U. S. marijuana law enforcement may not be "proper," according to a statement written by Supreme Court Justice Clarence Thomas. The legal opinion made public Monday (June 28) was in response to a case the court was asked to consider. That case, which involved a Colorado marijuana business attempting to challenge the tax burden created by federal prohibition and 280E, is a "prime example" of the "mixed signals" coming from the federal government regarding cannabis, according to the Supreme Court justice. Read More >>
INVESTOR ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: Class Action Lawsuits filed on behalf of BMY, LSPD, PTON, ZG Investors, Lead Plaintiff Deadlines Set
Kahn Swick & Foti, LLC ("KSF") and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors of pending deadlines in the following securities class action lawsuits:
Bristol-Myers Squibb Company (BMY)
Class: Investors who received Contingent Value Rights ("CVRs") (BMY.RT) in exchange for their shares of Celgene Corporation (CELG) pursuant to Bristol-Myers' acquisition of Celgene on November 20, 2019
Lead Plaintiff Motion Deadline: December 6, 2021
MISLEADING PROSPECTUS
To learn more, visit https://www.ksfcounsel.com/cases/nyse-bmy/
Lightspeed Commerce, Inc. (LSPD)
Class Period: 9/11/2020 - 9/28/2021
Lead Plaintiff Motion Deadline: January 18, 2022
SECURITIES FRAUD
To learn more, visit https://www.ksfcounsel.com/cases/nyse-lspd/
Peloton Interactive, Inc. (PTON)
Class Period: 12/9/2020 - 11/4/2021
Lead Plaintiff Motion Deadline: January 18, 2022
SECURITIES FRAUD
To learn more, visit https://www.ksfcounsel.com/cases/nasdaqgs-pton/
Zillow Group, Inc. (Z, ZG)
Class Period: 2/10/2021 - 11/2/2021
Lead Plaintiff Motion Deadline: January 18, 2022
SECURITIES FRAUD
To learn more, visit https://www.ksfcounsel.com/cases/nasdaqgs-z/
If you purchased shares of the above companies and would like to discuss your legal rights and your right to recover for your economic loss, you may, without obligation or cost to you, contact KSF Managing Partner, Lewis Kahn, toll-free at 1-877-515-1850, via email (Lewis.Kahn@KSFcounsel.com), or via the case links above.
If you wish to serve as a Lead Plaintiff in the class action, you must petition the Court on or before the Lead Plaintiff Motion deadline.
About
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation's premier boutique securities litigation law firms. KSF serves a variety of clients – including public institutional investors, hedge funds, money managers and retail investors – in seeking to recover investment losses due to corporate fraud and malfeasance by publicly traded companies. KSF has offices in New York, California, Louisiana and New Jersey.
To learn more about KSF, you may visit www.ksfcounsel.com .
Contact:
Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
lewis.kahn@ksfcounsel.com
1-877-515-1850
1100 Poydras St., Suite 3200
New Orleans, LA 70163
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CLAIMSFILER ALERTS BRISTOL MYERS Investors to Lead Plaintiff Deadline in Class Action Lawsuit Against Bristol-Myers Squibb Company - BMY
- ClaimsFiler, a FREE shareholder information service, reminds investors with losses in excess of $100,000 that they have until December 6, 2021 to file lead plaintiff applications in a securities class action lawsuit against Bristol-Myers Squibb Company ("BMS" or "the Company") (NYSE: BMY), if they received Contingent Value Rights ("CVRs") (NYSE: BMY.RT) in exchange for their shares of Celgene Corporation (NASDAQ: CELG) pursuant to BMS' acquisition of Celgene on November 20, 2019 . This action is pending in the United States District Court for the Southern District of New York .
Get Help
BMS investors should visit us at https://claimsfiler.com/cases/nyse-bmy-3/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
On January 3, 2019 , BMS and Celgene agreed to a merger under which Celgene shareholders would receive $50 in cash, one share of BMS common stock, and one CVR for each share of Celgene common stock. Each CVR would provide holders a contingent right to receive $9 in cash if certain milestones were reached, which consisted of FDA approval of three applications by certain deadline dates. On January 1, 2021 , BMS announced that one of the deadlines had not been met and terminated the CVRs.
