Evotec and Lygature announced their cooperation in a new initiative for the development of novel antibacterial agents today: Gram-Negative Antibacterials NOW (“GNA NOW”). The new GNA NOW project, led by Evotec, managed by Lygature and funded by the Innovative Medicines Initiative (IMI), will work on the development of novel antibacterial agents to battle antimicrobial resistance in gram-negative bacteria. The multi-stakeholder consortium includes nine other partners from academia, industry and SMEs: Nosopharm, BIOASTER, Helmholtz Centre for Infection Research, North Bristol National Health Service Trust, University of Liverpool, Inserm, Erasmus Medical Center, Medical University of Vienna, and Fraunhofer IME.
Collectively, the GNA NOW members will progress three programmes in parallel with the goal of bringing one through completion of Phase I studies and one reaching Investigational New Drug (IND) stage and/or up to two programmes reaching clinical development candidate stage, by 2024.
GNA NOW is supported by the IMI, a joint initiative between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), of which Evotec is a member. The IMI, the world’s largest public-private partnership (PPP) in life sciences, will match Evotec’s in-kind contribution with a € 12 m grant over the next six years, to fund the activities of the consortium. This award will allow the eleven partners of this consortium to build European platforms of excellence around each step of the critical path for drug discovery and development. European experts will join forces to contribute to “mechanism of action elucidation”, “medicinal chemistry and design”, “in vitro profiling”, “pre-candidate efficacy studies”, “candidate PK/PD studies”, “safety and ADME”, “CMC”, as well as “clinical studies and modelling”.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are extremely glad to initiate GNA NOW with the backing of the European Commission and the EFPIA. Bacterial infections are a growing threat around the globe and are driving the need for innovative therapeutics with new mechanisms of action. GNA NOW gives us the opportunity to join forces with leading institutions of both the public and the private sector across Europe to develop new gram-negative antibacterial agents as quickly and as efficiently as possible.”
Dr Kristina Orrling, program manager at Lygature and GNA NOW project coordinator, commented: “By joining forces we can fend off a grim future where a simple urinary infection can be fatal. Together, we’ll strengthen the antibacterial arsenal.”
About antibiotic-resistant bacteria and GNA NOW Antibiotic-resistant bacteria were estimated to be responsible for 670,000 infections and 33,110 attributable deaths in the EU and the European Economic Area (EEA) in 2015. From a global perspective, antimicrobial resistance could kill up to ten million people every year by 2050, which could cost up to € 94 trillion ($ 100 tn). In February 2017, the WHO published a list of priority pathogens for the development of new antibiotics. Carbapenem-resistant gram-negative bacteria (Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter baumannii) were at the top of that list, with critical priority.
GNA NOW is an Evotec-led joint initiative of eleven partners, project managed by Lygature, with the goal of developing novel antibacterial agents and bringing one of the three simultaneously developed compounds through completion of Phase I studies plus one compound reaching Investigational New Drug (IND) stage and/or up to two compounds reaching clinical development candidate stage, by 2024.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853979. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
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Public and private sectors from Massachusetts and the Netherlands want to boost investment and innovation opportunities across both sides of the Atlantic.
Cambridge (MA), 23 July 2019 – During an official economic mission from the Netherlands to Boston led by Prime Minister Rutte, representatives from public investment agencies, the biotech industry and other organizations convened to discuss a broad-based partnership to advance ongoing collaboration in life sciences between the Netherlands and the Commonwealth of Massachusetts. TheMassachusetts Office of International Trade and Investment and the Dutch Ministry of Economic Affairs and Climate Policy signed a Memorandum of Understanding laying the basis for a Massachusetts – the Netherlands Transatlantic Life Sciences Partnership.
The signature of the Memorandum of Understanding (MOU) is a testimony to the strategic importance of life sciences as well as a mutual recognition of Massachusetts and the Netherlands as two international biotech hubs. Indeed, Massachusetts counts nearly 70,000 people working in life sciences, with Boston-Cambridge alone boasting more than 500 biotech companies, 5 of the top 6 hospitals in the U.S., and 48 colleges. The Netherlands is a younger yet rapidly growing biotechnology hub at the heart of the EU, with more than 420 biopharmaceutical companies, 12 research universities, 85 hospitals, around 200 public-private partnerships and is the home to the European Medicines Agency (EMA). The Netherlands is also one of the most concentrated life sciences and health clusters worldwide, featuring 2,900 companies within a 200km radius.
In addition to the signatories, Health-Holland, MassBio, HollandBIO and the Henri A. Termeer Tribute Committee will provide support for accelerating the growth of their life sciences hubs and the global opportunities for their respective domestic research organizations and companies. The partnership entails regular dialogues to promote a mutual understanding of the environment for life sciences in Europe, in the U.S. and worldwide, and facilitate global expansion. Collectively, these organizations will set-up various activities to foster collaboration and partnership across the Atlantic such as exchange of scientific results, pitches of research projects and generally fostering the flow of talent, ideas and people between the two ecosystems.
Focco Vijselaar, Director-General Enterprise and Innovation at Ministry of Economic Affairs and Climate Policy: “The Netherlands and Massachusetts have successful life sciences communities. By joining forces in this partnership they can both be strengthened.”
Mark Sullivan, Executive Director of Massachusetts Office of International Trade and Investment: “By signing this MoU we underline the great opportunities that lie ahead of two formidable life sciences ecosystems, here in Massachusetts as well as in the Netherlands. This international partnership will help create economic development and investment in the sector.”
