Citi: Pmab to Become EGFR MAb of Choice; Raising ABGX Target Price to $17
November 3, 2005 SUMMARY
* We provide more info on Ph III Pmab data. The hazard ratio was 0.54 indicating a 46% reduction in tumor progression rate. This was derived from the Kaplan-Meier curves for PFS for the two arms, where the curves separated at 8 wks (time of 1st scan) & remained separated. The 95% confidence intervals did not overlap suggesting the Pmab benefit remained robust.
* With these data, we believe Pmab is likely to become the EGFR Mab of choice given its better safety profile (lower infusion rxns, no premedication) and greater flexibility (every 2 wks) vs. Erbitux (every wk, premed required).
* We have raised our Pmab U.S. sales ests to $225MM from $188MM in FY07, to $334MM from $295MM for FY08, & to $592MM from $510MM for FY09 driving our ABGX EPS ests to ($0.43) from ($0.55) for FY07, to $0.00 from ($0.12) for FY08 & to $1.15 from $0.89 for FY09. Our ABGX target price is revised to $17 per share from $13 per share.
SUMMARY VALUATION AND RECOMMENDATION DATA
OPINION
This morning, partners Amgen and Abgenix held a conference call to discuss the
positive top-line results of the pivotal Phase III International trial (Study
408), which compared panitumumab (Pmab) in combination with best supportive
care versus best supportive care (BSC) in patients with advanced (third-line)
colorectal cancer (CRC). The 463-patient study achieved a statistically
significant benefit in the primary endpoint of progression-free survival (PFS).
Specifically, the companies indicated that the hazard ratio was 0.54 in favor
of Pmab indicating that treatment with Pmab provided a 46% decrease in tumor
progression rate with a p value of 0.000000001. These data were derived from a
Kaplan-Meier analysis of the primary endpoint of PFS, where the curves showed a
distinct separation beginning at eight weeks, the time of the first
radiographic scan to assess tumor progression, and remained separated. The
companies indicated that the 95% confidence intervals (i.e., error bars) for
the two curves never overlapped implying that the data was exceptionally
robust.
Given the advanced stage of disease for these patients, Amgen and Abgenix
highlighted how almost all patients in the best supportive care arm had
progressed by the first 8-week scan, and therefore, suggested that an analysis
of the rate of tumor progression versus median PFS may be more useful in
assessing treatment effect. Patients treated with Pmab plus BSC who achieved a
partial response or had stable disease accounted for a significant amount of
the differential in rate of tumor progression. According to the companies,
these patients represented about 40% of patients in this treatment arm. To
further underscore the strength of the data, the companies indicated that
various sensitivity analyses, including the region of the tumor (colon versus
rectal) and the number of prior chemotherapy regimens, confirmed the robust
benefit of the Pmab plus BSC arm compared to best supportive care alone. The
companies also indicated that this benefit was also independent of whether the
patient was assessed with a scan at the pre-specified time points (i.e.,
initially at 8 weeks then every 4 weeks for the next two scans and then every 8
weeks) or at more frequent intervals for scanning in either treatment arm. As
a reminder, physicians were allowed to conduct a radiographic scan at any time
he/she believed the patient may be experiencing disease progression (i.e.,
potential tumor progression). In our opinion, the consistency of the data
showing a benefit with Pmab plus BSC under a variety of sensitivity analyses
highlights the robust efficacy of this compound. In addition, the companies
indicated that response to Pmab was not differentiated by level of EGFR
expression. We note that the product label for Erbitux indicates that patients
need to be assessed for EGFR expression levels prior to receiving treatment as
the study for Erbitux had shown a differential response based on levels of EGFR
expression.
The secondary endpoint in study 408 of objective response rate was also met.
While the specific response rate data as well as the median PFS were not
disclosed, Amgen and Abgenix indicated that the response rate observed was
consistent with results from prior studies including: (1) the two ongoing U.S.
studies, one in third-line colorectal cancer (study 167) and another in
patients with low or negative EGFR expression as a third-line treatment for CRC
(study 250) where the response rate was approximately 10%; and (2) the previous
Phase II monotherapy study of Pmab where the response rate was approximately
9%. In addition, another secondary endpoint in study 408 of overall survival
will be evaluated at the 12-month time point. The overall survival data are
expected to become available in the second quarter of 2006. The companies
indicated that the median follow-up to date is approximately 20 weeks. Despite
the fact that the review of the overall survival data is ongoing, the companies
indicated the undisclosed median progression free survival (PFS) data is likely
to remain unchanged as there have been 401 progression events already among the
463 patients enrolled. We believe the detailed data, including primary and
secondary endpoints as well as detailed safety data, will be presented at the
2006 American Society of Clinical Oncology (ASCO) meeting next June.
We had expected there was a high likelihood of positive top-line results from
this Phase III Pmab study given data from prior clinical studies and from
clinical studies of Bristol-Myers Squibb/ImClone's Erbitux in similar settings.
