Secura Bio Acquires Global Rights To Farydak®

News provided by

Mar 12, 2019, 10:03 ET

HENDERSON, Nev. and SAN DIEGO, March 12, 2019 /PRNewswire/ -- Secura Bio, Inc. (www.securabio.com), 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."

About Farydak® (panobinostat)

Farydak (panobinostat) is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic alteration that results in a relaxing of chromatin, leading to transcriptional activation. In vitro, panobinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat. Panobinostat shows more cytotoxicity towards tumor cells compared to normal cells.

About multiple myeloma

Epigenetics is the cell programming that governs gene expression and cell development. In multiple myeloma, the normal epigenetic process is disrupted (also called epigenetic dysregulation) resulting in the growth of cancerous plasma cells, potential resistance to current treatment, and ultimately disease progression.

Multiple myeloma impacts approximately 81,000 people in the United States. Multiple myeloma is a cancer of the plasma cells, a kind of white blood cell present in bone marrow—the soft, blood–producing tissue that fills the center of most bones. The cancer is caused by the production and growth of abnormal cells within the plasma, which multiply and build up in the bone marrow, pushing out healthy cells and preventing them from functioning normally. Multiple myeloma is an incurable disease with a high rate of relapse (when the cancer returns) and resistance (when the therapy stops working), despite currently available treatments. It typically occurs in individuals 60 years of age or older, with few cases in individuals younger than 40.

Farydak® Important Safety Information

Farydak can cause serious side effects, including diarrhea and heart problems.

Diarrhea is common with Farydak and can be severe. Patients should tell their healthcare provider (HCP) right away if they have abdominal (stomach) cramps, loose stool, diarrhea, or feel like they are becoming dehydrated. HCPs may prescribe medicines to help prevent or treat these side effects. Taking or using stool softeners or laxative medicines may worsen diarrhea, patients should talk to their HCP before taking or using these medicines.

Farydak can cause severe heart problems which can lead to death. Risk of heart problems may be increased with a condition called "long QT syndrome" or other heart problems. Patients should call their HCP and get emergency medical help right away if they have any of the following symptoms of heart problems: chest pain, faster or slower heartbeat, palpitations (feel like heart is racing), feel lightheaded or faint, dizziness, blue colored lips, shortness of breath, or swelling in legs.

Farydak can cause severe bleeding which can lead to death. It may take patients longer than usual to stop bleeding while taking Farydak. Patients should tell their HCP right away if they get any of the following signs of bleeding: blood in stools or black stools (look like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that cannot be controlled, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, feeling dizzy or weak, confusion, change in speech, or headache that lasts a long time.

Farydak is a prescription medicine used, in combination with bortezomib and dexamethasone, to treat people with a type of cancer called multiple myeloma after at least two other types of treatment have been tried. It is not known if Farydak is safe and effective in children.

Patients should tell their HCP about all of the medicines they take, including prescription and over–the–counter medicines, vitamins and herbal supplements.

Patients should take Farydak exactly as the HCP tells them to take it. The HCP will tell patients how much Farydak to take and when to take it. The HCP may change the dose or stop treatment temporarily if patients experience side effects. Patients should not change the dose or stop taking Farydak without first talking with their HCP.

Patients should avoid eating star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Farydak. These foods may affect the amount of Farydak in the blood.

Low blood cell counts are common with Farydak and can be severe. Low platelet count (thrombocytopenia) can cause unusual bleeding or bruising under the skin. Low white blood cell count (neutropenia) can cause infections. Low red blood cell count (anemia) may make a patient feel weak, tired, or they may get tired easily, look pale, or feel short of breath.

There is an increased risk of infection while taking Farydak. Patients should contact their HCP right away if they have a fever or have any signs of an infection including sweats or chills, cough, flu–like symptoms, shortness of breath, blood in phlegm, sores on body, warm or painful areas on body, or feeling very tired.

Patients should call their HCP right away with any of the following symptoms of liver problems: feel tired or weak, loss of appetite, dark amber colored urine, upper abdominal pain, yellowing of skin or the white of eyes.

The most common side effects of Farydak include tiredness, nausea, swelling in arms or legs, decreased appetite, fever and vomiting. Patients should tell their HCP if they have any side effect that is bothersome or that does not go away.

Please see full Prescribing Information, including Boxed WARNING, for Farydak® (panobinostat) capsules at www.farydak.com

About Secura Bio, Inc.

Secura Bio is an integrated, commercial-stage biopharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies for physicians and their patients. For more information on Secura Bio, please visit www.securabio.com

SOURCE Secura Bio, Inc.