Orphan Environment

In 1983, Congress passed and President Reagan signed the Orphan Drug Act to promote drug development for rare diseases. Together with legislation in Europe and Japan, legal monopolies were created one disease and one drug at a time in the world’s largest markets assuring orphan drugs extraordinary profitability.

With over 10,000 rare disorders, but only 130 drugs presently sold with orphan status in the United States and 95 in the European Union, orphan drug development should remain an open field with lucrative opportunities for some time1.

Big Pharma Competition

In one of the largest reallocations of capital in American business history, Big Pharma is moving tens of billions of dollars from in-house research to the acquisition of compounds from smaller biopharmas and universities. They are joined in this by “Big Biotechs” like Gilead Sciences. This trend is especially strong in orphan diseases, an area of rapidly expanding interest among even the largest firms. How can small and medium-sized firms compete against behemoths with external business development staffs of hundreds, outside consultants, and billions to spend?

To be successful in this more competitive environment, firms that rely on inlicensing to fill their pipelines need specialized help from the most experienced outfit in orphan drug acquisitions, Daedalus Biotech Advisors.

Information – Always The Best Investment

Money is not the key to drug development success; information is. Just as the enormous sums Big Pharma spent on in-house research proved disappointing, so these giants might have no more success relying on externally developed drug candidates. Nevertheless, every biopharma must recognize the magnitude of the change, and account for the increased competition.

At best, drug development is a very expensive business with long time horizons and heavy odds against success. Before the first dollar is spent, it is crucially important to acquire every possible bit of information, including alternative acquisition opportunities, market size, development cost, regulatory and pricing environment, and potential competition. Without thorough information search and analysis a firm can easily find itself in a multi-year clinical Calvary. This caveat is especially important in the orphan field where patient numbers are small and first approvals have government-guaranteed exclusivity.

Technology advances and changes in information organization now allow access to the work of virtually every research institution, teaching hospital, and commercial enterprise worldwide. Test results and clinical observations no longer go without notice outside the immediate research and treatment environment, contributing to a fuller understanding of the course of diseases and the activity of compounds that are (or might be) used to treat them.

Daedalus’ management has an unexcelled understanding of orphan drug acquisition and development gained over the decades since Genentech, Cetus, and a handful of other founding biotech firms appeared. Supported by a proprietary, multi- domain database providing comprehensive coverage of orphan assets worldwide from research bench to market, Daedalus’ clients benefit from a dominant IT position.

Biopharmas Upping their Game

Daedalus does not seek to supplant existing business development management, but to identify and assist in acquiring, partnering, and licensing the most desirable drugs, drug candidates, and technology. With hundreds of firms searching among 40,000 compounds for efficacy in 10,000 orphan disorders, even the largest firm will benefit from expert assistance.

For twenty-five years firms ranging in size from pharmaceutical majors down to biopharma start-ups have retained Daedalus to give them an edge in meeting their acquisition and development goals. And employing us means there is no full-time burden on a firm’s balance sheet.

Academic Sourcing

Coverage of drug candidates in development at universities, teaching hospitals, and independent research institutes is of increasing importance, with commercial firms seeking to source a growing number drug candidates from them yearly. Worldwide Daedalus monitors 1,000 universities and hundreds of independent institutions in the vanguard of biomedical research.

Start-up: Getting it Right the First Time

High quality drug candidates provide the crucial starting point for new biopharmas. A firm boasting impressive management and a Nobel-level scientific advisors can still fail; but, one with only adequate management can succeed given a single first-rate compound. The first compound is existentially important for the success of a new biopharma.

bioXcross: The New Biopharma M&A Model -- from “One to One” to “Many to Many”

bioXcross is meant to act as a central listing of orphan assets and services. Supported by Daedalus’ company database as well as its own private IT, bioXcross will serve as a uniquely valuable tool to identify orphan biopharma assets.

There are too many diseases, compounds, and market participants to be satisfied with the current accidental system of biopharma transactions, dating from a time when investment banks were dominant and access to information severely limited. Even now biopharma companies up for sale are shown to an average of only three potential buyers.

A registrant may list an unlimited number of assets and services, each with a virtually unlimited amount of space in free text form. Listings may remain for an extended period of time. Although sponsored by us, listing entails no commitment to Daedalus.

Fees

Clients pay nothing to list on bioXcross.

Daedalus’ consulting fees are assessed either as a single payment or on an hourly basis negotiated with the client. Contract research fees are likewise determined in prior discussion with the client.

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1 Drugs do not enjoy orphan exclusivity for an unlimited time.

Copyright © 2006 Daedalus Biotech Advisors