On March 31, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into an agreement to transfer the exclusive worldwide development and marketing rights (excluding Japan and Asia) for its investigational anticancer agent E7777 to Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) (Press release, Eisai, MAR 31, 2016, View Source [SID:1234510237]).

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Under this agreement, Eisai will be responsible for development and marketing of E7777 in Japan and Asia, while Dr. Reddy’s will be responsible for development and marketing of the agent in all other regions. Furthermore, Dr. Reddy’s holds an option for the rights to develop and market the agent in India. Through this agreement, the two companies aim to accelerate development and maximize the value of E7777. From Dr. Reddy’s, Eisai will receive milestone payments in line with obtaining marketing approval and the achievement of sales targets.

E7777 is a fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. A Phase II clinical study of the agent in patients with cutaneous T-cell lymphoma or peripheral T-cell lymphoma is currently underway in Japan. Preparations are simultaneously in progress for a Phase III clinical study of the agent in patients with cutaneous T-cell lymphoma in the United States.

Eisai positions oncology as a key franchise area, and is committed to providing new treatment options for patients with cancer in order to further contribute to addressing unmet medical needs that exist in the treatment of cancer as well as increase the benefits provided to patients and their families.

About E7777

E7777 is a fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. A Phase II clinical study of the agent in patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma is currently underway in Japan. In addition, preparations are in progress for a Phase III clinical study of the agent in patients with cutaneous T-cell lymphoma in the United States.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) is a type of cutaneous non-Hodgkin’s lymphoma that comes in a variety of forms, and is the most common type of T-cell non-Hodgkin’s lymphoma. In CTCL, T-cells (a type of lymphocyte that plays a role in the immune system) become cancerous and develop into skin lesions, leading to a decrease in quality of life (QOL) of patients with this disease due to severe pain and pruritus. While CTCL is often regarded as a low-grade lymphoma, it is slowly progressive and can take anywhere from several years to upwards of ten to reach tumor stage. Once the disease reaches this stage, the cancer is highly malignant and has usually spread to the lymph nodes and internal organs, resulting in a poor prognosis, and therefore this is currently a disease with significant unmet medical need.

About Peripheral T-cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a type of non-Hodgkin lymphoma and classified as intermediate-grade. Often discovered once the disease has progressed, symptoms include swelling and lumps in the lymph nodes, fever, night sweats and weight loss. Among PTCLs, while prognosis is good for ALK-positive anaplastic large cell lymphoma which tends to affect adults aged between 20 and 30, other disease types often affect people aged around 60, and with poor prognosis and situations where treatment is difficult, PTCL is a disease with significant unmet medical need.

On March 31, 2016 PharmaMar (MSE:PHM) reported positive top-line results of its Phase III clinical trial -ADMYRE- with Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM) (Press release, PharmaMar, MAR 31, 2016, View Source [SID:1234510222]). Aplidin has shown a statistically significant 35% reduction in the risk of progression or death over the comparator (p=0.0054). The study has met its primary endpoint.

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This pivotal, randomized, open-label, international, multicenter Phase III clinical trial, called ADMYRE, enrolled 255 patients in 83 medical centers across 19 countries (including the U.S, Europe and Asia-Pacific) with relapsed or relapsed and refractory multiple myeloma after at least three but no more than six prior therapeutic regimens.

The efficacy of plitidepsin in combination with dexamethasone versus dexamethasone alone has been evaluated by means of PFS calculated using the IMWG (International Myeloma Working Group) criteria and other secondary efficacy endpoints. A full description of the final ADMYRE data will be submitted for presentation at an upcoming medical meeting.

"Taking into account these positive results, we intend to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year", said Luis Mora, Managing Director of the Oncology Business Unit of PharmaMar, who added "I´d like to thank all the patients, physicians and the dedicated team at PharmaMar who helped participate in the success of this trial. Aplidin may be our second drug of marine origin in the market".

As previously disclosed PharmaMar has entered into licensing agreements to market and distribute the drug candidate Aplidin with Specialised Therapeutics Asia, covering several Asian countries, Australia and New Zealand; with TTY Biopharm in Taiwan; and with a co-promotion agreement in 8 European countries with Chugai Pharma Europe.

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hematological malignancies, that is caused by malignant plasma cells that very rapidly multiplyi . Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produces the antibodies necessary to fight infectionsii. Abnormal cells produce a type of antibody that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to established disease. In 2015, 26,850 new cases were diagnosed in the US, and about 11,200 people died of this diseaseiii.In Europe, the incidence is 4.5–6.0 out of 100 000 diagnosed per yeariv .

About APLIDIN (plitidepsin)

Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It is a first-in-class drug specifically targeting eEF1A2 in tumor cells. Plitidepsin is currently in clinical development for hematological cancers, including this Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A