NEW YORKMany biologic therapeutic manufacturers face
critical choke-points in the future as they attempt to
satisfy market demand, according to William R. Rohn, chief operating
officer of IDEC Pharmaceuticals, the San Diego-based company that
produces the anti-CD20 monoclonal antibody rituximab (Rituxan) in
the United States.
Although Mr. Rohn sees no problem in satisfying future demand for
Rituxan, his company is planning to build a new $300 to $400 million
facility to fulfill the need for future products now in their
pipeline. Zevalin (ibritumomab tiuxetan, IDEC-Y2B8), an
investigational radio-immunotherapy in the late stages of development
as a treatment for certain non-Hodgkins lymphomas, will
continue to be manufactured in IDECs current FDA-licensed
Speaking at an IDEC business presentation before market analysts and
others, Mr. Rohn pointed out that biologic pharmaceuticals are often
used to treat chronic diseases that may require dosing over long
periods of time and, therefore, significant quantities of drug.
So clearly, being able to supply commercial markets is an
important issue today, he said.
There will be choke points, he said, because hundreds of biologics
are under development, and there are potential limitations on market
penetration due to a shortage of contract manufacturing capability to
supply the product. In IDECs case, building a substantial
manufacturing facility will help reduce the drug development cycle
time, since it will relieve the companys reliance on contract
manufacturing schedules and availability.
Another way to reduce drug development time is to manage clinical
trial data better, Mr. Rohn said. His company has invested in data
management systems to squeeze that process down, he said.
IDEC is going to electronic filings of its biologic license
applications (BLAs) in an attempt to shorten the FDA review time.
The Rituxan BLA was about 46,000 pages in approximately 138 volumes,
Mr. Rohn said, while the Zevalin BLA is about 94,000 pages in more
than 300 volumes. But the text is all contained on 12 CD-roms.
This will be one of the first fully electronic BLAs submitted
to the FDA, and the feedback we have gotten from the agency is that
electronic submissions do indeed reduce review time, he said.
Next month, at the American Society of Hematology (ASH) annual
meeting, IDEC will present the final results of a phase III study
comparing a standard course of rituximab as the control arm with a
combination of rituximab plus Zevalin in patients with relapsed or
refractory B-cell non-Hodgkins lymphoma. Interim analysis data
have already been presented showing an 80% response rate for the
rituximab/Zevalin combination vs 44% for rituximab alone.
An Oncology Franchise
Mr. Rohn, whose company focuses on the development of targeted
therapies for the treatment of cancer and autoimmune diseases, was
asked what it takes to develop a successful oncology
He answered that the company needs to offer itself as a good
partner, one that is willing to share revenues or profits with other
small biotechnology companies and not just take products in exchange
IDEC is open to revenue and profit sharing, he said. For example, the
company entered into a collaborative agreement with Genentech in 1995
for the clinical development and commercialization of Rituxan.
Building an oncology franchise also means establishing marketing
expertise. In oncology, Mr. Rohn explained, smaller drug companies
can compete with bigger ones.
Oncology is not a brute force marketing therapeutic
category. With a very small group of people, 70 to 100, you can
canvass all of the decision-makersthe oncologists and
hematologistswho manage patients with cancer in this country.
So with a good commercial infrastructure, you can be very successful
going head to head with Bristol-Myers, Upjohn, SmithKline-Beecham, etc.
In the oncology market, success is determined by marketers who
understand the nuances of the therapeutic category and can talk in
the language of the key clinical decision-makers. Ultimately,
success in terms of having a long-term oncology business is based on
developing more products faster, he said.