The lawsuit charges BMS with failing to take diligent efforts to meet the milestones, as required by the CVR agreement, in order to avoid paying the CVR buyout. As a result, the statements in the Joint Proxy concerning the efforts BMS would make to meet the milestones, the likelihood that the milestones would be met and the purported value of the CVRs were materially false and misleading when made.
The case is SM Merger/Arbitrage, L.P., et al., v. Bristol-Myers Squibb Company, et al ., 21-cv-8255.
About ClaimsFiler
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com .
View original content: https://www.prnewswire.com/news-releases/claimsfiler-alerts-bristol-myers-investors-to-lead-plaintiff-deadline-in-class-action-lawsuit-against-bristol-myers-squibb-company---bmy-301435724.html
SOURCE ClaimsFiler
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New Research Analysis Shows VINIA Reduces Oxidation Of LDL-Cholesterol To Support Cardiovascular Improved Functioning
New research analysis affirms the addition of the following structure function claims for VINIA® according to FDA Guidelines for Dietary Supplements:
- VINIA® prevents Lipid Oxidation
- VINIA® protects the body by preventing oxidative damage to the cells
- VINIA® reduces oxidation of LDL cholesterol
BioHarvest Sciences Inc. (CSE: BHSC) ("BioHarvest" or the "Company") reports that recent research analysis provides additional support for anti-oxidation structurefunction claims of VINIA®. This analysis, when added to the clinical study [1] conducted by the Company, provides a clear substantiation to BioHarvest's claims relating to anti-oxidation, lipid anti-oxidation, and scavenging free radicals.
The Company studied five Randomized Controlled Trials (RCT) [2] that were conducted with grapes in the form of red wine and juice, and which reported decreased LDL-C oxidation as well as reduction in DNA oxidative damage and other oxidative outcomes. Meta-analysis [3] of four RCTs found that grape polyphenols reduced LDL-C oxidation both with respect to the control group and with respect to baseline. This meta-analysis provides additional support that VINIA® has the beneficial effect of decreasing lipid oxidation, given that VINIA® red grape powder boasts the full spectrum of the active red grape ingredients (all polyphenols, including Piceid-Resveratrol).
Dr. Yochi Hagay, the CTO, said, "Cholesterol damages the cardiovascular functioning when it gets oxidized. The unique composition of VINIA® (that includes a complex of polyphenols with Piceid resveratrol) reduces the oxidation of the lipids as well as improves blood flow. These combined actions provide for an improved cardiovascular functioning. I believe that further clinical trials and research will prove additional important benefits of VINIA®."
Ilan Sobel, the CEO, said "The unique functional capabilities of VINIA® are creating a significant demand for VINIA® across the USA, similar to the demand we have been experiencing in Israel. These additional structure function claims broaden the scope of benefits that VINIA® brings to the US consumers and will raise further awareness for the brand and no doubt continue to increase growth momentum."
To access USA and Israel sales information, the Company refers readers to the press release issued on October 5, 2021 available at www.bioharvest.com.
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
For further information, please contact:
Dave Ryan, VP Investor Relations & Director
Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
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Facebook
LinkedIn
YouTube
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. There is no assurance that the Israeli market results will translate directly into the U.S. markets which may depend on different consumer preferences and more substantial marketing expenditures and resources. There is no assurance that the broaden scope of benefits of VINIA® being brought to the US consumers or the unique functional capabilities of VINIA® will raise further awareness for the brand and continue to increase growth momentum. There is no assurance that strong sales metrics experienced to date in the USA or in Israel will result in future demand or increase for VINIA® sales. Markets for nutraceuticals are unpredictable and subject to changes in consumer tastes and trends as well as economic factors beyond our control. Delays and cost overruns may result in delays achieving our objectives obtaining market acceptance, and regulatory approvals for geographic expansion is subject to risk and cannot be guaranteed. Projected sales of Cannabis will require the Company to obtain production and/or export licensing which cannot be assured.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
REFERENCES
[1] Reference for BioHarvest's clinical trial
1. Nachum Vaisman and Eva Niv.Daily consumption of red grape cell powder in a dietary dose improves cardiovascular parameters: a double blind, placebo-controlled, randomized study", 2015. Int J Food Sci Nutr. 66(3):342-966(3):342-9.
