Published monthly euroPLX 71 Lisbon (Portugal) November 25 + 26, 2019 by RauCon GmbH & Co. KG Rudolf-Diesel-Str. 9 69115 Heidelberg, Germany

Business Developer Vol. 15 # 5 | May | 2019 Company Mergers and Acquisitions Abound: Less Management Changes

* Acquisition: Aura Health Inc. has market for gene therapies. 20 May name to Zyla Life Sciences in the which Evotec will acquire Just closed the acquisition of an 80% 2019 (www.catalent.com) coming weeks. The name change Biotherapeutics, Inc., for up to $ equity interest in Pharmadrug reflects an intention to shift the 90 m including potential perfor- * Licensing and Distribution: Production GmbH for total consid- company’s focus from an abuse- mance-based earn-out compo- Cumberland Pharmaceuticals eration of €5.0 million in a move to deterrent technology company to nents expected within the next Inc. has entered into an exclu- enter the Europan market. 17 May a broader commercial life sciences three years. Just Biotherapeutics sive agreement with China’s 2019 (www.aurahealthinc.com) business committed to bringing is a unique technology company Winhealth Pharma Group for the important products to patients that integrates highly synergistic * Name change: Blake Insomnia licensing rights of Acetadote® and healthcare providers. 16 May scientific expertise and ML driven Therapeutics, Inc has submitted a (acetylcysteine) Injection, used to 2019 (www.egalet.com) technologies for design, develop- name change request to rebrand prevent or reduce liver damage ment, and manufacturing of bio- as BioHemp International. 15 May resulting from acetaminophen * Distribution: Emerald Health logics. 20 May 2019 (www.evotec. 2019 (www.biohempinternational. overdose, and Caldolor® (ibupro- Therapeutics, Inc. has been com) com/) fen) Injection, which is used to authorised by PEI Cannabis and treat pain and fever in the hospital Manitoba Liquor & Lotteries * Acquisition: Roche and Spark * Toll manufacture: Cantargia AB setting. The agreement will pro- Corporation to supply Emerald- Therapeutics, Inc. intend to refile and Patheon Biologics B.V. (part vide Winhealth licensing rights to branded cannabis products into on or about 23 May 2019 their of ThermoFischer Scientific) have commercialise both FDA approved those provinces. Emerald has also respective Premerger Notification signed an agreement regarding drugs in China. 15 May 2019 fulfilled its first shipments of pre- and Report Forms under the future production of the antibody (www.cumberlandpharma.com) mium cannabis products to PEI Hart-Scott-Rodino Act, in order CAN04 (nidanilimab). CAN04 Cannabis and to licensed private to provide the U.S. government is currently in phase IIa clinical * Acquisition: Cure Pharmaceutical, retailers in Saskatchewan. 14 May additional time to complete its development for non-small cell an innovative drug delivery and 2019 (emeraldhealth.ca/en) review of the proposed $4.8 billion lung cancer and pancreatic cancer. development company, has closed transaction. 14 May 2019 (www. 13 May 2019 (cantargia.com) on the previously announced * Acquisition: EVER Pharma roche.com) acquisition of Chemistry Holdings Holding Ges.m.b.H (Austria) * Acquisition: Catalent, Inc., has Inc., a formulation technology announced that it has com- * Acquisition: H. Lundbeck A/S completed the $1.2 billion acquisi- company that is developing inno- pleted the acquisition of Amneal and and Abide Therapeutics, Inc. tion of Paragon Bioservices, Inc., a vative delivery systems for a vari- Deutschland GmbH, a subsidiary signed a definitive agreement in leading viral vector development ety of industries. The acquisition of Amneal Pharmaceuticals that which Lundbeck LLC has agreed to and manufacturing partner for was an all-stock transaction using operates the company’s commer- acquire Abide. Under the terms of gene therapies. With the addition common stock. In connection cial operations in Germany. The the agreement, Lundbeck may pay of Paragon’s specialised expertise with the signing and closing of acquired entity will be rebranded USD 250 million (approximately in adeno-associated virus (AAV) this acquisition, CURE received a to EVER Pharma GmbH. Financial DKK 1.65 billion) upfront with a vectors, the most commonly used total of $10M in cash. 14 May 2019 terms were not disclosed. 