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In the current economic environment there has been a massive increase in not only bankruptcies, but also Individual Voluntar

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

y Arrangements (IVAs). IVAs are viewed as the only alternative to bankruptcy for many, allowing them to retain at least som

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

Examples of combination products may in

control over their financial arrangements.

Recently there has been a spate of negative press comment, with many market obs

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

ervers highlighting the fact that many IVA customers have since moved into bankruptcy, thereby calling into question the ori

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

inal advice. The concern for many is the large costs and commissions which are charged for the advice, and then the small a

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

Combination pro

ounts of the actual IVA payments which are forwarded to creditors, with the vast majority retained for ongoing fees.

Over t

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

he last couple of years there has been a mass of Debt Management companies introduced to the London Stock Exchange, and they

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

have so far reporting bumper figures, with ever more positive forecasts for the future. After the recent bad press it seems

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

that many people are actually considering their positions more carefully, and seeking a possible alternative to IVAs. This

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

has resulted in a sharp downturn in recent business enquiries, and some of these companies are a little more subdued with re

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

ards to their thoughts for the future.

There are currently four major Debt Management companies listed on the stock market,

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

Following aspects would a

which include:

Name: Accuma
Value: ?73m

Name: Debt Free Direct
Value: ?138m

Name: Debtmatters
Value: ?74m

dd to the challenges in developing combination products:

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

Name: Money Debt & Credit
Value: ?12m

While all of the above companies are valued in the millions of pounds, they hav

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

all taken a big hit this week on the back of consumer scepticism. While there is most definitely a market for debt advice

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

especially as the economy seems to be reaching a major turning point - it may take some time to rebuild customer confidence

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

in the advice available.

In an industry which is dealing with people who are in grave financial trouble, some of the commi

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

Professional from academic institutions, pharmaceutical industries, health care indust

sions which the companies are rumoured to take for advice, executing and monitoring IVAs seem a little too high for many. T

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

ere is most defiantly a need for more transparency in what charges, commissions, etc are connected with these agreements.

.

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

While it will be interesting to see how the sector recovers from the recent set-back, and how consumers react in the immedia

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

Companies that provide selfless information through particip

e future, the response of the banking sector and credit card companies may be interesting - will they take a softer approach

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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