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What does Google, Microsoft and Dell have in common? These three well established companies, along with other large busin

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

ess organizations have went public before through the IPO or initial public offering.

So what is an IPO?

In financial t

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

Examples of combination products may in

rms, IPO or initial public offering is the first issuance of a company’s shares to the general public usually to interest

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

ed investors. These shares are allowed to be transacted in the stock market where they can be brought and sold.

One thin

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

to note is the shares allocated to the public do not constitute 100% of the company’s shares. Only a certain percentage

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

Combination pro

is allocated to the public. Usually the company owner or the board of directors will still hold the majority of the share

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

.

So why does a company offer an IPO?

One of the most common reasons companies offer IPO is to raise capital for the co

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

mpany. The main reason is because companies plan to use the money gathered from IPO to further expand their business or t

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

increase their business operations.

While IPO may sound like a good way for companies to raise money, they are disadvan

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

tages as well. The chief disadvantage is there are heavy legal compliance and financial regulations that needs to be foll

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

wed strictly.

The IPO Process

The first step for any company to offer an IPO is to get several investment banks as unde

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

Following aspects would a

rwriters. The purpose of underwriters is to assess the business, operational and financial background of the company in o

dd to the challenges in developing combination products:

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

der to determine the value of the company’s shares to be sold to the public. Once it is agreed, the company will sign an

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

agreement with the lead underwriter to sell shares on the market and the underwriters can proceed to sell these shares to

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

any interested investors.

For large corporations dealing with billions of dollars of shares, several large 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

nks may act as underwriters. These banks are paid commissions for shares that they sell. The underwriters will also help

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

Professional from academic institutions, pharmaceutical industries, health care indust

he company deal with the legal and financial regulations imposed by the country.

Most multinational companies that plan

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

to hold an IPO will also need to comply with the rules and regulations of different countries therefore sometimes law fir

.

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

s may also be involved in some cases.

Once the IPO is successfully launched, companies will need to submit their annual

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

Companies that provide selfless information through particip

business earnings reports to the financial securities board since the company’s shares will be listed in the stock market

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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