Akari Therapeutics’ Nomacopan Graδβ§nted U.S. Orphan Drug Designation for HematopoiλΩ etic Stem Cell Transplantation-Associated✘♣£< Thrombotic Microangiopathy (HSCT-TMA)
Akari Therapeutics, Plc , a biopharmaceutical α$"company focused on innovative therapeu≠ ™tics to treat orphan autoimmune aΩ™nd inflammatory diseases where the complemβγ€♣ent (C5) and/or leukotrie ✘'γne (LTB4) systems are implica©'ted, today announced that the U.S. Food ☆♠and Drug Administration™₹™ (FDA) has granted orphan d↕ασrug designation for nomacopan for the tre'♥✔¶atment of hematopoietic st"↕em cell transplantation-associated thrombotic miπ croangiopathy (HSCT-TMA).Orph★₩an drug designation for nεγ♠•omacopan follows Fast Track designatio←£ n that the Company received from the FDA ≈" earlier in August 2019 for th ∏ ★e same indication in ♦pediatric patients. The Company continues to ✘"σ¥progress towards a pivotal φ"♦trial for HSCT-TMA wi¥×∑Ωth nomacopan, which is expected to start in •αδthe fourth quarter of 2019.“We are pleased∏"$• to obtain orphan drug desi®÷β gnation for nomacopan in HSCT-TMA, a devasα₹¥tating rare disease for whi↓&¥↕ch there are currently no apprε¥oved treatments,” said Cl★"©ive Richardson, Chie÷δ>'f Executive Officer of Akar♣≤i Therapeutics. “The granting∏ε✔∑ of orphan drug designation and ☆♥Fast Track designation ∑✘β'by the FDA for nomacopan undersc←∑↔ores the significant unmet medical need in this↔ασ disease. We look forward to taking ad•≠vantage of the opportunities that FDA σ£orphan drug designation and Fast Track &÷→designation provide across all s§$♦tages of drug development in orde>♥↔r to bring this potential new↕♣↔ treatment option to patients as rapidly as®¶γπ possible.”Orphan drug designation by the≠≈↕γ FDA is granted to promote the deve₽₩lopment of drugs that target condΩ↕≥←itions affecting 200,000 or fewer U.S. p ∏atients annually and that are ¶¶£expected to provide significant therapeutic aΩγ✘$dvantage over existing treatments. Orphan desi•₩φgnation qualifies Akari for variou↕>♦s benefits, including seven years of✔× market exclusivity following marketing appr§ oval, tax credits on U.S. c✘≈ ₹linical trials, eligibilit¥€y for orphan drug grants, and a waiver of cert ↕≤§ain administrative fees≤™.About Akari TherapeuticsAkari is a biophaφ∏rmaceutical company focusλ ed on developing inhibitors of acute and ←∞↔chronic inflammation, specifically₽₹ for the treatment of rare and •≤§ orphan diseases, in particular those where tλ✔he complement (C5) or leukotriene (LTB4) s¥∏δ<ystems, or both complement and le✔$ukotrienes together, play a p←♥<rimary role in disease progression. Ak≥ ari's lead drug candidate, noβ✔β♠macopan (formerly known as ∏δCoversin), is a C5 complement inhibitor that also★≠∞£ independently and specifically inhibits leukotr≥ ₽iene B4 (LTB4) activityδ . Nomacopan is currently b≤÷≥eing clinically evaluated in four indications: b↕±ullous pemphigoid (Bα>©P), atopic keratoconjuncti∞vitis (AKC), thrombotic micro↕≈≠angiopathy (TMA), and paroxysmal nocturnal hγεemoglobinuria (PNH).↓®≤ Akari believes that the dual action of n≥™ >omacopan on both C5 and LTB4 may be >≥beneficial in both AKC and BP.Cautionary Nπ×ote Regarding Forwar&∞γd-Looking StatementsCertain statements in this pα&ress release constitute “forward-lookin ♣g statements” within the meaning of the Private₩♥← Securities Litigation Reform Act o×≠¶f 1995 regarding, among other÷ things, statements related to th≤∑→e offering, the expected gro&"☆ss proceeds and the expec<βted closing of the offering.