Company Fact Sheet Phase IIa study in Celiac Disease by kerrib


									Company Fact Sheet                                                                       • Phase IIa study in Celiac Disease completed April, 2007
 • Leading mucosal biology company focused on the discovery,
   development and commercialization of therapeutics to treat                            • Initiating Phase IIb for Celiac Disease in H2 2007
   autoimmune and inflammatory diseases.
                                                                                         • Initiating Phase II in Type 1 Diabetes and IBD H2 2007
 • Lead products in development for:
                                                                                         • Worldwide market for the first lead in multiple indications
     Celiac Disease (”CD”)             Phase II                                            > $2.0bn
     Type 1 Diabetes (”T1D”)           Initiating Phase IIa, H2 2007
     IBD                               Initiating Phase IIa, H2 2007                     • Led by highly experienced drug developers and top-tier venture
     Asthma                            Toxicology                                          capital funds

 • 84 patents issued in the US, EU and other countries and 75
   patent applications pending worldwide.                                               The Company
 • Exclusive license of tight junction antagonist and agonist                           Alba Therapeutics Corporation is a development stage mucosal
   platform from University of Maryland, Baltimore.                                     biology and barrier function company focused on the discovery,
                                                                                        development and commercialization of peptides and small
Senior Management                                                                       molecules that regulate the functional state of tight junctions (TJ)
Blake Paterson, MD                  CEO and Co-Founder                                  and paracellular permeability. Zonulin, an endogenous signaling
Jeff Church, CPA                    Chief Financial Officer                             protein that transiently and reversibly opens the TJs of epithelial
Sefik Alkan, PhD                    EVP, Discovery                                      and endothelial tissues such as the intestinal mucosa, blood
Stuart Sedlack                      SVP, Corporate Development                          brain barrier and pulmonary epithelia, is one of several regulatory
Sharon Rowland, PhD                 VP, Regulatory Affairs                              pathways under investigation by Alba. As increased paracellular
Anne Shiflett, CPA                  VP, Finance & Administration                        permeability is implicated as a causal factor in many disease states,
Roberto Allen, Esq                  Senior Director, Legal                              modulation of permeability by TJ regulatory pathways represents a
Linda Arterburn, PhD                Senior Director, Pharm/Tox                          very important therapeutic opportunity. Applications range from
                                                                                        the treatment of diseases involving tight junction dysfunction and
Founded                             2004                                                autoimmunity to vaccine and drug delivery.
Industry                            Biotechnology
                                                                                        While the Alba’s portfolio provides breadth and depth for
Sector                              Immunomodulation                                    future discovery and drug development in many areas, the most
                                    and Inflammation                                    immediate opportunities for commercialization are within the
                                                                                        immunomodulation and inflammation (”IDI”) therapeutic area. IDI
Headquarters                        Baltimore, Maryland                                 is a rapidly growing and promising area of biotherapeutics with
                                                                                        the potential to achieve revenues of $80bn by 2012. There are
Employees                           35
                                                                                        many diseases whose etiology is thought to be inflammation or
Financing                           Series A, $30m                                      immune mediated. Consequently, TJ mediators, including zonulin
                                    Seed capital, $1.6m                                 receptor antagonists such as AT-1001, may have an extended
                                    Grants and awards, $1.3m                            role in the prevention or modification of multiple disease states.

Shareholders                        Venture Debt, $10m                                  Business Strategy
                                    SV Life Sciences                                    Alba is concentrating its principal efforts on clinical and product
                                    Alta Partners
                                    HealthCap Venture Capital                           development activities supporting AT-1001 (Parozotide acetate)
                                    Red Abbey Venture Partners                          in CD, IBD and T1D. Alba is also focusing its efforts to exploit
                                    Esperance BioVentures                               its leadership in mucosal biology and barrier function and the
                                    Astellas Ventures                                   mechanistic understanding of the TJ regulatory pathways by
                                                                                        continuing to develop a pipeline of zonulin antagonists and
                                                                                        agonists which address therapeutic opportunities where the
Investment Highlights                                                                   unmet medical need remains very high.
 • Rapid registration pathway in initial indication; significant unmet
   medical need                                                                         Alba’s strategy is to retain as much pipeline value as possible
                                                                                        by building a business which is capable of commercializing
 • FDA granted “Fast Track” designation to Alba’s lead product,                         its products in US specialty markets while relying on strategic
   AT-1001, for treatment of Celiac Disease in October 2005                             pharmaceutical partners to sell and market in the broader primary
 • Phase I, including positive Phase Ib Proof of Concept study,                         care markets in the US and worldwide.
   completed March, 2006

