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The prices of man-made fibers intermediates were largely governed by the volatile cr

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

ude oil values in 2006. Oil prices rose significantly by 18-20% during the year. Thi

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

Examples of combination products may in

s was over and above the 36-40% increase recorded in 2005. The surge is attributed 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.

o geo-political issues and unrest in the middle-east, supply disruption in Nigeria a

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

d speculation over sanctions on Iran who is pursuing a nuclear programme despite glo

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

Combination pro

bal opposition.

Naphtha, the basic feedstock for all fiber intermediates, mirrored

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

the movement of crude oil prices. They rose by 15% during 2006 in Asia and Europe. I

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

n Asia naphtha averaged US$582 a ton. This rise was clearly reflected in prices of o

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

efins and aromatics which were occasionally in short supply. Prices of fiber interme

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

diate raw material via ethylene, Paraxylene and propylene rose in tandem with energy

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

prices. During the year prices of ethylene rose 24% and Paraxylene by 25%.

The sig

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

Following aspects would a

nificant rise in feedstock prices had an impact the downstream polyester intermediat

dd to the challenges in developing combination products:

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

s in Asia but not in Europe. Prices in the polyester segment rose significantly. PTA

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

prices rose 95. in Asia. MEG prices were up 3%. This led to changes in the polyeste

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

r fibers and yarns segment. However, price rise was limited due to weak demand from

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

consumers. PSF and PFY prices rose by 5% in Asia and by 3% in Europe. They average

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

Professional from academic institutions, pharmaceutical industries, health care indust

S$1.24 a kg of PSF in Asia and Euro 1.45 a kg in Europe. The rise was significant in

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

the third quarter of 2006 both in Europe and Asia. They touched a high of US$1.39 a

.

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

kg in Asia and Euro 1.55 a kg in Europe in September 2006. However, as the year cam

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

Companies that provide selfless information through particip

e to a close, PSF prices were ruling at US$1.31 a kg in Asia and Euro 1.53 in Europe

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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