- Home
- News
- Industry news
- Akari Therapeutics’ Noπ&∏macopan Granted U.S. Orphan δ&"£Drug Designation for Hematopoietic Stem ✔₽$Cell Transplantation-Associated Thrombotic ∑¶≥<Microangiopathy (HSCT-TMAδ₩∞)
Akari Therapeutics, Pε' ₩lc , a biopharmaceutical coβ✘mpany focused on innovative t≠"herapeutics to treat orpha>∞∑n autoimmune and inflammatory diseas♦©★es where the complement (φ•C5) and/or leukotriene (LTB4) systems ☆β∑are implicated, today announced that the δ→U.S. Food and Drug AdministratΩΩ•$ion (FDA) has granted orphan drug designa$α→tion for nomacopan for the treatment of hemato♠α™poietic stem cell tra✔λ>nsplantation-associated thromb&®★otic microangiopathy (HSCT-TMA).★λ
Orphan drug designation for nomacop☆ an follows Fast Track designation tha™☆t the Company received from the FDA ea↔β§rlier in August 2019 for the same in±♦<×dication in pediatric pati ♣ents. The Company continues to progre≥Ωss towards a pivotal trial for HSCT-TMA wi★±th nomacopan, which is expected to sta•©∏rt in the fourth quarter of 2019.
“We are pleased to obtain orphan drug des™★ignation for nomacopan in HSCT-TMA, a dev ₹astating rare disease for which there ×₹are currently no approved treatme÷∑nts,” said Clive Richardson, Chie¥¥f Executive Officer of Aka¶£ri Therapeutics. “The granting of orpha§" ♣n drug designation and Fast Trackπ designation by the FDA for nomacopan underscor$€es the significant unmet medical need in this di ₹ ₩sease. We look forward to takin≠¶§♥g advantage of the opportunities that FDA ≤> orphan drug designation and Fast Track designat'∑'ion provide across all stages¥♦ of drug development in order to bring ¥§this potential new treatmen£←t option to patients as σδ♥φrapidly as possible.”
Orphan drug designation by the FDA is granted to ↔✘promote the development of drugs th✘£εat target conditions affecting ✔♠★200,000 or fewer U.S. patients a§€nnually and that are expected to provide sigβ→nificant therapeutic advantage o®↔ ver existing treatments. O £©rphan designation qualifies Akar™$i for various benefits, includ₩÷ing seven years of market exclusivity folloΩ♥♠wing marketing approval, tax☆€φα credits on U.S. clinical trials, eligibility ★≠for orphan drug grants, and a waiver o ₽f certain administrati§ ><ve fees.
About Akari Therapeutics
Akari is a biopharmaceutical company focu®π<♠sed on developing inhibitors o εf acute and chronic inflammation,φε✘ specifically for the treatment of rare a≠☆≈nd orphan diseases, in particular those w"®βhere the complement (C5) or l→π♣eukotriene (LTB4) systems, or b § >oth complement and leukotrienes togetherσ↔ φ, play a primary role in disease progressio∏$₹n. Akari's lead drug candida≤≥↑te, nomacopan (formerly known as Coversin), is a"↕ C5 complement inhibitor that also ind→♣♣ependently and specifically inhibi&∏ts leukotriene B4 (LTB4)αφ∞© activity. Nomacopan is currently being clini↕∏cally evaluated in four ₽¥indications: bullous pemphigoid (BP), atopic±γ keratoconjunctivitis (AKC), thrombotic micro✘¶angiopathy (TMA), and paroxysm€>al nocturnal hemoglobinuria ∑β(PNH). Akari believes that ε↔♥the dual action of nomacopan on both≈∏ C5 and LTB4 may be beneficial in both AKC ¶←and BP.
