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Cristiana Bernini

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Acquisition of a research centre in France

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Oncodesign closed an agreement with GSK to acquire the François Hyafil Research Centre located in Villebon-sur-Yvette (Essonne), including transfer of the team of the highly qualified drug discovery staff (approx. 57 people). Under the terms of the agreement, GSK will provide €35 million support over a four year period. Funds will allow Oncodesign to integrate the site and its capabilities into its business.

Established in 1987 and located in a new state-of-the-art research facility opened in 2010, the François Hyafil Research Centre was most recently a Flexible Discovery Unit of GSK. The facility includes delivery of medicinal chemistry, biology, in vivo pharmacology and drug metabolism/pharmacokinetics capabilities with experience in many therapeutic areas.

Partnership with WHO for visceral leishmaniosis

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Gilead Sciences entered a partnership with the World Health Organization (WHO) to provide $20 million in funding and drug donations over five years to expand access to diagnostic services and treatment for visceral leishmaniosis (VL). The collaboration includes the donation of 380,000 vials of amphotericin B liposome for injection to meet the needs of WHO to treat VL in key endemic countries, including Bangladesh, Ethiopia, India, Nepal, South Sudan and Sudan.

VL, also known as kala-azar, is the world’s second-deadliest parasitic infectious disease and affects up to 300,000 people annually in resource-limited countries.

New biomanufacturing facility

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GE will invest €150 million in a new biopharmaceutical manufacturing campus on Industrial Development Agency (IDA) Ireland’s strategic site at Loughbeg, Ringaskiddy, Co. Cork.

The new GE BioPark Cork will feature Europe’s first KUBio™, prefabricated, off-the-shelf bio-manufacturing facilities, owned and run by GE customers, and will serve as focal point for further investment in next-generation biopharmaceutical manufacturing in Ireland. The campus is expected to be home to more than 500 new jobs when fully operational; 400 with biopharma companies and a further 100 employed directly by GE. The construction phase, subject to planning approvals, is expected to begin by mid- 2017.

Collaboration in the dermatological area

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Chugai Pharmaceutical and Galderma Pharma announced a global license agreement for nemolizumab (CIM331). The anti-IL-31 receptor A humanized monoclonal antibody was created by Chugai, and is currently under development for atopic dermatitis and pruritus in hemodialysis patients. Chugai will grant Galderma an exclusive license for the development and marketing of the product worldwide, with the exception of Japan and Taiwan. Chugai will continue to be responsible for product manufacturing and supply of nemolizumab, which is based on Chugai’s proprietary antibody engineering technology ACT-Ig. IL-31 has been identified as a pruritogenic cytokine,1 and reported to be associated with pruritus in many diseases including atopic dermatitis and hemodialysis.

Acquisition and collaboration

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Bristol-Myers Squibb announced the acquisition of Cormorant Pharmaceuticals, a private Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases. Cormorant’s lead candidate HuMax-IL8 is a phase 1/2 monoclonal antibody targeted against interleukin-8. The rights to HuMax-IL8 were acquired by Cormorant from Genmab A/S in 2012 under an exclusive license agreement.
BMS will also collaborate with PsiOxus Therapeutics to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent nivolumab to treat a range of tumor types in late-stage cancer patients.

Collaboration for phase 1b studies

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A new collaboration on a phase 1b study will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Eli Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC. The combination of the two agents could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+/HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.

A deal for antibiotics

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AstraZeneca entered an agreement with Pfizer to sell the commercialisation and development rights to its late-stage small molecule antibiotics business in most markets globally outside the US. The portfolio comprises the approved antibiotics meropenem, ceftaroline fosamil and ceftazidime-avibactam, and two further products still under clinical development (ATM-AVI and CXL).

Under the terms of the agreement, Pfizer will make an upfront payment to AstraZeneca of $550 million upon completion and a further unconditional payment of $175 million in January 2019.

Funds for Zika vaccine

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The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services has agreed to grant Sanofi Pasteur with $ 43,2 millions for the manufacture of an inactivated Zika vaccine. The Zika vaccine candidate has been jointly developed by the vaccine global business unit of French multinational in collaboration with the Walter Reed Army Institute of Research (WRAIR). The new funds shall allow to take WRAIR’s Zika purified inactivated virus (ZPIV) vaccine into phase II development with manufacturing and characterization of the vaccine product as well as optimization of the upstream process to improve production yields.

Innovation Credit to run phase 3 trials

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The Netherlands Enterprise Agency granted an Innovation Credit (’Innovatiekrediet’) of € 3.4 million to Dutch biopharma SME Alloksys Life Sciences for the execution of phase 3 clinical trials. The goal is to reach registration of RESCAP® (RESCuing Alkaline Phosphatase).

Founded in 2006, Alloksys Life Sciences is developing the platform as an anti-ischemic injury and anti-inflammatory compound in acute clinical settings like open heart and other major surgery, organ transplantation, blood loss trauma and severe burn wounds.

The public offer has been accepted

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Mylan has completed the acquisition of Meda and the company is now a controlled subsidiary of Mylan. “Meda opens up a number of new opportunities for us, such as significantly expanding our over-the-counter presence into a $1 billion business. Additionally, Meda accelerates our expansion in attractive emerging markets, such as China, Southeast Asia, Russia and the Middle East, and provides us opportunities to maximize our efficient, high quality operating platform and broad product portfolio”, said Mylan president Rajiv Malik.

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