Here's two releases on Nipent. Sales don't amount to much yet (about $2m last year):
Feb 17, 1999
Johns Hopkins Symposium on SuperGen's Nipent® (Pentostatin)
Calls for Expanded Use
Developmental strategies outlined during Johns Hopkins Oncology Center- sponsored conference: "Future Development of Pentostatin: Opportunities for Using a Highly Effective, Safe Agent for Hematologic and Autoimmune Diseases"
SAN RAMON, Calif., February 17, 1999 -- SuperGen Inc. (Nasdaq: SUPG & SUPGW) announced today that renowned oncologists from leading medical institutions across the United States and Europe gathered in San Juan, Puerto Rico, on February 12th and 13th to discuss clinical findings and future developmental strategies related to SuperGen's proprietary drug Nipent® (pentostatin).
"Clinical data from more than 25 centers presented at the symposium clearly demonstrates the breadth of Nipent's efficacy in a variety of hematologic malignancies, including chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and low-grade non-Hodgkin's lymphoma (NHL), as well as autoimmune diseases," said conference co-chairman Michael Grever, M.D., Professor and Director of the Division of Hematologic Malignancies, Johns Hopkins Oncology Center.
"Nipent also may play a significant role in hematopoetic cell transplantation and graft vs. host disease," Grever added. "The greatest potential in the future will involve Nipent in combination with other agents."
"The conference was a resounding scientific success with far-reaching implications for SuperGen," said Dr. Joseph Rubinfeld, president, chief executive officer and chairman of SuperGen. "The new indications, including various leukemias, bone marrow transplantation and graft vs. host disease, cumulatively address markets with a potential of over $500 million."
Feb 26, 1999
SuperGen Files Supplemental New Drug Application with FDA for Nipent® in Mature T-cell Malignancies Including Cutaneous T-cell Lymphoma
Company's Strategy is to Establish Nipent as the Basic Drug for Treating Wide Variety of Lymphomas and Chronic Leukemias
SAN RAMON, Calif., February 26, 1999 -- SuperGen Inc. (Nasdaq: SUPG & SUPGW) announced today that it has filed a supplemental New Drug Application (SNDA) with the Food and Drug Administration (FDA) seeking approval for new indications for its already marketed drug, Nipent®. The indications requested are for the treatment of various mature T-cell lymphomas particularly cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The Company has received an "orphan drug" designation for CTCL, granting SuperGen seven years of market exclusivity from the time the drug is approved.
"This NDA submission is not only a significant milestone in our strategy to extend Nipent beyond its initial indication," said Dr. Joseph Rubinfeld, Chairman and Chief Executive Officer of SuperGen, "but also an important development in our mission to become a dominant cancer-fighting company with an extensive drug portfolio. At the recent Johns Hopkins symposium on Nipent, the leading oncologists agreed that Nipent and Nipent combined with other agents have tremendous potential."
There are approximately 16,000 patients with CTCL and up to 24,000 with PTCL in the U.S. An estimated 1,200 new cases of CTCL and 6800 cases of PTCL are diagnosed each year. CTCL is a cancer of lymphocytes (white blood cells) that can involve the bone marrow and internal organs in addition to the skin. A total of 191 patients from published studies and studies conducted by the Southwest Oncology Group and the European Organization for Research and Treatment of Cancer received Nipent as a single chemotherapeutic agent. All patients had rapidly progressing disease or disease refractory to other treatments. Thirty-six percent responded to treatment with Nipent. Most investigators describe the treatment as being well tolerated, with low bone marrow toxicity.
Recently, a drug was approved by the FDA for CTCL. However, approval is limited to a subset of patients whose malignant cells express the CD25 component of the Interleukin-2 (IL-2) receptor. Only about 50 percent of the patient population expresses this receptor, and in these trials 30 percent of the patients with the IL-2 receptor responded. Nipent acts by blocking the enzyme adenosine deaminase in the cells and does not require the presence of surface receptors; therefore, it can be used in the management of all patients.
"A substantial medical need exists for treating advanced CTCL, PTCL, and other mature T-cell lymphomas. We trust that the FDA will expedite its consideration of Nipent for these indications. Clinical studies of Nipent have yielded promising results, and Nipent's safety profile, established over many years, is highly favorable," said Rajesh Shrotriya, M.D., SuperGen's Executive Vice President and Chief Scientific Officer.
And from their 10K:
ESTIMATED
U.S. MARKET(1)
INDICATION STATUS -------------------
--------------------------------- ------------------------------------- ($MILLIONS)
<S> <C> <C>
Hairy Cell Leukemia Currently marketed in the U. S. $ 15
Cutaneous T-cell lymphoma NDA filed in February 1999 65
Chronic lymphocytic leukemia Clinical studies ongoing 150
Non-Hodgkin's lymphoma Clinical studies ongoing 150
Prolymphocytic leukemia Clinical studies ongoing 10
</TABLE>
We are currently marketing Nipent-Registered Trademark- (pentostatin for
injection), a proprietary drug that we acquired from Warner-Lambert Company in
1996. Nipent-Registered Trademark- is approved for the treatment of Hairy Cell
Leukemia, a type of B-lymphocytic leukemia. In 1998, our net sales of
Nipent-Registered Trademark- in the United States were approximately $2.1
million, which represented 14% of the estimated total United States market of
$15 million for products used to treat this disease. Our net sales of
Nipent-Registered Trademark- of $1.5 million in 1997 and $225,000 in 1996 were
from the finished goods inventory obtained when we acquired the drug. In
December 1997, we received approval from the FDA to begin selling our own
commercially manufactured Nipent-Registered Trademark-. Thereafter, sales have
consisted of product manufactured at our subcontractor's facility.
We are selling this drug only in the United States, although we have rights
to sell it in Canada and Mexico. We may sell it outside of North America for
diseases other than cancer until September 2006, at which time we may sell the
drug worldwide for any disease. Warner-Lambert retained a worldwide,
royalty-free license to sell Nipent-Registered Trademark- outside North America
but has agreed not to sell Nipent-Registered Trademark- in North America through
September 2006. In 1997, Warner-Lambert further agreed to buy all its
Nipent-Registered Trademark- for sales outside the United States from us through
at least October 2004. Shipments under this supply agreement
------------------------
(1) Estimates based on available industry data.
3
<PAGE>
commenced in the first quarter of 1998. We believe we can manufacture sufficient
product to actively promote sales of Nipent-Registered Trademark-, satisfy the
supply agreement referred to above, and conduct clinical trials for other
indications in both oncology and non-oncology fields.
Although Nipent-Registered Trademark- is approved only for the treatment of
Hairy Cell Leukemia, we believe that the drug has a unique mechanism of action
and may have activity in a variety of cancers and other diseases with larger
markets. In oncology fields, we are pursuing treatments for lymphatic
malignancies and disorders, such as cutaneous T-cell lymphoma, chronic
lymphocytic leukemia, non-Hodgkin's lymphoma and prolymphocytic leukemia.
Nipent-Registered Trademark- has received Orphan Drug Designation by the FDA for
use against cutaneous T-cell lymphoma and chronic lymphocytic leukemia. If
results from ongoing trials are consistent with previously completed trials, we
intend to pursue approval for both of these diseases. We filed for FDA approval
to use Nipent-Registered Trademark- to treat various mature T-cell lymphomas and
cutaneous T-cell lymphoma in February of 1999.
And finally a paper discussing Nipent (pentostatin, DCF) and other drugs:
science.springer.de
I doubt this is ever going to be a blockbuster, but it might well be a nice niche drug and significant for a company of SUPG's size.
Peter |
