07.21.14
Headquarters: New Brunswick, NJ
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www.jnj.com
TOP SELLING DRUGS
After years marked by manufacturing problems, product recalls and a consent decree at the company’s Fort Washington, PA facility, J&J is moving ahead with quality programs and additions to its pipeline. The company has restored supplies of over-the-counter drugs that had been affected by quality problems and recalls. Over the past four years, it has introduced 11 new products, including the prostate cancer drug, Zytiga.
According to CEO Alex Gorsky, J&J is the fastest growing Top 10 pharma company in the U.S., Europe and Japan, and has continued to invest about 11% of sales each year to support R&D.
J&J is currently focusing on global markets, wth over 275 companies in 60 countries. Currently, 55% of the company’s business coms from outside the U.S, and 22% of market growth from the BRIC nations (Brazil, Russia, India and China).
The company plans to introduce simeprevir for hepatitis C, its “breakthrough” drugs ibrutinib and daratumumab for the treatment of hematologic malignancies, as well as sirukumab and guselkumab for immune mediated diseases. The company also has plans for esketamine, an antidepressant based on its version of ketamine. The company is moving quickly in Japan and China, where Janssen plans to file nine NME’s and six brand line extensions by 2017.
Last year, FDA rejected, for the third time, its supplemental New Drug Application (sNDA) for rivaroxaban, citing the need for more clinical data proving safety and efficacy.
However the company has scored a number of approvals, for instance, for Siltuximag (CNTO 328), a treatment for multicentric Castleman’s disease, a rare blood disease similar to lymphoma.
FDA also approved Imbruvica, developed by Pharmacyclics and J&J as a treatment for mantle cell lymphoma.
J&J subsidiary Janssen Pharmaceuticals has submitted its new once daily antiretroviral drug, Prestiza, for FDA approval as an HIV treatment.
Prestiza reportedly contains darunavir, a protease inhibitor developed by Janssen’s research and development team in Ireland, and cobicistat, a boosting agent developed by Gilead Sciences.
Darunavir is already sold as an HIV treatment, but use of Gilead’s boosting agent would allow the two products to be combined, resulting in a single pill daily therapy.
The company plans to extend its range of hepatitis C therapies, and recently acquired a drug candidate GSK2336805, from GSK, who had developed it with Vertex Pharmaceuticals. Janssen plans to test it in combination with simeprevir, a drug that it developed with Medivir, that is awaiting regulatory approval to be used in combination with the standard therapy of interferon and ribavirin.
Janssen hopes that the Glaxo drug can take the place of interferon in that cocktail. Its hepatitis C drug Olysio did well in clinical trials, and has been approved by FDA.
J&J has also taken steps to make its clinical trial data more transparent. Janssen R&D LLC now has a clinical trial data sharing arrangement with Yale University School of Medicine’s open door access project, to share clinical trials data to enhance public health. Working with an independent third party is expected to improve scientific understanding of diseases and treatment opportunities. The company has also created innovationcenters in London, Shanghai, Boston, San Francisco and San Diego to form what CEO Gorsky calls an “international network of scientific entrereneurs.”
Battling Cancer
J&J moved more aggressively to extend its range of prostate cancer treatments by acquiring Aragon Pharmaceuticals, which has developed ARN-509, now in Phase II development for castration-resistant prostate cancer. The drug would complement J&J’s existing treatment, Zytiga (abiraterone acetate), which has been approved in the U.S. and Europe.
In the hot field of immunooncology, J&J Innovation and Janssen Biotech are collaborating with The Dana Farber Research institues. The company made some acquistions last year, notably buying Synthes. However, it has also been focusing its efforts and divesting of businesses that don’t seem to fit. J&J recently sold its Ortho Clinical Diagnostics to The Carlyle Group.
