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- Alnylam Pharmaceuticals Provides Pe ±rspective on Positive Complete Results fr©$om ORION-11 Phase 3 Study→←β of Inclisiran
Alnylam Pharmaceuticals, Inc., th♦✘€e leading RNAi therapeutics c₹☆ompany, today provided €←perspective on the positive complete res→¶©×ults from the ORION-11 Ph≤≈∞ase 3 study of inclisiran, an RNAi t §Ω♣herapeutic in development for the•∑ treatment of hypercholesterolemia. These res↔π≠ults were presented ea€₩♣φrlier today by Alnylam’s partn ↑♦er The Medicines Company an♠♥±¥d collaborators at the European S♦≤ociety of Cardiology’s ESC Congress 2019 in Pari₩§€₽s, France.
“The ORION-11 results represent a landmark ±↑event for Alnylam and RNAi therapeutics. ±δWith over 1,600 patients e☆¥nrolled, ORION-11 is the largest ever randomεπized, double-blind, placebo-controlled study of₽€←₩ any RNA-based medicine. The results f↔≈rom the study demonstrate significant effic"♠acy for a drug administered±™φ subcutaneously once¥∞ every six months and a very encouragin g safety profile, with predominantl••✔y mild and transient injection sit★'e reactions as the only reported drug-∞ ♣related finding,” said Joh$αn Maraganore, Ph.D., Chief Executive Officer o☆↔f Alnylam. “These results furthe∏∑£δr support the safety of our RNAi therapeutics•₽α platform and provide the largest demonstratio≠♠n to date suggesting that<γ£ there is no systematic evidence fo÷♦₹r a platform-specific safety s•≈ignal. Consequently, these results greatly stren Ωgthen our conviction for the future₽☆Ω potential of RNAi thera peutics in large populat"★☆ion diseases. Moreover, the phaφΩ∑rmacology of RNAi therapeutics, as i♠nfrequently administered medicines, c<≈reates what we believe to be a very att ©≠>ractive profile for the treatment of common≤✘≤ diseases. Finally, assum™$ing a positive regulatory rev€×€iew, the significant inclisiran royalties of®≠↓$ up to 20 percent will provide ®αγσyet another source of relatively near-t€♣>erm revenues and will®$ support Alnylam’s transition toward a self-s$↔♥ustainable financial profile for↕♥®Ω continued and future growth.”
ORION-11 now becomes the ★™→σthird positive Phase 3 study for an RNAi ↓₩•therapeutic and the second in 2019 alone. A♣∞♦ssuming ORION-9 and -10 are ×similarly positive and followi♣$ng regulatory submissions and review, Alnyl↔✔∑am expects inclisiran co✘ ÷uld reach the market around late 2020.
A video of Dr. Maraganore commen± ↕ting on the implications of the ORION-1÷≥$1 results can be vieσ₩↕↓wed on the Company’s website, www.al¶✘nylam.com.
About Inclisiran
Inclisiran, the first cholesterol-lowering tΩΩherapy in the RNAi therapeutics←✘ class, is an investigaσ∑÷tional therapy in Phase 3 clinical developmen&↓t to evaluate its ability to lΩ ≠ower low-density lipoprotein cholesteroγ✔×☆l (also known as LDL-C) throug$φσ≠h twice-yearly dosing. Inclisiran harn±σesses the body’s natural pr✔↓ocess of RNA interference"☆ to specifically prevent production of the PC∞←πSK9 protein in the liver which©$≤Ω enhances the liver’s aσ↔∞bility to remove LDL-C f♥γrom the bloodstream, thereby lowering LDL-C level ∑s. In Phase 2 studies, inclisiran provided c¥♦linically significant LDL-C reductions©♠ greater than 50 percent in additi→≤λ₹on to the effects of statins and/or'₩ ezetimibe, and LDL-C reductions werαγ£e sustained throughout the>₹ six-month dosing inte♠← rval. The safety and efficacy of inclisiran were β&δ≠evaluated in the ORI☆↓∏ON-11 Phase 3 study with pδεositive results; these results have not↔∏☆ been evaluated by the FDA, the EMA or ®¥♦λany other health authority. Inclisiβφran is not yet approved for use by the FDA or an&y other regulatory authority. In February 20λ≠€13 Alnylam granted global rights under a licens™↓e and collaboration a¶>greement to The Medicines Compβ←any to develop, manufacture, and commercializ↔∏♦e inclisiran.
