Purchase includes Lynnwood, WA Biologics Manufacturing Facility
BOSTON, Feb. 1, 2018 /PRNewswire/ — Boston-based cancer company Partner Therapeutics, Inc. (PTx) announced today that it has acquired the global rights to develop, manufacture, and commercialize Leukine (sargramostim) from Sanofi. Leukine is an immuno-stimulant that promotes the growth and activation of a broad range of white blood cells important in activating the body's immune response to fight infections. Leukine is used to treat or prevent severe and life-threatening infections and is the only immune modulator approved by the FDA for the treatment of acute myelogenous leukemia (AML) in older patients and for use in both allogeneic and autologous bone marrow transplantation.
In connection with the acquisition of Leukine, PTx will also acquire a dedicated manufacturing facility in Lynnwood, Washington. The facility is a state of the art biologics manufacturing plant that was certified for commercial production in 2012. The Lynnwood facility will serve as the core manufacturing and supply chain center for PTx's operations.
Leukine is the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF). It has been demonstrated to promote growth and activation of monocytes, macrophages, neutrophils and dendritic cells. It is currently indicated for the treatment of AML in older adults to reduce the incidence of severe and life-threatening infections resulting in death; use in the treatment of allogeneic bone marrow transplants to reduce the incidence of bacteremia and other culture positive infections and shorten the median duration of hospitalization; and to prolong the survival of patients who are experiencing bone marrow transplant failure or delay.
PTx will support the development of Leukine for new indications. The product is being tested in a diverse set of clinical trials for its potential to improve survival and reduce adverse events in combination with leading immuno-oncology therapies. A 250 patient, randomized Phase II study in refractory melanoma in combination with ipilimumab demonstrated an improvement in survival (hazard ratio of 0.64) over ipilimumab alone1. Leukine is currently being tested in a Phase III trial in front-line melanoma in combination with ipilimumab and nivolumab, being conducted by the ECOG-ACRIN Cancer Research Group (Principal Investigator: F Stephen Hodi, MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute) and sponsored by the National Cancer Institute (ClinicalTrials.gov Identifier: NCT02339571).
Leukine is also in development for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). Data presented at the 2016 annual meeting of the American Society of Hematology, demonstrated Leukine's ability to increase survival in non-human primates exposed to myelosuppressive doses of radiation without supportive whole blood transfusions or individualized antibiotics2. A supplemental biologics licensing application (sBLA) was filed in September of 2017 with the FDA requesting approval of Leukine for the treatment of H-ARS. In December, the application was granted Priority Review with a PDUFA date of March 29, 2018.
"We are delighted to have the opportunity to build a new future for Leukine and welcome the talented and dedicated team in Lynnwood to the PTx family," said Robert Mulroy, CEO of PTx. "The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections."
"In contrast to other approved growth factors that stimulate one cell type, Leukine's ability to stimulate a broader variety of cells, endows it with unique clinical potential to address serious medical needs across hematologic diseases and cancer as well as infectious, neurological and pulmonary disorders," said Dr. Debasish Roychowdhury, Chief Medical Officer. "We are excited to have the opportunity to work with investigators and healthcare professionals to explore new indications that can take advantage of Leukine's unique biological and immuno-stimulatory attributes and clinical properties."
PTx plans to provide commercial and medical support of Leukine in the United States and explore commercialization opportunities outside the U.S.
Leukine® (sargramostim) is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.
Important Safety Information for Leukine (sargramostim)
- Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%); in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant use with chemotherapy and radiotherapy.
- Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
- Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
- Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
- Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
- Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
- If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
- Leukine therapy should be discontinued if disease progression is detected during treatment.
- Drugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving Leukine. Interactions between Leukine and other drugs have not been fully evaluated.
1. Hodi FS, et al. Ipilimumab Plus Sargramostim vs Ipilimumab Alone for Treatment of Metastatic Melanoma A Randomized Clinical Trial. JAMA. 2014;312(17):1744-1753
2. Clayton NP, et al. Sargramostim Accelerates Leukocyte Recovery and Improves Mortality Rate at Day 60 in a Non-Human Primate Model of Hematopoietic Acute Radiation Syndrome When Administered 48 h after Total Body Irradiation. Blood 2016: 128:2512
SOURCE Partner Therapeutics, Inc.