John Maraganore, co-chair of The Henri A. Termeer Tribute Committee, Board Member of BIO and CEO of Alnylam Pharmaceuticals, Inc.: “This MOU is a great demonstration of the international leadership of Massachusetts in life sciences, as well as the fast-growing development of the Netherlands as an environment that champions a vibrant ecosystem for life sciences and healthcare innovation. As a company headquartered in Cambridge, MA and with strategic and growing European operations in the Netherlands, we are strongly convinced that the collaboration potential between innovators in these two leading life sciences hubs is immense, and patients are waiting for the fruits of our work.”
Hans Schikan, Top Team member of Health-Holland: “Working together is part of the Dutch DNA. By collaborating with the best we can identify innovative solutions that matter.”
Robert K. Coughlin, President and CEO, MassBio: “Disease has no borders, and neither should the research and development necessary to create new therapies and cures. We’re looking forward to embarking on this international partnership with the Netherlands and sharing the talent, resources, and capabilities of Massachusetts’ innovation ecosystem so we can all more efficiently bring new tomorrows to patients around the globe.”
Annemiek Verkamman, Managing Director at HollandBIO, the Dutch biotech industry association: “This transatlantic partnership provides a solid basis for increased collaboration between both our vibrant life sciences communities. We are looking forward to helping create opportunities for innovation and investments and fostering mutual understanding of our life sciences ecosystems.”
Mark Sullivan (Massachusetts Office of International Trade and Investment) and Focco Vijselaar (Dutch Ministry of Economic Affairs and Climate Policy) sign the MoU laying the basis for a Massachusetts – the Netherlands Transatlantic Life Sciences Partnership. Standing, the Dutch Minister for Medical Care Bruno Bruins. The representation of the supporting organizations of the MoU and the trade mission to Boston. From left to right: Hans Schikan (Health-Holland), Henne Schuwer (Dutch Ambassador in the United States), John Maraganore (Henri A. Termeer Tribute Committee, Alnylam Pharmaceuticals), Charlie Baker (Governor of Massachusetts), Belinda Termeer (Henri A. Termeer Tribute Committee), Mark Rutte (Prime Minister of the Netherlands), Robert Coughlin (MassBio), Bruno Bruins (Dutch Minister for Medical Care and Sport), Annemiek Verkamman (HollandBIO), Hans de Boer (VNO-NCW), Travis McCready (Massachusetts Life Sciences Center).
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Osteo-Pharma, a Dutch Life Sciences company developing novel pharmaceuticals and medical devices to improve the local healing of bone fractures and defects, today has announced that it has successfully completed a large preclinical study in mini-pigs, which shows its OsteoActivator coated collagen membranes to effectively promote new bone formation. The data obtained indicated a 24% increase of new bone within 6 weeks in defects covered by an OsteoActivator membranes as compared to uncoated collagen membranes. Importantly, OsteoActivator membranes were shown to be well tolerated and there were no findings of inflammation.
“We are very encouraged by the results of this clinically relevant mini-pig study that was performed in collaboration with the group of Prof. John Jansen from the Radboud university medical center (Nijmegen, The Netherlands) and are a good basis to advance into clinical studies in 2020” said Jan Gossen, chief executive officer of Osteo-Pharma.
Multi-partner collaboration aims to advance the discovery and development of critically-needed innovative TB antibiotics
As part of the Company’s 10-year initiative to drive progress against tuberculosis (TB), Johnson & Johnson today announced that it has launched an international research consortium to discover and develop new TB antibiotics in collaboration with eight European academic and biotechnology partners. Co-funded by Europe’s Innovative Medicines Initiative (IMI) and Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), the initiative—called RESPIRI-TB—is the first in a series of new collaborations that Johnson & Johnson is undertaking to advance TB research and development.
TB is the world’s deadliest infectious disease, killing an estimated 1.6 million people in 2017 alone.[i] Current TB treatment regimens have suboptimal cure rates because they are lengthy, complex and difficult for patients to adhere to, and growing resistance to first-line treatments is compounding this challenge. Drug-resistant TB (DR-TB) is the single biggest contributor to the rising global health challenge of antimicrobial resistance (AMR).
“Over the past half century, just two new TB medicines have been developed. To achieve the ambitious global goal of ending TB, we urgently need many more innovative therapies,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “No single company or institution holds all the answers. As we did in the case of HIV, we need to work together to advance the very best science as quickly as possible. We are proud to be a founding partner in the RESPIRI-TB consortium, and we look forward to working with our global partners to develop the necessary TB treatments of the future.”
The ultimate goal of the RESPIRI-TB
collaboration is to help enable the development of a new, more efficient
combination drug regimen to cure multidrug-resistant TB (MDR-TB), with a focus
on shortening treatment duration and minimizing the likelihood of resistance.
To this end, the partners will work to advance the discovery and early-stage
development of new compounds from different drug classes that could be used –
in combination with each other or with existing therapies, such as Janssen’s
bedaquiline. Bedaquiline was the first novel TB medicine to be approved in more
than 40 years and, today, is one of the last lines of defense against MDR-TB.