About RNAi
RNAi (RNA interferen♦δα'ce) is a natural cellular process of gen ✔♣e silencing that represen&€↕↑ts one of the most promising and ra" φpidly advancing frontiers in biology and d♦♦rug development today. Its ↓€discovery has been heralded as “a major s♠₽÷¥cientific breakthrough that happens once every ±∑£decade or so,” and was recognized wi•₹©φth the award of the 2006 Nobel Prize f↔<"or Physiology or Medicine. By harnessin¶• g the natural biological process of RNAi occαφ∏☆urring in our cells, a new class of medicines™ , known as RNAi therapeutics, is ♦ε®now a reality. Small iα↓✔∑nterfering RNA (siRNA), the molecules that ¶↑∏♦mediate RNAi and comprise Aln•€ylam's RNAi therapeutic plat©εform, function upstream of today’s medicinε↑©&es by potently silencing me₹"≥✘ssenger RNA (mRNA) – the genetic precursors – t✔✘≤hat encode for disease-causing proteins,✔≥ thus preventing them fro♠∞≤♣m being made. This is a revolutionary approach ✔with the potential to transform the care€>♠ of patients with ge∞≤>εnetic and other diseases.
About Alnylam Pharmac₹↓euticals
Alnylam is leading the translatio♥×>★n of RNA interference (RNεα∞Ai) into a whole new class of inno♣•vative medicines with the potential to trans ∏↓form the lives of people afflicted with rare≈≥™≥ genetic, cardio-metabolic, hepatic infectiou→♠φ¶s, and central nervous system (CNS)/ocular dis××eases. Based on Nobel Prize-winn±§≈ing science, RNAi therape "utics represent a powerful←δ, clinically validated approach π&≠≤for the treatment of a wide$≈' range of severe and debilitatingφ✔₹→ diseases. Founded in 2002, Alnylam is dβ∞ elivering on a bold vision to turn s≤$cientific possibility into reality, with a 'robust discovery platform. Al¶✔≥♠nylam’s first commercial RNAi §♠ πtherapeutic is ONPATTRO£α® (patisiran) approved in the U.S., E×Ω±U, Japan and Canada. Alnylam has a d✔ ¶eep pipeline of investigationa≈¶γl medicines, including five product candidates that> are in late-stage development. Looking forwardδ≤, Alnylam will continue to execute oγ™±n its "Alnylam 2020" strategy of building aγ±γ± multi-product, commercial-stage biopha•↔£rmaceutical company with a sustainable₹♥ ™ pipeline of RNAi-based medicines to ad♠>₽≥dress the needs of pφ↔<atients who have lim÷>★ited or inadequate treatment options. Alnylam ±¥βemploys over 1,200 people worldwide a§&₹nd is headquartered in Cambridge, MA. For more $₹information about our people, scienc₩© e and pipeline, please visit www.a₹ ₩ lnylam.com and engage with us on Twittδ¶☆ er at @Alnylam or on LinkedInφ↕∞★.
