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Bioworld Today, Sept BIOWORLDTM TODAY THE DAILY BIOPHARMACEUTICAL NEWS SOURCE DECEMBER 2 , 2014 BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS VOLUME 25, NO. 232 CLINICAL TRIALS PART 2: GENDER J&J options Modern’s Who’s the default? Increases in women’s dual RANKL, TNF-alpha inhibitors in potential participation in studies bring uneven gains $277M deal By Anette Breindl, Science Editor By Cormac Sheridan, Staff Writer Twenty-four years after the NIH established the Office of Research on Women’s Health, and 21 years after the NIH Revitalization Act of 1993 first required that women DUBLIN – Modern Biosciences plc (MBS) be included in clinical trials, certainly the letter of the law has been achieved. Women could earn up to £176 million (US$277 are now the majority of participants in NIH-funded trials. million) in up-front and milestone payments from an option and licensing The whole picture, though, is much more complex, and more uneven. Increased deal with the Janssen Biotech Inc. arm of participation has led to gains in some areas. But in other areas, far too little is Johnson & Johnson that covers a series known about whether and how drug responses and optimal treatments differ for See Gender, page 3 See Modern, page 4 REPORT U.S. NEWS DEALS AND M&A ONLINE DATA GRAB SMALL MARKET, SAYS ANALYST Astrazeneca partners Big hack attack? Biotech Avanir migraine CRL with Cancer Research target in capers by ‘FIN4,’ no investor surprise; UK to find new targets says security firm report hangup in device use By Nuala Moran, Staff Writer By Randy Osborne, Staff Writer By Randy Osborne, Staff Writer LONDON – Astrazeneca plc is extending Half of the more than 100 firms targeted As expected, the FDA hit Avanir its reach further into academic research by a group of hackers out to intercept Pharmaceuticals Inc. late Wednesday with in the UK, signing an agreement to give confidential data regarding potentially a complete response letter (CRL) related to the medical charity Cancer Research UK market-moving disclosures are biotech the new drug application (NDA) for AVP- (CRUK) access to its library of 2 million See FireEye, page 5 See Avanir, page 6 See CRUK, page 7 IN THIS ISSUE LATIN AMERICA NEWCO NEWS Abivax to commercialize Carsgen’s China-led Stock movers, p. 2 Cuban vaccines from series A to fund clinical Financings, p. 2, 4 the Finlay Institute trials of CAR-T candidate Other news to note, p. 5, 7-9, 11, 12 By Sergio Held, Staff Writer By Cornelia Zou, Staff Writer In the clinic, p. 6, 12, 13 BOGOTA, Colombia – A deal between HONG KONG – Carsgen, a Chinese Pharma: Other news to note, Cuban and French vaccine developers developer of cancer therapies, p. 6, 10, 13, 14 looks to tap into Cuba’s strength as a announced its completion of an vaccine producer while reaching out to undisclosed series A financing led by Pharma: In the clinic, p. 14 markets in Asia and Latin America, China-based health care private equity See Abivax, page 8 See Carsgen, page 9 For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_Inquiry. NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. For Customer Service Inquiries, NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. Or email [email protected]. Copyright ©Thomson Reuters. Reproduction is strictly prohibited. Visit our website at www.bioworld.com. TUESDAY, DECEMBER 2, 2014 BIOWORLD™ TODAY PAGE 2 OF 14 FINANCINGS STOCK MOVERS 12/1/2014 Abeona Therapeutics Corp, of Cleveland, closed a $3.6 million Company Stock in $ Change in % financing to complete preclinical development of therapies Nasdaq Biotechnology -$36.59 -1.15% to treat children with mucopolysaccharidosis type III, or Calithera Biosciences -$2.13 -19.96% MPS III, the rare genetic disorder also known as Sanfilippo syndrome. U.S. investors included Cure Sanfilippo Foundation, Glycomimetics Inc. -$1.29 -13.33% Sanfilippo Research Foundation, Team Sanfilippo, the Abby Pozen Inc. -$1.26 -14.17% Grace Foundation and the National MPS Society. The round Uniqure NV -$1.78 -11.83% also included investments from Spain’s Stop Sanfilippo and Sanfilippo B Foundation, Geneva-based Fondation Sanfilippo Tekmira Pharmaceuticals -$1.89 -10.83% and Mexico’s Red Sanfilippo Foundation. Sanfilippo syndrome, Biotechs showing significant stock changes Monday which has no approved treatments and no cure, is a group of four deadly genetic diseases that result from the body’s inability to break down certain sugars properly. Abeona is focusing company’s largest existing shareholder, Sofinnova Partners, initially on gene therapies for Sanfilippo syndrome types A and also participated. James Healy of Sofinnova Ventures, Jonathan B and expects to initiate human trials in early to mid-2015. Silverstein of Orbimed and Albert Cha of Vivo Capital joined Alimera Sciences Inc., of Atlanta, inked an agreement with Ascendis’ board. The company said proceeds will be used to Deerfield