Amgen Showcases Oncology Pipeline At ASCO 2020
THOUSAND OAKS, Calif., May 13, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from its oncology pipeline and marketed portfolio will be presented during the ASCO20 Virtual Scientific Program taking place May 29 - 31, 2020.
Notable data from the oncology pipeline include updated first-in-human studies evaluating sotorasib (AMG 510), a first-in-class investigational KRAS(G12C )inhibitor, in patients with advanced colorectal cancer (CRC) and other solid tumors. Updated results from a Phase 1 dose escalation study of AMG 330, a BiTE(®) (bispecific T cell engager) molecule, in acute myeloid leukemia will be featured in an oral presentation.
"The development of Amgen's innovative medicines is rooted in our deep understanding of human and cancer genomes, which drives the advancement of next generation cancer treatments," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "At ASCO, the data we are sharing reinforce our commitment to advancing first-in-class therapies that can alter the course of cancer care for patients who need it most."
Amgen's abstracts are available on the ASCO website and include:
Clinical Data Abstracts (pipeline)
-- CodeBreak 100: Activity of AMG 510, a Novel Small Molecule Inhibitor of
KRAS(G12C), in Patients With Advanced Colorectal Cancer Abstract #4018,
Poster Discussion
-- CodeBreak 100: Phase 1 Study of AMG 510, a Novel Small Molecule
KRAS(G12C) Inhibitor in Patients (pts) With Advanced Solid Tumors Other
Than Non-Small Lung Cancer (NSCLC) or Colorectal Cancer (CRC) Abstract
#3511, Poster Discussion
-- Updated Results From Phase 1 Dose Escalation Study of AMG 330, a
Bispecific T Cell Engager Molecule, in Patients With Relapsed/Refractory
Acute Myeloid Leukemia (R/R AML) Abstract #7508, Oral Presentation
-- Characterization of Clinical Pharmacokinetics and Exposure-Response
Relationships of AMG 330, a Bispecific CD33 T Cell Engager Antibody
Construct, in Patients With Relapsed/Refractory AML Abstract #7536,
Poster
-- Efficacy and Safety of ABP 798 Compared with Rituximab: Results From the
Comparative Clinical Study in Patients with Non-Hodgkin's Abstract
#8044, Poster
KYPROLIS(® )Clinical Data Abstract
-- Efficacy and Safety of Carfilzomib, Dexamethasone, Daratumumab (KdD)
Twice-Weekly at 56 mg/m2 and Once-Weekly at 70 mg/m2 in Relapsed or
Refractory Multiple Myeloma (RRMM): Cross-Study Comparison of CANDOR and
MMY1001 Abstract #8526, Poster
IMLYGIC(®) Clinical Data Abstracts
-- Early Safety From a Phase I, Multicenter, Open-Label Clinical Trial of
Talimogene Laherparepvec (T-VEC) Injected (inj) Into Liver Tumors In
Combination With Pembrolizumab (Pem) Abstract #3015, Poster Discussion
-- Association Between Complete Response and Survival in Advanced Melanoma
Treated with Talimogene Laherparepvec (T-VEC) Plus Ipilimumab (ipi)
Abstract #10029, Poster
Amgen Webcast Investor Meeting
Amgen will host a webcast call for the investment community in conjunction with the ASCO20 Virtual Scientific Program on Friday, May 29, at 1:00 p.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate to discuss Amgen's oncology program, including data being presented on the Company's KRAS(G12C) inhibitor sotorasib.
Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.
About KRAS
The subject of almost four decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.(1,2) Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.(2 )A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.(3) KRAS(G12C) has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRAS(G12C) inhibition across a broad variety of tumor types.
About BiTE(®) Technology
BiTE(®) (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.
About KYPROLIS(®) (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.(4) KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.(5) In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.(4,5)
Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:
-- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or refractory
multiple myeloma who have received one to three lines of therapy
-- As a single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have received one or more lines of
therapy
KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.
Important U.S. KYPROLIS(®) (carfilzomib) Safety Information
Cardiac Toxicities
-- New onset or worsening of pre-existing cardiac failure (e.g., congestive
heart failure, pulmonary edema, decreased ejection fraction),
restrictive cardiomyopathy, myocardial ischemia, and myocardial
infarction including fatalities have occurred following administration
of KYPROLIS. Some events occurred in patients with normal baseline
ventricular function. Death due to cardiac arrest has occurred within
one day of administration.
-- Monitor patients for signs or symptoms of cardiac failure or ischemia.
Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS
for Grade 3 or 4 cardiac adverse events until recovery, and consider
whether to restart at 1 dose level reduction based on a benefit/risk
assessment.
-- While adequate hydration is required prior to each dose in Cycle 1,
monitor all patients for evidence of volume overload, especially
patients at risk for cardiac failure. Adjust total fluid intake as
clinically appropriate.
