Novartis acquisition of Vedere Bio : US-based stealth-stage company Vedere Bio has been acquired by Swiss pharma giant Novartis in a deal worth up to $280 million, for its preclinical intravitreally-injected AAV gene therapy programs.
The company is engaged in advancing photoreceptor-protein-based optogenetic therapies that are intravitreally delivered to the retina for restoring functional vision.
Vedere Bio’s shareholders were paid $150 million upfront and will stand to receive up to $130 million in payments based on achieving early regulatory and clinical milestones.
Jay Bradner – President of the Novartis Institutes for BioMedical Research, commenting on Novartis acquisition of Vedere Bio, said: “The medical need for new therapies to treat blindness is unambiguous.
“Vedere Bio’s innovative technologies expand the potential for gene therapy to improve the lives of patients facing vision loss due to photoreceptor death attributable to a number of prevalent eye diseases.”
The company was formed in June 2019 in the Atlas Venture incubator.
Vedere Bio was launched with a Series A financing of $21 million. The optogenetics gene therapy company started lab operations at LabCentral in Cambridge, Massachusetts where it is said to have advanced its lead programs from concept to development candidate within 12 months.
Just ahead of its acquisition by Novartis, some of the earlier-stage vision restoration and vision preservation assets, which leveraged its ocular gene therapy toolbox were spun out into a newly formed entity called Vedere Bio II.
Commenting on Novartis acquisition of Vedere Bio, Cyrus Mozayeni – CEO, President of Vedere Bio and Atlas Venture Entrepreneur in Residence said: “Vedere Bio’s photoreceptor-protein-based optogenetics program has important advantages over competing approaches and brings us one step closer to delivering functional vision to patients in need. Our proprietary intravitreal capsids enable not only Vedere Bio’s optogenetics products but also other ocular gene therapies.
“Our sale to Novartis is an important milestone in advancing Vedere Bio’s most advanced programs to patients around the world. At the same time, I look forward to working with our experienced team to advance our highly innovative, earlier stage assets as part of the newly established Vedere Bio II.”]]> https://www.pharmanewsdaily.com/novartis-acquires-optogenetics-gene-therapy-company-vedere-bio/feed/ 0 77132
Eli Lilly and Company (Lilly) has signed a $375 million deal with the US government for the supply of 300,000 vials of bamlanivimab (LY-CoV555) 700mg, an investigational neutralizing antibody for the treatment of Covid-19
LY-CoV555 is the first antibody candidate to come out from Lilly’s collaboration with AbCellera Biologics, which was announced in March this year. The collaboration’s objective is to develop antibody therapies for the prevention as well as treatment of the novel coronavirus.
According to Lilly, the US government will accept the vials of the neutralizing antibody if it secures an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Earlier this month, the US pharma giant had filed a request to the FDA seeking an EUA for the use of bamlanivimab in mild to moderate Covid-19 in high-risk patients.
The initial agreement between Lilly and the US government is for delivery of the neutralizing antibody over the two months after an EUA. It also offers the option for the federal government to buy up to an additional 650,000 vials till 30 June 2021, under the same terms as the initial agreement.
The deal will be subject to agreement from Lilly, availability of the product, and also the medical requirement in the country.
David A. Ricks – Lilly chairman and CEO said: “Supply agreements with governments – such as this one with the U.S. government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy.
“The U.S. is experiencing a surge in COVID-19 cases and associated hospitalizations, and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”
Lilly expects to manufacture up to a million doses of bamlanivimab 700 mg by the end of this year, with 100,000 doses ready to be dispatched within days of authorization for use across the world.
Bamlanivimab is a neutralizing IgG1 monoclonal antibody (mAb) that is directed against the spike protein of SARS-CoV-2, the virus that causes Covid-19.
Lilly had wrapped up a phase 1 study of bamlanivimab in hospitalized Covid-19 patients.
A phase 2 study in those who were diagnosed recently with Covid-19 in the ambulatory setting is going on.
On the other hand, a phase 3 study of bamlanivimab to study its ability in the prevention of Covid-19 is going on in residents and staff at long-term care facilities.
