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Basel, 9 July 2007
Roche and Alnylam form major
alliance on RNAi therapeutics
- Roche accesses Nobel Prize winning technology for
drug discovery and development
- Alnylam’s site in Germany to become Roche’s Center of
Excellence for RNAi therapeutics
- Alnylam to receive 331 million US dollars in upfront
payments and equity investment
Roche and the US-based biopharmaceutical
company Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today that they have entered into a major
alliance in which Roche obtains a non-exclusive license to Alnylam’s technology platform for developing
RNAi (RNA interference) therapeutics. The alliance will initially cover four therapeutic areas: oncology,
respiratory diseases, metabolic diseases and certain liver diseases. Alnylam and Roche also will collaborate
on RNAi drug discovery for one or more disease targets in these therapeutic areas. In addition, Roche
will acquire Alnylam’s European research site located in Kulmbach, Germany (Bavaria), subject to regulatory
approval. This site will become Roche’s Center of Excellence for RNAi therapeutics discovery.
RNAi
is a potential foundation for a whole new class of human therapeutic products. RNAi is a natural mechanism
that the body uses to inhibit expression of certain genes. Harnessing the activity of RNAi creates a
direct opportunity to develop specific and potent drugs against diseases that are difficult to treat.
"Alnylam
has made significant advances in RNAi therapeutics, one of the most promising approaches to tomorrow’s
healthcare technology. Working together with Alnylam provides us with new capabilities to target complex
diseases within our focus areas,” said Lee E. Babiss, Head of Roche Global Pharma Research. “Our mission
is to find novel solutions for patients who suffer from difficult to treat diseases and we will be fully
committed to this goal, together with our new colleagues located at the acquired site in Kulmbach."
“We
are pleased to form this new alliance with Roche, which is widely recognised for its commitment to innovation
in biotechnology. We look forward to working together to advance our transformative technology into
a whole new class of drugs,” said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam.
“Such significant support from Roche will also strengthen Alnylam’s efforts to build a leading innovation-based
biopharmaceutical company. Indeed, together with our demonstrated commitment to scientific excellence,
advancement of our pipeline and unparalleled intellectual property estate, we believe that this new
alliance greatly extends our leadership position in the discovery and development of RNAi therapeutics.”
Alnylam-Roche
Collaboration
Alnylam has granted to Roche a non-exclusive license providing Roche
access to broad Alnylam intellectual property (IP) and know-how, including fundamental, chemistry and
delivery IP. Indications will initially include oncology, respiratory disease, metabolic disease and
certain liver diseases. Alnylam maintains the right to non-exclusively license its IP to additional
partners in potential future agreements. In addition, Alnylam and Roche will collaborate on one or more
disease targets to be identified in the future in exchange for milestone and royalty payments.
The
transaction includes Roche’s acquisition of Alnylam’s European research site in Kulmbach, Germany (Bavaria),
with about 40 employees. The team in Kulmbach will remain dedicated to RNAi therapeutics discovery as
a new Center of Excellence for RNAi therapeutics within Roche’s global research organisation.
The
alliance could be valued at over 1 billion US dollars in consideration of upfront payments, potential
product milestone payments for multiple products and field expansion payments, excluding potential royalties
on future sales of commercial products. Under the terms of the agreement, Roche will pay Alnylam 331
million US dollars in upfront cash payments and equity investment, including 1.975 million shares of
Alnylam common stock the Roche Venture Fund agreed to purchase at 21.50 US dollars per share, representing
just less than five percent of Alnylam’s outstanding common stock. Roche will also pay Alnylam milestones
on products as they advance in development and commercialisation as well as royalties on future sales
of commercial products. Further, Roche may pay Alnylam field expansion payments to increase the number
of therapeutic areas.
The close of the agreements, including Roche’s
purchase of Alnylam shares and purchase of Alnylam’s site in Germany, is subject to certain regulatory
approvals and is expected to occur within approximately 30 days.
About
RNAi
RNAi (RNA interference) is a revolution in biology, representing a breakthrough
in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery
and development. Its discovery has been heralded as “a major scientific breakthrough that happens once
every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology
and drug discovery today which was awarded the Nobel Prize in October 2006. RNAi is a natural process
of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural
biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known
as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently
silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made.
RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.
About
Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel
therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in
RNAi to address significant medical needs, many of which cannot effectively be addressed with small
molecules or antibodies, the current major classes of drugs. Alnylam is leading the translation of RNAi
as a new class of innovative medicines with peer-reviewed research efforts published in the world’s
top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these
capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II
human clinical trials for the treatment of respiratory syncytial virus (RSV) infection. In addition,
the company is developing RNAi therapeutics for the treatment of influenza, hypercholesterolemia, and
liver cancers, amongst other diseases. The company’s leadership position in fundamental patents, technology,
and know-how relating to RNAi has enabled it to form major alliances with leading companies including
Merck, Medtronic, Novartis, Biogen Idec, and Roche. The company, founded in 2002, maintains global headquarters
in Cambridge, Massachusetts. For more information, visit www.alnylam.com.
About
the Roche Venture Fund
The Roche Venture Fund makes investments in early stage
biotech and diagnostics companies to support innovative technologies and medicines. Based in Basel,
Switzerland, the Roche Venture Fund manages a portfolio of over 25 companies in 10 countries.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As one of the world’s
biggest biotech companies and an innovator of products and services for the early detection, prevention,
diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s
health and quality of life. Roche is one of the world leaders in in-vitro diagnostics and drugs for
cancer and transplantation, a market leader in virology and active in other major therapeutic areas
such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the
Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales
of 8.7 billion Swiss francs. Roche employs roughly 75,000 people worldwide and has R&D agreements
and strategic alliances with numerous partners, including majority ownership interests in Genentech
and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com. |
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