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Theralpha corporate overview_february2012


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Theralpha corporate overview_february2012

  1. 1. Innovative therapeutics for pain managementExecutive Summary INNOVATIVE THERAPEUTICS FOR PAIN MANAGEMENT FUND RAISING ROUND A €5M TO REACH END PHASE I WITH EFFICACIE DATA FOR 2 DRUG CANDIDATES AND CTA FOR ONE IN 3 YEARSTheralpha SAS is a specialty biopharmaceutical company that develops novel and innovative drugs addressingunmet needs in pain management. Theralpha was founded by David Dellamonica, Michel Lazdunski, and MarcVasseur, all experienced professionals, recognized internationally in the biotechnology and pharmaceuticalindustry, who have complementary expertise in successfully managing drug development and businessoperations. Founders own 100% of the Company. Damian Marron, CEO of Trophos and former executive VP ofNicOx, recently joined the board of directors of Theralpha. Theralpha is based in Sophia Antipolis, France.Theralpha is a product development-oriented company. Theralpha is focused on rapidly advancing its leadcompounds through late-pre-clinical and early clinical development value-creating milestones.By leveraging its founders’ experience, its pain expert network and a lean operations model, Theralpha intendsto proceed aggressively with the development of its assets and become an attractive acquisition target for aPharma/Biotech within 3-5 years.The Company’s founding assets originate from worldwide exclusive licenses from IPMC (Institut dePharmacologie Moleculaire, CNRS, Sophia Antipolis, France) and ProTherapeutics (National University ofSingapore). Specifically, the IPMC-originating assets are based on research made by Professor Michel Lazdunskiand his team who have pioneered for more than 10 years the discovery of peptides found in animal venomsthat selectively inhibit Acid Sensing Ion Channels (ASICs) which are directly implicated in pain signaltransmission. The NUS originating drug candidate acts through nNOS pathway. THA902 THA903 THA904 Target ASIC 3 – Nav 1.8 Indirect activation of the ASIC1a, ASIC1b, ASIC1a+2a, Block pain perception by enkephalines system ASIC1a+1b nociceptors Stage Preclinical Late preclinical End Discovery Patent 2029 2027 and 2031 2031 expiration First in man Q3, year 3 Q2, year 2 Q4, year 2 First  Inflammatory pain : sever  Acute pain  Inflammatory and Indication Osteoarthritis pain Neuropathic painThe company’s drug candidates are small peptides composed of natural amino acids which are effective inmultiple animal models of pain. Our pipeline includes 3 candidate drugs: THA902 that targets ASIC3, Nav1.8and THA904 that targets ASIC1a, ASIC1b and ASIC1a+2a; THA903 –the peptide licensed from NUS- is notdirected against ASICs, and has a mechanism of action involving activation of endogenous enkephalins. Thesedrug candidates have demonstrated strong activity in classical pharmacological models of chronic, neuropathicand inflammatory pains, and acute pain. They all present an excellent safety profile. 1/4 Copyright © 2012 2229, route des Crêtes 06560 Valbonne Sophia Antipolis France. -
  2. 2. Innovative therapeutics for pain managementTheralpha pipeline & indications: Drug Candidates Lead MoA Administation Preclinical Clinical Partner and Indications Confirmation PHARMACO ADME, TOX IND Phase I Phase IITHA902 ASIC3 & Controlled-release Subcutaneous (SC), formulation withInflammatory Pain : Nav1.8 Intra-articular (IA) CURRENT STATUS Flamel (NASDAQ:Osteoarthritis ANTAGONIST FLML)THA903 ENKEPHALINS Sublingual CURRENT STATUS SubAlgic ConsortiumAcute pain RELEASETHA904 ASIC1a,1b Intrathecal,Neuropathic pain - Subcutaneous CURRENT STATUS ANTAGONISTInflammatory pain The arrows indicate what will be achieved in 3 years  THA902 is peptide which is a potent and specific ASIC3 & Nav1.8 inhibitor. It is effective by subcutaneous injection and has a number of possible indications in inflammatory pain, including osteoarthritis pain (First development), and post-operative pain.  THA903 is a small peptide derived from venom, which is active by sublingual administration with indications in the treatment of chronic nociceptive and acute pain.  THA904 is a potent specific inhibitor of ASIC1a, ASIC1b and ASIC1a+2a, ASIC1a+1b. It can be delivered both by intrathecal and subcutaneous route and has been demonstrated in animal models to be effective for all types of pain. THA902 has completed pharmacology, and is 24 months ahead of Phase I. THA903 has completed some regulatory preclinical requirements and can enter Phase I in 20 months. THA904 is a recently patented peptide, which is 36 months to first in man.Since inception, the Company has successfully managed to:  Acquire an exclusive worldwide license for venom-derived analgesic peptides THA902 and TH904 from CNRS. This includes the worldwide exclusive right on 4 families of patents covering the peptides and their targets.  Acquire an exclusive worldwide licence for a venom-derived analgesic peptide (THA903), discovered at National University of Singapore (NUS, Singapore) and initially developed by ProTherapeutics, a NUS spin-off. We filed a new patent (PCT) for this drug candidate on February 2011 .  Conclude a first refusal right agreement in the domain of pain therapeutics with IPMC (CNRS, Sophia Antipolis), an institution recognized worldwide as a leading place for ion channel pharmacology. 2/4 Copyright © 2012 2229, route des Crêtes 06560 Valbonne Sophia Antipolis France. -