Additionally, bamlanivimab is being evaluated in the US National Institutes of Health-led ACTIV-2 study of ambulatory Covid-19 patients.]]> https://www.pharmanewsdaily.com/lilly-signs-375m-deal-to-supply-covid-19-candidate-bamlanivimab-to-us-govt/feed/ 0 77129
Exact Sciences, a US molecular diagnostics company, has agreed to acquire Thrive Earlier Detection in a cash cum stock deal worth up to $2.15 billion, in a move to become a leading player in blood-based, multi-cancer screening.
Based in Cambridge and Baltimore, Thrive Earlier Detection is a healthcare company focused on incorporating earlier cancer detection into routine medical care.
The healthcare company developed an early-stage screening test called CancerSEEK.
With an early version of the cancer screening test, Thrive Earlier Detection held a prospective, interventional study in a real-world clinical setting in 10,000 patients.
The CancerSEEK screening test by using its mutation and protein biomarker approach, is said to have achieved encouraging results by detecting 10 different types of cancer in the study. These include seven with no recommended screening guidelines, with very less false positives.
Exact Sciences, by bringing together highly complementary scientific approaches and the strengths of the two firms, anticipates developing a more accurate test and speed up the widespread adoption of the CancerSEEK screening test.
Kevin Conroy – Chairman and CEO of Exact Sciences said: “The acquisition of Thrive is a giant leap toward ensuring blood-based, multi-cancer screening becomes a reality and eventually, the standard of care. We couldn’t be more excited that Exact Sciences will be at the forefront of this incredible opportunity to serve patients.
“We have long respected the Thrive team for their rigorous scientific approach, having participated in both funding rounds as an investor. We are proud to take our partnership to the next level by leveraging Exact Sciences’ established R&D team and highly accurate testing platform to augment development of CancerSEEK and accelerate its commercialization.
“By combining the expertise of both organizations, we believe we can bring this powerful technology to patients faster.”
As per the terms of the deal, Thrive Earlier Detection will be paid $1.7 billion at the time of closing, which will be made up of 65% in Exact Sciences’ shares and 35% in cash. An additional payment of $450 million will depend upon the meeting of certain milestones associated with the development and commercialization of a blood-based, multi-cancer screening test.
David Daly – CEO of Thrive Earlier Detection said: “Thrive is driven by the knowledge that if cancer is caught early enough, it can be more effectively treated or even cured, and every patient deserves a chance for a better outcome.
“Our team has made significant progress toward our mission and we are eager to collaborate with and benefit from Exact Sciences’ expertise, and believe that together we will enable broader, quicker adoption of our test. With the support of our ongoing partnership with Johns Hopkins University, we are energized to contribute meaningfully to our shared mission of advancing the fight against cancer and providing life-changing answers to patients in need.”
The deal, which is subject to regulatory approval and the meeting of other conditions, is expected to be wrapped up during Q1 2021.
In a separate deal worth $410 million, Exact Sciences announced the acquisition of Base Genomics, an epigenetics company based in the UK, with an objective to extend its DNA methylation capabilities.]]> https://www.pharmanewsdaily.com/exact-sciences-to-acquire-thrive-earlier-detection-for-2-15bn/feed/ 0 77120
Paramit, a US-based manufacturer of medical devices and life science instruments, has signed a deal to acquire Austria-based S.I.E. SOLUTIONS, as part of a strategic expansion into Europe.
The financial terms of the deal were not disclosed.
S.I.E SOLUTIONS is engaged in providing embedded technology solutions to customers across the healthcare and security technology sectors.
Established in 1994, the company is said to have a strong footprint in Austria and Germany. It is expected to complement the existing design and manufacturing capabilities of Paramit, besides serving as the latter’s headquarters in Europe.
S.I.E SOLUTIONS, through the support and investment of the US firm, will be able to ramp up its manufacturing and development capabilities locally in Europe. Besides, it will be in a position to deliver Paramit’s combined know-how and expertise, which includes the latter’s vPoke computer directed assembly and zero defect manufacturing processes, to its customers in Europe.
Billoo Rataul – CEO of Paramit said: “The company’s experience and highly specialized focus complement Paramit’s own product development and manufacturing capabilities. Together, we will deliver an enhanced and comprehensive product realization offering to our customers around the world.
