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- Akari Therapeutics’ Nomacopan Granted U.S. Orphan Drug Designation for Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy (HSCT-TMA)
Akari Therapeutics, Plc , a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for nomacopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).
Orphan drug designation for nomacopan follows Fast Track designation that the Company received from the FDA earlier in August 2019 for the same indication in pediatric patients. The Company continues to progress towards a pivotal trial for HSCT-TMA with nomacopan, which is expected to start in the fourth quarter of 2019.
“We are pleased to obtain orphan drug designation for nomacopan in HSCT-TMA, a devastating rare disease for which there are currently no approved treatments,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics. “The granting of orphan drug designation and Fast Track designation by the FDA for nomacopan underscores the significant unmet medical need in this disease. We look forward to taking advantage of the opportunities that FDA orphan drug designation and Fast Track designation provide across all stages of drug development in order to bring this potential new treatment option to patients as rapidly as possible.”
Orphan drug designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. Orphan designation qualifies Akari for various benefits, including seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four indications: bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes that the dual action of nomacopan on both C5 and LTB4 may be beneficial in both AKC and BP.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements related to the offering, the expected gross proceeds and the expected closing of the offering. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the departure of our former Chief Executive Officers and other executive officers; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements 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 than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.
Official registration and consultation channels:
Contact：Ann
Phone: 021-65650305
From :businessinsuranceU.S. commercial property/casualty rates rose 5% on average in the fourth quarter of 2019, up from 4% in the third quarter, reflecting insurers’ intent to continue to increase prices across most lines, online insurance exchange MarketScout Corp. said Monday.“Auto rate increases have been up all year long; however D&O (directors & officers) and professional rate increases have spiked significantly in the fourth quarter,” Richard Kerr, CEO of MarketScout Corp. said in a statement.Insurers are carefully analyzing their property exposures using catastrophe modeling tools, he said. “We expect many of the major property catastrophe insurers to curtail their 2020 writings in California brush and East and Gulf Coast wind areas. Naturally, this will result in higher rates to insureds,” Mr. Kerr said.D&O liability rates increased by 8.25%, while commercial auto increased 8% in the quarter, and professional liability rates were up 6%, and umbrella/excess rates were up 5.5%, according to MarketScout.Commercial property rates increased 5.25% in the quarter, and business interruption rates were up 5%, while all other lines showed smaller increases, except for workers compensation, where rates fell 1%, MarketScout said.By industry class, transportation and habitational saw the highest average rate increases at 9% and 8.25% respectively, MarketScout said.Large accounts – those with $250,001 to $1 million in premium – saw a rate hike of 5.5% in the fourth quarter, as did jumbo accounts, which have more than $1 million in premium. Small accounts – those with up to $25,000 in premium – were up 5%, while medium accounts – those with $25,001 to $250,000 in premium – were up 4.5%.The “steady trend” of upward rates reflects insurers’ plans to continue increasing prices across all lines except for workers compensation, MarketScout said.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
From :insurancejournalIt was a relatively quiet year for the Southeast in terms of major catastrophes compared with 2018 when Hurricane’s Michael and Florence caused major damage in the region. This year, Hurricane Dorian sideswiped the Southeast coast and made landfall on the Outer Banks of North Carolina but most of the area was spared. Still, Aon said economic damage in the U.S. and Canada was poised to approach a combined $1.5 billion.Florida spent the year recovering from Hurricane Michael, which was upgraded to a Category 5 storm by NOAA in April. Florida officials have repeatedly called on the insurance industry to speed up the recovery process, with nearly 12% of claims still open a year after the storm hit.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
From:businessinsuranceeinsurance renewals at Jan. 1, 2020, mainly saw single-digit increases, with some exceptions, according to reports by reinsurance brokers released Thursday.Willis Re, the reinsurance brokerage of Willis Towers Watson PLC, and Guy Carpenter & Co. LLC, a unit of Marsh & McLennan Cos. Inc. both reported that year-end reinsurance renewals varied by account and region, but the retrocessional reinsurance was under pressure.Rates on line for property catastrophe reinsurance programs remained stable and property per risk pricing was driven by individual program performance, the Willis report said.Although some Lloyd’s of London syndicates took firm positions on rate increases and the London market authorized capacity decreased, that capactiy was replaced by new capital and a strong supply from other markets, Willis Re said.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 among the largest increases. Property catastrophe accounts without losses renewed at flat to up 5%, while loss hit accounts were up 10% to 20%, Willis Re said.According to the Guy Carpenter report, the brokerage’s global property catastrophe rate on line index rose 5% in 2019.According to the Willis Re report, other large increases were seen in Central and Eastern Europe, where property programs 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 the single or low double digits, the report said.The Jan. 1 renewals saw some “difficult” negotiations, according to a letter in the report from James Kent, global CEO, Willis Re.The Guy Carpenter report said the reinsurance market was “asymmetrical,” adding “this is certainly not a one-size-fits-all market” and while overall capacity remained adequate, “allocated capacity tightened notably in stressed classes.”Dedicated reinsurance capital rose 2% in 2019 and the year saw approximately $60 billion in global insured catastrophe losses, according to Guy Carpenter, which was significantly lower than 2017 and 2018.Alternative capital, however, contracted by approximately 7% percent “as investors were more cautious with new investments after assessing market dynamics and pricing adequacy,” Guy Carpenter said.The retrocession market “was challenged … by trapped capital, a lack of new capital and continued redemptions from third-party capital providers,” a statement issued with the Guy Carpenter report said.However, significant retrocession providers returned to the market in the past two weeks, Willis Re said.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
Major information technology companies in India are running the risk of termination of their $1 billion contracts following Boeing Co.’s decision to halt the production of its 737 Max jets, MoneyControl reported citing the Business Standard. Companies like Tata Consultancy Services Ltd., Infosys Ltd., HCL Technologies Ltd., Cyient Ltd. and L&T Technology Services Ltd. have outsourcing contracts with Boeing or its suppliers and Boeing’s jet crisis is expected to affect these IT companies in the short run.From:businessinsuranceOrganizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
France-based eyewear maker Essilor International S.A. has discovered fraudulent activities at one of its factories in Thailand that could cause €190 million ($213 million) in financial losses to the company, The Irish Times reported citing Reuters. The company has filed complaints in Thailand and has fired all the involved employees. It hopes to recover the losses from frozen bank accounts, insurance and lawsuits.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
