Company Overview and Project Timeline - AKTIV

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Transcript Company Overview and Project Timeline - AKTIV

AKTIV-DRY
Welcome to Aktiv-Dry
What We Do
AKTIV-DRY
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Project management and systems integration
– Craft synergistic relationships
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License our technologies
– Technology transfer
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Build/Assemble Bubble Dryers and PuffHalers to clients’ specs
– cGMP unit at SIIL in India
– Special unit for Sandia’s “energetic”
compounds
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Formulate clients’ compounds as dry
powders
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Alternative to lyophilization
Improved stability
Remove residual solvents
Engineer particle size for
• Regional deposition by inhalation or other
administration
• Enhancing dissolution rates
Intellectual Property
• Five domestic patents
– CAN-BD, Spray-freeze drying
• Foreign patents
– Europe, U.K., Germany, France, Switzerland, China,
Australia
– Japan application
• Three domestic applications
– PuffHaler, myo-Inositol formulations
• One PCT application
– Sublingual delivery, myo-Inositol stabilizer
• Trademarks
AKTIV-DRY
Company Background
• Aktiv-Dry founded in 2002
Privately held
Organized as a Colorado LLC
University of Colorado spinout
Exclusive license from CU to core
technology, with right to sublicense
• www. aktiv-dry.com
AKTIV-DRY
Management
AKTIV-DRY
• Bob Sievers – Co-founder, CEO
– Prof. Chemistry & Biochemistry, CU Boulder. Former Regent.
– Co-founder Sievers Instruments
Ionics Sievers GE Analytical
– Sculptor
• Brian Quinn – Co-founder, Pres./COO
– Engineer, Fluid Physicist, MBA
– Co-founder, officer: Commercial Titan Inc., The Hintha Group,
WyoChina Petroleum Inc., HydroMet Inc.
– Sailboat Skipper, Mountaineer
Ernst & Young Entrepreneur of the Year
Finalists in 2006
Core Technology
AKTIV-DRY
The CAN-BD® Nebulizer - Heart of the Bubble Dryer®
Near-critical or supercritical
CO2 (80 to 100 atm)
Drug solution or suspension
Emulsion of product
stream in liquid CO2
10
cm
Flow restrictor tube
ID = 75 µm
Restrictor tip
CO2 flashes upon rapid 100X
decompression to atmospheric
pressure
Plume
Carbon dioxide Assisted Nebulization with a Bubble Dryer
Bubble Dryer Capabilities
AKTIV-DRY
Lab Scale Unit (1 g/hr)
Development Scale Unit (4 g/hr)
Spray Dryer Modified As A Bubble Dryer®
AKTIV-DRY
Production Scale Unit
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Modified Niro Production Minor by
replacing the mechanical nebulizer
with a CAN-BD nebulizer
 Drying tower diameter 1.2 m
 Cylindrical height 0.75 m
 Conical height 0.9 m
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100 g/hr (or 10,000 doses of 10 mg
each per hour)
New Product - The PuffHaler® DPI
Designed
 For needle-free
delivery
 For mass
vaccination
campaigns
 To cost ≤ 10¢ per
vaccination
AKTIV-DRY
Representative Pharmaceutical Products
Dried by CAN-BD
Vaccines
Live attenuated measles virus
Live attenuated influenza virus
Hepatitis B surface antigen(HBsAg)
Human papilloma virus
Antibodies
PRIMATZED® anti-CD4
Human IgG
Anti-human lambda light chain
Proteins
Alpha-1-antitrypsin
Trypsinogen
Lactate dehydrogenase
Lysozyme
Insulin
Alkaline phosphatase
Carbohydrates
Myo-inositol, Trehalose, Mannitol, Lactose,
Sucrose, Sorbitol
Formulation
Constituents
Buffers: Tricine, sodium potassium phosphate,
sodium acetate
Surfactants: Palmitic acid, stearic acid, Tween
20, Tween 80, Pluronic F68
Amino acids: Arginine, methionine, leucine,
glycine, etc.
Metal chelating agents: EDTA, DTPA
Antibiotics
Kanamycin sulfate
Capreomycin sulfate
Moxifloxacin hydrochloride
Tobramycin sulfate
Amoxycillin
Doxycycline
Cefazolin
Ciprofloxacin
Amikacin
Rifampin
Antivirals
Relenza, siRNA
Other
PEG, PVP
Hydrolyzed gelatin
Sodium chloride
DPPC (lung surfactant)
Salbutamol (asthma drug)
Albuterol sulfate
Cromolyn sodium
Phytosterols* (nutraceutical)
Naproxen*
Budesonide*
Betamethasone*
Amphotericin B*
Cyclosporin*
AKTIV-DRY
Near-term Dry Powder Formulation Projects
AKTIV-DRY
• Pentavalent vaccine stabilization
• Hepatitis B stabilization and unit-dose packaging;
myo-Inositol for inhibition of pulmonary carcinomas
• Broad spectrum vaccines
 Harmsen/Montana State University
• Aerosol delivery of HPV
 Garcea and Cape/University of Colorado
• Biodefense
 Bukeyrev/Galveston National Lab, others
• Early age measles vaccine delivery
 Griffin/Johns Hopkins, with manufacturers, others
Conclusion
AKTIV-DRY
We are eager to discuss interesting collaborative
projects and other exciting business opportunities for
which our technologies will enable new products
 Vaccines, other biologics,
 Anti-virals, antibiotics, anti-inflammatories
 Vectors
 Expressed genes, etc.
 Non-pharmaceutical
CONTACTS
AKTIV-DRY
• www.Aktiv-Dry.com
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Telephone: (303) 350-3060; toll-free 866-690-7045
Dr. Brian Quinn,, extension 101,
Dr. Pankaj Pathak, extension 112,
Dr. Bob Sievers, extension 106.
Mail: Aktiv-Dry LLC, 4900 Nautilus Ct. N, Suite 200, Boulder, CO 80301, USA