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Bioworld Insight BioWorld Insight The news source of record covering the development of innovative human therapies October 30, 2017 Actionable Intelligence • Incisive Analysis Volume 25, No. 44 Society needs to urgently address antimicrobial resistance By Peter Winter, Editor The challenge of antimicrobial resistance (AMR) is one we need to urgently solve. In the U.S., the CDC estimates at least 2 million people become infected with bacteria that are resistant to currently available antibiotic therapies annually and approximately 23,000 people will die each year as a direct result of those infections. The threat of AMR has certainly been recognized worldwide and has become a top priority for global policy and public health. See AMR, page 3 Cheaper and faster also testing the drug in combination with immune Oncology drugs checkpoint inhibitors. “You often hear people say inhibiting PD-1 move to China seeking and CCR4 is like reducing the brake on a car. Plinabulin is like adding the fuel,” Huang patients and approvals explained. Nevertheless, she sees opportunities By Brian Orelli, Staff Writer for plinabulin in combination with both With a third of the world’s cancer patients residing chemotherapy and immune checkpoint inhibitors, Inside in China and upward of half of them enrolling in “Chemotherapy isn’t going away; nivolumab only clinical trials, small U.S.-based companies are has a 20 percent response rate.” Money raised by biotech looking across the Pacific to test their oncology On the neutropenia side, last week the company in 2017 drug candidates. enrolled its first patient in China in the global page 4 The advantages of lower cost and increased speed phase II/III trial testing plinabulin as a prevention of chemotherapy-induced neutropenia. The Week in review are clear, according to Lan Huang, CEO of New page 2 York-based Beyondspring Inc. Huang estimated See Oncology, page 4 that Beyondspring’s phase III trial will cost $20 million to $30 million, compared to $100 million Word on the street to $200 million if it ran the same trial in the U.S. Money raised by biotech: 2017 vs. 2016 page 2 exclusively. On the speed side, she estimated a Jan. 1 – Oct. 26, 2017: $38,697M phase III program can be run in two to three years Week in Washington Jan. 1 – Oct. 27, 2016: $27,274M by enrolling patients in both the U.S. and China, page 6 25,000 compared to four to five years for U.S.-based 23,025 trials. Biopharma/nonprofit deals 20,000 page 7 “We’re using plinabulin as a case study to prove this model,” Huang told BioWorld Insight. 14,961 Gainers and losers Beyondspring’s lead asset, plinabulin, binds to 15,000 for the week beta tubulin and activates GEF-H1, a guanine nucleotide exchange factor. The release of GEF-H1 page 14 Millions actives downstream pathways, leading to c-Jun 10,000 activation, release of interleukin cytokines and 8,618 BioWorld stock report 7,054 6,951 the maturation of dendritic cells. page 15 5,464 The process has a two-pronged effect with the 5,000 interleukins, especially interleukin-6, helping to prevent neutropenia – low levels of neutrophils 0 – that is often a side effect of chemotherapy. Public offerings Public/Other* Private biotechs And the dendritic cells help with tumor antigen * Includes financings of public biotech firms with the exceptions of presentation, which encourages the immune public offerings and certain investments from corporate partners. system to attack the tumor, so Beyondspring is © 2017 Clarivate Analytics Monday, October 30, 2017 BioWorld Insight Page 2 of 16 Week in review Word on the street Financings “We are still in a system where we are delivering Star Wars Ablynx NV generated just over $200 million in an upsized IPO. advancements and technologies into the Flintstones health care system.” ADC Therapeutics SA generated $200 million in a private financing round. Freda Lewis-Hall, chief medical officer at Pfizer Inc., speaking at the Cleveland Clinic’s 15th Medical Innovation Summit Adial Pharmaceuticals Inc. has filed to raise $16 million in its IPO. “Essentially, this means that cell therapy products derived from Allena Pharmaceuticals Inc. has established terms for its IPO one starting cell line (ES cell or iPS cell), edited by ‘Universal by planning to sell 5.33 million shares of its common stock Donor Cell’ technology, can then be applied to any recipients, priced between $14 and $16 per share. which may enhance efficiencies in our regenerative medicines Corbus Pharmaceuticals Holdings Inc. priced a $32.5 million business.” underwritten public offering. Yoshitsugu Shitaka, president of the Astellas Institute for Regenerative Medicine, on gaining the global rights to use set the price for its upcoming IPO at $5 per share. Genprex Inc. Universal Cell’s Donor Cell technology It plans to offer a minimum of 2 million shares and a maximum of 4.5 million shares. “If Puerto Rico’s power grid isn’t restored by the end of the year, Hutchison China Meditech Ltd. said it intends to offer $262 many