5. Toaldo, I.M., F.A. Cruz, E.L. da Silva, and M.T. Bordignon-Luiz. 2016. Acute consumption of organic and conventional tropical grape juices (Vitis labrusca L.) increases antioxidants in plasma and erythrocytes, but not glucose and uric acid levels, in healthy individuals.
Nutr Res. 36:808-817
[2] References for the 5 RCTs
1. Gaiotti, and A. De Lorenzo. 2015. Changes in LDL Oxidative Status and Oxidative and Inflammatory Gene Expression after Red Wine Intake in Healthy People: A Randomized Trial. Mediators of inflammation. 2015:317348
2. Estruch, R., E. Sacanella, F. Mota, G. Chiva-Blanch, E. Antunez, E. Casals, R. Deulofeu, D.Rotilio, C. Andres-Lacueva, R.M. Lamuela-Raventos, G. de Gaetano, and A. UrbanoMarquez. 2011. Moderate consumption of red wine, but not gin, decreases erythrocyte superoxide dismutase activity: a randomised cross-over trial. Nutrition, metabolism, and cardiovascular diseases: NMCD. 21:46-53.
3. Guler, A., A. Candemir, O. Merken, F.B. Asiklar, Y. Dilli, and N. Yildiz. 2019. Determination of physical, biochemical and antioxidant properties and mineral composition of some new developed grape varieties and selected clones from Turkey. FRESENIUS ENVIRONMENTAL BULLETIN. 28:10146-10153.
4. Martins, N.C., G.P. Dorneles, A.S. Blembeel, J.P. Marinho, I.C.T. Proenca, M.J.V. da Cunha Goulart, G.B. Moller, E.P. Marques, D. Pochmann, M. Salvador, V. Elsner, A. Peres, C. Dani, and J.L. Ribeiro. 2020. Effects of grape juice consumption on oxidative stress and
inflammation in male volleyball players: A randomized, double-blind, placebo-controlled clinical trial. Complement Ther Med. 54:102570.
5. Toaldo, I.M., F.A. Cruz, E.L. da Silva, and M.T. Bordignon-Luiz. 2016. Acute consumption of organic and conventional tropical grape juices (Vitis labrusca L.) increases antioxidants in plasma and erythrocytes, but not glucose and uric acid levels, in healthy individuals.
Nutr Res. 36:808-817
[3] Reference for the meta-analysis
1. Lupoli, R., P. Ciciola, G. Costabile, R. Giacco, M. Minno, and B. Capaldo. 2020. Impact of Grape Products on Lipid Profile: A Meta-Analysis of Randomized Controlled Studies. J Clin Med. 9
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/103503
News Provided by Newsfile via QuoteMedia
Amgen Announces Positive Top-Line Results From Otezla® Phase 3 DISCREET Study In Moderate To Severe Genital Psoriasis
- Amgen (NASDAQ: AMGN) today announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla ® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.
In addition, all secondary endpoints were also met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (defined as at least a 4-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis Symptoms for subjects with a baseline score of ≥ 4); affected body surface area (BSA) change from baseline; Dermatology Life Quality Index (DLQI) change from baseline; and static Physician's Global Assessment (sPGA) response (defined as sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16 with Otezla versus placebo.
"Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis."
The type and rate of adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea and nasopharyngitis.
Patients completing the double-blind phase of the trial continued or switched to Otezla during the extension phase of the study and will be treated through week 32. The study is ongoing and is planned to complete in the first half of 2022.
Detailed results from the 16-week double-blind phase of the study will be submitted for presentation at an upcoming medical conference.
In the U.S., Otezla is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet's Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 650,000 patients worldwide with moderate-to-severe plaque psoriasis, active psoriatic arthritis or Behçet's Disease. 1
About DISCREET (PSOR-025)
DISCREET (PSOR-025) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. The study randomized 289 patients 1:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and will be treated through week 32.
The primary endpoint was the proportion of patients who achieve modified sPGA-G response at week 16 (defined as modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16).
