BOSTON (Reuters) - Celgene Corp is set to showcase its research pipeline to Wall Street on Thursday -- hoping to prove that it has a long-term growth story that goes beyond its flagship multiple myeloma drug Revlimid.
The company will provide details on its experimental drugs for lung cancer; chemotherapy-induced anemia; multiple myeloma; Crohn's disease, a gastrointestinal disorder; psoriasis, a skin disorder; and psoriatic arthritis, a related condition that causes pain and swelling of the joints.
Summit, New-Jersey based Celgene has become one of the world's biggest biotechnology companies based on the success of its cancer drug Thalomid, or thalidomide, which was approved in Europe some 50 years ago and widely prescribed to treat insomnia and morning sickness.
Celgene's shares have almost quadrupled over the past five years, twice the gain of the NYSE Arca Biotech Index.
Thalidomide was withdrawn after being shown to cause birth defects but was later approved in the United States to treat leprosy and then cancer, with a strict safety protocol. Thalomid, and Celgene's successor drug Revlimid, generated combined sales of $2.1 billion in 2009 -- nearly 80 percent of the company's total revenue. Now Celgene aims to show it has more than one story to tell.
"In general, low expectations for pipeline products set up a favorable scenario for investors, as any new data could be a positive sentiment driver," said Jason Kantor, an analyst at RBC Capital Markets Corp, in a recent research note.
In the short term, investors are focused on Revlimid, which dominates the multiple myeloma market along with Thalomid and Velcade, a drug made by Millennium Pharmaceuticals. Millennium is now owned by Japan's Takeda Pharmaceutical Co Ltd.
Several studies have suggested that using Revlimid as a maintenance therapy, either after first using other drugs or after a stem cell transplant, could improve outcomes. Data from key trials will be presented at medical meetings later this year.
If it can be shown to add benefit as a maintenance therapy, sales could increase from $1.7 billion in 2009 to $3.82 billion by 2013 according to a consensus forecast from Thomson Pharma.
The multiple myeloma market as a whole is expected to more than double from $2.1 billion in 2008 to $5.3 billion in 2018, according to research firm Decision Resources, driven by increased use of Revlimid and the launch of several emerging therapies.
One of those is expected to be Celgene's experimental drug pomalidomide, which is in a class of immunomodulating drugs known as IMiDs that also include Revlimid. Another is carfilzomib, developed by Onyx Pharmaceuticals Inc.
"Carfilzomib and pomalidomide are the most promising emerging therapies in development, owing to their efficacy and tolerability," said Decision Resources analyst Andrew Merron in a recent research report.
Celgene is also testing Revlimid for chronic lymphocytic leukemia, Non-Hodgkin's Lymphoma, prostate cancer and colorectal cancer.
PSORIASIS DRUG APREMILAST
Celgene will also be focusing on its experimental drug apremilast, a treatment for psoriasis and psoriatic arthritis, which is moving into late-stage clinical trials.
Geoff Meacham, an analyst at J.P. Morgan, predicted recently that apremilast could generate peak annual sales of at least $500 million. The drug would compete with Amgen Inc's Enbrel, which dominates the psoriasis market. Enbrel, which inhibits a protein known as tumor necrosis factor, or TNF, is delivered by injection.
Apremilast, an oral drug, is designed to modulate the immune system by inhibiting multiple pro-inflammatory cell types by blocking an enzyme known as PDE-4.
The PDE-4 class of drugs has been difficult to develop, failing either due to lack of efficacy or unacceptable side effects. On Monday, U.S. drug reviewers questioned the efficacy of a proposed PDE-4-inhibitor from Forest Laboratories Inc for chronic obstructive pulmonary disease.
Apremilast is designed to be more effective and have fewer side effects than some older drugs in the class.
Celgene will also focus on the potential for amrubicin, its experimental treatment for patients with relapsed small cell lung cancer. While small cell lung cancer constitutes only about 15 percent of all lung cancers, it tends to be faster growing than the more common non-small cell lung cancer.
Amrubicin, which is in a late stage trial, is a topoisomerase II inhibitor, a class of drugs that include the anthracycline chemotherapeutic agents. Anthracyclines have been associated with cardiotoxicity that can lead to heart failure in long-term cancer survivors.
However, Celgene said last year that pooled results from two studies showed it might be less toxic to the heart than traditional drugs in the same class.
The company will also update analysts on its drug PDA-001, which uses human placenta-derived stem cells to treat Crohn's disease. The drug, which is being developed in the company's cellular therapeutics division, is the first to be developed from its stem cell portfolio.
Celgene will also discuss a drug called ACE-011 that it is developing with Acceleron Pharma Inc that is designed to treat chemotherapy-induced anemia.
(Reporting by Toni Clarke; Editing by Tim Dobbyn)
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