The
new consortium includes nine research teams spanning five European countries
with expertise in mycobacterial diseases and drug target investigation, as well
as project management. In addition to Janssen, members include: Leiden
University Medical Center and the University of Leiden (Netherlands, which will
serve as the project coordinator); University of Antwerp, Belgium; Sorbonne
University, France; Medical University of Vienna, Austria; University of
Copenhagen, Denmark; Mitologics, France; and FFUND B.V., Netherlands.
In
addition to RESPIRI-TB, the research consortium will also work to build a
pipeline of drug candidates for the non-TB mycobacterial (NTM) species M. avium and M. abscessus through a second project, RESPIRI-NTM. Although NTM infections are less prevalent than TB, currently
available treatments for NTM infections are suboptimal, underscoring the urgent
need for new therapeutic options.
“Tuberculosis and related diseases represent a major threat to public health worldwide, and a collaborative approach is essential if we are to develop new, safe and effective treatments,” said Pierre Meulien, Executive Director, IMI. “I am delighted that the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners in RESPIRI-TB and RESPIRI-NTM have come together to form the type of strategic, multi-sector alliances we need to boost the world’s response to the threat of these serious infectious diseases.”
IMI
is supporting the development of a number of multi-partner research consortia
under its AMR Accelerator program that aim to speed TB drug development across
the R&D spectrum – from discovery/early-stage development (i.e.,
RESPIRI-TB) to later-stage translational development – with the overarching
goal of dramatically improving TB treatment regimens.
Together,
these and other company-specific and collaborative R&D efforts will help
drive critical and necessary TB innovation. This is in line with the current
draft of the World Health Organization’s Global Strategy for TB Research and
Innovation, which is currently undergoing review and is expected to be
finalized for adoption by the World Health Assembly in May 2020.
[i] World Health Organization. Global Health Observatory (GHO) data. Tuberculosis. Last accessed June 2019. Available at: https://www.who.int/gho/tb/en/
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The Netherlands Centre for One Health (NCOH) was allocated a budget of two million euro Public-Private Partnership (PPP) Allowance to organise and realise their first PPP call. This call involves strategic partnerships under the Knowledge and Innovation Agenda of Top Sector Life Sciences & Health (LSH): One Health call.
The research projects should fit within the NCOH Strategic Research Agenda and one of its Solution Sets ‘Preventive Strategies’ or ‘Prophylactic Vaccines’. All NCOH partners can apply for collaborative innovation projects; though specific NCOH consortium criteria must be met.
Funding conditions
Depending on the type of research (fundamental, industrial or experimental) and the contributions by private and public partners within the project, between €250,000 and €750,000 PPP Allowance can be applied for. Submitted projects should have a total size of max. €1 million, including co-financing. An important condition is that an application must consist of a collaboration with at least one private party and an NCOH consortium of at least two contributing NCOH partners with multiple PhD students, befitting the NCOH research programme.
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Ida Haisma is benoemd tot Directeur Leiden Bio Science Park. Zij zal leiding gaan geven aan de transformatie van het Leiden Bio Science Park van science park tot innovatiedistrict. Hiertoe zal zij een nieuwe parkorganisatie gaan opbouwen en optreden als gezicht van het park.
Ida Haisma is een ondernemende vernieuwer en verbinder met de nodige ervaring in Life Sciences & Health. Momenteel leidt ze een corporate innovatieprogramma en adviseert ze start ups in de energie‐sector. Daarvoor was zij plaatsvervangend directeur van de Vereniging Innovatieve Geneesmiddelen. Daar ontwikkelde ze strategische agenda’s voor de sector en werkte ze met bedrijven, kennisinstellingen en overheden voor de Nederlandse Life Sciences & Health‐Sector.
Ze bezit veel kennis van en ervaring met het creëren van sterke innovatieclusters. Ze was de eerste directeur van The Hague Security Delta, het Nederlandse veiligheidscluster met inmiddels meer dan 200 bedrijven, kennisinstellingen en overheden dat zij vanaf de start heeft opgebouwd. Eerder was zij ook plaatsvervangend directeur bij het Kenniscentrum Grote Steden (NICIS), waar ze de samenwerking tussen overheden, bedrijven en kennisinstellingen rond grootstedelijke ontwikkeling bevorderde.
Ida Haisma zal per 1 september a.s. haar werkzaamheden beginnen.
HollandBIO connects and supports the Dutch biotech industry. We represent over 200 companies in the field of medical, agrifood and industrial biotech. And, HollandBIO is growing steadily. Today, we are proud to welcome Incyte Biosciences to the HollandBIO community!
Incyte Biosciences is a company founded on the premise that investment in good science and the rigorous pursuit of R&D excellence can translate into new medicines that can positively affect patients’ lives. Their therapeutic focus primarily is oncology. Incyte recognizes that they do not have a monopoly on good ideas and innovative approaches to therapy and enjoy working with like-minded partners who want to join forces to improve the lives of patients living with cancer and other diseases. Founded in 2002, Incyte Corporation’s global headquarters are located in Wilmington, Delaware, US, and today, the company employs more than 1,200 people worldwide. The Benelux office is located in Amsterdam.
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admedicum Business for Patients GmbH is a European expert group for patient engagement with industry with a focus on R&D. They design and implement programs for patient-orientation in the healthcare industry in Europe and internationally and have been assisting industry partners since 2015. admedicum believes in listening to patients, learning from patients and involving patients early on in new therapy development.
admedicum brings patients and companies together to make sure products and services are both tailored to meet the needs of the patients and are economically sustainable. The expert team provides down-to-earth day-to-day patient-centric business solutions. admedicum collaborated with HollandBIO to create the Patient Engagement Guide, a free practical guide for companies in the pharmaceutical and biotech industry who want to start engaging patients or improve patient engagement.