About Psoriasis
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location. 2 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 7.5 million people in the United States 3,4 About 80% of those patients have plaque psoriasis, the most common type of the disease. 5 Up to 63% of patients with psoriasis are affected in the genital area at any time during the course of the disease. 6
About Otezla ® (apremilast)
Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Otezla ® (apremilast) U.S. INDICATIONS
Otezla ® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Otezla ® (apremilast) U.S. IMPORTANT SAFETY INFORMATION
Contraindications
- Otezla ® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting.
- Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur.
- Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide.
- Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla.
- Behcet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo.
- Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla.
- Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo.
- Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo.
- Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo.
- Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.
Adverse Reactions
- Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4).
- Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2).
- Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9).
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/ .
- Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition.
- Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.
Please click here for Otezla ® Full Prescribing Information.
Amgen Inflammation
Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate-to-severe rheumatoid arthritis, psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.
For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.
Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It's a commitment that extends beyond introducing novel therapies.
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 biologics manufacturing 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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
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 BeiGene, Ltd., Kyowa Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, 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, 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. Global economic conditions may magnify certain risks that affect our business. 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
Michael Strapazon , 805-313-5553 (Media)
Trish Rowland, 805-447-5631 (Media)
Arvind Sood , 805-447-1060 (Investors)
1 Data on File at Amgen Inc.
2 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis . Accessed January 24, 2020 .
3 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics . Accessed January 24, 2020 .
4 Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol . 2004;14(1):41–45.
5 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque . Accessed January 24, 2020 .
6 Kim A. P. Meeuwis , Alison Potts Bleakman , Peter C. M. van de Kerkhof , Yves Dutronc, Carsten Henneges , Lori J. Kornberg & Alan Menter : Prevalence of genital psoriasis in patients with psoriasis. Journal of Dermatological Treatment, 29:8, 754-760, DOI: 10.1080/09546634.2018.1453125
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FDA Approves New KYPROLIS® Combination Regimen With DARZALEX FASPRO® and dexamethasone For Patients With Multiple Myeloma At First Or Subsequent Relapse
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS ® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
"I am pleased that the addition of subcutaneous daratumumab to KYPROLIS plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden," said David M. Reese , M.D., executive vice president of Research and Development at Amgen.
The expansion of the KYPROLIS prescribing information to include DARZALEX FASPRO plus dexamethasone was supported by the ongoing, Phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluating the clinical benefit of DARZALEX FASPRO administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma.
Updated data from the PLEIADES study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting, demonstrating that response rates with KYPROLIS in combination with DARZALEX FASPRO and dexamethasone were similar to those in the Phase 3 CANDOR study (KYPROLIS combined with intravenous [IV] DARZALEX and dexamethasone [DKd]), which supported the first-ever approval of an anti-CD38 monoclonal antibody in combination with KYPROLIS. 1 The PLEIADES study met its primary endpoint, demonstrating an overall response rate of 84.8 percent with DARZALEX FASPRO- Kd.
"Managing and coping with relapsed disease is a particularly challenging time in a patient's treatment journey, and having the option of subcutaneous daratumumab as part of the DKd treatment regimen will be a welcomed option for many of our patients," said Dr. Saad Usmani , M.D., chief of Myeloma Service at Memorial Sloan Kettering Cancer Center. "Administration time can be drastically reduced, as compared to the intravenous daratumumab formulation in combination with carfilzomib and dexamethasone."
Serious adverse reactions occurred in 27% of patients who received KYPROLIS in combination with DARZALEX FASPRO and dexamethasone. The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea and peripheral edema. Fatal adverse reactions occurred in 3% of patients.
Amgen will be submitting marketing applications globally.
DARZALEX FASPRO ® and DARZALEX ® are registered trademarks of Johnson & Johnson.
About PLEIADES
The ongoing, Phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluated the clinical benefit of DARZALEX FASPRO administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma. The efficacy of KYPROLIS in combination with DARZALEX FASPRO and dexamethasone was evaluated in 66 patients with relapsed or refractory multiple myeloma in a single-arm cohort of PLEIADES.
