ROCKLAND, Mass., May 28, 2015 /PRNewswire/ -- EMD Serono, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, today announced two critical management appointments to lead its entry into oncology. EMD Serono's diversified oncology and immuno-oncology pipeline includes multiple, high-priority projects currently in development to optimize patient outcomes in challenging cancers that have significant unmet patient need.
David Trexler, Senior Vice President of Oncology Commercial
David Trexler, Senior Vice President of Oncology Commercial, will lead the strategy of the EMD Serono oncology franchise and will be responsible for maximizing growth opportunities by building a performance-driven oncology team focused on customer and patient centricity.
David Trexler has more than 25 years of experience in branded pharmaceutical marketing, sales and business development. He joins EMD Serono from Eisai, Inc., where he served as Senior Vice President of the Americas Oncology Business Unit. At Eisai, Mr. Trexler successfully led the oncology sales and marketing teams, expanding Eisai's reach in strategic markets across the Americas. Mr. Trexler previously held senior leadership roles at Mylan Bertek Pharmaceuticals and Sanofi-Aventis Pharmaceuticals.
Dr. Zhen Su, Vice President of Oncology Medical, will lead the medical strategy and team for the franchise. A physician executive with more than 15 years of experience, Dr. Su has strong clinical expertise in oncology, immuno-oncology and urology. He has held positions in academic and pharmaceutical medicine, including general management, clinical development, medical affairs and business development. Prior to EMD Serono, Dr. Su served as Associate Vice President and Global Head of Jevtana® (cabazitaxel) at Sanofi. Prior to joining industry, Dr. Su held several academic positions, including Assistant Professor of Surgery at Duke University, where he also received his fellowship in oncology. He has deep ties to the oncology community, having worked with leading oncologists at organizations across the country. Dr. Su earned his MD degree from the Technical University of Dresden, Germany and completed his MBA training at the University of Toronto, Canada.
"This is an exciting time for the oncology franchise of EMD Serono as we initiated our commercial presence in the United States and continue to advance our pipeline," said Paris Panayiotopoulos, President and Managing Director of EMD Serono. "Our long-standing commitment and focus on specialty care is a driving force behind our expansion in oncology. The experience and passion that David and Zhen possess aligns perfectly with our commitment to address challenging cancers, champion patient care and forge a new path in oncology management."
Earlier this month, the company announced the launch of the co-promotion of XALKORI® (crizotinib) with Pfizer. This co-promotion is part of a larger global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer to jointly develop and commercialize avelumab*, an investigational anti-PD-L1 monoclonal antibody, to accelerate the development of immuno-oncology medicines for patients with cancer. The immuno-oncology alliance will also advance Pfizer's anti-PD-1 antibody.
This month, the company also announced with its partner Threshold Pharmaceuticals that the U.S. Food and Drug Administration has granted Fast Track designation for the development of its investigational compound evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. This is the second indication for this compound to receive Fast Track designation from the FDA, following the granting of the designation for the development of evofosfamide in combination with doxorubicin for the treatment of advanced soft tissue sarcoma to the company's co-development partner, Threshold Pharmaceuticals, in November 2014. Evofosfamide is currently under evaluation in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial).
*Avelumab is an investigational agent. Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C).
About XALKORI® (crizotinib)
XALKORI is a kinase inhibitor indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The U.S. indication is not limited to any specific line of therapy. XALKORI® is a registered trademark of Pfizer Inc.
XALKORI® Important Safety Information
Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.2% of patients treated with XALKORI across clinical trials (n=1225). Transaminase elevations generally occurred within the first 2 months of treatment. Monitor with liver function tests including ALT and total bilirubin every 2 weeks during the first 2 months of treatment, then once a month and as clinically indicated. Permanently discontinue for ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 times ULN (in the absence of cholestasis or hemolysis), otherwise temporarily suspend and dose reduce XALKORI as indicated.
Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with XALKORI. Across clinical trials (n=1225), 2.5% of XALKORI-treated patients had any grade ILD, 0.9% of patients had Grade 3 or 4, and 0.5% had fatal cases. These cases generally occurred within 2 months after the initiation of treatment. Monitor patients for pulmonary symptoms indicative of pneumonitis. Exclude other causes and permanently discontinue XALKORI in patients with drug related pneumonitis.
QT Interval Prolongation: QTc prolongation can occur in patients treated with XALKORI. Across clinical trials (n=1225), QTc prolongation (all grades) was observed in 2.7% of patients and QTc greater than 500 ms on at least 2 separate ECGs occurred in 1.4% of patients. Avoid use of XALKORI in patients with congenital long QT syndrome. Consider periodic monitoring with electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc greater than 500 ms or greater than or equal to 60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia, otherwise temporarily suspend and dose reduce XALKORI as indicated.
Bradycardia: Symptomatic bradycardia can occur in patients receiving XALKORI. Across clinical trials, bradycardia with a heart rate less than 50 beats per minute occurred in 11% of patients treated with XALKORI (n=1174). Monitor heart rate and blood pressure regularly. Avoid using XALKORI in combination with other agents known to cause bradycardia to the extent possible. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring. Otherwise temporarily suspend and resume or dose reduce XALKORI as indicated.
Embryofetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI. If the patient or their partner becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus.
Adverse Reactions: Safety was evaluated in a phase 3 study in patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=172) or chemotherapy (n=171). Serious adverse reactions were reported in 37.2% patients treated with XALKORI. The most frequent serious adverse reactions reported in patients treated with XALKORI were pneumonia (4.1%), pulmonary embolism (3.5%), dyspnea (2.3%), and ILD (2.9%). Fatal adverse reactions in XALKORI-treated patients occurred in 9 (5%) patients, consisting of: acute respiratory distress syndrome, arrhythmia, dyspnea, ILD, pneumonia, pneumonitis, pulmonary embolism, respiratory failure, and sepsis. Common adverse reactions occurring in 25% included vision disorder (diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters), diarrhea, nausea, vomiting, constipation, edema, decreased appetite, fatigue, upper respiratory infection, and dysgeusia. Grade 3 or 4 events occurring at a higher incidence with XALKORI than with chemotherapy and at greater than 2% incidence were syncope (3%), QT prolongation (3%), and pulmonary embolism (5%). Elevation of ALT of any grade occurred in 76% of patients and grade 3 or 4 in 17% of patients. Neutropenia of any grade occurred in 49% of patients and grade 3 or 4 in 12% of patients. Lymphopenia of any grade occurred in 51% of patients and grade 3 or 4 in 9% of patients. Renal cysts occurred in 4% and neuropathy in 19% of patients treated with XALKORI.
Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Dose reduction may be needed for co-administered drugs that are predominantly metabolized by CYP3A.
Nursing Mothers: Given the potential for serious adverse reactions in nursing infants, consider whether to discontinue nursing or discontinue XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. As crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma Crizotinib concentrations. Use caution in patients with hepatic impairment.
Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr<30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild and moderate renal impairment.
For more information and full prescribing information, please visit www.XALKORI.com.
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
Evofosfamide is currently under evaluation in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase III trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase II trial for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.
Merck KGaA, Darmstadt, Germany, signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold to co-commercialize in the U.S.
Evofosfamide is currently under clinical investigation and has not been approved for use in the U.S., Europe, Canada, or elsewhere. Evofosfamide has not yet been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.
Avelumab (also known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and may induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November, 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc, New York, US
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc, New York, US, enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.
About EMD Serono
EMD Serono, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, is a leading U.S. biopharma company focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.
For more information, please visit www.emdserono.com.
Merck KGaA, Darmstadt, Germany
Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials and generated sales of 11.3 billion in 2014. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.