twitter.com/JNJComm
www.jnj.com
Headcount: | 128,100 | |
Year Established: | 1887 | |
Pharma Reveneus: | $28,125 | 1% |
Total Revenues: | $71,312 | 6% |
Net Income: | $13,831 | 32% |
R&D Budget: | $8,183 | 14% |
TOP SELLING DRUGS
Drug | Indication | 2013 sales | (+/- %) |
Remicade (infliximab) | inflammation | $6,673 | 9% |
Zytiga | cancer | $1,698 | 77% |
Prezista | infection | $1,673 | 18% |
Velcade | cancer | $1,660 | 11% |
Stelara (ustekinumab) | psoriasis | $1,504 | 47% |
Procrit | anemia | $1,367 | -7% |
Risperdal | schizophrenia | $1,318 | -8% |
Invega | schizophrenia | $1,248 | 57% |
After years marked by manufacturing problems, product recalls and a consent decree at the company’s Fort Washington, PA facility, J&J is moving ahead with quality programs and additions to its pipeline. The company has restored supplies of over-the-counter drugs that had been affected by quality problems and recalls. Over the past four years, it has introduced 11 new products, including the prostate cancer drug, Zytiga.
According to CEO Alex Gorsky, J&J is the fastest growing Top 10 pharma company in the U.S., Europe and Japan, and has continued to invest about 11% of sales each year to support R&D.
J&J is currently focusing on global markets, wth over 275 companies in 60 countries. Currently, 55% of the company’s business coms from outside the U.S, and 22% of market growth from the BRIC nations (Brazil, Russia, India and China).
The company plans to introduce simeprevir for hepatitis C, its “breakthrough” drugs ibrutinib and daratumumab for the treatment of hematologic malignancies, as well as sirukumab and guselkumab for immune mediated diseases. The company also has plans for esketamine, an antidepressant based on its version of ketamine. The company is moving quickly in Japan and China, where Janssen plans to file nine NME’s and six brand line extensions by 2017.
Last year, FDA rejected, for the third time, its supplemental New Drug Application (sNDA) for rivaroxaban, citing the need for more clinical data proving safety and efficacy.
However the company has scored a number of approvals, for instance, for Siltuximag (CNTO 328), a treatment for multicentric Castleman’s disease, a rare blood disease similar to lymphoma.
FDA also approved Imbruvica, developed by Pharmacyclics and J&J as a treatment for mantle cell lymphoma.
J&J subsidiary Janssen Pharmaceuticals has submitted its new once daily antiretroviral drug, Prestiza, for FDA approval as an HIV treatment.
Prestiza reportedly contains darunavir, a protease inhibitor developed by Janssen’s research and development team in Ireland, and cobicistat, a boosting agent developed by Gilead Sciences.
Darunavir is already sold as an HIV treatment, but use of Gilead’s boosting agent would allow the two products to be combined, resulting in a single pill daily therapy.
The company plans to extend its range of hepatitis C therapies, and recently acquired a drug candidate GSK2336805, from GSK, who had developed it with Vertex Pharmaceuticals. Janssen plans to test it in combination with simeprevir, a drug that it developed with Medivir, that is awaiting regulatory approval to be used in combination with the standard therapy of interferon and ribavirin.
Janssen hopes that the Glaxo drug can take the place of interferon in that cocktail. Its hepatitis C drug Olysio did well in clinical trials, and has been approved by FDA.
J&J has also taken steps to make its clinical trial data more transparent. Janssen R&D LLC now has a clinical trial data sharing arrangement with Yale University School of Medicine’s open door access project, to share clinical trials data to enhance public health. Working with an independent third party is expected to improve scientific understanding of diseases and treatment opportunities. The company has also created innovationcenters in London, Shanghai, Boston, San Francisco and San Diego to form what CEO Gorsky calls an “international network of scientific entrereneurs.”
Battling Cancer
J&J moved more aggressively to extend its range of prostate cancer treatments by acquiring Aragon Pharmaceuticals, which has developed ARN-509, now in Phase II development for castration-resistant prostate cancer. The drug would complement J&J’s existing treatment, Zytiga (abiraterone acetate), which has been approved in the U.S. and Europe.
In the hot field of immunooncology, J&J Innovation and Janssen Biotech are collaborating with The Dana Farber Research institues. The company made some acquistions last year, notably buying Synthes. However, it has also been focusing its efforts and divesting of businesses that don’t seem to fit. J&J recently sold its Ortho Clinical Diagnostics to The Carlyle Group.