Merck Highlights Progress on Its Strategic Initiative to Sharpen Commercial and R&D Focus; Drive Growth and Productivity


May 6, 2014 7:59 am ET

Company Provides Updates on Near-Term Opportunities and Immuno-Oncology Strategy

  • Announced Sale of Consumer Care Business to Bayer AG for $14.2 Billion; Enters into Worldwide Collaboration with Bayer to Market and Develop Novel Therapies for Cardiovascular Disease
  • MK-3475 BLA Accepted for Priority Review by FDA; Company Announced Plans to File in EU in 2014
  • Provided Updates on Clinical Development Programs for Oncology, Hepatitis C and HIV
  • Confirmed Plans to File Odanacatib for the Treatment of Osteoporosis in Second Half of 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today is hosting an Investor Briefing at the company’s research facility
in Boston. The briefing is also available via webcast at
starting at 9:00 a.m. EDT.

Members of the company’s senior management team provided updates on the
progress Merck has made on its multi-year, strategic initiative to
sharpen its commercial and research and development (R&D) focus, bolster
its innovative pipeline and accelerate efforts to redesign its operating
model and reduce its cost base.

New, Focused Operating Model

Merck has implemented a focused, more agile operating model and a more
flexible cost structure in order to drive growth and productivity for
the long term. This has allowed the company to reduce costs, while at
the same time take proactive steps to further sharpen its R&D and
commercial focus and bolster its innovative pipeline. This includes
greater integration between the company’s commercial and R&D
organizations and improved therapeutic, pipeline and market
prioritization to focus on the best opportunities for growth.

“We’re focusing on improving our growth opportunities by investing in
the right programs, products and markets,” said Kenneth C. Frazier,
chairman and chief executive officer, Merck. “Merck is about translating
cutting-edge science into medicines and vaccines that save and improve
lives throughout the world. By bringing to market new products that make
a meaningful difference to patients, payers and providers, we’ll
continue to drive value for our shareholders and society.”

Merck announced in January that it was evaluating strategic options for
all areas of the business, including Consumer Care and Animal Health, to
determine whether or not they are core to its strategy. As a result,
Merck today announced
the sale of its Consumer Care business
to Bayer AG for $14.2 billion
and entered into a worldwide collaboration with Bayer to market and
develop a novel portfolio of soluble guanylate cyclase (sGC) modulators
for the treatment of pulmonary arterial hypertension (PAH) and chronic
thromboembolic pulmonary hypertension (CTEPH). As part of the
collaboration, Bayer will receive a $1 billion up-front payment with the
potential for additional milestone payments upon the achievement of
agreed-upon sales goals.

During today’s Investor Briefing, Merck said it will continue to explore
ways to augment its Animal Health business. The company continues to
view the business as one that will generate long-term shareholder value.

Advancing a Suite of Opportunities

Merck’s pipeline contains many promising candidates that represent a
suite of near- and long-term opportunities that will drive growth and
shareholder value. The company has prioritized its R&D efforts to focus
on innovative candidates with meaningful, differentiated attributes. At
the same time, Merck has increased its commercial focus on key
therapeutic areas that provide the best opportunities for the business
and deliver the greatest value for customers, including diabetes, acute
hospital care, vaccines and oncology.

During the meeting, company executives reaffirmed Merck’s objective of
being the premier research-intensive biopharmaceutical company. The
executives also discussed progress made towards prioritizing the
company’s R&D portfolio and provided updates on advances in the
company’s late-stage pipeline and plans for expanding its clinical
programs to advance its novel candidates in hepatitis C, HIV, diabetes
and immuno-oncology.

