Business Wire

Theramex Announces an Agreement with Enzene Biosciences Limited for the Development and Commercialisation of Tocilizumab, a Biosimilar for the Treatment of Rheumatoid Arthritis

Share

Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has entered into an agreement with Enzene Biosciences Limited to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialised from 2026 in Europe, the UK, Switzerland, and Australia.

Theramex’s Tocilizumab product will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors. The reference product RoActemra® is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate; moderate to severe RA adult patients who have not responded well/intolerant to DMARDs or Anti-TNFs; active systemic juvenile idiopathic arthritis in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids; juvenile idiopathic polyarthritis in patients 2 years of age and older unresponsive to MTX; treatment of Giant Cell Arteritis in adults; and chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

Rheumatoid arthritis is a chronic condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists. There may be periods where symptoms become worse, known as flares. A flare can be difficult to predict, but with treatment it's possible to decrease the number of flares and minimise or prevent long-term damage to the joints. Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss1.

“Rheumatoid arthritis affects more women than men, so the addition of this biosimilar drug to our existing Rheumatology portfolio continues our strategic determination to improve access and affordability of important treatments for women. We are excited to expand our focus in Rheumatology to now include rheumatoid arthritis to help even more patients with bone diseases and joint pain”, said Theramex CEO Robert Stewart .

Dr. Himanshu Gadgil, Enzene's Whole Time Director said, "The development of Enzene’s Tocilizumab, through our innovative efforts in the manufacturing of monoclonal antibodies, marks another highlight in a series of endeavours driven by our mission to provide affordable and expanded access to crucial medicines. Our partnership with Theramex bolsters our mission to bring affordable healthcare to patients across the world”.

About Theramex

Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen to and understand our patients, serve their needs and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through every stage of life.

About Enzene Biosciences Ltd.

Enzene is an innovation-driven biotech company, a subsidiary of Alkem Laboratories Ltd. (One of the top five pharmaceutical companies in India*) located in Pune, India. Enzene's focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. Enzene also offers a range of biologics CDMO and CMO services.

(*as per the latest IQVIA data of MAT July 2021)

For more information on Enzene Biosciences Ltd., please visit www.enzene.com

For more information on Alkem Laboratories Ltd., please visit www.alkemlabs.com

1 https://www.nhs.uk/conditions/rheumatoid-arthritis/

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Theramex
Jesús López | Associate Director, Communication & Digital | Jesus.Lopez@Theramex.com

Enzene Biosciences Ltd.
For media enquiries,
Dr. Tarun Chawla
Head - Business Development & Business Operations
Enzene Biosciences Ltd.
For any further enquiries, please reach out to: bd@enzene.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Feeling ’22: Mary Kay Inc. Announces Awards, Milestones, and Accomplishments From First Half of the Year28.7.2022 20:02:00 EEST | Press release

Mary Kay Inc. is feeling ’22. Throughout the first half of the year, the iconic global entrepreneurship company has furthered its innovations in skin science, continued its social impact efforts, and garnered several prestigious awards for its business and leadership. It’s a thing of beauty—and the nearly 60-year-old brand is just getting started. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005228/en/ Mary Kay logo (Graphic: Mary Kay Inc.) 2022 AWARDS & HIGHLIGHTS 30 total awards for business excellence, social impact and sustainability 10 employer awards recognizing Mary Kay as a great place to work and for operational excellence 7 awards for Mary Kay’s c-suite and senior leadership 17 self-released reports reinforcing Mary Kay’s operational and philanthropic efforts supporting its sustainability commitments for its Enriching Lives Today for a Sustainable Tomorrow strategy 3 mentions in annual reports from social i

Asaf Ashkenazi Named CEO of Verimatrix28.7.2022 19:00:00 EEST | Press release

Regulatory News: Verimatrix (Euronext Paris: VMX) (Paris:VMX), today announced the appointment of Asaf Ashkenazi as Chief Executive Officer effective Monday, August 1st, 2022. Amedeo D’Angelo, Chairman and Chief Executive Officer since 2015, remains Executive Chairman of Verimatrix effective the same day. Asaf Ashkenazi joined Verimatrix in 2018 and currently serves as Chief Operating Officer. He will lead the company’s ongoing business model transformation announced last year that focuses on recurring subscription-based revenue sources and new products. “This evolution and reinforcement of the Verimatrix governance structure aligns well with the company’s needs as we further the progression of our business model,” Amedeo D’Angelo said. “I look forward to working closely with Asaf in his newly expanded role as CEO during this strategic development of Verimatrix.” Previously leading the company’s R&D, product, sales and marketing operations, Asaf Ashkenazi will continue to harness his d

GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign28.7.2022 18:00:00 EEST | Press release

The new GUESS Fall-Winter 2022 advertising campaign sees the brand off to explore the history-steeped streets of Granada, Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005098/en/ GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign (Photo: Business Wire) The FW22 campaign is immortalized through the lens of fashion photographer Tatiana Gerusova, under the guidance of GUESS?, Inc.’s Chief Creative Officer, Paul Marciano. The new campaign features a sizzling lineup: German-born, Polish fashion model Kim Dammer, Serbian model Nina Kostić, Spanish model Lidia Santos, Italian model Mario Ermito, and French model Xavier Grey. GUESS Women The campaign showcases an enticing array of GUESS pieces, highlighting must-have accessories and elevated animal and botanical prints. The collection brings a fresh and youthful breeze of contemporary color and style to grey winter days. Against the alluring continent

Innovaderm Bolsters European Presence With Two Newly-Established Operations Hubs (Spain & Poland)28.7.2022 17:00:00 EEST | Press release

Innovaderm announced today that its strategic European expansion initiative has reached a major milestone with the launch of two key centres of operations in Poland and Spain. Biotechnology and pharmaceutical companies can officially partner with the CRO’s team of experts in Europe to manage clinical trials in psoriasis, acne, atopic dermatitis and other dermatology indications. This includes adherence to stringent regulatory requirements, patient recruitment, site selection, clinical monitoring and protocol writing. “To date, we have successfully completed more than 500 clinical trials at 2,900 sites,” says Dave Selkirk, Innovaderm’s Chief Operating Officer. “The presence of two operations hubs in Europe will allow us to go one step further and accelerate the development of promising therapies that have the potential to transform lives. As we look to the future, our goal is to continue supporting innovation in research and the increasing number of patients with skin conditions worldwi

Echosens Partners with World Hepatitis Alliance on World Hepatitis Day, July 28, Urges Importance of Testing and Treatment28.7.2022 16:07:00 EEST | Press release

Echosens, a high-technology company offering liver diagnostic solutions, establishes its support of World Hepatitis Day (WHD), July 28 by partnering with the World Hepatitis Alliance as a bronze sponsor. The commemoration calls for greater awareness of the 357 million people who live with viral hepatitis but are unaware of it. The campaign’s theme “I can’t wait” highlights the need to accelerate the fight against viral hepatitis and the importance of testing and treatment for the real people who need it. “Echosens recognizes that every 30 seconds, someone in the world dies from a hepatitis-related illness, and we join hands with organizations throughout the world to advance increased vigilance around liver health,” says Dominque Legros, Echosens Group CEO. “It is gratifying to see that this year's theme for World Hepatitis Day aligns with our mission for early detection that can result in more effective intervention, treatment and better outcomes.” Viral hepatitis is an inflammation of

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom