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PDC Biotech GmbH (PDC) is a private biopharmaceutical company developing innovative therapeutics for the treatment of preterm labour and primary dysmenorrhea, two areas of significant unmet medical need and large market potential.
The primary focus for the company is the development of a pipeline of products which are antagonists of the receptor for prostaglandin F2α (FP receptor). PDC has licensed exclusive worldwide rights to a family of FP receptor antagonists from Theratechnologies Inc. (www.theratech.com) which include both peptides (compounds composed of at least two amino acids) and peptidomimetics (peptide-like compounds).
The company is currently in late preclinical stage development on its lead product, PDC31. The upcoming major milestones are as follows:
- File CTA/IND in 2010
- Complete Phase l/ll in 2011
PDC31 has been shown to block uterine contractions in vitro and in animal models of preterm labour that are the industry standard models used to predict results in humans. Excessive uterine contractility mediated by PGF2α is involved in both preterm labour and primary dysmenorrhea, and the company's resources can be used to develop both core programs in tandem, thereby reducing development costs. PDC31 is an intravenous (IV) formulation, which is suitable for development in preterm labour, which is treated in a hospital setting and requires a rapid onset of action. The company will also explore non-IV formulations (PDC41 Series) such as a nasal formulation, which would be more convenient for use in primary dysmenorrhea, where the patient would self-administer the drug.
The company's initial focus is on obtaining clinical proof-of-concept of the ability of PDC31 to stop uterine contractions in healthy women with primary dysmenorrhea. A positive outcome with the IV formulation will support moving forward with this formulation for preterm labour, and with development of a non-IV formulations in primary dysmenorrhea.
PDC's management team has strong expertise in licensing and drug development, specifically in preterm labour and has a well thought-out clinical development strategy which has been discussed with clinical experts in both the US and Europe. Patent applications claiming composition of matter, pharmaceutical compositions and therapeutic uses of the peptides and peptidomimetics have been filed in all major jurisdictions and respective patents have already issued in the US.
In September, 2009 PDC closed a Series A round of financing of over 4 million. MIG Verwaltungs AG (Munich) and Edmond de Rothschild Investment Partners (Paris) co-led the round. In addition to this Series A round the company had previously received 1 million in seed funding from the Austrian Wirtschaftsservice (AWS) and a grant of 517, from the Zentrum für Innovation und Technologie (ZIT; an agency of the City of Vienna for promotion of innovation and technology). Since May 2008 the company has raised over 5.56 million (approx. CDN $8.9 million).
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