The
new oropharyngeal cancer trial is the third trial planned under the clinical
collaboration between ISA Pharmaceuticals and Regeneron. ISA101b, an
immunotherapy targeting human papillomavirus type 16 (HPV16), is currently in a
Phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck
cancer in combination with Libtayo, a PD-1 inhibitor that is being jointly
developed by Regeneron and Sanofi. A second Phase 2 trial investigating the
same combination in cervical cancer is also planned. More than 60 percent of
head-and-neck cancers and approximately 55 percent of cervical cancers are
HPV16 induced.
Under the revised
agreement, the clinical collaboration offers a potential shortened
path to first approval in the HPV16-positive oncology indications being studied
in the next few years. The agreement also streamlines ISA Pharmaceuticals’
access to license fees, milestone payments and royalties. Together with the
recently secured 20 million Euro loan from the European Investment Bank,
development of ISA101b is now fully funded through the data readout of ongoing
and planned pivotal trials which will support regulatory filings.
“This
agreement will accelerate the development and commercialization of our lead
asset, ISA101b, to treat two important cancers with high unmet medical needs.”
commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals.“We are extremely pleased to be working with Regeneron and for their
continued support of both ISA Pharmaceuticals and our clinical studies in both
indications.”
“Thanks to this updated clinical collaboration, we are able to rapidly diversify our research into a broader array of HPV16-induced cancers,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. “ISA101b offers a validated mechanism of action, and we look forward to working with ISA Pharmaceuticals to determine the synergistic potential of combining this novel immunotherapy with Libtayo to better address these difficult-to-treat cancers.”
Johnson & Johnson today announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.
Paul Stoffels, M.D.,
Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson
& Johnson, said, “Based on the strength of the preclinical data we have
seen so far and interactions with the regulatory authorities, we have been able
to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we
are continuing our efforts to build important global partnerships and invest in
our vaccine production technology and manufacturing capabilities. Our goal is
to ensure we can deliver a vaccine to the world and protect people everywhere
from this pandemic.”
The randomized,
double-blind, placebo-controlled Phase 1/2a study will evaluate the safety,
reactogenicity (response to vaccination), and immunogenicity (immune response)
of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S,
recombinant
in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and
older. The study will take place in the U.S. and Belgium.
The Company is in discussions with
the National Institutes of Allergy and Infectious Diseases with the objective
to start the Phase 3 SARS-CoV-2
vaccine, Ad26.COV2-S, recombinant,
clinical trial ahead of its original schedule, pending outcome of Phase 1
studies and approval of regulators.
As
the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, it
continues to increase manufacturing capacity and is in active discussions with
global partners to ensure worldwide access. The Company committed to the goal of supplying
more than one billion doses globally through the course of 2021, provided the
vaccine is safe and effective.
Johnson &
Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and
the Biomedical Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health & Human Services.
COVID-19 is caused by
SARS-CoV-2, which belongs to a group of viruses called coronaviruses that
attack the respiratory system. There is currently no approved vaccine for
COVID-19.
For more information on Johnson & Johnson’s multi-pronged approach to combatting the pandemic, visit: www.jnj.com/coronavirus.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 18:03:522020-06-16 18:03:53Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July← #nieuws
In Ovo, spinoff from Leiden University, will receive €2.5 million from the prestigious European Innovation Council (EIC) Accelerator Pilot grant to support its mission to stop the culling of male chicks around the world.
Every year, the poultry industry culls 6.5 billion chicks. These are male, don’t lay eggs and so they are useless in egg production. In Ovo develops a high-throughput screening machine, that gender types the egg instead of the chick. The machine will make it possible to only hatch the females and prevents the killing of billions of male chicks. The company works in collaboration with a number of large industry players and technology providers and is well on its way to solve this decades old problem. Germany and France are putting legislation in place to end the culling of day-old chicks by 2022 and the technology that In Ovo is working on will help make this a reality.
The EIC Accelerator
The EIC Accelerator (previously known as the SME Instrument) is part of the European Innovation Council (EIC) pilot that supports top-class innovators and entrepreneurs with funding opportunities and acceleration services. The EIC Accelerator supports high-risk, high-potential small and medium-sized companies to help them develop and launch new innovative products and services that could drive economic growth.
