EXECUTIVE SUMMARY by mikeholy

VIEWS: 18 PAGES: 3

									                                                                              PDC Biotech GmbH
                                                                              Kärntner Ring 10
                                                                              TOP 12, A- 1010
                                                                              Vienna, Austria
                                                                              www.pdcbiotech.com



                                   EXECUTIVE SUMMARY

PDC Biotech GmbH (PDC) is a private biopharmaceutical company which began in Canada and
relocated to Austria in May 2008. PDC is 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 that PDC intends to develop into an oral formulation) .

The company is currently in late preclinical stage development on its lead product, PDC31. The upcoming
major milestones are as follows:
   • CTA/IND 2009
   • Phase l/ll 2010
   • Major out-licensing agreement/partner early 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 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.

Preterm labour is defined as regular contractions associated with cervical changes occurring before 37
weeks of gestation. Preterm birth, which is considered to be the most important perinatal challenge
facing industrialized countries, is most often preceded by preterm labour. There are currently no approved
tocolytics (drugs used to relax or stop uterine contractions and therefore stop preterm birth) in North
America. There has been one tocolytic approved in the last 10 years in Europe, an oxytocin antagonist
which has not been widely adopted. FP antagonists are likely to be more effective than oxytocin
antagonists because of their more direct action and particularly in early preterm labour, which is most
often triggered by a prostaglandin-mediated inflammatory response, secondary to infection.

In the US, annual costs for babies with a diagnosis of prematurity/low birth weight are estimated at over
$26 billion. Recently, the landscape for developing new therapies to prolong pregnancy and prevent
preterm birth has improved dramatically with recent FDA actions setting precedents for the acceptance of
surrogate endpoints of infant mortality and morbidity. PDC will be testing an injectable formulation,
PDC31 in the late stages of pregnancy. It is standard hospital procedure to begin an IV infusion for
hydration when a woman comes to the hospital in premature labour and so this formulation is ideal.

Safety, both maternal and neonatal, is a critical issue of any drug for use in pregnant women even if it is
only near the end of the pregnancy as in preterm labour. The specific action of PDC31 at the FP receptor
combined with the limited distribution of FP receptors provides the potential for a wide margin of safety.
Additionally, as PDC31 is not a “small molecule” but an octapeptide, distribution across the placenta to
the fetus is anticipated to be negligible.
                                                                                                        Page 2



Primary dysmenorrhea is a very common and very disabling condition found in approx. 10-15% of
women of childbearing age with a reported prevalence of 60-93% among adolescent females. Severe
abdominal pain is caused by frequent and prolonged uterine contractions that decrease blood flow to the
myometrium resulting in ischemia. This painful women’s health condition has been estimated to account
for 600 million lost work hours and $2 billion in lost productivity annually in the US alone. Excessive
concentrations of PGF2α are responsible for the uterine hypercontractility associated with primary
dysmenorrhea and underpin the current use of NSAIDs in these women.                   However, NSAIDs are
associated with significant gastrointestinal toxicity and carry the risk of cardiovascular and renal toxicities
as well. Blocking the FP receptor directly is expected to provide a better safety profile than NSAIDs, with
a more rapid onset of action, and therefore more immediate relief of symptoms. PDC plans to initially
develop a suitable topical formulation (PDC41), most likely a nasal or vaginal formulation, and ultimately
an oral peptidomimetic for this indication.

FP receptor antagonists also have potential for use during human in vitro fertilization (IVF), as well as in
veterinary applications. The company intends to generate preclinical proof-of-concept data and divest
these non-core programs early on, in order to offset the costs of company’s core programs.

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 an injectable
formulation would support moving forward with the injectable in preterm labour, and with development of
a topical formulation (PDC41) in primary dysmenorrhea. The company believes that this data would be
sufficient for licensing one or both programs worldwide, either to suitable pharmaceutical partners or to
support continued development internally.

PDC’s management team has strong expertise in licensing and drug development specifically in the
tocolytics area 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.

