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We are very encouraged by the data being presented at ASH on emapalumab in primary HLH, and we look forward to investigating emapalumab in additional diseases for which interferon gamma is considered pathogenic
Cristina de Min, Chief Medical Officer at Novimmune, and Milan Zdravkovic, Chief Medical Officer and Head of Research & Development at Sobi
Joint protection remains a significant challenge in the long-term treatment of haemophilia keeping individuals from living a life without constraints of their disease and these results confirm that our therapies can play a role in the effective prevention of joint bleeds
Milan Zdravkovic, Head of Research & Development and Chief Medical Officer
We are thrilled that the clinical data on emapalumab in primary HLH has been selected for presentation at this important medical congress. We appreciate this recognition from ASH as it confirms the relevance of the underlying science to further the understanding of HLH, and the spotlight this shines on a very rare life-threathening disease. This would not have been possible without the support of the study investigators and participanting patients over a number of years
Milan Zdravkovic, Chief Medical Officer and Head of Research & Development at Sobi
The FDA approval of Gamifant marks an important milestone in Sobi’s vision to bring transformative treatments to patients with a high medical need,
Guido Oelkers, Sobi President and CEO
As the largest Sweden-based pharmaceutical company listed on Nasdaq Stockholm, our growth in the European financial market has been substantial over the past years. Paula has an excellent network and knowledge of the field and we look forward to expand and further develop our relations with investors and the financial community under her leadership
Guido Oelkers, CEO
I am excited about adding Synagis to our portfolio as it remains the only product preventing RSV infection in this vulnerable patient group with a great medical need. The addition of Synagis will become an important strategic catalyst for Sobi’s future development and will form a powerful platform for growth in rare diseases.
Guido Oelkers, CEO
The strong growth continued during the quarter.
Guido Oelkers, CEO
Sobi has unique capabilities, a heritage in biologics manufacturing, development and supply, and a very exciting future within the rare disease space. I look forward to working with the teams to develop an effective and agile organisation set for growth.
Anne Marie de Jonge Schuermans
I am very pleased that we were able to enrol the first patient in this important study. We look forward to learning more about how SOBI003 may potentially be able to help patients in the future as we enrol more patients into the study,
Dr. Paul Harmatz, UCSF Benioff Children's Hospital in Oakland California.
We believe this transaction is an excellent fit for Sobi and consistent with our strategy of expanding our commercial Specialty Care portfolio, stengthening our business in the US.
Guido Oelkers, Sobi CEO and President
We see transparency as an integral part of our business, and the EFPIA Disclosure Code is an important mechanism for ensuring long-term trust for and within our industry. Dialogue and interaction between healthcare professionals and organisations is essential in building sustainable value for rare disease patients and rare disease communities around the world. Our commitment to transparency ensures that we meet the high standards for integrity that patients, prescribers, budget holders, other stakeholders and we ourselves expect
Max Tullberg, Chief Compliance Officer at Sobi
By gathering data on outcomes such as physical activity and joint health status, we maintain our focus on research that reflects a meaningful difference for patients, providing protection beyond bleed prevention. The real-world data generated thus far support the safety profile of our products. Since both products are indicated for all age groups, in prophylaxis, on-demand as well as in surgery, they also provide the opportunity for individualised treatment.
rmin Reininger, Senior Vice President, Head of Medical and Scientific Affairs
2017 was a great year and 2018 is off to a strong start, with total revenue growth of 41 per cent, leading to revenues of SEK 1,964 M for the quarter. Elocta and Alprolix® continued to deliver impressive results in Haemophilia, and both Kineret and Orfadin® showed solid growth in Specialty Care. The FDA accepted an Investigational New Drug (IND) application for SOBI003 and granted Fast Track status. Kineret received a positive opinion for the treatment of Still’s disease in the EU, followed by the European Commission (EC) approval after the end of the quarter.