As a reminder, at this year's ASCO meeting, Amgen and Abgenix released data
from a Phase II study indicating an overall response rate of 9%, a median
progression-free survival time of 13.6 weeks, and a median overall survival
time of 37.6 weeks (median follow up of 30.9 weeks) when Pmab was administered
as a single agent therapy in patients with positive EGFR tumor expression who
failed standard chemotherapy (i.e., a fluoropyrimidine +/- leucovorin and
either irinotecan or oxaliplatin or both). A summary of these results are
provided below:
Phase II Panitumumab Monotherapy Study - Objective Response Data
Cohort A (n=105) Cohort B (n=44) Total (n=148)
Overall response 7 patients (7%) 6 patients (14%) 13 patients (9%)
- Partial response 7 patients (7%) 6 patients (14%) 13 patients (9%)
- Complete response 0 patients (0%) 0 patients (14%) 0 patients (0%)
Stable disease 36 patients (34%) 7 patients (6%) 43 patients (29%)
Progressive disease 35 patients (33%) 24 patients (56%) 59 patients (40%)
Cohort A: 2+ or 3+ EGFr overexpression by IHC in =10% of tumors
Cohort B: 2+ or 3+ EGFr overexpression by IHC in <10% of tumors, but 1+ or 2+
or 3+ in =10% of tumor cells
Source: 2004 ASCO Meeting, Presentation, Hecht et al. and Nov. 2005
Chemotherapy Foundation Meeting
Phase II Panitumumab Monotherapy Study -- Survival Data
Kaplan-Meier data, in Cohort A (n=100) Cohort B (n=41) Total (n=141)
weeks
Median PFS, 95% CI 16.0 (9.6, 16.4) 8.3 (8.0, 16.3) 13.6 (8.3, 16.1)
Median Overall 39.9 (23.3, 44.7) 37.5 (24.1, 47.7) 37.6 (25.6, 42.4)
Survival, 95% CI
Cohort A: 2+ or 3+ EGFr overexpression by IHC in =10% of tumors
Cohort B: 2+ or 3+ EGFr overexpression by IHC in <10% of tumors, but 1+ or 2+
or 3+ in =10% of tumor cells
Source: 2004 ASCO Meeting, Presentation, Hecht et al. and Nov. 2005
Chemotherapy Foundation Meeting
Pivotal Phase III Study Design (Study 408): The randomized, controlled trial
enrolled 463 patients in Europe, Australia, and Canada who had failed more than
two chemotherapy regimens, including fluorouracil (5-FU), irinotecan, AND
oxaliplatin. Some patients had also received prior treatment of Avastin but
not within three months of being enrolled in this study. The study was
designed to evaluate the effectiveness of best supportive care plus panitumumab
(n=231) as a stand-alone therapy administered every other week versus best
supportive care in patients (n=232) with spreading colorectal cancer who have
failed standard chemotherapy. Patients were randomized to receive 6 mg/kg IV
every other week of panitumumab with no pre-medication necessary. The first
scan was scheduled at 8 weeks and then at every 4-week interval for the next
two scans, and then every 8 weeks thereafter. After 48 weeks, scans are
scheduled for every three months. Physicians could also elect to scan patients
if physicians felt a patient was showing signs of disease progression. The
local physician reviewed each of the scans, but the final data analysis was
conducted by an independent central review committee. The results from this
independent committee were disclosed today and are expected to be presented at
ASCO next year. As noted, the study was powered to show a 33% decrease in
tumor progression rate. Secondary endpoints included response rate, overall
survival, and safety.
