Alnylam Pharmaceutical ↔​↔s, Inc., the leading RNAi therapeutics co$∞mpany, today provided perspective on th§&↕e positive complete r​←esults from the ORION-11 Phase 3 study of≠<→→ inclisiran, an RNAi therapeutic in developmen≥≠t for the treatment of hypercholesterolemia.δ₽↔→ These results were presented earlier today by ¶ ∏πAlnylam’s partner The Medici‍δ↔nes Company and collaborators at the European So'βciety of Cardiology’s ESC ₽ Congress 2019 in Paris, France.“The ORIOσ←"N-11 results represent a landma¶→≠rk event for Alnylam and RNAi therapeutics. W>÷₹εith over 1,600 patients"<✘↓ enrolled, ORION-11 is the largest ever randomize✔♠♠♥d, double-blind, placebo-controlle↑±≤&d study of any RNA-based medicine. The results f©$rom the study demonstr®↑↓&ate significant efficacy for a dr↑÷Ω‌ug administered subcutaneously once e  very six months and a very encourag→'ing safety profile, with predominantly mi×≈ld and transient injection site reactionΩ₽₩>s as the only reported drug-related↕σΩ finding,” said John Maraga​&♥$nore, Ph.D., Chief E÷®xecutive Officer of Alnyl₩ am. “These results further su★₩&pport the safety of our RNAi therapeu₹←♠σtics platform and provid×←e the largest demonstration to date suggesting t←ε₩hat there is no systematic evidence for a platfo​"rm-specific safety signal. Consequentlyαπ♥₹, these results greatly strengthen ו'our conviction for the future potent♥↔ ial of RNAi therapeutics in large population $$ σdiseases. Moreover, the pharβ≤↑macology of RNAi therapeutics, as inf&​<requently administered medγ ✘•icines, creates what we believe ₽¶to be a very attractive profile for the t₹>€≤reatment of common diseases. Finally, assuming ≥©♥a positive regulatory review, the significant inφ≠™©clisiran royalties of up to 20 pe♠ ×★rcent will provide yeε ±t another source of relatively÷©✘< near-term revenues and ↔• will support Alnylam’s✔≠• transition toward a ♥★self-sustainable financial profile for cont©♠÷≠inued and future growth.”ORION-11 now becomes t☆$he third positive Phase 3 study for an RN‍≈ Ai therapeutic and the second in 2019 alone. ✘"φAssuming ORION-9 and -10 are similarly po☆₽sitive and following regulat‍£♣ory submissions and review, Alnylam expect'λs inclisiran could reach the ∑∏≤market around late 2020.A video of Dr.©φ≤ Maraganore commenting on the implications of ←φ¶↔the ORION-11 results can be viewed on t§ §he Company’s website, wwwΩ↕↓σ.alnylam.com.About Inclis$•$iranInclisiran, the first cholesterol-♣φ↑​lowering therapy in the↑γ RNAi therapeutics class, is an investigationa>±↕l therapy in Phase 3 clinical development to↕€ evaluate its ability to lΩ↓§☆ower low-density lipoprotein cholesterol ✔π ≥(also known as LDL-C) through twice∑¥σ-yearly dosing. Inclisiran harnesses the body’<₹s natural process of RNA interfe∏₩‍ rence to specifically prevent production of ♣&the PCSK9 protein in t♥♥×εhe liver which enhances ★☆¥ the liver’s ability to remove LDL £•-C from the bloodstream, thereby lΩ♠owering LDL-C levels. In Phase 2 studies, in♠ε♥clisiran provided clinically✔α significant LDL-C reductions greater than 50 p☆π§ercent in addition to the effects of st¥™∑atins and/or ezetimibe, and LDL-C reduct₽©ions were sustained ±¶throughout the six-month >€§©dosing interval. The s >afety and efficacy of incl≈✘♠isiran were evaluated in t↕$he ORION-11 Phase 3 study with positive∞σ results; these results have not been evalua≤¶✔ted by the FDA, the EMA or any ☆∑∞other health authority.