“This subsidy enables us to speed up development, scale up the company, and will have massive positive impact on the poultry industry across the globe”, says Wouter Bruins, director at In Ovo. “We are grateful and very happy to receive such a prestigious grant and look forward to working with the council on accelerating our business. Together, we can improve both sustainability and animal welfare in food production on a very large scale.”
In Ovo is one of only 72 companies that are awarded the grant. During this round, the EIC received 3,976 applications from companies based in more than 20 European countries, making it the most competitive round of this funding instrument to date. The company was supported by Scale-up Ventures and the Netherlands Enterprise Agency (RVO).
The company
In Ovo is a spinoff from Leiden University, founded by Wil Stutterheim and Wouter Bruins. It aims to positively impact the lives of billions of chicks and thousands of farmers, through the development and launch of new technologies. In Ovo is previously supported by investments from Leiden University, Evonik Industries and VisVires New Protein.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 17:52:162020-06-16 17:52:18In Ovo awarded €2.5 million EU grant← #nieuws
De Inclusieve Vaccine Alliantie (IVA) heeft
afspraken gemaakt met AstraZeneca over de levering van in totaal 300 tot 400
miljoen doses van het COVID-19-vaccin AZD1222 van de Oxford Universiteit. Als
alles goed gaat, worden de eerste leveringen voor het einde van dit jaar
verwacht. Binnen de IVA bundelen Duitsland, Frankrijk, Italië en Nederland de
krachten in de onderhandeling met ontwikkelaars en producenten van potentiële
coronavaccins. De deal met AstraZeneca zijn de eerste afspraken van de
alliantie om te zorgen dat een potentieel coronavaccin voor Europa snel beschikbaar
kan komen.
De corona-pandemie stelt de wereld voor ongekende uitdagingen. Wereldwijd bundelen partijen de krachten om zo snel mogelijk effectieve vaccins en geneesmiddelen te ontwikkelen. Dat vergt meer dan investeren in onderzoek alleen. In een recente publicatie gaat de Organisatie voor Economische Samenwerking en Ontwikkeling (OESO) in op de vraag hoe beleid de eerlijke en universele toegang tot behandelingen en vaccins voor het coronavirus kan stimuleren. De OESO adviseert publieke partijen ook later in het proces te investeren, te helpen om het risico te dragen, pull mechanismen uit te werken, om productiecapaciteit uit te breiden parallel aan ontwikkeling en bovenal grootschalige internationale samenwerking. Met haar aanpak lijkt de IVA die aanbevelingen ter harte te nemen.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 17:44:272020-06-16 17:44:28Inclusieve Vaccin Alliantie sluit deal met AstraZeneca← #nieuws
On Friday the 12th of June, a couple of international
teams that joined the MIT COVID-19 Challenge at the beginning of April had the
opportunity to pitch their solutions against COVID-19 to a group of Dutch
stakeholders from the Life Sciences & Health community to explore
possibilities to implement their solution in the Netherlands.
HollandBIO is proud supporter of the
MIT COVID-19 Challenge and together with Health~Holland, Innovation Attaché
Network in the US and the team of the MIT COVID-19 Challenge organized this
follow-up pitch session. After the pitches, the Dutch stakeholders offered
support for collaboration and implementation possibilities.
Due to great interest a lot of Dutch
partners joined the pitch session including NeLL, Takeda, Invest in Holland,
Noaber Foundation, Taskforce Health Care, RVO, NL Venture Builders,
InnovationQuarter, ZonMW and the Dutch Taskforce for Applied Research (SIA).
Especially in times when the focus tends to be national, support of
cross-border collaboration should be supported.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 17:37:502020-06-16 17:37:51MIT COVID-19 Challenge; sequel in the Netherlands← #nieuws
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces that it has reached agreement to acquire Erber Group for an enterprise value of €980m. The value of the transaction represents an EV/EBITDA multiple of about 14x the 2020 EBITDA (fiscal year ending September 2020). The transaction – which excludes two smaller units in the Erber Group – is expected to be earnings enhancing in the first year upon completion.
