Top Selling Monoc...
Follow
Find
22.0K views | +10 today
 
Scooped by Krishan Maggon
onto Top Selling Monoclonal Antibodies 2014
Scoop.it!

Killing Cancer Through the Immune System - UCSF

Killing Cancer Through the Immune System - UCSF | Top Selling Monoclonal Antibodies 2014 | Scoop.it
UCSF News Services
Killing Cancer Through the Immune System
UCSF News Services
...
Krishan Maggon 's insight:

The marketing success of Ipilimumab has started the immunotherapy of cancer era.

more...
Krishan Maggon 's curator insight, February 4, 2014 7:47 AM
Krishan Maggon 's insight:

The marketing success of Ipilimumab has started the immunotherapy of cancer era.

Gilbert Faure au nom de l'ASSIM's curator insight, February 4, 2014 11:31 AM

obv

Top Selling Monoclonal Antibodies 2014
Top Selling Monoclonal Antibodies 2014
Abstract A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.
Curated by Krishan Maggon
Your new post is loading...
Your new post is loading...
Scooped by Krishan Maggon
Scoop.it!

Top Selling Monoclonal Antibodies 2014

Top Selling Monoclonal Antibodies 2014 | Top Selling Monoclonal Antibodies 2014 | Scoop.it

A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.

Krishan Maggon 's insight:

Best Selling Monoclonal Antibodies 2014

 

by

 

Krishan MaggonPharma Biotech R&D AdvisorNew York, USA  and Geneva, Switzerland.

 

Now available on the web for public.   4/2/2015

 

 

 

 

 

 

 

Brand/INN

Targets

Indications

Companies

Global Sales $ billions

 

2011     2012     2013    2014

Humira

Adalimumab

TNFα

RA,PS,AS,

PsA, CD, UC

AbbVie, Eisai

7.9           9.3         11         12.7

Remicade

Infleximab

TNFα

RA,PS,AS,

PsA, CD, UC

J&J, Merck, Mitsubishi Tanabe

6.8             7.7         9.7       9.8

MabThera/

Rituxan

Rituximab

CD20

RA,

Roche

6.0             6.9         7.5        7.6

Avastin

Bevacizumab

VEGF

mRCC, mCRC, NSCLC

Glioblastoma

Breast cancer

Roche

                  6.0        6.5        7.0

Herceptin

Trastuzumab

HER2

Breast cancer HER2+

Roche

                  6.0        6.5        6.8

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapy : Scientific Reports : Nature Publishing Group

Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapy : Scientific Reports : Nature Publishing Group | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Dengue virus (DENV) is the most important mosquito-borne viral infection in humans. In recent years, the number of cases and outbreaks has dramatically increased worldwide. While vaccines are being developed, none are currently available that provide balanced protection against all DENV serotypes. Advances in human antibody isolation have uncovered DENV neutralizing antibodies (nAbs) that are capable of preventing infection from multiple serotypes. Yet delivering monoclonal antibodies using conventional methods is impractical due to high costs. Engineering novel methods of delivering monoclonal antibodies could tip the scale in the fight against DENV. Here we demonstrate that simple intramuscular delivery by electroporation of synthetic DNA plasmids engineered to express modified human nAbs against multiple DENV serotypes confers protection against DENV disease and prevents antibody-dependent enhancement (ADE) of disease in mice. This synthetic nucleic acid antibody prophylaxis/immunotherapy approach may have important applications in the fight against infectious disease.

  
Krishan Maggon 's insight:

SCIENTIFIC REPORTS | ARTICLE OPEN

 Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapySeleeke Flingai,Emily M. Plummer,Ami Patel,Sujan Shresta,Janess M. Mendoza,Kate E. Broderick,Niranjan Y. Sardesai,Kar Muthumani& David B. WeinerAffiliationsContributionsCorresponding authorScientific Reports 5, Article number: 12616 doi:10.1038/srep12616Received 21 January 2015 Accepted 02 July 2015 Published 29 July 2015
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Degradation and Stabilization of Peptide Hormones in Human Blood Specimens

Degradation and Stabilization of Peptide Hormones in Human Blood Specimens | Top Selling Monoclonal Antibodies 2014 | Scoop.it