-- For patients >= 75 years, the risk of cardiac failure is increased.
Patients with New York Heart Association Class III and IV heart failure,
recent myocardial infarction, conduction abnormalities, angina, or
arrhythmias may be at greater risk for cardiac complications and should
have a comprehensive medical assessment prior to starting treatment with
KYPROLIS and remain under close follow-up with fluid management.
Acute Renal Failure
-- Cases of acute renal failure, including some fatal renal failure events,
and renal insufficiency adverse events (including renal failure) have
occurred. Acute renal failure was reported more frequently in patients
with advanced relapsed and refractory multiple myeloma who received
KYPROLIS monotherapy. Monitor renal function with regular measurement of
the serum creatinine and/or estimated creatinine clearance. Reduce or
withhold dose as appropriate.
Tumor Lysis Syndrome
-- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have
occurred. Patients with a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each dose
in Cycle 1, and in subsequent cycles as needed. Consider uric acid
lowering drugs in patients at risk for TLS. Monitor for evidence of TLS
during treatment and manage promptly, and withhold until resolved.
Pulmonary Toxicity
-- Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure,
and acute diffuse infiltrative pulmonary disease such as pneumonitis and
interstitial lung disease have occurred. Some events have been fatal. In
the event of drug?induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
-- Pulmonary arterial hypertension (PAH) was reported. Evaluate with
cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for
PAH until resolved or returned to baseline and consider whether to
restart based on a benefit/risk assessment.
Dyspnea
-- Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea
to exclude cardiopulmonary conditions including cardiac failure and
pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until
resolved or returned to baseline. Consider whether to restart based on a
benefit/risk assessment.
Hypertension
-- Hypertension, including hypertensive crisis and hypertensive emergency,
has been observed, some fatal. Control hypertension prior to starting
KYPROLIS. Monitor blood pressure regularly in all patients. If
hypertension cannot be adequately controlled, withhold KYPROLIS and
evaluate. Consider whether to restart based on a benefit/risk
assessment.
Venous Thrombosis
-- Venous thromboembolic events (including deep venous thrombosis and
pulmonary embolism) have been observed. Thromboprophylaxis is
recommended for patients being treated with the combination of KYPROLIS
with dexamethasone or with lenalidomide plus dexamethasone. The
thromboprophylaxis regimen should be based on an assessment of the
patient's underlying risks.
-- Patients using hormonal contraception associated with a risk of
thrombosis should consider an alternative method of effective
contraception during treatment.
Infusion Reactions
-- Infusion reactions, including life?threatening reactions, have occurred.
Signs and symptoms include fever, chills, arthralgia, myalgia, facial
flushing, facial edema, laryngeal edema, vomiting, weakness, shortness
of breath, hypotension, syncope, chest tightness, or angina. These
reactions can occur immediately following or up to 24 hours after
administration. Pre-medicate with dexamethasone to reduce the incidence
and severity of infusion reactions. Inform patients of the risk and of
symptoms and seek immediate medical attention if they occur.
Hemorrhage
-- Fatal or serious cases of hemorrhage have been reported. Hemorrhagic
events have included gastrointestinal, pulmonary, and intracranial
hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood
loss. Reduce or withhold dose as appropriate.
Thrombocytopenia
-- KYPROLIS causes thrombocytopenia with recovery to baseline platelet
count usually by the start of the next cycle. Monitor platelet counts
frequently during treatment. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
-- Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS
can cause increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as appropriate.
Thrombotic Microangiopathy
-- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including
fatal outcome have occurred. Monitor for signs and symptoms of TTP/HUS.
Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS
is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
-- Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is
suspected, discontinue and evaluate with appropriate imaging. The safety
of reinitiating KYPROLIS is not known.
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
-- In a clinical trial of transplant-ineligible patients with newly
diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone
(KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence
of serious and fatal adverse events was observed in patients in the KMP
arm. KMP is not indicated for transplant-ineligible patients with newly
diagnosed multiple myeloma.
Embryo-fetal Toxicity
-- KYPROLIS can cause fetal harm when administered to a pregnant woman.
-- Females of reproductive potential should be advised to avoid becoming
pregnant while being treated with KYPROLIS and for 6 months following
the final dose. Males of reproductive potential should be advised to
avoid fathering a child while being treated with KYPROLIS and for 3
months following the final dose. If this drug is used during pregnancy,
or if pregnancy occurs while taking this drug, the patient should be
apprised of the potential hazard to the fetus.
ADVERSE REACTIONS
-- The most common adverse reactions in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
-- The most common adverse reactions in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache,
cough, edema peripheral.
Please see full Prescribing Information at www.kyprolis.com.
About IMLYGIC(®) (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.
IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.
The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.
INDICATION & LIMITATIONS OF USE
IMLYGIC(®) (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations of use: IMLYGIC(®) has not been shown to improve overall survival or have an effect on visceral metastases.
