InterMune Expands International Strategic Partnership With Boehringer Ingelheim to Include Ovarian
Cancer
BRISBANE, Calif., Oct. 16 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN)
today announced that it has expanded its international strategic partnership
with Boehringer Ingelheim International GmbH to include the development and
commercialization of interferon gamma-1b for the treatment of ovarian cancer.
Under this partnership, InterMune has the responsibility for the clinical
and regulatory development of interferon gamma-1b, and Boehringer Ingelheim
retains an option to exclusively promote interferon gamma-1b under Boehringer
Ingelheim's trade name, Imukin(R), in all countries outside of the United
States, Canada and Japan. InterMune may opt to promote the product where
Boehringer Ingelheim does not do so. The indications previously included
under the agreement are idiopathic pulmonary fibrosis (IPF), tuberculosis,
systemic fungal infections, chronic granulomatous disease (CGD) and
osteopetrosis.
"The expansion of this agreement allows InterMune to broaden the
opportunity for interferon gamma-1b around the world, and to reach an
additional $500 million in new market opportunities," said John J. Wulf,
Senior Vice President of Corporate Development at InterMune. "We are pleased
that Boehringer Ingelheim is confident in InterMune's ability to develop
interferon gamma and are excited about the drug's potential as combination
therapy in certain cancers."
"InterMune is an excellent partner for Boehringer Ingelheim for expanding
the number of approved indications for Actimmune(R) and Imukin(R)," said Prof.
Rolf G. Werner, Head of Corporate Division Biopharmaceuticals at Boehringer
Ingelheim.
InterMune will participate in the profits from developing interferon
gamma-1b for new indications in the defined territories through a specified
royalty schedule. The agreement provides InterMune with royalties on
Imukin(R) net sales above specified levels.
Interferon gamma-1b is sold in the United States and Canada under the
trade name Actimmune(R) and in other countries as Imukin(R). Imukin(R) is
currently approved for CGD in 41 countries, and Actimmune(R) is currently
approved in the United States for CGD and severe, malignant osteopetrosis.
Actimmune(R) and Imukin(R) are manufactured by Boehringer Ingelheim Austria
GmbH (Vienna), part of the Boehringer Ingelheim group of companies.
InterMune plans to initiate a global Phase III ovarian cancer trial for
Actimmune(R) in combination with carboplatin and paclitaxel-based chemotherapy
toward the end of this year. This Phase III trial is based upon the results
of a randomized controlled trial in 148 women who had undergone primary
surgery for ovarian cancer, with the control arm receiving cisplatin and
cyclophosphamide, and the experimental arm adding interferon gamma to this
regimen. Progression-free survival at three years was improved from 38% in
the control arm to 51% in the treatment group. This corresponded to median
times to disease progression of 17 and 48 months (p=0.031) and a three-year
overall survival of 58% and 74%, respectively.
InterMune is a commercial-stage biotechnology company dedicated to
developing innovative products for the treatment of serious pulmonary and
infectious diseases and cancer. InterMune has three marketed products, growing
product revenues and advanced-stage clinical programs addressing a range of
diseases with attractive commercial markets. For additional information about
InterMune, please visit intermune.com.
Boehringer Ingelheim offers the entire production technology chain at its
biopharmaceutical manufacturing facilities in Vienna (Austria), Biberach
(Germany) and St. Joseph/ Missouri (USA) with additional fill-and-finish
capacities in Bedford/ Ohio (USA). It has the world's largest capacities for
contract manufacturing of mammalian cell culture and fill-and-finish for
biopharmaceuticals and is Europe's leading manufacturer of biopharmaceuticals.
The Boehringer Ingelheim group of companies, headquartered in Ingelheim,
Germany, is one of the 20 leading pharmaceutical corporations in the world.
Boehringer Ingelheim, which has some 140 affiliated companies worldwide,
focuses on human pharmaceuticals and animal health. The human pharmaceuticals
business, which accounts for 95% of sales, is comprised of prescription
medicines, consumer health care products and chemicals and biopharmaceuticals
for industrial customers.
In 2000, Boehringer Ingelheim posted revenues of more than EUR 6 billion
and spent almost EUR 1.0 billion on R&D, equivalent to 16% of net sales.
Fixed asset investments totalled a record EUR 497 million.
Except for the historical information contained herein, this press release
contains certain forward-looking statements concerning certain of InterMune's
clinical development, marketing, sales and revenue goals that involve risks
and uncertainties. All forward-looking statements and other information
included in this press release are based on information available to InterMune
as of the date hereof, and InterMune assumes no obligation to update any such
forward-looking statements or information. InterMune's actual results could
differ materially from those described in InterMune's forward-looking
statements. Factors that could cause or contribute to such differences
include, but are not limited to those discussed under the heading "Risk
Factors" and the risks and factors discussed in InterMune's most recent
periodic reports (i.e., 10-K, 10K/A, 10-Q and 8-K) filed with the SEC. In sum,
these significant risks include, but are not limited to: the uncertainty of
success of InterMune's efforts in research, development, commercialization,
product acceptance, third-party manufacturing and capital raising; the
uncertain, lengthy and expensive regulatory process; uncertainties associated
with: obtaining and enforcing patents important to its business, being an
early-stage company and relying on third-party payors' reimbursement policies;
competition from other products; and product liability lawsuits.
SOURCE InterMune, Inc.
Web Site: intermune.com
CONTACT: Lisa Hansen, Manager, Investor Relations of InterMune,
Inc., +1-415-466-2242, or lhansen@intermune.com; or Kerstin
Felix, Corporate Division Public Relations, R&D Communications,
of Boehringer Ingelheim GmbH, +49-6132-77-9040, or
felixk@ing.boehringer-ingelheim.com |