Erber Group’s specialty animal nutrition and health businesses, Biomin and Romer Labs, specialize primarily in mycotoxin risk management, gut health performance management, and food and feed safety diagnostic solutions, expanding DSM’s range of higher value-add specialty solutions. Romer Labs also complements DSM’s human nutrition and health offering to food industry customers. Sanphar and EFB, representing 7% of Erber Group’s total sales, are not included in this transaction.
The acquired businesses have combined sales of €330m and an Adjusted EBITDA margin above 20% for the twelve months to the end of March 2020, with a high single-digit organic sales growth rate over the past 5 years. The acquisition will be debt financed, with committed bridge financing in place. DSM continues to benefit from a strong balance sheet and remains committed to maintaining a strong investment grade credit profile.
With state-of-the-art research and manufacturing facilities and approximately 1,200 employees around the world, the acquisition of Erber Group is a unique strategic opportunity that provides revenue-enhancing synergies from the combined offering, global customer base, and complementary geographic strengths. Austrian-based Erber Group offers DSM the opportunity to enter the mycotoxin risk management market as the world leader and extends the company’s position as one of the top suppliers in the rapidly growing animal gut performance management market.
Mycotoxins occur as a result of natural fungus contaminants in animal feed and threaten the health of both animals and humans. In addition to increasing the risk of illness, mycotoxins also reduce the nutritional value of feed. Biomin’s patented and proprietary technology provides the most scientifically advanced mycotoxin protection available. Biomin is also a major producer of phytogenic and probiotic feed alternatives to antibiotics, which complements and strengthens DSM’s position in the rapidly growing global eubiotics market for improving animal gut health.
Romer Labs is at the forefront of diagnostic technology with innovative testing solutions for the analysis of mycotoxins in feed and food, food allergens and pathogens as well as veterinary drug residues, with accredited full-service labs in Austria, UK, USA and Singapore. DSM’s extensive global network of food and beverage customers as well as feed customers stand to benefit from Romer Labs’ expertise and the combined group’s data-based quality assurance offering.
The acquisition of Erber Group further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use of water and land.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 17:35:442020-06-16 17:35:45DSM to add world-leading animal nutrition and health specialty businesses with acquisition of Erber Group← #nieuws
Vorige week verscheen de nieuwste Horizonscan Geneesmiddelen – inclusief COVID-19 special. Vanwege het grote aantal producten en de snel opvolgende ontwikkelingen wordt het overzicht van geneesmiddelen tegen COVID-19 maandelijks door het Zorginstituut geactualiseerd. Daarnaast start het Zorginstituut (ZIN) met de voorbereiding van de volgende, halfjaarlijkse update.
Met deze scan brengt
ZIN patiënten, behandelaars, ziekenhuizen, zorgverzekeraars en overheidsorganen
vroegtijdig op de hoogte van ontwikkelingen op het gebied van geneesmiddelen.
Verwacht je de aankomende twee jaar geneesmiddelen op de markt te brengen? Of
uitbreidingen van bestaande indicaties? Dan zoekt het ZIN jouw bijdrage voor de
volgende scan.
Met de nieuwe uitvraag
verzamelt ZIN gegevens voor de scan die in december 2020 live gaat. De deadline
voor het aanleveren van input is 3 augustus 2020. Producten verschijnen
overigens sowieso op de scan, ongeacht of de fabrikant informatie aanlevert.
Het Zorginstituut gebruikt hiervoor informatie van “(Horizon)scanners” en
werkgroepen van experts. Door zelf informatie aan te leveren, draag je als
bedrijf bij aan de volledigheid en accuraatheid van de scan. HollandBIO juicht
deze mogelijkheid dan ook toe.
Meer
weten of bijdragen?
