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Hay Daily News: Dallas, TX | December 29, 2006

Yes, hay is getting short and we are working off of barn stored reserves at this time. So, no

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

t only will we see an increase in hay price due to the end of the hay season, but we will feel it even more (our pocket books, that is) because this stored hay has be

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

Examples of combination products may in

en "put up" in the barn throughout the season by the hay producers.

"Put Up" you might ask? Basically that equates to a $0.30 - $0.50 per bale cost to the p

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

oducer to store his hay (load the bale of hay from the field onto a trailer, move the trailer to the hay barn – unload the bale of hay from the trailer, and stack the

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

bale of hay in the hay barn). In general, that's why you'll find a difference in the price "in the field" vs "out of the barn".

To make matte

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

Combination pro

s worse, everyone who has hay right now knows its present and future value. This year is and will be an interesting test of character for our hay pro

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

ducers!

Market prices nationwide will also be affected by seemingly unexplainable blips on a graph. Here's what I mean...do you remember in June/early July

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

2006 when hay prices went sky high for about 2 weeks then settled back into their steady price incline?

Well, we are about to experience the same type of phe

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

omenon, but its due to a completely different source and at first glance, it's not going to make any sense at all. So what's about to happen?

Well, late spr

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

ing, early summer 2006, savvy hay producers/brokers/investors realized that the hay shortage was going to be bad...really bad. So, as most savvy investors tend to do,

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

they invested - at the right time and with a plan.

That plan was to pull fresh hay cuttings off the market or not to release them at all - p

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

Following aspects would a

ut them in the barn and store them until hay prices hit "price target 1". At level 1, they will release, for example, 20-30% of this hay. Result - we will see a very

dd to the challenges in developing combination products:

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

short term stabilization in hay prices.

This trend will continue and we will see the various levels / plateaus on a graph, until everyone is completely out

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

f hay. And each hay investor’s bottom line is different, so we'll likely feel the impact regionally rather than on a nationwide basis.

For example, a bale of

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

Coastal or Alicia Bermuda Hay could be purchased (resale price) for $2.50 - $3.50 late spring/early summer 2006. By the time mid fall arrived, that same bale cost $4

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

50 - $5.00 in the field. Now, in the barn (add $0.50) and settling into winter, you are going to find that same bale of hay priced between $4.50 and $8.00!
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
trong>

Yes, that's quite a range, I know. But, the 2006 hay season has turned into the wild west as the gap between supply and demand grows larger e
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ach and every day.

Another interesting point to note is that, in general, the hay producer or custom baler's profit is almost always in the fourth o
.

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
last cutting of the season. So, you might imagine how it could be tempting for them to hold on as long as possible.

Theory and reasoning aside, in the next
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
edition, I will be sharing my thoughts with you on what to do NOW about your particular hay situation...

Copyright 2006 Hay-Bale.com

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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