An Introduction to InfaCare

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An Introduction to InfaCare
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Contents

• Mission Statement
• Management Team/Board of Directors
• Business Model
• Project Pipeline
• Hyperbilirubinemia its Risks
• Introduction to Stanate (stannsoporfin)

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InfaCare Pharmaceutical Corporation

• Mission Statement
• We will become the industrys leading
  specialty pharmaceutical company focused on the
  unmet needs of neonates and older children by
  acquiring, developing and commercializing
  innovative solutions which raise their quality of
  life.

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Management Team

• Chairman CEO- Dr. Robert A. Vukovich
• 30 years of drug development/acquisition and
  marketing experience
• COO John R. Post
• 29 years experience in new drug development,
  marketing, licensing, and sales. Ex. Pfizer
  Inc., Boehringer Ingelheim.
• CFO Wendy Shusko, CPA
• 15 years in finance, operations. Ex. Roberts
  Pharmaceutical Corp

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Board of Directors

• Extensive Experience in Drug Development,
  Marketing, Sales Operations, and Government
  Affairs
• Digby Barrios (BMS, Boehringer Ingelheim,
  Sepracor)
• Edward Breslow (EMC, Bose, Texas Instruments)
• William Crouse (HealthCare Partners, JJ,
  DuPont, Revlon, BMS)
• Marilyn Lloyd (US Congresswomen, TN)
• Wendy Shusko (Roberts, Wellspring)
• A. James Ueberroth (Procept, Boehringer
  Ingelheim, Sterling, BMS)
• Richard Vietor (Merrill Lynch, DBL, Citibank)
• Robert A. Vukovich Chairman (WPC, Roberts,
  BMS, Revlon, W-L)

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Business ModelSpecialty Pharmaceutical Concept

• Focus on Neonatal/Pediatric Products
• Under-occupied space (neonatal/pediatric)
• Market segment often referred to as therapeutic
  orphans
• License and Develop Late-stage Development
  Candidates
• Provides shorter lower risk development
  pathways
• Cooperative regulatory climate (FDAMA/BPCA)(1)
• Develop New Formulations of Existing FDA-Approved
  Drugs
• Execute Acquisitions to Complement Portfolio
  Enhance Sales
• ____________________
• (1) Food and Drug Administration Modernization
  Act of 1997 (FDAMA) Best Pharmaceuticals for
  Children Act of 2002 (BPCA)

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Project Portfolio

• Stanate for treatment of hyperbilirubinemia (HB)
• Target market 1 billion
• Bethanechol for treatment of Infantile GERD(3)
• Target market 400 million
• Sincalide for treatment of Neonatal Ileus
• Target market 100 million
• Neonatal-Specific Dosage Forms
• Develop dosage forms appropriate for the NICU to
  ease
• administration and reduce dosing errors

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____________________ (3) Gastroesophageal Reflux
Disease (GERD)
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• Hyperbilirubinemia
• and
• Stanate
• (A New Way to Battle Jaundice)

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Hyperbilirubinemia A Clear and Present Danger
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Hyperbilirubinemia (HB)

• Hyperbilirubinemia Jaundice
• A Widespread Issue
• 60 of all babies develop jaundice, or
  hyperbilirubinemia
• Cause is excess bilirubin, a neurotoxin
• Bilirubin peaks 3-5 days of age, after hospital
  discharge
• Linked to breast feeding, which is rising in U.S.
• Moderate cases possible neurological deficits,
  hearing loss, learning disabilities and possibly
  autism and allergies
• Severe cases Kernicterus (increasing) and
  possibly cerebral palsy
• The leading cause of hospital re-admission
• Current treatment, phototherapy (PT), is
  remedial, not preventative in nature

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Problems with Phototherapy

• Side Effects
• Dehydration
• Hyperthermia (body temperature must be monitored)
• Eye protection required
• Watery and frequent stools
• Deficiencies
• Does not prevent jaundice, only remediates (slow
  onset)
• Bilirubin rebound occurs with cessation
• Requires constant monitoring of patient
  (intensity dependent)
• Adverse Behavioral effects
• Isolation from mother
• Reduced sensory input
• Reduced ability to breast feed
• Cost Estimated annual expense 1.7BB

