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Transnational Corporation, on Tuesday, said that British Telecom had not pulled out of the te

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

chnical services agreement between the two companies for the management of NITEL and its mobi

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

Examples of combination products may in

e subsidiary, Mtel.

Transcorp acquired a 51 per cent stake in NITEL last year under the priv

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

atisation exercise handled by the Bureau of Public Enterprises.

However, there were reports

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

hat BT had pulled out, citing unavailability of working capital to turn around the telecoms f

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

Combination pro

rms and the lack of adherence to corporate governance principles.

But, the Head of Corporate

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

Affairs, Transcorp, Mr. Adedayo Ojo, said in a statement in Lagos on Tuesday, that it was th

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

first phase of the agreement with BT that had been concluded.

He said that BT representativ

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

and Managing Director of Mtel, Mr. John Weir, had not been relieved of his post by the Board

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

of Mtel.

He said, “That stage basically covered the diagnostics and evaluation of the state

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

of affairs in NITEL and Mtel.

“However, both BT and Transcorp are still in negotiations rega

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

Following aspects would a

ding a longer term agreement. Transcorp is also pursuing opportunities to bring in potential

dd to the challenges in developing combination products:

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

strategic investors in NITEL and Mtel.”

According to him, “Transcorp is in the final stages

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

f negotiations with strategic investors and we will issue detailed information as soon as tho

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

e negotiations are completed and the appropriate regulatory approvals are in place.”

On the

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

subscription level for its recently concluded Initial Public Offering, Ojo explained that the

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

Professional from academic institutions, pharmaceutical industries, health care indust

e was no basis to say that it was undersubscribed.

“There is no basis to speculate that an I

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

O that has recorded more than 250,000 was undersubscribed as the Registrars are still compili

.

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

ng the returns which will need to be approved by the Board of Transcorp and the Securities an

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

Companies that provide selfless information through particip

Exchange Commission, before the subscription level can be determined and announced,” he said

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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