Here's some interesting news...
Schering-Plough Acquires Marketing Rights to
Ribi's Melacine in Canada
HAMILTON, Mont. and EDMONTON, Alberta, June
24 /PRNewswire/ -- Ribi ImmunoChem Research, Inc.
(Nasdaq: RIBI) announced today that Schering-Plough
Corporation (NYSE: SGP) of Madison, New Jersey, has
acquired exclusive rights in Canada to distribute, market
and sell Melacine melanoma theraccine, Ribi's novel
therapeutic melanoma vaccine currently under regulatory
review. This amends the distribution agreement for
Melacine announced in March of 1998 and gives
Schering-Plough exclusive marketing rights to Melacine
on a worldwide basis, once approved. Canadian
marketing rights to Melacine were previously held by
Biomira Inc. (Nasdaq: BIOMF) of Edmonton, Alberta.
"We are very pleased to expand our agreement with
Schering-Plough to include Canada," said Robert E. Ivy,
CEO, President and Chairman of Ribi ImmunoChem
Research, Inc. "Their knowledge of the worldwide
oncology market and biotherapeutic experience selling
Intron A (interferon alfa-2b, recombinant) as adjuvant
therapy for early-stage melanoma makes
Schering-Plough Ribi's ideal partner to market Melacine
as a patient-friendly therapy for the treatment of
melanoma."
Alex McPherson, MD, PhD, Biomira's President and
CEO, said "Relinquishing the Canadian marketing rights
for Melacine is in line with our announced focus on our
own vaccine product candidates. From a business
perspective, it would not be prudent for Biomira to build
the infrastructure necessary for Canadian marketing at
this time. We have, however, been pleased to play a role
in working with Ribi toward this pending Canadian
approval and any financial obligations on Biomira's part
have been recovered in this transfer agreement."
Ribi filed a New Drug Submission (NDS) for Melacine in
Canada in 1997 based on results of a completed Phase 3
clinical study in patients with Stage IV melanoma. An
answer is expected in the near future. In addition to the
Canadian NDS, a Marketing Authorization Application
for Melacine as monotherapy for Stage IV (disseminated)
melanoma was filed with the European Medicines
Evaluation Agency in March of 1998, with a decision
expected by the end of this year. Ribi also plans to file a
Biologic License Application for Melacine with the U.S.
Food and Drug Administration in the second half of
1998. If approved, Melacine potentially would be the
first tumor-specific therapeutic cancer vaccine to be
commercialized.
When all patient data included in the completed Phase 3
trial were analyzed, no statistically significant difference in
median survival was found between the Melacine arm
and the commonly used four-drug chemotherapy arm.
However, when data on only those patients who
experienced complete and partial objective clinical
responses were analyzed, there was a trend favoring
Melacine, with a median survival of 34 months compared
to 15 months for patients treated with chemotherapy.
Further, patients receiving Melacine enjoyed superior
quality of life during therapy as compared to the
four-drug chemotherapy control arm.
Melacine is also being studied in two additional Phase 3
trials. The Southwest Oncology Group is conducting a
trial of Melacine in patients with Stage II melanoma, as
adjuvant therapy after surgical removal of primary
disease. In cooperation with Schering-Plough, Ribi is
conducting a trial using combination therapy of Melacine
and Intron A in Stage IV melanoma. Results from these
two trials are expected in 1999.
"Ribi is very enthusiastic regarding the potential approval
of Melacine from the Canadian, European and U.S.
regulatory agencies, and the support of Schering-Plough
as our marketing partner. We are working together
closely to take advantage of their expertise in the
regulatory review process and to coordinate Ribi's plans
for producing commercial quantities of Melacine,"
explained Mr. Ivy. "If approved for use in all stages of
melanoma, worldwide sales of Melacine could approach
between $300-400 million annually."
Ribi ImmunoChem Research, Inc., a biopharmaceutical
company founded in 1981, is engaged in the development
of immunomodulators for use in preventing and treating
human disease.
Forward Looking Information Statements in this news
release are based on current expectations. Actual results
may differ materially based upon various risk factors.
Additional information regarding risk factors is contained
in the Company's Form 10-K for the year ended 1997,
as filed with the U.S. Securities and Exchange
Commission.
/CONTACT: Robert E. Ivy, Chief Executive Officer,
President and Chairman, or Kris Dyszynski, Director,
Licensing Activities of Ribi ImmunoChem Research, Inc.,
406-363-6214/ |
