Slide show - Cornell University

advertisement
IDEC Pharmaceuticals Corporation (IDPH)
Incorporated in 1985; currently 995 employees; located in San Diego, CA
Primarily engaged in the research, development, manufacture, and commercialization of
targeted therapies for the treatment of cancer, autoimmume, and inflammatory diseases.
2 commercial products: Rituxan (in partnership with Genentech) and Zevalin (IDEC)
Both Rituxan and Zevalin are monoclonal antibodies directed against CD20 which target
CD20-expressing B cells including Non-Hodgkin’s Lymphoma B cells
3-5 pipeline products: IDEC-114*, IDEC-131*, IDEC-151, IDEC-152, IDEC-160, IDEC-201
Total revenue (12 months): $441 mil
R & D expenses for 2002: $93.6 mil
Income (12 months): $159 mil = 36% profit margin
Current price: ~ $ 33
Earnings per share: ~ $ 0.85
P/E: ~34
PEG: 1.3x – 1.5x
Outstanding shares: 155 mil
Market capitalization: $ 5.0 bil
PROPRIETARY TECHNOLOGIES by IDEC
PRIMATIZED Antibody Technology
PRIMATIZED antibodies are chimeric antibody molecules consisting of the variable
antigen-binding region from a mouse antibody fused to the constant region of a primate
antibody (macaque). Primatized antibodies are structurally identical to human antibodies
and reduce potential human-anti-mouse reactivity. IDEC was issued a US patent in 1998
for the development of PRIMATIZED antibodies. Macaque monkeys can also be
immunized with human antigens to develop genetically engineered primatized antibodies
which are produced in host cell lines. 3 product candidates currently under development
utilize this technology.
Proprietary Vector Technology
IDEC has developed methods of engineering mammalian cell cultures using proprietary
gene expression technologies or vector technologies that rapidly and reproducibly select for
stable cells to produce high levels of desired proteins. This allows for efficient production
of proteins at yields that are competitive with current commercial cell culture
manufacturing methods, and has been used in the production of Rituxan.
Fab
Ag
Ag
Hybridoma Technology
Fa
IgL k,l
IgH m,d,g,e,a
Fb
Fc
A hybridoma is a cell line in which
an antibody-producing B cell
(human)
is
fused
to
an
immortalized or long-lived mouse
cell to produce a hybrid cell. The
hybrid cell is cloned and expanded
in culture to yield continuous
production of an antibody of predetermined specificity.
Industry-wide sales projections of monoclonal antibody therapeutics
16
14
$ Billions
12
10
8
6
4
2
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Credit Suisse First Boston
Company
Abgenix
Amgen
Biogen
Corixa
Genentech
Glaxo-Smith Kline
IDEC
Imclone
Johnson & Johnson
Medarex
Medimmune
Xoma
Zymogenetics
Ticker
ABGX
AMGN
BGEN
CRXA
DNA
GSK
IDPH
IMCLE
JNJ
MEDX
MEDI
XOMA
ZGEN
Price
11.8
64.6
45.2
7.6
72.8
41.8
40.6
36.6
53.5
7.1
38.1
6.3
15.3
P/E
n/a
n/a
36.8
n/a
323.13
19.9
43.79
n/a
23.45
n/a
69.11
n/a
n/a
Market cap
$ Mil
1,035
83,251
6,712
382
28,303
129,000
6,298
2,691
158,900
546
9,612
451
704
52 wk hi-lo
4.52 - 14.65
Ab-EGF
5.06 - 9.23
ENBREL (TNF inhibitor)
28.43 - 50.52 Avonex (IFN-1a for MS), Amevive (psoriasis)
Bexxar (anti-CD20-I131)
7.52 - 7.76
Rituxan (anti-CD20)
25.10- 75.24
Bexxar (anti-CD20-I131)
31.35 - 43.87
Rituxan, Zevalin (anti-CD20-Yt90)
20.76 - 47.67
5.24 - 47.13
Erbitux (anti-EGFR)
41.40 - 61.30
Remicade (TNFR inhibitor)
2.55 - 9.00
UltiMab
20.37 - 42.09
Synagis (mAb blocks RSV infection)
2.84 - 8.00
Raptiva (anti-CD11a)
4.98 - 18.00
protein discovery via bioinformatics
EXECUTIVE OFFICERS
William H. Tastetter, Ph.D.