IMPORTANT SAFETY INFORMATION
Contraindications
-- Do not administer IMLYGIC(®) to immunocompromised patients, including
those with a history of primary or acquired immunodeficient states,
leukemia, lymphoma, AIDS or other clinical manifestations of infection
with human immunodeficiency viruses, and those on immunosuppressive
therapy, due to the risk of life-threatening disseminated herpetic
infection.
-- Do not administer IMLYGIC(®) to pregnant patients.
Warnings and Precautions
-- Accidental exposure to IMLYGIC(®) may lead to transmission of
IMLYGIC(®) and herpetic infection, including during preparation and
administration. Health care providers, close contacts, pregnant women,
and newborns should avoid direct contact with injected lesions,
dressings, or body fluids of treated patients. The affected area in
exposed individuals should be cleaned thoroughly with soap and water
and/or a disinfectant.
-- Caregivers should wear protective gloves when assisting patients in
applying or changing occlusive dressings and observe safety precautions
for disposal of used dressings, gloves, and cleaning materials. Exposed
individuals should clean the affected area thoroughly with soap and
water and/or a disinfectant.
-- To prevent possible inadvertent transfer of IMLYGIC(®) to other areas
of the body, patients should be advised to avoid touching or scratching
injection sites or occlusive dressings.
-- Herpetic infections: Herpetic infections (including cold sores and
herpetic keratitis) have been reported in IMLYGIC(®)-treated patients.
Disseminated herpetic infection may also occur in immunocompromised
patients. Patients who develop suspicious herpes-like lesions should
follow standard hygienic practices to prevent viral transmission.
-- Patients or close contacts with suspected signs or symptoms of a
herpetic infection should contact their health care provider to evaluate
the lesions. Suspected herpetic lesions should be reported to Amgen at
1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the
option of follow-up testing for further characterization of the
infection.
-- IMLYGIC(®) is sensitive to acyclovir. Acyclovir or other antiviral
agents may interfere with the effectiveness of IMLYGIC(®). Consider the
risks and benefits of IMLYGIC(®) treatment before administering
antiviral agents to manage herpetic infection.
-- Injection Site Complications: Necrosis or ulceration of tumor tissue may
occur during IMLYGIC(®) treatment. Cellulitis and systemic bacterial
infection have been reported in clinical studies. Careful wound care and
infection precautions are recommended, particularly if tissue necrosis
results in open wounds.
-- Impaired healing at the injection site has been reported. IMLYGIC(®)
may increase the risk of impaired healing in patients with underlying
risk factors (e.g., previous radiation at the injection site or lesions
in poorly vascularized areas). If there is persistent infection or
delayed healing of the injection site, consider the risks and benefits
of continuing treatment.
-- Immune-Mediated events including glomerulonephritis, vasculitis,
pneumonitis, worsening psoriasis, and vitiligo have been reported in
patients treated with IMLYGIC(®). Consider the risks and benefits of
IMLYGIC(®) before initiating treatment in patients who have underlying
autoimmune disease or before continuing treatment in patients who
develop immune-mediated events.
-- Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the
injection site has been reported in a patient with smoldering multiple
myeloma after IMLYGIC(®) administration in a clinical study. Consider
the risks and benefits of IMLYGIC(®) in patients with multiple myeloma
or in whom plasmacytoma develops during treatment.
-- Obstructive Airway Disorder: Obstructive airway disorder has been
reported following IMLYGIC(®) treatment. Use caution when injecting
lesions close to major airways.
Adverse Reactions
-- The most commonly reported adverse drug reactions (>= 25%) in
IMLYGIC(®)-treated patients were fatigue, chills, pyrexia, nausea,
influenza-like illness, and injection site pain. Pyrexia, chills, and
influenza-like illness can occur at any time during IMLYGIC(®)
treatment, but were more frequent during the first 3 months of
treatment.
-- The most common Grade 3 or higher adverse reaction was cellulitis.
Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.
About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life - not just their cancer journey - so they can take control of their lives.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.
For more information about Amgen Biosimilars, follow us on www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including Adaptive Biotechnologies (including statements regarding such collaboration's ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), BeiGene, Ltd., or the Otezla(®) (apremilast) acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)
References:
1. Cox A, et al. Drugging the undruggable RAS: Mission possible? Nat Rev
Drug Discov. 2014 Nov;13(11):828-51.
2. Fernandez-Medarde A, Santos E. Ras in cancer and developmental diseases.
Genes Cancer. 2011 Mar;2(3):344-58.
3. Lipford, JR. Pre-clinical development of AMG 510: the first inhibitor of
KRASG12C in clinical testing. Oral presentation at AACR 2019, Atlanta,
GA. March 29-April 3, 2019.
4. Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple
myeloma: 10 years later. Blood. 2012 Aug 2;120(5):947-59.
5. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2013 Feb 7;121(6):893-7.
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