Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (March 2010)
25 slides from Palatin Technologies's investor presentation, March 2010
Slide 1: Corporate Presentation March 2010
Corporate Presentation March 2010
Slide 2: Forward-Looking Statement
Forward-Looking Statement The statements in this presentation that relate to future plans, events or performance are forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve signif
Slide 3: Company Profile
Company Profile Palatin is a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonists with a focus on melanocortin and natriuretic peptide receptor systems. Palatin’s internally developed drug pipeline utilizes proprietary approaches to discover
Slide 4: Palatin Product Development Overview
Palatin Product Development Overview • Bremelanotide (BMT), a peptide melanocortin receptor (MCR) agonist, for treatment of sexual dysfunction, targeting erectile dysfunction (ED) in patients non-responsive to current therapies and female sexual dysfunction (FSD) • PL-6983, a back-up melanocortin re
Slide 5: Palatin Pipeline Status
Palatin Pipeline Status Program Preclinical Phase 1 Phase 2 Melanocortin Receptor Programs BMT: ED BMT: FSD PL-6983: ED & FSD MCR Compound: Obesity/Diabetes (Partnered with AstraZeneca) Natriuretic Receptor Programs PL-3994: Heart Failure PL-3994: Acute Severe Asthma PL-3994: Refractory Hypertension
Slide 6: Melanocortin Sexual Dysfunction Program
Melanocortin Sexual Dysfunction Program
Slide 7: Sexual Dysfunction Program Overview
Sexual Dysfunction Program Overview • Palatin has extensive clinical experience with bremelanotide (BMT), an MCR-4 peptide agonist for the treatment of both Erectile Dysfunction (ED) and Female Sexual Dysfunction (FSD) – Evaluated in over 2000 patients – Demonstrated efficacy as a treatment for both
Slide 8: Bremelanotide ED Market Opportunity
Bremelanotide ED Market Opportunity 20% are “marginally satisfied” but 35% of patients are satisfied have no alternative treatment options PDE-5 inhibitor users 35% discontinue PDE-5 inhibitor therapy following initial prescription Initial Target Population BMT estimated global peak sales: $550 mill
Slide 9: PDE-5 Inhibitor Non-Responsive Patients
PDE-5 Inhibitor Non-Responsive Patients • Multiple BMT ED studies have demonstrated efficacy in a broad range of patients, including those non-responsive to PDE-5 inhibitor treatment • Phase 2 clinical studies evaluating BMT co-administration with PDE-5 inhibitor demonstrate additive effect • Signif
Slide 10: Bremelanotide ED Program
Bremelanotide ED Program • Intranasal (IN) BMT has significant efficacy: – Small number of patients experienced an increase in blood pressure (BP) – Gastrointestinal (GI) AE’s are problematic • FDA End of Phase 2 Position: intranasal BMT – BMT safety and efficacy profile is appropriate for PDE-5 inh
Slide 11: Importance of BMT Plasma Levels
Importance of BMT Plasma Levels 500 Plasma BMT (ng/mL) 400 High AE Rate 300 200 Target 100 Therapeutic Range Sub-therapeutic 0 IN IN IN IN IN SC 5 10 15 5 .5 5 7. 12 2. Dose (mg) 11
Slide 12: No Effects of BMT on Δ SBP
No Effects of BMT on Δ SBP 15 BMT Systolic Blood Pressure baseline (mm Hg) Placebo 10 5 0 Change from predose -5 -10 -15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Day 12
Slide 13: Bremelanotide ED Development Program
Bremelanotide ED Development Program • SC repeat dose study in target demographic, men 45-65 – Additional pharmacokinetic and safety data in target population – Reduce risk of Phase 2 program • Phase 2B in PDE-5 inhibitor non-responsive patients – Evaluate co-administration with a PDE-5 inhibitor –
Slide 14: Female Sexual Dysfunction
Female Sexual Dysfunction • Female Sexual Dysfunction (FSD) represents a large untapped market – ~18 million post-menopausal women in the US suffer from some form of FSD – There are no FDA approved treatments available • Significant portion of the market represents an opportunity for multiple produc
Slide 15: BMT in the Treatment of FSD
BMT in the Treatment of FSD • Significant efficacy in Phase 2 intranasal FSD clinical studies • Bremelanotide has effects on arousal and desire – FDA accepted endpoints for approval • Women with FSD taking BMT reported an improvement in the quality of their sexual experience – Quality of orgasm impr
Slide 16: BMT Phase 2B Post-Menopausal Data
BMT Phase 2B Post-Menopausal Data P<0.001 6 P<0.001 P<0.003 % Change from Baseline 60 P<0.001 Arousal Success Rate 5 50 # of SSE’s 4 40 3 30 Placebo 2 20 BMT 1 10 0 0 BSL 1 mos. 2 mos. 1 mos. 2 mos. SSE: “Satisfying Sexual Events,” the Arousal success rate, the % of FDA required registration endpoin
Slide 17: Natriuretic Peptide Receptor Programs
Natriuretic Peptide Receptor Programs
Slide 18: Natriuretic Program Overview
Natriuretic Program Overview • Development program for compounds selective for NPR-A, NPR-B and NPR-A/B • Significant potential for NPR agonists to address unmet medical needs: – Heart Failure (HF) to reduce re-hospitalization rates and cardiac remodeling and improve survival – Acute severe asthma i
Slide 19: PL-3994 Clinical Results
PL-3994 Clinical Results • Phase 1 & 2A placebo-controlled dose escalation studies – Well tolerated - no adverse or severe adverse events – Clear dose response for key pharmacological effects – Prolonged duration of effect – Met key pharmacology endpoints SBP, ↑diuresis, ↑natriuresis, ↑cGMP plasma
Slide 20: Sub-chronic HF Indication
Sub-chronic HF Indication • HF with history of frequent hospitalization for worsening symptoms – Hospitalization leads to decreased survival – Identified by NIH Institute of Medicine as a high priority medical issue – Significant driver of hospital costs • PL-3994 treatment for 3-6 months post-hospi
Slide 21: Acute Severe Asthma
Acute Severe Asthma • Published data support bronchodilator activity of IV and aerosol NPR-A agonist • NPR-A agonism relaxes smooth muscle in airways – effect is increased under conditions of β2 overload • NPR-A cGMP pathway is independent of β2-ADR/cAMP pathway • β2 refractory, acute severe asthma
Slide 22: PL-3994 for Asthma/COPD
PL-3994 for Asthma/COPD* Subcutaneous Market Potential >$500M Nebulized Market Potential >$1B Dry Powder Market Potential >$3B *Crossover use of asthma therapeutics in COPD approx. 30% of asthma market 22
Slide 23: Refractory Hypertension
Refractory Hypertension • PL-3994 lowers BP through a mechanism different than currently approved agents – NPR-A agonism • PL-3994 acts synergistically with ACE inhibitors to lower BP • PL-3994 administered as an adjunct to standard therapy • Greater then 1.5 million patients have refractory hyperte
Slide 24: AstraZeneca Obesity Collaboration
AstraZeneca Obesity Collaboration • AstraZeneca is a global pharmaceutical company with a strong emphasis in metabolic disease • Exclusive global licensing and research collaboration – $10M up front and $12M milestones received – Royalties on commercialization – $85M in development and $60M in sales
Slide 25: Financial Snapshot
Financial Snapshot Ticker Symbol NYSE AMEX: PTN 52-Week Price Range $0.06 - $0.48 Shares Outstanding as of 3/10 ¾Common 106M ¾Fully Diluted 131M Market Capitalization $30M Cash and Investments Balance as of 12/31/09 $7.4M 25
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