Safety Data. In terms of safety, the companies indicated that panitumumab was
well tolerated. The most common side effect was acneiform rash, a known
reaction of this class of compounds. Other less commonly observed side effects
were fatigue, nausea, and mild diarrhea. In addition, the companies indicated
that commonly observed side effects with this class of EGFR inhibitors,
including conjunctivitis (approximately 17% incidence rate), folliculitis, nail
infections, and others, were seen in this study, although none of these
occurred with high frequency at severe levels (i.e., Grade 3 or 4). As a
reminder, data released yesterday from a Phase II 24-patient study of
panitumumab in combination with chemotherapy in first-line colorectal cancer at
the Paris ECCO (European Cancer Conference) meeting indicated that
conjunctivitis occurred at a rate of 17% (none at Grade 3 or 4), which raised
investor concerns. We note that the Erbitux BOND study showed a similar rate
of conjunctivitis (14%, any grade) in patients treated with Erbitux and
irinotecan, and as indicated, we believe this is a relatively common yet mild
side effect observed with this class of compounds.
The dropout rate in this study was relatively low. Overall, only 13 patients
(6%) in the panitumumab plus best supportive care arm discontinued therapy due
to adverse events, which was two times higher than the best supportive care arm
alone. Importantly, Amgen and Abgenix also emphasized that there were only
rare, if any, severe infusion reactions and symptoms associated with this were
rare. As a result, administration of panitumumab did not require pre-
medication. This is in direct contrast to competitor ImClone/Bristol-Myers
Squibb's Erbitux, which has a black box warning on its label related to the
potential for severe infusion and hypersensitivity reactions. Given the
potential for severe infusion reactions, particularly in the first infusion,
pre-medication with administration of Erbitux is typically required.
Regulatory Strategy. Based on these results and fast-track designation for
panitumumab, Amgen plans to initiate a rolling regulatory submission later this
year, which is expected to be complete by Q1 2006. The companies plan to
request a priority review (i.e., 6-month) given the strength of the data and
the need for improved treatments for this advanced disease. Whether the BLA is
also considered for accelerated approval, which would require further studies
to assess the impact on survival in the future, is likely to be dependent on
the outcome of the overall survival data analysis from this Phase III study.
Revising Our Abgenix Financial Model. Given these positive Phase III
panitumumab results, we have revised our panitumumab U.S. sales estimates in
our financial model. As a reminder, Abgenix has a 50/50 profit-sharing
arrangement with Amgen on panitumumab. We have revised our U.S. Pmab sales
estimates to $225 million from $188 million for fiscal 2007, to $334 million
from $295 million for fiscal 2008, and to $592 million from $510 million for
fiscal 2009. Thus, we have adjusted Abgenix's profit share of the panitumumab
revenues to $70 million from $58 million for fiscal 2007, to $111 million from
$100 million for fiscal 2008 and to $195 million from $170 million for fiscal
2009. Consequently, our EPS estimates are adjusted to ($0.43) from ($0.55) for
fiscal 2007, $0.00 from ($0.12) for fiscal 2008 and $1.15 from $0.89 for fiscal
2009.
Our Abgenix financial model continues to suggest the company will achieve
profitability in fiscal 2009 with our revised EPS estimate of $1.15 (previously
$0.89) per share. We have lowered our discount rate to 25%-30% (previously
30%-35%), as we believe Panitumumab is a potential approvable product with less
regulatory risk now given the positive Phase III top-line results released
today. Our target price is revised to $17 per share from $13 per share based
on applying a P/E multiple of 30-35x and a discount rate of 25%-30% to our 2009
earnings of $1.15. We believe this multiple is appropriate when one examines
historically what investors have been willing to apply on biotechnology
companies with a lead compound in advanced stages of development and
significant growth prospects. Such companies typically trade at a multiple in
the range of 23x-39x, by our estimates, with a mean of approximately low 30s.
Given the positive pivotal data from Abgenix's lead product candidate (i.e.,
panitumumab), we believe that Abgenix should trade at a multiple near the high-
end of this comparable range. We note that Abgenix is partnered with a major
biotechnology company, Amgen, for this program.
Impact to Amgen Financial Model. We have yet to include any panitumumab-
related revenue (from colorectal cancer or other indications) in our Amgen
model, but we estimate these revenues will have a minimal impact on our fiscal
2006 EPS estimate of $3.66 for Amgen. For fiscal 2007, we estimate the
potential impact will still be modest of approximately $0.03-$0.05 to our EPS
estimate of $4.22 for Amgen.
