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Most appraisers use three approaches to establish the value of a property. The

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

Sales Comparison Approach is normally considered to be the best indication of v

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

Examples of combination products may in

alue for residential property.

Sales Comparison Approach: In this approach the

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

appraiser finds three to four comparable properties in the neighborhood which

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

ave recently sold. Ideally, these properties are within a one-half mile radius

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

Combination pro

of the subject property and have sold within the last six months. The appraiser

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

compares the sold properties to the subject property. The factors used in the

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

omparison include square footage, number of bedrooms and bathrooms, property ag

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

e, lot size, view, and property condition.

Cost approach: This approach consid

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

ers the value of the land, assumed vacant, added to the cost to reconstruct the

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

appraised building as new on the date of value, less the accrued depreciation t

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

Following aspects would a

he building suffers in comparison with a new building.

Income capitalization a

dd to the challenges in developing combination products:

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

pproach: In this approach the potential net income of the property is capitaliz

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

ed to arrive at a property value. This approach is suited to income-producing p

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

operties and is usually used in conjunction with other valuation methods. The p

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

rocess of converting a future income stream into a present value is known as ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

pitalization.

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

M & M Resources Unlimited, Inc.

Helping customers since 1986

1577 Ridge Road

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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

West, Suite 119 - Rochester, NY 14615 Office: (585) 865-0950 Fax: (585) 865-3

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

Companies that provide selfless information through particip

202 Toll Free: 1-800-937-2350

Licensed Mortgage Banker/NYS Banking Departmen

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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