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Better health. Within reach. Every day. Value of Value added medicine / Industrial perspective Hakima Hoseh 2-3 May 2018 Value of VAM industrial perspective
Better health. Within reach. Every day.
Value of Value added medicine / Industrial
perspective Hakima Hoseh
2-3 May 2018
Value of VAM industrial perspective
Hikma Pharmaceuticals PLC
Outline
2
VAM definition
How to achieve ?
Value of VAM
Patients
Society
Industry
Success Factors of VAM
Challenges
FDA 505b2 approvals in number
Conclusion
Value of VAM industrial perspective
Hikma Pharmaceuticals PLC
Definition VAM
Value of VAM industrial perspective 3
Value added medicines are “medicines based on
known molecules that address healthcare needs
and deliver relevant improvements for patients,
healthcare professionals and/or payers”
Where approval will rely upon studies “were not
conducted by or for the applicant and for which
the applicant has not obtained a right of reference
or use from the person by or for whom the
investigations were conducted” (section 505(b)(2) of the FD&C Act).
They represent an opportunity for increasing the
cost-effectiveness of treatments or services that
may bring substantial value to individual patients ,
society and industry.
Value is achieved through
Medicine repositioning/
Indication , pediatric ,…
Medicine Reformulation ,
modified release , Nano ,…
Medicine combination,
Drug /Drug , or Drug /device ,..
VAM
Hikma Pharmaceuticals PLCValue of VAM industrial perspective
5
WHY VAM …..Value for patients
VAM are looking forward to a better quality of life with their treatment.
VAM moving from a one-size-fits-all to a much more tailored and patient specific approach.
VAM are a new horizon that contribute to addressing unmet
patient needs. .
VAM can ensure better adherence and compliance
Hikma Pharmaceuticals PLC
WHY VAM
Value for society
Value of VAM industrial perspective 6
Addressing a number of medicine-related healthcare inefficiencies
Enhancing healthcare system efficiency by improving healthcare provision and organization
Contributing to sustainability of healthcare systems through economic advantages
Hikma Pharmaceuticals PLC
WHY VAM
Value of VAM industrial perspective 7
Val
ue
for
ind
ust
ry Bring innovation through PLC and increase company portfolio
Give a competitive edge for the company through providing the unmet needs of their local communities
Increase rate of partnership and contract manufacturing
make use of important knowledge of safety and efficacy from previous clinical studies and Post marketing
Hikma Pharmaceuticals PLC
Key success factors for industry
Value of VAM industrial perspective 8
• Know the value of an opportunity when you spot one” Through market research and understand patient journey to cure
Commercial best practices
Regulations + Right price
• Be creative in sourcing ideas. Many good ideas come from outside the organization
Ideas focus on patient needs
Clear Added value
• Clear regulatory pathway
• Premium pricing policy
• Understand targeted market
regulations
Challenges in MENA of VAM industry
Page 9
Challenges
No incentives
Weak cross referencing
Limited research in
HS
Limited resources
cost of investment
Pharma industry is
time limited
Hikma Pharmaceuticals PLCValue of VAM industrial
perspective 10
FDA approvals 2009-2015 505 b2 Guidance was published Oct. 1999
Hikma Pharmaceuticals PLC
Number of approved 505b2 products 2015-2017
Value of VAM industrial
perspective 11
45 44
22
4842
62
NCE 505B2
0
10
20
30
40
50
60
70
2017
2015
2016 2017
2016
2015
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf
Hikma Pharmaceuticals PLCValue of VAM industrial
perspective 12
Zyrtec D (cetrizine and pseudoephedrine combo) – new
combination product
Zecuity (sumatriptan iontophoretic transdermal system) – new
drug-device combination product
Duraclin (clonoidine) – new formulation and route
Sclerosol (sterile talc) – new molecular entity
Children’s Advil Cold Suspension – new formulation
Methylphenidate Oral Solution – new dosage form
Methylphenidate Chewable Tablets – new dosage form
Doxil (doxorubicin) Liposomal Injection – new dosage form
Altocor (lovastatin) ER Tablets – new dosage form
Vandazole (metronidazole) Vaginal Gel
Forticol (calcitonin-salmon) Nasal Spray
Luxiq Foam (betamethasone) – new delivery tech
Canasa (mesalamine) Suppositories – new delivery tech.
Some of approved products as VAM in FDA
Hikma Pharmaceuticals PLC
Conclusion
Value of VAM industrial
perspective 13
• Clear Regulatory pathway
• To establish a clear system to calculate value• Unmet need
• Degree of innovation
• Patient adherence and quality of life
• Economic attributes
• Clear incentives
• Data exclusivity
• Premium prices
• Fast track approvals
• Post market studies commitments
• Pharmaceutical industry in MENA to invest more in VAM.
• Industry and regulatory bodies to establish
Hikma Pharmaceuticals PLC
Better Health Within Reach Every day
Value of VAM industrial
perspective 14
