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Biopharmaceuticals Product Launch

 News Release - November 4, 2020

Sobi launch Doptelet(R) (avatrombopag) in Europe

STOCKHOLM, Nov. 4, 2020 -- (Healthcare Sales & Marketing Network) -- Sobi™ Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced the commercial launch of Doptelet® (avatrombopag) in Europe, with the United Kingdom as the first country for launch. Doptelet is a thrombopoietin receptor agonist (TPO-RA) approved for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.

Patients with CLD typically require one to three invasive diagnostic and therapeutic procedures per year, and each of these procedures carries a risk of bleeding. Thrombocytopenia, if not effectively treated, can lead to serious uncontrolled bleeding, resulting in prolonged hospitalisations and other post-procedure complications.

Doptelet mimics the biological effects of thrombopoietin (TPO) in stimulating the development and maturation of megakaryocytes, resulting in increased platelet counts1. In ADAPT-1 and ADAPT-2, two global phase 3 clinical studies in adult patients with severe thrombocytopenia and CLD, Doptelet was shown to effectively increase platelet counts and reduce both platelet transfusions and rescue procedures for bleeding when undergoing invasive procedures2.

"The launch of Doptelet offers an additional treatment option for patients living with CLD," said Sofiane Fahmy, Head of Europe at Sobi. "Since the acquisition of Dova Pharmaceuticals, our focus has been on expanding sustainable patient access to Doptelet from the US to Europe. We are delighted that Doptelet is now available in the UK for this initial indication, and we look forward to continue rolling out Doptelet in other European markets."

As a part of the Sobi's commitment to haematology treatments, the roll out of Doptelet in the EU will continue to bring Doptelet to new markets and new indications subject to regulatory approval.

About thrombocytopenia in chronic liver disease

Thrombocytopenia, a reduction in the number of platelets in the blood, is a common complication in patients with CLD, with the extent of thrombocytopenia often worsening with the severity of liver disease. Thrombopoietin (TPO), the principal physiological regulator of platelet production, is produced in the liver and stimulates bone marrow production of platelets, which are critical blood components for controlling bleeding. As a result of damage to the liver in patients with CLD, TPO production is reduced, which consequently results in decreased platelet production and thrombocytopenia.

About Doptelet® (avatrombopag)

Doptelet is an orally administered thrombopoietin (TPO) receptor agonist that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count.

It is approved by both the US Food & Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and by the European Medicines Agency (EMA) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. In June 2019, Doptelet was approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterised by low number of platelets. The incidence of primary ITP in adults is 3.3/100 000 adults per year with a prevalence of 9.5 per 100 000 adults3.

About Sobi

Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,500 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenues amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.

1 Fukushima-Shintani M, et al. Eur J Haematol 2009

2 Terrault N, et al. Gastroenterology 2018

3 Lambert et l. Blood 2017


Source: Swedish Orphan Biovitrum

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