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This is perhaps a startling thought to many people. But while I do find it provocative, it is perhaps not very far-fetched

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

and has its merits. Of course, if one believes that Provenge is a guaranteed blockbuster than the thought is simply absur

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

Examples of combination products may in

d. But if one takes what I consider a more realistic view that the path to Provenge’s success is extremely difficult then,

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

perhaps, getting rid of Provenge is not such a bad idea.

Dendreon is burning close to 100 million dollars per year, with

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

most of the money going to Provenge clinical trials, building manufacturing facilities for Provenge, preparing the sales f

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

Combination pro

rce for Provenge, etc. Provenge, Provenge, Provenge – everything else seems to be on the back burner. While the company st

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

ill has cash at the moment, it is running out of it fast. In fact, the money will have to be raised sometime in 2006, befo

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

e or soon after the launch of Provenge.

Dendreon will likely to be starving for cash till 2008 before the money from the

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

Provenge sales may start trickling down. And what if the trickle is very meager? Two-three years from now new cheaper drug

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

could well outcompete Provenge and reduce it to a fancy expensive drug with limited patient base. There are several compe

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

titors that could bring their drugs relatively soon after Provenge hits the market. Prostvac-VF from Therion, GVAX from Ce

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

Following aspects would a

ll Genesys (CEGE), and DN-101 from Novacea come to mind. While these drugs are likely to be approved after Provenge, they

dd to the challenges in developing combination products:

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

ill most likely be much cheaper to produce because they are not custom-manufactured for each patient. With so many drugs t

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

argeting the prostate cancer, the ability of a company to deliver drugs that are competitive price-wise could be the most

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

ritical for winning a substantial share of the market.

I would go as far as to suggest that the scenario according to whi

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

ch Provenge is not even able to pay for the cost of its own development is quite likely. At the same time, the cash that D

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

Professional from academic institutions, pharmaceutical industries, health care indust

ndreon has now could be used to more speedily pursue highly promising Trp8 inhibitors that are currently in the pre-clinic

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

al development. ~130M in cash is large enough to push Trp8 program well into phase II clinical trials. It may be unfortuna

.

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

e that the money will be spent on Provenge, a possible money sink with no meaningful return to the shareholders. DNDN shou

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

Companies that provide selfless information through particip

ld continue to produce good setup for the short-term trader but it may not be such a great play for the long-term investor

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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