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Disorders Linked to Moderate Jaundice
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Raising Awareness Sentinel Event Alert
Non-Invasive Testing

• The Joint Commission on Accreditation of
  Healthcare Organizations (JCAHO), issued a
  Sentinel Event Alert to all hospitals in 2001
  mandating procedures for the prevention of
  HB/Kernicterus
• Hospitals risk losing accreditation if they do
  not practice increased diligence regarding HB
• JCAHO specifies using the Bhutani Nomogram to
  identify infants at risk of HB
• Non-invasive serum bilirubin determinations
  possible with new Bilichek(5) device
• Obviates need for blood draw, facilitates use of
  Bhutani Nomogram

____________________ (5) Developed by SpectRx,
Inc. (NasdaqSPRX)
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Guiding Treatment StrategiesThe Bhutani Nomogram
Use of the Nomogram in the first 2 days can
identify which infants will develop HB and
therefore be candidates for treatment before
hospital discharge
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Raising Pediatric AwarenessNew AAP Guidelines

• New AAP Guidelines for management of
  hyperbilirubinemia published July 1, 2004
  (Pediatrics 114(1)).
• Guidelines require higher level of vigilance by
  health care personnel prior to hospital
  discharge.
• Exchange transfusions indicated if neurologic
  signs of CNS toxicity noted, even if bilirubin
  level falling.
• Guidelines state that Stanate when approved
  should be used as alternative treatment.
• Authors of new AAP Guidelines are members of
  InfaCare Pediatric Advisory Board.

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Preparing for StanateSummary

• Jaundice- A Widespread Healthcare Issue
• JACHO Sentinel Event Alert
• Establishes the urgency
• New American Academy of Pediatrics Guidelines
• Establishes clear guidelines to minimize
  incidence of HB
• Includes Bhutani Nomogram- Helps identify
  patients at risk
• New Non-Invasive Assays
• Facilitates easy bilirubin testing nomogram use
• Address Hyperbilirubinemia Risks
• Stanate The First-in-Class treatment option

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Stanate

• A New Way to Battle Jaundice

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StanateR(stannsoporfin)

• First-in-Class Treatment Option
• Competitive Inhibitor of Heme Oxygenase
• Enzyme that converts heme into bilirubin
• Single Intramuscular Dose
• Rapidly Reduces Bilirubin Levels
• One Dose Prevents Bilirubin Production at its
  Source for 6-8 days

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Stanate Phase I II Clinical DataClinical
Superiority to Phototherapy (PT)

• Frequency distribution of peak bilirubin in
  G-6-PD(6) deficient neonates treated with either
  Stanate or PT

____________________ (6) Glucose-6-Phosphate
Dehydrogenase (G-6-PD)
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Stanate Clinical Outcome SummaryBattling
Jaundice
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Stanate Clinical Data SummaryBattling Jaundice

• 762 Patients Treated
• Dose ranging, R/PC/DB(9) study (231)
• Randomized direct comparison to PT (44)
• Pre-term infants. Dose ranging, R/PC/DB study
  (235)
• G-6-PD deficient infants R/OL(10) comparison to
  PT (172)
• Randomized open label (80)
• Safety
• Reversible photosensitivity, erythema
• 5-year follow-up clean
• Efficacy
• Noted in all studies with regard to reduction in
  bilirubin and reduced PT
• Stanate Prevents Hyperbilirubinemia Superior
  to PT

____________________ (9) Randomized,
placebo-controlled, double-blind
(R/PC/DB) (10) Randomized, open-label (R/OL)
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Stanate Battling Jaundice
R

• Hyperbilirubinemia swiftly treated
• Role of PT Exchange Transfusions greatly
  reduced
• Kernicterus potentially eliminated
• Paradigm shift in treatment (prevention vs.
  remediation)
• Reliance on parent reporting of jaundice reduced
  or eliminated
• Reduced time in the NICU Well Baby Nursery
  Cost Reduction
• Avoid potential disorders linked to moderate HB
• Overall Threat of Jaundice Significantly Reduced

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InfaCare Pharmaceutical Corporation

• Mission Statement
• We will become the industrys leading
  specialty pharmaceutical company focused on the
  unmet needs of neonates and older children by
  acquiring, developing and commercializing
  innovative solutions which raise their quality of
  life.