17 May commitment to pay future devel- vector to deliver DNA to cells, (www.curepharmaceutical.com) 2019 (www.everpharma.com) opment and sales milestones to Catalent is positioned to capitalise the group of current owners of up on strong industry tailwinds in the * Name change: Egalet Corp­or­ * Acquisition: Evotec AG signed to USD 150 million (approximately potentially $40 billion addressable ation announced it will change its a definitive agreement under DKK 1 billion). This acquisition pro- vides Lundbeck a novel discovery of higher-risk MDS (HR-MDS). 13 to Ethicon as part of its strategy Clermont Ferrand, France, is an platform and a U.S.-based research May 2019 (www.onconova.com) to focus on core business areas. independant, family-owned phar- hub. 6 May 2019 (www.lundbeck. akeda will receive $3.4 billion maceutical company focusing on * New facility: Inc. open a com) upfront in cash and up to an microbiome medicine: discovery, new 175,000 square-foot manu- additional $1.9 billion in poten- product development, clinical * Distribution: Lupin Limited and facturing facility in Andover, Mass. tial milestone payments from studies and manufacturing of Live Aptissen S.A. have entered into a Pfizer’s Andover site houses Novartis, and approximately Biotherapeutic Products. definitive distribution agreement commercial manufacturing and $400 million upfront in cash from under which Aptissen has granted product development functions, Based in Radomir, Danhson-BG Ethicon. 8 May 2019 (www.takeda. Lupin the exclusive rights to mar- with colleagues dedicated to (www.danhson.bg) is a Bulgarian, co.jp) ket, distribute and sell the current the development and produc- privately owned holding company Aptissen products in Canada. tion of high-quality complex that develops, manufactures and BD People on the Move This includes immediate rights to biologics and vaccines. With its markets branded generic prod- distribute Synolis VA for the treat- modular and flexible design, the * Accord Healthcare Ltd.: Cerem ucts. The company is a part of an ment of Osteoarthritis. 9 May 2019 newly opened Andover Clinical Çavdar, who has been Manager international group with business (www.lupin.com) Manufacturing Facility (ACMF) will for Business Development and operations in Bulgaria, Russia, the expand the capacity for Pfizer’s In-Licensing, EMENA, left the com- CIS countries and South-East Asia. * Spin off: Nimble Therapeutics BioTherapeutics Pharmaceutical pany. (Corp Comm 5 May 2019) has begun operating as a stan- Being part of the Group Medigray, Sciences organisation to manufac- dalone business after spinning DR Pharma is a privately owned ture clinical supplies. Pfizer’s ACMF * Ltd: Yash Khosla, until out from F. Hoffmann La Roche pharmaceutical company manu- investment is over $200 million most recently Director of Business to commercialise its proprietary facturer and marketer of gener- and includes five independent Development & Licensing at Lupin chemical synthesis technology for ics products in Central America, manufacturing suites to advance Europe Ltd. has been has been drug discovery and development. Dominican Republic, and Peru, Pfizer’s robust pipeline of potential appointed as Regional Head of 30 Apr 2019 (www.nimblethera- with offices in San José, Costa Rica. new biotherapeutics and vaccines, Europe & ANZ and is registered for peutics.com) The company is based in San José, with more than 50 projects in euroPLX 70 Berlin. (Pers Comm 14 May 2019) Costa Rica. * Acquisition: Novartis has entered development. 