ANALYSIS OF COMPETITIVE LANDSCAPE -- PANITUMUMAB VS. ERBITUX
We expect many investors may try to draw comparisons between these results and
those for Bristol-Myers Squibb/ImClone's Erbitux. However, there are distinct
differences between the studies for Panitumumab and Erbitux in terms of patient
population and endpoints. As a reminder, Erbitux is approved for use once
weekly in combination with irinotecan or as a monotherapy based on data from
three trials conducted in patients with EGFR-expressing, metastatic colorectal
cancer. Patients included in the Erbitux studies had progressive disease after
receiving an irinotecan-containing regimen. As noted previously, patients in
the Phase III panitumumab study had failed more than two chemotherapy regimens
including fluorouracil, irinotecan, and oxaliplatin. Therefore, patients
enrolled in the panitumumab study represented more heavily pre-treated
patients. Specifically, all patients (n=463) enrolled in the panitumumab study
had failed more than two standard chemotherapy regimens as compared to only
about 44% (44/111) of patients in the Erbitux BOND study (see Table 1 below).
We believe the endpoint of objective response rates (ORR) may serve as the most
suitable measure for comparison given the limited data released at this time.
We provide data from the largest randomized, controlled study for Erbitux
called the BOND study in Table 1. In this study, 329 patients were randomized
to receive either Erbitux plus irinotecan (218 patients) or Erbitux monotherapy
(111 patients). Of the 329 patients, approximately two-thirds of the patients
had previously failed oxaliplatin treatment, 58% had colon cancer, and 40% had
renal cancer. The Erbitux dosing regimen for both arms of the trial was as
follows: 400 mg/mm for the initial dose; 250 mg/mm weekly until either disease
progression or some toxicity was reached. The most directly comparable results
to Panitumumab monotherapy studies are highlighted.
Table 1: Erbitux BOND study - Objective Response Rate (ORR) Per Independent
Review
Source: Erbitux label.
The BOND study for Erbitux also measured time to progression (TTP) as a
secondary endpoint, which may be considered the closest measurement to the
primary endpoint of progression-free survival (PFS) in the Phase III
panitumumab study. This may be especially relevant since Erbitux's TTP
definition included the event of death, which is also a necessary criterion for
PFS. Specifically, in the Erbitux BOND study, TTP was defined as the period
from the date of randomization to the first observation of disease progression
or to death from any cause within 60 days after randomization or the most
recent tumor assessment (Source: New England Journal of Medicine article on the
Erbitux BOND study published on July 22, 2004). Depending on the study design,
TTP as an endpoint can includes any disease progression or death whereas PFS
always includes death. While the definition for TTP in the Erbitux BOND study
includes death as an event, we note that both these endpoints are relatively
subjective and may be dependent on when MRI scans are conducted to monitor
disease progression. Tumor response for the Erbitux BOND study was evaluated
every 6 weeks for the first 24 weeks and then every 3 months thereafter. The
frequency of scans in the pivotal Phase III Panitumumab study was an initial
scan at 8 weeks followed by a scan every 4 weeks following a cycle of
treatment. Although, according to Abgenix, there were provisions in the Phase
III study to allow the physician to conduct a scan if progression was suspected
based on a clinical assessment. With this as a cautionary background, the most
directly comparable results from the Erbitux BOND study to the Panitumumab
monotherapy study are highlighted in Table 2 below.
Table 2: Time to Progression Per Independent Review
Source: Erbitux label.
We believe it is important to note in the discussion of endpoints that Erbitux
was approved under accelerated approval, and still has an unfulfilled
postmarketing commitment to the FDA to demonstrate a survival benefit. To meet
its obligation to the FDA, Bristol-Myers Squibb/ImClone are performing a Phase
III survival trial (BMS-006) in the second-line setting. This study, which is
being conducted with Merck KgaA, opened for patient enrollment in May 2003.
According to ImClone, the BMS-006 trial tests the addition of Erbitux to
irinotecan in patients who have failed oxaliplatin, 5-fluorouracil, and
leucovorin in the first line of therapy. A second study, BMS-014, was
discontinued and removed from the list of post-approval commitments with the
FDA's approval because of decreased feasibility. Data from the BMS-006 study
is expected by late 2006. We note that the FDA's Oncologic Drugs Advisory
Committee is planning to review unfulfilled commitments for Erbitux and other
oncology products at an upcoming meeting.
