Older men who receive pneumococcal vaccine not less likely to have heart attack, stroke: JAMA

April 19, 2016

Business Execution Highlights

Completed Key Technology Transfer Objectives with Takeda Alliance and Earned $20 Million Payment. Alnylam earned a $20 million technology transfer payment from Takeda as part of the strategic alliance the companies formed in May 2008. This payment is related to the achievement of certain pre-defined objectives in the transfer of Alnylam's platform technology, including documents, materials, and know-how, to Takeda for the development of RNAi therapeutics. Alnylam has now received $140 million in upfront and technology transfer payments from Takeda, and is eligible to receive an additional $10 million in technology transfer payments in 2011 in addition to future milestones, royalties, and product rights on RNAi therapeutic products developed by Takeda. Novartis Purchased Additional Shares of Alnylam Common Stock. In accordance with the terms of the 2005 Investor Rights Agreement between Alnylam and Novartis, Novartis elected to fully exercise its right to purchase 55,223 unregistered shares of Alnylam's common stock at a purchase price of $17.99 per share for total proceeds to Alnylam of approximately $1 million. Advanced 2007 Alliance with Roche. Alnylam announced that it had received a milestone payment from Roche related to the initiation of pre-IND studies for an RNAi therapeutic product candidate. Regulus Formed New Collaboration with GlaxoSmithKline (GSK). Regulus formed a new collaboration with GSK to develop and commercialize microRNA therapeutics targeting miR-122 in all fields with HCV infection as the lead indication. The new HCV collaboration includes the potential for more than $150 million in upfront and milestone payments, in addition to royalties on worldwide sales, to Regulus. Regulus and GSK aim to advance anti-miR-122 toward the clinic in 2011.

Intellectual Property (IP) Highlights

Expanded Patent Pool for Neglected Tropical Diseases (NTDs). Massachusetts Institute of Technology (MIT) and Technology Innovation Agency (TIA) have joined GSK and Alnylam in the Pool for Open Innovation against Neglected Tropical Diseases established in 2009 to aid in the discovery and development of new medicines for the treatment of NTDs in the world's least developed countries. BIO Ventures for Global Health (BVGH) was chosen to administer the patent pool. Advanced Alnylam's IP Estate with Continued Dominant Position. Alnylam made significant progress in advancing its IP estate for RNAi therapeutics, including:-- a new patent grant (JP Application No. 2006-317758) from the Japanese Patent Office in the Tuschl II patent series covering compositions, methods, uses, and systems for double-stranded RNAs;-- an allowance by the Korean Patent Office for the Tuschl II patent (Application No. 2008-701158);-- a successful outcome in German opposition proceedings for the Kreutzer-Limmer I '235 (DE 10066235) patent;-- an intent to grant notification from the European Patent Office for the Manoharan II patent (EP Application No. 04 718 537) covering compositions and methods, including pharmaceutical compositions, for chemically modified siRNAs with phosphorothioate and 2'-O-alkyl modifications;-- an allowance by the United States Patent Office (USPTO) of a patent in the "Woppmann et al." patent series (Application No. 10/560,336) that covers compositions and methods, including pharmaceutical compositions, for siRNAs; and,-- an allowance by the USPTO of a patent in the "Soutschek and Manoharan" patent family (Application No. 10/916,185), covering chemically modified siRNAs with "drug-like" properties for in vivo delivery.

In addition, significant progress was also made in the Regulus IP estate related to microRNA therapeutics, including:

-- a new grant from the Japanese Patent Office for a patent (JP 4371812) from the Tuschl III patent series pertaining to the discovery of mammalian microRNAs; and,-- an allowance from the USPTO of a new patent (Application No. 11/977,506) owned by Stanford University and licensed exclusively to Regulus, covering methods of antagonizing miR-181a to regulate immune response.

Announced Additional New Patents Issued or Granted Today. Alnylam announced today the issuance or grant of the following new patents owned, controlled, or licensed by Alnylam in the RNAi therapeutics field, including:-- an allowance from the USPTO of a new patent (Application No. 12/495,932) covering any microRNA of 17 to 25 nucleotides having at least one universal base;-- an allowance by the USPTO of a new chemistry-related patent (Application No. 10/561,324); and,-- multiple allowances of new target-related patents by the USPTO (Application Nos. 11/750,553, 11/477,028, 11/857,120 and 11/491,367), the South Africa Patent Office (Application No. 2007/03241), and the New Zealand Patent Office (Application No. 572403). Provided Update on Ongoing Litigation Regarding Tuschl I Patent Series. Alnylam and Max Planck asked the Court to dismiss MIT from any claims for monetary damages in the ongoing litigation related to the Tuschl I patent series. As part of the request for dismissal, MIT has stipulated that it will be bound by any declaratory, injunctive, or equitable relief to the extent that the Court may ultimately award such relief against the Whitehead Institute for Biomedical Research or the University of Massachusetts.

Organizational Highlights

Selected as One of 50 Most Innovative Companies in the World by MIT's Technology Review. Alnylam was selected as one of the 50 most innovative companies in the world by MIT's Technology Review, an annual recognition given to companies across several industries who have demonstrated the most impressive innovation in commercializing new technologies. Named to The Scientist Magazine's 2010 Best Places to Work in Industry. Alnylam was named one of the Best Places to Work in Industry by The Scientist magazine, ranking 8th on the Top 10 Small Companies list, and 12th overall.

Source: Alnylam Pharmaceuticals, Inc.