Sobi, Handok’s partner has built competitive pipelines

Sweden’s Sobi, Handok to establish a local joint venture and cooperate on introducing new drugs to Korea

Sobi has built pipelines through developing and acquiring treatments, specializing in rare diseases such as hemophilia and PNH

Sobi, a biopharmaceutical company headquartered in Sweden, announced that it will launch its new drugs for treating rare diseases, including primary hemophagocytic lymphohistiocytosis (HLH), immune thrombocytopenia (ITP), and alkaptonuria (AKU), in Korea.

 

Sobi and Handok have entered into a business agreement to launch in Korea.

 

According to the pharmaceutical industry, on the 14th, Swedish Orphan Biovitrum (Sobi) decided to establish a local joint venture with Handok.

 

The duo has announced plans to set up a firm in the first half of this year and to launch treatments for rare diseases in Korea.

 

Sobi, a global biopharmaceutical company headquartered in Sweden, specializes in rare diseases and provides innovative treatments in hematology, immunology, and specialized therapies.

 

Handok will start with new rare disease drugs, Empaveli and Doptelet, to obtain domestic approval

Sobi has built diverse rare diseases pipelines: ‘Gamifant’ targeting primary hemophagocytic lymphohistiocytosis (HLH), ‘Doptelet’ targeting immune thrombocytopenia (ITP), ‘Vonjo’ targeting myelofibrosis, ‘Synagis’ targeting respiratory syncytial virus (RSV), ‘Altuviio, Alprolix, and Elocta’ targeting hemophilia, ‘Empaveli’ targeting paroxysmal nocturnal haemoglobinuria (PNH), ‘Orfadin’ targeting alkaptonuria (AKU), ‘Zynlonta’ targeting blood cancer, and ‘Kineret’ targeting rheumatoid arthritis (RA).

Handok will first focus on obtaining domestic approval for two treatments, Empaveli and Doptelet, from Sobi’s pipelines.

 

Handok and Sobi entered into a strategic partnership last October to introduce these two treatments.

 

Handok anticipates that both treatments will obtain approval within this year.

 

Empaveli has received approval for treating paroxysmal nocturnal haemoglobinuria (PNH) in the United States, Europe, Australia, and Japan.

 

Empaveli is developed by Apellis Pharmaceuticals in the United States and Sobi has exclusive commercialization rights of the drug outside the United States.

 

Empaveli is the first treatment for PNH that targets the C3 complement.

 

It is designed to inhibit the process of C3 fragmentation, thereby preventing intravascular hemolysis and extravascular hemolysis.

 

Results from a phase 3 PEGASUS clinical trial confirmed the efficacy of Empaveli.

 

Empaveli demonstrated higher hemoglobin levels compared to Soliris, a C5 complement inhibitor.

 

Empaveli’s strength is in expanding indications.

 

In the previous year, Empaveli was approved in the United States for the treatment of geographic atrophy (GA) associated with macular degeneration.

 

Retinal GA is a condition that occurs in the late-stages macular degeneration, which causes damage to the center of the macular and leads to the death of retinal cells.

 

The clinical trial demonstrated that Empaveli significantly reduced the GA lesion growth by 22% at 24 months compared to a placebo.

 

Handok has an advantage in entering the domestic PNH market because it already has experience selling C5 complement inhibitors, Soliris and Ultomiris.

 

Handok sold Soliris and Ultomiris until 2022.

 

However, AstraZeneca decided to sell Alexion Pharmaceuticals and retrieved the sales rights.

 

Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) used to treat adult patients with primary chronic immune thrombocytopenia (ITP).

 

ITP, a type of bleeding disorder, is an autoimmune disorder in which the immune system attacks and destroys platelets.

 

In a 6-month trial, Doptelet elevated platelet levels to more than 50,000 counts for 12 weeks.

 

Based on these results, Doptelet received approval in the United States, Europe, Australia, and Japan.

 

Sobi has built diverse rare diseases pipelines In addition to Empaveli and Doptelet, Sobi’s pipelines include ‘Elocta, Alprolix, Altuviio’ for treating patients with hemophilia, ‘Gamifant’ for treating primary hemophagocytic lymphohistiocytosis (HLH), ‘Vonjo’ for treating myelofibrosis, ‘Synagis’ for treating respiratory syncytial virus (RSV), a new alkaptonuria (AKU) drug ‘Orfadin’, a CD19-directed antibody drug conjugate (ADC) ‘Zynlonta’, and a new rheumatoid arthritis (RA) drug ‘Kineret’.

 

Sobi has partnered with Sanofi to distribute three types of drugs in the hemophilia field jointly.

 

The two companies secured FDA approval for the new hemophilia drug, Altuviio, in the United States, alongside the already available hemophilia treatments Elocta (marketed as Eloctate in Korea) and Alprolix.

 

Altuviio can be used for routine prophylaxis and perioperative management of bleeding.

 

During clinical trials, patients receiving Altuviio reported no bleeding episodes for a year.

 

Sobi also sells RSV treatments.

 

In 2018, the company successfully acquired the sales rights for Synagis, which was developed by multinational pharmaceutical company AstraZeneca.

 

Synagis is a monoclonal antibody that was approved as an alternative to prevent lower respiratory tract infection caused by respiratory syncytial virus (RSV) globally.

 

Sobi also focuses on developing new ADC drugs, which are trending globally.

 

Zynlonta is an antibody-drug conjugate (ADC) targeting CD19, which is highly expressed in a B cell surface.

 

The drug was approved in the United States and Europe.

 

Zynlonta faces competition from chimeric antigen receptor T cell (CAR-T) therapy and dual-specific antibodies.

 

In addition, Sobi has experience in successfully launching new drugs for rare diseases with unmet needs, including primary hemophagocytic lymphohistiocytosis (HLH) and alkaptonuria (AKU).