From Merck:

Merck Completes Tender Offer to Acquire Cubist

Wednesday, January 21, 2015 8:00 am EST

PDFPrint

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the successful completion of the tender offer for all of the outstanding shares of common stock of Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) at a purchase price of $102.00 per share. As of the tender offer expiration yesterday, 58,039,667 shares of common stock of Cubist were validly tendered and not properly withdrawn from the tender offer, representing approximately 75.7 percent of the outstanding common stock of Cubist on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares.

Following consummation of the tender offer, Merck expects to complete the acquisition of Cubist later today through a merger of Merck’s wholly owned subsidiary with and into Cubist without stockholder approval. Upon completion of the merger, all outstanding shares of common stock of Cubist, other than shares held by Cubist in treasury or shares held by Cubist’s stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $102.00 offer price per share without interest, less any applicable withholding taxes.

In addition, upon completion of the merger, Cubist will become a wholly owned subsidiary of Merck and the common stock of Cubist will cease to be traded on the NASDAQ Stock Market.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements”. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

From Merck:

Merck Provides Update on Strategic Actions to Transform the Company and Build a Platform for Sustained Future Growth at the 33rd Annual J.P. Morgan Healthcare Conference

• KEYTRUDA, First FDA-Approved Anti-PD-1 Therapy, Filed and Launched Within Five Months
• Company Expects to Submit sBLA for KEYTRUDA in Mid-Year 2015 for Advanced Non-Small Cell Lung Cancer
• NDA Submission for Hepatitis C Combination Regimen, Grazoprevir/Elbasvir (MK-5172/MK-8742), Planned for First Half of 2015
• Seven New Products were Approved in 2014
• Company Announced Acquisition of Cubist, Acquired Idenix and Divested its Consumer Care Business
• Targeted Cost Savings are on Track to be Realized by the End of 2015

Monday, January 12, 2015 7:00 am EST

PDFPrint

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today will report on the ongoing execution of its multi-year, strategic initiative to sharpen its commercial and research and development (R&D) focus, redesign its operating model and reduce its cost base. In October 2013, Merck launched its global initiative to transform the company into a more competitive and innovative company and to build a platform for sustained future growth.

“Over the past 15 months, we’ve seen the results of our transformation strategy, including advancing major pipeline candidates, completing multiple business development actions and securing first-in-class product approvals,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “As a result of our strong and continued commitment to the pursuit of science and R&D, our labs are focused on many of the most innovative areas in biomedical research today, which we believe is the best way to create intrinsic value for both society and for our shareholders.”

Positioned for Long-Term Growth Through Innovation

As a result of prioritizing its research efforts in the core areas where it can make the most impact on addressing critical areas of unmet medical need, Merck is now focused on many of the world’s most urgent global health challenges, including immuno-oncology, hepatitis C, cardiometabolic disease, antimicrobial resistance and Alzheimer’s disease. Merck accelerated several of its key clinical programs in 2014, positioning the company for long-term growth.

• In addition to being the first anti-PD-1 therapy approved in the United States, KEYTRUDA (pembrolizumab) received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in two tumor types: advanced melanoma and advanced non-small cell lung cancer (NSCLC).
• In mid-year 2015, Merck expects to submit a supplemental Biologics License Application (sBLA) to the FDA for KEYTRUDA for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative NSCLC whose disease has progressed on or following platinum-containing chemotherapy.
• In 2014, Merck engaged in multiple research collaborations in oncology, and data for KEYTRUDA was presented in seven different types of cancer. KEYTRUDA continues to be studied in more than 30 cancers and in 20 combination settings.

Merck also continued to accelerate its R&D efforts in its other core areas of focus, such as hepatitis C.

• The company expects to file a New Drug Application (NDA) with the FDA in the first half of 2015 for grazoprevir/elbasvir (MK-5172/MK-8742), the company’s investigational oral, once-daily combination regimen for the treatment of chronic hepatitis C virus (HCV) infection.
• Merck bolstered its hepatitis pipeline in 2014 by acquiring Idenix Pharmaceuticals.
• As a result of the acquisition, the Phase 2 C-CREST studies (NCT02332707 and NCT02332720) have been initiated to study combination regimens of grazoprevir and MK-3682 (formerly IDX21437) with either elbasvir or MK-8408 for the treatment of HCV infection.

In total, Merck now has more than 10 Phase 3 clinical programs in its core therapeutic areas, as well as in other areas with significant potential such as Alzheimer’s disease, and has multiple strategic collaborations.

• Merck recently initiated its first Phase 3 study (NCT02275780) of doravirine (MK-1439), an investigational HIV medicine.
• In addition to oncology collaborations, Merck also initiated several other clinical research collaborations in 2014, such as working with NewLink on the development of an investigational Ebola vaccine and a cardiovascular-focused collaboration with Bayer.

Focused Commercial Strategy Provides a Strong Platform for Growth and Leadership

Additionally, Merck has taken several steps to create and maximize near- and longer-term commercial leadership opportunities that create value for sustained growth.

• The initial indication for KEYTRUDA was filed and launched in the United States within five months in 2014; the company continues to focus efforts on this priority launch. Additionally, filings are underway in the European Union and globally for advanced melanoma.
• Merck bolstered its product portfolio by entering into an agreement to acquire Cubist Pharmaceuticals, a global leader in the discovery, development and supply of antibiotics to treat serious and potentially life-threatening infections.
• Following the completion of the acquisition of Cubist in the first quarter of 2015, Merck looks forward to launching ZERBAXA (ceftolozan/tazobactam), a recently approved antibiotic to treat Gram-negative bacteria, a key cause of in-hospital infections.
• In total, Merck received approval for seven products in 2014, such as GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and BELSOMRA (suvorexant).

Reduced Operating Costs Drive Profitability and Investment in Innovation and Late-Stage Portfolio

In 2014, the company’s redesigned operating model enabled Merck to remain on track to meet its goal of realizing $2.5 billion in annual net cost savings by the end of 2015. These savings are off of the company’s full-year 2012 expense levels. As part of its prioritization efforts, the company continued to review its assets to determine whether they could provide the best short- and longer-term value with Merck or elsewhere.

• As a result, Merck divested its consumer care business to Bayer for $14 billion, which provided capital to the company to better resource its core areas of focus and return cash to shareholders.
• Merck determined its Animal Health business remains a key growth driver and is committed to looking for ways to augment this critical business.
• In 2014, the company continued to streamline its physical footprint, divesting multiple sites within its manufacturing network around the world and completing the closures of facilities in Whitehouse Station and Summit, N.J.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Merck to Present at the 33rd Annual J.P. Morgan Healthcare Conference | Merck Newsroom Home

Merck to Present at the 33rd Annual J.P. Morgan Healthcare Conference | Merck Newsroom Home

Advancing Oncology Research Through Clinical Trials - YouTube

Video (2:41)



Advancing Oncology Research Through Clinical Trials - YouTube

From Merck:

Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes

Monday, November 24, 2014 8:00 am EST

PDFPrint

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

“Merck is committed to helping patients with type 2 diabetes and we are excited about the submission of the new drug application for omarigliptin in Japan,” said Peter Stein, M.D., vice president, clinical research, diabetes and endocrinology, Merck Research Laboratories. “More than six million adults in Japan have type 2 diabetes¹ . If approved in Japan, omarigliptin could provide an important new treatment option to help these patients attain their blood sugar goals.”

The new drug application for omarigliptin is based on a comprehensive clinical development program in Japan. The results from the first Phase 3 study of omarigliptin, conducted in Japan, were presented recently at the 50^th European Association for the Study of Diabetes (EASD) Annual Meeting².

Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development program that includes nine Phase 3 clinical trials involving approximately 7,500 patients with type 2 diabetes in support of planned regulatory filings.

