04/24/2017 Caligor supporting Puma’s expanded access program for breast cancer therapy
Caligor Opco LLC is providing regulatory and logistical management for Puma Biotechnology’s expanded access program (EAP) for its investigational breast cancer therapy, neratinib.
04/12/2017 Caligor to Support Puma Biotechnology’s Expanded Access Program for PB272 (Neratinib) in the United States
SECAUCUS, N.J., April 12, 2017 – Caligor Opco LLC, which specializes in early access to medicines and drug life-cycle management, today announced that it will provide regulatory and logistical management for Puma Biotechnology’s (Nasdaq: PBYI) expanded access program (EAP) for its investigational breast cancer therapy, PB272 (neratinib), in the United States.
The U.S. Food and Drug Administration (FDA) permits expanded access to investigational drugs for treatment use for patients with serious or immediately life-threatening diseases or conditions who do not otherwise qualify for participation in a clinical trial and lack satisfactory therapeutic alternatives.
The EAP will provide access to neratinib for the treatment of early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. Patients must not be able to participate in any ongoing neratinib clinical trial to qualify for the EAP. Caligor also is providing regulatory, logistical, and supply chain support for Puma’s Managed Access Program for neratinib outside the United States.
“We are gratified by the trust and confidence Puma has placed in us,” said Tammy Bishop, Caligor’s Chief Commercial Officer. “Within the past year, the FDA has introduced a streamlined application process and new guidance designed to improve its expanded access programs, and those initiatives have been extremely positive. We look forward to working with regulators and physicians to facilitate access to neratinib for patients who may benefit from this therapy.”
About the Neratinib Expanded Access Program
The neratinib EAP is a program for U.S. patients with early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. This EAP is being administered on behalf of Puma by Caligor Opco. U.S. healthcare professionals seeking more information about the neratinib EAP can email neratinibUSA@caligorrx.com for additional information. Patients who are interested in enrolling in the neratinib EAP should speak with their physician to determine if neratinib is an appropriate option. Neratinib is an investigational agent and, as such, has not been approved by the FDA or any other regulatory agencies in any markets.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a global company that manages the regulatory, logistics and supply chain needs for global access programs as well as the sourcing, storing and distribution of comparator drugs for clinical trials. Caligor’s global access programs help to meet the medical needs of patients worldwide by providing access to medicines in situations where the drug has not yet been approved, or is otherwise commercially unavailable. In addition, through its proprietary TrialAssist™ program, Caligor optimizes its services by providing for labeling, QP certification, storage, distribution and destruction of clinical trial and unlicensed medicines managed in the access programs. The company serves pharmaceutical and biotechnology companies from facilities in Secaucus, New Jersey and Dartford, UK, as well as strategically situated depot locations worldwide. More information is available at https://caligorrx.com.
Tammy Bishop, Caligor Opco LLC, +1 508-850-6307
Scott Solomon, Sharon Merrill Associates, +1-617-542-5300
03/01/2017 Caligor Enhances Operational and Commercial Leadership to Meet Growing Global Demand for its Clinical Trial Supply Services
David Edwards Joins as New CEO; Tammy Bishop Named Chief Commercial Officer
SECAUCUS, NJ – March 1, 2017
Following a record year for its clinical trial supply and global access services in 2016, Caligor Opco LLC today further enhanced its operational and commercial leadership teams, appointing David Edwards as its new Chief Executive Officer. Tammy Bishop will assume the new role of Chief Commercial Officer and continue to be a member of the Board of Directors.
02/08/2017 Caligor Appoints Andrea Chopek and Craig LaMarca to its Rapidly Growing Clinical Trial Services Business Unit
SECAUCUS, NJ – February 8, 2017
Caligor Opco LLC, which specializes in global comparator sourcing, early access to medicines and drug life-cycle management, has named two seasoned pharmaceutical executives to its rapidly growing Clinical Trial Services (CTS) business unit. Andrea Chopek has been appointed Global Head of Business Development for CTS. Craig LaMarca has been named Global Head of Business Development for TrialAssist™, a business line under CTS. Both positions are new for the company, which recently expanded its international operations with the opening of a state-of-the-art, 33,000-square-foot facility in the UK.
12/15/2016 Caligor Opco Selected to Support Puma Biotechnology’s Managed Access Program for Neratinib Outside the United States
Secaucus, N.J., December 15, 2016
Caligor Opco LLC, which specializes in early access to medicines and drug life-cycle management, is partnering with Puma Biotechnology (NYSE: PBYI) to implement and oversee the company’s Managed Access Program for PB272 (neratinib). Managed access programs provide physicians and patients access to medicines when there are limited or no other therapeutic options available.
09/13/2016 Caligor Appoints Life Sciences Industry Veteran Alex Shvartsburg as Chief Financial Officer and Chief Operating Officer
Secaucus, N.J., September 13, 2016
Caligor, a portfolio company of Diversis Capital, LLC, announced today that it has appointed Alex Shvartsburg as chief financial officer and chief operating officer. Mr. Shvartsburg brings more than 20 years of experience in the life sciences industry, serving in leadership roles with some of the world’s preeminent multinational organizations.
04/08/2016 Diversis Capital Acquires Caligor Rx, a Leader in Clinical Trial Supply and Logistics Services
Los Angeles, Calif., April 8, 2016
Diversis Capital, LLC, a Los Angeles-based private equity firm focused on acquiring and growing small- and middle-market companies, today announced that it has acquired the majority of the assets of Caligor Rx, Inc. Based in Secaucus, New Jersey with an additional facility in Dartford, UK, Caligor provides services that enable pharmaceutical and biotechnology companies to maximize the value of their clinical supply chain investments. Financial terms of the transaction were not disclosed.
03/31/2015 Caligor Rx Becomes Corporate Alliance Member of Global Genes™
Secaucus, New Jersey, March 26, 2015
Caligor Rx, a global leader in pharmaceutical sourcing and supply for clinical trials and Global Access Programs, today announced that it has partnered with Global Genes™, a leading rare disease patient advocacy organization.
01/13/2015 Caligor Names Karen Frascello Vice President of Business Development & Marketing, Global Access Programs
Secaucus, NJ, January 13, 2015
Caligor Rx, a leader in global specialty pharmaceutical services, today announced that it has named Karen Frascello to the new position of Vice President of Business Development & Marketing for the Company’s Global Access Programs (GAP). GAP is Caligor’s term for programs that are sometimes referred to as “named patient,” “expanded access,” “early access” or “compassionate use.” These programs are specifically intended for patients who have exhausted their treatment options and for whom appropriate therapies exist outside standard commercial channels. A GAP can be established for an individual patient or for a group of patients. Full Release