Akari Therapeutics’ Nomacopan G♠€ranted U.S. Orphan Dλ←rug Designation for Bullous Pemphigoid
Akari Therapeutics, Plc, a biΩ₽opharmaceutical company focused on ☆ σinnovative therapeutεσ≠ics to treat orphan autoimmune and inflammatoγ©ry diseases where the complement (C5) and/or leu™¥$≥kotriene (LTB4) systems are♣$ implicated, today announced t ≠☆hat the U.S. Food and Drug Admi≈♥nistration (FDA) has grant★↔ed orphan drug designation foγ←r nomacopan for the treatment of b≠λ∑ullous pemphigoid (BP).“BP, a severe bli♥ σstering skin condition with no approε♥★ved treatments, is an exciting theε✔φrapeutic target for our lead dru¥≤g candidate, nomacopan§π. It is also a disease of increasing prevalence λ↑due to an aging population and improving σ∑"diagnosis,” said Clive Richardson, ♣ ♠Chief Executive Office ☆δΩr of Akari Therapeutics. “Orphan drug desΩε"ignation for nomacopan≥> is a major step forward for the progrσ₹✔am, positioning nomacopan for eligi↑"bility for an additional seven yea✘←rs of marketing exclusivity✔ in BP if nomacopan i¶∑Ωs approved by the FDA. ♣ ≈This news is in addition to the recent orphan dr↔₩↕>ug designation recei ™σ±ved for our HSCT-TMA program.”Th$•e Company plans to release new sa♣™φfety and efficacy data from an ongoing Phase I"β£≠I trial with nomacopan in patients with BP×±↑ at an oral presentaε₹tion by Dr. Christian Ω∑€Sadik at the 28th European Academy of Derma₩→♦¶tology and Venereology (EAD↔α♦©V) Congress on October 10,♥σ 2019. In August, the Company ↔≥•δannounced new data demonstrating the synλ₹Ωergistic benefits of nomacopan’s dua₹®∞l C5 and LTB4 inhibitory activity in pemphigoid §±disease, generated by Dr. Christi "σan Sadik’s group at University of Lubeck, ≥π"Germany, and published in the August 2019 eⱕdition of JCI Insight<" [link].Orphan drug ←↕★designation by the FDA is gr✘∞anted to promote the ₹★ ÷development of drugs that tar♠♠get conditions affecting 200,000 or fewer U.S. p∏πatients annually and that are expected to ↔φprovide significant therapeutic advantage over π<©existing treatments. Orphan desi§★≥gnation qualifies Akari $≥♦for various benefits, including sev♣•en years of market exclusivity following marββketing approval, tax™' credits on U.S. clinical trials, eli≈☆gibility for orphan drug grants, and a w∏♥<aiver of certain administrative feγ♥es.2019 Asia-pacific pharma ∞λIP Leader Summit:http://en.zenseegroup.com/p/5109→₽34/will be held in&nbsπ>✔↑p;Beijing on&nbε♠♥¥sp;November 14-15, an₩←d will attract more than 500 induγ∞♥>stry experts from domestic and foreign pharmaceut ≤ical companies, biotech♠>nology companies, governments, associati↓$♠ons, law firms, intellectual property age↑βnts and other companies to attend.Official regis α©εtration and consultation channels:Cont♥¶act:AnnPhone: 021-6565030×✘Ω5Email:Marketing@zenseegroupσ∏.comhttp://en.zenseegroup.com/p/510934/