STOCKHOLM, Sweden I June 12, 2019 I Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has signed an agreement to acquire, from Novimmune’s shareholders, a newly established company owning emapalumab and related assets, giving Sobi access to world-class R&D capabilities in the field of Immunology. The acquisition means that the previously announced exclusive licence agreement with Novimmune will be superseded.
Through the acquisition of emapalumab, Sobi gains access to:
- All assets relating to emapalumab including intellectual property, patent rights, data and know-how
- All relevant and highly experienced employees involved in the clinical and biopharmaceutical development of emapalumab
- Options for the shared financial rights to NI-1701 and NI-1801, two product candidates in the field of immuno-oncology
- A priority review voucher within the US Food & Drug Administration’s priority review programme, which offers companies investing in orphan drugs a cost reduction for the application fee for future products and shortens the review period. The voucher can be used or sold by Sobi.
The consideration for the acquisition is CHF 515 M (SEK 4,897 M), of which CHF 400 M was previously committed in the exclusive licence agreement for emapalumab. The acquisition is expected to be earnings neutral in 2019 and completed during Q3 2019, subject to customary closing conditions.
The acquisition is debt-financed, with new credit facilities made available by BNP Paribas, Danske Bank, Skandinaviska Enskilda Banken and Svenska Handelsbanken.
“The acquisition of emapalumab and related assets is an important step in the transformation of Sobi in becoming a global leader in rare diseases,” says Guido Oelkers, Sobi President and CEO. “This will allow us to realise the full potential of emapalumab as an important treatment in the area of Immunology and address a significant unmet medical need.”
“Immunology is one of our key focus areas where we can make a significant difference to patients’ lives. We look forward to welcoming our new colleagues to join us in this mission and create an even stronger Sobi.”
Ed Holdener, Chairman of Novimmune, says: “I have spent 11 years with Novimmune and I am extremely positive about the future of what we have built. The selected teams will become a part of Sobi, a leading rare disease company. Based on our collaboration over the past 12 months I can see a nice and growing cultural fit between the two organisations. I am proud that the commercialisation of emapalumab, marketed as Gamifant in the US, is making excellent progress. It pays tribute to the hard work of our teams who have developed this drug.”
Martin Ebner, the representative of Patinex and BZ Bank holding a majority interest in Novimmune, adds: “I have been supporting Novimmune over the past 15 years. I am greatly pleased that I have helped bring an important medicine like emapalumab to patients with a high unmet medical need. I believe that Sobi will be a good owner of this business.”
About emapalumab
Emapalumab is a monoclonal antibody (mAb) that binds to and neutralises interferon gamma (IFNγ). In the US, emapalumab is indicated for paediatric (newborn and older) and adult primary haemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Emapalumab is indicated to be administered through intravenous (IV) infusion over one hour twice per week until haematopoietic stem cell transplant (HSCT). Visit www.gamifant.com for more information, including full US prescribing Information.
Emapalumab was developed and submitted for approval to the FDA by Novimmune. Sobi acquired the global rights to emapalumab from Novimmune through an exclusive licensing agreement announced in July 2018, which is now superseded by the above announced acquisition.
About Sobi
At Sobi, we are transforming the lives of people affected by rare diseases. As a specialised international biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of haematology, immunology and specialty care. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving. The hard work and dedication of our approximately 1050 employees around the globe has been instrumental in our success across Europe, North America, the Middle East, Russia and North Africa, leading to total revenues of SEK 9.1 billion in 2018. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.
SOURCE: Swedish Orphan Biovitrum
Post Views: 265
STOCKHOLM, Sweden I June 12, 2019 I Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has signed an agreement to acquire, from Novimmune’s shareholders, a newly established company owning emapalumab and related assets, giving Sobi access to world-class R&D capabilities in the field of Immunology. The acquisition means that the previously announced exclusive licence agreement with Novimmune will be superseded.
Through the acquisition of emapalumab, Sobi gains access to:
- All assets relating to emapalumab including intellectual property, patent rights, data and know-how
- All relevant and highly experienced employees involved in the clinical and biopharmaceutical development of emapalumab
- Options for the shared financial rights to NI-1701 and NI-1801, two product candidates in the field of immuno-oncology
- A priority review voucher within the US Food & Drug Administration’s priority review programme, which offers companies investing in orphan drugs a cost reduction for the application fee for future products and shortens the review period. The voucher can be used or sold by Sobi.
The consideration for the acquisition is CHF 515 M (SEK 4,897 M), of which CHF 400 M was previously committed in the exclusive licence agreement for emapalumab. The acquisition is expected to be earnings neutral in 2019 and completed during Q3 2019, subject to customary closing conditions.
The acquisition is debt-financed, with new credit facilities made available by BNP Paribas, Danske Bank, Skandinaviska Enskilda Banken and Svenska Handelsbanken.
“The acquisition of emapalumab and related assets is an important step in the transformation of Sobi in becoming a global leader in rare diseases,” says Guido Oelkers, Sobi President and CEO. “This will allow us to realise the full potential of emapalumab as an important treatment in the area of Immunology and address a significant unmet medical need.”
“Immunology is one of our key focus areas where we can make a significant difference to patients’ lives. We look forward to welcoming our new colleagues to join us in this mission and create an even stronger Sobi.”
Ed Holdener, Chairman of Novimmune, says: “I have spent 11 years with Novimmune and I am extremely positive about the future of what we have built. The selected teams will become a part of Sobi, a leading rare disease company. Based on our collaboration over the past 12 months I can see a nice and growing cultural fit between the two organisations. I am proud that the commercialisation of emapalumab, marketed as Gamifant in the US, is making excellent progress. It pays tribute to the hard work of our teams who have developed this drug.”
Martin Ebner, the representative of Patinex and BZ Bank holding a majority interest in Novimmune, adds: “I have been supporting Novimmune over the past 15 years. I am greatly pleased that I have helped bring an important medicine like emapalumab to patients with a high unmet medical need. I believe that Sobi will be a good owner of this business.”
About emapalumab
Emapalumab is a monoclonal antibody (mAb) that binds to and neutralises interferon gamma (IFNγ). In the US, emapalumab is indicated for paediatric (newborn and older) and adult primary haemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Emapalumab is indicated to be administered through intravenous (IV) infusion over one hour twice per week until haematopoietic stem cell transplant (HSCT). Visit www.gamifant.com for more information, including full US prescribing Information.
Emapalumab was developed and submitted for approval to the FDA by Novimmune. Sobi acquired the global rights to emapalumab from Novimmune through an exclusive licensing agreement announced in July 2018, which is now superseded by the above announced acquisition.
About Sobi
At Sobi, we are transforming the lives of people affected by rare diseases. As a specialised international biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of haematology, immunology and specialty care. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving. The hard work and dedication of our approximately 1050 employees around the globe has been instrumental in our success across Europe, North America, the Middle East, Russia and North Africa, leading to total revenues of SEK 9.1 billion in 2018. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.
SOURCE: Swedish Orphan Biovitrum
Post Views: 265