Panitumumab's Differential Safety and Dosing Benefit. As mentioned previously,
we believe the objective response clinical data suggests Panitumumab is at
least equivalent in efficacy to ImClone/Bristol-Myers Squibb's Erbitux. Thus,
we believe panitumumab has the opportunity to become the EGFR monoclonal
antibody of choice based on its better safety profile (lower infusion
reactions, no pre-medication) and greater flexibility (every 2 weeks) vs.
Erbitux (every week, pre-medication required). Specifically, Panitumumab has
shown lower infusion reactions with no need for pre-medication (better safety
profile) and greater administration flexibility (every two weeks). Further, we
note that data from a Phase I study presented at the 2005 ASCO meeting reveal
that Panitumumab has anti-tumor activity in a range of flexible dosing
regimens, including every week, every other week, and every three weeks.
We note Erbitux's label was updated on September 1, 2005 to primarily reflect
the recommendation for a one-hour observation period following Erbitux
infusions. The updated label indicates that longer observation periods may be
necessary for those who experience infusion reactions. This information was
distributed by a subsequent Dear Healthcare Provider letter. We remind
investors that since the product's launch, Erbitux's label has included a black
box warning related to infusion reactions, which occur in approximately 3% of
patients and are characterized by rapid onset of airway obstruction, urticaria,
and hypotension.
Planning for Panitumumab Expansion. While today's top-line results in advanced
colorectal cancer are significant, we believe Amgen and Abgenix are aiming to
carve out larger market opportunities for Panitumumab by moving it into the
earlier setting in colorectal cancer in combination with other targeted
therapies and traditional chemotherapeutic regimens. To support this goal, the
companies announced earlier this year the initiation of the PACCE study
(Panitumumab Advanced Colorectal Cancer Evaluation). As a reminder, this
trial is a randomized, multi-center, open-label study that is targeted to
enroll approximately 1,000 patients to evaluate the potential benefits of
adding Panitumumab administered every other week to Avastin and either
oxaliplatin or irinotecan-based chemotherapy for the first-line treatment of
metastatic colorectal cancer. The primary endpoint for this study is
progression free survival and secondary endpoints include response rate,
overall survival, and safety. We expect this interim analysis will be
available for an internal review in Q4 2005 with the data expected to be
presented in 2006 at an appropriate medical meeting. Since this study just
began enrolling at the end of April 2005, the interim analysis release may
reflect a surrogate endpoint, such as response rate. We note that the pivotal
study for Avastin plus standard chemotherapy in the first line metastatic
setting, the median overall survival for patients was nearly 11 months. On
today's call, Amgen's Senior Vice President of R&D, Roger Perlmutter, MD, PhD,
conveyed his belief that panitumumab is best used in an earlier CRC setting
rather than in the salvage setting as was investigated in study 408. We note
that success in this setting would greatly expand the opportunity for
panitumumab.
VALUATION AND RISKS -- COMPANIES DISCUSSED
Amgen Inc. (AMGN--$77.51; 1M)
Valuation
Our target price is $100. We believe Amgen should trade on par with the large-
cap biotech companies given the robust earnings growth and advancing pipeline.
The large-cap biotech companies currently trade at a group average PEG (P/E to
growth) ratio of approximately 1.4x (range: 1.2-x1.9x) and an average P/E in
the high-20s (range: 19x-53x). Our target price of $100 per share is derived
by applying an approximate PEG ratio of 1.4x and P/E multiple in the high-20s
to our 2006 EPS estimate of $3.66.
We have also applied a second valuation approach utilizing an analysis of
residual earnings. In other words, the value of the equity is assessed by
adding the present value of the residual earnings plus the book value of the
company. Residual earnings is defined as the earnings stream remaining after
accounting for the required return on investment, and is determined by
subtracting the multiple of the required return on investment times the book
value from projected earnings per year. Using this analysis for Amgen, we
calculated a book value per share of $14.92 and assumed a time horizon of three
years. Our estimate for the discount rate is 9.0%, which assumes a beta of
1.00 for AMGN, a market risk premium of 5.0% and a risk free rate of 4.0%. In
addition, we assumed a constant growth rate of 7.5% for the biotech industry.
Using this approach, we also derive a target price of approximately $100-$105
per share, based on earnings estimates.
Risks
We rate Amgen Medium Risk due to the moderate predictability of the company's
financial results, strong cash flow, low debt-to-earnings ratio (15%), and
moderate stock price volatility compared to other large-cap biotechnology
companies. Key risks we see to Amgen achieving our valuation target include
the following: any delay in clinical development or regulatory approval of
developing products could have a material impact on the company's earnings.