Guido Oelkers, CEO
With this new indication, patients with Still’s disease will get access to an alternative treatment with an established safety profile
Norbert Oppitz, Head of Specialty Care
His experience from the pharmaceutical industry, numerous company integrations and the global roles he has held will be of great value for Sobi, supporting our organisation and our journey to become a global leader in rare dise
Guido Oelkers, CEO
Sustainability is a vital part of our vision and overall corporate strategy. A sustainable business entails a commitment to responsibility for patients and employees, reduced environmental impact from operations and treatment, as well as long-term sustainable profitability so that we can continue to reinvest in developing new therapies for rare diseases and serve our communities for many years to come
Guido Oelkers, CEO
It is a pleasure to welcome Henrik to Sobi. His experience from the pharmaceutical industry and specifically from acquisitions and deal making in specialty pharma will be of immense value for Sobi on our journey to become a global leader in rare diseases and specialty care
Guido Oelkers, CEO
We are very pleased with the CHMP positive opinion which recommends including this indication for Kineret in the EU. Sobi is committed to improving the lives of people affected by rare diseases, and this recommendation, if approved by the European Commission, would help address an unmet medical need for people with Still’s disease
Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi
“2017 was an outstanding year for Sobi. We delivered and exceeded expectations. Our Haemophilia franchise continues to grow rapidly. During the year, we established our new business area Specialty Care which we expect to be a strong contributor to future growth. We also made advancements in our pipeline portfolio, initiating several clinical studies.”
Guido Oelkers, CEO
“With the outcome of the adjudication of both of these tenders, Sobi has demonstrated our desire to provide access to these innovative products in a very sustainable manner.”
Steve Bojakowski, Sobi’s Patient Access Lead for the UK and the Republic of Ireland
We are very pleased with the IND acceptance and Fast Track status granted by the FDA. It is an important step towards initiating the first clinical study with SOBI003 in children affected by MPS IIIA. The Fast Track status granted by the FDA is a milestone and acknowledgement of the significant unmet medical need that SOBI003 may be fulfilling
Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi
In collaboration with Bioverativ, we will continue to explore the potential of Alprolix to reduce the burden of disease and create meaningful improvement in the lives of people living with haemophilia
Armin Reininger, M.D.,Ph.D., Head of Medical and Scientific Affairs, Sobi
Together with Bioverativ, we have long been committed to transforming the care of people with haemophilia through our treatments and ongoing research
Armin Reininger, M.D., Ph.D., Head of Medical and Scientific Affairs, Sobi
The introduction of new nitisinone dosing options, such as Orfadin oral suspension, is the result of Sobi listening to feedback from patients and caregivers and continuing to innovate to meet their needs
Bob McLay, Vice President and General Manager of Sobi Canada Inc.
We are very pleased with having initiated this confirmatory clinical study investigating the safety and efficacy of anakinra in people with Still’s disease. This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need
Milan Zdravkovic, Senior Vice President, Chief Medical Officer and Head of Research & Development at Sobi.
Krassimir Mitchev, MD, PhD, Vice President and Medical Therapeutic Area Head of Haemophilia at Sobi
We are very encouraged by the results of this study as they reinforce the positive impact prophylactic treatment with Elocta/ELOCTATE has the potential to provide on joint health and patient outcomes
A strong business performance was shown across the portfolio in the third quarter, with the main contributors being Elocta and Alprolix. Elocta sales increased more than 600 per cent compared to the same period last year and Alprolix sales increased with approximately 500 per cent. This strong growth momentum encourages us to be confident around the prospects of our Haemophilia franchise.
Guido Oelkers, CEO
We are delighted that Norbert could join Sobi. Norbert is a true entrepreneur, and his experience will be instrumental in realising our ambitions to bring Sobi to the next level as we look for external growth opportunities for our Specialty Care business
Guido Oelkers, President and CEO of Sobi
We are very happy to receive the approval by the FDA of the new dosing frequency for Orfadin. Orfadin is the first nitisinone product approved for once daily use in the US This is an important step towards reducing the treatment burden of people with HT-1 and it follows Sobi’s introduction of Orfadin 20mg capsules and Orfadin oral suspension
Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research & Development at Sobi.
New data will reinforce that Elocta and Alprolix treatment can maintain low ABRs, therefore helping improve the long-term quality-of-life for people with haemophilia A and B
Krassimir Mitchev, MD, PhD, Vice President and Medical Therapeutic Area Head of Haemophilia at Sobi
We are very pleased with the orphan drug designation from the FDA for SOBI003. MPS IIIA is a severe and debilitating disease, and this development program is an important part of our mission of being pioneers in rare diseases. We are currently in the late pre-clinical phase and expect to initiate the first clinical trial with SOBI003 in 2018
Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi.
