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.
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.
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.
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.
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.
Apr. 30, 2014, 7:36 AM
- Reuters reports that the French pharmaceutical firm (SNY) is working with Evercore partners to find a buyer for a portfolio of mature drugs that include treatments for high blood pressure and cardio-metabolic diseases.
- The businesses, which generate ~$3.7B in annual sales, should fetch between $7B and $8B.
- Generic firms or specialty pharma companies are likely acquirers.
- Sanofi's initiative is consistent with other members of big pharma who want to shed smaller, less profitable and/or non-core businesses in order to focus on their principal growth drivers.
- (JNJ) (MRK) (PFE) (GSK) (LLY) (NVS) (AZN)
Apr. 30, 2014, 7:16 AM
- The European Commission approves Otsuka Pharmaceutical Company's combination therapy Deltyba (delamanid) for the treatment of pulmonary multdrug-resistant tuberculosis.
- The disease remains a significant public health threat in poor countries.
- The FDA approved Johnson & Johnson's (JNJ) Sirturo(bedaquiline) in late 2012.
Apr. 30, 2014, 7:06 AM
- Citing its concern that Ethicon's morcellation devices may have a role in spreading uterine cancer Johnson & Johnson (JNJ) suspends global sales of the product until it has a better understanding of the matter.
- On April 17 the FDA issued an advisory to the medical community discouraging physicians from using laparoscopic power morcellators to remove fibroids because of a risk of worsening uterine sarcomas.
- The company states that its action is not a product removal since the morcellation procedure remains a therapeutic option for certain patients after risk evaluation and informed consent.
Apr. 29, 2014, 9:49 AM
- Allergan (AGN +0.6%) is holding early-stage talks with Sanofi (SNY) and Johnson & Johnson (JNJ) to see if they're interested in topping Valeant's (VRX) $45.7B bid for the Botox maker, Bloomberg reports.
- Sanofi and J&J are mulling their options, although it's not clear whether they are interested.
- Bayer has also been contacted, but it's focusing on trying to win an auction for Merck's over-the-counter medicines operations.
Apr. 24, 2014, 10:48 AM
Apr. 17, 2014, 8:39 AM
- Aiming to capture a chunk of Janssen Pharmaceuticals' (JNJ) ORTHO EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System 150/35 mcg/day) $150M U.S. sales, Mylan (MYL) launches its generic equivalent XULANE.
- The product is indicated for the prevention of pregnancy in women who use a transdermal patch as a method of contraception.
- According to IMS Health, Mylan has 300 ANDAs pending FDA approval representing $104.5B in branded sales. 42 are first-to-file submissions representing over $25B in branded sales.
Apr. 15, 2014, 6:25 PM
- Surgical device maker ConMed (CNMD) is exploring a sale of the company, Reuters reported earlier today, after activist investors late last year took issue with its performance and corporate governance.
- The company's advisers, BoA Merrill Lynch and Greenhill, reportedly have contacted orthopedic device makers in recent weeks to gauge interest.
- CNMD has an attractive orthopedics and sports medicine business that could appeal to companies such as Zimmer Holdings (ZMH), Johnson & Johnson (JNJ), Stryker (SYK), Covidien (COV) and Medtronic (MDT).
- CNMD shares gained 7.2%, rallying from a loss before the report late in the session.
Apr. 15, 2014, 3:51 PM
- Johnson & Johnson's (JNJ +2%) hepatitis C drug Olysio (simeprevir) blew out Q1 expectations with its $354M in sales. Wells Fargo analyst Lawrence Biegelsen forecasted only $23M.
- Some observers believe that many physicians are prescribing the drug in combination with Gilead's (GILD +2.3%) Sovaldi (sofosbuvir) thereby inflating the full regimen cost to ~$150,000 in the U.S.
- A 12-week course of treatment of Olysio costs $66,360.
JNJ vs. ETF Alternatives
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.
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