ZIN licht de uitvraag en werkwijze hier op haar eigen website verder toe. Voor vragen, nadere toelichting en het insturen van input neem je contact op met het Zorginstituut via horizonscan@zinl.nl. Natuurlijk zijn we bij HollandBIO na een aantal verschenen scans ook erg benieuwd naar jullie ervaringen en suggesties voor verbeteringen. Leuk als je deze wilt delen met HollandBIO’s Britt.
Plantbased
leader Upfield announced plans to build a new state-of-the-art Food Science
Centre and Beyond Meat will open a new co-manufacturing facility of its first
production site outside the US. Both Upfield and Beyond Meat have chosen the
Netherlands to realize their plans.
Both
companies want to start with their activities in 2021. Upfield explains it has
chosen for the Netherlands, because of the Wageningen ecosystem. Wageningen is
considered as the Silicon Valley of the food industry and a world-class
location for food innovation. Wageningen University is ranked as the world’s
leading University in Agri-Food. Upfield will invest €50 million for their Food
Science Center.
HollandBIO
is working on an attractive business climate for all biotechnology related
businesses, whether entrepreneurs work on innovation in plants, medicines,
vaccines, cultured meat or biobased materials. By attracting these two big
Agri-Food disruptors, the Netherlands demonstrates its potential role in
helping to enable a transition to a more sustainable food system.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 17:06:582020-06-16 17:06:59Upfield and Beyond Meat choose for the Netherlands← #nieuws
Kite has received approval to implement a variation to the Yescarta Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational.
https://www.youtube.com/watch?v=IN8hLsgyZeM
Time-lapse video of the construction of Kite’s cell therapy manufacturing facility located outside of Amsterdam.
“Kite is focused foremost on the needs of patients living with cancer and we are proud to now manufacture cell therapy directly in Europe,” said Christi Shaw, Chief Executive Officer of Kite. “This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week.”
Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The facility has the capacity to produce therapy for up to 4,000 patients per year.
“With the enhanced technology and processes at our new facility we are pleased to be leading the next chapter in the manufacture and delivery of CAR T therapy,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Our new European manufacturing facility is dedicated to cutting-edge cell engineering, enabling patients to receive their potentially life-saving treatment more quickly.”
“The prognosis for patients with refractory large B-cell lymphoma is poor, with a median survival of approximately six months with the prior standard of care,” said Marie José Kersten, MD, PhD, Amsterdam University Medical Centers, Amsterdam, the Netherlands. “Timely access to cell therapy is critical, and the ability to manufacture CAR T cell therapies in Europe is welcomed by the clinical community.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 16:19:392020-06-16 22:50:35Kite Receives EMA approval for CAR-T Cell therapy manufacturing facility in Europe← #nieuws
Goed
nieuws! Rybelsus® (semaglutide tabletten) heeft als eerste geneesmiddel de
pilot ‘Parallelle Procedures CBG-ZIN’ volledig doorlopen. Nederland is daarmee een van de
eerste landen binnen de EU waarin het middel wordt vergoed. In de pilot wordt
een werkwijze ontwikkeld voor meer parallelle processen voor registratie en
vergoeding. Dat houdt in dat het vergoedingstraject al start terwijl het
registratietraject nog niet is afgerond. Hierdoor is het geneesmiddel sneller
toegankelijk voor de patiënt. Het sneller beschikbaar krijgen van innovatieve
geneesmiddelen voor patiënten is een ambitie van de overheid,
patiëntenorganisaties, behandelaren en de farmaceutische industrie.
HollandBIO
is erg enthousiast over de pilot, die naadloos aansluit bij het HollandBIO
programma Sneller & beter van lab naar patiënt. Binnen dit programma pleit
HollandBIO voor oplossingen waarbij gezondheidswinst, innovatie én
betaalbaarheid hand in hand gaan. Eén van die oplossingsrichtingen is een
adaptief ecosysteem waarin registratie, vergoeding en toegang door maatwerk en
samenwerking naadloos op elkaar aansluiten. De pilot is een mooie eerste stap
om zo’n adaptief ecosysteem een stap dichterbij te brengen.
