pharmafocusasiaMarch 13, 2019
Tag: farydak® , Panobinostat , Secura Bio
Secura Bio, Inc., an integrated, commercial-stage biopharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies, today announced that it has acquired the global rights to Farydak® (panobinostat) from Novartis.
Farydak® (panobinostat) is a prescription oral medication used in combination with proteasome inhibitors and corticosteroids to treat patients with relapsed or refractory multiple myeloma who had received prior treatments. Farydak is a member of the histone deacetylase (HDAC) inhibitor family with a very potent and unique mode of action slowing the growth of multiple myeloma cells.
Multiple myeloma is a cancer that forms malignant plasma cells in the bone marrow, and is the second most common blood cancer with over 160,000 cases diagnosed globally per year, with over 30,000 in the United States. Despite the increased availability of treatments, the disease is characterized by recurrent relapses and remains incurable for most patients leading to approximately 106,000 deaths per year worldwide, over 12,000 of which are in the United States.
On February 23, 2015 Farydak® received FDA accelerated approval for use in patients with multiple myeloma, and on August 28, 2015 it was approved by the European Medicines Agency for the same use. Farydak® has received marketing authorization in 53 countries to date for the treatment of patients with multiple myeloma.
Secura Bio is dedicated to working with health care professionals to ensure Farydak's® benefit to patients is well understood by cancer care teams and by ensuring that the medicine is available to those who need it. Secura Bio is also investigating the opportunity to develop new potential dosages and product combinations for Farydak®.
"We are very pleased to acquire worldwide rights to Farydak® as we execute our plan to aggressively build a meaningful, worldwide oncology portfolio," said Joseph M. Limber, President and CEO of Secura Bio. "Farydak will be a critical cornerstone of our strategy, as it offers a potentially valuable and high-growth treatment option for physicians in their therapeutic regimen for multiple myeloma patients when combined with a variety of other multiple myeloma therapies."
"Farydak represents an exciting agent with a unique mechanism of action that is part of a promising class of drugs in this setting," said study investigator Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at Dana–Farber Cancer Institute. "Importantly, Farydak has been shown to improve progression–free survival in relapsed multiple myeloma patients who have received at least two prior regimens, including bortezomib and an IMiD, which is an area of particular unmet medical need."
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