pared to crizotinib, the current standard of care, in people with
ALK-positive NSCLC. While Gazyva/Gazyvaro showed positive
results in a major clinical trial (Gallium) in follicular lymphoma, a
separate trial (Goya) of the medicine in diffuse large B-cell lymphoma, did not reach its primary study goal.
Also on the cancer battlefront, during the year, Roche launched
the global cancer immunotherapy Centers of Research Excellence
(imCORE) Network. This network brings together many of the
world’s leading scientific and clinical experts in cancer immunotherapy to collaborate in investigating the most promising new
treatment approaches. The goal is to rapidly initiate preclinical
and clinical research based on the latest scientific discoveries and
to aggregate and share data to accelerate the search for cures for
people with cancer. The imCORE Network will focus on identifying approaches to expand the number of people who benefit
from cancer immunotherapy by exploring new ways to activate a
person’s immune system to fight their cancer.
Roche will invest up to roughly $100 million to support basic
and clinical research collaborations related to cancer immunotherapy. This investment is incremental to Roche’s on-going research and development of investigational medicines and treatment approaches in the field of cancer immunotherapy.
To further bolster its research efforts, Roche entered a collaboration with Catalent, through its subsidiary Redwood
Bioscience, to develop next-generation molecules coupling
different therapeutic modalities using Catalent’s proprietary
Roche gains non-exclusive access to the SMARTag platform and will have an option to take commercial licenses to
develop molecules directed to a defined number of targets. Use
of SMARTag, Catalent’s programmable protein-modification
technology, combined with the highly stable hydrazino-Pictet-Spengler (HIPS) conjugation platform, will permit evaluation of
alternative sites of drug conjugation so that Roche may develop
molecules optimized for efficacy, safety and stability.
Roche paid Catalent an up-front fee of $1 million and is to
provide additional research funding during the initial phase of
the collaboration. Catalent has the potential to receive up to $618
million in development and commercial milestones, plus royalties on net sales of products, if Roche pursues commercial licenses and all options are exercised.
RESTRUCTURING SMALL MOLECULES NETWORK
At the end of 2015, Roche unveiled plans to restructure its small
molecules manufacturing network. The plans called for the closure of four manufacturing sites in Clarecastle, Ireland; Leganes,
Spain; Segrate, Italy; and Florence, SC, in the U.S. The decision
was made to address current underutilization as a result of its
The transition began in 2016 and is planned to end by 2021.
During the year, Roche divested two of the facilities. The 300,000
sq.-ft. API manufacturing plant in Florence was sold to Patheon.
At the time of the sale Roche entered into a multi-year supply
arrangement with the contract development and manufacturing
The Spanish facility in Leganes was sold to the contract
manufacturing organization (CMO) Famar. In addition, the two
companies at the time of sale signed a long-term manufacturing agreement that will allow Famar Leganes to supply Roche in
the future from this facility with the current portfolio of products
produced at the site.
With these changes Roche is responding to the evolution of
its small molecule portfolio towards specialized medicines produced in lower volumes. To support the manufacture of a new
generation of specialized small molecule medicines—produced
in lower volumes than traditional medicines—Roche is investing
roughly $310 million in a dedicated facility in Kaiseraugst, Switzerland to provide future technology requirements. CP
“A major highlight [of 2016] was the U.S. launch of Roche’s cancer
immunotherapy medicine Tecentriq. It is the first FDA-approved treatment for
people with a specific type of bladder cancer in more than 30 years.”
Roche headquarters in Basel, Switzerland. With $38.4 billion in sales, Roche is the
fourth largest drug maker in the world.