Together with our clients from the industry, admedicum makes patient-industry collaboration happen by acting as advisors, designers, and enablers to build trustworthy and effective relationships between patients and the industry. admedicum helps to merge benefit for patients and value-for-money for the industry. Their staff has vast experience guiding companies to meet the expectations of regulatory and HTA authorities in regard to patient-relevant data.
Read more about how admedicum aligns products and services of companies with the needs of patients on their website.
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AM-Pharma haalt maar liefst €116 miljoen op om
de behandeling die het ontwikkelt tegen acuut nierfalen naar de kliniek te brengen.
De medische vraag naar een medicijn is groot. Jaarlijks overlijden wereldwijd
ongeveer 700.000 mensen aan acuut nierfalen, en er is nog geen behandeling
voorhanden. De financieringsronde is een van de grootste ooit van een
zelfstandig Nederlands biotech bedrijf, en kwam tot stand door een consortium
van bestaande en nieuwe investeerders. Voor AM-Pharma start hiermee een spannende
nieuwe fase, waarvoor het bedrijf flink uit zal breiden. De deal onderstreept
de potentie en innovatiekracht van de Nederlandse biotech sector, die eerder
deze week al een enorme boost kreeg dankzij de versterkte samenwerking tussen
Galapagos en Gilead.
De laatste stap die AM-Pharma moet zetten op
de lange route van lab naar registratie is bepaald geen sinecure. AM-Pharma wil
zijn kandidaat-geneesmiddel testen bij 1.400 patiënten, verspreid over honderd
ziekenhuizen in twaalf landen. De studie moet voldoende data opleveren voor
goedkeuring van het Europees Medicijn Agentschap (EMA) en de FDA in de VS.
Het succes van AM-Pharma betekent dat de
Nederlandse biotech sector weer een groeidiamant rijker is. Het bedrijf is
illustratief voor de kwaliteit en potentie van de sector, maar ook voor de
moeilijke route die een biotech bedrijf van lab naar patiënt moet bewandelen.
Vorig jaar publiceerde AM-Pharma veelbelovende resultaten van een eerdere
klinische studie in het gezaghebbende Journal of American Medical Assocation
(JAMA). Toch trok farmaceut Pfizer zich vanwege een strategische koerswijziging
terug als partner van AM-Pharma, waarna het kleine bedrijf op zoek moest naar
nieuwe financiers. De goede data, de grote medische noodzaak en de volharding
van het AM-Pharma team onder leiding van CEO Erik van den Berg maakten dit
succes mogelijk.
Het is uitzonderlijk dat een biotech bedrijf
zelfstandig deze stap richting registratie zet. Meestal wordt voor zogenaamde
fase III studies samenwerking gezocht met een grote farmaceut die de financiële
middelen en de infrastructuur heeft om deze veeleisende fase te doorlopen. Een
andere meer gebruikelijke route om kapitaal op te halen is een beursgang.
Het aantrekken van financiering is en blijft
een van de grootste uitdagingen voor start-ups en scale-ups in de biotech. Het Nederlandse
financieringslandschap vertoont fikse gaten. Een uitgekiende financieringsmix
voor biotech bedrijven in alle fases van ontwikkeling moet het huidige
marktfalen aanpakken. Invest-NL kan daar hopelijk aan bijdragen. De nationale
investeringsinstelling in oprichting heeft alles in zich om de gaten te dichten
en door te investeren in biotech start-ups en scale-ups een brug te slaan
tussen de publieke regelingen en private investeerders. Zo kan Invest-NL dienen
als vliegwiel voor innovatie en de AM-Pharma’s van morgen het broodnodige
steuntje in de rug geven.
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TPI
is op zoek naar Nederlandse bedrijven die hun proefdiervrije innovaties willen
publiceren in een bidbook: een mooie kans om je bedrijf in de kijker te spelen!
TPI staat voor Transitie Proefdiervrije Innovatie. Deze transitie is gaande:
wetenschap, gezondheidszorg, beoordeling van veiligheid en acceptatie van
dierproeven veranderen. TPI staat ook voor de groep die deze ontwikkelingen wil
versnellen: RIVM, NFU, VSNU, ZonMw, Samenwerkende Gezondheidsfondsen, Stichting
Proefdiervrij en de ministeries van LNV, VWS, EZK, OCW en IenM. Het TPI-netwerk
signaleert dat er behoefte is meer te zien van wat start en scale ups allemaal
ontwikkelen zonder proefdiergebruik.
TPI nodigt
leveranciers van proefdiervrije innovaties daarom uit om zich in het TPI
bidbook te profileren. Het doel is om met zo’n bidbook overzichtelijk te laten
zien wat en waarom Nederlandse start en scale ups proefdiervrij innoveren. Het
bidbook wordt gepresenteerd tijdens de International pioneer2policymaker
conference ‘Accelerating animalfree innovations’ van 27-29 november 2019.
Wil
je dat TPI jouw bedrijfsprofiel in het bidbook opneemt? Laat het HollandBIO dan
uiterlijk 23 juli weten via info@hollandbio.nl.
