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Johnson & Johnson (JNJ)

  • Jun. 18, 2014, 9:15 AM
    • Vertex Pharmaceuticals (VRTX) licenses its influenza drug candidate VX-787 to J&J (JNJ) unit Janssen Pharmaceuticals. Under the terms of the agreement, Vertex receives an upfront payment of $30M, additional development and commercial milestone payments and royalties on future sales.
    • VX-787 works by directly inhibiting the replication of the flu virus. In a Phase 2a study, the drug met its primary endpoint of statistically significant improvements in viral and clinical measurements.
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  • Jun. 12, 2014, 4:16 PM
    • Privately-held biosimilar developer Epirus Biopharmaceuticals acquires Zalicus (ZLCS +38.9%) in an all-stock deal. The post-merger firm will be named Epirus Biopharmaceuticals. Current ZLCS shareholders will own ~19% of the combined enterprise. Their proportion could go down as low as 14% if Zalicus' cash position falls below $9M at closing.
    • Epirus's pipeline includes biosimilars for Janssen's (JNJ -0.8%) Remicade, AbbVie's (ABBV -1.1%) Humira and Genentech's (RHHBY -0.6%) Avastin.
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  • Jun. 12, 2014, 9:21 AM
    • Taking advantage of a special waiver that allows it to deny routine coverage of drugs based on cost and efficacy, Oregon Health Plan intends to limit access to Gilead's (GILD) Sovaldi and J&J's (JNJ) Olysio. The combination therapy, which is becoming more and more popular among clinicians, costs $150,000 per regimen. Covering a third of the 7,000 OHP members with Hep C for Sovaldi alone ($84,000/regimen) would cost $196M. This would double its system-wide drug spending. Last year, the Plan spent a total of $377M for pharmaceuticals for all of its 600K members.
    • In 2012, Governor John Kitzhaber agreed to cap OHP costs in exchange for $1.9B in federal aid over five years. If costs rise above 3.4%/year it must reimburse the feds hundreds of millions of dollars.
    • The OHP situation is getting a lot of scrutiny because of the budget-busting consequences of paying for ultra-expensive drugs. Many observers hope its actions spur debate on how to curb prices without stifling innovation.
  • May. 29, 2014, 10:49 AM
    • Johnson & Johnson (JNJ +0.1%) and Bausch & Lomb are among the companies fined 19.6 yuan ($3M) for price fixing in China's contact lens and eyeglass market. Chinese authorities have fined companies in other medical industries for price-related infractions as it grapples with its ballooning health care costs.
  • May. 22, 2014, 10:57 AM
    • Executives at Johnson & Johnson's (JNJ -0.6%) $28.5B Medical Devices and Diagnostics segment meet with institutional investors today discuss the business and outline their plans to drive global growth.
    • Key points include: ~$1.8B in R&D investments last year; a pipeline of more than 30 major product filings by the end of 2016; $6B in device sales; acquisition of Spectrum Vision enables the delivery of more than 85% of Acuvue contact lenses the same day or next day across all time zones in Russia; China operations grew 18% last year to $1.4B.
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  • May. 20, 2014, 5:07 PM
    • The FDA approves Takeda's Entyvio (vedolizumab) for the treatment of moderate-to-severe ulcerative colitis and moderate-to-severe Crohn's disease in adult patients who have not responded to one or more standard therapies.
    • Vedolizumab is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells and function as bridges for cell-to-cell interactions. The mAb works by blocking the migration of circulating inflammatory cells across blood vessels and into areas of inflammation in the GI tract.
    • Related tickers: (SHPG) (JNJ) (AZN) (BIIB) (ABBV)
  • May. 19, 2014, 11:32 AM
    • In a survey of specialists, Research firm Decision Resources Group finds that Gilead's (GILD +1.3%) HCV treatment Sovaldi accounts for 50% of the patient share followed by J&J's (JNJ -0.3%) Olysio at 20%.
    • The majority of Olysio prescriptions are being written for the off-label combination with Sovaldi with or without ribavarin. Trending analysis shows that the off-label prescribing for the combination has more than doubled with 30% of specialists reporting having at least some patients on the regimen.
    • Hepatologists are more likely to prescribe the Sovaldi/Olysio combination than gastroenterologists or infectious disease specialists. The latter two have the majority of their HCV-1 patients on first-gen protease inhibitor therapy. The reason for the disparity appears to be awareness.
  • May. 16, 2014, 8:55 AM
    • The European Commission approves J&J (JNJ) unit Janssen Pharmaceuticals' Olysio (simeprivir) for the treatment of Hepatitis C genotype 1 and 4 infection in combination with other medicines.
    • Olysio is already approved for sale in the U.S., Japan, Canada and Russia. It will be available in the EU in 2H 2014.
    • Related tickers: (GILD) (ABBV) (BMY) (MRK)
  • May. 15, 2014, 9:32 AM
    • Actavis (ACT) and J&J (JNJ) unit Janseen Pharmaceuticals extend their supply and distribution agreement for Janssen's Concerta (methylphenidate hydrochloride extended-release tablets) to December 31, 2017. Janssen will continue to manufacture and supply all dosage strengths of the authorized generic product and Actavis will continue to market it in the U.S. and pay Janssen 50% of net sales.