Alnylam Forward Looking Statements
Various statements in this r★₽§elease concerning Alnyl≤am's future expectations, plans an♣₹πd prospects, including, without limitation, the potential implications of the ™→ORION-11 results for patients, Alnylam'' →↑s views with respect to the safety♦÷←¶ of RNAi therapeutics, its views regarding the fφ♥>$uture potential of RαNAi therapeutics in large populatioσ≤αn diseases, its expectations re&↔garding the timing of results to be reporte✘★€♣d by The Medicines Company from th<∏≠e ORION-9 and ORION-10 st φ≈udies of inclisiran and the ∏regulatory review of an☆£ NDA for inclisiran, its expectati₹©ons regarding the receipt of ro↕×♠yalties from The Medicines Comp>☆any on sales of inclisiran, if approvedσ÷ by regulatory authorπ€ities, its plans to achieve a self-su↔ε₽stainable financial pr₽∑ofile for continued and future growth, and≥± ∏ expectations regarding its “Alnylam 2020” guidance for the advancement an₽φ∞×d commercialization of RNAi the®ε↑♥rapeutics, constitute forward-looking statem¶≥εents for the purposes of the saf£ ∏e harbor provisions →∞≤under The Private Securities Litig≤±ation Reform Act of 1995. Actual results and<←•ε future plans may diffe<₹r materially from th☆λ♠ose indicated by these forward-looking statements↔π as a result of various important risks, uncerta✘> inties and other factors, including, wit ♦hout limitation, Alnylam's ability to discover ∏€¥and develop novel drug ca≥∞£♦ndidates and delivery approa¥Ωches, Alnylam’s and its partners’ abi×σ←lity to successfully demonstrate theδα efficacy and safety of its produc★επ★t candidates, including™₩§ inclisiran, the pre-cl€∏←inical and clinical results for its product candiβ$πdates, which may not be replicated or co∞ ntinue to occur in other subjects or i∏₩n additional studies or otherwis↕≈✘e support further development of product cand βidates for a specified indication or at׶ all, actions or advice of regulatory agenciesγ¶, which may affect th →©≠e design, initiation, timing, conπ₽£∏tinuation and/or progress≥§β of clinical trials →≥÷or result in the need for additional pre-clinicaεβ'l and/or clinical test≈±¥ing, delays, interruptions or faiβ•lures in the manufacture and supply of its >product candidates, obtaining, maintaining and pr ✘otecting intellectual property, Alnyla'↕$m's ability to enforce its intelδ®↑∏lectual property rights against third parties anφ₹₽£d defend its patent portfolio agains♥<t challenges from third$σ♥♠ parties, Alnylam’s and its partners’ abil∑≥ity to obtain and maintain regul±¶•♦atory approval, pricing and rei'∏mbursement for products, including inφ↕εclisiran, progress in establ✘π↕±ishing a commercial and ex-United States i✔≈nfrastructure, successfully launching, marketΩ€≠©ing and selling its approved produc©• ts globally, Alnylam’s ability to ₽♥≈ successfully expand the i±ε✔ndication for ONPATTRO in the future, α&competition from others using technology simi✘®↓lar to Alnylam's and others devel↔¥ oping products for similar uses, Aln∏≠"σylam's ability to manage its growth and op∞σ erating expenses, obtain additional fundα☆≥ing to support its business activities, and eβ♣™stablish and maintain strategic business all≠ ©iances and new business initiatives, Al≥ε✘&nylam's dependence on third parties for devel±λopment, manufacture and distribution of₹♣§™ products, the outcome of litigatiδ¶< on, the risk of governmen→™t investigations, and unexpected expenditures, a®β's well as those risks m♣•ore fully discussed in the “Risk Factors” λ♠ φfiled with Alnylam's most ™★recent Quarterly Report on Form 10-Q filed with εσthe Securities and Exchange Commission (SEC) and εβin other filings that ×σAlnylam makes with the SEC. In aδ'ddition, any forward-looking stateαβments represent Alnylam's views only₽λ₩ as of today and should ☆≤$πnot be relied upon as representing its views as ↔ of any subsequent dat∑™e. Alnylam explicitly disclaims ₹¶any obligation, except to the extent required ☆∞→•by law, to update any fo•∞₽rward-looking statements.
the 2019 Asia-pacific pharma IP Leader Summ₽φ←φit: http://en.zenseegroup.≤ε com/p/404716/ will be held in Beijing on November 14-15, and will attract more than ¶≈≥500 industry experts →©γfrom domestic and foreign phar↑£↑φmaceutical companies, biotechnol §ogy companies, governments, associations, la¶₩→w firms, intellectual prop€§erty agents and other companies to± attend.
