The UK-based biotech company Plasticell announced a collaboration agreement with the Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) of Singapore to progress its therapeutic stem cell pipeline. Plasticell will initially apply proprietary genome editing technology to insert functional multi-transgene cassettes into specific loci of human stem cell lines. The engineered lines will be used by Plasticell in multiple projects focused on precisely directed stem cell differentiation, phenotypic screening for drug discovery and in next-generation immuno-oncology applications.
Cristiana Bernini
Drug discovery collaboration for neurodegenerative diseaeses
The exploitation of Evotec‘s unique induced pluripotent stem cell (“iPSC”) platform for the systematic drug screening in patient-derived disease models is at the centre of the new strategic collaboration agreement signed with Celgene Corporation. The project will initially address Amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and multiple other neurodegenerative disorders. Evotec will receive an upfront payment of $ 45 million, while Celgene holds exclusive options to in-license worldwide rights to Evotec programmes developed from the company’s compound library.
An agreement to test antimicrobial peptides
Swedish biotech companies Symcel and Colzyx entered a new partnership agreement in order to test Colzyx’s 25 different new collagen VI derived antimicrobial peptides, a first-in-kind new class of molecules characterised by the ability to kill bacteria in different ways. Each peptide will be tested independently or in combination with others. The analysis will be run with the aid of Symcel’s innovative cell-based assay tool for real-time cellular bioenergetic measurements calScreener™, that enables the calorimetric measurement of heat generated by metobolism and provides the rapid generation of unique information that can’t be acquired through other experimental methods.
Expansion of the kidney health alliance
The development of CCX140 for renal diseases will enter the already existing alliance signed between Vifor Pharma, a company of the Galenica Group, and ChemoCentryx. The experimental drug is an orally-administered inhibitor of the chemokine receptor CCR2 and it has already completed a phase 2 clinical trial in patients with diabetic nephropathy. The project will now focus on the joint development of CCX140 in rare kidney diseases. Under the terms of the agreement, ChemoCentryx will receive an upfront cash payment of $ 50 million and will be responsible for the clinical development of the candidate product in rare renal diseases.
A Swedish collaboration against mitochondrial myopathy
A new collaboration agreement has been signed between the Swedish company NeuroVive Pharmaceutical and Karolinska Institutet in order to develop NeuroVive’s cyclophilin inhibitor compound NV556 for the treatment of mitochondrial myopathy, an area of high unmet medical need. The new compound is expected to have higher specificity and tolerability than ciclosporin, which may facilitate better optimization of dosage. The collaboration will allow NeuroVive to reinforce its presence in the genetic mitochondrial disease key focus area where the company is also developing NVP015 compounds in mitochondrial respiratory chain diseases.
New biopharmaceutical production facility
Merck’s allergy business Allergopharma opened in March 2017 its new biopharmaceutical production in Reinbek, near Hamburg (Germany). The new capacity is a cornerstone in the global expansion of Allergopharma, a leading player in the allergen immunotherapy (AIT) of type I allergies, such as hay fever or allergic asthma. The factory covers 6,000 square meters and it is characterised by an entirely glass cleanroom, in which the company will manufacture its products for causal treatment. The new building has ultra-modern technological operations, a glass visitors’ foyer with a view of the cleanrooms and the potential for extension to accommodate further filling lines.
Acquisition in rare disease for Sucampo Pharmaceuticals
The global biopharmaceutical player Sucampo Pharmaceuticals announced the acquisition of Vtesse. The deal, valued $200 million upfront, will allow Sucampo to increase its focus on specialized diseases with high unmet need and to leverage the focus on orphan and paediatric diseases. The acquisition will also diversify Sucampo’s pipeline of development products with Vtesse’s late stage program in Niemann-Pick Disease Type C1 (NPC-1). VTS-270, which is currently in a pivotal phase 2b/3 trial, has been granted breakthrough therapy designation in the U.S. and orphan designation in both the U.S. and EU. Results from the pivotal trial are expected in mid-2018.
Merck expands its global biodevelopment capacity
Merck announced the expansion of its end-to-end biodevelopment centers, including the opening of two new process development centers in the Shanghai and Boston metropolitan areas. Each will provide a full range of process development capabilities and services, including cell line development services, both upstream and downstream process development, as well as non-GMP clinical production. The operation address the increasing customer demand for bioprocessing products, manufacturing capabilities.
New round of investment for Ixchelsis
Ixchelsis, a start-up company based at Discovery Park, Sandwich, Kent (UK), will receive an additional $ 12 million investment from Pfizer Venture Investments (PVI) of interest/venture investments and TVM Life Science Ventures VII in order to fully finance the planned phase 2b study o
f IX-01 in patients with severe lifelong premature ejaculation.
The company already achieved, in January 2016, a positive clinical proof of concept (POC) for its candidate product, an oral oxytocin receptor antagonist which has demonstrated significant efficacy and a very benign safety and toleration profile. The starting of the new phase 2b study is planned for early 2017. «This funding will also support our CMC and toxicology activities enabling rapid progression to phase 3» said Gary Muirhead, CEO of Ixchelsis Ltd.
IX-01 was originally discovered at the Pfizer Sandwich site in the U.K. «It’s great to see that our efforts have helped IX-01 to advance through exploratory development and into phase 2b dosing ranging», said Barbara Dalton, vice-president, PVI and board member of Ixchelsis.
Joint Declaration on EU industrial strategy
Efpia, the European federation of the pharmaceutical indutry associations, is among the more than ninety industrial associations that signed the “Joint Declaration on EU industrial strategy”. The document report about the difficult conditions the European manufacturing industry is facing and highlights its strong innovative potential and the high skills of its workforce.
According to the Declaration, between 2000 and 2014, the share of manufacturing in total EU output fell from 18.8% to 15.3%, while 3.5 million manufacturing jobs were lost between 2008 and 2014. The main threat comes from countries which are putting industry at the very top of their political agendas: some examples are the “Make in India” strategy and the “Made in China 2025” that seeks to turn China into the “leading manufacturing power”. Also the shift of the new US president Donald J. Trump towards “America First” will inevitably have a strong impact on their industrial policy, according to the industrial associations.
Despite reindustrialisation of Europe was one of the top priorities of the mandate of the newly insidiated European Commission President Jean-Claude Juncker, the concrete actions are still largely insufficient. The Declaration calls the European Commission to:
- reaffirm its commitment to reaching the target of 20% of GDP from industry, with an ambitious and realistic timeline;
- adopt an Action Plan to tackle the challenges that the industrial sectors are facing, in the framework of a Communication that would include concrete steps and milestones; and
- commit to implement this Action Plan in a timely manner and regularly report on progress.
The industry is ready, says the Declaration, to step up its cooperation with the European Commission, the European Parliament and the Competitiveness Council to define and implement this ambitious and coordinated European industrial strategy that will help safeguard the world leadership of European manufacturers and jobs in Europe.
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