9 May 2019 (www. pfizer.com) into an agreement with Takeda * CytoDyn, Inc.: Brendan Rae, Excella GmbH & Co. KG is the Pharmaceutical Company Limited German manufacturing site of * Acquisition: Pfizer Inc. has Ph.D., J.D., who comes from Serina to acquire the assets associated Fareva, a Luxembourg based com- entered into a definitive agree- Therapeutics where he was Chief with Xiidra® (lifitegrast ophthalmic pany focusing on research, manu- ment to acquire all the shares of Business Officer, responsible for solution) 5% worldwide, a pre- facturing and packaging solutions Therachon Holding AG, a privately- partnering, out licensing and over- scription treatment approved to for cosmetic, make-up, pharma- held clinical-stage biotechnology all company strategy has been treat both signs and symptoms of ceutical, industrial and household company focused on rare diseases, appointed as Senior Vice President dry eye by inhibiting inflammation products. with assets in development for of Business Development. (Press caused by the disease. Deal terms Release 14 May 2019) the treatment of achondroplasia Located in Hohenlockstedt, include a USD 3.4 billion upfront and short bowel syndrome (SBS). Germany, G. Pohl-Boskamp payment with potential milestone * Phytopharm Kl ka S.A.: Paula Under the terms of the agreement, GmbH & Co. KG (www.pohl- payments of up to USD 1.9 billion. Lecka, who has been Business Pfizer will acquire Therachon boskamp.de) is one of Germany’s As part of the agreement, Novartis Development Manager finished for $340 million upfront with an leading mid-sized pharmaceutical will be taking on approximately her employment for the company. additional $470 million in addi- companies focusing on cardiovas- 400 employees associated with (Corp Comm 6 May 2019) tional payments contingent on the cular, respiratory/ENT, urology and the product. 9 May 2019 (www. achievement of key milestones in parasitology areas. The company novartis.com) Newcomers to euroPLX the development and commer- exports its products to more than 70 Berlin - part 2 * Licensing: Onconova Therap­ cialisation of TA-46 for the treat- 40 countries. ment of achondroplasia, a genetic eutics, Inc. has entered into More than 15% of the companies condition and the most common Based in the town of Fisciano, Italy, a license agreement for the registered for euroPLX 70 Berlin form of short-limbed dwarfism. 8 Genetic SpA (www.geneticspa. Greater China territory with HanX are companies which have never May 2019 (www.pfizer.com) com) is an R&D focused pharma- Biopharmaceuticals, Inc. , a China- attended any euroPLX event ceutical company with a portfolio based pharmaceutical company before. See part 2 of the list: * Divestiture: Takeda Pharmaceut­ of prescription drugs, medical focused on the development, reg- ical Company Limited has entered devices and dietary supplements istration, and commercialisation of Located in Böblingen, Germany, into agreements to divest its in several therapeutic areas. novel oncology products in China, AAA-Pharma (www.aaa-pharma. Xiidra® (lifitegrast ophthalmic to develop and commercialise de) is part of the Woerwag group, solution) 5% product (“Xiidra®”) With headquarters in Esbjerg, rigosertib, a novel and targeted representing its German generics to Novartis and its TachoSil® Denmark, Nordic Prime (nor- anti-cancer compound currently in business. Fibrin Sealant Patch (“TachoSil®”) dicprime.dk) is a Danish parallel a Phase 3 study for the treatment Biose (www.biose.com) of importer of quality medicine, buy- ing from within the EU and selling V-Ensure Pharma Technologies to the Nordic countries, primarily Pvt. Ltd. (www.v-ensure.com) Denmark and Sweden. of , is a contract research company based focusing Perffarma (www.perffarma.com) on forms such as injectables, solid is a French company servicing the orals, and liquid oral suspensions. in mar- kets of Central Europe, Maghreb, Veeda Clinical Research Pvt. Latam and East Africa. Ltd. (www.veedacr.com) is an independent CRO based in With more than 165 products in Ahmedabad, India, offering a anti-hypertensives, anti-diabetics, diverse range of clinical studies. lipid-lowering, anti-infective, antibiotics, respiratory manage- Zinereo Pharma is a newly estab- ment, hematinics, anti-allergics, lished spin-off of the Spanish steroids, psychotropics, calcium company Biofabri S.L. specialised and vitamin supplements and oth- in the development and manufac- ers, Unison Pharmaceuticals Pvt ture pharmaceutical products and Ltd (www.unisonpharmaceuticals. probiotics. com) of Ahmedabad, Gujarat, India, ranks among the top 40 companies of this country.

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