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NEW IMI PROJECT “GNA NOW” KICKS OFF ITS BATTLE AGAINST ANTIMICROBIAL RESISTANCE
Gezondheid, InnovatieklimaatEvotec and Lygature announced their cooperation in a new initiative for the development of novel antibacterial agents today: Gram-Negative Antibacterials NOW (“GNA NOW”). The new GNA NOW project, led by Evotec, managed by Lygature and funded by the Innovative Medicines Initiative (IMI), will work on the development of novel antibacterial agents to battle antimicrobial resistance in gram-negative bacteria. The multi-stakeholder consortium includes nine other partners from academia, industry and SMEs: Nosopharm, BIOASTER, Helmholtz Centre for Infection Research, North Bristol National Health Service Trust, University of Liverpool, Inserm, Erasmus Medical Center, Medical University of Vienna, and Fraunhofer IME.
Collectively, the GNA NOW members will progress three programmes in parallel with the goal of bringing one through completion of Phase I studies and one reaching Investigational New Drug (IND) stage and/or up to two programmes reaching clinical development candidate stage, by 2024.
GNA NOW is supported by the IMI, a joint initiative between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), of which Evotec is a member. The IMI, the world’s largest public-private partnership (PPP) in life sciences, will match Evotec’s in-kind contribution with a € 12 m grant over the next six years, to fund the activities of the consortium. This award will allow the eleven partners of this consortium to build European platforms of excellence around each step of the critical path for drug discovery and development. European experts will join forces to contribute to “mechanism of action elucidation”, “medicinal chemistry and design”, “in vitro profiling”, “pre-candidate efficacy studies”, “candidate PK/PD studies”, “safety and ADME”, “CMC”, as well as “clinical studies and modelling”.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are extremely glad to initiate GNA NOW with the backing of the European Commission and the EFPIA. Bacterial infections are a growing threat around the globe and are driving the need for innovative therapeutics with new mechanisms of action. GNA NOW gives us the opportunity to join forces with leading institutions of both the public and the private sector across Europe to develop new gram-negative antibacterial agents as quickly and as efficiently as possible.”
Dr Kristina Orrling, program manager at Lygature and GNA NOW project coordinator, commented: “By joining forces we can fend off a grim future where a simple urinary infection can be fatal. Together, we’ll strengthen the antibacterial arsenal.”
About antibiotic-resistant bacteria and GNA NOW Antibiotic-resistant bacteria were estimated to be responsible for 670,000 infections and 33,110 attributable deaths in the EU and the European Economic Area (EEA) in 2015. From a global perspective, antimicrobial resistance could kill up to ten million people every year by 2050, which could cost up to € 94 trillion ($ 100 tn). In February 2017, the WHO published a list of priority pathogens for the development of new antibiotics. Carbapenem-resistant gram-negative bacteria (Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter baumannii) were at the top of that list, with critical priority.
GNA NOW is an Evotec-led joint initiative of eleven partners, project managed by Lygature, with the goal of developing novel antibacterial agents and bringing one of the three simultaneously developed compounds through completion of Phase I studies plus one compound reaching Investigational New Drug (IND) stage and/or up to two compounds reaching clinical development candidate stage, by 2024.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853979. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Source: Lygature
Massachusetts and the Netherlands kickoff international partnership in life sciences
IJzersterk innovatieklimaat, Hollandbio, InnovatieklimaatPublic and private sectors from Massachusetts and the Netherlands want to boost investment and innovation opportunities across both sides of the Atlantic.
Cambridge (MA), 23 July 2019 – During an official economic mission from the Netherlands to Boston led by Prime Minister Rutte, representatives from public investment agencies, the biotech industry and other organizations convened to discuss a broad-based partnership to advance ongoing collaboration in life sciences between the Netherlands and the Commonwealth of Massachusetts. TheMassachusetts Office of International Trade and Investment and the Dutch Ministry of Economic Affairs and Climate Policy signed a Memorandum of Understanding laying the basis for a Massachusetts – the Netherlands Transatlantic Life Sciences Partnership.
The signature of the Memorandum of Understanding (MOU) is a testimony to the strategic importance of life sciences as well as a mutual recognition of Massachusetts and the Netherlands as two international biotech hubs. Indeed, Massachusetts counts nearly 70,000 people working in life sciences, with Boston-Cambridge alone boasting more than 500 biotech companies, 5 of the top 6 hospitals in the U.S., and 48 colleges. The Netherlands is a younger yet rapidly growing biotechnology hub at the heart of the EU, with more than 420 biopharmaceutical companies, 12 research universities, 85 hospitals, around 200 public-private partnerships and is the home to the European Medicines Agency (EMA). The Netherlands is also one of the most concentrated life sciences and health clusters worldwide, featuring 2,900 companies within a 200km radius.
In addition to the signatories, Health-Holland, MassBio, HollandBIO and the Henri A. Termeer Tribute Committee will provide support for accelerating the growth of their life sciences hubs and the global opportunities for their respective domestic research organizations and companies. The partnership entails regular dialogues to promote a mutual understanding of the environment for life sciences in Europe, in the U.S. and worldwide, and facilitate global expansion. Collectively, these organizations will set-up various activities to foster collaboration and partnership across the Atlantic such as exchange of scientific results, pitches of research projects and generally fostering the flow of talent, ideas and people between the two ecosystems.
