Dec. 8, 2014, 5:04 PM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) initiate a collaborative study to evaluate the safety and efficacy of the former's talimogene laherparepvec and the latter's Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma.
- The study will have two phases: Phase 1 will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected stage IIIB to IVM1c melanoma. The second phase will be randomized to evaluate the safety and efficacy of the two drugs. Approximately 110 patients will be enrolled across 35 sites in the U.S., Europe and Australia.
- Pembrolizumab is a PD-1 inhibitor. Talimogene laherparepvec is designed to promote tumor antigen release to initiate an anti-tumor immune response which may be complimentary to pembrolizumab's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.
- The FDA recently accepted for review Amgen's BLA for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma. The PDUFA date is July 28, 2015. An MAA has also been submitted in Europe.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)
Dec. 8, 2014, 1:38 PM
- The FDA approves Amgen's (AMGN +1.9%) Orphan Drug-designated Xgeva (denosumab) for the treatment of patients with hypercalcemia of malignancy (HCM) refractory to biphosphonate therapy.
- HCM is a serious complication in patients with advanced cancer. It results from cancer-driven increases in bone resorption and, if untreated, can lead to serious complications and death. Patients with the condition have poor prognoses.
- Among the benefits of the Orphan Drug tag is a seven-year period of market exclusivity for the indication following approval.
Dec. 8, 2014, 9:08 AM
- In a Phase 2 study evaluating Amgen's (NASDAQ:AMGN) Blincyto (blinatumomab) in patients with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukemia (ALL), 78% of patients receiving Blincyto experienced a complete MRD response after one treatment cycle. Nearly all (98%) occurred within the first treatment cycle.
- The data were presented at the American Society of Hematology meeting in San Francisco.
- Blincyto is the company's most advanced bispecific T cell engager (BiTE) immunotherapy. The technology helps the body's immune system detect and attack malignant cells. The modified antibodies are designed to engage two different targets simultaneously thereby juxtaposing T cells to cancer cells and triggering apoptosis (cell death). The FDA approved it last week for use in ALL.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Dec. 8, 2014, 7:08 AM
- In a 218-patient Phase 3 trial, Novartis (NYSE:NVS) unit Sandoz's investigational filgrastim biosimilar demonstrated similarity to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also demonstrated that repeated switching at each cycle between in the investigative biosimilar and Neupogen showed no impact on efficacy, safety or immunogenicity.
- Neutropenia is an abnormally low number of neutrophils, a type of white blood cells that are the primary defense against infections.
- The FDA accepted for review Sandoz's application for filgrastim in July. It is the first such acceptance in the U.S. under the Biologics Price Competition and Innovation Act of 2009.
- Neupogen generated ~$1.2B in sales the past four quarters.
Dec. 3, 2014, 1:25 PM
- The FDA approves Amgen's (AMGN -0.9%) Blincyto (blinatumomab) for the treatment of patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell lymphoblastic leukemia (B-cell ALL).
- Blincyto is called a T-cell engager because it acts as a connector between CD19, a protein found on the surface of most B-cell lymphoblasts and CD3, a protein on T-cell lymphocytes.
- It was approved five months ahead of its May 19, 2015 PDUFA date by virtue of its Breakthrough Therapy, Priority Review and Orphan Drug designations.
Nov. 25, 2014, 4:47 PM
- Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
- 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
- All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
- Previously: Positive Phase 3 results for brodalumab
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
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Nov. 24, 2014, 11:54 AM
- Amgen (AMGN +0.9%) terminates all company-sponsored clinical trials of rilotumumab in advanced gastric cancer. Its decision is based on a safety review by the independent data monitoring committee that found an increase in deaths in the rilotumumab and chemotherapy treatment arm compared to the chemo alone group. Protocol-defined futility criteria would have likely have been met at the planned interim analysis scheduled for March 2015.
- EVP of R&D Sean E. Harper, M.D., says, "While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area. There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide."
Nov. 22, 2014, 8:25 AM
- Harvard Business School's Bill George is troubled by the trend of activist investors shifting their wrath to some of America’s best companies, which he says may net nice profits in the short term but places the competitiveness of America’s great global companies at risk.
- An example is Amgen (NASDAQ:AMGN), whose stock has gained 185% in the past five years, but Dan Loeb still wants to split the company; George says this would destroy a productive innovator by taking away the cash it needs to develop new drugs and fuel growth.
- PepsiCo’s (NYSE:PEP) 52% increase in three years is double that of Coca-Cola, yet Nelson Peltz is agitating to split the company in two, as he did with Kraft - which has struggled, as has its Mondelez spinout.
