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RDD Pharma Israel

RDD Pharma, a clinical stage company with programs in:
1. Fecal incontinence (Phase 2a)
2. Chronic anal fissure (Phase 3 ready).
3. Pruritus Ani - preclinical development
4. Radiation Colitis - animal studies

- All rograms utilize a 505(b)2 strategy .
- Anal Fissure IP goes out to 2030.
Website:
www.rddpharma.com
Year Founded
2009
Main Sector
Biotech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

Company focused on ano-rectal diseases

Experienced management team

Lead product targets $600M market with poorly
addressed needs

Follow on product targets a $3B US market

Pipeline - Three clinical stage products:

  • PHASE III READY – ANAL FISSURE
  • PHASE IIa – FECAL INCONTINENCE ONGOING
  • PHASE II READY – PRURITUS ANI

De-risked 505(b)2 regulatory path

Supporting Metrics or Evidence

Fecal Incontinence - P1 Proof of Concecpt + Phase 2a Ongoing

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Current Financing Needs

OrbiMed Israel (invested $4M in 2012) is a lead investor and has committed to $3M of a $15M Series B.

Current Timeline

Anal Fissure  - Phase 3 to commence 1Q2015

Fecal Incontinence - Phase 2a data read March/April 2015

Current Investors

OrbiMed

Ofakim Hi-Tech Ventures

Corporate Finance Holding GmbH

Mor Research

IP Status

Nifedipine Capository™ - Device for Treating the Anal Sphincter

–      Japan                         Granted (new)

–      Australia                   Granted

–      Korea          Allowed (new)

–      Israel           Allowed (new)

–      USA            Granted

–      Canada                     Allowed

Fecal Incontinence

–      US – National Phase

Radiation Colitis

–      Methods for Treating and Ameliorating Radiation-induced Gastrointestinal Tract Injury

Pruritus Ani

–      Method of Treating Anal Pruritus and Other Perianal Disorders

–      USA-issued patent: April 1, 2014

Recent Milestones

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Management Team Highlights

Jason Laufer CEO 

•       Over 25 years in healthcare clinical and commercial operations

•       Global BD & Licensing at URL Pharma (acquired by Takeda for $800M), Managing Director at CELLGRO® (acquired by Corning , and CEO at Elutex

Nir Barak, MD CMO and Founder

•       More than 10 years as internal medicine physician

•       Career integrating R&D and clinical medicine

•       Formerly CSO/Founder of OBEcure Ltd.

 

Robert Niecestro PhD Regulatory Affairs

  • Over 25 years of experience in the healthcare industry
  • Managing Director of Accelapharm, VP Reg. of Axsome Rx and EVP of Clinical & Reg. Affairs at TG Rx
  • VP Clinical & Reg. Affairs at Keryx Biopharma

 

Monil Shah, PharmD MBA Clinical Advisor

  • VP, Clinical Affairs at Ventrus Biosciences
  • Over 15 years in clinical management roles at BMS, Celgene, Amgen, and Novartis

Jason Laufer
CEO