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You have your property for sale for $500,000 and somebody comes knocking on your door one day to offer you $1 mil for it. Why would anyone offer to pay you twice what

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

you were asking? Four explanations are possible:

They know something about your property that you do not know. (You should find out what that is as quic

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

Examples of combination products may in

kly as possible and before you sign any contract with the first buyer. Your property might be worth even more than $1 mil.)

They are totally clueless.

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

(If the buyer is inexperienced, you are likely to wait a long time for them to figure out what to do and how to do it, and there is no guarantee that they ever will f

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

igure it out. You cannot afford to turn your property over to them and subsidize their education.)

They are speculators. (They will offer you anything

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

Combination pro

because they do not intend to pay you. All they want to do is tie your property up and try to flip it to somebody else. You might not find out until they terminate th

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

e contract that they did absolutely nothing except shop your property around to get a third party to buy them out of the deal with you. If you do not pay attention to

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

the terms and conditions proposed by the buyer, you could be holding the bag 10 or 15 months down the road when the buyer either bails out of the deal or comes back

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

o ask you for even more time.)

They are making the deal contingent on one or more conditions. (Before you sign with the buyer, you need to get hard an

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

swers to hard questions, such as what are the odds that they will be able to satisfy these conditions, how long it would take to do it, and what is their track record

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

)

Always remember that there are three parts to every offer: the money, the terms and the buyer. Each of these should be weighed and evaluated in the

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

Following aspects would a

context of the offer as a whole. In other words, you should not just grab the offer that has the highest number on it because the best offer is not necessarily the o

dd to the challenges in developing combination products:

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

ne with the highest price. After all, your critical question as a seller is: when will I get my money and what are the odds that I will get it?

The best offer

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

s the one that is most likely to get to closing. It has the best chance of closing because: (a) it is subject to conditions that can probably be satisfied; and (b) it

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

is from a builder who is motivated and financially capable and who has a track record of experience and a current or recent positive relationship with the municipali

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

y.

Before you sign a contract and take your property off the market, you need to know that the use of your property proposed by the buyer is realistic and doab

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

Professional from academic institutions, pharmaceutical industries, health care indust

le and that the buyer is motivated and able to move the ball down field through approvals to settlement. When you do not have these assurances, you are simply rolling

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

the dice. You are gambling that the buyer will hang in there (i.e., not terminate the contract) until that future, unknown date by which they will be able to satisfy

.

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

all of the contingencies. If they are either inexperienced or not real buyers, they might take a great deal of time to accomplish nothing. The worst of it, however, i

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

Companies that provide selfless information through particip

s not just the time that gets wasted. It is the fact that because you tied up your property with them, you could not sell it to somebody who was a real buyer

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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