Alnylam Pharmaceuticals, Inc., the leading RNAi"↑< therapeutics company, tε₹oday provided perspectiv✔©≈e on the positive complete results from the OR∑​∏ION-11 Phase 3 study o₹​f inclisiran, an RNAi ther↔​apeutic in development for the ₽ treatment of hyperch₩εαolesterolemia. These results were presenteε→d earlier today by Alnylam’s p™¥artner The Medicines Company and collaborators at∞∑​ the European Society of Cardiolog₩‍✔y’s ESC Congress 2019 in Paris, Franc®Ω←e.“The ORION-11 results represeδ÷♣♣nt a landmark event for Alnylaαγm and RNAi therapeutics.₽≈♥δ With over 1,600 patients e☆ nrolled, ORION-11 is the largest ever ↕®randomized, double-blind, placebo-controlledπβγπ study of any RNA-based med✘≥₩icine. The results from the study demonstr←¶₹ate significant efficacy for a drug admφφinistered subcutaneous ★$®ly once every six months and a•↓ very encouraging safety profile, with predominan ↑tly mild and transient injection site r¶→eactions as the only reported drug-≈∑λ✔related finding,” said•↓ John Maraganore, Ph.D∑×‍., Chief Executive Officer of Alnylam. “These♦≤ results further support the safety of our RNA→×♥i therapeutics platform and prov∞§ide the largest demonstration to dat♠♣ <e suggesting that there is no systemati¥≥>£c evidence for a platform-specific safety si♠αgnal. Consequently, these©≥♥ results greatly strengthen ou↔↕​r conviction for the futur×≤§∞e potential of RNAi therapeut↕ α™ics in large population diseaπ¥≈ses. Moreover, the pharmacology of¶©€↕ RNAi therapeutics, as infrequently adminiε§&•stered medicines, creates‍‍ what we believe to be a very attractive profile ε≠σ₩for the treatment of common disease✔₹s. Finally, assuming a positive regulator>¥∞γy review, the significant inclisiran r§γ≥•oyalties of up to 20 percent will provide yet ↕γanother source of relatively n$ε≈ear-term revenues and will support Alnylam’s tΩ€γransition toward a se↔'±™lf-sustainable financial p♣εγ±rofile for continued and future growth∑¥.”ORION-11 now becomes thδπ☆e third positive Phase 3 study for a©>®αn RNAi therapeutic and σ∑ &the second in 2019 alone. Assuming ORION-9 aδ•'‌nd -10 are similarly positive a☆ ☆♦nd following regulatory submissions and review,> ¶β Alnylam expects inclisiran could reach the ma≥σrket around late 2020.A video of D∏>r. Maraganore commenting on t™"§he implications of the ORI₽π∏ON-11 results can be viewed on the Company’® s website, www.alnylam.com.Abo♦€✘®ut InclisiranInclisiran↔✘, the first cholesterol-lowering therapy ↕©in the RNAi therapeutics class, is α←> an investigational therapy in Phase 3 clinical σΩ©αdevelopment to evaluate its abili♦×₩ty to lower low-density lipoprotein cholesterol (↑γ↕also known as LDL-C) through twice-yearly do•÷sing. Inclisiran harnesses the body’s natural pε rocess of RNA interference to≤× specifically prevent production of the PCSK9 pr£©∑"otein in the liver which enh<™ ances the liver’s ability←$ ≈ to remove LDL-C from the bloodstream, the"£εreby lowering LDL-C level≤™s. In Phase 2 studies,  ←≥>inclisiran provided clini∞ '‌cally significant LDL-C reductio¥€↔ns greater than 50 percent in addition t♦λ$βo the effects of statins and/or ezet∏∏÷©imibe, and LDL-C reductio$∑±ns were sustained throughout the six-month dosin ₽←g interval. The safety an↕>®™d efficacy of inclisiran ☆β<were evaluated in the O§≤¥RION-11 Phase 3 study with positive results↑✔; these results have not been evaluated by the Fα★₹DA, the EMA or any other health authγ♥←♦ority. Inclisiran is not'β yet approved for us‍←e by the FDA or any other regula ↓δtory authority. In Fe¶•bruary 2013 Alnylam g¶§ranted global rights under a license↓γ‍ and collaboration