Wij
zijn trots dat koploperNovo Nordisk zo flexibel inspeelde op
deze mooie kans. We kijken uit naar de resultaten en ervaringen van de volgende
kandidaten. Uiteraard hoopt HollandBIO dat de pilot in de nabije toekomst
resulteert in een verbeterd proces van registratie en vergoeding, waarbij
innovatieve geneesmiddelen significant sneller beschikbaar zijn voor
Nederlandse patiënten.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-06-16 16:01:562020-06-16 16:01:57Geneesmiddel sneller van lab naar patiënt: eerste parallelle procedure CBG-ZIN afgerond
ISA Pharmaceuticals Strengthens Strategic Immuno-Oncology Collaboration with Regeneron
Gezondheid, InnovatieklimaatISA Pharmaceuticals, a private clinical-stage immunotherapy company, plans to initiate a potentially pivotal clinical trial for the combination of ISA101b and Libtayo® (cemiplimab) in oropharyngeal cancer, a type of head-and-neck cancer, under its strategic immuno-oncology collaboration with Regeneron. In addition, Regeneron will increase its equity stake in ISA Pharmaceuticals.
The new oropharyngeal cancer trial is the third trial planned under the clinical collaboration between ISA Pharmaceuticals and Regeneron. ISA101b, an immunotherapy targeting human papillomavirus type 16 (HPV16), is currently in a Phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck cancer in combination with Libtayo, a PD-1 inhibitor that is being jointly developed by Regeneron and Sanofi. A second Phase 2 trial investigating the same combination in cervical cancer is also planned. More than 60 percent of head-and-neck cancers and approximately 55 percent of cervical cancers are HPV16 induced.
Under the revised agreement, the clinical collaboration offers a potential shortened path to first approval in the HPV16-positive oncology indications being studied in the next few years. The agreement also streamlines ISA Pharmaceuticals’ access to license fees, milestone payments and royalties. Together with the recently secured 20 million Euro loan from the European Investment Bank, development of ISA101b is now fully funded through the data readout of ongoing and planned pivotal trials which will support regulatory filings.
“This agreement will accelerate the development and commercialization of our lead asset, ISA101b, to treat two important cancers with high unmet medical needs.” commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals.“We are extremely pleased to be working with Regeneron and for their continued support of both ISA Pharmaceuticals and our clinical studies in both indications.”
“Thanks to this updated clinical collaboration, we are able to rapidly diversify our research into a broader array of HPV16-induced cancers,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. “ISA101b offers a validated mechanism of action, and we look forward to working with ISA Pharmaceuticals to determine the synergistic potential of combining this novel immunotherapy with Libtayo to better address these difficult-to-treat cancers.”
Source: ISA Pharmaceuticals
Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
GezondheidJohnson & Johnson today announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic.”
The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.
The Company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.
As the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, it continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access. The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.
COVID-19 is caused by SARS-CoV-2, which belongs to a group of viruses called coronaviruses that attack the respiratory system. There is currently no approved vaccine for COVID-19.
For more information on Johnson & Johnson’s multi-pronged approach to combatting the pandemic, visit: www.jnj.com/coronavirus.
Source: Johnson & Johnson (press release)
In Ovo awarded €2.5 million EU grant
Voedsel en materialen, InnovatieklimaatIn Ovo, spinoff from Leiden University, will receive €2.5 million from the prestigious European Innovation Council (EIC) Accelerator Pilot grant to support its mission to stop the culling of male chicks around the world.
Every year, the poultry industry culls 6.5 billion chicks. These are male, don’t lay eggs and so they are useless in egg production. In Ovo develops a high-throughput screening machine, that gender types the egg instead of the chick. The machine will make it possible to only hatch the females and prevents the killing of billions of male chicks. The company works in collaboration with a number of large industry players and technology providers and is well on its way to solve this decades old problem. Germany and France are putting legislation in place to end the culling of day-old chicks by 2022 and the technology that In Ovo is working on will help make this a reality.
The EIC Accelerator
The EIC Accelerator (previously known as the SME Instrument) is part of the European Innovation Council (EIC) pilot that supports top-class innovators and entrepreneurs with funding opportunities and acceleration services. The EIC Accelerator supports high-risk, high-potential small and medium-sized companies to help them develop and launch new innovative products and services that could drive economic growth.
