Acquisition Expands Alnylam Intellectual Property Estate, Includes Several Early and Broad RNAi Patent Families
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 8, 2008--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi
therapeutics company, announced today that it has acquired the
intellectual property (IP) assets of Nucleonics, Inc., a privately held
biotechnology company. The Nucleonics IP estate includes over 100 active
patent filings, including 16 that have granted worldwide and 6 that have
been granted in the U.S., Europe, or Japan - the world's largest
pharmaceutical markets.
The Nucleonics IP estate includes certain early patents and patent
applications, notably the "Li & Kirby," "Pachuk I," and "Giordano"
patent families, that cover broad structural features of RNAi
therapeutics and extend the breadth of Alnylam's "fundamental" IP, which
is comprised of the Crooke, Fire & Mello, Kreutzer-Limmer, Glover,
Tuschl I, Tuschl II, Hannon, and Kay patent families. With this
acquisition, Alnylam has extended the scope of its overall IP estate for
RNAi therapeutics, which now includes over 1,800 active cases. Financial
terms of the acquisition were not disclosed; however, this transaction
does not change Alnylam's financial guidance of ending the year with
greater than $500 million in cash.
"Nucleonics was one of the first companies in the RNAi therapeutics
space focused primarily on gene therapy applications of RNAi. As they
built their company, they acquired a number of early and broad patent
families that are relevant for development and commercialization of all
RNAi therapeutics, including synthetic small interfering RNAs, or
'siRNAs,' the molecules that mediate RNAi, which remain Alnylam's sole
focus," said Barry Greene, President and Chief Operating Officer of
Alnylam. "When added to our existing IP estate, which is already
dominant in the field, the Nucleonics IP estate provides further
strengthening of a portfolio that is buttressed across all possible
dimensions. Importantly, Alnylam's IP estate is defined by a very large
number of distinct patent elements that in aggregate define the overall
strength of our exclusivity in the RNAi therapeutics field."
"The Nucleonics IP portfolio we acquired today adds very significantly
to our current IP estate for RNAi therapeutics," said Donna Ward, Ph.D.,
Vice President, Intellectual Property at Alnylam. "In particular, we are
extremely pleased to obtain early and broadly applicable RNAi IP assets,
including the Li & Kirby, Pachuk I, and Giordano patent families, which
have very early priority dates going back to 1998. Clearly, these new IP
elements complement our existing fundamental IP, such as the Crooke,
Tuschl II, and Kreutzer-Limmer patent families, as well as many others -
all of which Alnylam holds exclusively."
Amongst over 100 active patent filings, the Nucleonics IP estate
includes several early filed patent applications, including:
-- the Li & Kirby patent family (USSN:10/038,984, among other applications
in the family) from the Medical College of Georgia, which covers methods
for attenuating the expression of a target gene in vertebrates using a
double stranded RNA (dsRNA);
-- the Pachuk I patent family (USSN:10/009,134, among other applications in
the family) from Wyeth, which covers double stranded RNA to reduce gene
target expression, methods of inhibiting the function of a protein with
dsRNA and multi-targeting dsRNAs, which target either the coding or
non-coding portions of a gene; and
-- the Giordano patent family (USSN:10/762,395, among other applications in
the family), which covers methods of down-regulating expression of gene
targets using RNAi, methods of achieving intracellular RNAi for gene
expression regulation and therapeutic applications, and methods of
identifying dsRNA delivery complexes with reduced toxicity.
Rodman & Renshaw, LLC advised Alnylam on this transaction.