- Peltz also is trying to break up DuPont (NYSE:DD) even though the stock has climbed 250% since Ellen Kullman became CEO in 2009; a disjointed conglomerate without a clear strategy, DuPont's stock had slipped 62% since 2000.
- Bill Ackman successfully partnered to put Allergan (NYSE:AGN) in play, which resulted in a sale, but George says the deal was unnecessary for a stock that had gained 2,400% since David E.I. Pyott became CEO in 1998.
- In each case, George says leaders were forced to focus on saving their companies instead of winning global competitive battles, creating great products and building new businesses.
Nov. 21, 2014, 7:19 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting regulatory approval for Novartis' (NYSE:NVS) secukinumab for the first-line systemic treatment of adult patients with moderate-to-severe plaque psoriasis. A final decision by the European Commission usually takes about 60 days.
- Secukinumab is an interleukin-17A inhibitor and will be sold under the brand name Cosentyx. It will compete with Amgen's (NASDAQ:AMGN) Enbrel (etanercept) which generated $4.6B in sales the past four quarters. In clinical trials, secukinumab demonstrated superiority to etanercept in skin clearance measurements.
- Last month, an FDA advisory committee voted unanimously in favor of approval for secukinumab for the same indication.
- Previously: Ad Comm backs approval of secukinumab
Nov. 20, 2014, 7:41 AM
- According to IMS Health (NYSE:IMS) global drug spending will top $1T this year led by Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) for hep C and new cancer drugs. The projected spend of $1.06T represents a 7% increase from last year.
- By 2018, drug spending is projected to rise to $1.3T. Hepatitis C and cancer meds will add ~$100B each, while diabetes care will contribute $78B. Leading the charge in cancer will be Roche's (OTCQX:RHHBY) Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine), Pharmacyclics' (NASDAQ:PCYC) Imbruvica (ibrutinib) and Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib).
- The ever-increasing tab for meds will be controversial because payers' budgets are being stressed while drug developers defend their prices citing high development costs.
- There is already some push back in cancer. Britain's National Institute for Health and Care Excellence (NICE), which sets guidelines for the National Health Service on costs, procedures and technologies, is balking at approving Roche's Gazyvaro (obinutuzumab) and Kadcyla citing their high cost relative to additional benefits over existing therapies.
- Previously: Roche's Gazyvaro not NICE in the UK
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Nov. 19, 2014, 12:35 PM
- During the scientific sessions at the American Heart Association meeting in Chicago, investigators presented results from six Phase 3 clinical trials of Regeneron Pharmaceuticals (REGN +1.2%) and Sanofi's (SNY -0.2%) (OTCQB:SNYNF) cholesterol-lowering product candidate, alirocumab, compared to placebo or statins.
- The trials assessed alirocumab in patients with hypercholesterolemia who were at high cardiovascular risk, had an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) and/or a history of intolerance to two or more statins. All six studies met their primary efficacy endpoint of change from baseline in LDL-C at week 24. Patients receiving alirocumab showed a mean reduction in LDL-C from baseline of 36 - 62%, depending on the study, compared to the comparator drugs' mean reduction of 0.5 - 23%.
- Regulatory submissions will be made to the FDA and EMA by the end of next month.
- Alirocumab is a PCSK9 inhibitor that will compete with Amgen's (AMGN +0.2%) evolocumab for supremacy in what is expected to be a $10B post-statin market. Amgen filed its BLA in August, but Regeneron and Sanofi bought an FDA voucher for $67.5M a few months ago that will cut the FDA's review time from 10 months to six, meaning that the projected approval time for both drugs will be about the same (June).
- Amgen filed a patent infringement lawsuit against the two firms last month.
- Previously: Amgen sues Sanofi and Regeneron
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug
- Previously: Biotechs to use priority review voucher for cholesterol-lowering drug candidate
Nov. 14, 2014, 12:00 PM| Nov. 14, 2014, 12:00 PM | 41 Comments
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Nov. 11, 2014, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Nov. 10, 2014, 11:02 AM
- The FDA accepts for review Amgen's (AMGN +1.1%) Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol. The BLA was submitted on August 27, 2014.
- Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
- The PDUFA date is August 27, 2015.
- Previously: Amgen cholesterol-lowering therapeutic candidate succeeds in Phase 3 trial
- Previously: Amgen submits MAA for cholesterol-lowering mAb
- Previously: Evolocumab successful in two Phase 3 studies
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