Chairman, Chief Executive Officer (1986)
William R. Rohn
President, Chief Operating Officer (1993)
Paul C. Grint, M.D.
Senior Vice President, Chief Medical Officer (2001)
Nabil Hanna, Ph.D.
Senior Vice President, Chief Scientific Officer (1990)
Wolfgang Berthold, Ph.D.
Senior Vice President, Biopharmaceutical Sciences (2000)
John M. Dunn
Senior Vice President, Legal and Compliance,
General Counsel and Corporate Secretary (2002)
Connie L. Matsui
Senior Vice President, Planning and Resource Devt (1992)
Edward M. Rodiriguez
Vice President, Finance and Controller (1991)
Michael E. Wiebe, Ph.D.
Vice President, Quality (2001)
Mark C. Wiggins
Vice President, Marketing and Business Devt (1998)
Cash and Cash Equivalents = $1,447,865,000
Operating Expenses
Dec 31, 2002
Dec 31, 2001
Dec 31, 2000
Research and
Development
$93,648,000
$86,299,000
$68,922,000
Selling, general, and
Administrative
(marketing
$95,241,000
$55,241,000
$27,767,000
Cost of Revenue/
Manufacturing
$1,457,000
N/A
$2,134,000
Dec 31, 2002
Dec 31, 2001
Dec 31, 2000
Total Revenue
$404,222,000
$272,677,000
$154,682,000
Net Income
$148,090,000
(+45% from
previous year, 37%
profit))
$101,659,000
(+111% from
previous year, 37%
profit))
$48,145,000
(+11% from
previous year, 31%
profit)
$0.85 per share
(+44%)
$0.59 per share
(+96%)
$0.30 per share
(+0%)
Revenues
RITUXAN
•Humanized anti-CD20 monoclonal antibody approved for NHL in November 1997; also being
used off-label to treat CLL; first monoclonal Ab approved for treatment of cancer
•Co-marketed by Genentech—sales reached $779 mil by 2001 and has steadily grown for the past
four years ($152, $262, $424, $779 mil); IDEC retains approx. 40% of total sales; Estimate $1.38
bil in total sales for 2003; Expect 4-8% growth each quarter; $2500 per 500 mg dose
•Estimated that 300,000 people in the US are afflicted with NHL (140,000 treatable with Rituxan)
•Efficiency: Overall response rate of 48% with 6% complete response rate with a median time of
11.6 months
•Achieved new approval in 2001 to expand its use in patients with relapsed or refractory, low-grade
or follicular CD20+ B cell NHL, up to eight rather than four weekly infusions, and use of Rituxan
in the treatment of bulky disease (tumors greater than 10 cm in diameter)
•Approved in Japan for NHL co-promoted by Nippon-Roche and Zenayaku Kogyo
•60 percent of patients undergoing treatment with Rituxan plus cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) are still in remission after more than 4 to 7 years
•Data from a phase III trial in Europe (GELA) indicate that patients with aggressive NHL treated
with Rituxan plus CHOP show a 23 percent improvement in survival over patients treated with
CHOP alone
•Preclinical evidence that Rituxan may be useful for the treatment of autoimmune and inflammatory
diseases, either alone or in combination with other drugs, including immune thromocytopenic
purpura (ITP), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA)
Sales of Zevalin
Price per Dose = $17,000
Sales to Date:
• $13.7million since April 2002
• $5.7million in Q1 2003
Projections from S&P:
• $68 million in 2003,
• $118 million in 2004,
• $200 million in 2007
ZEVALIN
•Anti-CD20 (retuximab) non-humanized antibody coupled to yttrium-90 (beta-emitter) was approved
for NHL in February 2002. IDEC has exclusive rights to this product in the US. Outside, Schering
AG has exclusive marketing rights with IDEC receiving milestone payments and royalties.