    • Under the terms of the contract, Actavis may pursue FDA clearance of its own ANDA for a generic version of the product and launch it at after 2017.
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  • May. 14, 2014, 7:35 AM
    • Britain's healthcare cost effectiveness agency NICE says J&J's (JNJ) Zytiga (abiraterone) is not worth giving to patients who have yet to receive chemotherapy. The drug is currently approved for use in some men after chemo.
    • Apparently, J&J's own economic model shows Zytiga is not cost effective when used earlier. The once-daily tablet costs 2,930 pounds ($4,900) for a 120-tablet regimen.
    • Institute of Cancer Research deputy chief executive Paul Workman is disappointed in NICE's decision and urges the parties to work together on a revised price that would make the economics attractive.
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  • May. 14, 2014, 7:22 AM
    • An analysis of more than 120 studies finds that naltrexone, Forest Labs' (FRX) Campral (acamprosate), J&J's (JNJ) Topamax (topiramate) and H. Lundbeck A/S' Selincro (nalmefene) all helped alcoholics reduce their drinking.
    • The oldest FDA-approved alcoholism drug, Antabuse (disulfiram), did not prevent a return to the bottle.
    • Alkermes Plc's (ALKS) injectable Vivitrol (naltrexone) reduced patients' heavy drinking days but there were not enough studies to draw conclusions.
    • The drugs are underutilized because many primary care physicians refer patients with drinking problems to specialists like drug counselors or to groups like AA. None of these providers can prescribe medicines.
    • There are almost two dozen drugs that are used off-label to combat alcoholism. No one product works for everyone, though. On average, 12 people need to be treated with acamprosate for one person to benefit. For naltrexone, the ratio is 20:1.
    • Predictably, the researchers say more studies are needed.
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  • May. 13, 2014, 9:40 AM
    • J&J (JNJ +0.6%) unit Janssen Pharmaceuticals submits an sNDA for a label expansion for its injectable schizophrenia drug Invega Sustenna (paliperidone palmitate) for the treatment of schizoaffective disorder as a monotherapy or adjunctive therapy.
    • If cleared, it will be the only long-acting injectable drug approved for the condition.
    • The product has been available since 2009 as a treatment for schizophrenia.
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  • May. 12, 2014, 12:10 PM
    • The South Korean colossus is investing $2B in the biotech arena in an effort to drive growth from its $347B revenue base. Its main initial focus will be biosimilars with a planned 2016 launch in Europe of an Enbrel biosimilar and a 2017 launch of a Remicade biosimilar.
    • The global market for biosimilars, while lagging in the U.S. due to regulatory uncertainty, is expected to grow to $24B by 2019.
    • According to unit chief Christopher Hansung Ko, "Our mandate is to become No. 1 in everything we enter into, so our long-term goal is to become a leading pharmaceutical company in the world."
    • Related tickers: (IBB) (JNJ) (AMGN) (BIIB) (XBI) (SSNLF) (SSNGY)
  • May. 11, 2014, 2:30 AM
    • Sanofi (SNY), Johnson & Johnson (JNJ) and other major pharmaceutical companies have rebuffed Allergan's (AGN) inquiries as to whether they would be interested in buying the botox maker, Bloomberg reports.
    • Sanofi isn't interested, while J&J is concerned about the problems of combining the two biggest makers of breast implants in the U.S. Allergan has also approached GlaxoSmithKline (GSK) and Novartis (NVS).
    • Allergan contacted the possible suitors as it's not happy with an acquisition offer of $45.7B from Valent (VRX) that is being supported by Bill Ackman's Pershing Square.
    • Some of the firms that Allergan has approached would possibly buy parts of the company, but not the whole business.
  • May. 9, 2014, 8:18 AM
    • Johnson & Johnson's (JNJ) Janssen Pharmaceuticals unit gives the International Partnership for Microbicides (IPM) the global rights to its experimental AIDS drug dapivirine. The charity is conducting two late-stage clinical trials in Africa evaluating the safety and effectiveness of a vaginal ring combined with dapivirine and a contraceptive. The original agreement extended the rights to IPM for developing nations only.
  • May. 7, 2014, 12:43 PM
    • Johnson & Johnson's (JNJ +1%) Janssen Pharmaceuticals unit submits an sNDA to the FDA for the use of Olysio (simeprevir) with Gilead Sciences' (GILD -0.2%) NS5B polymerase inhibitor sofosbuvir for the treatment of genotype 1 chronic hepatitis C in adult treatment-naive patients with advanced fibrosis and null responders with all stages of fibrotic disease. The product is currently approved as a combination therapy with peginterferon alfa and ribavirin as a treatment for HCV-1 for compensated liver disease including cirrhosis.
    • The company's regulatory submission is based on data from the Phase 2 Optimist trial which included the fibrosis and null-responding patients cited above.
    • Last month, Janssen started a Phase 3 trial to examine the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of HCV-1 patients.
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Company Description
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.