About Alnylam Intellectual Property (IP)
Alnylam's IP estate includes issued, allowed, or granted fundamental
patents in many of the world's major pharmaceutical markets that claim
the broad structural and functional properties of RNAi therapeutic
products. These include:
-- the Crooke Patents (U.S. Patent Nos. 5,898,031, 6,107,094, 7,432,249,
7,432,250 and EP 0928290) issued in over 12 countries and licensed
exclusively from Isis Pharmaceuticals, Inc. to Alnylam for RNAi
therapeutics, which cover compositions, methods, and uses of modified
oligonucleotides to inactivate a target mRNA mediated by a double
stranded RNase, such as "RISC," which is the cellular enzyme complex
that mediates RNAi;
-- the Kreutzer-Limmer I '623 patent (EP 1144623) granted in August 2002,
maintained in amended form in June 2006 and owned by Alnylam, which
covers methods, medicaments, and uses of siRNAs having, among other
structural features, a length of 15 to 21 base pairs;
-- the Kreutzer-Limmer I '945 patent (EP 1214945) granted in June 2005 and
owned by Alnylam, which covers compositions, methods, and uses of siRNAs
with a length between 15 and 49 nucleotides;
-- the Kreutzer-Limmer I '167 patent (DE 10080167) granted in October 2007
and owned by Alnylam, which covers pharmaceutical compositions and uses
of siRNAs with a length between 15 and 49 nucleotides that target
certain broad categories of mammalian genes;
-- the Kreutzer-Limmer I '235 patent (DE 10066235), granted in January 2008
and owned by Alnylam, which covers methods, uses, and medicaments of
siRNAs, with a length between 15 and 49 nucleotides, expressed through a
vector;
-- the Kreutzer-Limmer II '061 patent (EP 1352061), granted in May 2006 and
owned by Alnylam, which covers therapeutic compositions, methods, and
uses of siRNA and derivatives directed toward over 125 disease targets;
-- the Tuschl II '704 patent (U.S. Patent No. 7,056,704) issued in June
2006 and exclusively licensed to Alnylam from the Max Planck Society,
which broadly covers methods of making siRNAs to silence any and all
disease targets;
-- the Tuschl II '196 patent (U.S. Patent No. 7,078,196) issued in July
2006 and exclusively licensed to Alnylam from the Max Planck Society,
which broadly covers methods of making siRNAs with or without chemical
modifications;
-- the Tuschl II '044 patent (EP 1407044), granted in January 2008 and
exclusively licensed to Alnylam from the Max Planck Society, which
broadly covers compositions, methods, and uses of siRNAs;
-- the Tuschl II patent (JP 4 095 895) granted in May 2008 in Japan and
exclusively licensed to Alnylam from the Max Planck Society, which
broadly covers compositions, methods, uses, and systems of siRNAs;
-- many divisional and continuing patent applications pending of the
aforementioned issued or granted patents and additional patent
applications pending, including patents and patent applications covering
inventions by Fire & Mello (U.S. Patent No. 6,506,559), Glover, Li &
Kirby, Pachuk, Tuschl, Hannon, Giordano, and Kay.
In addition to fundamental patents, Alnylam is the exclusive licensee in
the field of RNAi therapeutics for more than 150 issued chemistry
patents owned or controlled by Isis Pharmaceuticals broadly covering
chemical modifications, including motifs and patterns of modifications
of oligonucleotides, including RNAi therapeutics. These patents include:
-- phosphorothioate and 2'-O-methyl modifications of oligonucleotides
(Buhr, U.S. Patent No. 6,476,205);
-- 2'-Ribose modifications of oligonucleotides (Cook, U.S. Patent Nos.
5,670,633; 6,005,087; 6,531,584; and 7,138,517);
-- chemical conjugates of oligonucleotides (Manoharan, U.S. Patent No.
6,153,737); and,
-- "overhang," "blunt-end," and nucleotide pairing design motifs (Woppmann
et al., UK 2417727), which is owned by Alnylam.
In addition to fundamental and chemistry patents, Alnylam is also the
exclusive licensee in the field of RNAi therapeutics for certain
delivery patents, including those owned and controlled by Tekmira
Pharmaceuticals, Inc. covering delivery of oligonucleotides, including
RNAi therapeutics, with liposomal formulations. These patents include:
-- formulations of oligonucleotides, including siRNAs, in cationic
liposomes (Wheeler, U.S. Patent Nos. 5,976,567 and 6,815,432; and
Semple, U.S. Patent No. 6,858,225).
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 a wide range of disease areas, including liver cancers,
hypercholesterolemia, Huntington's disease, and TTR amyloidosis. 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 Medtronic, Novartis, Biogen Idec, Roche,
Takeda, and Kyowa Hakko. To reflect its outlook for key scientific,
clinical, and business initiatives, Alnylam established "RNAi 2010"
in January 2008 which includes the company's plan to significantly
expand the scope of delivery solutions for RNAi therapeutics, have four
or more programs in clinical development, and to form four or more new
major business collaborations, all by the end of 2010. Alnylam is a
joint owner of Regulus Therapeutics LLC, a joint venture focused on the
discovery, development, and commercialization of microRNA therapeutics.
Founded in 2002, Alnylam maintains headquarters in Cambridge,
Massachusetts. For more information, please visit http://www.alnylam.com.
Alnylam Forward-Looking Statement
Various statements in this release concerning Alnylam's future
expectations, plans and prospects, constitute forward-looking statements
for the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by these forward-looking statements as a
result of various important factors, various important factors,
including the company's ability to successfully prosecute, maintain and
enforce its patents, including the patents acquired from Nucleonics, as
well as those risks more fully discussed in the "Risk Factors" section
of its most recent quarterly report on Form 10-Q on file with the
Securities and Exchange Commission. In addition, any forward-looking
statements represent Alnylam's views only as of today and should not be
relied upon as representing its views as of any subsequent date. Alnylam
does not assume any obligation to update any forward-looking statements.
CONTACT: Alnylam Pharmaceuticals, Inc.
Cynthia Clayton (Investors), 617-551-8207
or
Yates Public Relations
Kathryn Morris (Media), 845-635-9828
Source: Alnylam Pharmaceuticals, Inc.