Soligenix Announces SGX301 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency
Princeton, NJ – February 2, 2017 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today SGX301 (synthetic hypericin) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of cutaneous T-cell lymphoma (CTCL).
The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS). Launched in April 2014, EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible.
PIM status, the first phase of EAMS, which is awarded following an assessment of early nonclinical and clinical data by the MHRA, has been created as an early signal to companies that the development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme, once further development work has been conducted. In this second phase, the product is made available to UK patients before a marketing authorization is approved. This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises.
The criteria products must meet to obtain the PIM designation are:
Criterion 1 – The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations).
Criterion 2 – The medicinal product is likely to offer major advantage over methods currently used in the UK.
Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence, as justified by the applicant, that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits.
“We are excited that the MHRA agrees that SGX301 meets the specified criteria for PIM designation,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “This is now the second of our programs to receive this important designation, with the first being SGX942 for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy. We look forward to working with the MHRA to advance both programs and leverage the potential benefits of the EAMS scheme to make these important products available to patients and physicians facing the challenges of CTCL and severe oral mucositis.”
