iBio, Inc. today announced that it has entered in↓​±£to the initial Statement o" ®f Work (“SOW1”) undeπβ✘€r its Memorandum of Understanding (“M✔™OU”) with AzarGen Bio♣πtechnologies (Pty.) Ltd. (“AzarGe ±n”).Following iBio’s successful u©δαse of its technologies and manufac♠ turing capabilities to advance the develo₽‌÷pment of AzarGen’s surfactant prδλotein therapeutic through an initial as →≤≠sessment of production fea☆↓α×sibility, in May 2017, the two companies expanded♦' their collaboration by initiating the& § development of a plant-made ♣©✘rituximab for the South African market underσ∏✔ the MOU.Pursuant to the SOW1, iBio will ma↔₩nufacture research quantities of a σ>plant-made rituximab for AzarGen usingδ∑≤ iBio’s proprietary FastPhγ<₽ arming™ System. Following batch production, t•≤↑€he drug product candidat≥↑e will undergo testing via iBio CDMO’s ™¥λ♠bioanalytical services.“After de☆÷monstrating the success of our platform throug←₹α₩h our opening project with AzarGen, we areγ‌ now advancing to the ne>←β®xt stage of the two companies’ collab>"₹oration,” commented Robert B. Kay, iBio’s Chair₽♥man and CEO. “We look forward to helping Az γ‌arGen develop a plant-based, bi®♣€o-similar rituximab prλσoduct for the South Africa™≥ n market.”“The early success in coα≥↑↔mbining iBio’s and AzarGen's ​✔©♣advanced genetic engineering and s₽★ynthetic biology techniques in plants reall‍×★y empowered us to evolve our business pl©​↑♣ans and product priorities to initiate develπ÷ ₹opment of a biosimilar™©©∏ version of rituximab,≤  Ω” said Dr. Mauritz Venter, CEO ♣₹★of AzarGen. “As we continue to moφ©ve toward the initiation of a§→​&dvanced pre-clinical activities, we are c§×₽onfident that iBio CDMO is ideally suited to ₩​‍provide us with the requisite long-term proc☆ ≠₹ess development and cGMP manufactur ✘<ing support. We are excited to take this importanπ£₹t step forward in advancing thisδ§ program. Focusing on accessibility and affordabiσ∏¥lity of biological medicine for tγσ<he African continent, we look forward to inα®itiating additional pro¶↑←♠jects with iBio as we progre₹₹♥γss.”Rituximab was firs'<t approved by the U.S. Food and D↓™rug Administration in 1997 f✘¥or treatment of certain B cell non-Hodgkin ly♦εmphomas. Since that time, its clinical ©σuses have expanded to encompα←ass treatment of chronic l↕σ✔‍ymphocytic leukemia, a→→¥s well as a range of λ∏≤autoimmune diseases, including certaπε✔in types of rheumatoid arthritis. Rituximab ∑♠≤"has been placed on the Wo§×rld Health Organization’s List of Essentia÷σ↔l Medicines and it was ranked as one ​& ×of the world’s top-10 selling pharmaceutiα♠cals in 2018.2019 Asia-↑∏‍αpacific pharma IP Leader Summit: htγ₩♦™tp://en.zenseegroup.com/p/404716/ will be ☆§ held in Beijing  o∏×n November 14-15, an★☆β€d will attract more than 500 industry exper₽©∞ts from domestic and foreign pharmaceutical co₩ mpanies, biotechnology companies, goΩδ ↔vernments, associations, law firms, intel↕÷♣lectual property agents and other companies to$‌ " attend.Official regist★✔βration and consultation channels:Contac₹β₽t：AnnPhone: 021-65650305Email× ：Marketing@zenseegroup.comhttp://www.zenseegro&₹×→up.com/forms/view/22113/

Akari Therapeutics, Plc, a biopha☆®≈rmaceutical company focused on λ‌innovative therapeutics to treat orphan ™'±autoimmune and inflam♣₽≤matory diseases where the com↔¥plement (C5) and/or leukotriene (LTB4) systems €≥←are implicated, today anΩ☆™nounced that the U.S. Food and D↔♣<£rug Administration (FDA) has granted orphan ™∏drug designation for nomacopan ≠↕φ for the treatment of ↔♠εbullous pemphigoid (BP).“B'&ε¶P, a severe blistering skin condition with no↑πφ approved treatments, is an excitin↓↓g therapeutic target for our le♠>↕®ad drug candidate, nomac♣☆opan. It is also a disease of increasing prevᣩalence due to an agi♦¥ng population and improvin←♣g diagnosis,” said Clive Ri♣∑chardson, Chief Executive Officer ∞≠≠>of Akari Therapeutics. “O£∞↑ rphan drug designation for nomacopan is ↔®a major step forward f≤¶‍≥or the program, positioning nomacopan for el≤↔×igibility for an additional seven yearsβ↕φβ of marketing exclusivity in BP if n€₽×omacopan is approved by the FDA≤≥γ. This news is in addition to theδ↔§ recent orphan drug designatio✔€↕n received for our HSCT-TMA program.”The Co♣♥mpany plans to release new safety and efficacyσ←≥> data from an ongoing Phase II trial wiπ≥™₽th nomacopan in patients with ↑∞☆↓BP at an oral presentation by Dr. Christia¥®ε♦n Sadik at the 28th European$φ Academy of Dermatology and Ve☆ nereology (EADV) Congress on October 10,≤≠∞ 2019. In August, th≠'∏δe Company announced new daγ♥πta demonstrating the synergδ§∞¶istic benefits of nomacopan’s dual C5  σ‌ and LTB4 inhibitory activity in pemphigoid≈↓→✔ disease, generated by Dr. Christian Sadi¶¶&☆k’s group at University of Lubeck, Germaβεny, and published in the Augus×∑€t 2019 edition of JCI Insight [link∏₹ε].Orphan drug designation by the FDA is gγδ‍ranted to promote the development of drugγδ‍'s that target conditio↔♦♦ns affecting 200,000 or fewer U.S. patiεφents annually and that are expecte±Ωd to provide significant therape₹γ★utic advantage over existi★​ng treatments. Orphan designation qualifies A ​kari for various benefits, inclu‍ ☆≤ding seven years of market exclus​♣ε∑ivity following marketing appr≈σ∞‌oval, tax credits on U.S. clinic✔€al trials, eligibility for orphan drug ♣φ≤grants, and a waiver φδof certain administrative fees.201β  ≈9 Asia-pacific pharma IP Leader Summitε♥•:http://en.zenseegroup.c←¶∑£om/p/510934/will be held in Beijing&α∞nbsp; on November 14-15, and wil₩'l attract more than 500 ind​©♦₩ustry experts from domestic and for ‍εeign pharmaceutical companies, biotech‌$♠nology companies, governments, association®α s, law firms, intellectual property agents and oπ​¶¥ther companies to atte γnd.Official registration and consultatio§♥n channels:Contact：AnnPhone: 021-6565×λ∏0305Email：Marketing@zenseegroup.comhttp≠$₩♠://en.zenseegroup.com/p/510934/