®φ← These forward-looking statem§ε↔ents reflect our current vie∑☆ws about our plans, intentions, expectations,×↕ strategies and prosp'γects, which are based ★↕≥on the information currently av"₽ailable to us and on assumptions weβ have made. Although we believe that our×↓ plans, intentions, expeλγ★¥ctations, strategies and ±•φ÷prospects as reflected in or suggeλ↓≥₩sted by those forward-looking statemen☆λ σts are reasonable, we can give no assuranδεce that the plans, intentions, expectations o¶♦♦<r strategies will be attained or achieved. Furt♦•hermore, actual results ♦© ≠may differ materially from those desc∑≥'↓ribed in the forward-looking≤γ£ statements and will be affected by a<↓∏₽ variety of risks and factors that are beyond<Ω≠÷ our control. Such ri£∞ sks and uncertainties for our comp☆↕any include, but are§$• not limited to: needs for'✔₩≠ additional capital to fund φ$♥our operations, our ability to cont§₩inue as a going concern; u®×≤ncertainties of cash flow®"™s and inability to meet working capital need∑↑✔€s; an inability or delay in obta'→ining required regulator♦•≤y approvals for nomacopan and any o∑αther product candidates, which may result in unλπαexpected cost expendi↔">♥tures; our ability to obtain orphan drug des ≈ignation in additional indications; risks inhe↔©rent in drug development ®"in general; uncertainties in obtaining succ ®essful clinical results for ↔↔nomacopan and any other product cand ¥&idates and unexpected costs tha♠φ÷γt may result therefrom; ↓¥difficulties enrolling p↔↑ ₹atients in our clinical trials; faγφβilure to realize any value of nomac≤☆∏↓opan and any other product cand₽×'idates developed and being developed in light≠≥γ of inherent risks and diff±♥<™iculties involved in successfully bringin$←g product candidates to market;'σ inability to develop new product✔♦ candidates and support existing✘'δ↓ product candidates; the a©♠ §pproval by the FDA and EMA and any other σ$ similar foreign regulatory authorities of ot₹"≠→her competing or superior products brought to mar♣'ket; risks resulting from unfo←€•reseen side effects; risk that the mar£σket for nomacopan may not be a£✘s large as expected; risks associated with t₹₽ γhe departure of our former Chief Execut&§↓←ive Officers and other executive o♠☆λfficers; risks associated with the SEC inve✘≠stigation; inability to obtain, mainta≥¶in and enforce patents and oth♦♣↑€er intellectual property rights or∞ the unexpected costs associated wit ±h such enforcement or litigation; ×↕∏inability to obtain and £'★maintain commercial manufacturing arλ&≤rangements with third party manuf₩↕∑$acturers or establis•&h commercial scale manufactu↕₩"£ring capabilities; the inability to timel§₩↕y source adequate su₽₩∑♥pply of our active pharmaceutical ingredien₩ ts from third party manufacturers oγ©×n whom the company depen↑™×ds; unexpected cost increases and pri↔$cing pressures and risks♣&∞Ω and other risk factors detailed in our publi←σ±c filings with the U.S. Securities and Exchan&€ ge Commission, including our most recently fileπγ≠♣d Annual Report on Form 20-F $♠filed with the SEC. ©δ ®Except as otherwise noted, <ε∞these forward-looking statements spe✘✘★ak only as of the date of this press re•®↑lease and we undertake no obligation to upd↔≠ate or revise any of these statements to refl↔♣↓ect events or circumstances occ≥☆→urring after this press release. We cau↔→✔>tion investors not to place co≠£nsiderable reliance on the Ω←>forward-looking statements contained in< this press release.the γ±2019 Asia-pacific pharma IP ≤∏αLeader Summit will be held &× in Beijing on&nb•♦sp;November 14-15, and will attract more than 50'0 industry experts from domestic a ₽βnd foreign pharmaceut♦¥$€ical companies, biotechnology companie★₩s, governments, associatio×↓☆ns, law firms, intelle ♦ctual property agents and other compaΩ↔'nies to attend.Official registration and <γconsultation channel>♣s:Contact:AnnPhone: 021-65650305Email:Marketε₹>ing@zenseegroup.comhttp://en.zenseegroup.com/pσ✔$✔/510934/