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With all the changes in the market, is it time to start looking at your loan structure? Should you star

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

t thinking about fixing a portion of your mortgage, or the entire amount? Can you lower the amount you

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

Examples of combination products may in

re paying by consolidating your debt? These are all very tricky questions, and the best place to start

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

is to look at your existing debt load and how much room you have to move. Do you have a buffer zone ar

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

und what you earn, as compared to what you spend? This is an important factor in not over-extending you

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

Combination pro

self on your loan(s).

Then you need to decide what you are comfortable with; no one can predict exactl

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

y what the market will do in the coming months, but most observers believe interest rates will probably

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

continue to rise, to a degree.

If you want to maintain the flexibility of extra repayments or redraw e

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

rlier extra payments, then you may want to look at fixing a portion of your loan. For example, you can

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

fix 50% of your loan so you know what your repayments for that portion of the loan will be for a set am

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

unt of time, and leave the remainder in a variable rate for the flexibility.

If you feel that you need

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

Following aspects would a

of a more conservative approach then you may want to fix the entire amount. This way you know what the

dd to the challenges in developing combination products:

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

repayments will be for the length of time the loan is fixed. You can only make limited extra repayments

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

during this time, and paying out the loan before the end of the fixed rate period will attract addition

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

l break fees, so it is best to look at your longer-term plans to make sure you are not going to want to

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

refinance or pay out the loan before the end of the fixed term. Keep in mind that banks are likely to

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

Professional from academic institutions, pharmaceutical industries, health care indust

harge more interest on a fixed rate loan that a variable rate loan.

You may also want to sit down with

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

your mortgage broker, accountant and or financial planner to discuss your overall financial strategy to

.

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

see how the increased rates may influence your strategies.

*Disclaimer: This document is for informat

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

Companies that provide selfless information through particip

on purposes only, and must not be relied upon as a substitute for professional services or legal advice

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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