Official registration and consultation channels:
Contact：Ann
Phone: 021-65650305
From :businessinsuranceU.S. commercial proper >≤ty/casualty rates rose 5% on average in t♠₽∑he fourth quarter of 2019, up from 4%→↕ in the third quarter, reflecting iπ€$✘nsurers’ intent to cΩπ¥ontinue to increase prices across most♦™ lines, online insurance exchange Marγ≈ketScout Corp. said Monday.“Auto raγ&te increases have been up all year→ long; however D&O (d<∑irectors & officers) and pro™fessional rate increases have↕φ$ spiked significantly in the fouα★$rth quarter,” Richard Kerr, CEO o ♥±×f MarketScout Corp. sai d in a statement.Insurers are carefully ana"βlyzing their property exposures using cataε ✔Ωstrophe modeling tools, he said. “We expect m≤"↓any of the major property ∏♠catastrophe insurers to c♥™←urtail their 2020 writi₹♠ngs in California bru÷∑₽sh and East and Gulf Co↔↔ast wind areas. Naturally, this will result in ±←♣$higher rates to insureds,” Mr. Kerr said.₩÷♣D&O liability rates increased by 8.25%, whi ™©le commercial auto increase→•d 8% in the quarter, and professional l≈★π₽iability rates were up 6%, and umbrella/exce↑≥• ss rates were up 5.5%, according to Ma✔≤∑rketScout.Commercial property rate±↕βσs increased 5.25% in the quarter™♦ ×, and business interruption raβ"≠tes were up 5%, while all other lines showed↕¶✘✘ smaller increases, except for workers compensat☆ε<ion, where rates fell 1←≤ε%, MarketScout said.By industry class, ≈♠transportation and hab ↔itational saw the highest averag≤↕e rate increases at 9% and 8.25% §®respectively, MarketS✘¥λcout said.Large accounts – those wit♠✘↓↑h $250,001 to $1 million in premium – saw a rφφσ©ate hike of 5.5% in th♦$γΩe fourth quarter, as did jumbo ac××counts, which have more than $1 mi$φllion in premium. Small $&accounts – those with up to $25,000 inΩ↓δ premium – were up 5±←%, while medium accounts – those with $25,00ε↔÷1 to $250,000 in premium – were up 4.€¶λ5%.The “steady trend” of upwa±Ω€ rd rates reflects insurers’ ↓€λplans to continue increasing prices acro≤σ ↔ss all lines except for wo $rkers compensation, MarketScout said.φ↓✔Organizer：China Insurance Digital &&↓♠≤amp; AI Development 2020Web:http://en.zenseegroup♦.com/p/560573/Contact:Ann≥₩÷ 021-65650305
From :insurancejournalIt wa☆¶®s a relatively quiet year for the Southeast in δ€←terms of major catastrophγ≤÷es compared with 2018 when Hurricane’s Michael anα∏d Florence caused major damage in t<©αhe region. This year, Hurricane Dorian λ>$<sideswiped the Southeast coast ☆;and made landfall on the Outer Banks of Nλ₩"εorth Carolina but most of t∏₹'↔he area was spared. Still, Aon said economi≥βc damage in the U.S. and Canada §γ;was poised to approach a c×$•↕ombined $1.5 billion.Florida spent the ye∑↔ar recovering from Hurricane ∏βMichael, which was upgraded to a↑σ← Category 5 storm by NOAA in Apri→§πγl. Florida officials have repeatedl≈'♦y called on the insurance indu≤✘€stry to speed up the r©≥♠<ecovery process, with nearly 12% of claim ₹€ s still open a year afteσ€≠αr the storm hit.Organizer：China Insurance Dφ¶igital & AI Development 202 ₽"←0Web:http://en.zenseegroup.co♣ ₩ m/p/560573/Contact:Ann 021-65650305
From:businessinsuranceeinsurance renewals at Jan₩×. 