by Jizu Yi, David Warunek, David Craft

Abstract

Plasma hormone peptides, including GLP-1, GIP, Glucagon, and OXM, possess multiple physiological roles and potential therapeutic and diagnostic utility as biomarkers in the research of metabolic disorders. These peptides are subject to proteolytic degradation causing preanalytical variations. Stabilization for accurate quantitation of these active peptides in ex vivo blood specimens is essential for drug and biomarker development. We investigated the protease-driven instability of these peptides in conventional serum, plasma, anticoagulated whole blood, as well as whole blood and plasma stabilized with protease inhibitors. The peptide was monitored by both time-course Matrix-Assisted Laser Desorption Ionization Time-to-Flight Mass Spectrometry (MALDI –TOF MS) and Ab-based assay (ELISA or RIA). MS enabled the identification of proteolytic fragments. In non-stabilized blood samples, the results clearly indicated that dipeptidyl peptidase-IV (DPP-IV) removed the N-terminal two amino acid residues from GLP-1, GIP and OXM(1-37) and not-yet identified peptidase(s) cleave(s) the full-length OXM(1-37) and its fragments. DPP-IV also continued to remove two additional N-terminal residues of processed OXM(3–37) to yield OXM(5–37). Importantly, both DPP-IV and other peptidase(s) activities were inhibited efficiently by the protease inhibitors included in the BD P800* tube. There was preservation of GLP-1, GIP, OXM and glucagon in the P800 plasma samples with half-lives > 96, 96, 72, and 45 hours at room temperature (RT), respectively. In the BD P700* plasma samples, the stabilization of GLP-1 was also achieved with half-life > 96 hours at RT. The stabilization of these variable peptides increased their utility in drug and/or biomarker development. While stability results of GLP-1 obtained with Ab-based assay were consistent with those obtained by MS analysis, the Ab-based results of GIP, Glucagon, and OXM did not reflect the time-dependent degradations revealed by MS analysis. Therefore, we recommended characterizing the degradation of the peptide using the MS-based method when investigating the stability of a specific peptide.

Krishan Maggon 's insight:

Citation: Yi J, Warunek D, Craft D (2015) Degradation and Stabilization of Peptide Hormones in Human Blood Specimens. PLoS ONE 10(7): e0134427. doi:10.1371/journal.pone.0134427

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

PCSK9 Inhibitors: Bargain Among Biologics? - MedPage Today

PCSK9 Inhibitors: Bargain Among Biologics? - MedPage Today | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Against other monoclonal antibodies, the cost doesn't look so steep

 

When alirocumab (Praluent) became the first PCSK9 inhibitor on the U.S. market last week, drugmakers Sanofi and Regeneron Pharmaceuticals announced its price tag with a flourish.

Set at $1,120 per 28-day treatment cycle -- or about $14,600 per year -- the wholesale acquisition cost fell well above what analysts had anticipated but positioned alirocumab as "the lowest priced patient-administered monoclonal antibody therapy on an annualized basis," the companies noted.

 

Krishan Maggon 's insight:
$35,724.62 for adalimumab in rheumatoid arthritis and for maintenance dosing in a variety of other indications$29,902.68 for rituximab (Rituxan) in rheumatoid arthritis$63,345.10 to $126,690.20 for bevacizumab (Avastin) in metastatic colorectal cancer$48,855.52 to $67,176 for trastuzumab (Herceptin) in adjuvant breast cancer$15,394.93 to $25,658.22 for ranibizumab (Lucentis) across ocular settings$12,917.69 for infliximab (Remicade) in the first year for rheumatoid arthritis
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Graves’ Disease Patients with Persistent Hyperthyroidism and Diffuse Lymphoplasmacytic Infiltration in the Thyroid Show No Histopathological Compatibility with IgG4-Related Disease

Graves’ Disease Patients with Persistent Hyperthyroidism and Diffuse Lymphoplasmacytic Infiltration in the Thyroid Show No Histopathological Compatibility with IgG4-Related Disease | Top Selling Monoclonal Antibodies 2014 | Scoop.it

by Eijun Nishihara, Mitsuyoshi Hirokawa, Mitsuru Ito, Shuji Fukata, Hirotoshi Nakamura, Nobuyuki Amino, Akira Miyauchi 

 

AbstractBackground

IgG4-related disease is a novel disease entity characterized by diffuse lymphoplasmacytic infiltration rich in IgG4-positive plasma cells and fibrosis into multiple organs. There is still controversy over whether some thyroid diseases are actually IgG4-related disease. The objective of this study was to elucidate the clinicopathological features of Graves’ disease with diffuse lymphoplasmacytic infiltration in the thyroid.

Patients and Methods

Among 1,484 Graves’ disease patients who underwent thyroidectomy, we examined their histopathological findings including the degree of lymphoplasmacytic and fibrotic infiltration and levels of IgG4-positive plasma cells in the thyroid. Their clinical pictures were defined by laboratory and ultrasonographic evaluation.

Results

A total of 11 patients (0.74%) showed diffuse lymphoplasmacytic infiltration in the stroma of the thyroid gland. Meanwhile, other patients showed variable lymphoid infiltration ranging from absent to focally dense but no aggregation of plasma cells in the thyroid gland. Based on the diagnostic criteria of IgG4-related disease, 5 of the 11 subjects had specifically increased levels of IgG4-positive plasma cells in the thyroid. Fibrotic infiltration was present in only 1 patient developing hypothyroidism after anti-thyroid drug treatment for 4 years, but not in the other 10 patients with persistent hyperthyroidism. Obliterative phlebitis was not identified in any of the 11 subjects. Thyroid ultrasound examination showed 1 patient developing hypothyroidism who had diffuse hypoechogenicity, but the other hyperthyroid patients had a coarse echo texture.

Conclusions

In our study, Graves’ disease patients with persistent hyperthyroidism who had diffuse lymphoplasmacytic infiltration rich in IgG4-positive plasma cells in the thyroid showed no concomitant fibrosis or obliterative phlebitis.

