatory diseases, due to loss of exclusivity in Europe. Zetia sales declined $635 million from $717 million and that of Vytorin went down to $320 million from $417 million. Remicade sales declined to $455 million from $607 million.

Merck's anti-PD-1 therapy,

Merck, a global healthcare leader, known as MSD outside the United States and Canada, announced results from the randomized, pivotal phase 3 study, Keynote-006, in the treatment of unresectable advanced melanoma. In the study, Keytruda (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).

On March 24, 2015, Merck announced that Keynote-00 would be stopped early based on these data (link). The results were presented at the American Association for Cancer Research (AACR) annual meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published in the New England Journal of Medicine.

“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, Keytruda was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris and lead author of the New England Journal of Medicine publication.

In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for Keytruda based on Keynote-006 for the first-line treatment of advanced melanoma. Merck recently submitted data from Keynote-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application.

Keytruda was the first anti-PD-1 therapy approved in the United States and is currently indicated in the United States for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Merck begins 5-year CAP in diabetes education for medical, nursing & pharmacy undergraduates in UAE

Merck, a leading company for top-quality high-tech products in the pharmaceutical, chemical and life-science sectors, in collaboration with Emirates Diabetes Society (EDS) announces the start of Merck Capacity Advancement Program (CAP) in Diabetes education for medical, nursing and pharmacy undergraduates and primary healthcare providers so that  ultimately they act as  Diabetes ambassadors across the UAE.

The 5 year programme will be accredited by the European Accreditation Council of Continuous medical Education (EACCME) and developed by EXCEMED – Excellence in Medical Education and Oxford Centre of Diabetes, Churchill Hospital, Oxford, UK.

The impact of the Merck Diabetes education programme will be even further due to a free educational platform, www.managediabetesonline.org, to centralize and disseminate the educational value of the unique program across the globe.

During his visit to United Arab Emirates, Dr. Frank Stangenberg-Haverkamp, Chairman of the Executive Board and Family Board of E. Merck KG and member of the Merck family, said: “Merck is pleased to launch the Merck Capacity Advancement Program in UAE as part of our commitment to building healthcare capacity and providing sustainable access to high-quality health solutions and safe medicines in the Middle East.”

“The CAP will provide critical education and empowerment to those affected and dealing with diabetes to show the way to manage and prevent the silent deadly disease.” he added Emirates Diabetes Society - EDS plays a vital role in educating health providers who in turn help care-givers deal better with the syndrome. EDS is collaborating with Merck to arrange this course for Students of health Sciences.

Rasha Kelej, vice president, head of global business responsibility and Market Development, Merck Serono, emphasized:” Merck Capacity Advancement Program- CAP as part of Merck responsibility agenda will improve access to better Diabetes care as part of our commitment to the social and economic development of UAE. Supporting Diabetes education will contribute significantly to improving awareness, early diagnosis and prevention of the disease across the country”.