The availability of funding for Xiapex within NHS England is an important milestone for the Dupuytren’s community in the UK, as healthcare professionals can now offer people with contracture a non-invasive treatment option
Neil Dugdale, General Manager UK & RoI at Sobi
We are committed to improving the lives of people with Haemophilia B, and consider this an important step forward to reduce the treatment burden
Milan Zdravkovic, Senior Vice President, Chief Medical Officer and Head of Research & Development at Sobi
The approval of Elocta in Saudi Arabia is an important development for the haemophilia community in the Middle East and will enable physicians to offer their patients a wider range of treatment options
Ahmad Abu-Dahab, Regional Director Middle East, & Turkey
obi’s vision is to support that patients are diagnosed at birth, receive effective and sustainable therapy, and go on to live full and healthy lives no matter where in the world they live. This approval is another important step on this journey,
Bodil Jonason, Vice President Commercial Operations and Head of Global Brands at Sobi.
We took a major step in 2016 by launching Elocta and Alprolix, two first in class extended half-life Fc fusion clotting factors to people with haemophilia in Europe and in parts of the Middle East
Geoffrey McDonough
Sobi has a long-term commitment to improve the lives of people living with HT-1, and the modified storage recommendation is a further step in this journey
Bodil Jonason, Vice President Commercial Operations and Head of Global Brands at Sobi
The interim data from B-YOND confirm the safety profile of Alprolix, and show that adult, adolescent and paediatric subjects maintained low annual bleed rates with prophylactic dosing of Alprolix every 1-2 weeks
John Pasi, MD, PhD, principal investigator of the study, Professor of Haemostasis and Thrombosis at The Royal London Hospital, Barts and the London School of Medicine and Dentistry
“Sobi is committed to providing a consistent and reliable supply of Elocta across our territories and the recent EMA approval is another important step toward fulfilling that commitment
Philip Wood, Vice President and Commercial Therapeutic Area Head Haemophilia at Sobi
Through Fc fusion technology, Alprolix uses the body’s natural pathway to prolong the time the therapy remains in the body
Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of haemophilia at Sobi
Sobi has a long-term commitment to improve the lives for people affected by hereditary tyrosinemia type 1, and the above modified dosing regimen is a further step in this journey
Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research & Development at Sobi.
A-SURE is an important study which aims to evaluate the effectiveness of Elocta in a real world-setting
Stefan Lethagen, Vice President Medical & Clinical Sciences, Haemophilia at Sobi
There is a persistent and significant unmet medical need for resolving pain in people affected by acute gout, and there is a strong scientific rationale for investigating the safety and efficacy of anakinra in this disease
Milan Zdravkovic, Senior Vice President, Head of Research & Development at Sobi
“Sobi has been committed to supporting the HT-1 community globally for more than two decades, and we were the first to develop this treatment and make it available in Canada through Health Canada’s Special Access Programme
Bob McClay
We are happy to build on our successful relationship with Horizon Pharma to support providing treatment to people living with UCDs
Alan Rafensperger
We believe that Sobi's current distribution of Ammonaps uniquely qualifies it to effectively provide Ravicti to people living with UCDs in European markets.”
Francoise de Craecker
The overall results indicate that there is a significant need to advance standard of care within haemophilia
Stefan Lethagen, Vice President Medical & Clinical Sciences, Haemophilia at Sobi.
MPS IIIA is a severe and debilitating disease with devastating consequences for patients. We hope that SOBI003 will provide these patients with a treatment where there is none today
Stephen James, Head of Research and Translational Sciences
Securing reimbursement for Alprolix across the UK, relatively soon after EU marketing authorisation approval is an important milestone toward making this new development in haemophilia B therapy available to people and families living with haemophilia B
Neil Dugdale, General Manager UK & Republic of Ireland
Milan brings an creative global translational and development profile which can build and expand upon our strong legacy of biologics innovation.”
Geoffrey McDonough, President and CEO at Sobi
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