Krishan Maggon 's insight:

Citation: Nishihara E, Hirokawa M, Ito M, Fukata S, Nakamura H, Amino N, et al. (2015) Graves’ Disease Patients with Persistent Hyperthyroidism and Diffuse Lymphoplasmacytic Infiltration in the Thyroid Show No Histopathological Compatibility with IgG4-Related Disease. PLoS ONE 10(7): e0134143. doi:10.1371/journal.pone.0134143

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Medicare and Medicaid at 50 Years

Medicare and Medicaid at 50 Years | Top Selling Monoclonal Antibodies 2014 | Scoop.it
In this Special Communication, Kaiser Family Foundation CEO Drew Altman and Senator William Frist review the history and roles of Medicare and Medicaid in the US health system and discuss the program’s future.
more...
Krishan Maggon 's curator insight, July 29, 7:49 AM

JAMA  

July 28, 2015, Vol 314, No. 4 >  Special Communication | July 28, 2015Medicare and Medicaid at 50 Years: Perspectives of Beneficiaries, Health Care Professionals and Institutions, and Policy MakersDrew Altman, PhD1; William H. Frist, MD1,2[+] Author AffiliationsJAMA. 2015;314(4):384-395. doi:10.1001/jama.2015.7811.
Scooped by Krishan Maggon
Scoop.it!

Did α-Synuclein and Glucocerebrosidase Coevolve? Implications for Parkinson’s Disease

Did α-Synuclein and Glucocerebrosidase Coevolve? Implications for Parkinson’s Disease | Top Selling Monoclonal Antibodies 2014 | Scoop.it

by James M. Gruschus

Abstract

Mutations in the GBA1 gene are associated with increased risk of Parkinson's disease, and the protein produced by the gene, glucocerebrosidase, interacts with α-synuclein, the protein at the center of the disease etiology. One possibility is that the mutations disrupt a beneficial interaction between the proteins, and a beneficial interaction would imply that the proteins have coevolved. To explore this possibility, a correlated mutation analysis has been performed for all 72 vertebrate species where complete sequences of α-synuclein and glucocerebrosidase are known. The most highly correlated pair of residue variations is α-synuclein A53T and glucocerebrosidase G115E. Intriguingly, the A53T mutation is a Parkinson's disease risk factor in humans, suggesting the pathology associated with this mutation and interaction with glucocerebrosidase might be connected. Correlations with β-synuclein are also evaluated. To assess the impact of lowered species number on accuracy, intra and inter-chain correlations are also calculated for hemoglobin, using mutual information Z-value and direct coupling analyses.

Krishan Maggon 's insight:

Citation: Gruschus JM (2015) Did α-Synuclein and Glucocerebrosidase Coevolve? Implications for Parkinson’s Disease. PLoS ONE 10(7): e0133863. doi:10.1371/journal.pone.0133863

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease — NEJM

Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease — NEJM | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Original Article from The New England Journal of Medicine — Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease

 

BACKGROUND

A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian–Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.

Full Text of Background...

 METHODS

We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57. We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15.

Full Text of Methods...

 RESULTS

Follow-up data were available for 10,165 of 10,275 participants (99%) in CYD14 and 19,898 of 20,869 participants (95%) in CYD15. Data were available for 3203 of the 4002 participants (80%) in the CYD23 trial included in CYD57. During year 3 in the CYD14, CYD15, and CYD57 trials combined, hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group. Pooled relative risks of hospitalization for dengue were 0.84 (95% confidence interval [CI], 0.56 to 1.24) among all participants, 1.58 (95% CI, 0.83 to 3.02) among those under the age of 9 years, and 0.50 (95% CI, 0.29 to 0.86) among those 9 years of age or older. During year 3, hospitalization for severe dengue, as defined by the independent data monitoring committee criteria, occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group. Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3% (95% CI, 55.7 to 64.5) for all participants, 65.6% (95% CI, 60.7 to 69.9) for those 9 years of age or older, and 44.6% (95% CI, 31.6 to 55.0) for those younger than 9 years of age.

Full Text of Results...

 CONCLUSIONS

Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up, the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group. (Funded by Sanofi Pasteur; ClinicalTrials.gov numbers, NCT00842530, NCT01983553, NCT01373281, andNCT01374516.)

Krishan Maggon 's insight:

ORIGINAL ARTICLE

Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease

Sri Rezeki Hadinegoro, M.D., Ph.D., Jose Luis Arredondo-García, M.D., Maria Rosario Capeding, M.D., Carmen Deseda, M.D., Tawee Chotpitayasunondh, M.D., Reynaldo Dietze, M.D., H.I. Hj Muhammad Ismail, M.B., B.S., Humberto Reynales, M.D., Ph.D., Kriengsak Limkittikul, M.D., Doris Maribel Rivera-Medina, M.D., Huu Ngoc Tran, M.D., Ph.D., Alain Bouckenooghe, M.D., Danaya Chansinghakul, M.D., Margarita Cortés, M.D., Karen Fanouillere, M.Sc., M.P.H., Remi Forrat, M.D., Carina Frago, M.D., Sophia Gailhardou, Pharm.D., Nicholas Jackson, Ph.D., Fernando Noriega, M.D., Eric Plennevaux, Ph.D., T. Anh Wartel, M.D., Betzana Zambrano, M.D., and Melanie Saville, M.B., B.S. for the CYD-TDV Dengue Vaccine Working Group

July 27, 2015DOI: 10.1056/NEJMoa1506223

more...
Gilbert Faure au nom de l'ASSIM's curator insight, July 28, 12:50 AM

major clinical research for mundial population

Scooped by Krishan Maggon
Scoop.it!