•Provides a new treatment option for patients when Rituxan or chemotherapy is not sufficient;
concentrates the effect of radioimmunotherapy to the site of the tumor
•Each treatment is complete in 8 days, but patient must make several hospital visits for treatment and
imaging, and requires an integrated effort among the hospital community and physicians/oncologists
using Zevalin to treat NHL disease.
•Efficiency: 74% overall rate and 15% complete response (80% with Rituxan combined versus 56%
Rituxan alone n=143)
•CMS reimbursement rule (wage index adjustment) for Zevalin became effective in March 2003 has
led roughly 24% of the hospitals to lose money with the Zevalin regimen. Expect no sales from
these hospitals, thereby reducing the Zevalin sales estimates from $36 mil down to $27 mil.
•Competes with Bexxar (Corixa/Glaxo-Smith-Kline) 131I-coupled anti-CD20 mAb (beta/gamma
emitter); Bexxar produced a 70% overall response rate in low-grade NHL (35% complete response
lasting a median of 3+ years n=251); 40% complete response rate in patients who are resistant to
Retuximab treatment
Charlotte Wolter, NHL patient, and Dr. Thomas Witzig, M.D., Hematologist, on
Zevalin
NEW PRODUCTS IN THE PIPELINE….
IDEC-114* (primatized anti-CD80 or anti-B7.1)
This Ab selectively targets co-stimulatory B7-1 ligand on APCs. The neutralized
molecule cannot bind to the CD28 and CTLA-4 receptors on T cells, thus blocking the
second signal for inflammatory T-cell activation.
• Two Phase II clinical trials for treatment of PSORIASIS (inflammation of skin
affecting 1.5 Mil people in US) – DISCONTINUED due to lack of efficacy
XOMA humanized anti-CD11a (Raptiva/Xanelim/Efalizumab) blocks T cell binding
Developed and marketed by Genentech
Psoriasis (BLA/MAA); Rheumatoid Arthritis, Psoriatic Arthritis (Phase II)
RECENTLY HALTED
CORIXA PVAC proprietary immunomodulator based on heat-killed Mycobacterium
vaccae (Phase II)
• Phase I/II clinical trial initiated in January 2002 for treatment of relapsed or
refractory NON-HODGKINS LYMPHOMA and also in combination with Rituxan
(estimated 300,000 patients in US have some form of NHL, 140,000 of which are lowgrade NHL or transformed low-grade NHL)
NEW PRODUCTS continued….
IDEC-131* (anti-CD40L or anti-CD154)
CD40L is a member of the TNFR family; expressed on activated T cells; provides costimulatory help to CD40-expressing B cells, macrophages, and dendritic cells.
Ultimately reduce Ab production and restore normal immune response.
• 1 Phase II clinical trial in PSORIASIS
XOMA Raptiva
CORIXA PVAC
MEDAREX HuMax-CD4 (out-licensed to GENMAB)
• 1 Phase II clinical trial in IMMUNE THROMBOCYTOPENIC PURPURA (anti-platelet
disease)
• 1 Phase II clinical trial in CROHN’S DISEASE (Inflammatory bowel disease)
JOHNSON & JOHNSON/CENTOCOR Remicade (anti-TNF; approved)
XOMA Neuprex rBPI21(Phase II)
•1 physician-sponsored IND in MULTIPLE SCLEROSIS (demyelinating disease affecting 2.5 mil
worldwide, 350,000 in US)
CORIXA Anergix.MS (MHC class II complexed with MS peptide; Phase I/II done)
* Clinical trials for IDEC-131 were suspended in 2002 due to safety
concerns (thromboembolism), and are expected to resume in 2003
NEW PRODUCTS continued….
IDEC-151 (primatized anti-CD4)
CD4 is expressed on thymocyte subsets and mature T cells; Helper T cells use CD4 to bind
MHC class II. IDEC-151 is thought to prevent the helper T cell from becoming activated,
without seriously affecting other immune system functions.