1, 2020, mainly saw single-digit increases↔>, with some exceptions, according to reports byδ≈♠≤ reinsurance brokers rel≤♣©eased Thursday.Willis Re, the rei₽™nsurance brokerage of Willis Towers Watson PL★'←δC, and Guy Carpenter ™♥ & Co. LLC, a unit of Marsh & McLennan Co☆♥ s. Inc. both reported that yea☆>≈r-end reinsurance renewals varied by acφ ∏₹count and region, but t★₽βhe retrocessional re₽∞insurance was under pressure.Rates on line for 'property catastrophe reinsurance programs rem↑≥ained stable and property per risk pricin∏₽∞g was driven by individual program perforλ$₹↑mance, the Willis report s'φaid.Although some Ll☆♠ oyd’s of London syndicates took firm♠≤ positions on rate increases and¶∏ the London market authorized capacity •&decreased, that capactiy w↔♦as replaced by new capital and a strong supply fγ¶→rom other markets, Willis Re sai↑•₽d.U.S. loss-free accounts renewed at flat to "☆☆up 10% while those with losses ♣ →saw increases of 10% to 50%, ™₩∑ the Willis Re report said, which was amo× ng the largest increases. Property catastrophe ¶<₩¥accounts without losses re♣'newed at flat to up 5%, while€&≠ loss hit accounts were up 10% to 20%, Williβ πs Re said.According to the Guy Carpen✔"ter report, the brokerage’s global prope÷¥rty catastrophe rate on line index ro䱕se 5% in 2019.According to the Willis Re report,✘•> other large increases were seen in¶£& Central and Eastern Euro↓∑pe, where property progδα♣♣rams with losses saw increases of 5% to↔©© 20%, and Canada, where such ✘✔÷accounts renewed up 10% to 40%.Most ✘÷other regions and countries saw←↑≠ property increases in th↑ e single or low double digits, the repor>≠¥±t said.The Jan. 1 renewals saw some “difficulλ≠≥$t” negotiations, according to a letter in th©β¶αe report from James Kent, glo×φ₽ bal CEO, Willis Re.The Guy$® Carpenter report said the reinsurance mar<±ket was “asymmetrical,” adding “€✔this is certainly not a one-size-fit↑Ω≥s-all market” and while overall >βπ∞capacity remained adequate, “allocated cap♥€acity tightened notably in stΩ£φressed classes.”Dedicated reinsurance capiβ≠tal rose 2% in 2019 ≈✘and the year saw approximately ε₽$60 billion in global in←$♦sured catastrophe losses, a✔≈ccording to Guy Carpenter, which wasγ€α significantly lower th∞♣×an 2017 and 2018.Alternative capital, $★£≤however, contracted by app§€₽roximately 7% percent “as investors were moγσ÷re cautious with new∞£ investments after assessing market d✘←ynamics and pricing adeqΩuacy,” Guy Carpenter said.The retrocession mδΩπ♥arket “was challenged … by trapped capit≥₹ al, a lack of new capital and continued redφ&≥©emptions from third-party capital providers&≈,” a statement issued with ×♦the Guy Carpenter report said.However≈★αγ, significant retrocession pro£→viders returned to the market i∑♥₹n the past two weeks,☆↓♣ Willis Re said.Organizer：China Insurance δ©¥Digital & AI Development 2020We☆¥b:http://en.zenseegroup.com/p/560573/Ω ©Contact:Ann 021-65650305
Major information technology companies in India a$±re running the risk of termination&™ of their $1 billion contracts £₽following Boeing Co.’s decision to halt the prod"αuction of its 737 Max jets, δφ♦MoneyControl reported '•citing the Business Stand÷₩&ard. Companies like Tata Consultancy $Services Ltd., Infosys Ltd.σ←, HCL Technologies Ltd., Cπ★↑yient Ltd. and L&T Technology ₽¶♠Services Ltd. have outsourcing contract>×™"s with Boeing or its suppl₽"φiers and Boeing’s jet crisis is expec§ λ ted to affect these IT companies in theλ×÷® short run.From:businessinsuranceOrg>©anizer：China Insurance Digital &a∏∑δ₹mp; AI Development 2020Web:http://e ≥γ•n.zenseegroup.com/p/560573/φ₽Contact:Ann 021-65650305
France-based eyewear maker Eβ£≠ ssilor International S.A. has discovered¶©♥ fraudulent activities at one of its factoσ≈'ries in Thailand that cou₩♥ ld cause €190 million ($213 millio÷δ→n) in financial losse•✘•s to the company, The Irish T$∏>imes reported citing≥≤ Reuters. The company© has filed complaints in > Thailand and has fired all the in÷ πvolved employees. It hopes to recov→Ωer the losses from froze$n bank accounts, insurance and lawsuits.Organizε₹≤er：China Insurance Digital & AI Development¶£ 2020Web:http://en.zenseegroup.com/p/560573/Co ✘¥ntact:Ann 021-65650305