FDA approves diagnostic test to differentiate between types of HIV infection - FDA.gov

FDA approves diagnostic test to differentiate between types of HIV infection - FDA.gov | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The U.S. Food and Drug Administration today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
Krishan Maggon 's insight:

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay is to aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute HIV-1 infection. It may be used in adults, children two years of age and older, as well as in pregnant women. The assay may also be used to screen organ donors for HIV-1/2 when the blood specimen is collected while the donor’s heart is still beating. However, the assay is not approved for use in screening blood or plasma donors, except in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Overcoming Challenges in Developing Antibody Drugs Against Immune Check Point Targets - An Interview with Dr. Jing Li, Vice President, WuXi Biologics - Top Chinese CRO, Biopharma News, Drug Develop...

Overcoming Challenges in Developing Antibody Drugs Against Immune Check Point Targets - An Interview with Dr. Jing Li, Vice President, WuXi Biologics - Top Chinese CRO, Biopharma News, Drug Develop... | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The approval of anti-CTLA-4 antibody, Ipilimumab (BMS), and the recent approvals of two anti-PD-1 antibodies, Pembrolizumab (Merck) and Nivolumab (BMS), have greatly attracted more attention to the immune check-point therapy field.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients

Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients | Top Selling Monoclonal Antibodies 2014 | Scoop.it
#Regeneron & @SanofiUS announce FDA approval of new treatment to manage high LDL #cholesterol: http://t.co/ZZ1c5FCECt

 

TARRYTOWN, N.Y. and PARIS, July 24, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

 

Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses (75 mg and 150 mg). Both doses of Praluent are available in a single 1 milliliter (mL) injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks.

 

The approval of Praluent was based on data from the pivotal Phase 3 ODYSSEY program, which showed consistent, positive results compared to placebo, which included current standard of care therapy (statins). In the ODYSSEY LONG TERM trial which evaluated Praluent 150 mg every two weeks, Praluent reduced LDL cholesterol by 58 percent versus placebo at week 24 when added to current standard of care, including maximally tolerated statins. In ODYSSEY COMBO I, Praluent 75 mg every two weeks as an adjunct to statins reduced LDL cholesterol by an additional 46 percent compared to placebo at week 12. At week 24 in the same trial, Praluent reduced LDL cholesterol by 43 percent compared to placebo. In this study, if additional LDL cholesterol lowering was required based on pre-specified criteria at week 8, Praluent was up-titrated to 150 mg at week 12 for the remainder of the trial. Eighty-three percent of patients remained on their initial 75 mg dose.

 

Praluent is generally well-tolerated with an acceptable safety profile. Local injection site reactions including redness, itching, swelling or pain/tenderness where the injection is given were the most common events (7.2 percent with Praluent versus 5.1 percent with placebo) and resulted in a low discontinuation rate that was comparable to placebo (0.2 percent with Praluent versus 0.4 percent with placebo). Patients receiving Praluent had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo. Other common adverse events occurring more frequently in patients with Praluent than placebo included symptoms of the common cold and flu or flu-like symptoms.

 

 

 

Krishan Maggon 's insight:

The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost (WAC). The U.S. WAC price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.

 

Earlier today, the companies announced that the European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. The European Commission (EC) is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in September 2015.

 

 

more...
Krishan Maggon 's curator insight, July 24, 3:37 PM

The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost (WAC). The U.S. WAC price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.

 

Earlier today, the companies announced that the European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. The European Commission (EC) is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in September 2015.

Scooped by Krishan Maggon
Scoop.it!

Novavax RSV F Nanoparticle Vaccine: World Vaccine Congress 2015

Respiratory Syncytial Virus F-protein nanoparticle vaccine candidate (RSV F Vaccine)

RSV is a widespread disease that causes infections of the lower respiratory tract. While RSV affects individuals of all ages, it acutely impacts infants, the very young, the elderly and others with compromised immune systems. RSV is the number one cause of hospitalization in infants ages 0 to 12 months in the U.S. and is a significant cause of infant morbidity and mortality globally 1 . Current estimates indicate that RSV is responsible for over 30 million new acute lower respiratory infection episodes and between 150,000 and 200,000 deaths in children under five years of age 2 . In the U.S., nearly all children become infected with RSV before they are two years of age; it has been associated with 20% of hospitalizations and 15% of office visits for acute respiratory infection in young children 3 . In addition, it is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection or its complications annually in the U.S., and up to 180,000 are hospitalized for serious respiratory symptoms 4 . The World Health Organization (“WHO”) estimates that the annual global disease burden for RSV is 64 million cases. Because there is no approved prophylactic vaccine, an RSV vaccine has the potential to protect millions of patients from this far-reaching unmet medical need.

