Sun Pharma and Merck & Co. Inc., Enter into Licensing Agreement for Tildrakizumab


September 17, 2014 7:30 am ET

Merck & Co., Inc., (NYSE:MRK), known as MSD outside the United States
and Canada, and Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO,
Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) through their
respective subsidiaries, today announced an exclusive worldwide
licensing agreement for Merck’s investigational therapeutic antibody
candidate, tildrakizumab, (MK-3222), which is currently being evaluated
in Phase 3 registration trials for the treatment of chronic plaque
psoriasis, a skin ailment.

Under terms of the agreement, Sun Pharma will acquire worldwide rights
to tildrakizumab for use in all human indications from Merck in exchange
for an upfront payment of U.S. $80 million. Merck will continue all
clinical development and regulatory activities, which will be funded by
Sun Pharma. Upon product approval, Sun Pharma will be responsible for
regulatory activities, including subsequent submissions,
pharmacovigilance, post approval studies, manufacturing and
commercialization of the approved product. Merck is eligible to receive
undisclosed payments associated with regulatory (including product
approval) and sales milestones, as well as tiered royalties ranging from
mid-single digit through teen percentage rates on sales.

“Consistent with our previously announced global initiative to sharpen
our commercial and R&D focus, including prioritizing our late stage
pipeline candidates, we are pleased to enter into this agreement with
Sun Pharma to help realize the potential of tildrakizumab for patients
with chronic plaque psoriasis,” said Iain D. Dukes, Ph.D., senior vice
president, Business Development and Licensing, Merck Research

“Sun Pharma is very pleased to enter into this collaboration with Merck,
a recognized leader in the field of inflammatory/immunology therapies,
for this late-stage candidate for chronic plaque psoriasis,” said Kirti
Ganorkar, senior vice president, Business Development, Sun Pharma. “This
collaboration is a part of our strategy towards building our pipeline of
innovative dermatology products in a market with strong growth

The transaction is subject to customary closing conditions, including
the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

About Tildrakizumab

Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal
antibody that binds specifically to IL-23p19 and is therefore designed
to selectively block the cytokine IL-23. Human genetics suggest that
inhibiting IL-23 is effective for treating inflammatory conditions. In
clinical studies for the treatment of chronic plaque psoriasis,
tildrakizumab demonstrates efficacy in blocking inflammation by blocking
IL-23. Other potential indications, which may be evaluated in future,
include psoriatic arthritis and Crohn’s Disease.

Further details of the Phase 3 clinical trials can be found at:

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
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About Sun Pharma

Established in 1983, listed since 1994 and headquartered in India, Sun
Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN,
NSE: SUNPHARMA, BSE: 524715) is an international specialty
pharmaceutical company with over 75% sales from global markets. It
manufactures and markets a large basket of pharmaceutical formulations
as branded generics as well as generics in US, India and several other
markets across the world. For the year ending March 2014, overall
revenues were at US$2.7 billion, of which US contributed US$1.6 billion.
In India, the company is a leader in niche therapy areas of psychiatry,
neurology, cardiology, nephrology, gastroenterology, orthopedics and
ophthalmology. The company has strong skills in product development,
process chemistry, and manufacturing of complex dosage forms. More
information about the company can be found at

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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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 (

Ian McConnell, 908- 423-3046
Justin Holko, 908-423-5088
Sun Pharma
Frederick Castro, +91-22-66455964
Nimish Desai, +91-22-66455717

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