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  • Just Other Articles - Are You Buying What the Seller's Selling?

    I just lost a million dollars!

    That’s right, I had the plan all laid out and was in action on a deal that would have put one million dollars in my pocket i
    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
    n six months. Now I have zero, nada, nothing. And you know whose fault it is? Mine!

    Why? Because I had the transaction structured based on my experience, t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e way I had done business. But the other guy had the transaction structured on his experience, the way he did business - and our minds were miles apart.

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

    me explain. There was an ad in the Sunday paper offering a steel building (80 X 210 with an 18 ft clear ceiling) for sale. It had to be moved. I went to se
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    it and could see instantly that it was in good shape. It was being used as a retail showroom and repair shop for a bicycle business. It had been used as su
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    h for almost twenty years - same owner. Now the city wanted the land (the retailer had been renting the site) and the shop owner had to move. He found anoth
    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
    r location and no longer needed the building.

    The building included everything that was attached; several air conditioners, all the lighting and bathroom f
    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
    xtures, lots of wrought iron gates and fences, the security system, the fire sprinkler system, office doors, partitions, and paneling - everything

    I asked
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    he seller how much he wanted.

    “One fellow offered me $15,000.”

    “Is that what you want? Will that make the deal?”

    He said yes and I said I would take it.
    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
    e shook hands and I said I would be back as soon as my lawyer told me how to separate the building from the land so I could make the purchase and have evide
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ce of ownership. He said fine.

    A 16,800 sq ft building for less than a dollar a sq ft - with all the equipment to make it usable as a warehouse - what a d
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    al!

    On the way to talk to the lawyer I went over the calculations one more time. Similar warehouse space in our area rents for $12 to $15 a sq ft a year; s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    y $200,000. The building, taking it down, moving it and setting it back up; say $75,000. An acre of improved industrial land, site prepared; $100,000. Total
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    cost would be less than one year’s income. Capitalize the income at 10 and I have a building worth $2.0 million! Put a first mortgage on it for $1,175,000
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and I recover the cost and put a million dollars in my pocket.

    The next morning I called the seller and said I’m coming over. He said too late, I sold to a
    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
    guy about an hour ago. He came in gave me the money.

    “What? We had a deal!” I screamed into the phone. “We shook hands. We made a deal.”

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

    Professional from academic institutions, pharmaceutical industries, health care indust
    to him, as I knew it would. The deal was gone I had lost out.

    I was mad. The more I thought about it the madder I got. I had all sorts of plans for the se
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ler. I was going to sue; I was going to … until I realized I was the problem. I was at fault. I screwed up.

    You see, in my mind, I was buying a million dol
    .

    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
    ar warehouse and I needed to cover all the legal stuff (I am a real estate broker). This was a good size deal. It had to be done right. But in the seller’s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ind he was selling a $15,000 bicycle. All he wanted was a credit card, cash, or a check he could verify.

    Make sure you are buying what the seller’s selling


    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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