Takeda to Highlight Ixazomib Clinical Development Program at Upcoming International Myeloma Workshop

“IMW presents an important opportunity for the multiple myeloma community to come together,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Therapeutic Area Unit, Takeda. “Ixazomib’s TOURMALINE program, which we anticipate will have over 3,000 patients when fully enrolled, is the embodiment of Takeda’s commitment to addressing the unmet needs in multiple myeloma, and now contains a pivotal trial in every major segment of this patient population. We look forward to presenting an overview of this program at IMW and engaging with our partners in the fight against multiple myeloma.”

Ixazomib is currently under review with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed and/or refractory multiple myeloma, and has been granted accelerated assessment and priority review, respectively. The regulatory submissions are based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of once-a-week oral ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Additional filings in other countries are planned to begin this year. Ixazomib is the first oral proteasome inhibitor in late stage clinical development for the treatment of patients with multiple myeloma.

Ixazomib presentations at IMW 2015 are as follows:

Format/Timing:  Poster Discussion; Thursday, September 24, 2015 (6:40-7:40 p.m. CEST)
Abstract No:       0110
Abstract Title:    Four Phase 3 Studies of the Oral Proteasome Inhibitor (PI) Ixazomib for Multiple Myeloma in the Newly-Diagnosed, Relapsed/Refractory, and Maintenance
Settings: Tourmaline-MM1, -MM2, -MM3, and -MM4
Authors:               Jesus San Miguel, Philippe Moreau, Vincent Rajkumar, Antonio Palumbo, Thierry Facon, Gareth Morgan, Robert Orlowski, Michele Cavo, Hermann Einsele, Frank
Neumann, Richard Labotka, Sagar Lonial, Paul Richardson

Location:            Poster Area, 1^st Floor

Format/Timing:  Poster Display; Friday, September 25, 2015 (6:40-7:40 p.m. CEST)
Abstract No:       0112
Abstract Title:    The Current Unmet Medical Needs in the Treatment and Management of Multiple Myeloma (MM)
Authors:              Paul Richardson, Antonio Palumbo, Maria-Victoria Mateos, Helgi van de Velde, Tomas Skacel, Sagar Lonial
Location:             Poster Area, 1^st Floor

Format/Timing:               Poster Discussion; Thursday, September 24, 2015 (6:40-7:40 p.m. CEST)
Abstract No:       0167
Abstract Title:    Phase 3 Study of the Oral Proteasome Inhibitor Ixazomib for Relapsed/Refractory AL Amyloidosis: TOURMALINE-AL1
Authors:               Giampaolo Merlini, Angela Dispenzieri, Deborah Berg, Douglas V. Faller, Ai-Min Hui, Raymond L. Comenzo
Location:            Poster Area, 1^st Floor

Format/Timing:  Poster Discussion; Friday, September 25, 2015 (6:40 – 7:40 p.m. CEST)
Abstract No:       0177
Abstract Title:    Safety Profile of Oral Ixazomib: Experience from 761 Patients Across 14 Phase 1 or Phase 1/2 Clinical Studies
Authors:               Sagar Lonial, Kathleen Colson, R. Donald Harvey, Shaji Kumar, Ai-Min Hui, Guohui Liu, Deborah Berg, Paul Richardson
Location:            Poster Area, 1^st Floor


About Ixazomib and the TOURMALINE Trials
Ixazomib is an investigational oral proteasome inhibitor which is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the United States and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials.

Ixazomib’s clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:

• TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
• TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
• TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
• TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
• TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
  For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov.
  
  About Multiple Myeloma
  Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer with approximately 39,000 new cases in the EU and 114,000 new cases globally per year.
  
  About Takeda Oncology
  Takeda Oncology is the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited. Takeda aspires to cure cancer by delivering novel medicines to meet the unique and urgent needs of people living with cancer, their loved ones and the health care providers who support them around the world. Takeda is the 11^th largest global oncology company with a portfolio of paradigm-changing therapies and an extensive pipeline of investigational products that have the potential to significantly improve patient outcomes across a number of cancers. By combining the power of leading scientific minds with our agile and entrepreneurial spirit and the vast resources of a global pharmaceutical company, Takeda Oncology is finding new and innovative ways to improve the treatment of cancer. Additional information about Takeda Oncology is available through its website, www.takedaoncology.com.
  
  About Takeda
  Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:

Amy Atwood
Takeda Oncology
Phone: +1-617-444-2147
E-mail: [email protected]

Kate Burd
Takeda Development Centre Europe Ltd.
Phone: +44-7974-151510
E-mail: [email protected]

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