Merck said it also anticipates several regulatory actions and potential
product launches in 2014 including:

  • Launches

    • GRASTEK (Timothy Grass Pollen Allergen Extract), a sublingual
      allergen immunotherapy tablet for grass pollen-induced allergic
    • RAGWITEK (Short Ragweed Pollen Allergen Extract), a sublingual
      allergen immunotherapy tablet for ragweed pollen-induced allergic
  • Under Review

    • MK-3475, an investigational anti-PD-1 antibody for advanced
    • Suvorexant, an investigational orexin inhibitor for the treatment
      of insomnia
    • ZONTIVITY (vorapaxar), an investigational, novel PAR-1 antagonist
      for reduction of atherothrombotic events in patients with a prior
      heart attack or with peripheral arterial disease and no history of
      stroke or transient ischemic attack
    • V503, an investigational 9-valent HPV vaccine
    • Vaniprevir, an investigational, novel protease inhibitor for the
      treatment of hepatitis C (under review in Japan)
  • Filings Anticipated in 2014

    • Sugammadex, an investigational medicine for the reversal of
      neuromuscular blockade
    • Odanacatib, an investigational, novel cathespin K inhibitor for
      the treatment of osteoporosis

The company confirmed plans to submit a New Drug Application (NDA) for
odanacatib in the second half of 2014 and said that data from its large
fracture outcomes study have been submitted for presentation at a
medical meeting later this year. In the Phase 3 fracture study,
odanacatib substantially reduced the risk of osteoporotic fractures vs.
placebo, including vertebral, non-vertebral and hip fractures, and the
risk reduction was robust and sustained. Adverse experiences were
generally balanced between the odanacatib and placebo groups. Among
adjudicated adverse effects associated with odanacatib, morphea (areas
of skin thickening with itching) was reported uncommonly (<0.2%), with
improvement after discontinuation of treatment, and femoral shaft
fractures of an atypical type were rare (<0.1%). Both were higher than
placebo. There were no reported cases of osteonecrosis of the jaw.
Numerical imbalances were also seen for adjudicated atrial fibrillation
and strokes, though major cardiovascular events were balanced overall.

Additional late-stage pipeline opportunities where Merck has a legacy of
leadership and an established global presence were also discussed:

  • In hepatitis C, the company has initiated Phase 3 trials for
    MK-5172/MK-8742, its all-oral combination regimen, and also plans to
    initiate studies in combination with sofosbuvir for evaluating shorter
    durations of therapy.
  • In HIV, the company plans to commence a Phase 3 trial in the fourth
    quarter of 2014 for its non-nucleoside reverse transcriptase
    inhibitor, doravirine (MK-1439), and for raltegravir once-daily, a new
    formulation of its integrase inhibitor ISENTRESS.
  • In diabetes, the company plans to file omarigliptin, a once-weekly
    DPP-4 inhibitor, in Japan by the end of 2014. In addition, in
    collaboration with Pfizer, Merck continues to evaluate ertugliflozin,
    an investigational oral sodium glucose cotransporter (SGLT2)
    inhibitor, in Phase 3 trials.

Delivering in Immuno-oncology

Merck is investing to be a leader in oncology and is focused on
advancing MK-3475. The company announced
that the FDA has accepted its Biologics License Application (BLA) for
for the treatment of advanced melanoma in patients
previously treated with ipilimumab and granted priority review status.
The PDUFA date for the BLA is October 28, 2014.

Conference and Webcast Information

There will be a live webcast of the event available on Merck’s website
starting at 9:00 a.m. EDT. Software needed to listen to the webcast may
be obtained on the corporate website and should be downloaded prior to
the beginning of the webcast. A replay of the webcast will be available
by the end of the day on May 6, 2014. Institutional investors, analysts
and members of the media also can participate in the event by dialing
(706) 634-2289 or (877) 214-9289 and using ID code number 42688075.

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
consumer care 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
and connect with us on Twitter,
and YouTube.

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 (

Steve Cragle, 908-423-3461
Ian McConnell 908-423-3046
Joe Romanelli, 908-423-5185
Carol Ferguson, 908-423-4465

Unsubscribe from email alerts