New drug development is a series of complex
activities invariably involving tremendous financial investment. The
undertaking, to bring a new drug to market, makes it almost impossible for smaller,
privately held pharmaceutical companies, to even dream of such endeavors.
Is
it possible for companies, lacking the resources of the pharmaceutical majors,
to expand the use of existing drugs, established in some countries but not
marketed in others?
Our PharmaCompass
analysis this week looks at products, which have monographs in the European
Pharmacopoeia but have never been approved in the United States.
Would it surprise you that amylmetacresol, one
of the two active ingredients in Strepsils, one of the world’s largest-selling sore throat product has never been approved for use in the
United States?
-Reckitt Benckiser,
the company that owns the Strepsils brand, markets Cepacol for sore-throat relief in
the United States. While Strepsils contains, amylmetacresol
and dichlorobenzyl alcohol, Cepacol
has a completely different set of active ingredients i.e. benzocaine
and menthol.
-Interestingly, while on the topic of throat relief, pholcodine,
an opioid cough
suppressant, is not prescribed in the United States
where it is a Schedule I drug. However, as a class B substance in the United Kingdom, it can be purchased
over-the-counter (OTC) in most pharmacies.
-Ergometrine, used to facilitate childbirth, while on the WHO’s essential drug list for important medications in a basic health system has
also never been sold in the United States.
-Hypertension and congestive heart failure drug cilazapril is sold across Canada and other European countries. Although cilazapril
is supposed to have limited
advantages over other drugs in the same class, exports out of India to
Turkey, New Zealand and Canada indicate a robust demand in these countries.
-Some molecules, discovered in France like, anti-diarrhoeal drugs nifuroxazide
and racecadotril,
lipid lowering ciprofibrate
or anti-cancer agent buserelin are
used extensively in select countries. However, for reasons unknown, they have
never been approved in other parts of the world.
-Lymecycline, a broad-spectrum antibiotic belonging to the
tetracycline class, is used in the treatment
of acne and marketed by Galderma SA, a completely owned subsidiary of Nestle. Lymecycline is 5,000 times more soluble than tetracycline
base and has unique pharmacological
activity amongst the tetracycline class of molecules. As the product
has been on the market for over a decade, generic versions are now also
available across Europe.
-As antibiotics continue to get increased attention in view of the growing concern of ‘superbugs’, there are antibiotics like roxithromycin
and flucloxacillin, which are sold in the UK and Australia but have never
obtained approval in the United States.
Are
these products safe?
Countries like France, United Kingdom, and
Canada, where many of the above mentioned drugs are marketed, have active
pharmacovigilance programs, which monitor drugs, should there be any serious
adverse events. Continued use for years in well regulated pharmaceutical
markets is usually proof that the products are safe.
However, for the antibiotic flucloxacillin,
concerns have been identified regarding a genetic link associated
with liver injury. While flucloxacillin
has not been approved in the United States, the FDA website does provide details
on this risk.
Liver toxicity concerns have limited the
sales of some commonly used OTC products like nimesulide
and propyphenazone
(brand name: Saridon) in some countries. Yet, there are parts of the developing
world, where the sales continue to increase.
There are graver concerns for products like
cisapride,
which was launched by Janssen
for increased motility of the gastrointestinal tract but was withdrawn, from
the US market, due to concerns of fatalities linked to cardiac arrhythmias.
The product continues to be exported from India to countries like Switzerland,
Thailand, Mexico, China and Canada.
Our
View:
Reviewing the export data out of India, on
the PharmaCompass database, it is
clear that in the markets, where the above mentioned products are sold, there
is substantial demand.
Major pharmaceutical companies have little
incentive in taking old molecules global since there is little intellectual
property protection to assure the profits that they are used to. However, for
others there may be an opportunity worth considering.
Launching a new product is always a
Herculean challenge, but hopefully the successful use in existing patient
populations, is a good starting point.
API manufactures can also review these products
since there may be better margins in these niche molecules when compared with
others, which have become commodities.
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