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CytoDyna?s New Approach to Drug Development: Why We Think Ita?s Better

^{Published on 2010-01-06 13:05:18 - Market Wire}
 

SANTA FE, N.M.--([ BUSINESS WIRE ])--The following is an opinion editorial provided by Allen D. Allen, CEO, CytoDyn, Inc.:

"improving the public health by engaging in research for the purpose of discovering and making available to the public new and improved medical drugs and information"

As reported by [ AIDS Treatment News ] on December 31, 2009, [ CytoDyn, Inc. ] (Pink Sheets: CYDY) has entered into an Agreement with The General Hospital Corporation d/b/a [ Massachusetts General Hospital ] for a clinical trial of Cytolin®, our Company's novel immune therapy for treating HIV/AIDS. The Agreement between CytoDyn and Massachusetts General Hospital takes a different approach to new drug development that merges elements of the private and public sectors. CytoDyn believes this approach is superior to the standard modalities because it can provide:

• Enhanced ROI for pharmaceutical companies.
• Reduced burden on taxpayers.
• Accelerated progress in clinical medicine.

New Drug Development in The Public Sector

The federal government obtains tax dollars from individuals and corporations on an involuntary basis and redistributes those dollars to public teaching hospitals for the purpose of funding basic medical research. The government reduces risk (the risk of criticism) by funding research that is popular in the academic community and is otherwise politically correct. However, as is generally true in academia, researchers are under no obligation to produce results that have utility or that provide taxpayers with any tangible benefits. On the other hand, faculty members at most public teaching hospitals are expected to publish original research papers in the peer-review journals. Since these published papers constitute a contribution to medical knowledge, this knowledge provides society with an intangible benefit in return for the tax dollars expended. Moreover, the basic research conducted by such institutions sometimes contributes to a tangible benefit for society. As a case in point, a significant portion of the basic science that underlies Cytolin®, i.e., the "prior art," was funded by the [ National Institute of Allergies and Infectious Diseases. ]

New Drug Development in The Private Sector

Individual and institutional investors voluntarily place their money at risk to provide operating capital for use by the drug companies. These for-profit companies spend hundreds of billions of dollars conducting clinical trials. Most of the drugs studied wind up failing because they were selected on the basis of intuition, fad theories, anecdotal observations or microbiological phenomena. Nonetheless, the new drugs that are successful can generate such large earnings that the drug companies have historically offered investors a substantial return on investment. In contemporary times, however, the pressure to constrain the costs of prescription medications, along with the economic downturn, have motivated the drug companies to reduce risk by favoring "me too" drugs, i.e., new drugs that differ from successful drugs only to the extent necessary to satisfy the novelty requirements of patent law. This has had the inevitable effect of limiting innovation, making it less likely that a drug company will develop a new drug that leads to a significant advance in clinical medicine.

New Drug Development at CytoDyn

The study CytoDyn is funding at Massachusetts General Hospital is science-intensive and is intended as a prelude to a follow-on clinical trial at the same Institution. Over and above conducting the study, Massachusetts General Hospital, not CytoDyn, designed the study and serves as its sponsor, all as part of its mission of "improving the public health by engaging in research for the purpose of discovering and making available to the public new and improved medical drugs and information," to quote the recitals of the Agreement between Massachusetts General Hospital and CytoDyn.

In other words, CytoDyn is funding research of a type that is usually funded by the government, except that the funds represent money voluntarily placed at risk by investors rather than tax dollars. While CytoDyn will retain its intellectual property rights and will have access to the study data, it will not own the data, which will be owned by Massachusetts General Hospital. This research, therefore, provides Massachusetts General Hospital with an opportunity to pursue its mission of conducting relevant and potentially seminal research using funds from a non-governmental source representing a deep-pocket segment of the economy. This would not be possible in the case of a drug that does not reflect a potential scientific breakthrough, such as a "me too" drug.

One advantage for CytoDyn is in avoiding the high costs associated with the FDA's regulation of clinical trials, especially when those trials are sponsored by a drug company. These regulations are intended to protect the public from what, in this author's opinion, is more a case of innumeracy than greed on the part of the drug companies. While cynics may tend to blame greed when unsafe drugs manage to escape regulatory safeguards, it ill serves the bottom line of a drug company to market a new drug that is initially profitable but has to be withdrawn due to safety issues and then generates billions of dollars in extraordinary expenses needed to settle or defend litigation.

In summary, the approach to new drug development funded by CytoDyn at Massachusetts General Hospital:

1. Provides pharmaceutical companies with an improved and cost-effective way of moving new drugs through the FDA, a benefit for the shareholders of those companies.
2. To gain this advantage, pharmaceutical companies must develop breakthrough drugs that significantly advance clinical medicine in order to qualify as research appropriate for public teaching hospitals. The resulting progress in clinical medicine would accrue to the benefit of the public.
3. In the process, billions of dollars are made available from the private sector for research to be conducted at public teaching hospitals, reducing the burden on taxpayers.