Thursday, September 17, 2009
Top 10 Biologics Sales Top $41 billion
Immunex Corp. patented the first biological response modifier approved for the treatment of rheumatoid arthritis (RA), called Enbrel, after cloning the soluble tumor necrosis factor (TNF) receptor gene in 1989. TNF, found in high amounts in the joints of arthritis sufferers, promotes inflammation. The genetically engineered fusion product Enbrel inhibits TNF by binding to it, which aids the patient by reducing the swelling, stiffness and pain from RA. Immunex, acquired by Thousand Oaks, Calif.-based Amgen Inc. for $10.3 billion in July 2002, continues to manufacture Enbrel. Enbrel sales for 2008 were up, despite U.S. approval of Humira for psoriasis.
Rituxan has experienced a gainful 12-year market run, bringing in more than $22 billion through 2008. Considering the dramatically increasing prevalence in its disease indications, Rituxan could become the first biologic to join big pharma blockbusters in the exclusive $50 billion club. Genentech Inc. and Biogen Idec Inc. state on their websites that they are preparing to make FDA submissions for Rituxan in previously untreated and relapsed chronic lymphocytic leukemia. A Phase III trial for Rituxan in treating vasculitis is ongoing.
Approved for five indications in the U.S., the revenue for Humira has been increasing rapidly over the years, more than tripling in sales from 2005 to 2008. In 2007, it brought in more than $3 billion, and it continued the trend in 2008, reaching sales of more than $4.5 billion. According to Abbott's 10-K filed in February 2009, the company forecasts worldwide Humira sales to increase more than 25 percent in 2009. Cambridge Antibody Technology Group plc (CAT), of Cambridge, UK, developed the technology for Humira and initiated the research program. In 1995, it signed an agreement with Knoll Aktiengesellschaft, which was acquired by Abbott in March 2001. CAT was acquired by MedImmune Inc. in 2007.
The first anti-angiogenesis drug approved for cancer treatment, Avastin usually is combined with cancer-killing chemotherapy. A humanized IgG1 monoclonal antibody targeting vascular endothelial growth factor (VEGF), it helps stop new blood vessel formation in tumors and it also may improve drug delivery so that chemotherapy can kill more effectively. Even without approval for wet age-related macular degeneration, many doctors use it instead of the more expensive drug Lucentis (ranibizumab, Genentech). There also is huge interest in using Avastin in combination therapies, and the drug is being studied in 30 cancers in more than 450 trials.
Breast cancer patients with human epidermal growth factor receptor-2-positive tumors are candidates for Herceptin therapy. Even though the drug is only appropriate for a patient subgroup, Herceptin's success is validating the premise that pharmacogenomic drugs can attain blockbuster revenue. Herceptin has been on the market for a dozen years, in the billion-dollar annual revenue club for at least the last seven years, has no non-litigious patent competition until 2019, and has numerous ongoing trials to expand its application even further. Such factors could render Herceptin a stalwart workhorse for Genentech and an enduring ROI for Roche for most of the upcoming decade.
Remicade was developed by Centocor, a Johnson & Johnson company. As a chimeric monoclonal antibody, Remicade uses both mouse and human components. According to Robert L. Shook in his book Miracle Medicines (2007), mouse cells are used to produce a protein, which is a cross between a mouse and human protein. It is engineered into a gene structure and introduced into a mouse cell to produce a specific protein, Remicade. The drug is administered by intravenous infusion.
Novartis AG developed the first anticancer drug that targets cancer cells more specifically. Gleevec, a 2-phenylaminopyrimidine derivative, inhibits a number of abnormal tyrosine kinase enzymes, thereby turning off the signal of Bcr-Abl, a protein that is associated with cancer. Iimatinib mesylate is marketed in the U.S. as Gleevec, and in Europe and Australia as Glivec.
Neulasta is the leading anticancer therapeutic used to maintain the utility of the immune system during solid tumor chemotherapy. The drug is a synthetic form of the natural granulocyte-colony stimulating factor that promotes an increase in infection-resistant neutrophils, and it is made using the bacteria Escherichia coli. The drug binds to cell surface receptors of neutrophil precursors to change cell behavior through signaling processes that induce the production of neutrophils.
Lantus has the same type of glucose-lowering power as both commercial NPH hu insulin and insulin that is naturally produced by non-diabetics. Lantus (insulin glargine) is a soluble injectable human insulin analog produced by recombinant DNA technology (in K12 laboratory strain of E. coli). One asparagine replaced by glycine and two arginines at one end of its structure are the only difference from human insulin. Lantus minimizes spikes in insulin levels and provides 24-hour basal insulin levels with one dose, because it forms microprecipitates that are released slowly and constantly into the patient's system over a longer period of time than NPH hu insulin.
Aranesp springs from what could have been a huge loss for Amgen in the anemia market. The company licensed its epoetin alpha to Ortho Biotech Products LP, except for one indication in the U.S. Outside of the U.S., Ortho Biotech markets it as Eprex for all approved indications; inside the U.S., the drug is marketed as Procrit for indications other than kidney dialysis. Amgen's Epogen, the only indication the company retained rights to in the country, is indicated in the U.S. for the treatment of anemia in patients with end-stage renal disease. Its blockbuster Aranesp is a longer-lasting formulation of EPO.
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