LEXINGTON, Mass., Nov. 7, 2019 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced today that it appointed John McManus to serve as the company's Chief Business Officer. In his role as CBO, Mr. McManus will oversee business development activities and government relations for PTx and serve on the Company's executive management team.
Mr. McManus has over 20 years of leadership experience in the biopharmaceutical industry that includes leading the transformation of several biotech companies through strategic partnerships and execution of value-based strategies. Prior to joining PTx, John was the CEO of Aeolus Pharmaceuticals, where he managed a $100+ million BARDA contract for the advanced development of a radiation medical countermeasure. Before joining Aeolus, John served in strategic and financial roles at Spectrum Pharmaceuticals where he focused on oncology and NeoTherapeutics where he focused on Alzheimer's, Parkinson's, ALS and spinal cord injury. John holds a B.S. in International Finance and Business Economics from the University of Southern California.
"We are very pleased to welcome John to our team to lead our business development activities," said Bob Mulroy, PTx's Chief Executive Officer. "His breadth of experience as a biotech executive and business leader will be tremendous assets for our team as we continue to build and grow the opportunity for Leukine to help patients in need. We also will benefit from John's extensive experience working with the U.S. government to advance our ability to serve as a partner for a wide range of important government programs."
"I am excited to join the PTx team in strengthening and expanding the Leukine franchise and identifying additional products that would benefit from the Company's development and clinical expertise," said Mr. McManus. "Leukine is a critical drug in the treatment of adults and children facing life-threatening diseases and a key medical countermeasure for improving survival after lethal levels of radiation exposure. I am especially excited about working to support the development of Leukine in new indications like melanoma and diseases of the central nervous system like Alzheimer's and Parkinson's and expanding its use as a medical countermeasure through development partnerships with third parties including the U.S. government. I see tremendous potential for Leukine to help patients across a number of difficult-to-treat diseases."
PTx acquired the global rights to develop, manufacture, and commercialize Leukine in 2018.
Leukine is a multi-lineage immune-stimulant that has been demonstrated to promote growth and activation of monocytes, macrophages, neutrophils and dendritic cells. It is the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF). 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; to prolong the survival of patients who are experiencing bone marrow transplant failure or delay; and to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
About Leukine® (sargramostim)
Leukine® is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity3.
Important Safety Information for LEUKINE® (sargramostim)
- LEUKINE® is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE®.
Warnings and Precautions
- Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE®. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE® therapy and institute medical management. Permanently discontinue LEUKINE® in patients with serious allergic reactions.
- LEUKINE® can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
- Do not administer LEUKINE® simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
- Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE® administration. LEUKINE® should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
- Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE® administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE® with caution in patients with preexisting cardiac disease.
- If ANC > 20,000 cells/mm3 or if WBC counts > 50,000/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.
- Treatment with LEUKINE® may induce neutralizing anti-drug antibodies. Use LEUKINE® for the shortest duration required.
- Liquid solutions containing benzyl alcohol (including LEUKINE® Injection) or LEUKINE® for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
- Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE® should be avoided.
Adverse events occurring in >10% of patients receiving LEUKINE® in controlled clinical trials and reported in a higher frequency than placebo are:
- In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
- 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, increase creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
- In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema
Please see full Prescribing Information for LEUKINE® at www.leukine.com
Indications and Usage
LEUKINE® (sargramostim) is a leukocyte growth factor indicated for the following uses:
- LEUKINE® is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
- LEUKINE® is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
- LEUKINE® is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
- LEUKINE® is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
- LEUKINE® is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
- LEUKINE® is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
About Partner Therapeutics, Inc.:
PTx is an integrated commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.
SOURCE Partner Therapeutics, Inc.