In June 2008, the company received € 1 million seed funding from the Austrian Wirschaftservice (AWS) in
Austria following an in depth review of the company’s business plan and scientific data. Significant
progress has been made towards the filing of a Clinical Trial Application (CTA) in 2009 with approximately
€600,000 of the €1 million expected to be spent by about December 2008.

The company is currently seeking an equity financing of a minimum of €1.6 million for 2009 and €1.8
million for 2010. These amounts will be added to the further funding expected from the Austrian
government and will enable the company to advance PDC31 into the clinic, completing the Phase I/II
clinical trial and advancing its pipeline of follow-on compounds.

The end of year 2010 Phase l/ll milestone represents the first major inflection point for the company at
which time several possible courses of action will be discussed with our investors. These possible
directions could include:
    • Out-licensing some or all of the programs- revenue from such an out license is anticipated to
         ensure future sustainability of the company
    • Co development with a marketing or development partner
    • Divestiture of the company
    • An IPO or another financing if other in licensing opportunities become available




PDC Biotech GmbH                                    Page 2                                     November 2008
EXECUTIVE SUMMARY
                                                                                                  Page 3



Management team


                    Diane Kalina, B.Sc., C.Dir. President & CEO
.                   Ms. Kalina’s 17 years with GSK included positions as Head of Marketing and
                    Director of New Products and Licensing. She has developed an extensive
                    international network and assisted over 30 pharmaceutical and biotech
                    companies with over 60 Canadian and International agreements. She also spent
                    3 years as President and Board of Director member of the successful start-up
                    biotech company YM BioSciences Inc. She has served on the boards of four
                    publicly traded Canadian biotech companies. Diane is Principal Consultant and
                    President of BioCatalyst Yorkton Ltd., a licensing and partnerships consultancy.
                    She resides in Toronto and Vienna.




                    Patricia Griffin M.Sc., Executive Vice President & Chief Development Officer
                    Ms. Griffin is well versed in the area of preterm labour. As Director of International
                    Product Development with Ferring Pharmaceuticals in Europe, Patricia completed
                    the development of 2 novel obstetrics products. More recently in her 17-year
                    career, she was Vice President, Business Development at GlycoDesign, a
                    Canadian biotech company (since acquired by Inflazyme) where she established
                    and managed international strategic alliances for the company’s cancer,
                    cardiovascular and inflammation programs. Patricia is also President of Griffin
                    Biopharma Consulting, which provides consulting services in business
                    development and drug development to pharmaceutical and biotech companies as
                    well as universities.




                    Dr Algirdas Lukoševičius Vice President of Business Operations
                    Throughout Dr Lukosevicius’ 20-year pharmaceutical industry career, he has
                    consistently achieved success in building businesses – from coordinating drug
                    disposition for more than 80 new drug clinical trials at Yale New Haven Hospital to
                    launching and building two successful entrepreneurial companies in the United
                    States and Europe. He has created nearly a half of a billion dollars in value for the
                    businesses he developed. Dr Lukosevicius holds a Doctor of Clinical Pharmacy
                    Degree from the University of Illinois at Chicago and an undergraduate degree in
                    Pharmacy from St. John’s University, New York. He resides in Vienna.




                    Dr Roman Götz PhD, PMP® Senior Project Manager
                    Dr Götz graduated in Chemical Engineering from Vienna University of Technology
                    and subsequently became certified as a Project Management Professional
                    (PMP®). He has spent more than 9 years with in the pharmaceutical industry
                    mainly in process validation and project leadership in product development and
                    process implementation. Most recently he held the position of Global Project
                    Manager Vaccines with Baxter BioScience. He also has specialized training in
                    European Patent Law and spent two years preparing patent and trademark
                    applications for the patent attorneys of Kopecky & Schwarz of Vienna.




PDC Biotech GmbH                        Page 3                                          November 2008
EXECUTIVE SUMMARY

								
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