of the drug and device companies with manufacturing million of American depositary shares. facilities there may need to relocate some of their production.” Idera Pharmaceuticals Inc. priced its underwritten public FDA Commissioner Scott Gottlieb offering, with net proceeds expected to be approximately $46.8 told a House subcommittee last Tuesday million. Ignyta Inc. priced an underwritten public offering for gross “Putting the federal government’s purchasing power to work to proceeds of approximately $160 million. save seniors and the taxpayers money is simply common sense. Immune Design Corp. priced a public offering of 19.5 million The fact that we continue to pay retail rates for wholesale shares at $4.10 each. purchases is . ridiculous. It’s long past time we put an end [to] this sweetheart deal for big pharma.” Immune Pharmaceuticals Inc. closed its public offering of Peter Welch (D-Vt.), who along with Sen. Bernie Sanders units for gross proceeds of $18 million. (I-Vt.) and Reps. Elijah Cummings (D-Md.) and Lloyd Doggett Prometic Life Sciences Inc. entered a binding letter of intent (D-Texas), is sponsoring legislation to allow Medicare to directly to secure an $80 million line of credit from Structured Alpha LP. negotiate Part D prescription drug prices Practical information For Sales Inquiries: http://clarivate.com/life-sciences/news/bioworld. NORTH BioWorld Insight AMERICA, Tel: +1-855-260-5607. Outside of the U.S. and Canada, Tel. +44-203- BioWorld Insight (ISSN# 1541-0579) is published every Monday by Clarivate 684-1797. For Customer Service Inquiries, NORTH AMERICA, Tel: +1-800-336- Analytics. 4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. For ad rates & information, contact Chris Venezia toll free at (855) 260-5607 or, Opinions expressed are not necessarily those of this publication. Mention of outside the U.S. and Canada, at (646) 522-6243, email christopher.venezia@ products or services does not constitute endorsement. clarivate.com. © 2017 Clarivate Analytics. All rights reserved. Republication or redistribution For photocopy rights or reprints, please contact Chris Venezia toll free at of Clarivate Analytics content, including by framing or similar means, is (855) 260-5607 or, outside the U.S. and Canada, at (646) 522-6243, or by email prohibited without the prior written consent of Clarivate Analytics. Clarivate at [email protected]. and its logo are trademarks of the Clarivate Analytics group. (GST Send all press releases and related information to [email protected]. Registration Number R128870672) Our newsroom Business office John Borgman (Director of Commercial Competitive Intelligence), Donald R. Lynn Yoffee (News Director), Jennifer Boggs (Managing Editor), Peter Winter Johnston (Senior Director, Current Awareness) (BioWorld Insight Editor), Marie Powers (News Editor), Anette Breindl (Senior Science Editor), Mari Serebrov (Regulatory Editor), Amanda Lanier (Managing Contact us Editor), Karen Pihl-Carey (Analyst), Ann Duncan (Senior Production Editor), Jennifer Boggs, (770) 880-3631 | John Borgman (831) 462 2510 | Anette Ann Marie Griffith (Production Editor) Breindl, (770) 810-3134 | Michael Fitzhugh, (770) 810-3064 | Donald R. Staff writers: Michael Fitzhugh, Randy Osborne, Shannon Ellis, John Fox, Johnston, 678-641-0970 | Nuala Moran, 44-7778-868-579 | Randy Osborne, Brian Orelli, Nuala Moran, Cormac Sheridan, Alfred Romann, Tamra Sami (770) 810-3139 | Marie Powers, (770) 810-3136 | Mari Serebrov, (770) 810-3141 | Cormac Sheridan, 353-87-6864323 | Peter Winter, (770) 810-3142 | Lynn Yoffee, (770) 361-4789 Monday, October 30, 2017 BioWorld Insight Page 3 of 16 AMR Continued from page 1 “If there are not attractive pull mechanisms A panel at the BIO Investor Forum (BIF) held in San Francisco to justify expensive phase II and III studies, recently discussed the incentives now in place to encourage biopharmaceutical companies to participate in that endeavor, there is a risk that push incentives funding where, up until now, many have been reluctant to get involved. may not be sufficient to secure the full devel- Moderator Gregory Frank, director, Infectious Disease Policy opment and commercialization of new AMR at the Biotechnology Innovation Organization (BIO), set the stage with the grim statistic that according to the Review on products. Antimicrobial Resistance, a report funded by the U.K., if drug- The Biotechnology Innovation Organization resistant pathogens continue to proliferate faster than our development of new medicines to treat them, then by 2050, 10 (CARB) initiative and the U.K. government’s call in 2016 for a million lives will be lost due to AMR-related infections each year concerted global effort to tackle antibiotic resistance. at a combined cost to the global economy of $100 trillion. Panelist Heather Shane, executive director, California That is the challenge facing us and solutions will require a Life Science Institute (CLSI) CARB-X, explained that the global effort in order to control.
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