On December 6, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported the initiation of a Managed Access Program for PB272 (neratinib) (Press release, Puma Biotechnology, DEC 6, 2016, View Source [SID1234516961]). Managed access programs provide physicians and patients access to medicines when there are limited or no other therapeutic options available.

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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 the Company expects will consist of high dose loperamide and budesonide.

Puma Biotechnology has partnered with Caligor Opco LLC, which specializes in early access to medicines, to implement and oversee the Managed Access Program for neratinib.

"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."

Questions or inquiries regarding the Neratinib Managed Access Program should be directed to [email protected].

About Caligor

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 View Source