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TMCNet:  Alnylam Announces United States Patent and Trademark Office (USPTO) Issues Patent Covering RNAi Therapeutics for the Treatment of Hepatitis B Virus (HBV) Infection

[June 12, 2014]

Alnylam Announces United States Patent and Trademark Office (USPTO) Issues Patent Covering RNAi Therapeutics for the Treatment of Hepatitis B Virus (HBV) Infection

CAMBRIDGE, Mass. --(Business Wire)--

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has issued a new patent (U.S. patent no. 8,618,277, or "'277 patent") in the company's McSwiggen patent estate. The McSwiggen patent estate broadly describes chemical modifications of RNAi therapeutics needed to achieve "drug-like" properties in siRNA, the molecules that mediate RNAi. Specifically, the '277 patent includes claims that the company believes are critical for the development of RNAi therapeutics for the treatment of hepatitis B virus (HBV) infection. This patent is held exclusively by Alnylam and is not licensed to any third parties. The McSwiggen patent estate comprises a core component of Alnylam's overall intellectual property (IP) estate for the advancement of RNAi therapeutics, and was recently obtained through the company's acquisition of Sirna Therapeutics from Merck.

"We are pleased with the USPTO's decision to issue the '277 patent from our McSwiggen patent family, a key component of the IP estate we recently obtained through our acquisition of Sirna Therapeutics from Merck. Our '277 patent has broad, sequence-independent claims on chemically modified siRNAs which we believe are critical for the development and commercialization of RNAi therapeutics for the treatment of HBV infection," said Laurence Reid, Ph.D., Senior Vice President and Chief Business Officer of Alnylam. "Our IP estate remains a cornerstone in our efforts to advance RNAi therapeutics to patients in need. In the case of the '277 patent, we intend to maximize the value of this newly issued IP solely through the advancement of ALN-HBV - our GalNAc-conjugated siRNA targeting the HBV genome for the treatment of HBV infection - where we expect to select our Development Candidate by this year's end and to file an investigational new drug application at or around year-end 2015."

The McSwiggen patent family includes 23 granted patents around the world, including patents in the U.S.1 and the EU2, and generally describes chemical modifications of siRNA. The '277 patent includes broad, sequence-independent issued claims on compositions of chemically modified siRNA targeting HBV, including:

  • siRNA that mediates RNAi against a hepatitis B virus target mRNA wherein each strand is between 18 to 24 nucleotides; and
  • sense and antisense strand each comprising 10 or more 2'-deoxy, 2-O-Me, 2'-F or universal base modified nucleotides and 10 or more pyrimidines of the sense and/or antisense strand are 2'-deoxy, 2-O-Me, 2'-F.

Such chemical modifications of siRNA are generally required to achieve in vivo potency and durability for RNAi therapeutics. Additional HBV-directed claims for the McSwiggen patent family are pending in filed patent applications.

Granted claims of the '277 patent, as well as other granted Alnylam owned or licensed patents, are provided on the company's website, and in aggregate broadly cover siRNA and their use in a wide range of lengths from 15 to 49 nucleotides, and chemical modifications with naturally or non-naturally occurring nucleotides, including, for example acyclic nucleotides such as those termed "unlocked nucleobase analogs." In addition, Alnylam's owned or licensed patents broadly cover delivery of RNAi therapeutics, including those that employ GlNAc-siRNA conjugate technology. Finally, Alnylam's IP estate also includes patents that broadly cover siRNA toward a wide range of disease targets.

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 2006 Nobel (News - Alert) Prize for Physiology or Medicine. 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. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, target the cause of diseases by potently silencing specific 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 leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics as genetic medicines, including programs as part of the company's "Alnylam 5x15TM" product strategy. Alnylam's genetic medicine programs are RNAi therapeutics directed toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. These include: patisiran (ALN-TTR02), an intravenously delivered RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR) in patients with familial amyloidotic polyneuropathy (FAP); ALN-TTRsc, a subcutaneously delivered RNAi therapeutic targeting TTR for the treatment of ATTR in patients with TTR cardiac amyloidosis, including familial amyloidotic cardiomyopathy (FAC) and senile systemic amyloidosis (SSA); ALN-AT3, an RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD); ALN-CC5, an RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases; ALN-AS1, an RNAi therapeutic targeting aminolevulinic acid synthase-1 (ALAS-1) for the treatment of hepatic porphyrias including acute intermittent porphyria (AIP); ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia; ALN-AAT, an RNAi therapeutic targeting alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency-associated liver disease; ALN-TMP, an RNAi therapeutic targeting TMPRSS6 for the treatment of beta-thalassemia and iron-overload disorders; ALN-ANG, an RNAi therapeutic targeting angiopoietin-like 3 (ANGPTL3) for the treatment of genetic forms of mixed hyperlipidemia and severe hypertriglyceridemia; ALN-AC3, an RNAi therapeutic targeting apolipoprotein C-III (apoCIII) for the treatment of hypertriglyceridemia; and other programs yet to be disclosed. As part of its "Alnylam 5x15" strategy, as updated in early 2014, the company expects to have six to seven genetic medicine product candidates in clinical development - including at least two programs in Phase 3 and five to six programs with human proof of concept - by the end of 2015. Alnylam is also developing ALN-HBV, an RNAi therapeutic targeting the hepatitis B virus (HBV) genome for the treatment of HBV infection. The company's demonstrated commitment to RNAi therapeutics has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis, Monsanto, The Medicines Company, and Genzyme, a Sanofi company. In March 2014, Alnylam acquired Sirna Therapeutics, a wholly owned subsidiary of Merck. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 200 peer-reviewed papers, including many in the world's top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, Cell, the New England Journal of Medicine, and The Lancet. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.

Alnylam Forward-Looking Statements

Various statements in this release concerning Alnylam's future expectations, plans and prospects, including without limitation, Alnylam's views with respect to the potential for RNAi therapeutics, including ALN-HBV for the treatment of HBV infection, its expectations with respect to the selection of a Development Candidate and the timing of regulatory filings to initiate a clinical trial for ALN-HBV, its expectations regarding its "Alnylam 5x15" product strategy, its plans regarding commercialization of RNAi therapeutics, including ALN-HBV, and its views with regard to the scope of its IP estate, 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, including, without limitation, Alnylam's ability to manage operating expenses, Alnylam's ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam's and others developing products for similar uses, Alnylam's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam's dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC (News - Alert)) and in other filings that Alnylam makes with the SEC. 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 explicitly disclaims any obligation to update any forward-looking statements.

1 Issued U.S. patents in the McSwiggen patent family include U.S. Patent Nos: 7,923,547; 7,956,176; 7,989,612; 8,202,979; 8,232,383; 8,236,944; 8,242,257; 8,268,986; 8,273,866; 8,507,661; 8,618,277.

2 Granted EU patents in the McSwiggen patent family include EU Patent Nos: 1423406; 1458741; 1627061; 2278004; 2287306.


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