•Completed a Phase II clinical trial n =32 in combination with methotrexate for RHEUMATOID
ARTHRITIS (RA) (2 million people affected in the US and 1-2 percent worldwide); results promising
JOHNSON & JOHNSON/CENTOCOR Remicade (anti-TNF)
CORIXA Anergix.RA (MHC class II - collagen peptide complex; completed Phase I/II)
Anervax.RA (peptide vaccine; completed Phase II)
MEDAREX HuMax-CD4 and HuMax-IL-15 (outlicensed to GENMAB)
AMGEN/WYETH Enbrel soluble TNFR (neutralizes TNF) ABBOTT rTNFR
IDEC-152 (primatized anti-CD23)
CD23 or FcReRII is a C-type lectin; low affinity receptor for IgE; expressed on mature B
cells, activated macrophages, eosinophils, follicular DCs, and platelets
•1 Phase I/II clinical trial initiated Feb 2002 n=30 for ALLERGIC ASTHMA and ALLERGIC
RHINITIS (17 million people affected in the US); reduction in IgE levels but no observable reduction in
clinical symptom scores
•1 Phase I study initiated in Sep 2002 for CHRONIC LYMPHOCYTIC LEUKEMIA (30% of all
leukemias, 7% NHLs, 8,100 new cases each year in US)
NEW PRODUCTS continued….
IDEC-160 (HMN-214)
This is a licensed, orally-administered small molecule developed by Nippon Shinyaku of Japan
• 1 Phase I clinical trial initiated Sep 2002 (in US only) for treatment of solid tumor cancers
• Shinyaku has a Phase I/II trial in and marketing rights Japan/Asia
IDEC-201 (beta-interferon gene therapy)
IDEC-201 is a beta-interferon gene therapy based on a replication-defective adenoviral vector. Licensing
agreement signed in January 2003 to co-develop this drug with BIOGEN for treatment of GLIOMA
(brain cancer affecting 36,000 people in the US); Biogen and IDEC share worldwide development and
marketing rights on this product
• Phase I/II clinical trial for treatment of GLIOMA ongoing
OTHER TECHNOLOGIES AND TREATMENTS IN THE WORKS…
DOMAIN-DELETED ANTIBODIES
“Domain-deleted” antibodies have fragments of the constant region in the immunoglobulin
heavy chain removed
Coupled to yttrium-90, “domain-deleted” antibodies could potentially provide successful
delivery of radioisotope to solid tumors such as prostate, ovarian, colon, and lung cancers
Anticipate launching a pilot study with yttrium-90 labeled domain-deleted antibodies in 2003
CANCER VACCINES / THERAPY
Currently collaborating with NCI to combine the prostate specific antigen PAGE-4 with
IDEC’s patented PROVAX adjuvant technology in therapeutic vaccines for human clinical
trials on prostate cancer (189,000 men in US affected with prostate cancer) MEDAREX
MDX-010 (Anti-CTLA4) Phase I/II for prostate and melanoma
Preclinical studies of IDEC-152 (anti-CD23) in the treatment of chronic lymphocytic leukemia
(CLL). All CLL cells express CD23. Anticipate launching a Phase I/II trial with IDEC-152 on
CLL this year
PATENT/LEGAL ISSUES
RITUXAN and ZEVALIN
Lawsuits filed by GSK in May 1999 and Sept 2000 regarding patent infringement of
Rituxan sales in US and Europe—settled by Genentech and GSK
Lawsuits filed by GSK and Corixa in Sept 2001 in US and Europe regarding patent
infringement of manufacture and sales of Zevalin—under appeals in Europe, settled in
US through a lump-sum licensing agreement
ANTI-CD40L
Lawsuits filed by Dartmouth and Columbia for anti-CD40L—resolved???