From time to time, the Centers for Medicare/Medicaid Services (CMS) proposes
changes in the reimbursement for drugs, such as Epogen, Aranesp, Neupogen and
Neulasta, and other products which could limit the pricing and use of these
drugs. Additionally, if sales for key products such as Aranesp, Neulasta,
Epogen, Neupogen or Enbrel fail to grow, shares would likely be impacted.
If the impact on the company from any of these factors proves to be greater
than we anticipate, the stock will likely have difficulty achieving our target
price.
Abgenix, Inc. (ABGX--$12.90; 2S)
Valuation
In order to value the company, we have utilized a discounted earnings analysis
and applied a discount rate and P/E multiple, both of which we believe are
appropriate for a high-growth biotechnology company with a Phase III program,
to a projected EPS estimate for the company. Our financial model suggests the
company will achieve profitability in fiscal 2009 with our revised EPS estimate
of $1.15 (previously $0.89) per share. We have lowered our discount rate to
25%-30% (previously 30%-35%), as we believe Panitumumab is a potential
approvable product with less regulatory risk now given the positive Phase III
top-line results released today. Our target price is revised to $17 per share
from $13 per share based on applying a P/E multiple of 30-35x and a discount
rate of 25%-30% to our 2009 earnings of $1.15. We believe this multiple is
appropriate when one examines historically what investors have been willing to
apply on biotechnology companies with a lead compound in advanced stages of
development with significant growth prospects. Such companies typically trade
at a multiple in the range of 23x-39x, by our estimates, with a mean of
approximately low 30s. Given the positive pivotal data from Abgenix's lead
product candidate (i.e., panitumumab), we believe that Abgenix should trade at
a multiple near the high-end of this comparable range. We note that Abgenix is
partnered with a major biotechnology company, Amgen, for this program.
We have also assessed Abgenix's valuation using a discounted cash flow (DCF)
analysis. Our DCF analysis assumes a time horizon of 10 years, with 2015
serving as our year for assessing a terminal value. Our estimate for a cost of
equity is revised to approximately 9% from 10%. Our cost of equity assumes a
beta of 1.15 (previously 1.10), a market risk premium of 3.8% (previously
5.0%), and a risk free rate of approximately 4.21% (previously 4.50%). We have
also applied a terminal growth rate of 6.0%. Using this approach, we arrive at
a target price of approximately $17 per share.
Risks
We believe a Speculative Risk rating is warranted for Abgenix given the
company's dependence on panitumumab (ABX-EGF) and the high volatility of its
shares. We outline the Risks we see to Abgenix achieving our valuation target
below.
Like all biotechnology companies developing proprietary products, Abgenix is
subject to clinical development setbacks, which could delay or hamper
profitability. Currently there is an acute shortage of manufacturing capacity
in the monoclonal antibody area and many companies, including Abgenix, are
building new commercial-scale facilities to address this issue. Furthermore,
any patent issues in the EGFr antagonist field will likely have a negative
effect on the shares of Abgenix. Abgenix is also highly dependent on its
corporate partners, Amgen and AstraZeneca for funding and commercialization
support. Any termination of these relationships would be materially
detrimental to Abgenix.
We also note, however, that if Abgenix's lead product, panitumumab,
demonstrates positive results in other studies that this could represent an
opportunity for the stock's price appreciation.
Investment Thesis
We rate the shares of Abgenix (ABGX) Hold/Speculative risk (2S) with a target
price of $17 per share (previously $13). Continued progress of the company's
late-stage clinical pipeline remains a key focus. In this regard, positive
news on the development of panitumumab (ABX-EGF), a fully human monoclonal
antibody targeted to the EGF receptor for cancer, will be critical for
significant appreciation of the stock. The company in conjunction with
partner, Amgen, is conducting a number of clinical studies of panitumumab in
three cancer indications: colorectal cancer, renal cell carcinoma, and non-
small cell lung cancer. The pivotal Phase III program for panitumumab is
focused on the development of panitumumab as a monotherapy in refractory
colorectal cancer patients. The company and its partner, Amgen, continue to
expect to initiate a BLA filing by year-end and complete this filing by Q1
2006. We continue to believe the market for EGFR inhibitors in cancer is
sizable enough to support multiple players.
ANALYST CERTIFICATION APPENDIX A-1
I, Elise Wang, research analyst ... |