Novavax is developing a respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) for the benefit of three susceptible target populations: the elderly, infants (receiving protection through antibodies transferred from their mothers who would be immunized during the last trimester of pregnancy) and pediatrics.

Krishan Maggon 's insight:
RSV Elderly Program RSV Maternal Immunization Program PATH Vaccine Solution Clinical Development Agreement - RSV Maternal Immunization Program RSV Pediatric Program
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Monoclonal Antibodies As A Future Therapeutic Against Neurodegenerative Diseases

Monoclonal Antibodies As A Future Therapeutic Against Neurodegenerative Diseases | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Read how Monoclonal Antibodies are A Future Therapeutic Against Neurodegenerative Diseases
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Poor Clinical Results Push XOMA Corp (NASDAQ:XOMA) to the Bottom of the Charts

Poor Clinical Results Push XOMA Corp (NASDAQ:XOMA) to the Bottom of the Charts | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The good thing about biotechs is that a successful clinical trial could send the company flying on the charts. Unfortunately, there is a flip side to...
Krishan Maggon 's insight:

Xoma is the black hole of monoclonal antibodies R&D having wasted $ 1.5 billion of shareholders money to show nothing?

 

It should get into biosimilar as it picks up poor mabs to fail in Phase III.

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Novel Colitis Immunotherapy Targets Bin1 and Improves Colon Cell Barrier Function - Online First - Springer

Novel Colitis Immunotherapy Targets Bin1 and Improves Colon Cell Barrier Function - Online First - Springer | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Novel #Colitis #Immunotherapy Targets Bin1 & Improves Colon Cell Barrier Function http://t.co/dTUkJkXV1R

 

AbstractBackground

Ulcerative colitis (UC) is associated with defects in colonic epithelial barriers as well as inflammation of the colon mucosa resulting from the recruitment of lymphocytes and neutrophils in the lamina propria. Patients afflicted with UC are at increased risk of colorectal cancer. Currently, UC management employs general anti-inflammatory strategies associated with a variety of side effects, including heightened risks of infection, in patients where the therapy is variably effective. Thus, second generation drugs that can more effectively and selectively limit UC are desired.

Aim

Building on genetic evidence that attenuation of the Bin1 (Bridging integrator 1) gene can limit UC pathogenicity in the mouse, we pursued Bin1 targeting as a therapeutic option.

Methods

Mice were injected with a single dose of Bin1 mAb followed by oral administration of 3 % DSS in water for 7 days.

Results

In this study, we offer preclinical proof of concept for a monoclonal antibody (mAb) targeting the Bin1 protein that blunts UC pathogenicity in a mouse model of experimental colitis. Administration of Bin1 mAb reduced colitis morbidity in mice; whereas unprotected mice is characterized by severe lesions throughout the mucosa, rupture of the lymphoid follicle, high-level neutrophil and lymphocyte infiltration into the mucosal and submucosal areas, and loss of surface crypts. In vitro studies in human Caco-2 cells showed that Bin1 antibody altered the expression of tight junction proteins and improved barrier function.

Conclusions

Our results suggest that a therapy based on Bin1 monoclonal antibody supporting mucosal barrier function and protecting integrity of the lymphoid follicle could offer a novel strategy to treat UC and possibly limit risks of colorectal cancer.

Krishan Maggon 's insight:
Digestive Diseases and SciencesJuly 2015Date: 21 Jul 2015Novel Colitis Immunotherapy Targets Bin1 and Improves Colon Cell Barrier FunctionSunil Thomas, Joanna M. Mercado, James DuHadaway, Kate DiGuilio, James M. Mullin, George C. Prendergast
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

10-Year Follow-up Study on Safety and Efficacy of Adalimumab - MD Magazine

10-Year Follow-up Study on Safety and Efficacy of Adalimumab - MD Magazine | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Study shows that adalimumab led to sustained clinical and functional responses in nearly one-third of treatment-refractory patients who completed 10 years of treatment.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Fifty Shades of Cancer Immunostimulation, Part 4: Double the Pleasure—Monoclonal Antibodies and Cytokines

Fifty Shades of Cancer Immunostimulation, Part 4: Double the Pleasure—Monoclonal Antibodies and Cytokines | Top Selling Monoclonal Antibodies 2014 | Scoop.it
BY ROBERT G. BELL We continue our discussions with two of the heavyweights of cancer immunotherapies, monoclonal antibodies and cytokines. Monoclonal antibodies (MAbs) for cancer therapies are bioe...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Evaluation of candidate vaccine approaches for MERS-CoV - Nature.com

Evaluation of candidate vaccine approaches for MERS-CoV - Nature.com | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Nature.com
Evaluation of candidate vaccine approaches for MERS-CoV
Nature.com

