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STUTTGART, Germany I January 25, 2018 I A tissue-based map of the human proteome suggests that about 75 % are intracellular or secreted targets not accessible for conventional monoclonal antibody and chimeric antigen receptor (CAR) T-cell therapy (Uhlen et al., Science, 2015). Thus, the large pool of intracellular protein targets, including overexpressed oncogenic proteins, mutated tumor suppressorsand gene products of translocation, remains untapped so far. Part of the intracellular antigen proteins are degraded to protein fragments that are eventually presented on the cell surface as a composite antigen comprised of a variable linear sequence peptide (typically 9-10 amino acids in length) buried within a major histocompatibility complex (MHC) molecule, also referred to as human leukocyte antigen (HLA) class I, for recognition by T-cell receptors.

STUTTGART, Germany I January 25, 2018 I A tissue-based map of the human proteome suggests that about 75 % are intracellular or secreted targets not accessible for conventional monoclonal antibody and chimeric antigen receptor (CAR) T-cell therapy (Uhlen et al., Science, 2015). Thus, the large pool of intracellular protein targets, including overexpressed oncogenic proteins, mutated tumor suppressors and gene products of translocation, remains untapped so far. Part of the intracellular antigen proteins are degraded to protein fragments that are eventually presented on the cell surface as a composite antigen comprised of a variable linear sequence peptide (typically 9-10 amino acids in length) buried within a major histocompatibility complex (MHC) molecule, also referred to as human leukocyte antigen (HLA) class I, for recognition by T-cell receptors.

Time-to-market is a key success factor for novel recombinant coagulation factors from new market entrants and established marketers

STUTTGART, Germany I July 1, 2013 I Last week the FDA approved Baxter’s novel recombinant factor IX (rFIX) product RIXUBIS as the first new rFIX for hemophilia B in more than 15 years. This approval marks the beginning of a fierce race for shares in the hemophilia market. The total hemophilia market for recombinant factor VIII, IX and VIIa products totaled US$ 7.2 bln in 2012 with steady growth rates during the last decade. There are 46 different molecules and R&D approaches for novel recombinant coagulation factors for hemophilia A and B in the pipeline of which 24 are in clinical development or under regulatory review. Given this tight competition, time-to-market will be an important success.

In addition, results of a recently published study about the risk of developing inhibitors with recombinant or plasma-derived factor VIII products left one recombinant factor VIII (rFVIII) rather vulnerable to market erosion because it was associated with a significantly higher rate of inhibitor formation than the main competitor products. This finding might be the starting point for a shift in market shares among the currently marketed recombinant factor VIII products and future ones.

The new report “Recombinant Coagulation Factors 2013 – The Race to Market and for Market Shares: A Technology & Pipeline Assessment and Corporate Benchmarking Analysis” will explain the potential development and approval timelines of each of the advanced molecules. The report provides detailed profiles of active recombinant coagulation factors in clinical development. Preclinical projects are valued on the basis of the underlying technologies. Emerging alternative therapeutic approaches are described and assessed. The detailed target pipeline assessments put emphasis on the competitive situation regarding stage of development, inhibitor profile, half-life, administration frequency, clinical success and especially time to approval/market.

About La Merie
La Merie Publishing is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.

About PipelineReview.com
PipelineReview.com is the Biologics News Center and Online Store of La Merie Publishing focused on Research and Development in the Biopharmaceutical Industry.  FREE R&D Newletters conveniently bring via e-mail a daily or weekly selection of the most interesting news from biopharmaceutical R&D. For more information visit www.pipelinereview.com

SOURCE: La Merie Publishing

  • Weight reduction as unique feature of GLP-1R agonists
  • Results of cardiovascular outcomes studies eagerly awaited
  • Demonstration of protective effect on beta cells could further boost the market potential

STUTTGART, Germany | March 19, 2012 | La Merie Publishing released a new analysis of glucagon-like peptide-1 receptor (GLP-1R) agonists regarding business, commercial, clinical and scientific aspects. The report entitled “Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists - A Target Pipeline and Stakeholder Analysis 2012” analysed the GLP-1R agonist pipeline. The study revealed that in addition to the three approved and marketed GLP-1R agonists (Byetta, Victoza and once-weekly Bydureon) 66 R&D projects including eight life cycle versions are in the pipeline over all R&D stages.

The vast majority of new GLP-1R agonists are designed to have improved features which mainly are based on convenience (less frequent administration or non-invasive/oral administration). Molecules with less frequent subcutaneous administration make out half of all projects with 13 projects in clinical phases II or III, while 18 R&D projects are directed to non-invasive or oral administration of GLP-1R agonists with only one program in phase II. A strongly emerging third cluster of novel GLP-1 R agonists is that of GLP-1R agonists in combination with insulin at a fixed ratio and of GLP-1R co-agonists or dual targeting GLP-1R agonists, i.e. agonists which also act at the receptor of glucagon (mostly) or GIP.

