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Teva introduces liquid formulation of Treanda injection in US market

JerusalemWednesday, November 19, 2014, 18:00 Hrs  [IST]

Teva Pharmaceutical Industries Ltd., announced the commercial availability of a liquid formulation of Treanda (bendamustine HCI) Injection. This new liquid formulation removes the step of reconstituting lyophilized powder with sterile water prior to adding the required dose of medicine to the infusion bag and administering to a patient. By eliminating the need for reconstitution, preparation time for healthcare professionals is reduced.

“Treanda continues to play a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen,” said Paul Rittman, vice president and general manager, Teva Oncology. “With the new liquid formulation of Treanda, we are not only building on the legacy of this important product, but also furthering Teva’s commitment to continuously improving our medicines.”

Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

Treanda is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Treanda was approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in March 2008. Efficacy relative to first line therapies other than chlorambucil has not been established. Treanda received its second approval in October 2008 for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Treanda has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of Treanda remains unknown, bendamustine is active against both quiescent and dividing cells. Preclinical studies suggest that Treanda may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway).

Chronic lymphocytic leukemia (CLL) is one of four main types of leukemia. CLL begins with a change to a single white blood cell, or lymphocyte, of the bone marrow. Over time, the CLL cells multiply, replacing normal lymphocytes in the marrow and lymph nodes. As the amount of lymphocytes increases in the blood and bone marrow, there is less room for healthy white and red blood cells as well as platelets, which may result in infection, anemia and bleeding.

Non-Hodgkin lymphoma (NHL) is a disease in which cancer cells form in the lymphatic tissue in the body. Because lymph tissue is found throughout the body, NHL can begin almost anywhere in the body and spread to almost any tissue or organ. There are approximately 60 different types of NHL, which are formed from either B-cells or T-cells. The majority of non-Hodgkin lymphomas (80 to 90 per cent) are formed by B-cells. Types of NHL are generally divided into two categories–indolent and aggressive.

Indolent non-Hodgkin lymphomas (iNHL) are slow-growing lymphomas. The median survival of patients with indolent lymphoma is approximately 10 years. Indolent lymphomas are often responsive to therapy but usually relapse.

Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.

 
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