Focco Vijselaar, Director-General Enterprise and Innovation at Ministry of Economic Affairs and Climate Policy: “The Netherlands and Massachusetts have successful life sciences communities. By joining forces in this partnership they can both be strengthened.”
Mark Sullivan, Executive Director of Massachusetts Office of International Trade and Investment: “By signing this MoU we underline the great opportunities that lie ahead of two formidable life sciences ecosystems, here in Massachusetts as well as in the Netherlands. This international partnership will help create economic development and investment in the sector.”
John Maraganore, co-chair of The Henri A. Termeer Tribute Committee, Board Member of BIO and CEO of Alnylam Pharmaceuticals, Inc.: “This MOU is a great demonstration of the international leadership of Massachusetts in life sciences, as well as the fast-growing development of the Netherlands as an environment that champions a vibrant ecosystem for life sciences and healthcare innovation. As a company headquartered in Cambridge, MA and with strategic and growing European operations in the Netherlands, we are strongly convinced that the collaboration potential between innovators in these two leading life sciences hubs is immense, and patients are waiting for the fruits of our work.”
Hans Schikan, Top Team member of Health-Holland: “Working together is part of the Dutch DNA. By collaborating with the best we can identify innovative solutions that matter.”
Robert K. Coughlin, President and CEO, MassBio: “Disease has no borders, and neither should the research and development necessary to create new therapies and cures. We’re looking forward to embarking on this international partnership with the Netherlands and sharing the talent, resources, and capabilities of Massachusetts’ innovation ecosystem so we can all more efficiently bring new tomorrows to patients around the globe.”
Annemiek Verkamman, Managing Director at HollandBIO, the Dutch biotech industry association: “This transatlantic partnership provides a solid basis for increased collaboration between both our vibrant life sciences communities. We are looking forward to helping create opportunities for innovation and investments and fostering mutual understanding of our life sciences ecosystems.”
Photography by © Kyle Klein and the Embassy of the Kingdom of the Netherlands in the USA
Enhanced Bone Regeneration Properties of Osteo-Pharma’s OsteoActivator coated collagen membranes
GezondheidOsteo-Pharma, a Dutch Life Sciences company developing novel pharmaceuticals and medical devices to improve the local healing of bone fractures and defects, today has announced that it has successfully completed a large preclinical study in mini-pigs, which shows its OsteoActivator coated collagen membranes to effectively promote new bone formation. The data obtained indicated a 24% increase of new bone within 6 weeks in defects covered by an OsteoActivator membranes as compared to uncoated collagen membranes. Importantly, OsteoActivator membranes were shown to be well tolerated and there were no findings of inflammation.
“We are very encouraged by the results of this clinically relevant mini-pig study that was performed in collaboration with the group of Prof. John Jansen from the Radboud university medical center (Nijmegen, The Netherlands) and are a good basis to advance into clinical studies in 2020” said Jan Gossen, chief executive officer of Osteo-Pharma.
Source: Osteo-Pharma
Johnson & Johnson Establishes International Consortium to End Tuberculosis
GezondheidMulti-partner collaboration aims to advance the discovery and development of critically-needed innovative TB antibiotics
As part of the Company’s 10-year initiative to drive progress against tuberculosis (TB), Johnson & Johnson today announced that it has launched an international research consortium to discover and develop new TB antibiotics in collaboration with eight European academic and biotechnology partners. Co-funded by Europe’s Innovative Medicines Initiative (IMI) and Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), the initiative—called RESPIRI-TB—is the first in a series of new collaborations that Johnson & Johnson is undertaking to advance TB research and development.
TB is the world’s deadliest infectious disease, killing an estimated 1.6 million people in 2017 alone.[i] Current TB treatment regimens have suboptimal cure rates because they are lengthy, complex and difficult for patients to adhere to, and growing resistance to first-line treatments is compounding this challenge. Drug-resistant TB (DR-TB) is the single biggest contributor to the rising global health challenge of antimicrobial resistance (AMR).
“Over the past half century, just two new TB medicines have been developed. To achieve the ambitious global goal of ending TB, we urgently need many more innovative therapies,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “No single company or institution holds all the answers. As we did in the case of HIV, we need to work together to advance the very best science as quickly as possible. We are proud to be a founding partner in the RESPIRI-TB consortium, and we look forward to working with our global partners to develop the necessary TB treatments of the future.”
The ultimate goal of the RESPIRI-TB collaboration is to help enable the development of a new, more efficient combination drug regimen to cure multidrug-resistant TB (MDR-TB), with a focus on shortening treatment duration and minimizing the likelihood of resistance. To this end, the partners will work to advance the discovery and early-stage development of new compounds from different drug classes that could be used – in combination with each other or with existing therapies, such as Janssen’s bedaquiline. Bedaquiline was the first novel TB medicine to be approved in more than 40 years and, today, is one of the last lines of defense against MDR-TB.
The new consortium includes nine research teams spanning five European countries with expertise in mycobacterial diseases and drug target investigation, as well as project management. In addition to Janssen, members include: Leiden University Medical Center and the University of Leiden (Netherlands, which will serve as the project coordinator); University of Antwerp, Belgium; Sorbonne University, France; Medical University of Vienna, Austria; University of Copenhagen, Denmark; Mitologics, France; and FFUND B.V., Netherlands.
In addition to RESPIRI-TB, the research consortium will also work to build a pipeline of drug candidates for the non-TB mycobacterial (NTM) species M. avium and M. abscessus through a second project, RESPIRI-NTM. Although NTM infections are less prevalent than TB, currently available treatments for NTM infections are suboptimal, underscoring the urgent need for new therapeutic options.
