An extensive English summary of the course Preclinical Drug Research followed in academic year . Obtained result with this summary was 17/20. The explanations during the class were attentively noted and processed with the slides and course material to a complete summary. The summary consists of fol...
PHARMACEUTICAL INDUSTRY
Introduction
The process of developing a molecule to a drug is very long (can take up to 15 years).
- very risky: probability to fail is high " drug development is expensive
- drugs can be subdivided in:
o chemicals: small molecules (e.g. aspirin)
o natural products: complex molecules (e.g. arthemeter for malaria)
o biologicals: vaccine, gene therapy, interferon, insulin, EPO (bio-source)
A drug can have three names: chemical, generic and tradename. (e.g. aspirin)
- chemical name: acetylsalicylic acid " used by scientists
- generic name: aspirin " universal name
o when a drug is developed, it is patented
o when the patent expires, other companies can resell the drug for a much
cheaper price = it becomes a generic drug
- trade name: for example Sedergine® (registered trademark)
o if they resell it, they give it a new tradename, although it remains the same
generic drug
Facts and figures: R&D
R&D, also known as Research and Development: some facts:
- after computer/electronics, the cost for R&D for biopharmaceuticals is highest
- the 3 largest dominating markets are EU, Japan and the USA
- cost for R&D is increasing, although the approvals by the FDA are decreasing
o FDA: US Food & Drug Administration (1 European Medicine Agency EMA)
o the cost per drug to bring it to the market is therefore increasing
o ± $1,5B: depending on research complexity, registration requirements, ...
o
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,Costs and spending
Drug development
1. Preceding the start of the development, comes the discovery (figure says 2-5 years,
while it is most of the time 10-20 years).
2. The patent must be applicated at the start of drug development (is valid for 20 years).
3. Preclinical drug research: pharmacology, -kinetics, -dynamics, toxicity, …
4. Clinical drug research:
a. Phase I: healthy volunteers, first time the drug is given to humans
i. dosing in low concentrations
ii. mostly male volunteers because of the reproductive toxicity hazard
b. Phase II: first efficacy evaluation in a small group of patients
i. this group is really well chosen
ii. first indication of the therapeutic potential of the drug
c. Phase III: global scaling evaluation of the drug all around the world
i. testing the therapeutic indication in a very diverse patient group
d. Phase IV: post-marketing vigilance
i. all the patients who received treatment
ii. doctors/paramedics need to report adverse effects of the drug
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,! The patent is valid for 20 years: so, there is a small window for the company to make the
most profit out of the drug before it becomes generic!
" in the past: when there was a new indication for the drug, the duration of the patent
could be expanded by 5 years
" nowadays it is not possible anymore: all indications must be addressed from the start
" the timing to take a patent is critical and very difficult
o too early: there is not much time after registration of the drug to earn profits
before the patent expires
o too late: because of espionage, your idea can be stolen
Generic drugs are not good for innovation: why?
- after several years: the patent expired and competition with other companies starts
- we speak of a shrinking of the market exclusivity
- at that moment, the earnings drop enormously
- and so does the budget to use in R&D for new drug discovery
- generic drugs are good for the patients: it makes the drugs a lot cheaper
Development costs and revenue cycle
- Revenue cycle: under the zero line, we invest money 1 above the line, we earn money
- Biggest expenses in clinical development
o this cost is also sharply increasing nowadays
o we face more complex diseases, for which we need to include more patients in
the clinical trials
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, Challenges in the pharmaceutical industry: Competition and failure
- Generic competition: products which differ in
some aspects but are capable of satisfying the
same basic need of the purchaser.
- Price containment: companies can not charge
what they want
- Poor product differentiation: if you come up
with a look-a-like
o the better the differentiation, the better the sales are in the market
o for example: a better taste, a longer half-life, or more potent
- Me-too drugs: very close related products
- Parallel importation: if drugs are imported form a country where the drugs are cheaper
- Counterfeiting: unofficial drugs, mostly internet medicines
Failure rates in drug development
100 drugs enter real development, and there
are strong indications they will work
" only 8 of them are approved!
Pharmacokinetics is a major drop-out:
e.g.: too short half-life, metabolism issues, ...
Product positioning
Generics: e.g. aspirin
Mega-blockbusters e.g. Rocefoxib (Vioxx®)
Niche markets: e.g. Zolgensma (for baby Pia)
" medical differentiation is high " low competition
" sales volume of product is low: few people buy it
" unit prices are high to earn their investment back
and maximize profit
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