Takeda Pharmaceutical Company Stock

Takeda Pharmaceutical Company Limited, a biopharmaceutical company, engages primarily in the research, development, production and global commercialization of pharmaceutical products.

The company focuses its research and development (R&D) efforts on four therapeutic areas: oncology, rare genetics and hematology, neuroscience, and gastroenterology (GI). It also makes targeted R&D investments in plasma-derived therapies (PDT) and vaccines.

The company’s key growth driver products in its key business areas include the following Growth & Launch Products: ENTYVIO, ALOFISEL, TAKHZYRO, LIVTENCITY, GAMMAGARD LIQUID/KIOVIG, HYQVIA, CUVITRU, ALBUMIN/FLEXBUMIN, ALUNBRIG and EXKIVITY. It supports R&D efforts across three areas: Innovative Biopharma, Plasma-Derived Therapies (PDT) and Vaccines.

In GI, the company’s principal products include the following:

ENTYVIO (vedolizumab), a treatment for moderate to severe ulcerative colitis and Crohn’s disease. ENTYVIO is approved in 74 countries worldwide.

ALOFISEL (darvadstrocel), a treatment for complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to approximately one conventional or biologic therapy. ALOFISEL was approved in Europe in 2018, becoming the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe. ALOFISEL was also approved in Japan in 2021.

TAKECAB (vonoprazan fumarate), a treatment for acid-related diseases. TAKECAB was launched in Japan in 2015 and has achieved significant growth driven by its efficacy in reflux esophagitis and the prevention of recurrence of gastric and duodenal ulcers during low-dose aspirin administration. Takecab (Chinese brand name: Vocinti) was approved for reflux esophagitis in 2019 in China.

GATTEX/REVESTIVE (teduglutide (rDNA origin)), a treatment for patients with short bowel syndrome (SBS) who are dependent on parenteral support. In 2019, the U.S. Food and Drug Administration (the FDA) approved extending the indication of GATTEX to include children 1 year of age and older with short bowel syndrome (SBS). GATTEX/REVESTIVE was also approved in Japan in 2021.

DEXILANT (dexlansoprazole), a treatment for gastric acid-related disorders, such as healing of all the grades of erosive esophagitis (EE), maintaining the healing of EE and relief of heartburn and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), continues to decline in revenue due to generic competition.

In rare diseases, the company’s principal products are:

TAKHZYRO (lanadelumab-flyo), for the prevention of hereditary angioedema (HAE) attacks. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein, an enzyme that is chronically uncontrolled in people with HAE. TAKHZYRO was approved in both the U.S. and Europe in 2018, in China in 2020, and in Japan in 2022 and the company is working to expand into further geographic areas.

LIVTENCITY (maribavir), a treatment for adults and pediatric patients (12 years of age and older and weighing approximately 35 kg) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir, launched in the U.S. in December 2021. Early uptake has been strong as the first and only antiviral agent that targets and inhibits the pUL97 protein kinase and its natural substrates.

ELAPRASE (idursulfase), an enzyme replacement therapy for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis Type II (MPS II)).

REPLAGAL (agalsidase alfa), an enzyme replacement therapy for the treatment of Fabry disease, marketed outside of the U.S., and also approved in China in 2020. Additionally, the company had acquired the manufacturing and marketing approval and the marketing rights of REPLAGAL in Japan from Sumitomo Dainippon Pharma as of February 2022.

ADVATE (antihemophilic factor (recombinant)), a treatment for hemophilia A (congenital factor VIII deficiency) for the control and prevention of bleeding episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADYNOVATE/ADYNOVI (antihemophilic factor (recombinant) (PEGylated)), an extended half-life recombinant factor VIII treatment for hemophilia A. ADYNOVATE/ADYNOVI uses the same manufacturing process as the standard half-life recombinant factor VIII therapy ADVATE, and adds a proven technology, PEGylation (a chemical process that prolongs the amount of time a compound remains in circulation, potentially allowing for fewer injections), which the company exclusively licensed from Nektar Therapeutics (Nektar).

In Plasma-Derived Therapies (PDT) Immunology, the company’s principal products are:

GAMMAGARD LIQUID/KIOVIG (Immune Globulin Intravenous (Human) 10%), a liquid formulation of the antibody replacement therapy immunoglobulin (IG), for the treatment of adult and pediatric patients two years of age or older with primary immunodeficiencies (PID) (administered either intravenously or subcutaneously), and adult patients with multifocal motor neuropathy (MMN) (administered intravenously). KIOVIG is the brand name used for GAMMAGARD LIQUID in many countries outside of the U.S. KIOVIG is approved in Europe for patients with PID and certain secondary immunodeficiencies, and for adults with multifocal motor neuropathy (MMN).

HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), a product, including human normal IG and recombinant human hyaluronidase (licensed from Halozyme). HYQVIA is the only subcutaneous IG treatment for PID patients with a dosing regimen that requires only one infusion up to once per month and one injection site per infusion to deliver a full therapeutic dose of IG. HYQVIA is approved in the U.S. for adults with PID, and in Europe for patients with PID syndromes and myeloma or CLL with severe secondary hypogammaglobulinemia and recurrent infections.

CUVITRU (Immune Globulin Subcutaneous (Human), 20% Solution), indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age and older. CUVITRU is also indicated in Europe for the treatment of certain secondary immunodeficiencies. CUVITRU is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments.

