12/15/2009 11:23:58 AM
Ruggell, Liechtenstein, 15 December 2009 - Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, announced today that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted SME (Small and Medium Sized Enterprise) status to Pantec Biosolutions. The SME status provides Pantec Biosolutions access to provisions for administrative and financial assistance, and the cost of the company’s approval process will decrease.
Christof Boehler, CEO of Pantec Biosolutions, commented: ”Pantec will benefit greatly now that it has been granted SME status by the EMEA. This is a crucial step towards a centralized EMEA regulatory approval procedure of our first clinical programme P.L.E.A.S.E. IVF (In Vitro Fertilization), in which a Phase I study was already successfully completed.”
The SME program is an EMEA initiative to address the needs of small and medium sized companies who are developing medicinal products in Europe. Companies with SME status can receive assistance, information and training from dedicated EMEA employees. These companies are also eligible for reduced or deferred fees associated with regulatory submissions, scientific advice and inspections.
About Pantec Biosolutions and P.L.E.A.S.E.®
Pantec Biosolutions AG is a private drug delivery company specialised in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E.® (Painless Laser Epidermal System) platform enables efficient, needle-free and painless administration of biopharmaceutical drugs, in varying and individualised dosages, through partnered patch technology. The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of US$1.5 – 2 billion.
Pantec Biosolutions’ P.L.E.A.S.E.® platform is available both for the development of the Company’s own pipeline and for penetration into new markets through strategic partnerships. Pantec Biosolutions is based in Ruggell, Liechtenstein.
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