“In addition, with our highly-skilled teams and combined expertise, we can support a wider range of medical devices and life science instruments for our customers, including those delivering innovative solutions across various diagnostic, therapeutic, surgical, and drug discovery applications.”
As per the terms of the deal, Paramit will acquire System Industrie Electronic and its German subsidiary – System Industrie Electronic Deutschland.
The deal, which is subject to customary regulatory approvals, is likely to be wrapped up in Q4 2020.
Markus Dillinger and Josef Krojer – Managing Directors of S.I.E. SOLUTIONS said: “As part of the Paramit family, our customers will benefit in particular from an increase in production depth and an expansion of service capabilities.
“In addition, with our expertise in embedded solutions and our excellent market position in Europe, we can provide a strong and valuable local presence for Paramit in Europe.
“The combined and highly congruent experience of the two companies, especially in the IVD, life sciences & medical device sectors, will enable us to take advantage of the strong growth opportunities in these markets and better serve our customers.”]]> https://www.pharmanewsdaily.com/paramit-to-acquire-s-i-e-solutions-to-expand-into-europe/feed/ 0 77117
German pharma giant Bayer has agreed to acquire US clinical-stage gene therapy company Asklepios BioPharmaceutical in a deal worth up to $4 billion.
The portfolio of Asklepios BioPharmaceutical features investigational pre-clinical and clinical stage candidates, which are being developed for the treatment of neuromuscular, cardiovascular, central nervous system, and metabolic diseases.
Asklepios BioPharmaceutical was established in 2001 and is based in Research Triangle Park, North Carolina.
Through the deal, Bayer will get full rights to the US firm’s gene therapy platform, which includes an intellectual property portfolio and a contract development and manufacturing organization (CDMO), which is expected to provide a base for future partnerships in the area of adeno-associated virus (AAV) therapies.
Bayer said that the deal complements its last year’s acquisition of US cell therapy company BlueRock Therapeutics. Furthermore, it strengthens the German group’s goal to develop platforms with the potential of making an impact across multiple therapeutic areas.
Stefan Oelrich – President of Bayer Pharmaceuticals Division, commenting on Bayer acquisition of Asklepios, said: “As part of our strategy, we are building new therapeutic platforms including cell and gene therapies.
“As an emerging leader in the rapidly advancing field of gene therapies, the expertise and portfolio of AskBio supports us in establishing highly innovative treatment options for patients and further strengthens our portfolio.
“We want to help patients whose medical needs are not yet met by today’s treatment options and we are looking forward to work together with the team at AskBio.”
As per the terms of the deal, Bayer will pay Asklepios BioPharmaceutical an upfront amount of $2 billion followed by up to $2 billion in the form of potential success-based milestone payments.
Bayer said that nearly 75% of the potential success-based milestone payments are likely to be made during the course of the coming five years and the remaining amount later on.
Asklepios BioPharmaceutical will continue to operate as a standalone company on an arm’s-length basis after the acquisition, said Bayer.
Commenting on Bayer acquisition of Asklepios, Sheila Mikhail – CEO and Co-Founder of AskBio BioPharmaceutical, said: “With Bayer‘s worldwide reach and translational expertise, especially in pathway diseases, our combined cultures of scientific advancement and commitment to patients, along with the retention of AskBio’s independent structure, Bayer and AskBio are positioned to provide accelerated development of gene therapies to treat more patients who can benefit from them.”
Bayer acquisition of Asklepios is expected to be wrapped up in Q4 2020 once it satisfies customary closing conditions such as obtaining the necessary regulatory approvals.]]> https://www.pharmanewsdaily.com/bayer-to-acquire-us-gene-therapy-company-asklepios-in-4bn-deal/feed/ 0 77108
AstraZeneca said that clinical trials for the AZD1222 Covid-19 vaccine candidate, have resumed in various parts of the world after regulators across the US, UK, Brazil, Japan, and South Africa confirmed that it was safe to continue them.
The US Food and Drug Administration (FDA) has authorized the restart of AZD1222 clinical trials in the US after the resumption of trials in other nations in recent weeks.
AstraZeneca said that the FDA looked into all safety data from trials in other parts of the world and came to the conclusion that it was safe to resume the Covid-19 vaccine trial.
