PHARMACY

AstraZeneca enters agreement to develop Unit Dose Budesonide asthma drug

BY Alaric DeArment

NEW YORK AstraZeneca has entered into an agreement with MAP Pharmaceuticals to develop and commercialize Unit Dose Budesonide, MAP’s nebulized formulation of the asthma drug, the two companies announced Friday.

UDB, which is in phase 3 trials and designed for treating asthma in children, has the potential to be nebulized more quickly and at a lower nominal dose than other available formulations of budesonide.

Under the agreement, AstraZeneca will pay MAP an upfront cash payment of $40 million and a potential $35 million in milestone payments related to the phase 3 study. MAP may also receive up to $240 million in other development and regulatory milestones. AstraZeneca will also support and fund the establishment of a sales force for MAP to co-promote UDB in the United States for an unspecified period of time after product launch.

“MAP Pharmaceuticals’ advancement in Unit Dose Budesonide represents an important potential new option for treating children confronting asthma,” AstraZeneca CEO David Brennan said. “AstraZeneca’s heritage in treating pediatric asthma, combined with MAP Pharmacueticals’ expertise, can open new areas of opportunity for both companies and has the potential to bring significant medical benefit to the wider community.”

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Biosimilars could save significant amounts in healthcare costs, report concludes

BY Alaric DeArment

ARLINGTON, Va. A report by the Congressional Budget Office on the potential savings that biosimilars could create has drawn a response from the Generic Pharmaceutical Association.

“As Congress grapples with both the economic and healthcare crises facing our nation, the CBO Budget Options Report is concrete evidence that bringing safe, effective and affordable biogenerics to patients can result in significant healthcare cost savings for the federal government,” GPhA president and chief executive officer Kathleen Jaeger said in a statement.

“Specifically, the CBO Budget Options Report states that establishing a pathway for the approval of biogenerics will result in a multi-billion dollar savings potential for the federal government.”

Currently, the law does not permit the Food and Drug Administration to approve biosimilars, sometimes called biogenerics.

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FDA approves Genzyme drug to support bone marrow transplant recovery

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.

Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.

Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.

Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.

“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”

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