Subjects - Finance

An IVA is a legally binding agreement between the debtor and his/her creditors. With an IVA you can significantly reduce y

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

our debt, stop being charged a high level of interest, save your home and possessions and negotiate a monthly payment whic

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

Examples of combination products may in

h is much smaller and easier to manage than what you are paying right now.

How does an IVA work?

Once you have decided t

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

hat an IVA is the best solution for you an Insolvency Practitioner (IP) will assess your financial situation and decide on

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

a repayment amount. An application form will be sent to the court for an Interim Order following which no creditor can ta

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

Combination pro

ke legal action against you. For an IVA to be approved a creditors meeting will be arranged which you should attend. Durin

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

g the course of this meeting creditors will be called upon to vote for or against the arrangement. If the creditors vote f

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

r the IVA it gets approved immediately. However if creditors who represent 25% of your total debt vote against it the meet

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

ing will be suspended for a later date. Therefore an IVA needs the support of 75% of the creditors who represent your tota

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

l debt.

Your IVA has been approved. What Next?

Once your IVA has been approved your IP assumes the role of tracking your

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

IVAs progress. It is your responsibility to pay the agreed repayment amount every month to the IP who will ensure that t

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

Following aspects would a

he payment is distributed among your creditors as agreed upon earlier. When the term of your IVA agreement is over you wil

dd to the challenges in developing combination products:

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

l be free from your debts no matter how much has been paid off. Remember if you fail to keep up to your monthly repayments

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

it could result in the failure of your IVA.

The IVA Advantage

• Legally binding agreement to get rid of your debts<

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

r> • All interest rates are frozen
• Can help wipe off up t 75% of your debts
• A single affordable and easy 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

manage monthly payment at the end of which your remaining debts are discharged
• End to creditor harassment/collecto

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

Professional from academic institutions, pharmaceutical industries, health care indust

r calls or mails/legal action against you
• Repair your credit rating
• Retain your car and home
• You will

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

definitely be debt free within 5 years or less

Did you know that nearly half of the Insolvencies in 2006 were IVAs?

Dur

.

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

ing the year 2006 ?1.4 billion of debt written off by creditors and UK broke over 100,000 insolvencies. 2006 appeared to b

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

Companies that provide selfless information through particip

e a year of increasing unemployment and rising bills which left hapless debtors turn to IVA to help ease their debt burden

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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Whether you're a large, limited company falling behind on your bills, or the sole trader of a small business that hasn't paid themselves in months, there is one common ground which they both share.

The best, though somewhat misleading way to describe the difference between public relations and publicity is that publicity is designed to keep you in the news and public relations is designed to keep you out.

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Subjects - IVA: A Bright Debt Free Future Awaits You

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