agreement to The Medicin∑£÷es Company to develop, manufactβ✘ure, and commercialize inclisiran.About RNAiR₽≤ NAi (RNA interference) is a natural €α cellular process of gene silencing that reφ$₩←presents one of the most promising and r×Ω∑βapidly advancing frontiers in biβ$←>ology and drug develo✔¥pment today. Its dis δcovery has been heralded as “a major scienφ↑≤tific breakthrough that happen♠♠s once every decade or so,” a¥¶δεnd was recognized with the award o✔$™♥f the 2006 Nobel Prize for Physio♠★∑¶logy or Medicine. By harnes×☆↔©sing the natural biological process of §>σ€RNAi occurring in our cell≠>₩s, a new class of medicines, k✔‌nown as RNAi therapeutics, is≠¶Ω now a reality. Small $γ✘βinterfering RNA (siRNA), the molecules that medi♥®ate RNAi and comprise Alnylam's RN‍​≤Ai therapeutic platform, function upstream of t×>∞oday’s medicines by po≠₩₽tently silencing messenger RNA (mRNA)↕Ω☆ – the genetic precursors – that δπ♦Ωencode for disease-causing proteins,¶©₹ thus preventing them£∞♥ from being made. This£₹↔♠ is a revolutionary approach witδ÷‌h the potential to transform the care of patien‌'ts with genetic and other d>↓iseases.About Alnylam Pharmaceutica÷‍↓lsAlnylam is leading the transl‌♣ation of RNA interference®™ (RNAi) into a whole new class of innovative ≤↔€medicines with the potential to tr≤∞ansform the lives of peo≤∑ple afflicted with rare genetic, cardiΩ<o-metabolic, hepatic in÷α>€fectious, and central nervous system (β&÷↑CNS)/ocular diseases. Based on Noᣕbel Prize-winning sciλ₩♠Ωence, RNAi therapeutics represent a powerfu♣≤l, clinically validated approach'δ™± for the treatment of a wide range of severe and¥↑ debilitating diseases. Founded ©★♣→in 2002, Alnylam is delivering on✔'↕¥ a bold vision to turn s∑ "cientific possibility into reality, wiφ↔th a robust discovery platform. Alnylσ•am’s first commercial RNAi therapeutic is ONPATT​€ RO® (patisiran) approved in the U.S¥βδ., EU, Japan and Canada. Al✔±€₽nylam has a deep pip✔σeline of investigatio↕•♠nal medicines, including five p✘≈roduct candidates that are in late-stage developγ‍β<ment. Looking forward, Alnylam will continue to e÷↔xecute on its "Alnylam 2020" strateg&±y of building a multi-product, commerci₩  al-stage biopharmaceutical company with a sus↔$ tainable pipeline of¥♠ RNAi-based medicines φ ≈to address the needs of patients who have lim☆≈≤§ited or inadequate treatment opt ≥∏ions. Alnylam employs over 1,"¶"200 people worldwide and is headquartered in •™"Cambridge, MA. For mor≤≥e information about our peop↔>©le, science and pipel£π¶↕ine, please visit www.alnylam.com and eng✔>ε≈age with us on Twitter at γ✘@Alnylam or on LinkedIn.Alnylam Fo ✘rward Looking StatementsVar↓'×εious statements in this release c♣ ∞oncerning Alnylam's future expectations, p§≠lans and prospects, including, without limα✘≠¥itation, the potential implications of the ORION-§¥∞11 results for patients, Alnylam's views withε↓ respect to the safety of RNAi therapeutics≠¶σ, its views regarding the ‌£future potential of RNAi therap‌✔eutics in large population diseases, i> 'ts expectations regarding the timing of♠λ•α results to be reported by The Medic ≈ines Company from the ORION-9 and ORION-1☆‌↓$0 studies of inclisiran and the r​§egulatory review of an NDA fo∞↓r inclisiran, its expectations "™ regarding the recei$£λpt of royalties from The Medicines α&¥εCompany on sales of inclisiran, if app&↕∑roved by regulatory authorities, i☆↑∑ts plans to achieve a selλ>εf-sustainable financial profile‍×↔ for continued and future growth,§¶φ and expectations regarding its ™λ✔“Alnylam 2020” guidance for the advanc↔≠≥ement and commercialization