Main Subject - Business

Mergers and acquisitions in the business world are often in the news. For every successful

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

case that is reported, there are several failed moves that may never come to light because

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

Examples of combination products may in

f the secrecy that usually shrouds the negotiations.

Mergers are slightly different from a

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

cquisitions. In the former, stockholders of the two companies come together and share inter

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

st in the new enlarged entity. Based on the valuation of the companies concerned, the share

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

Combination pro

holding pattern may change. An example: Company A, which is stronger, and Company B, which

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

s not doing well, merge. The shareholders of B may be given one share in A for every 2 shar

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

es they hold in B. If it were to be an acquisition, A would purchase the controlling or sub

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

tantial portion of B's stock, and take over that company.

Motives behind mergers and acqui

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

sitions could be different in each case. Sometimes it may be to save taxes. Continuing with

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

the earlier mentioned example, the accumulated losses of B could be set off against the pro

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

Following aspects would a

fits of A, resulting in substantial tax savings.

There could be other reasons for a merger

dd to the challenges in developing combination products:

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

or acquisition, like expanding the market base or complementing the existing activities.

P

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

lans and negotiations for mergers and acquisitions are normally kept secret until the deal

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

s almost through. Usually the professional groups involved in the process are investment ba

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

nkers, consultants and lawyers specializing in the field. Often, the services of another ty

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

Professional from academic institutions, pharmaceutical industries, health care indust

e of specialists known as 'interim managers' may be utilized also, to smooth out the transi

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

tion pangs.

All mergers and acquisitions are supposed to be done for the benefit of the st

.

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

ckholders of both companies. In reality this may not be always true. Those who have stocks

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

Companies that provide selfless information through particip

should carefully study proposals for mergers and acquisitions before consenting to the move

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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