The launch of the once daily GLP-1R agonist Victoza from Novo Nordisk in 2010 boosted the market size to US$ 1.7 bln in 2011. Victoza became a blockbuster in its second year on the market. The unique feature of weight reduction associated with the use GLP-1R agonists clearly differentiates this antidiabetic drug class from other established antidiabetics. The profound blood glucose lowering effect without significant hypoglycemia made GLP-1R agonists to a strongly emerging antidiabetic drug class. Gastrointestinal side effects such as nausea, vomiting and diarrhea seem to be associated with the pharmacologic effect of GLP-1R agonism.

About La Merie Publishing

La Merie Publishing is an independent business information provider for the biopharmaceutical industry. We publish reports and newsletters, and provide the service of preparing tailor-made reports. The full range of our products are commercialized via our associated biotech portal www.PipelineReview.com and reselling partners. For more information visit www.lamerie.com.

With potentially more than 20 products in the recombinant coagulation factors market within 5 to 6 years, it will be mandatory to meet the needs of a US$ 6.2 bln market in 2010 in order to gain a relevant market share

SITGES, Spain | October 26, 2011 | The Business Intelligence firm La Merie S.L. conducted its 3rd analysis of the coagulation factor market and R&D pipeline and benchmarked the product target profiles by a market research study among haemophilia specialists. The target pipeline analysis showed that the number of clinical stage projects of recombinant coagulation factors doubled to more than 22 within one year. The first regulatory files have been submitted and regulatory approvals in all classes of recombinant coagulation factors are feasible within the next four years.

The global market of recombinant coagulation factors was US$ 6.2 bln in 2010 and showed a continuous annual growth rate of 8.5% over the last 5 years. Given the strong pipeline activities, the recombinant coagulation factor market may become overcrowded with nearly 30 new and established products from more than 10 different suppliers within 5 to 6 years. The fierce competition for market shares makes it mandatory to meet the needs of the market with clear differentiation factors.

The primary target profile of novel recombinant coagulation factors puts emphasis on reducing the administration frequency by prolongation of the half-life which is easily measurable in experimental and clinical studies. However, the market survey among hematologists revealed a different priority for which the study participants would accept a higher price. Physicians would not accept higher annual treatment costs for a less frequent administration regimen. And if once-weekly dosing were not feasible, additional advantages will be required to sell the product.

These results and more were found in the search conducted by La Merie. The report can be acquired at La Merie’s online store (www.pipelinereview.com). The report “Coagulation Factors 2011 – who does meet the market needs? A Pipeline Assessment, Market Survey and Corporate Benchmark Analysis” provides a description, evaluation and assessment of the recombinant coagulation factor R&D pipelines as of October 2011. The authors analyze and assess the target pipeline for each of the coagulation factors for haemophilia and work out the target profiles of development projects. A market research study was conducted to challenge industry’s target profiles and evaluate the sensitivity for pricing. The report is built upon primary and secondary search for information and use of a proprietary database and news portal. A market survey was conducted among haematologists from haemophilia care centers. In house analysts with experience in biopharmaceutical R&D and business development authored the report and analysed and assessed the findings.

About La Merie

La Merie S.L. is a Business Intelligence enterprise dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.

SOURCE: La Merie Business Intelligence

100 blockbuster drugs with combined sales of US$ 249 bln; 61% small molecule blockbusters with US$ 150 bln compared with US$ 85 bln for 31 biologic blockbusters

SITGES, Spain | November 23, 2011 | The Business Intelligence firm La Merie S.L. released its new compilation of Blockbuster Drugs 2010. The search identified 100 blockbuster drugs with sales of more than US$ 1 bln in 2010. Total sales of all blockbuster drugs in 2010 were US$ 249 bln. Twelve of them were Mega-Blockbusters with 2010 sales of more than US$ 5 bln, half of them antibodies and the other half were small molecules. Combined 2010 sales of the TOP 10 small molecule blockbusters were slightly higher than those of antibodies & proteins: US$ 63.7 bln versus US$ 55 bln. There were 5 blockbuster peptide drugs totalling 2010 sales of US$ 9 bln and only 3 vaccine blockbuster drugs with combined sales of US$ 5 bln. Of the 100 blockbuster drugs, 61% were small molecules, 10% recombinant antibodies and 21% therapeutic proteins. The therapeutic areas with the highest combined blockbuster drug sales were cardiovascular (US$ 51 bln), followed by oncology (US$ 46 bln) and neurology & psychiatry (US$ 40 bln).

These results and more were found in an elaboration prepared by La Merie Business Intelligence and published in a complimentary report on November 14, 2011. The pdf document entitled “Blockbuster Drugs 2010” can be downloaded for free at La Merie’s News Center and Online Store www.pipelinereview.com.

The report has been published as a special issue of R&D Pipeline News on November 14, 2011 and has 24 pages. The reports lists the 100 blockbuster drugs with information on Drug name; Target; Class of compound; Company; Product Category; and Source of information with hyperlink and sales figures. The report summarizes the TOP 10 best selling blockbuster drugs in 2010 separately for small molecules, antibodies & proteins, peptides and vaccines. In addition, sales of blockbuster drugs were analyzed by therapeutic area and within each therapeutic area split per product category, i.e. small molecules, antibodies, proteins, peptides and vaccines.

