Henderson, NV and San Diego, CA (Press Release) – 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.