of RNAi therap✔©eutics, constitute forward-looking statements€₽ for the purposes of the safe harbor ≥€< provisions under The P±∞rivate Securities Litigation Reform Act ™±of 1995. Actual results and future plans may ¶♣¥§differ materially from those indicated by tβλ‌≤hese forward-looking∑  statements as a result of various im™"∏portant risks, uncertainties ✔ ®and other factors, including, without l•✘♦imitation, Alnylam's abi$±>lity to discover and develop novel drug candida↕•↓←tes and delivery approa π&ches, Alnylam’s and  ♥>•its partners’ ability ≥ ‍δto successfully demonstrat λσe the efficacy and safety of its product can®αdidates, including inclisiran, the pre-c​↕♣linical and clinical results for its product can♥• didates, which may not be replicated or®↓ε continue to occur in other subjects or in addit♣♥€÷ional studies or otherwise support further dev↑§×αelopment of product candidates f‌←©αor a specified indication or ♥ at all, actions or advice o ↓f regulatory agencies, which may affect the d♠↑₹esign, initiation, timi×φ★φng, continuation and/or  π↕→progress of clinical trials or resul &¶t in the need for additional pre-clinical and/∞↕πor clinical testing, delays, i♣↑✔nterruptions or failures in the manufactur←≥★♦e and supply of its product candidates, obt✔♣aining, maintaining and protecting intellectual pδ♠☆roperty, Alnylam's ab∞¥δility to enforce its intellectual pro↑α≠‌perty rights against t$≈★✘hird parties and defend its ₩®→​patent portfolio against challenges from thε¶₹ird parties, Alnylam’≠✘s and its partners’ ability to obtainδσ♦← and maintain regulatory approval, pricing andδ> reimbursement for products, including inclisir←★an, progress in establ₹>ishing a commercial anλ∞d ex-United States infrastructure, successfu εγlly launching, marketing and selling its approved→∏≤ products globally, Alnylam’s ability to successf≈☆∑ully expand the indication for ONPATTRO ‍₩↕↑in the future, compet •β↕ition from others using &©£®technology similar to$∑ ✔ Alnylam's and others developing products for §×₩'similar uses, Alnylam's a§×αbility to manage its grβ©★δowth and operating expenses, obtain addit∏&ional funding to support its→∏ business activities, and establ$±♦ish and maintain strategic ↕₽business alliances and new business≠→$™ initiatives, Alnylam's dependence on third parti≥↕es for development, manufact‌↓&§ure and distribution of p≤↑Ωroducts, the outcome of litigation, t≥✔♥he risk of government investigati♥¶ ←ons, and unexpected expenditures, ​₽ as well as those risks ☆←βmore fully discussed in the “Risk Factors”€α™ filed with Alnylam's most recent Quarterly Repo‌λrt on Form 10-Q filed with the Securiti>∞★es and Exchange Commission δ¥↕™(SEC) and in other filings th≠↕±at Alnylam makes with the SEC. In addition, anyδγ" forward-looking statemen>§Ωts represent Alnylam's views only as of today and¶Ω should not be relied upon as repr↕₹∞esenting its views aφ‌&s of any subsequent date. Alnylam" ≠ explicitly disclaims any oblig®↓‍ation, except to the exten∞∑γt required by law, to update any f♦₩"​orward-looking statements.the 2019 As≈ ∞ia-pacific pharma IP Leader Summit: htt♠↓p://en.zenseegroup.c¶δom/p/404716/ will be he™£∑δld in Beijing  on&n∞✘↑♥bsp;November 14-15, ↑"and will attract more× γ than 500 industry experts from domestic ∑>☆δand foreign pharmaceutical comp♦ anies, biotechnology comλ‍"panies, governments, associati±↑∏ons, law firms, intellectual pr↕Ωoperty agents and other co≤£✔mpanies to attend.Official registratio←♠<n and consultation channels:Contact：A∞$↑&nnPhone: 021-65650305E∑↓÷↑mail：Marketing@zenseegroup.∏α₽♥comhttp://en.zenseegroup.com/p/510934/