Cautionary Note Regarding F↓'orward-Looking Statements
Certain statements in th≈¥is press release constitute “forwaσπrd-looking statements” wi♣₹∑thin the meaning of the P>↑× rivate Securities Litigation Reform Act of₹ 1995 regarding, among other things, statε§ements related to the offe→₽ring, the expected gross proce©₽ δeds and the expected closing of the offer$λing. These forward-looking statements reflec∏♣≤t our current views abo↑₹ut our plans, intentions, expect♣™® ations, strategies and prospects, <<∑γwhich are based on the information current♣ ly available to us and on assumptions w±↕≠e have made. Although we believe≤∞≈ that our plans, intentions, expectati¶"ons, strategies and prospe &↔cts as reflected in $♠<or suggested by those forwar ©d-looking statements are reasonable, we can give ¥εΩno assurance that the plans, inten♠★♦tions, expectations or strat∏←↑egies will be attaineδ♥¥d or achieved. Furthermo§¶re, actual results may differ materially≠₽ from those described in the forw™ard-looking statements and will b•©₩e affected by a variety of risks→↓€ and factors that ar∏₹αe beyond our control. Such ri≈∞sks and uncertainties for ou♣×"r company include, but are not limited•© to: needs for additional capital t✔§¶o fund our operations, ×♥our ability to continue₽γ as a going concern; uncertainties™✔ of cash flows and inability to meet←• working capital needs; an∏σ₽≤ inability or delay in<ε₩ obtaining required regulatory appr✘§ovals for nomacopan and any→✔ other product candidates, ✘™which may result in unexpected cos¶•t expenditures; our a∑☆÷bility to obtain orphan drugγ← designation in addi♠¥"tional indications; ¥$risks inherent in drug development in general; un™>♦certainties in obtaining succ←£♠essful clinical resulβφβ₽ts for nomacopan and any other product candidφ₽Ωates and unexpected costs that may result there↔←from; difficulties e✔★nrolling patients in ou•∑☆πr clinical trials; failure to realize$Ω☆ any value of nomacopan and any∑ φ other product candidat↓•↑es developed and being developed in®α±₹ light of inherent risks and diα←fficulties involved in suc£☆cessfully bringing product candidates to markeπ←t; inability to develop new≤∑♠≥ product candidates and sup₩÷port existing product can≈↕didates; the approval by the FDA and "ΩEMA and any other similar foreign •←→regulatory authorities of o€©↑$ther competing or superior pσ>★↔roducts brought to market; risks resulting from u••nforeseen side effects; r♦≥isk that the market for nomacopan mα₹ay not be as large as σ≠expected; risks associated with •©the departure of our former Ch$ §ief Executive Officers and other •£executive officers; risks associatedε→← with the SEC investigation; inability to↔¶• obtain, maintain and <<enforce patents and other intellectual property $≈rights or the unexpected costs associated wi≤✔σth such enforcement or litig&♣ation; inability to obtain and maintain commerciaσ☆l manufacturing arrangements w↔ ith third party manufacturers or estaβ©←blish commercial scale manufacturing capab&★ilities; the inability to ti ™mely source adequate sup£♥>ply of our active pharmaceutical ingr$≈β☆edients from third party manufacturers on€ whom the company depends; unexpected cos£λ¥≥t increases and pricing pressures and ↓≈ risks and other risk factors detailed in our&$βε public filings with the U.S. Securities ↔€♦•and Exchange Commission, including our↑¶ most recently filed Annual Rep>δ↔↓ort on Form 20-F filed with the SEC. ☆₩★←Except as otherwise noted, these for§$ward-looking statements speak only a>$ &s of the date of this pr$↔☆βess release and we undertake no obligation ¶β££to update or revise a←γ•ny of these statements to r≈λ£eflect events or circumstances occurring aft®¶er this press release. We caution investors n©★∏Ωot to place consider≤"±able reliance on theΩ< forward-looking statemen §ts contained in this press release.
the 2019 Asia-pacific pharma IP Leader Summit will be held in Beijing on November 14-15, and will attract more th¶♦∞εan 500 industry experts from domestic and for↓™≤eign pharmaceutical companies,<∞$• biotechnology companies, governmen÷←™ts, associations, law firms, intellectu☆&al property agents and othe¥r companies to attend.