“This subsidy enables us to speed up development, scale up the company, and will have massive positive impact on the poultry industry across the globe”, says Wouter Bruins, director at In Ovo. “We are grateful and very happy to receive such a prestigious grant and look forward to working with the council on accelerating our business. Together, we can improve both sustainability and animal welfare in food production on a very large scale.”
In Ovo is one of only 72 companies that are awarded the grant. During this round, the EIC received 3,976 applications from companies based in more than 20 European countries, making it the most competitive round of this funding instrument to date. The company was supported by Scale-up Ventures and the Netherlands Enterprise Agency (RVO).
The company
In Ovo is a spinoff from Leiden University, founded by Wil Stutterheim and Wouter Bruins. It aims to positively impact the lives of billions of chicks and thousands of farmers, through the development and launch of new technologies. In Ovo is previously supported by investments from Leiden University, Evonik Industries and VisVires New Protein.
Source: In Ovo
Inclusieve Vaccin Alliantie sluit deal met AstraZeneca
Gezondheid, InnovatieklimaatDe Inclusieve Vaccine Alliantie (IVA) heeft afspraken gemaakt met AstraZeneca over de levering van in totaal 300 tot 400 miljoen doses van het COVID-19-vaccin AZD1222 van de Oxford Universiteit. Als alles goed gaat, worden de eerste leveringen voor het einde van dit jaar verwacht. Binnen de IVA bundelen Duitsland, Frankrijk, Italië en Nederland de krachten in de onderhandeling met ontwikkelaars en producenten van potentiële coronavaccins. De deal met AstraZeneca zijn de eerste afspraken van de alliantie om te zorgen dat een potentieel coronavaccin voor Europa snel beschikbaar kan komen.
De corona-pandemie stelt de wereld voor ongekende uitdagingen. Wereldwijd bundelen partijen de krachten om zo snel mogelijk effectieve vaccins en geneesmiddelen te ontwikkelen. Dat vergt meer dan investeren in onderzoek alleen. In een recente publicatie gaat de Organisatie voor Economische Samenwerking en Ontwikkeling (OESO) in op de vraag hoe beleid de eerlijke en universele toegang tot behandelingen en vaccins voor het coronavirus kan stimuleren. De OESO adviseert publieke partijen ook later in het proces te investeren, te helpen om het risico te dragen, pull mechanismen uit te werken, om productiecapaciteit uit te breiden parallel aan ontwikkeling en bovenal grootschalige internationale samenwerking. Met haar aanpak lijkt de IVA die aanbevelingen ter harte te nemen.
Lees meer
MIT COVID-19 Challenge; sequel in the Netherlands
Hollandbio, InnovatieklimaatOn Friday the 12th of June, a couple of international teams that joined the MIT COVID-19 Challenge at the beginning of April had the opportunity to pitch their solutions against COVID-19 to a group of Dutch stakeholders from the Life Sciences & Health community to explore possibilities to implement their solution in the Netherlands.
HollandBIO is proud supporter of the MIT COVID-19 Challenge and together with Health~Holland, Innovation Attaché Network in the US and the team of the MIT COVID-19 Challenge organized this follow-up pitch session. After the pitches, the Dutch stakeholders offered support for collaboration and implementation possibilities.
Due to great interest a lot of Dutch partners joined the pitch session including NeLL, Takeda, Invest in Holland, Noaber Foundation, Taskforce Health Care, RVO, NL Venture Builders, InnovationQuarter, ZonMW and the Dutch Taskforce for Applied Research (SIA). Especially in times when the focus tends to be national, support of cross-border collaboration should be supported.
DSM to add world-leading animal nutrition and health specialty businesses with acquisition of Erber Group
Voedsel en materialen, InnovatieklimaatRoyal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces that it has reached agreement to acquire Erber Group for an enterprise value of €980m. The value of the transaction represents an EV/EBITDA multiple of about 14x the 2020 EBITDA (fiscal year ending September 2020). The transaction – which excludes two smaller units in the Erber Group – is expected to be earnings enhancing in the first year upon completion.