Lawsuits filed by IDEC against Immunex for anti-CD40L patent infringement
IMMUNOTHERAPY INDUSTRY: COMPARABLE COMPANIES
Company
Abgenix
Amgen
Biogen
Corixa
Genentech
Glaxo-Smith Kline
IDEC
Imclone
Johnson & Johnson
Medarex
Medimmune
Xoma
Zymogenetics
Ticker
ABGX
AMGN
BGEN
CRXA
DNA
GSK
IDPH
IMCLE
JNJ
MEDX
MEDI
XOMA
ZGEN
Price
10.3
60.54
38.89
7.6
55.48
40.78
32.86
18.59
53.32
4.74
32.83
5.71
12.4
P/E
n/a
n/a
31.2
n/a
239.1
19.1
36.5
n/a
23.9
n/a
60.1
n/a
n/a
Market cap
$ Mil
904
Ab-EGF
78,067
ENBREL (TNF inhibitor)
5,774
Avonex (IFN-1a for MS), Amevive (psoriasis)
383
Bexxar (anti-CD20-I131)
28,303
Rituxan (anti-CD20)
125,900
Bexxar (anti-CD20-I131)
5,096
Rituxan, Zevalin (anti-CD20-Yt 90)
1,369
Erbitux (anti-EGFR)
158,100
Remicade (TNFR inhibitor)
366
UltiMab
8,276
Synagis (mAb blocks RSV infection)
411
Raptiva (anti-CD11a)
570
protein discovery via bioinformatics
POTENTIAL RISKS OF INVESTMENT
1)
Slowing Rituxan sales growth: 95% of IDEC’s sales are dependent on Rituxan
2)
Zevalin’s failure to gain NHL market share and failure to obtain approval in Europe
3)
Competition if Corixa/GSK’s Bexxar is approved
4)
Adverse ruling in patent litigation regarding Zevalin and Rituxan
5)
Competitive drug pricing
6)
Reliance on third-party vendors and contract manufacturers (e.g. Yttrium-90)
7)
Limited sales and marketing experience
8)
Uncertainties in new drug approvals and clinical trials
9)
Healthcare reimbursement and reform (e.g. CMS categorized Zevalin as a procedure
rather than a drug)
10)
Product liability
RHEUMATOID ARTHRITIS
Rheumatoid Arthritis (RA) is a chronic, systemic, inflammatory disease that chiefly affects
the synovial membranes of multiple joints in the body.
RA is considered an autoimmune disease that is acquired and in which genetic factors
appear to play a role. The presence of HLA-DR4 antibody in 70 percent of patients with
RA lends support to the genetic predisposition to the disease. Rheumatoid Factor(s) (RF)
are antibodies to IgG, and are present in 60-80 percent of adults with the disease. High
titers of RF are usually associated with more severe and active joint disease, greater
systemic involvement, and a poorer prognosis for remission. RA, as well as other
autoimmune diseases, includes widespread immunologic and inflammatory alterations of
connective tissue.
The prevalence of the disease is 1-2 percent of the general population world-wide with 2
million people affected in the US. Females with RA outnumber males by a 3:1 margin.
Onset of the disease in adults is usually between the ages of 40 to 60 years, although it can
occur at any age.
The etiology of RA is unknown. Viral or bacterial infections are suspected.
Indolent NHL
Follicular lymphoma comprises 20% of all non-Hodgkin's lymphomas and up to 70% of the indolent
lymphomas. Most patients with follicular lymphoma are over age 50. Nodal involvement is most
common, often accompanied by splenic and bone marrow disease. The median survival ranges from 8 to
12 yrs, thus designated "indolent." The vast majority of patients with advanced-stage follicular
lymphoma are not cured with current therapeutic options. Rate of relapse is fairly consistent over time,
even in patients who have achieved complete responses to treatment. Therapeutic options include purine
nucleoside analogs, oral alkylating agents, combination chemotherapy, interferon, and monoclonal
antibodies. Radiolabeled monoclonal antibodies, vaccines, and autologous or allogeneic bone marrow or
peripheral stem cell transplantation are under clinical evaluation. Rearrangement of the bcl-2 gene is
present in over 90% of patients with follicular lymphoma; over-expression of the bcl-2 protein is
associated with the inability to eradicate the lymphoma by inhibiting apoptosis.
