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FDA Nod for New Formulation of Teva's Treanda

TEVA AKRX ACT

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Teva Pharmaceutical Industries Ltd. (TEVA - Analyst Report) recently received FDA approval for a new formulation of its oncology drug, Treanda. Treanda, which was earlier available as an injection, will now be available in a liquid formulation as well.

The approval of the liquid formulation will improve convenience of use for healthcare professionals. Earlier, healthcare professionals had to reconstitute the lyophilized powder with sterile water before adding the medicine to the dilutent and administering to a patient. With the approval of the liquid formulation, this step will no longer be required.

Teva said that its supplemental New Drug Application for the liquid formulation was granted priority review by the FDA.

Treanda is used in indolent B-cell non-Hodgkin lymphoma patients whose disease has progressed during or within six months of treatment with Rituxan (rituximab) or a Rituxan-containing regimen, and in patients with chronic lymphocytic leukemia (CLL).

Treanda is the lead product in Teva’s oncology product portfolio. Treanda, which became a part of Teva’s portfolio following its acquisition of Cephalon, posted sales of $608 million in 2012.

We note that Teva has been working on strengthening its oncology portfolio. The company recently signed a couple of oncology deals. While Teva’s agreement with Champions Oncology Inc. is focused on the development of new and personalized therapeutic options for cancer patients, the multi-project alliance with the technology development arm of Cancer Research UK’s - Cancer Research Technology Ltd. (CRT) is aimed at the research and development of first-in-class cancer drugs that modulate DNA damage and repair response (DDR) processes in cancer cells.

Teva currently carries a Zacks Rank #3 (Hold). The company is going through a tough transition period given fewer large generic opportunities, potential new competition for branded products (especially Copaxone) and a higher cost base.

However, we are encouraged by Teva’s plans to improve its position. Teva said that it intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals and reduce the cost base. We expect investor focus to remain on the execution of the company’s new strategy.

At present, companies like Actavis, Inc. (ACT - Analyst Report) and Akorn, Inc. (AKRX - Snapshot Report) look well-positioned with both being Zacks Rank #2 (Buy) stocks.

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