“Tuberculosis and related diseases represent a major threat to public health worldwide, and a collaborative approach is essential if we are to develop new, safe and effective treatments,” said Pierre Meulien, Executive Director, IMI. “I am delighted that the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners in RESPIRI-TB and RESPIRI-NTM have come together to form the type of strategic, multi-sector alliances we need to boost the world’s response to the threat of these serious infectious diseases.”
IMI is supporting the development of a number of multi-partner research consortia under its AMR Accelerator program that aim to speed TB drug development across the R&D spectrum – from discovery/early-stage development (i.e., RESPIRI-TB) to later-stage translational development – with the overarching goal of dramatically improving TB treatment regimens.
Together, these and other company-specific and collaborative R&D efforts will help drive critical and necessary TB innovation. This is in line with the current draft of the World Health Organization’s Global Strategy for TB Research and Innovation, which is currently undergoing review and is expected to be finalized for adoption by the World Health Assembly in May 2020.
[i] World Health Organization. Global Health Observatory (GHO) data. Tuberculosis. Last accessed June 2019. Available at: https://www.who.int/gho/tb/en/
Source: J&J pressrelease
One Health applications for prophylactic vaccines and preventive strategies
InnovatieklimaatThe Netherlands Centre for One Health (NCOH) was allocated a budget of two million euro Public-Private Partnership (PPP) Allowance to organise and realise their first PPP call. This call involves strategic partnerships under the Knowledge and Innovation Agenda of Top Sector Life Sciences & Health (LSH): One Health call.
The research projects should fit within the NCOH Strategic Research Agenda and one of its Solution Sets ‘Preventive Strategies’ or ‘Prophylactic Vaccines’. All NCOH partners can apply for collaborative innovation projects; though specific NCOH consortium criteria must be met.
Funding conditions
Depending on the type of research (fundamental, industrial or experimental) and the contributions by private and public partners within the project, between €250,000 and €750,000 PPP Allowance can be applied for. Submitted projects should have a total size of max. €1 million, including co-financing. An important condition is that an application must consist of a collaboration with at least one private party and an NCOH consortium of at least two contributing NCOH partners with multiple PhD students, befitting the NCOH research programme.
More information: https://www.health-holland.com/calls/one-health
Ida Haisma benoemd tot Directeur Leiden Bio Science Park
InnovatieklimaatIda Haisma is benoemd tot Directeur Leiden Bio Science Park. Zij zal leiding gaan geven aan de transformatie van het Leiden Bio Science Park van science park tot innovatiedistrict. Hiertoe zal zij een nieuwe parkorganisatie gaan opbouwen en optreden als gezicht van het park.
Ida Haisma is een ondernemende vernieuwer en verbinder met de nodige ervaring in Life Sciences & Health. Momenteel leidt ze een corporate innovatieprogramma en adviseert ze start ups in de energie‐sector. Daarvoor was zij plaatsvervangend directeur van de Vereniging Innovatieve Geneesmiddelen. Daar ontwikkelde ze strategische agenda’s voor de sector en werkte ze met bedrijven, kennisinstellingen en overheden voor de Nederlandse Life Sciences & Health‐Sector.
Ze bezit veel kennis van en ervaring met het creëren van sterke innovatieclusters. Ze was de eerste directeur van The Hague Security Delta, het Nederlandse veiligheidscluster met inmiddels meer dan 200 bedrijven, kennisinstellingen en overheden dat zij vanaf de start heeft opgebouwd. Eerder was zij ook plaatsvervangend directeur bij het Kenniscentrum Grote Steden (NICIS), waar ze de samenwerking tussen overheden, bedrijven en kennisinstellingen rond grootstedelijke ontwikkeling bevorderde.
Ida Haisma zal per 1 september a.s. haar werkzaamheden beginnen.
HollandBIO welcomes Incyte Biosciences as a new member
HollandbioHollandBIO connects and supports the Dutch biotech industry. We represent over 200 companies in the field of medical, agrifood and industrial biotech. And, HollandBIO is growing steadily. Today, we are proud to welcome Incyte Biosciences to the HollandBIO community!
Incyte Biosciences is a company founded on the premise that investment in good science and the rigorous pursuit of R&D excellence can translate into new medicines that can positively affect patients’ lives. Their therapeutic focus primarily is oncology. Incyte recognizes that they do not have a monopoly on good ideas and innovative approaches to therapy and enjoy working with like-minded partners who want to join forces to improve the lives of patients living with cancer and other diseases. Founded in 2002, Incyte Corporation’s global headquarters are located in Wilmington, Delaware, US, and today, the company employs more than 1,200 people worldwide. The Benelux office is located in Amsterdam.
HollandBIO Welcomes admedicum Business for Patients as new member
Hollandbioadmedicum Business for Patients GmbH is a European expert group for patient engagement with industry with a focus on R&D. They design and implement programs for patient-orientation in the healthcare industry in Europe and internationally and have been assisting industry partners since 2015. admedicum believes in listening to patients, learning from patients and involving patients early on in new therapy development.
admedicum brings patients and companies together to make sure products and services are both tailored to meet the needs of the patients and are economically sustainable. The expert team provides down-to-earth day-to-day patient-centric business solutions. admedicum collaborated with HollandBIO to create the Patient Engagement Guide, a free practical guide for companies in the pharmaceutical and biotech industry who want to start engaging patients or improve patient engagement.
