E-Folder - Finance

Introduction

The exchange rate refers to the value of the US dollar against the values of currencies of other countries. Such a rate hel

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ps determine how much we pay for imported goods and services and how much we receive for what we export, among other things. When the val

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

e of the US dollar drops, imports become more expensive, and we tend to reduce the volume of our imports. Simultaneously, other countries

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

will pay LESS for some of our products and that will tend to boost export sales. If imports and exports are a substantial part of a count

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

y's economy, as is the case with Canada, the exchange rate plays a particularly important role in our economy. The exchange rate between

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

wo countries' currencies is particularly important if the two countries are heavily involved in trade.

What factors affect an exchange r

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ate?

A country's exchange rate is typically affected by the supply and demand for that country's currency in international exchange mark

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ts. This is typically known as a floating exchange rate. If demand, for say dollars, exceeds supply, then the value of the dollar will go

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

up. If however, the supply of dollars exceeds demand, then its value will go down. A huge amount of money is bought and sold on internati

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nal exchange markets for many different currencies.

Several factors influence the supply of, and demand for, a given country's currency.

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

If INTEREST rates are HIGHER in, say, the US than in other countries, then investors WILL choose to invest in the US, increasing demand

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

for the dollar, provided that the expected rate of inflation is not higher in the US than among our trading partners. If INTEREST rates a

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e LOWER in the US than in other countries, investors will choose NOT to invest in the US, decreasing demand for the dollar.

If the US IN

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

LATION rate is HIGHER, investors are LESS likely to prefer the US -even with higher interest rates- because of the expectation that the v

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

lue of the dollar will be ERODED by inflation. If our INFLATION rate is LOWER, investors are MORE likely to prefer the US, because there

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ill be NO expectation that the value of the dollar will erode.

Trade balance also has an effect on a country's currency. If world prices

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

for what a country exports rise in comparison with the cost of that country's imports, that country will be earning more for its exports

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

than it pays for its imports. The more demand there will be for that country's currency, the better the deal becomes. If investors are co

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

fident that the US economy will be strong, they will be MORE likely to buy American assets, pushing UP the dollar's value. If investors a

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e not so confident that the economy will be strong, they will be LESS likely to buy the country's assets, pushing the dollar's value DOWN

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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