Management and certain affiliates, which agreed fund late-stage trials of Transcon growth hormone to treat to purchase approximately $50 million in Alimera preferred growth hormone deficiency, or GHD, and in 2015 to initiate shares, contingent on undisclosed closing conditions. Alimera a phase I proof-of-concept program of Transcon treprostinil agreed to issue an additional 124.378 preferred shares as a to treat pulmonary arterial hypertension. Proceeds also subscription premium. The preferred stock may be converted are expected to support drug manufacturing, advance the into approximately 8.4 million common shares. Alimera plans development of preclinical candidates and enhance the to use the proceeds for U.S. commercial launch of its lead company’s clinical development and research organizations. product, Iluvien (fluocinolone acetonide), continued marketing Immune Pharmaceuticals Inc., of New York, said underwriters efforts in Europe and general corporate purposes. The financing exercised in part their overallotment option of approximately is expected to close by Dec. 17. Iluvien was approved by the 460,000 units at $2.50 apiece, bringing proceeds from the FDA in September to treat diabetic macular edema in patients company’s underwritten public offering to $9.685 million. previously treated with a course of corticosteroids who did not The company issued approximately 3.9 million units, each have a clinically significant rise in intraocular pressure. On consisting of one common share and one warrant to purchase Monday, Alimera’s shares (NASDAQ:ALIM) slipped 27 cents to 0.25 of a common share at an exercise price of $3.75 per share. close at $5.60. (See BioWorld Today, Sept. 30, 2014.) Separately, $1 million invested recently by an existing investor Ascendis Pharma A/S, of Copenhagen, completed a $60 was converted into 400,000 units consisting of 400,000 million series D financing co-led by Sofinnova Ventures, common shares and warrants to purchase up to 100,000 Orbimed and Vivo Capital with participation from Janus additional common shares. In total, the company raised Capital Management LLC, Venrock, RA Capital Management, $10.685 million in November. National Securities Corp. acted Rock Springs Capital and Sectoral Asset Management. The as sole book-running manager. PRACTICAL INFORMATION For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_ BIOWORLD TODAY Inquiry. NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. BioWorld™ Today (ISSN# 1541-0595) is published every business day by For ad rates & information, contact Tyler Beatty toll free at (855) 260-5607 or, outside Thomson Reuters, 115 Perimeter Center Place, Suite 1100, Atlanta, GA 30346 the U.S. and Canada, at (646) 822-4549, email [email protected]. U.S.A. For photocopy rights or reprints, please contact Tyler Beatty toll free at (855) 260-5607 or, outside the U.S. and Canada, at (646) 822-4549, or by email at tyler.beatty@ Opinions expressed are not necessarily those of this publication. Mention of thomsonreuters.com. products or services does not constitute endorsement. Send all press releases and related information to [email protected]. All Rights Reserved. No part of this publication may be reproduced without BUSINESS OFFICE the written consent of Thomson Reuters (GST Registration Number Donald R. Johnston (Senior Director, Editorial), Sarah Cross (Marketing Director), R128870672). Penney Holland (Web Production Manager), Tracie Webb (Customer Service Manager) OUR NEWSROOM CONTACT US Atlanta - Lynn Yoffee (Executive Editor), Jennifer Boggs & Amanda Lanier Jennifer Boggs, (770) 810-3120 // Anette Breindl, (770) 810-3134 // Sarah (Managing Editors), Peter Winter (BioWorld Insight Editor), Karen Pihl-Carey Cross, (770) 810-3138 // Michael Fitzhugh, (770) 810-3064 // Penney (Database Editor), Ann Duncan (Senior Production Editor), Marie Powers & Holland, (770) 810-3047 // Donald R. Johnston, (770) 810-3118 // Sharon Randy Osborne (Staff Writers) // East Coast - Anette Breindl (Science Editor), Kingman, 44 20-8995-3336 // Nuala Moran, 44 127-0812775 // Randy Mari Serebrov (Regulatory Editor) // West Coast - Michael Fitzhugh (Staff Osborne, (770) 810-3139 // Marie Powers, (770) 810-3136 // Mari Serebrov, Writer) // Europe - Sharon Kingman, Nuala Moran & Cormac Sheridan (Staff (770) 810-3141 // Cormac Sheridan, 353-87-6864323 // Tracie Webb, (770) Writers) 810-3130 // Peter Winter, (770) 810-3142 // Lynn Yoffee, (770) 810-3123 TUESDAY, DECEMBER 2, 2014 BIOWORLD™ TODAY PAGE 3 OF 14 probably made more progress than in the 24 years leading up Gender to it.” Continued from page 1 But just how much progress has been made remains impossible men and women. to know. Not very long ago at all, the lack of women in clinical trials For one thing, the NIH has “never broken down the trials was due to outright discrimination. In 1977, the FDA barred by diseases,” Greenberger pointed out.
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