Aggressive NHL
Diffuse large B-cell lymphoma is the most common of the non-Hodgkin's lymphomas, comprising 30% of
newly-diagnosed cases. Most patients present with rapidly enlarging masses, often with symptoms both
locally and systemically. The vast majority of patients with localized disease are curable with combined
modality therapy. For patients with advanced stage disease, 40% of presenting patients are cured with
doxorubicin-based combination chemotherapy. An international index for aggressive NHL (diffuse large
cell lymphoma) identifies 5 significant risk factors prognostic of overall survival: age (<60 years of age),
serum lactate dehydrogenase, stage (I or II versus III or IV), and extranodal site involvement (0 or 1
versus 2-4). Patients with 2 or more risk factors have less than a 50% chance of relapse-free and overall
survival at 5 years. This study also identifies patients at high risk of relapse based on specific sites of
involvement, including bone marrow, central nervous system (CNS), liver, lung, and spleen. A
retrospective analysis of 605 patients with diffuse large cell lymphoma who did not receive Some cases of
large B-cell lymphoma have a prominent background of reactive T cells and often of histiocytes, so-called
T-cell/histocyte-rich large B-cell lymphoma. This subtype of large cell lymphoma has a very aggressive
clinical course with frequent liver, spleen, and bone marrow involvement.
Non-Hodgkin’s Lymphoma Classifications
Low-grade
A Small lymphocytic, CLL (SL)
B Follicular, small cleaved cell (FSC)
C Follicular, mixed small cleaved and large cell (FM)
Intermediate-grade
D Follicular, large cell (FL)
E Diffuse, small cleaved cell (DSC)
F Diffuse mixed, small and large cell (SM)
G Diffuse, large cell cleaved or noncleaved (DM)
High-grade
H Immunoblastic, large cell (IBL)
I Lymphoblastic, convoluted or non-convoluted (LL)
J Small noncleaved cell, Burkitt’s or non-Burkitt’s (SNC)
History of Rituxan and Zevalin
Rituxan (Rituximab): a primatized MCA directed against CD20
• approved for use in refractory low-grade or follicular, CD20+, B-cell non-Hodgkin’s lymphoma in
1997--44,000 cases/year
• first monoclonal antibody approved for cancer therapy
• largest selling oncology product in the world-and it may grow as variations for its use are studied
and adopted (e.g., it is being used and tested as a Maintenance therapy)
• good preliminary data supports its use in rheumatoid arthritis and systemic lupus and phase 3 trials
are in progress
Zevalin (Ibritumomab tiuxetan): the same MCA conjugated to chelating agent that binds either a beta
or gamma emitter (for therapy or imaging)
• approved for treatment of relapsed or refractory low grade (to chemo and Rituxan), follicular, or
transformed B-cell non-Hodgkin's lymphoma (NHL) in February 2002
• first radioimmunotherpay approved for cancer therapy
Sales of Rituxan
Two-tier copromotion arrangement with Genentech + royalties from
non-US sales (from Roche)
in millions
Q1
Q2
Q3
Q4
Year Total
2003
$341.0
2002
$247.5
$274.9
$293.9
$346.6
$1,162.9
(385,809)
2001
$172.1
$187.7
$212.8
$246.0
$818.6 (251,428)
2000
$85.1
$102.8
$117.9
$138.3
$444.1 (132,782)
1999
$57.1
$74.4
$72.6
$75.3
$279.4
1998
$37.7
$34.8
$39.4
$50.6
$162.6
1997
-
-
-
$5.5
$5.5
( ) = Copromotion Profits + royalties from non-US sales
Sales of Zevalin
IDEC holds 100% marketing rights within the US and
signed an agreement with Schering AG for outside US
which pays milestones and royalties
IDEC only recently started getting reimbursed so revenues
are just beginning to be seen
2002 since April (13.7 million), 2003 Q1(5.7 million)
Future of Rituxan
• Rituxan sales decreased during the past quarter - is the
market saturated or does this reflect the price increase??
• Many clinical trials exploring Rituxan as treatment in
other diseases - would IDEC retain marketing rights for
this label?