Abstract

The emergence of Middle East respiratory syndrome coronavirus (MERS-CoV) as a cause of severe respiratory disease highlights the need for effective approaches to CoV vaccine development. Efforts focused solely on the receptor-binding domain (RBD) of the viral Spike (S) glycoprotein may not optimize neutralizing antibody (NAb) responses. Here we show that immunogens based on full-length S DNA and S1 subunit protein elicit robust serum-neutralizing activity against several MERS-CoV strains in mice and non-human primates. Serological analysis and isolation of murine monoclonal antibodies revealed that immunization elicits NAbs to RBD and, non-RBD portions of S1 and S2 subunit. Multiple neutralization mechanisms were demonstrated by solving the atomic structure of a NAb-RBD complex, through sequencing of neutralization escape viruses and by constructing MERS-CoV S variants for serological assays. Immunization of rhesus macaques confers protection against MERS-CoV-induced radiographic pneumonia, as assessed using computerized tomography, supporting this strategy as a promising approach for MERS-CoV vaccine development.

  
Krishan Maggon 's insight:

NATURE COMMUNICATIONS | ARTICLE OPEN

Evaluation of candidate vaccine approaches for MERS-CoVLingshu Wang,Wei Shi,M. Gordon Joyce,Kayvon Modjarrad,Yi Zhang,Kwanyee Leung,Christopher R. Lees,Tongqing Zhou,Hadi M. Yassine,Masaru Kanekiyo,Zhi-yong Yang,Xuejun Chen,Michelle M. Becker,Megan Freeman,Leatrice Vogel,Joshua C. Johnson,Gene Olinger,John P. Todd,Ulas Bagci,Jeffrey Solomonet al.AffiliationsContributionsCorresponding authorsNature Communications 6, Article number: 7712 doi:10.1038/ncomms8712Received 21 April 2015 Accepted 03 June 2015 Published 28 July 2015
more...
No comment yet.
Rescooped by Krishan Maggon from Lupus New Drugs Review
Scoop.it!

UCB Epratuzumab Fails Phase III trial in Systemic Lupus Erythematosus

UCB Epratuzumab Fails Phase III trial in Systemic Lupus Erythematosus | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Brussels (Belgium), 28 July 2015 – 0700 (CET) – regulated information.  UCB today announced that the two EMBODY™ Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus (SLE) did not meet their primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significantly higher than those who received placebo in addition to standard therapy. 

 

The EMBODY™ Phase 3 clinical program consisted of two identical studies – EMBODY™ 1 and EMBODY™ 2. EMBODY™ 1 and EMBODY™ 2 were multicenter, randomized, double-blind, placebo-controlled 48-week studies. In each study, patients (n= 786 for EMBODY™ 1;  n=788 for EMBODY™ 2) received placebo or treatment with 2400 mg of epratuzumab over four 12-week treatment cycles, administered as 600 mg every week for four weeks or 1,200 mg every two weeks for four weeks.  All patients were taking corticosteroids at the start of the trial, in addition to epratuzumab or placebo, while immunosuppressant and antimalarial therapies were administered per their standard therapy regimen. The primary endpoint of the studies was the percentage of patients meeting treatment response criteria at Week 48 according to a combined response index, the BILAG-based Combined Lupus Assessment (BICLA). 1

A high level review of the safety data did not identify any new safety concerns.  The most common adverse events in both studies were upper respiratory tract infection, urinary tract infection, headache and nausea.

 

Krishan Maggon 's insight:

About Epratuzumab
Epratuzumab is a monoclonal antibody to target CD22, a protein that modulates B-cells, which are key components of the immune system and can play a central role in the pathogenesis of SLE if they become overactive. While the mechanism of action of epratuzumab is not fully elucidated, data indicate that it binds to CD22, resulting in diminished SLE-related hyperactivity of B cells without depleting them.2

more...
Krishan Maggon 's curator insight, July 28, 6:22 AM

About Epratuzumab

Licensed from Immunomedics
Epratuzumab is a monoclonal antibody to target CD22, a protein that modulates B-cells, which are key components of the immune system and can play a central role in the pathogenesis of SLE if they become overactive. While the mechanism of action of epratuzumab is not fully elucidated, data indicate that it binds to CD22, resulting in diminished SLE-related hyperactivity of B cells without depleting them.2

Scooped by Krishan Maggon
Scoop.it!

Sanofi Dengue Vaccine protects 66% of subjects

Sanofi Dengue Vaccine protects 66% of subjects | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Lyon, France, - July 27, 2015 - Sanofi Pasteur, the vaccines division of Sanofi, announced today that new data analyses published in the New England Journal of Medicine (NEJM) provide a comprehensive picture of the potential public health impact of vaccinating endemic populations from pre-adolescence to adulthood against dengue. Not only is this the largest population at risk of dengue globally, but individuals 9 years of age and older also represent a highly mobile group capable of spreading disease more broadly during outbreaks and also contributing substantially to the economic burden of dengue, for example in number of lost school and work days due to the disease.

