Takeda Launches Adynovate To Advance Prophylaxis Treatment For Hemophilia Patients in India

Takeda Launches Adynovate To Advance Prophylaxis Treatment For Hemophilia Patients in India

• An extended half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, resulting in lower weekly infusion rates than standard FVIII, providing excellent prophylactic coverage
• Adynovate in combination with MYPKFIT®offers personalized treatment and enables HCPs and patients to monitor factor levels from home and help achieve optimum QOL outcomes
• Adynovate offers effective bleed resolution with closer to Zero spontaneous bleed in majority, better joint health and reduces infusion frequency and associated pain 

New Delhi, June, 2022: Takeda Pharmaceutical Company Limited, a global values-based, R&D-driven biopharmaceutical leader expanded its innovative rare diseases portfolio in India with the launch of Adynovate, an innovative extended half-life recombinant Factor VIII (rFVIII) treatment, using established technology (controlled PEGylation), for hemophilia A patients.

Adynovate in combination with MYPKFIT®, first and only FDA approved application offers personalized and interactive prophylaxis treatment option that enables both healthcare professionals (HCPs) and patients in real-time monitoring of factor VIII levels from the comfort of their homes on phone thereby adapting their activity decisions accordingly and help improve their quality of life. Alerts are sent to patients on prophylaxis when their estimated factor VIII levels are low, and reminds them when their infusions are due, thereby providing excellent prophylactic coverage.

Speaking at the launch, Serina Fischer, General Manager – India, Takeda said, “Patients are at the core of every decision at Takeda and we are committed to increasing the access of our highly innovative treatments that enhances the quality of life for patients here in India. The launch of Adynovate is yet another step to address the gaps in hemophilia treatment and to assist the healthcare professionals and patients in better management of the condition. We are hopeful that this new treatment offering will help redefine possibilities for hemophilia patients in India.”

Commenting on the benefits of prophylaxis for hemophilia A patients, Dr. Sandeep Arora, Head of Medical Affairs and Patient Services – India, Takeda*, said, “Individuals with severe hemophilia A have recurrent hemarthrosis, fragmentation of joint cartilage, bone destruction, and crippling which can be effectively reduced through prophylaxis as opposed to on-demand therapy. Studies show that an innovative extended half-life, Adynovate, helps patients to reduce dosing and infusion frequency thereby improving treatment adherence while providing personalized prophylactic coverage. Adynovate has been tested in comprehensive global clinical program demonstrating favorable safety and efficacy results that offer effective bleed resolution, better joint health, and almost ZERO spontaneous bleeds in majority”

Administered in three steps with BAXJECT III™ system, Adynovate eliminates the need to disinfect the vial, as vials are already assembled in the system housing. It can be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date thereby easing the handling and storing process.

As a global leader in pharmaceuticals, Takeda Pharmaceutical Company Limited has been focused on driving

comprehensive research to support the development of effective and innovative treatments in the company’s chosen therapy areas. Takeda India is part of Takeda Pharmaceutical Company Limited’s group of companies headquartered in Japan. The company focuses on hematology, genetic diseases, immunology, and gastrointestinal portfolios in the country.

Ref:

1. Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study, Robert Klamroth et al, Blood (2021) 137 (13): 1818–1827 (Link: https://doi.org/10.1182/blood.2020005673).

2. Long-term safety and efficacy results from the phase 3b, open-label, multicentre Continuation study of rurioctocog alfa pegol for prophylaxis in previously treated patients with severe haemophilia A, P Chowdary et al, Wiley Journal, Vol 26, Issue 4, July, 2020.

(Link: https://doi.org/10.1111/hae.14052)

ABBREVIATED PRESCRIBING INFORMATION

Before prescribing and for complete details please refer to the India Package Insert.