KYPROLIS was evaluated at a starting dose of 20 mg/m 2 on Cycle 1 Day 1, which was increased to 70 mg/m 2 as a 30-minute IV infusion on Cycle 1 Day 8 and Day 15, and then Day 1, 8 and 15 of each cycle; DARZALEX FASPRO 1,800 mg administered subcutaneously once weekly from Weeks 1 to 8, once every 2 weeks from Weeks 9 to 24 and once every 4 weeks starting with Week 25 until disease progression or unacceptable toxicity; and dexamethasone 40 mg per week.
For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03412565.
About CANDOR
CANDOR, a randomized, open-label Phase 3 study of KYPROLIS, DARZALEX (IV) and dexamethasone (DKd) compared to KYPROLIS and dexamethasone (Kd), has evaluated 466 relapsed or refractory multiple myeloma patients who have received one to three prior therapies. Patients were treated until disease progression. The primary endpoint was progression-free survival (PFS), and the key secondary endpoints were overall response rate, minimal residual disease and overall survival. PFS was defined as time from randomization until disease progression or death from any cause.
In the first arm, patients received KYPROLIS twice weekly at 56 mg/m 2 and dexamethasone in combination with DARZALEX. In the second arm (control), patients received KYPROLIS twice weekly at 56 mg/m 2 and dexamethasone.
CANDOR was initiated as part of a collaboration with Janssen, and under the terms of the agreement, Janssen co-funded the study. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. 2 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers. 2,3 Worldwide, approximately 176,000 people are diagnosed with multiple myeloma each year, and 117,000 patient deaths are reported on an annual basis. 3
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 200,000 patients worldwide have received KYPROLIS. 6
KYPROLIS is approved in the U.S. for the following:
- for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with
- Lenalidomide and dexamethasone; or
- Dexamethasone; or
- Daratumumab and dexamethasone; or
- Daratumumab and hyaluronidase-fihj and dexamethasone
- 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 , China , Colombia , Ecuador , Egypt , European Union, Hong Kong , India , Israel , Japan , Jordan , Kazakhstan , Kuwait , Lebanon , Macao , Malaysia , Mexico , Morocco , New Zealand , Oman , Peru , Philippines , Qatar , Russia , Saudi Arabi, Serbia, Singapore , S. Africa, S. Korea, Switzerland , Taiwan , Thailand , Turkey , United Arab Emirates , and the United Kingdom .
U.S. KYPROLIS ® (carfilzomib) Important Safety Information
INDICATIONS
- KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone or daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
- KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
IMPORTANT SAFETY INFORMATION FOR KYPROLIS
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. Premedicate 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, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection thrombocytopenia, cough, dyspnea and insomnia.
- The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.
Please see accompanying full Prescribing Information at www.kyprolis.com .
About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
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're advancing oncology at the speed of life™.
For more information, 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.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's .
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen .
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 BeiGene, Ltd., Kyowa Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, 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. Global economic conditions may magnify certain risks that affect our business. 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.
CONTACT: Amgen, Thousand Oaks
Megan Fox , 805-447-1423 (media)
Trish Rowland , 805-447-5631(media)
Arvind Sood , 805-447-1060 (investors)
References:
- Moreau P, Chari A, Haenel M, et al. Subcutaneous Daratumumab (DARA SC) Plus Standard-of-Care (SoC) Regimens in Multiple Myeloma (MM) across Lines of Therapy in the Phase 2 Pleiades Study: Initial Results of the Dara SC Plus Carfilzomib/Dexamethasone (D-Kd) Cohort, and Updated Results for the Dara SC Plus Bortezomib/Melphalan/Prednisone (D-VMP) and Dara SC Plus Lenalidomide/Dexamethasone (D-Rd) Cohorts. Abstract presented at the 62nd Annual Meeting of the American Society of Hematology. December 5-8, 2020 . Virtual Congress. Abstract 1380.
- Jakubowiak A. Management strategies for relapsed/refractory multiple myeloma: current clinical perspectives. Semin Hematol . 2012 Jul; 49 Suppl 1: S16-S32.
- Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin . 2021; 71(3):209-249.
- Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood . 2012 Aug 2 ;120(5):947-59.
- Kortuem KM and Stewart AK. Carfilzomib. Blood . 2013 Feb 7 ;121(6):893-7.
- Amgen Data on File.
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