The NEJM article reported results from a new pooled efficacy analysis of individuals 9 years of age and older at vaccination from the two Phase III studies of Sanofi Pasteur's dengue vaccine. The new analysis documented that the vaccine protects two-thirds of these individuals (66%) against dengue, providing even greater protection against two clinically-relevant manifestations of dengue, namely severe dengue (93%) and prevention of hospitalizations due to dengue (80%) that account for the greatest human and economic burden of dengue in endemic countries. In addition, the dengue vaccine candidate protected volunteers 9 years of age and older who were previously exposed to dengue (82%), as well as those who were naïve to dengue (52.5%) prior to vaccination.

The clinical development program for the vaccine candidate includes studies with four-year, long-term follow-up phases, in line with WHO guidelines for dengue vaccine development. Results from first 25 months of the two Phase III efficacy studies were published in 2014.[4],[5] Interim data from the third year of these studies and interim data from the third and fourth years of the Phase II extension study in Thailand published in the new NEJM article confirm the continuing reduction of hospitalized dengue in the vaccinated population 9 years of age and older.

The third-year interim data from the Asian Phase III study identified the need for further long-term surveillance in children under 9 years of age to assess the impact of the dengue vaccine candidate in these younger children.

Krishan Maggon 's insight:

New England Journal of Medicine Publishes New Analyses Confirming that Sanofi Pasteur's Vaccine Candidate Safely Protects 
Pre-Adolescents to Adults Against Dengue

- The highest burden of dengue disease globally in endemic countries is in pre-adolescent to adults age group[1],[2],[3] -

In a new pooled analysis, dengue vaccine candidate protected two out of three volunteers aged 9 years and older against all four dengue serotypesProtection against severe dengue reached 93% and prevention of hospitalizations due to dengue 80% in this age group

- Based on this clinical profile in 9 years of age and older, the dengue vaccine candidate has the potential to significantly reduce disease burden in endemic countries -

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Xoma 4th Phase III failure, lost 99.7% market cap, burnt $1.5 billion in R&D in 34 years

Xoma 4th Phase III failure, lost 99.7% market cap, burnt $1.5 billion in R&D in 34 years | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Xoma formed in 1981 was once a leading monoclonal antibody company. Poor management led it to concentrate on Sepsis leading to 2 majoor Phase III failures E5 and Neuprex/BPI over the next 2 decades. 

 

Its only approved drug Efalizumab licensed to Genentech and Serono and marketed as Raptiva for psoriasis was withdrawn from the market due to fatal brain infections PML. 

 

Gevokizumab failed in Phase II diabetes and Phase III uvetis trials.

 

 

Krishan Maggon 's insight:

Poor management cheaply sold away lucrative royalties on several blockbuster antibodies which Xoma developed for other companies. Royalties income from such deals are now worth multibillion dollars from Herceptin, Avastin and Humira etc. It sold its stake in Genmab.

 

Cash burn in 34 years   $1.5 billion, the company current market cap is $100 million only. Xoma is the black hole of monoclonal antibodies R&D. Massive destruction of shareholder value.

 

Every 1 dollar invested in Warren Buffet Berkshire Hathaway in 1981 is worth $ 471 today, 41.5 billion= worth $700 billion.

 

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Sanofi's Cholesterol drug Praluent® (alirocumab) would cost $15,000 per year | NYC Today

Sanofi's Cholesterol drug Praluent® (alirocumab)  would cost $15,000 per year | NYC Today | Top Selling Monoclonal Antibodies 2014 | Scoop.it

U.S. FDA has recently approved Praluent, a breakthrough treatment for cholesterol, developed by Sanofi and Regeneron Pharmaceuticals Inc. The treatment can be used by millions of people who have not been helped by existing treatments to control cholesterol or have side effects from statins. However, the high cost, $14,600 per year, will surely bring in the topic of high priced breakthrough treatment back in focus. Pharmaceutical companies have been accused in the past as well for pricing their medicines much higher in the United States compared to the cost of treatment in other countries.

The injectable drug, Praluent, is highly effective in reducing cholesterol levels. Health insurance companies have raised questions about the high price tag. Market analysts were expecting around $7,000 per year as treatment cost.

Praluent has potential to gain widespread usage among patients but the high cost of treatment could be a major factor. Earlier, Gilead Sciences has been criticized by health insurers and politicians for charging exorbitant price for its breakthrough hepatitis C treatment.

 

 

After FDA approval, John Rother, president of the National Coalition on Health Care said, “Breakthrough treatments such as Praluent hold tremendous medical promise for certain patients, but its price tag makes us question how long the health system can sustain these costs for patients managing chronic conditions over several years."

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Sealing the Envelope HIV - BioCentury.com

Sealing the Envelope HIV - BioCentury.com | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Research from two academic groups could bring HIV vaccines a step closer to the finish line by identifying new ways to stabilize trimers of the HIV envelope protein. The greater stability raises the chances that this antigen will elicit the broadly neutralizing antibodies needed for protection against a range of HIV strains, and could solve the long-standing problem of previous vaccines which primarily induced non-neutralizing antibodies.

