Catching the Bug for Novel Antibiotics: Roundtable Conference

Transcription

1 Leerink Swann & Company Catching the Bug for Novel Antibiotics: Roundtable Conference March 6, 2007 Nebojsa Janjic Chief Scientific Officer We are providing this information as of February 12, 2007 and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise.

2 Forward Looking Statements This presentation contains forward-looking statements about Replidyne, Inc. Our actual results could differ materially from those discussed due to a number of factors including, the success and timing of our pre-clinical studies and clinical trials; our ability to obtain and maintain regulatory approval of our product candidates and the labeling under any approval we may obtain; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in our Forms S-1 and most recent filing with the SEC. 2

3 Replidyne Mission Discovering, developing, in-licensing and commercializing innovative anti-infective products Anti-infective infective Opportunity Evergreen medical need Eventually resistance to all antibiotics Pharma shift to chronic diseases & other therapeutic areas Pediatric Opportunity Phase II faropenem anchor product Phase I REP8839 for impetigo 3

4 Replidyne Product Pipeline Discovery Preclinical Phase I Phase II Phase III NDA Faropenem Adult Bronchitis Sinusitis, pneumonia Faropenem Pediatric Acute otitis media REP8839 Skin infections impetigo, including MRSA Wound infections Discovery research C. difficile program DNA replication inhibition program 4

5 Faropenem Background Faropenem Medoxomil Discovered by Suntory (now Daiichi Asubio) Prodrug form of faropenem with improved bioavailability 13 Phase III clinical trials completed by Bayer 5000 patient safety database Licensed from Daiichi Asubio - March

6 Faropenem Adult - Timeline of Events Pre-NDA Meeting 4/05 NDA Submitted 12/05 NDA Accepted 2/06 Initiated AECB trial All non-inferiority studies End Non- Forest approvable Contract 10/06 2/07 Ongoing FDA dialogue AOM Results 3/6/07 Sinusitis Pneumonia Bronchitis Skin Infections 6

7 Regulatory Uncertainty Community Antibiotic Environment Faropenem: Demonstrated favorable safety ABS, AECB: Clear shift to superiority trials IDSA Bad Bugs, New Drugs initiative Regulatory challenge Faropenem goal: 1 st product to clear new requirements 7

8 Oral Antibiotics - Market Potential Oral Antibiotic Market Total Prescriptions Oral Antibiotic Market Sales Dollars Millions 300 $ Billions $ $ $ $ $ Source: IMS NPA Audit Source: IMS NSP Audit 8

9 Oral Antibiotics - Class Distinctions Beta-Lactams Macrolides/ Ketolides Quinolones Erythromycin Cipro Penicillins Cephalosporins Oral Penems Zithromax Levaquin Penicillin Keflex Faropenem Biaxin Avelox Amoxicillin Ceclor Ketek Factive Ampicillin Omnicef Tequin Augmentin 9

10 Beta-Lactams Dominating Oral Antibiotic Markets Adult Market Share Pediatric Market Share Quinolones 1% Other Antibiotics 2% Other Antibiotics 16% Quinolones 17% Beta-Lactams 43% Macrolides 29% Beta-Lactams 68% Macrolides/ Ketolides 24% Source: IMS NPA Audit million prescriptions Total market = $7.0 billion million prescriptions Total market = $1.5 billion 10

11 Acute Otitis Media (AOM) AOM Facts A common middle ear infection Most frequent pediatric infection 30 million office visits annually Younger ages, higher rates of treatment failure and recurrences Oral antibiotics are most widely prescribed medication AOM Class Beta Lactams Macrolides All Other Antibiotics 2006 Share 89.2% 8.7% 2.1% 11

12 Faropenem Pediatric Results Acute Otitis Media Faropenem effective in eradicating pathogens from the middle ear Confident in selecting dose for Phase III trials Large Phase II trial: Over 300 pediatric patients Liquid oral suspension Four doses tested, Administered twice daily Double tap design To present at upcoming medical conference 12

13 Adult Oral Antibiotic Branded Market Projected Patent Expiries Augmentin Cefzil Zithromax Augmentin XR Adult Branded Oral Antibiotic Patent Expiration Dates * Omnicef Avelox Biaxin XL Only CAP indication with black box warning Levaquin Ketek Factive Faropenem Base Molecule patent has expired Base Molecule Projected Composition of Matter Patent Expiry * Line extension patent expiration estimated based on Biaxin XL scenario Source: IMS Audits (launch), Orange Book (patent expiration) Note: Tequin removed from market by BMS in May 2006 Garenoxacin NDA was pulled by Schering Plough in Oct

14 Pediatric Broad Spectrum Oral Antibiotic Branded Market Projected Patent Expiries Pediatric Branded Oral Antibiotic Patent Expiration Dates Augmentin ES-600 Biaxin Zithromax Ce fzil Omnicef Faropenem Base Molecule patent has expired Base Molecule Projected Composition of Matter Patent Expiry Source: IMS Audits (launch), Orange Book (patent expiration) 14

15 Faropenem Action Points Restart AECB study as soon as possible Actively seek FDA guidance for regulatory requirements (end 1Q07) Partner for additional studies in adults Release top-line results on pediatric AOM Phase II study Meet with FDA for AOM regulatory requirements (end 2Q07) Decide on whether to pursue the pediatric program on our own 15

16 REP8839 Improving Topical Antibiotics Selective methionyl trna synthetase inhibitor Acquired all rights from GSK Initial target indication: Treatment of skin infections (including MRSA) Primary pediatric indication: Impetigo 16

17 REP8839 Development Status Discovery Preclinical Phase I Phase II Phase III NDA REP8839 Skin infections impetigo, including MRSA Wound infections KEY DATES IND filed in Q2, 2006 Phase I testing commenced July 2006 Phase I results expected 1H07 17

18 Impetigo Market Dynamics Third most common skin disease in children Incidence has increased 21% since 2004 Topical antibiotic prescriptions accounted for 48% of all impetigo treatments Topical antibiotic Bactroban (mupirocin), currently most frequently prescribed product for impetigo Pediatricians prescribe 66% of all prescription drugs used to treat impetigo 18

19 Preclinical Program C. Difficile Increasing public health threat in elderly patients Clostridium difficile program Identified microbiologically active compounds Potent in vitro activity against C. difficile In vivo efficacy High selectivity Target Product Profile Low oral bioavailability low systemic exposure Inhibition of toxin production Inhibition of sporulation Distinct, novel target 19

20 Discovery Program DNA Replication DNA Replication Inhibitors program Bacterial DNA replication is an essential process; new mechanism-of-action antibiotic High-throughput assays Target the DNA replication complexes from multiple bacteria Currently at lead optimization stage Broad-spectrum Gram-positive activity Target Product Profile Orally bioavailable (like Zyvox ) Bactericidal (unlike Zyvox ) Low spontaneous resistance rates Favorable safety profile 20

21 Financial Summary As of December 31, 2006 Cash balance at 12/31/06 $126 million Burn rate (full year 2006) $40 million 4Q06 & 2006 Year-End Reporting February 28,

22 Replidyne - Summary Discovering, developing, in-licensing and commercializing innovative anti-infective products Key Assets Faropenem Adult substantial revenue potential Faropenem Pediatric late stage beta-lactam opportunity Novel antibiotic pipeline addressing growing problem Positioned to Succeed Experienced management team Active business development Biopharma in strong financial position 22

23 Leerink Swann & Company Catching the Bug for Novel Antibiotics: Roundtable Conference March 6, 2007 Nebojsa Janjic Chief Scientific Officer We are providing this information as of February 12, 2007 and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise.