EX-99.1 2 a05-12182_1ex99d1.htm EX-99.1



















 

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Cellegy Pharmaceuticals, Inc.
(Nasdaq NM: CLGY)

 

 

C.E. UNTERBERG, TOWBIN

Micro-Cap Macro Opportunity

 

New York

 

July 2005

 

[LOGO]

 


 

Forward Looking Statements

 

This presentation contains certain forward-looking statements, including statements concerning product development, the results of clinical trials and future dates for regulatory submissions.  Actual results may differ materially from those contained in these forward-looking statements.  Even if results are positive, FDA approval and successful product commercialization is not assured or may be subject to significant delays.

 

For more information regarding these and other risk factors associated with the Company’s business, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2004 and other documents that the Company files with the Securities and Exchange Commission.

 

Investors should not place undue reliance on these forward-looking statements, which only address events as of the date of this presentation.

 


 

Cellegy Pharmaceuticals

 

A specialty pharmaceutical company focused on the development and commercialization of novel drugs for women’s health

 


 

Corporate Snapshot

 

Strong product pipeline in
women’s health

 

Two approvals in Europe; ongoing
discussions with FDA re approval

 

 

in United States

Revenue-generating company
from sales of products overseas

 

Additional late-stage products

 

 

 

 

 

 

30 personnel in CA & PA;
capabilities in pre-clinical & clinical
development

 

European revenues and significant
grant funding offset certain
operational costs

 

 

 

Expertise with topical formulations

 

Product licensing opportunities for
non-strategic products

 


 

Business Strategy

 

•                  Development of products in areas of:

 

•                  women’s health care

•                  sexual dysfunction

•                  gastroenterology

 

•                  Self-market and co-promote in US

 

•                  Out-license as appropriate overseas

 

•                  Maximize value of portfolio in short and mid-term

 

[LOGO]

 


 

2005 Accomplishments

 

•                  Awaiting final response from FDA on amended Cellegesic NDA

 

•                  Prioritization on the development of Savvy

 

•                  Launch of Rectogesic in UK by licensee ProStrakan

 

•                  Completion of $6 million financing

 

•                  Upgrade of professional staffing

 

•                  Settlement of PDI litigation and return of Fortigel product rights

 

•                  Continued efforts to license European approved products, Rectogesic and Tostrex, throughout the world, and Fortigel in the U.S.

 

•                  Redefined spending priorities and minimization of infrastructure

 

Still to be Accomplished

 

•                  Planned launch of Tostrex in Sweden

 

•                  Continuation of MRP process by ProStrakan for the approval of Rectogesic and Tostrex throughout Europe

 

•                  Movement of corporate headquarters to Pennsylvania from California

 


 

Product Pipeline

 

 

 

Pre-Clinical

 

Phase I

 

Phase II

 

Phase III

 

NDA

CellegesicTM (nitroglycerin ointment)

 

 

 

 

 

 

 

 

 

 

Pain reduction for anal fissures

 

 

 

 

 

FILED

 

 

 

 

Hemorrhoid therapy

 

 

 

 

 

 

 

 

 

 

Female Sexual Dysfunction (Dyspareunia)

 

 

 

 

 

 

 

 

 

 

Rectogesic® (nitroglycerin ointment)

 

 

 

 

 

 

 

 

 

 

Pain reduction for anal fissures (UK)

 

 

 

 

 

APPROVED

 

 

 

 

Anal fissures (Australia, New Zealand, South Korea)

 

 

 

 

 

APPROVED

 

 

 

 

Savvy® (1% C31G vaginal gel)

 

 

 

 

 

 

 

 

 

 

Prevention of HIV Transmission (Africa)

 

 

 

 

 

 

 

 

 

 

Contraception (US)

 

 

 

 

 

 

 

 

 

 

TostrelleTM (testosterone gel)

 

 

 

 

 

 

 

 

 

 

Female Sexual Dysfunction (libido)

 

 

 

 

 

 

 

 

 

 

FortigelTM (testosterone gel)

 

 

 

 

 

 

 

 

 

 

Male Hypgonadism (US)

 

 

 

 

 

 

 

 

 

 

TostrexTM (testosterone gel)

 

 

 

 

 

 

 

 

 

 

Male Hypodonadism (EU)

 

 

 

 

 

APPROVED

 

 

 

 

Nitro Oxide Donors

 

 

 

 

 

 

 

 

 

 

Restless Leg Syndrome

 

 

 

 

 

 

 

 

 

 

Raynaud’s Disease

 

 

 

 

 

 

 

 

 

 

 


 

Pipeline Market Size & Share

 

Product/Indication

 

Development
Stage

 

Est. US Patient
Population

 

Est. US
Market

 

Main
Physician
Specialties

 

 

 

 

(000’s)

 

($millions)

 

 

Cellegesic ointment

 

 

 

 

 

 

 

 

chronic anal fissures

 

Not approved in U.S.

 

700

 

$

140

 

CR Surgeon, GI

 

 

Approved in UK

 

750

 (Eur)

$

100

 (Eur)

CR Surgeon, GI

 

 

for Europe *

 

 

 

 

 

 

hemorrhoids

 

Off-label

 

9,000

 

$

1,300

 

ObGyn, GP

dyspareunia

 

Phase 1-2

 

5,000

 

$

750

 

ObGyn, GP, Urol

Savvy vaginal gel

 

 

 

 

 

 

 

 

contraception,
HIV prevention

 

Phase 3

 

21,000

 

$

1,000

 

ObGyn, GP, Urol

Fortigel gel

 

 

 

 

 

 

 

 

male hypogonadism

 

Phase 3

 

5,000

 

$

600

 

 

 

 

Approved in
Sweden for

 

6,000

 (Eur)

$

80

 (Eur)

Urol,
Endocrinology

 

 

Europe**

 

 

 

 

 

 

Tostrelle gel

 

 

 

 

 

 

 

 

female sexual dysfunction

 

Phase 2

 

15,000

 

$

2,000

 

ObGyn, GP, Urol

UC 781 vaginal gel

 

 

 

 

 

 

 

 

HIV prevention

 

Phase 1

 

 

 

$

1,000

 

ObGyn, GP, Urol

CVN vaginal gel

 

 

 

 

 

 

 

 

HIV prevention

 

Preclinical

 

 

 

$

1,000

 

ObGyn, GP, Urol

NO donors

 

 

 

 

 

 

 

 

Raynaud’s Disease

 

Preclinical

 

28,000

 

 

 

ObGyn, GP

Restless Legs Syndrome

 

Phase 1

 

12,000

 

 

 

Neurol, GP

 

*              Partnered in Europe with ProStrakan Ltd.; marketed in Australia, New Zealand, S. Korea.

**           Partnered in Europe with ProStrakan Ltd.

 


 

Women’s Healthcare Focus

 

•                  Market Leader in development of microbicide gels for:

•                  Contraception

•                  Prevention of HIV-AIDS in women

•                  Prevention of other important STDs

 

•                  Strong product portfolio

•                  Stage of development

•                  Mechanism of action

 

•                  IP protection through 2018

 

•                  Lead product Savvy (1% C31G vaginal gel)

 

[LOGO]

 


 

Savvy - 1% C31G Vaginal Gel

 

Product Advantages

 

•                  Contraceptive Gel that Prevents Transmission of STDs (HIV, HSV, Chlamydia)

 

•                  Clear, Odorless, in Pre-filled Applicator

 

•                  Bi-Directional Protection, Discreet, Easy to Use

 

•                  Likely to be First-in-Class

 

•                  Potential Worldwide Market over $1 billion, depending on indications approved

 


 

Savvy Development Status

 

•                  Leader in race to prevent HIV infection in women

 

•                  Over 3000 patients enrolled in Phase 3 trials in Africa

•                  Trials managed by top CRO, Family Health International

•                  Trials expected to be complete in late 2006

 

•                  HIV trials funded by grants from USAID

 

•                  Cellegy to provide drug to developing countries at “cost plus”

•                  Product commercialized by Cellegy in developed world markets

 

•                  Phase 3 contraception study underway in US

 

•                  Trial managed by Health Decisions Inc.