It can be noted that AstraZeneca had to pause AZD1222 vaccination in all its global trials on 6 September to enable independent monitoring committees to examine its safety data. This was part of the standard review process for safety events for clinical trials, said the pharma giant.
The global trials for AZD1222, which was co-invented by the University of Oxford and its spin-out company – Vaccitech, were paused last month following an unexplained event of a participant becoming unwell.
AstraZeneca said that the recommendations from the reviews of the independent monitoring committees have been backed by international regulators, who also confirmed that the AZD1222 Covid-19 vaccine trials were safe to resume.
Pascal Soriot – CEO of AstraZeneca said: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
AstraZeneca said that is not rare that in large scale vaccine trials, certain participants become sick, and every case has to be studied to make sure of the careful assessment of safety.
The pharma giant expects results from the late-stage trials later this year, based on the rate of infection within the communities where the studies are being held.
AstraZeneca will submit data readouts to regulators and publish them in peer-reviewed scientific journals. The pharma giant said that rolling reviews of the AZD1222 Covid-19 vaccine candidate have already commenced in countries where this regulatory pathway has been set up, giving regulators access to data as soon as they are ready.]]> https://www.pharmanewsdaily.com/astrazeneca-resumes-azd1222-covid-19-vaccine-trials-after-brief-pause/feed/ 0 77105
Precision Nanosystems (PNI) has received a funding boost of up to CAD 18.2 million from the Canadian government to develop a mRNA vaccine for Covid-19.
The funding from Canada’s Innovation, Science and Economic Development’s (ISED) Strategic Innovation Fund (SIF) will help the Vancouver-based biotech company to move its Covid-19 mRNA vaccine candidate to clinical trials.
Navdeep Bains – Canada Minister of Innovation, Science and Industry said: “An effective vaccine will be critical as we work to contain the COVID-19 virus and prevent future infections.
“Today’s contribution will support PNI to advance the development of an mRNA vaccine candidate through pre-clinical studies and clinical trials to help protect Canadians.”
Precision Nanosystems caters to more than 250 industry and academic partners with solutions for the development of vaccines, cell therapies, and gene therapies, in the areas of oncology, infectious diseases, and rare diseases.
With the investment from the Canadian government, Precision Nanosystems’ Chief Scientific Officer Dr Andrew Geall and his team will use their technology platforms and expertise in self-amplifying mRNA vectors, lipid-based drug delivery systems and nanomedicine manufacturing for developing a cost-effective vaccine for Covid-19.
James Taylor – CEO and co-founder of Precision Nanosystems said: “Since its inception PNI has executed on its mission to accelerate the creation of transformative medicines.
“It is an honor to be supported by the Canadian government in this global fight against COVID-19 and to further build capabilities for rapid response against COVID-19 and future pandemics.”]]> https://www.pharmanewsdaily.com/covid-19-mrna-vaccine-precision-nanosystems-gets-funding-boost-from-canadian-govt/feed/ 0 77102
Gilead Sciences has wrapped up its previously announced $21 billion acquisition of New Jersey-based biopharma company Immunomedics.
With the completion of the deal, Immunomedics has now become a fully-owned subsidiary of Gilead Sciences. The common stock of Immunomedics will be delisted from the Nasdaq Global Market.
Immunomedics, which has been acquired for $88 per share in cash by the US pharma giant, has been engaged in developing antibody-drug conjugates (ADCs) for the treatment of hard-to-treat cancers.
The company’s Trodelvy (sacituzumab govitecan-hziy) is the first ADC to be approved by the US Food Drug and Administration (FDA) for the treatment of metastatic triple-negative breast cancer. Trodelvy is also the first anti-Trop-2 ADC to have been approved by the FDA.
Commenting on Gilead acquisition of Immunomedics, Daniel O’Day – Chairman and CEO of Gilead Sciences said: “We are very pleased to reach today’s milestone and to welcome the talented Immunomedics team to the Gilead family. There is a lot of important work ahead of us to deliver on the vast potential that Trodelvy offers for patients with cancer.
“Together we will bring Trodelvy to many more patients around the world with triple-negative breast cancer and continue to explore its potential in many other types of cancer, both as a monotherapy and in combination with other treatments.”
