Swedish Orphan Biovitrum
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Swedish Orphan Biovitrum AB is an international
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company dedicated to treatments in the areas of
haematology Hematology ( always spelled haematology in British English) is the branch of medicine concerned with the study of the cause, prognosis, treatment, and prevention of diseases related to blood. It involves treating diseases that affect the produc ...
,
immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see there ...
and specialty care, based in
Stockholm Stockholm () is the Capital city, capital and List of urban areas in Sweden by population, largest city of Sweden as well as the List of urban areas in the Nordic countries, largest urban area in Scandinavia. Approximately 980,000 people liv ...
, Sweden. In 2020 it had a revenue of SEK 15.261 billion and 1,509 employees.


History

Sobi traces its origins to a subsidiary of Kärnbolaget Aktiebolag Biokemisk Industri in the 1930s, which changed its name to in 1951 and merged with to become KabiVitrum in the 1970s. Sobi has been involved in the process development and manufacturing of recombinant protein drugs since the technology was first developed around 30 years ago, then as part of KabiVitrum. Biovitrum was formed in 2001 through the merger of several units of
Pharmacia Pharmacia was a pharmaceutical and biotechnological company in Sweden that merged with the American pharmaceutical company Upjohn in 1995. History Pharmacia company was founded in 1911 in Stockholm, Sweden by pharmacist Gustav Felix Grönfeldt ...
(now
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
) and spun off to a consortium of investors led by
Nordic Capital Nordic Capital private equity funds focus on investments primarily in Northern Europe. Nordic Capital invests in selective industries with a particular focus on Healthcare, Tech & Payments and Financial Services. In addition selective investments ...
and MPM Capital Funds. Operations included a research unit focused on
metabolic diseases Inborn errors of metabolism form a large class of genetic diseases involving congenital disorders of enzyme activities. The majority are due to defects of single genes that code for enzymes that facilitate conversion of various substances (substrat ...
, a process development unit for protein drugs and a plasma product operation. In 2002 Sobi sold its plasma operation to
Octapharma Octapharma AG, founded in 1983, is a family-owned pharmaceutical company, and bills itself as "one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines " Ther ...
as part of efforts to concentrate operations on protein-based and small molecular drugs. In 2004, Biovitrum started to manufacture the active protein component for
Wyeth Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...
’s (now
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
’s) ReFacto® and ReFacto/Xyntha® drugs for treatment of
hemophilia Haemophilia, or hemophilia (), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, ...
, and marketing of specialty pharmaceuticals (ReFacto, Mimpara and Kineret®) was initiated in the Nordic region. In 2005, the research and development portfolio was expanded through the acquisition of Arexis, a Swedish biotech company, and the following year a partnership was formed with Syntonix (subsequently
Biogen Idec Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. History ...
) to jointly develop a drug for hemophilia B, a long-lasting recombinant factor IX Fc fusion protein candidate, rFIXFc. This partnership was extended the following year to also include the development of a long-lasting recombinant factor VIII Fc fusion protein candidate, rFVIIIFc, for the treatment of hemophilia A. In 2008, an agreement with Amgen regarding the acquisition of the products Kepivance and Stemgen as well as a global license for Kineret was signed In 2009, Sobi and partner
Biogen Idec Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. History ...
took the decision to enter final registration studies for the recombinant factor FIXFc. The company also received positive data regarding its Kiobrina phase II program, an investigational enzyme replacement therapy to improve growth in preterm infants who receive pasteurized breast milk or infant formula. In 2010,
Biovitrum Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to treatments in the areas of haematology, immunology and specialty care, based in Stockholm, Sweden. In 2020 it had a revenue of SEK 15.261 billion and 1,509 ...
acquired Swedish Orphan International Holding AB, a pioneer in
orphan drugs An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
, and Swedish Orphan Biovitrum AB (publ) was formed. In addition, the decisions to advance both
hemophilia Haemophilia, or hemophilia (), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, ...
projects as well as Kiobrina into phase III were taken. The following year the first patient was enrolled in the phase 3 study for Kiobrina and data from the rFVIIIFc hemophilia phase I/II study were presented showing an approximately 1.7-fold increase in half-life compared with Advate. The company also established a US subsidiary. In 2012 the supply agreement with
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
for ReFacto/Xyntha was extended until 2020 in addition to the agreement to return the co-promotion rights for the Nordic region for ReFacto to
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
for a payment of USD 47.4 M. The same year, the Sobi and partner
Biogen Idec Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. History ...
initiated global pediatric clinical trials of their long-lasting hemophilia A and B product candidates. Guido Oelkers was appointed President and CEO in May 2017, succeeding Geoffrey McDonough. Oelkers had previously been CEO of BSN Medical.


Company

Sobi is an international specialty healthcare company dedicated to rare diseases with a focus on treatments in haematology, immunology and speciality care. In 2013, Sobi had total revenues of SEK 2.2 billion (€253 M) and about 550 employees; by 2020 the revenue was SEK 15.261 billion and there were 1,509 employees. The share is listed at . The company's products include Elocta and
Alprolix Factor IX (or Christmas factor) () is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. It was discovered in 1952 after a young boy named Stephen Christmas ...
for the treatment of
haemophilia Haemophilia, or hemophilia (), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, ...
;
Doptelet Avatrombopag, sold under the brand name Doptelet, is a medication that used for certain conditions that lead to thrombocytopenia (low platelets) such as thrombocytopenia associated with chronic liver disease in adults who are to undergo a plann ...
for ITP and CLD; Kineret for several disorders; Synagis for
RSV RSV may refer to: Biology and medicine * Respiratory syncytial virus, causing respiratory disease * Rous sarcoma virus, causing cancer in chickens Road vehicles * Several :Aprilia motorcycles, Aprilia motorcycles, e.g.RSV4 * Minicar RSV, a US saf ...
and
Gamifant Emapalumab, sold under the brand name Gamifant, is an anti- interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH), which has no cure. The most common side effects include infections, hy ...
for pHLH, and the 2020 annual report shows a further six products as "pre-market" in the areas of
PNH PNH can stand for: * Police Nationale d’Haïti * Police Nationale d’Haïti Football Club * National Party of Honduras * Paroxysmal nocturnal hemoglobinuria * Parelli Natural Horsemanship * IATA Airport Code for Phnom Penh International Airp ...
,
haemophilia Haemophilia, or hemophilia (), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, ...
, sHLH, acute graft failure (aGF),
ALS Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a neurodegenerative disease that results in the progressive loss of motor neurons that control voluntary muscles. ALS is the most com ...
and chronic refractory
gout Gout ( ) is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot and swollen joint, caused by deposition of monosodium urate monohydrate crystals. Pain typically comes on rapidly, reaching maximal intensit ...
. The company also market a portfolio of specialty and rare disease products for partner companies.


Acquisitions and licenses

Synagis (From Astrazeneca)
Dova Pharmaceuticals


References

{{Authority control Pharmaceutical companies of Sweden Companies related to the Wallenberg family Swedish companies established in 2001 Pharmaceutical companies established in 2001 Manufacturing companies based in Stockholm Companies listed on Nasdaq Stockholm 2006 initial public offerings