•                  Trial costs funded by NICHD

•                  Target completion date 2H 2006

 

•                  Efficacy trials for prevention of other STDs to be funded by Cellegy

 

•                  Herpes, Chlamydia

 


 

Savvy Phase 1/2 Data Summary

 

•                  Five Phase 1/2 Trials Completed With Optimized Formulation

 

•                  3-Day Formulation Preference Study

•                  14-Day Safety Study

•                  Spermicidal Efficacy Study

•                  Male Tolerance Study

•                  MRI Imaging Study

 

•                  Safety Demonstrated After Two Weeks of Once or Twice Daily Use

 

•                  Efficacy Demonstrated as Spermicide

 

•                  Highly Acceptable Formulation as Reported by Participants

 

•                  Fast-Track Review Granted for HIV Prevention

 


 

Savvy 14-Day Safety Data

 

Moderate and Severe Adverse Events Reported & Observed

 

•                  Moderate or Severe Adverse Events:

 

•                  No Women Reported AEs With Savvy

 

•                  28% Women Reported AEs With N-9

 

•                  Clinician Observed Colposcopy Evaluation:

 

•                  3 adverse findings in 2 women with Savvy

 

•                  30 adverse findings in 13 women with N-9

 

•                  Savvy Showed Significantly Fewer Overall Adverse Events Compared With N-9, Well Tolerated and Highly Acceptable

 

•                  Confirms Results from Previous Formulation Study

 


 

Additional Clinical Data

 

Savvy 1% C31G Vaginal Gel

 

•                  Three Add-On Studies to the 14-Day Safety Trial:

 

1.              No adverse effects on vaginal microflora

 

2.              No inflammatory markers or cytokines observed in cytology

 

3.              No systemic absorption at 10 ng/ml (detection limit) in plasma

 

•                  Male tolerance study showed no adverse events (clinical examination) and acceptable (self-reported)

 

•                  In MRI study, excellent coverage of vaginal and cervical surfaces noted; no migration to the uterus; significant coverage noted 6 hours after application

 


 

Savvy Spermicidal Efficacy Data

 

Post-Coital Testing

 

[CHART]

 

•                  All doses showed release of active drug

 

•                  All doses showed >90% inhibition of sperm motility

 

•                  Concentration of drug released sufficient to kill STD pathogens such as Herpes and Chlamydia

 


 

Anticipated Savvy Clinical Timeline

 

2004

 

2005

 

2006

 

2007

 

Q1

 

Q2

 

Q3

 

Q4

 

Q1

 

Q2

 

Q3

 

Q4

 

Q1

 

Q2

 

Q3

 

Q4

 

Q1

 

Q2

 

Q3

 

Q4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Savvy 1.0% C31G HIV Prevention Studies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Savvy 1.0% C31G Contraceptive Efficacy Studies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NDA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Launch

 

 


 

Women’s Healthcare Focus

 

•                  Exciting near term market potential for Savvy

 

•                  Compelling need for this type of product

•                  Market research indicates high interest by users and prescribing physicians

•                  Allows women to take control

 

•                  Two promising backup products in pipeline

 

•                  Savvy has the potential to save millions of lives

 


 

Cellegy Pharmaceuticals
(Nasdaq NM: CLGY)

 

A Robust Product Pipeline

 

•                  2005

•                  Cellegesic - European partnering and sales

•                  Tostrex (Fortigel) European sales

 

•                  2007 Savvy (US)

•                  Advanced Phase 3 for HIV prevention in women (“Fast Track”)

•                  Phase 3 for Contraception

 

•                  2007 Fortigel (US)

•                  To be launched by partner

 

•                  2008 Tostrelle

•                  Partnering discussions in 2005

•                  Partner to launch in 2008

 


 

Summary

 

 

Large Target Markets

Late Stage Clinical Candidates,

with

Multiple Indications

Significant Revenue Potential

 

 

$50 million in Committed Grants

Favorable Risk-Reward Profile

 

Future Funding Based on Approvals

 


 

Cellegy Pharmaceuticals, Inc.
(Nasdaq NM: CLGY)

 

C.E. UNTERBERG, TOWBIN

Micro-Cap Macro Opportunity

 

New York

 

July 2005

 

[LOGO]