♣↔ Inclisiran is not yet approved for uσγ✔se by the FDA or any other regula§↓'tory authority. In February 2013 Alnylam gra 'nted global rights under a liε✘↑'cense and collaboration ag→♠ ✔reement to The Medicines Company to dev↑☆elop, manufacture, and commerci♥≥וalize inclisiran.About RNAiRNAi (R₩®$↔NA interference) is a natural cellular pr£δ•ocess of gene silencing that repre↕ε sents one of the most promising ×←✘✘and rapidly advancing frontiers in bπ₩≤γiology and drug development today. Its d™↔↑§iscovery has been heralded as “≈≤δ∞a major scientific breakthro∑±ugh that happens once every decade or so≤♠,” and was recognized wi₩©th the award of the 20‍→₹₩06 Nobel Prize for Physiology¶♥δ₩ or Medicine. By harnessing the naturaΩ±$l biological process of RNAi occurring in our c★™★$ells, a new class of medicines, known as ®$RNAi therapeutics, is now a reality. Sm∑∏≥∑all interfering RNA (λΩεsiRNA), the molecules that mediate φ RNAi and comprise Alnylam's RN±•Ai therapeutic platform, function upstream o‌'f today’s medicines by potently silenci±≠ng messenger RNA (mRNA) – the genetic precursors ≥∑– that encode for disease-ca©↔using proteins, thus ₹ σpreventing them from being made. This"∏≥× is a revolutionary approach with the p‌≤&‍otential to transform th™¥e care of patients with genetic and other d₹®'"iseases.About Alnylam Pharmaceut‌≠icalsAlnylam is leading th≥εe translation of RNA interference (RNAi) int ¥ ​o a whole new class of inno©δλvative medicines with the potential to tran↔≤‌§sform the lives of people afflicted with rare ge$​↑&netic, cardio-metabolic≤≈π‍, hepatic infectious,↑• and central nervous system (CNS)/o©"λ©cular diseases. Based on Nobel Prize-winning ‍φscience, RNAi therapeutics represent a‌₩ powerful, clinically validated approach f♦€ >or the treatment of a wide¶☆™ range of severe and debilitating diseδ± >ases. Founded in 2002, Alnylam is d∏¶elivering on a bold vision to turn scientific po £✔ssibility into reality♦π, with a robust discovery platf×™δ"orm. Alnylam’s first commerc&∏♥&ial RNAi therapeutic is ONPATTRO® (p♠ atisiran) approved in the U.S.,↔" EU, Japan and Canada. Alnylam has a deep p¶βipeline of investigational $ε♥£medicines, including five product candidates tha≤£t are in late-stage development. Lo¶∑♦oking forward, Alnylam will con$≈∏→tinue to execute on its ​‍¶"Alnylam 2020" strategy of buildin≥☆&‍g a multi-product, commercial-stage bi✘♣δ≤opharmaceutical company with a sustainable↑♥≠ pipeline of RNAi-based m→<φedicines to address the™≠ needs of patients who have limited or©'₩ inadequate treatmentπ★♣ options. Alnylam employs over 1,2¥ α00 people worldwide and is headq<→₽uartered in Cambridge, MA. For more ♠↑↔ information about our people, science ™↑✔ and pipeline, please visit www.alnylam.com a↔"↑nd engage with us on Twitter at @Alnylam or β<♣on LinkedIn.Alnylam Forward Looking Statem≈★φ₩entsVarious statements in this release concerni•'↕ng Alnylam's future expectations, plans aγ↑÷₽nd prospects, including, wσ↔​ithout limitation, theλφ potential implications of the ORION-πΩ÷11 results for patients, Alnylam's views with r∏™​espect to the safety of ¥ δ≥RNAi therapeutics, its views rega≥©∑☆rding the future potential of RN₩¥Ai therapeutics in large pop‌÷ulation diseases, its expectations re™♦garding the timing of results to be reportedλ€ by The Medicines Company from the ORI$£←£ON-9 and ORION-10 studies of Ω "inclisiran and the regul‌α↕​atory review of an NDA for inclisiran, ↑×its expectations regard ‌↔ing the receipt of royalties from The Me↑¥₽≈dicines Company on sales of inclisiran, if•δ approved by regulatory authorities, its pl$>ans to achieve a self-sustainable financial p≈©§¶rofile for continued and future growth, ≥±and expectations regarding its “Alnylam 2<¶020” guidance for the advancement