FLEXBUMIN (Human Albumin in a bag) and Human Albumin (glass), available as 5% and 25% solutions, indicated for hypovolemia, hypoalbuminemia due to general causes and burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime. FLEXBUMIN 25% is also indicated for hypoalbuminemia associated with adult respiratory distress syndrome (ARDS) and nephrosis, and hemolytic disease of the newborn (HDN).

In oncology, the company’s principal products include:

ALUNBRIG (brigatinib), an orally administered small molecule anaplastic lymphoma kinase (ALK) inhibitor used to treat ALK-positive non-small cell lung cancer (NSCLC), was granted accelerated approval in the U.S. in 2017, and the European Commission granted the product marketing authorization in 2018. The indication of ALUNBRIG was expanded to include newly diagnosed ALK-positive NSCLC patients, first in the U.S. in May 2020. ALUNBRIG was also approved in China in March 2022.

EXKIVITY (mobocertinib), a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum based chemotherapy, was granted accelerated approval in the U.S. in September 2021.

VELCADE (bortezomib), a treatment for multiple myeloma (MM) and patients with mantle cell lymphoma (MCL) who have already received at least one prior treatment, was approved in the U.S. in 2003.

LEUPLIN/ENANTONE (leuprorelin), a treatment for hormone-responsive cancers, such as prostate cancer or breast cancer in women, as well as children with central precocious puberty, women with endometriosis, infertility, and to improve anemia in women with uterine leiomyomata (fibroids).

NINLARO (ixazomib), the first oral proteasome inhibitor for the treatment of multiple myeloma (MM), was approved in the U.S. in 2015 for relapsed/refractory MM and was approved in Europe in 2016, in Japan in 2017, and in China in 2018. In Japan, NINLARO is also approved as a maintenance treatment for MM.

ADCETRIS (brentuximab vedotin), an anti-cancer agent used to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), has received marketing authorization in more than 70 countries worldwide and was approved in China in May 2020. The company jointly developed ADCETRIS with Seagen Inc. and has commercialization rights in countries outside the U.S. and Canada.

In neuroscience, the company’s principal products are:

VYVANSE (lisdexamfetamine dimesylate), a stimulant medication indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged six and above, and for the treatment of moderate to severe binge eating disorder in adults.

TRINTELLIX (vortioxetine), an antidepressant indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX was co-developed with H. Lundbeck A/S, and the company has commercialization rights in the U.S., where it was launched in 2014 and in Japan, where it was launched in 2019.

Strategy

An important part of the company’s business strategy is to protect its products and technologies using patents and trademarks, to the extent available.

Sales and Marketing

The company’s primary sales and marketing activities are organized around regional business units and select therapeutic area business units focused on the U.S., Japan, Europe and Canada, China, and Growth and Emerging Markets.

Licensing and Collaboration

The company enters into arrangements for licensing and collaboration for the development and commercialization of products with third parties.

ADCETRIS: The company entered into a collaboration agreement with Seagen, Inc. (Seagen) in 2009 for the global co-development of ADCETRIS and its commercialization around the world (other than the U.S. and Canada, where ADCETRIS is commercialized by Seagen). The company and Seagen equally co-fund the cost of selected development activities conducted under the collaboration.

TRINTELLIX: The company entered into a license, development, supply and commercialization agreement with H. Lundbeck A/S (Lundbeck) in 2007 for the exclusive co-development and co-commercialization in the U.S. and Japan of several compounds in Lundbeck’s pipeline for the treatment of mood and anxiety disorders. Under the agreement, both partners commercialize TRINTELLIX in the U.S. and Japan and have agreed to jointly develop the relevant compounds, with most of development funding provided by it.

Research and Development

The company’s research and development expenses were 526.1 billion JPY for the year ended March 31, 2022.

Regulation

The manufacturing of the company’s products is regulated by governmental health authorities around the world, including the FDA, the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), and National Medical Products Administration (NMPA).

After the Marketing Authorizations have been granted, the company must submit periodic safety reports to the EMA, if approval was granted under the Centralized Procedure, or to the National Health Authorities, if approval was granted under the Decentralized Procedure or the Mutual Recognition Procedure.

The company must offer discounted pricing for purchases by certain designated health care entities and federal agencies under certain federal programs, including the Public Health Service pharmaceutical pricing program (340B) and the Federal Supply Schedule.

Competition

GI: The company’s competitors include Janssen Biotech; AbbVie, Inc. (AbbVie); Pfizer Inc. (Pfizer); Amgen; Organon; AstraZeneca plc (AstraZeneca); and EMD/Serono.

Rare Diseases: The company’s competitors include Pfizer; Sobi; Bayer Healthcare LLC (Bayer); Sanofi; Novo Nordisk; Octapharma; CSL; Roche; Pharming; BioCryst; Sanofi Genzyme; Amicus; Isu Abxis; Protalix; Actelion (Janssen); Korean Green Cross; and JCR Pharmaceuticals.

PDT: The company’s competitors include CSL; Grifols; ADMA; Kedrion; BPL; and Octapharma.

Oncology: The company’s competitors include Merck & Co. (Merck)/MSD; Bristol-Myers Squibb (BMS); Pfizer; Novartis AG (Novartis); Roche; AstraZeneca; Amgen; Janssen Biotech; Karyopharm; Sanofi; and Oncopeptide.

Neuroscience: The company’s competitor includes AbbVie; Tris Pharma; Ironshore Pharmaceuticals; Adlon Therapeutics; and Supernus.

Other: The company’s competitors include Mochida and KOWA.

History

Takeda Pharmaceutical Company Limited was founded in 1781. The company was incorporated in Japan under the Companies Act of Japan in 1925.