                  800 W. Baltimore Street, Suite 400   Baltimore, Maryland 21201   P 410.319.0780   F 410.319.0834
Product Development

Lead product development is focused on

                                                                                                                     LO G CO LO
the application of the enteric coated oral



formulation of AT-1001 (“EC AT-1001”) for




autoimmune conditions including CD, IBD and

                                                                                                                I CO






                                                                                                           I N-


Alba recently completed an 86 patient Phase                 ANTAGONISTS
IIa study with EC AT-1001 for the treatment of                          EC AT-1001 Celiac Disease
CD and intends on announcing results in Q2
                                                                                  EC AT-1001 IBD
2007. The worldwide market for a CD therapy,
alone, may exceed $1bn. In the US, 3 million                                     EC AT-1001 T1D
Americans are estimated to be affected with                                       EC AT-1001 IBS
CD (NIH Consensus Statement on Celiac
Disease; August, 2004) and in Europe the                              AT-1001 Asthma (pulmonary)
prevalence is estimated to be in excess of 3                                Antagonist Candidates
million. In H2 2007, following additional IND
filings, EC AT-1001 will enter Phase IIa trials for
IBD and T1D.                                                            AT-1002 Vaccine Adjuvants
                                                                            AT-1002 Drug Delivery
Our second lead molecule, the zonulin agonist
AT-1002 is a 4th generation agonist under                                      Agonist Candidates
development for use as an antigen or drug
delivery agent. In multiple animal models,
AT-1002 has demonstrated high efficacy in
promoting both mucosal and systemic immunity
with vaccines and delivering macromolecules which are not                       Scientific Advisory Board
easily absorbed by the body. Induction of mucosal immunity                      Alessio Fasano, MD (Chair) - University of Maryland, Baltimore
without the safety or toxicity concerns of existing adjuvants is
                                                                                Richard DiMarchi, PhD - Indiana University
now a reality. Exploratory toxicology studies are underway and
IND enabling studies are currently planned for 2007.                            Jerrold R Turner, MD, PhD - University of Chicago
                                                                                Jon Meddings, MD - University of Alberta
Antigen and drug delivery is essential to the future growth of
the biologics industry, in that most biologics are hampered by                  John Sagartz, DVM, PhD - 7th Wave Laboratories
their inability to penetrate tissues of interest. Alba is currently             Morley Hollenberg, MD, PhD - University of Calgary
evaluating partnering opportunities for this asset with several
                                                                                W. Allan Walker, MD - Harvard University
strategic partners.

Board of Directors                                                              Development Advisory Board
Richard DiMarchi, PhD                                                           G. Alexander Fleming, MD (Chair) - Kinexum
Chair, Department of Chemistry, Indiana University.                             Alessio Fasano, MD - University of Maryland, Baltimore
Previously, Group Vice President, Eli Lilly; Co-founder of Ambrx.
                                                                                Jon Meddings, MD - University of Alberta
Lutz Giebel, PhD                                                                Allan Sedman, MD, PhD - Clinical pharmacology consultant
General Partner, SV Life Sciences.
Previously, Managing Partner, Didyma; Founder of Cythera, ExSAR                 Ivor Hill, MD - Wake Forest University
and MetaXen.                                                                    John Lachin, ScD - George Washington University
Daniel Janney                                                                   Mark Pescovitz - Indiana University
Managing Director, Alta Partners.
Previously, Senior Investment Banker, Montgomery Securities.
                                                                                For further information, please contact
Eugen Steiner, MD, PhD                                                          Stuart D. Sedlack
Venture Partner, HealthCap.                                                     SVP, Corporate Development
Previously, CEO, Creative Peptides & CEO, Affibody AB                           Alba Therapeutics Corporation
                                                                                800 West Baltimore Street, Suite 400
Blake Paterson, MD                                                              Baltimore, MD 21201
Co-Founder & CEO, Alba Therapeutics.                                            Tel: +1 410 319 0780
Previously, Executive Director, Oncology Acute Care & Inflammation              Fax: + 1 410 319 0834
Product Groups, Eli Lilly; Senior Director, Clinical Affairs, Parke-            E-mail:
Davis; COO, Integrity Pharmaceuticals.                                

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