  3. 3. Innovative therapeutics for pain management  Obtain sizeable non-dilutive financing leverage: Theralpha has succeeded in obtaining a total €3,5M funding commitment from public bodies: o €1M grant from OSEO for preclinical THA904 development o €2,55M grant from Eurobiomed / FUI (Fond Unique Interministeriel) for preclinical and clinical development of THA903 until end of Phase I o €40 k PACA cluster support grant for G&A expenses  Enter into a joint development program with Flamel Technologies (NASD: FLML) for a Medusa®- enabled, long-acting formulation (xl) of Theralpha’s THA902. o The development agreement has been structured to leverage Theralpha’s pioneering intellectual property and Flamel’s expertise in creating long-acting formulations of peptides, proteins, and other biologics. Flamel Technologies will be responsible for and will fund formulation chemistry and large animals trials, with the objective to improve efficacy and dosing, by reducing administration frequency, and consequently allowing better patient compliance. Theralpha will be responsible for pre-clinical testing of THA902xl pharmacodynamics.In terms of strategy and operations, the Company :  Will maintain a lean internal operations structure & will outsource most activities. The Company outsources its Research & Development activities, including exploratory research, preclinical &, clinical development, drug development, manufacturing and regulatory, while keeping internally project management and strategic functions.  Has built and will expand a strong worldwide network of renowned pain experts to support its development activities. This is exemplified by the Medical Advisory Board which includes clinical development experts and worldwide thought leaders.  Has acquired and will maintain a strong IP portfolio. The company secures and maintains intellectual property rights for its products and their applications.  Will pursue leveraging French and European public support: on top of the usual support to innovative companies, ie JEI status and tax credit, the company has already obtained €3.5M in grants from public bodies and intends to pursue all non-dilutive funding opportunities.  Is seeking alliances and partnership with pharma and large biotech. As exemplified by the agreement with Flamel Technologies, the company intends to find partners to leverage its development, obtain non-dilutive financing, and eventually to prepare for a future exit.Theralpha aims to raise €5M. Thanks to non-dilutive public funding leverage, Theralpha’s total budget for 3years will amount €7.6M and will allow taking 2 compounds up to Phase II. The founders are committed todevelop Theralpha as an attractive target for acquisition by mid/large pharmacos in a 3-5 years window. 3/4 Copyright © 2012 2229, route des Crêtes 06560 Valbonne Sophia Antipolis France. -
  4. 4. Innovative therapeutics for pain managementFounder’s team & Directors David Dellamonica is CEO and member of the board of directors. Before founding Theralpha, David Dellamonica was director of strategic development and intellectual property at TxCell (2006- 2009) where he demonstrated his skills in developing a biotechnology company, raising €10.5M from public and private bodies. Before joining TxCell, David Dellamonica was director of life sciences for the Agence Départementale d’Attraction des Investissements Internationaux (Nice, 2002-2006). David Dellamonica holds a diploma in Marketing and Management from Ecole Supérieure de Gestion (Paris, 1998) and an MBA (Lausanne, 2001). Michel Lazdunski, member of the board of directors is a world-renowned specialist of ion channels and their pharmacology. Michel Lazdunski is author of more than 700 publications, among which some of them have the highest rankings of citations. He has founded the Institute of Molecular Pharmacology (IPMC) and the Institute of Neuromolecular Medicine, both at Sophia Antipolis. Michel Lazdunski has also been advisor for a number of large pharmaceutical companies. Michel Lazdunski received recently the CNRS Gold Medal and Ernest Jung Gold Medal for medicine in 2011. Marc Vasseur, Chairman is an experienced biotechnology entrepreneur, who has founded, managed, grown and developed start-up businesses in Europe, USA and Asia. He recently (2007) founded and is CEO of a bio computing company named Sobios SA in partnership with Dassault Systems, the worldwide leader for modelling and simulation. He is also the co-founder (2003) and is non-executive chairman of Moleac Pte. Ltd. In 1990, Marc Vasseur co-founded and managed Genset NASDAQ SA, initially as CSO and later as President and CEO. Marc Vasseur became President and CEO of Serono Holding. Before, Marc Vasseur was Professor of virology at the University of Paris. Damian Marron, director, serves as Chief Executive Officer of Trophos SA. Mr. Marron has over 20 years biotechnology and pharmaceutical industry experience at the international level, in particular in the fields of R&D and corporate development. He has raised over €200M in public and private equity, patient association funding and non-dilutive grants. He served as Executive Vice President of Corporate Development of NicOx SA from 2002 to May 30, 2008. Prior to this, he was Head of the European Development Business at 3M Pharmaceuticals between 1997 and 2002.MSAB: Medical & Scientific Advisory Board Professor Michel Professor Christian Professor Claude Professor Alain Professor Carlos Lanteri-Minet Head of Jorgensen Inflammatory DUBRAY Head of ESCHALIER Head of Pain Belmonte President of department for pain specialist, Head of Pain Clinical Trial Pharmacology IBRO (International Evaluation and Pain Immuno-Rhumatology, Center for Ph I, II, III, Laboratory and Pain Brain Research Treatment (Nice Montpellier Hospital INSERM - Clermont Clinic, member of Organization) and Hospital) President of Ferrand Hospital AFSSAPS, Clermont Director of the the French & European Ferrand University and Institute of Pain Society hospital Neurosciences of Alicante (Spain) 4/4 Copyright © 2012 2229, route des Crêtes 06560 Valbonne Sophia Antipolis France. -