Meanwhile, Gilead Sciences has bagged Remdesivir FDA approval for the treatment of Covid-19 in patients needing hospitalization.]]> https://www.pharmanewsdaily.com/gilead-sciences-wraps-up-21bn-acquisition-of-immunomedics/feed/ 0 77096
Remdesivir FDA approval : Gilead Sciences, a California-based biopharma company, has bagged approval from the US Food and Drug Administration (FDA) for its antiviral drug Veklury (remdesivir) for Covid-19 treatment in patients requiring hospitalization.
This makes remdesivir the first approved treatment for coronavirus in the US.
Remdesivir FDA approved indication : Veklury has been approved by the FDA for the treatment of adults and pediatric patients, aged 12 years and who weigh a minimum of 40 kilograms.
The antiviral drug from Gilead Sciences has already been used for Covid-19 treatment under the emergency use authorization (EUA) issued by the FDA in May 2020 amid huge number of corona cases in the US.
It has to be noted that Remdesivir FDA approval does not cover the entire population that was authorized to be treated by the drug under the emergency use authorization.
To address this, the FDA has revised the emergency use authorization to cover those who are suspected to have Covid-19 or are confirmed to have as per lab tests and are aged under 12 years or weigh between 3.5 kilograms and 40 kilograms. The FDA said that clinical trials are going on to understand the safety and efficacy of Veklury (remdesivir) in this type of pediatric population.
Stephen M. Hahn – FDA Commissioner, commenting on Gilead Sciences remdesivir FDA approval, said: “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.
“As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Veklury (remdesivir) has been approved by the FDA based on the data of three randomized, controlled trials in Covid-19 patients hospitalized with mild-to-severe symptoms.
One of the three remdesivir clinical trials is the phase 3 ACTT-1 trial sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
In the ACTT-1 Covid-19 clinical trial, remdesivir could provide clinically meaningful improvements in multiple outcome assessments in the participating patients, in comparison to placebo.
The average Covid recovery time for patients treated with Veklury (remdesivir) was 10 days in the ACTT-1 clinical trial, compared to 15 days for those in the placebo group.
Commenting on Gilead Sciences remdesivir FDA approval, Daniel O’Day – Chairman and CEO of Gilead Sciences, said: “Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.
“The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”
In July 2020, Gilead Sciences was given conditional marketing authorization for Veklury (remdesivir) from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind Covid-19. Read more about – Veklury EU approval for Covid-19 treatment here.]]> https://www.pharmanewsdaily.com/gilead-sciences-bags-remdesivir-fda-approval-for-covid-19-treatment/feed/ 0 77093
VelosBio, a San Diego-based biopharma company, said that it has dosed the first patient in a phase 2 clinical trial of its investigational antibody-drug conjugate (ADC) VLS-101 in patients having solid tumors.
VLS-101, which is the company’s lead product candidate, targets a cell-surface protein called ROR1.
Expressed during embryofetal development, ROR1 is however not seen before birth. It is generally not expressed on normal cells in either children or adults but can reappear on malignant tissues, including on solid tumors.
By targeting the ROR1 protein, VLS-101 is designed to selectively deliver cancer-fighting therapeutics to tumor cells, while not affecting normal cells.
The mid-stage clinical trial of VLS-101 will aim to enroll patients who were previously treated with solid tumors. These include breast cancer, lung cancer, and other cancer that are thought to express ROR1.
The participating patients will be administered with VLS -101 2.5 mg/kg intravenously once every three weeks as long as they are safely benefiting from the drug candidate.
The primary endpoint of the phase 2 trial is the objective response rate as determined by standard response criteria. The clinical trial will evaluate safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the investigational antibody-drug conjugate and study the influence of biomarkers on the result.
Dave Johnson – CEO of VelosBio said: “VLS-101 dosing of the first patient in our Phase 2 solid tumor trial represents a key milestone for our lead ROR1-directed clinical program.
“Based on the broad expression of ROR1 across different cancer types, and our pre-clinical data showing VLS-101 antitumor activity in solid tumors, we are excited to advance this investigational candidate as a potential new therapy for difficult-to-treat cancers.”]]> https://www.pharmanewsdaily.com/velosbio-begins-phase-2-trial-of-vls-101-in-solid-tumors/feed/ 0 77064