Presentation:

Adynovate^® vials contain Human Coagulation Factor VIII (rDNA), Rurioctocog Alfa Pegol (PEGylated Recombinant Human FVIII) powder and solvent (2 or 5 ml sterilized water for injection). After reconstitution, nominally 250 IU/2 ml, 500 IU/2 ml, 750 IU/ 2ml, 1000 IU/2 ml, 1500 IU/ 2 ml and 2000 IU/5 ml per vial.

 Indication: Adynovate^® is a human antihemophilic factor indicated in children and adults with Hemophilia A (congenital factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use: Adynovate^® is not indicated for the treatment of von Willebrand disease.

Dosage and Administration: Treatment should be under the supervision of a physician experienced in the treat ment of Haemophilia. The dose and duration of the substitution therapy depend on the severity of the factor VIII (FVIII) deficiency, on the location and extent of the bleeding and on the patient’s clinical condition. For guidance on prophylactic and on demand treatment dosing, please refer to the Summary of Product Characteristics (SmP C). After reconstitution, it should be administered via the intravenous route at a maximum rate of 10 ml/min.

Contraindications: Adynovate^® is contraindicated in patients who have had prior anaphylactic reaction to Ady novate^®, to the parent molecule (Advate), mouse or hamster protein, or excipients of Adynovate^® (e.g. Tris, Mannitol, Trehalose, Glutathione, and/or Polysorbate 80).

Special warnings and precautions for use

Hypersensitivity Reactions: Hypersensitivity reactions are possible with Adynovate^®. Allergic-type hypersensi tivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, Advate.

Hypervolemia/Hemodilution: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of Adynovate^®. Monitor patients regularly for the development of factor VIII inhibitors by appro priate clinical observations and laboratory tests.

Interactions: No interactions of Adynovate^® product with other medicinal products have been reported.

Fertility, Pregnancy and Lactation: There are no data with Adynovate^® use in pregnant women to inform a drug-associated risk. There is no information regarding the presence of Adynovate^® in human milk, the effect on the breastfed infant, or the effects on milk production.

Undesirable Effects: Very common (≥1/10):Headache.

Common (≥1/100 to <1/10): Dizziness, Diarrhoea, Nausea and Rash.

Uncommon (≥1/1000 to <1/100): FVIII Inhibition (in previously treated patients), hypersensitivity, ocular hyper aemia, flushing, drug eruption, eosinophil count increased and infusion related reaction.

 Name and address of MA holder: Baxalta Bioscience India Pvt. Ltd., 1^st Floor, Plot no 70/A-26, Rama Road Industrial Area, Moti Nagar 24, New Delhi 110015, India.

Consumer Care No: 00080 0050 4087

Suspected Adverse Reactions should be reported to AE.India@takeda.com.

 Date of Preparation: September, 2021.

Based on revision of text of India PI : June, 2021

Further information is available on request.

C-APROM/IN/ADY/0003

###

 About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharm aceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic area s: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that con tribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveragi ng our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our e mployees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

 Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securi ties are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exempti on therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns inves tments are separate entities. In this press rel ease, “Takeda” is so metimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-loo king statements, beliefs or opinions regarding Takeda’s future business, future position and results of operati ons, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking stateme nts often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takeda’s estimates and assum ptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to appl icable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns rega rding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda’s opera tions and the timing of any such divestment(s), any of which may cause Takeda’s actual results, performance, achi evements or financial position to be materially different from any future results, performance, achievem ents or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information—D. Risk Factors” in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other rep orts filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Future results, performance, achi evements or financial position of Takeda could differ materially from those expressed in or implied by the for ward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda’s future results.

TAKEDA®Logo Disclaimer

TAKEDA®/TAKEDA Logo® (or actual logo) are registered trademarks of Takeda Pharmaceutical Company Limited.

MYPKFIT®, MYPKFIT Logo® and BAXJECT III™ are trademarks or registered trademarks of Baxalta Incorporated.

* Legal entity is Baxalta Biosciences India Private Limited, which is a part of Takeda group.