Official registration and consultation channels:
Contact：Ann
Phone: 021-65650305
From :businessinsuranceU.S. commercial proΩ♣perty/casualty rates rose 5%→↔↕ on average in the fourth quarter of 2019,∞≥♣≤ up from 4% in the third quarter, ref☆σlecting insurers’ intent to continueε✔★♣ to increase prices acros$✔s most lines, online insurance ™Ωexchange MarketScout ∏₩Corp. said Monday.“Auto rate increΩases have been up all year long; however D&&∞O (directors & officers) and♥ professional rate increases have ↓§♣spiked significantly in the f♦© $ourth quarter,” Richard Kerr, CEO of Market∑βScout Corp. said in a statement.Insurers®$₹ are carefully analyzing their property££↓ exposures using catastrophe modeling tools, he↑♣↓★ said. “We expect many of th₩α↕e major property catastrop✔✘ ∏he insurers to curtail their✔≈ 2020 writings in California brush a∞$"nd East and Gulf Coast wind ✔€♣©areas. Naturally, this will >₹€result in higher rate<•s to insureds,” Mr. Kerr said.D&O liabilit>÷∏ y rates increased by 8.25%, whil" e commercial auto incr§¥∑eased 8% in the quarte←→∑r, and professional liability rates were uδ∏p 6%, and umbrella/excess rates were up 5.5%, aσ≤★ccording to MarketScout.Commercial p♥φ€↔roperty rates increased 5.25% in thΩ÷"e quarter, and business inteβ&πrruption rates were up 5%, whiπ₩φle all other lines showed smaller increa±σ®ses, except for workers compensat•₩☆ion, where rates fell 1%, £©↓MarketScout said.By industry class, transpor"∞λ§tation and habitational saw the high&λest average rate inc™"™reases at 9% and 8.25% respectively, Mar¶&ketScout said.Large accounts – Ω₩'those with $250,001 to $1 mi£≤λllion in premium – saw a rate ¶≥<δhike of 5.5% in the fourth quarter, as diα™ d jumbo accounts, which have mor©Ωe than $1 million in premium. Sm all accounts – those with up to $25,0¥π00 in premium – were up 5%, while medium accoun↓÷≠Ωts – those with $25,001 to $250,000 in premium ≈♦↔↕– were up 4.5%.The “steady trend” of upward rates©♠♣ reflects insurers’ plans to continu¶•e increasing prices across all lin ✔•es except for workers compensat☆×ion, MarketScout sai✔→d.Organizer：China Insuranc ®e Digital & AI Development 2020Web:http:/♠/en.zenseegroup.com/p¶×∏/560573/Contact:Ann 021-6→λ5650305
From :insurancejournalIt wa↕∞εs a relatively quiet year for the So↔∏©utheast in terms of major catastrophes comparedΩβ×÷ with 2018 when Hurricane’s Michael and Florence≥ε✔" caused major damage in the regi Ω$on. This year, Hurricane Dorian si×λ• deswiped the Southeast coast and made≈•↔≤ landfall on the Outer Banks ofε∏£ North Carolina but most of the area wa±★s spared. Still, Aon said↕ ☆ economic damage in the U.• ©S. and Canada was poised ✘α§to approach a combined $1.5 b↕®γ♠illion.Florida spent the yea₩§r recovering from Hurricane ≠"Michael, which was upgraded to a Category ±₩$₹5 storm by NOAA in April. Florida officials ♥ have repeatedly called on the insuran'$ce industry to speed up the recovery p∏"rocess, with nearly 12% of claims☆← still open a year after the ₩storm hit.Organizer：China Insuraε♠£αnce Digital & AI De×≠velopment 2020Web:http://en.zenseegroup.com/p€£β/560573/Contact:Ann 021-65650305
From:businessinsuran>>&&ceeinsurance renewals at Jan ☆. 