About La Merie

La Merie S.L. is a Business Intelligence enterprise dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.

SITGES, Spain | March 7, 2011 | The Business Intelligence firm La Merie S.L. released its new compilation of biologics sales in 2010. In its fifth edition, the report revealed that 2010 sales of mainly recombinant therapeutic proteins and antibodies exceeded US$ 100 bln (from US$ 92 bln in 2009 to US$ 108 bln in 2010). Growth was mainly driven by therapeutic antibodies (+16% to +33% vs previous year) which accounted for 48% of biologics sales in 2010. Among the therapeutic proteins, double digit growth was reported for insulin and insulin analogs (+17%) and recombinant coagulation factors (+16%), whereas modest growth (4% to 7%) was observed for therapeutic proteins, except for erythropoietin which continued its descent (-3% vs 2009) and FSH products (-1%). The anti-TNF biologic etanercept continued to be the single best selling blockbuster molecule with 2010 sales of US$ 7.287 bln. The insulin analog detemir achieved for the first time blockbuster status and increased together with the neurotoxin Botox the number of blockbuster antibodies and proteins to 30. These results and more were found in an elaboration prepared by La Merie Business Intelligence and published in a complimentary report on March 7, 2011. The document entitled “TOP 30 Biologics 2010” can be acquired as a free download at La Merie’s News Center and Online Store PipelineReview.com (www.pipelinereview.com).

The “TOP 30 Biologics 2010” report presents in tabular format 2010 sales figures 1) of the TOP 30 branded biologic products with more than US$ 1 bln sales; 2) of the 14 top-selling classes of recombinant biologicals, i.e. proteins and antibodies (excluding vaccines and peptides), and in detail the sales figures of the individual products. In addition, information is provided on brand and generic names, target, class of compound, originator and licensee companies, product category and major indications. All information is fully referenced by a hyperlink leading to the original source of information.

About La Merie

La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.

About PipelineReview.com

PipelineReview.com is the News Center and Online Store of La Merie Business Intelligence focused on Research and Development in the Biopharmaceutical Industry. FREE R&D Newletters conveniently bring via e-mail a daily or weekly selection of the most interesting news from biopharmaceutical R&D. For more information visit www.pipelinereview.com.

SOURCE: La Merie Business Intelligence

Many good news (accelerated approval, impressive tumor response rates, strong pipeline fill-up, reasonable attrition rate) for the complex antibody-drug conjugate technology, but final technological, clinical and comercial validation needed

SITGES, Spain | September 19, 2011 | The Business Intelligence firm La Merie S.L. analysed antibody-drug conjugate technologies, stakeholders and the R&D Pipeline of 23 active clinical stage, 11 discontinued clinical stage, 7 close to phase I and 20 preclinical stage ADC compounds. The recent accelerated approval of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris based on stunning tumor response rates raised great enthusiasm among stakeholders in this field. Analysts expect strong sales of the expensive therapy. However, the FDA requests post-approval studies showing that the high response rates translate into improved survival and that the clinical benefit seen in a small study population can be confirmed in a larger population – Pfizer’s Mylotarg failed to show such a survival benefit. Genentech will be the next company to come up with survival data of its solid tumor ADC trastuzumab emtansine expected for 2012-2014. So far, only two controlled studies with ADC compounds have been published: one with Mylotarg failed to show a survival benefit, but T-DM1 pleased with an improved safety profile versus the combination of naked antibody with systemic chemotherapy.

Results of early stage clinical trials of a number of ADC projects promise anti-tumor activity in hematologic malignancies as well as in solid tumors, but also dose-limiting toxicities which still narrow the therapeutic window for the currently used drugs and linkers. Nevertheless, about half of the currently clinical stage ADC projects entered clinical development within the last year indicating a high interest in the industry which also is reflected by the numerous licensing deals of the technology providers with pharmaceutical and biotech companies. The attrition rate of ADC development projects so far is well within the rate in oncology, or even better. However, ADC technologies still can be improved and candidates are emerging but need more time for validation and maturation. These results and more were found in the search conducted by La Merie. The report can be acquired at La Merie’s online store (www.pipelinereview.com).

The report “Antibody-Drug Conjugates 2011 – real breakthrough still to come: A Technology, Stakeholder and R&D Pipeline Analysis” published in September 2011 provides the most complete compilation of information about antibody-drug conjugate (ADC) companies, technologies and products in R&D. A comprehensive analysis of the state of the art and key trends guides the reader through this complex subject. Stakeholders in the field of antibody-drug conjugates are analysed and their contribution to the growth of ADC technology and products is assessed. A critical appraisal of the clinical results of active and discontinued ADC projects and products is provided. ADC technologies and products are challenged for their commercial value and growth potential.

About La Merie

La Merie S.L. is a Business Intelligence enterprise dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.

About PipelineReview.com

PipelineReview.com is the News Center and Online Store of La Merie Business Intelligence focused on Research and Development in the Biopharmaceutical Industry. For more information visit www.pipelinereview.com.