Erber Group’s specialty animal nutrition and health businesses, Biomin and Romer Labs, specialize primarily in mycotoxin risk management, gut health performance management, and food and feed safety diagnostic solutions, expanding DSM’s range of higher value-add specialty solutions. Romer Labs also complements DSM’s human nutrition and health offering to food industry customers. Sanphar and EFB, representing 7% of Erber Group’s total sales, are not included in this transaction.
The acquired businesses have combined sales of €330m and an Adjusted EBITDA margin above 20% for the twelve months to the end of March 2020, with a high single-digit organic sales growth rate over the past 5 years. The acquisition will be debt financed, with committed bridge financing in place. DSM continues to benefit from a strong balance sheet and remains committed to maintaining a strong investment grade credit profile.
With state-of-the-art research and manufacturing facilities and approximately 1,200 employees around the world, the acquisition of Erber Group is a unique strategic opportunity that provides revenue-enhancing synergies from the combined offering, global customer base, and complementary geographic strengths. Austrian-based Erber Group offers DSM the opportunity to enter the mycotoxin risk management market as the world leader and extends the company’s position as one of the top suppliers in the rapidly growing animal gut performance management market.
Mycotoxins occur as a result of natural fungus contaminants in animal feed and threaten the health of both animals and humans. In addition to increasing the risk of illness, mycotoxins also reduce the nutritional value of feed. Biomin’s patented and proprietary technology provides the most scientifically advanced mycotoxin protection available. Biomin is also a major producer of phytogenic and probiotic feed alternatives to antibiotics, which complements and strengthens DSM’s position in the rapidly growing global eubiotics market for improving animal gut health.
Romer Labs is at the forefront of diagnostic technology with innovative testing solutions for the analysis of mycotoxins in feed and food, food allergens and pathogens as well as veterinary drug residues, with accredited full-service labs in Austria, UK, USA and Singapore. DSM’s extensive global network of food and beverage customers as well as feed customers stand to benefit from Romer Labs’ expertise and the combined group’s data-based quality assurance offering.
The acquisition of Erber Group further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use of water and land.
Source: DSM
Zorginstituut vraagt input voor Horizonscan geneesmiddelen
GezondheidVorige week verscheen de nieuwste Horizonscan Geneesmiddelen – inclusief COVID-19 special. Vanwege het grote aantal producten en de snel opvolgende ontwikkelingen wordt het overzicht van geneesmiddelen tegen COVID-19 maandelijks door het Zorginstituut geactualiseerd. Daarnaast start het Zorginstituut (ZIN) met de voorbereiding van de volgende, halfjaarlijkse update.
Met deze scan brengt ZIN patiënten, behandelaars, ziekenhuizen, zorgverzekeraars en overheidsorganen vroegtijdig op de hoogte van ontwikkelingen op het gebied van geneesmiddelen. Verwacht je de aankomende twee jaar geneesmiddelen op de markt te brengen? Of uitbreidingen van bestaande indicaties? Dan zoekt het ZIN jouw bijdrage voor de volgende scan.
Met de nieuwe uitvraag verzamelt ZIN gegevens voor de scan die in december 2020 live gaat. De deadline voor het aanleveren van input is 3 augustus 2020. Producten verschijnen overigens sowieso op de scan, ongeacht of de fabrikant informatie aanlevert. Het Zorginstituut gebruikt hiervoor informatie van “(Horizon)scanners” en werkgroepen van experts. Door zelf informatie aan te leveren, draag je als bedrijf bij aan de volledigheid en accuraatheid van de scan. HollandBIO juicht deze mogelijkheid dan ook toe.
Meer weten of bijdragen?
ZIN licht de uitvraag en werkwijze hier op haar eigen website verder toe. Voor vragen, nadere toelichting en het insturen van input neem je contact op met het Zorginstituut via horizonscan@zinl.nl. Natuurlijk zijn we bij HollandBIO na een aantal verschenen scans ook erg benieuwd naar jullie ervaringen en suggesties voor verbeteringen. Leuk als je deze wilt delen met HollandBIO’s Britt.