HIV env is the cell surface protein that allows the virus to enter T cells, and has been the main target for HIV preventive vaccines since it was found that bNAbs from some HIV patients recognize the protein and block viral infection of host T cells. The idea is that using HIV env in a vaccine will elicit similar bNAbs that can block infection in most patients.

Krishan Maggon 's insight:
Sealing the envelopeA stabilized HIV envelope could induce broadly neutralizing antibodies

By Stephen Parmley, Senior Writer

 BioCentury
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

EMA/CHMP: Praluent (alirocumab, Sanofi, Regeneron) recommended for approval to lower cholesterol

EMA/CHMP: Praluent (alirocumab, Sanofi, Regeneron) recommended for approval to lower cholesterol | Top Selling Monoclonal Antibodies 2014 | Scoop.it

EMA CHMP  July Meeting

 

The European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for Praluent (alirocumab) to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins. The medicine should be used in addition to a healthy diet. Other lipid-lowering therapies (statins and others) should also be used if tolerated.

 

High levels of cholesterol in the blood are common risk factors for heart disease, which is the leading cause of death globally.

Praluent belongs to a new class of medicines called PCSK9 inhibitors, which provide new options for the treatment of high cholesterol, an area where only few effective therapies have emerged since the introduction of statins. It is the second representative of this new type of monoclonal antibody (a type of protein) to be recommended for approval in the European Union (EU). Praluent blocks the PCSK9 protein, which would otherwise lower the number of LDL-receptors in the liver and through this, diminish the liver's ability to remove LDL-cholesterol (‘bad cholesterol’) from the blood.

 

The efficacy of Praluent was assessed in 10 phase III (late-stage) studies, involving close to 5,300 patients with hypercholesterolaemia (high blood cholesterol levels) and mixed dyslipidaemia (abnormal levels of fat in the blood, including high levels of LDL-cholesterol). Praluent reduced LDL-cholesterol for these patient groups. Available evidence does not yet allow the longer term benefits of Praluent for patients in reducing heart disease or death from heart disease to be determined.

 

The Committee for Medicinal Products for Human Use (CHMP) also looked at safety information from over 3,300 patients treated with Praluent. The Committee considered that the safety profile of Praluent is acceptable, with few patients discontinuing treatment or showing serious adverse events.

Krishan Maggon 's insight:

The company received scientific advice on quality, non-clinical and clinical aspects of the application from the CHMP. This is one of the Agency’s main tools to facilitate and stimulate research and development within the EU.

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Genes and Immunity - CTLA-4 as a genetic determinant in autoimmune Addison/'s ... - Nature.com

Genes and Immunity - CTLA-4 as a genetic determinant in autoimmune Addison/'s ... - Nature.com | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Genes and Immunity 

 

Abstract

In common with several other autoimmune diseases, autoimmune Addison’s disease (AAD) is thought to be caused by a combination of deleterious susceptibility polymorphisms in several genes, together with undefined environmental factors and stochastic events. To date, the strongest genomic association with AAD has been with alleles at the HLA locus, DR3–DQ2 and DR4. The contribution of other genetic variants has been inconsistent. We have studied the association of 16 single-nucleotide polymorphisms (SNPs) within the CD28–CTLA-4–ICOS genomic locus, in a cohort comprising 691 AAD patients of Norwegian and UK origin with matched controls. We have also performed a meta-analysis including 1002 patients from European countries. The G-allele of SNP rs231775 in CTLA-4 is associated with AAD in Norwegian patients (odds ratio (OR)=1.35 (confidence interval (CI) 1.10–1.66), P=0.004), but not in UK patients. The same allele is associated with AAD in the total European population (OR=1.37 (CI 1.13–1.66), P=0.002). A three-marker haplotype, comprisingPROMOTER_1661, rs231726 and rs1896286 was found to be associated with AAD in the Norwegian cohort only (OR 2.43 (CI 1.68–3.51),P=0.00013). This study points to the CTLA-4 gene as a susceptibility locus for the development of AAD, and refines its mapping within the wider genomic locus.

 

 

Krishan Maggon 's insight:

Genes and Immunity advance online publication 23 July 2015; doi: 10.1038/gene.2015.27

CTLA-4 as a genetic determinant in autoimmune Addison’s disease
OPEN

A S B Wolff1,10, A L Mitchell2,10, H J Cordell2, A Short3, B Skinningsrud4,5, W Ollier3, K Badenhoop6, G Meyer6, A Falorni7, O Kampe8, D Undlien4,5, S H S Pearce2 and E S Husebye1,9

 

Correspondence: Dr ASB Wolff, Department of Clinical Science, University of Bergen, Laboratory Building, 8th Floor, Bergen 5021, Norway. E-mail: Anette.boe@k2.uib.no

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Fast, Easy & Column-Free Cell Separation Ready Sep Go w/ EasySep™

Fast, Easy & Column-Free Cell Separation Ready Sep Go w/ EasySep™ | Top Selling Monoclonal Antibodies 2014 | Scoop.it
STEMCELL's EasySep product is a powerful immunomagnetic column-free cell isolation system for fast, easy isolation of virtually any cell type.
more...
No comment yet.