• Competition
Projections S&P $1.29billion in 2003; $1.44billion in 2004
But this ignores use for other indications
Rheumatoid arthritis
• a chronic condition
• 1 percent of the population (2/3 women)
• ‘overactive’ immune system attacks joints and causes crippling pain
• Current therapy are: anti-T cells or anti inflammatory drugs
• Rituxan is the only B cells directed therapy, but there is a controversy
about the importance of B cells in the disease
• Only minor side effects in preliminary studies and it is already and
FDA approved Drug
• So…...
Efficacy and Safety of Rituximab,a B-Cell Targeted
Chimeric Monoclonal Antibody: A Randomized, PlaceboControlled Trial in Patients with Rheumatoid Arthritis
(Edwards et al: Arthritis Rheum. 2002 Sep;46(9):S197. Abstract # 446.
Other Autoimmune Diseases
 effectiveness in one patient with refractory type II essential mixed
cryoglobulinemia (MC) and one with refractory Goodpasture's syndrome
 Treatment of Systemic Lupus (SLE) is promising
 complete remission in a patient with refractory Wegener's granulomatosis
 dramatic and sustained improvement" in five patients with refractory adult or
pediatric dermatomyositis
Future of Zevalin
•Direct Competition: Feb 23, 2003 infringement suit filed
against Corixa and GSK for Bexxar, a CD20 specific radioligated antibody
Projections:
•$68 million in 2003,
• $118 million in 2004,
•$200 million in 2007
•Additional studies may create new uses (other disorders or
primary treatment)
Existing products: Conclusions
• Use of existing products for slight variations in the cancer
area should continue to increase sales for several years
• Sales are already being driven by some off label use
• Preliminary data suggests approval for RA and related uses
will occur
• This could double (optimistically) the top line for existing
products, lowering P/E to below 20?? or increasing the
price of the stock??
IDEC Patents
Combination therapies for B-cell lymphomas comprising
administration of anti-CD20 antibody
Granted US and European patent protection
PRIMATIZED Antibody Technology
Chimeric antibody molecules consisting of the variable antigen-binding
region from mouse antibodies fused to the constant region of primate
antibodies (macaque). Primatized antibodies are structurally identical to
human antibodies and reduce potential human-anti-mouse reactivity.
Granted worldwide patent protection: covers antibody technology as well as
specific antigen targets of PRIMATIZED antibodies
Method for integrating genes at specific sites in mammalian
cells via homologous recombination and vectors for
accomplishing the same
Methods of engineering mammalian cell cultures using proprietary gene
IDEC literature
Zevalin and Rituxan: Clinical Trials
Additional Radiation Absorbed Dose Estimates for Zevalin
trade mark
Radioimmunotherapy. Cancer Biother Radiopharm. 2003
Apr;18(2):253-8.
Wiseman GA, Leigh BR, Dunn WL, Stabin MG, White CA.
Mayo Clinic, Rochester, MN.
Radiation Dosimetry Results From a Phase II Trial of
Ibritumomab Tiuxetan (Zevalin trade mark )
Radioimmunotherapy for Patients With Non-Hodgkin's
Lymphoma and Mild Thrombocytopenia. Cancer Biother
Radiopharm. 2003 Apr;18(2):165-78. Wiseman GA, Leigh BR,
Other:
Notch-regulated ankyrin-repeat protein inhibits notch1 signaling: m
signaling pathways involved in T cell development.
J Immunol. 2003 Jun 15;170(12):5834-41. Yun TJ, Bevan MJ. IDEC Ph
San Diego, CA 92121. Department of Immunology and Howard Hughes
University of Washington, Seattle, WA 98195.
CD154 Regulates Primate Humoral Immunity to Influenza.
Am J Transplant. 2003 Jun;3(6):680-688. Crowe JE, Sannella EC, Pfeiff
Azimzadeh A, Newman R, Miller GG, Pierson RN. Departments of Ped
Microbiology and Immunology, Cardiothoracic Surgery, and Medicine,
University Medical Center, Nashville, TN, USA IDEC Pharmaceuticals,
USA Nashville Veterans Affairs Medical Center, Nashville, TN, 37232,
Download