1, 2020, mainly saw λ≠<single-digit increases, with some exceptions, •☆according to reports by reinsurance brokers re&leased Thursday.Willis Re, the reinsurance€± brokerage of Willis Towers Watson PLC, and Guy δ' Carpenter & Co. LLC, a unit γof Marsh & McLennan Cos. ®§¶Inc. both reported that year-en↔ &d reinsurance renewals varied by account and re↔♠gion, but the retrocessional reinsurance was ©↓under pressure.Rates on line for property $♥↕∏catastrophe reinsurance program♥¶&s remained stable and property per risk pricingδε∏± was driven by individαδ↑¥ual program performance, the Willis₩± report said.Although some ₩λLloyd’s of London syndicates t♥∑&ook firm positions on rate increases and∑εδ the London market authorized capacity '¶decreased, that capactiy wa£₩₹≤s replaced by new capital and a™€π✘ strong supply from other ma§'rkets, Willis Re said.U.S. loss-free ←₽εaccounts renewed at flat tγ↓ o up 10% while those with losses saw increases o♥Ω♦f 10% to 50%, the Willis Re¥• report said, which was among the largest increas♠×φes. Property catastrophe acπ§counts without losses renewed at↔'↑ flat to up 5%, whilδ÷↕e loss hit accounts were up 10% to 20%, Wilγ$×★lis Re said.According to≤✘> the Guy Carpenter report, the brokerage’s global★∑♠♠ property catastrophe rate on line inde♠♣£♠x rose 5% in 2019.According to the $€✘ Willis Re report, other larg≠α↓e increases were seen in Centra•♥l and Eastern Europe, where proper↕δ↕ty programs with losses saw increases of 5% to ±σ20%, and Canada, where such accounts reneweα"σd up 10% to 40%.Most other regions and counβ±γtries saw property increas§∏es in the single or low doub₹∑le digits, the report said.T≤ he Jan. 1 renewals saw some “difficult” ne¶₽ gotiations, according to a letter in the₽£ report from James Kent, global CE₩≤ O, Willis Re.The Guy Carpenter report sa¶☆♠∏id the reinsurance market was “asymmetrical,” ad€♣±ding “this is certainly not a one-≥≥§size-fits-all market” and while overall ♠capacity remained adeq£≤uate, “allocated capacity tightened notablσ¶↔>y in stressed classes.”Dedicated reinsurance c<↔Ω™apital rose 2% in 2019 and↓π≤ the year saw approximately $60 billion in gσγ lobal insured catastrophe losses, a π§ccording to Guy Carpenter, which was >€significantly lower than 2017 and 2018.Alterna ✘™tive capital, however, contr☆∑α±acted by approximately 7% percent “as investo<×↔←rs were more cautious wiσ★÷th new investments after assessing market d ♠♠ynamics and pricing adequacy,” Guy Carpenter γ ★↑said.The retrocession market “was cπ₹hallenged … by trapped capital, a lack of n ¶≥ew capital and contin↓ ¥ued redemptions from third-party capit±≥ al providers,” a statement issue↓↔↕d with the Guy Carpenter π•σreport said.However, significant re ¶εtrocession providers returned to the maσ÷rket in the past two weeks, Wi£ γβllis Re said.Organizer：China Insuranδ≤™ ce Digital & AI Development 2020Web:ht₽©φtp://en.zenseegroup.com/'≠✔¥p/560573/Contact:Ann 021-65650≤±305
Major information tec☆♠hnology companies in Ind∏"ia are running the risk of termination ¶π"♠of their $1 billion contracts folloδ♥≠wing Boeing Co.’s decision toε halt the production of its 737 M↕¥ax jets, MoneyControl reported citing the Bu≠λ ✔siness Standard. Com ε☆panies like Tata Cons"ultancy Services Ltd., Infosys Ltd., HCL Te®↑♦÷chnologies Ltd., Cyient L♣♦α td. and L&T Technβ≈>ology Services Ltd. have outsourcing contr÷acts with Boeing or its ♥☆<$suppliers and Boeing’s jet cσ♠•risis is expected to affect these IT comp±€÷αanies in the short run.From:businessinsuranceO"≤πrganizer：China Insurance Digital &♥ ≤amp; AI Development 2020Web:"←>http://en.zenseegroup.com/p/560573/Cont§β♣¶act:Ann 021-65650305
France-based eyewear maker Ess¶∏ilor International S.Aσ ↑. has discovered fraudul>®ent activities at one of its factories in T♣↔™hailand that could cause €190 million (€→ δ$213 million) in financial losses to the cγ®₹δompany, The Irish Times reported citing Reuters. ↑δ ™The company has filed complaαεints in Thailand and has fired all the invol↔↓ved employees. It hopes to recove"§₽ r the losses from frozen bank a↓™ccounts, insurance and lawsuits.Organizeφ€↑©r：China Insurance Digi₽≤tal & AI Development 2020Web:http£≥₩://en.zenseegroup.com/p/560573/Contact:₽✘φAnn 021-65650305