Merck’s Commitment to Diabetes

Through our research initiatives, on our own and in collaboration with others, Merck is committed to strengthening its leadership in diabetes to deliver a broad portfolio of products to help patients with type 2 diabetes.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

___________________________
¹ IDF Diabetes Atlas. 6th Edition. Available athttp://www.idf.org/sites/default/files/DA6_Regional_factsheets_0.pdf

² Gantz, I et al. Effect of a novel once weekly DPP-4 inhibitor, omarigliptin in patients with type 2 diabetes: a double-blind, placebo- and sitagliptin-controlled, non-inferiority trial. Presentation 115, presented at 50th EASD Annual Meeting on September 17 2014. Available athttp://www.easd.org/images/easdwebfiles/annualmeeting/50thmeeting/Prog-at-Glance.html. Last accessed September 2014.

From Merck:

Merck and NewLink Genetics Enter Into Licensing and Collaboration Agreement for Investigational Ebola Vaccine

Clinical Development, Manufacturing Expertise, and Scale Critical to Success

Monday, November 24, 2014 7:30 am EST

PDFPrint

WHITEHOUSE STATION, N.J. & AMES, IA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.

The vaccine candidate, originally developed by the Public Health Agency of Canada (PHAC), is currently being evaluated in Phase I clinical trials. Pending the results of ongoing Phase I trials the U.S. National Institutes of Health (NIH) has announced plans to initiate, in early 2015, a large randomized, controlled Phase III study to evaluate the safety and efficacy of the rVSV-EBOV vaccine and another investigational Ebola vaccine co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline.

“Effective Ebola vaccines will be a critical component of comprehensive prevention and control measures for people at risk of Ebola virus infection and to stem future outbreaks globally,” said Dr. Julie Gerberding, president of Merck Vaccines. “Merck is committed to applying our vaccine expertise to address important global health needs and, through our collaboration with NewLink, we hope to advance the public health response to this urgent international health priority.”

According to Dr. Charles Link, chairman and chief executive officer of NewLink Genetics, “Merck's vaccine development expertise, commercial leadership and history of successful strategic alliances make it an ideal partner to expedite the development of rVSV-EBOV and, if demonstrated to be efficacious and well-tolerated, to make it available to individuals and communities at risk of Ebola virus infection around the world.”

Under the terms of the agreement, Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine candidate is under an exclusive licensing arrangement with a wholly-owned subsidiary of NewLink Genetics. Under these license arrangements, the PHAC retains non-commercial rights pertaining to the vaccine candidate.

Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the Walter Reed Army Institute of Research and the NIAID at the NIH. Additional Phase I studies are underway or planned to begin in the near future at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.

“This vaccine is the result of years of hard work and innovation by Canadian scientists. We are pleased that this new alliance coupled with the clinical trials currently underway will further strengthen the possibility that the vaccine will make a difference in the global response to the Ebola outbreak,” said Canada’s Minister of Health, Rona Ambrose.

About rVSV Vaccine Platform

This vaccine platform is based on an attenuated strain of vesicular stomatitis virus that has been modified to express an Ebola virus protein that plays an essential role in establishing virus infection. The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada’s National Microbiology Laboratory. A significant portion of the funding for the further development of the vaccine came from the CBRN Research and Technology Initiative, a federal program led by Defence Research and Development Canada. In 2010, the PHAC signed a licensing arrangement with BioProtection Systems (BPS), a wholly-owned subsidiary of NewLink Genetics, as the sole licensee for these vaccines and the underlying technology. BPS has worked with the PHAC to produce clinical trial materials and to move this vaccine candidate into Phase I studies.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

About NewLink Genetics Corporation

NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. BioProtection Systems, a wholly-owned subsidiary of NewLink Genetics Corporation, is focused on the research, development and commercialization of vaccines. BPS is focused on control of emerging infectious diseases, including improvement of existing vaccines and providing rapid-response prophylactic and therapeutic treatment for pathogens most likely to enter the human population through pandemics or acts of bioterrorism. For more information please visit http://www.linkp.com.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).

NewLink Genetics Corporation Forward-Looking Statement

This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements regarding plans to develop and commercialize our product candidates and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2013, and subsequent filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink's views as of any date subsequent to the date of this press release.