and commerci•™"alization of RNAi therapeutics, constitute forwa±<≈λrd-looking statements for the purpos↔®♣es of the safe harbor provisions under The Priv€•ate Securities Litigation Reform Act of 199↑≤"§5. Actual results and future plans may differ mat£ →erially from those indicate∏‍αd by these forward-looking statements§₹¥ as a result of various importan♦$∏δt risks, uncertainti∏≈es and other factors, including, withoutΩ₹§Ω limitation, Alnylam's ability to disco☆♣ver and develop novel drug caπ✔ndidates and delivery approaches, Alσ₹nylam’s and its partners’ abilit​★♣y to successfully demonstrate the efficacy a&↑ nd safety of its product candidate♥•εs, including inclisiran, the pre-clinical₩→ ™ and clinical results for its product candida∏ ₽<tes, which may not be replicat™ε≈♠ed or continue to occur in other subje  ε✘cts or in additional§  studies or otherwise support fur∞♥¶ther development of product ☆™candidates for a specified indica​∞±tion or at all, actions or advice of reg≥π&©ulatory agencies, which may affect ♦±£the design, initiation, timing,÷•≤ continuation and/or progress of clin♦↑ical trials or result in the need ↔×Ω"for additional pre-clinical and/or clinical ↑<testing, delays, interruption λ∞s or failures in the m &>anufacture and supply of its product cand←™idates, obtaining, maintaining and proγ↑γ→tecting intellectual property, Alnylam's abili‍☆♣ty to enforce its intellectual property ©♠rights against third parties and defend its pate$λnt portfolio against challenges from third parti&§es, Alnylam’s and its partners’ ability to ©¶£•obtain and maintain regulatory approval, pricing×₹∞φ and reimbursement for•÷ products, including★© inclisiran, progress in estaΩ"​‍blishing a commercial₩ ↓< and ex-United States infrastructure, ♥β↑successfully launching, marketing €♦ and selling its approved products÷  globally, Alnylam’s ability to successfully e®φεxpand the indication for ONPATTRO in the fut★σure, competition from others using technology si<✘milar to Alnylam's and•≤ others developing product≥ ±¥s for similar uses, Alnylam's abil∏↓↔δity to manage its growth and ∞←<operating expenses, obtain addit↓∞÷ional funding to support its business activit↕σ<↓ies, and establish and maintain strate₽™§gic business alliances and new bus∑♠iness initiatives, A‍↑<lnylam's dependence on th≤¶ird parties for development, manuf≈±✔acture and distribution of products, the≤♥δ✘ outcome of litigation, the risk of gove→$σrnment investigations, and ≥ unexpected expenditures, as well as t'♦↓♦hose risks more fully discussed in the “Risk Fact<≥ors” filed with Alnylam's mo$≥€±st recent Quarterly Repo↕βrt on Form 10-Q filed with the Se≈≤↔curities and Exchange Commiσ♣σssion (SEC) and in other filings that Alnyla☆♥m makes with the SEC. In addition, a≥≤λny forward-looking statements represent Alnyla≥≈±÷m's views only as of toda♦‍✔y and should not be relied upon as repre¥≤senting its views as o¥∞$₩f any subsequent date. Alnylam expl  icitly disclaims any obligation, except tε€o the extent required by law, to update any forwa★↑₩πrd-looking statements.the 2019 Asia-pacific ™'>≠pharma IP Leader Summit: http://en.zenseegroup≥'¶.com/p/404716/ will be held in B₩✘∏‌eijing  on November 14-15, and wil₹£l attract more than 500 industry expe$α¥rts from domestic and foreign ph<←armaceutical companies, biotechnology companies, ↓∞governments, associations, law firmsΩ‍, intellectual property agents and ≥<→®other companies to at‌₹×₩tend.Official registration and ±&±₩consultation channels:Contact：AnnPhon£↕"σe: 021-65650305Email：Marketing@zen®™©‍seegroup.comhttp://en.zenseegroup.com/p/51093β&÷¥4/