Together with our clients from the industry, admedicum makes patient-industry collaboration happen by acting as advisors, designers, and enablers to build trustworthy and effective relationships between patients and the industry. admedicum helps to merge benefit for patients and value-for-money for the industry. Their staff has vast experience guiding companies to meet the expectations of regulatory and HTA authorities in regard to patient-relevant data.
Read more about how admedicum aligns products and services of companies with the needs of patients on their website.
€116 miljoen voor AM-Pharma
IJzersterk innovatieklimaat, Hollandbio, Innovatieklimaat, UitgelichtAM-Pharma haalt maar liefst €116 miljoen op om de behandeling die het ontwikkelt tegen acuut nierfalen naar de kliniek te brengen. De medische vraag naar een medicijn is groot. Jaarlijks overlijden wereldwijd ongeveer 700.000 mensen aan acuut nierfalen, en er is nog geen behandeling voorhanden. De financieringsronde is een van de grootste ooit van een zelfstandig Nederlands biotech bedrijf, en kwam tot stand door een consortium van bestaande en nieuwe investeerders. Voor AM-Pharma start hiermee een spannende nieuwe fase, waarvoor het bedrijf flink uit zal breiden. De deal onderstreept de potentie en innovatiekracht van de Nederlandse biotech sector, die eerder deze week al een enorme boost kreeg dankzij de versterkte samenwerking tussen Galapagos en Gilead.
De laatste stap die AM-Pharma moet zetten op de lange route van lab naar registratie is bepaald geen sinecure. AM-Pharma wil zijn kandidaat-geneesmiddel testen bij 1.400 patiënten, verspreid over honderd ziekenhuizen in twaalf landen. De studie moet voldoende data opleveren voor goedkeuring van het Europees Medicijn Agentschap (EMA) en de FDA in de VS.
Het succes van AM-Pharma betekent dat de Nederlandse biotech sector weer een groeidiamant rijker is. Het bedrijf is illustratief voor de kwaliteit en potentie van de sector, maar ook voor de moeilijke route die een biotech bedrijf van lab naar patiënt moet bewandelen. Vorig jaar publiceerde AM-Pharma veelbelovende resultaten van een eerdere klinische studie in het gezaghebbende Journal of American Medical Assocation (JAMA). Toch trok farmaceut Pfizer zich vanwege een strategische koerswijziging terug als partner van AM-Pharma, waarna het kleine bedrijf op zoek moest naar nieuwe financiers. De goede data, de grote medische noodzaak en de volharding van het AM-Pharma team onder leiding van CEO Erik van den Berg maakten dit succes mogelijk.
Het is uitzonderlijk dat een biotech bedrijf zelfstandig deze stap richting registratie zet. Meestal wordt voor zogenaamde fase III studies samenwerking gezocht met een grote farmaceut die de financiële middelen en de infrastructuur heeft om deze veeleisende fase te doorlopen. Een andere meer gebruikelijke route om kapitaal op te halen is een beursgang.
Het aantrekken van financiering is en blijft een van de grootste uitdagingen voor start-ups en scale-ups in de biotech. Het Nederlandse financieringslandschap vertoont fikse gaten. Een uitgekiende financieringsmix voor biotech bedrijven in alle fases van ontwikkeling moet het huidige marktfalen aanpakken. Invest-NL kan daar hopelijk aan bijdragen. De nationale investeringsinstelling in oprichting heeft alles in zich om de gaten te dichten en door te investeren in biotech start-ups en scale-ups een brug te slaan tussen de publieke regelingen en private investeerders. Zo kan Invest-NL dienen als vliegwiel voor innovatie en de AM-Pharma’s van morgen het broodnodige steuntje in de rug geven.
Een greep uit de media
TPI Bidbook: sneller en beter met proefdiervrije innovaties
Gezondheid, InnovatieklimaatTPI is op zoek naar Nederlandse bedrijven die hun proefdiervrije innovaties willen publiceren in een bidbook: een mooie kans om je bedrijf in de kijker te spelen! TPI staat voor Transitie Proefdiervrije Innovatie. Deze transitie is gaande: wetenschap, gezondheidszorg, beoordeling van veiligheid en acceptatie van dierproeven veranderen. TPI staat ook voor de groep die deze ontwikkelingen wil versnellen: RIVM, NFU, VSNU, ZonMw, Samenwerkende Gezondheidsfondsen, Stichting Proefdiervrij en de ministeries van LNV, VWS, EZK, OCW en IenM. Het TPI-netwerk signaleert dat er behoefte is meer te zien van wat start en scale ups allemaal ontwikkelen zonder proefdiergebruik.
TPI nodigt leveranciers van proefdiervrije innovaties daarom uit om zich in het TPI bidbook te profileren. Het doel is om met zo’n bidbook overzichtelijk te laten zien wat en waarom Nederlandse start en scale ups proefdiervrij innoveren. Het bidbook wordt gepresenteerd tijdens de International pioneer2policymaker conference ‘Accelerating animalfree innovations’ van 27-29 november 2019.
Wil je dat TPI jouw bedrijfsprofiel in het bidbook opneemt? Laat het HollandBIO dan uiterlijk 23 juli weten via info@hollandbio.nl.
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