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Sometimes it seems that the hardest part of the commercial deal is not finding it but finishing it! Investors look diligently for deals, put them together an

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

d then the unthinkable happens – it falls apart. Why does this happen? There are four primary things that are terminal to deals. Make sure they don’t apply

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

Examples of combination products may in

to you!

Time:
The number one killer of deals in the commercial industry is time, that is, the inability for an investor and their team to get a deal cl

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

osed. Delays in getting to close weaken the resolve of all parties and make the deal more tenuous. For example, when parties cannot get addendums executed q

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

uickly suspicions quickly rise and often give way to canceling the transaction. In order to assure that your deal is on track making sure that you are usherin

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

Combination pro

g the paperwork with top priority. Communicate frequently with your team to assure that the data is flowing without delay. Use a checklist with “drop dead d

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

ates” to make sure your deal closes on or before the negotiated date.

Misleading your team:
Another quick way to derail a deal is to not give full and c

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

omplete information to your team and that includes your attorney, your real estate broker and your mortgage broker. Too often, borrowers try to mask or bury

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

damaging information about their employment, assets, credit scores or liens, and that information – when it comes out – delays the transaction and “time kills

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

deals”. Being very up front with your team will play to your benefit because knowing this information can help your mortgage broker, for example, to locate

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

a better loan program based on your situation. Always be upfront with any hurdles you see – these are the reasons you have a team -to help you solve these pr

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

Following aspects would a

oblems.

Bad analysis:
Good deals are so difficult to find that oftentimes investors are so excited to get them done that they skip over many parts of du

dd to the challenges in developing combination products:

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

e diligence. As a result, they miss critical items that will hinder the closing or kill it outright. Not performing a careful analysis of a property’s histo

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

rical financials will cause errors that will change the projected earnings numbers for a property and, consequently, change its projected value. When present

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

ed to a lender, they will question the valuation and a borrower’s credibility is tainted. Take the time and make sure that your due diligence is thorough and

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

accurate.

Over/Under Valuation:
This happens often. A buyer wants the property valued as highly as they can so they can leverage as much as the can wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

th their lender and increase the depreciable basis. Conversely, they lowball the property to get a better deal. The problem lies with fair market value and

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

perception. When a property won’t appraise it causes delays and raises questions. Do not try to fudge the valuation of a property. It never works.

Keep in

.

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

mind that in order to make a profit on a commercial deal, either through cash flow or appreciation (or both), the investor has to secure the deal first! Whe

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

Companies that provide selfless information through particip

n an investor moves quickly, deals honestly, and works diligently they deal will move through the process smoothly and gets done. Shortcuts lead to bad deals

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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