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.
Puma’s Managed Access Program for neratinib will enable participation from countries outside the United States, including European Union Member States, where permitted by applicable rules, procedures and regulatory authorities. The program 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 Puma’s managed access program. Patients in the managed access program will be given neratinib and will be instructed to take a prophylaxis during treatment to manage neratinib-related diarrhea, which Puma expects will consist of high dose loperamide and budesonide.
“The guiding principle behind our Managed Access Program is to provide neratinib – through physician-requested access – to patients with significant unmet medical needs as soon as practical, in a manner that is safe, ethical, compliant and effective,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “With Caligor managing the day-to-day operations of the program, we can direct our efforts toward our regulatory filings and implementing our plans for commercialization.”
“We are proud to partner with Puma to provide physicians with pre-commercial access to neratinib,” said Tammy Bishop, Chief Executive Officer of Caligor. “In addition to helping patients for whom clinical trial participation is not an option, this partnership underscores our strategic focus on expanding our global access business to new clients and new geographic markets.
“A key reason clients benefit from our pre-commercial access solution is that, rather than using a call center model, a physician overseeing a patient or group of patients interacts directly with Caligor’s experienced clinical professionals,” Bishop said. “Our unique, high-touch “peer-to-peer” approach ensures that physicians efficiently receive the most accurate and comprehensive clinical information pertaining to their program.”
Questions or inquiries regarding the Neratinib Managed Access Program should be directed to email@example.com.
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 can 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 unlicensed / unapproved 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 http://caligorrx.com/.
Tammy Bishop, Caligor Opco LLC, +1 508-850-6307
Scott Solomon, Sharon Merrill Associates, +1-617-542-5300