Upfield and Beyond Meat choose for the Netherlands
InnovatieklimaatPlantbased leader Upfield announced plans to build a new state-of-the-art Food Science Centre and Beyond Meat will open a new co-manufacturing facility of its first production site outside the US. Both Upfield and Beyond Meat have chosen the Netherlands to realize their plans.
Both companies want to start with their activities in 2021. Upfield explains it has chosen for the Netherlands, because of the Wageningen ecosystem. Wageningen is considered as the Silicon Valley of the food industry and a world-class location for food innovation. Wageningen University is ranked as the world’s leading University in Agri-Food. Upfield will invest €50 million for their Food Science Center.
HollandBIO is working on an attractive business climate for all biotechnology related businesses, whether entrepreneurs work on innovation in plants, medicines, vaccines, cultured meat or biobased materials. By attracting these two big Agri-Food disruptors, the Netherlands demonstrates its potential role in helping to enable a transition to a more sustainable food system.
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Kite Receives EMA approval for CAR-T Cell therapy manufacturing facility in Europe
Gezondheid, InnovatieklimaatKite has received approval to implement a variation to the Yescarta Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational.
“Kite is focused foremost on the needs of patients living with cancer and we are proud to now manufacture cell therapy directly in Europe,” said Christi Shaw, Chief Executive Officer of Kite. “This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week.”
Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The facility has the capacity to produce therapy for up to 4,000 patients per year.
“With the enhanced technology and processes at our new facility we are pleased to be leading the next chapter in the manufacture and delivery of CAR T therapy,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Our new European manufacturing facility is dedicated to cutting-edge cell engineering, enabling patients to receive their potentially life-saving treatment more quickly.”
“The prognosis for patients with refractory large B-cell lymphoma is poor, with a median survival of approximately six months with the prior standard of care,” said Marie José Kersten, MD, PhD, Amsterdam University Medical Centers, Amsterdam, the Netherlands. “Timely access to cell therapy is critical, and the ability to manufacture CAR T cell therapies in Europe is welcomed by the clinical community.”
Source: Kite (press release)
Geneesmiddel sneller van lab naar patiënt: eerste parallelle procedure CBG-ZIN afgerond
Gezondheid op maat, Hollandbio, UitgelichtGoed nieuws! Rybelsus® (semaglutide tabletten) heeft als eerste geneesmiddel de pilot ‘Parallelle Procedures CBG-ZIN’ volledig doorlopen. Nederland is daarmee een van de eerste landen binnen de EU waarin het middel wordt vergoed. In de pilot wordt een werkwijze ontwikkeld voor meer parallelle processen voor registratie en vergoeding. Dat houdt in dat het vergoedingstraject al start terwijl het registratietraject nog niet is afgerond. Hierdoor is het geneesmiddel sneller toegankelijk voor de patiënt. Het sneller beschikbaar krijgen van innovatieve geneesmiddelen voor patiënten is een ambitie van de overheid, patiëntenorganisaties, behandelaren en de farmaceutische industrie.
HollandBIO is erg enthousiast over de pilot, die naadloos aansluit bij het HollandBIO programma Sneller & beter van lab naar patiënt. Binnen dit programma pleit HollandBIO voor oplossingen waarbij gezondheidswinst, innovatie én betaalbaarheid hand in hand gaan. Eén van die oplossingsrichtingen is een adaptief ecosysteem waarin registratie, vergoeding en toegang door maatwerk en samenwerking naadloos op elkaar aansluiten. De pilot is een mooie eerste stap om zo’n adaptief ecosysteem een stap dichterbij te brengen.
Wij zijn trots dat koploper Novo Nordisk zo flexibel inspeelde op deze mooie kans. We kijken uit naar de resultaten en ervaringen van de volgende kandidaten. Uiteraard hoopt HollandBIO dat de pilot in de nabije toekomst resulteert in een verbeterd proces van registratie en vergoeding, waarbij innovatieve geneesmiddelen significant sneller beschikbaar zijn voor Nederlandse patiënten.
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