AiCuris and Merck Enter Exclusive Worldwide License Agreement for Investigational Portfolio Targeting Human Cytomegalovirus


October 15, 2012 2:00 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
and AiCuris today announced that they have entered into an exclusive
worldwide licensing agreement for AiCuris’ novel portfolio of
investigational medicines targeting Human Cytomegalovirus (HCMV),
including letermovir (AIC246), an oral, late-stage antiviral candidate
being investigated for the treatment and prevention of HCMV infection in
transplant recipients.

“There is a significant need for additional medicines for the treatment
of HCMV infection, which is one of the most common viral infections
affecting organ and bone marrow transplant patients,” said Dr. Roger
Pomerantz, senior vice president, Worldwide Licensing and Knowledge
Management, and Infectious Disease Franchise Head, Merck Research
Laboratories. “AiCuris has built a leading portfolio of innovative
antiviral HCMV candidates that are designed to address novel targets and
offer the potential for HCMV prophylaxis. This portfolio complements
Merck’s broad antiviral portfolio.”

Under the agreement, Merck, through a subsidiary, will gain worldwide
rights to develop and commercialize candidates in AiCuris’ HCMV
portfolio. AiCuris will receive a €110 million upfront payment and is
eligible for milestone payments of up to €332.5 million based on
successful achievement of development, regulatory and commercialization
goals for HCMV candidates, including letermovir, an additional back-up
candidate as well as other Phase I candidates designed to act via an
alternate mechanism. In addition, AiCuris will be entitled to receive
royalty payments reflecting the advanced stage of the clinical program
on any potential products that result from the agreement. Merck will be
responsible for all development activities and costs.

“This is the first development deal derived from AiCuris’ strong
pipeline, and we are very pleased to have Merck, a major global player
in healthcare, be our license partner,” commented Dr. Thomas Strüngmann,
majority investor in AiCuris.

“Merck’s ongoing commitment to infectious disease research, combined
with its experience in developing and marketing antiviral products,
makes them an excellent partner for AiCuris’ unique HCMV portfolio,”
added Dr. Helga Rübsamen-Schaeff, AiCuris’ CEO. “We very much look
forward to working with the scientists and clinical development teams at
Merck to maximize the therapeutic potential of these candidates for

Closing of the transaction is contingent upon obtaining clearance from
the relevant authorities.

About Letermovir

Letermovir (AIC246) is an investigational oral, once-daily candidate for
the prevention and treatment of HCMV infection. It is a potentially
first in class molecule derived from a novel chemical class
(quinazolines) and is designed to inhibit the HCMV viral terminase. In
April 2012, AiCuris announced that a randomized, placebo controlled
Phase IIb clinical trial evaluating the safety and efficacy of
letermovir in HCMV-seropositive allogeneic human blood precursor cell
recipients (bone marrow transplant patients) met all primary efficacy
endpoints. Letermovir has received Orphan Drug Status in the European
Union and the United States, where it has also been granted Fast Track

About HCMV

The Human Cytomegalovirus (HCMV) is widely spread in the human
population and can cause severe, life-threatening infections in cases of
immune incompetency or immune deficiency, such as, for example, cases in
transplant recipients, newborn babies and HIV/AIDS patients. HCMV
infection is characterized by fever, leucopenia (very low white blood
cell count) and thrombocytopenia (very low platelet numbers) with or
without specific organ dysfunction. Two main strategies to prevent HCMV
infection have been adopted: anti-HCMV drug prophylaxis or pre-emptive
treatment of transplant recipients who are at risk and have evidence of
HCMV infection upon screening.

About AiCuris

AiCuris GmbH & Co KG (name derived from Anti-Infective Cures) was
founded in 2006 as a spin-off from Bayer Healthcare AG. With its deep
roots in Bayer’s long history of successful anti-infectives drug
research and development, AiCuris is focused exclusively on the
discovery, research and development of novel, resistance breaking
antiviral and antibacterial agents for the treatment of severe and
potentially life-threatening infectious diseases. Majority investors are
Drs. Strüngmann, founders and former owners of the pharmaceutical
company Hexal. Besides the HCMV program, AiCuris is pursuing several
other candidates in various stages of clinical development including a
novel anti Herpes Simplex compound ready for Phase III clinical testing.
For more information, please visit

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