Thu, Jan. 8, 11:53 AM
- Investors show thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +27.9%) some love after yesterday's positive Ad Comm vote for Sandoz's biosimilar filgrastim. Shares are up on a 6x surge in volume albeit on turnover of only 150K.
- Epirus' lead product is BOW015 (infliximab), a biosimilar to Janssen's (JNJ +0.8%) Remicade. The product is currently marketed in India by Ranbaxy Laboratories Limited. A global Phase 3 trial to support regulatory submissions in other markets will commence this year.
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
Tue, Jan. 6, 4:07 AM
- Johnson & Johnson (NYSE:JNJ) has started a trial of its experimental Ebola vaccine in the U.K., saying it will produce 2M courses of the shot this year.
- The vaccine combines a shot from the company's Janssen unit with one developed by Bavarian Nordic (OTCPK:BVNRY).
- Drugmakers are racing against the clock to develop a vaccine against Ebola to curb an outbreak that has struck more than 20K and killed more than 8K in West Africa, according to the World Health Organization.
- JNJ +0.4% premarket
- Previously: J&J to begin testing Ebola vaccine in January (Oct. 22 2014)
Mon, Jan. 5, 1:48 PM
- Isis Pharmaceuticals (ISIS +8.1%) and Janssen Biotech (JNJ -0.6%) enter into a global collaboration to discover and develop antisense drugs to treat autoimmune disorders of the gastrointestinal (GI) tract. The partnership brings together Isis' RNA-targeted technology platform with Janssen's expertise in autoimmune disorders and therapeutic formulation.
- Under the terms of the agreement, Isis will receive an upfront payment of $35M and will be eligible for almost $800M in development, regulatory and sales milestones and license fees. It will also receive tiered royalties that average double digits on commercial sales.
Mon, Jan. 5, 9:14 AM
Dec. 29, 2014, 9:08 AM
- Gilead Sciences (NASDAQ:GILD) and Janssen R&D Ireland (NYSE:JNJ) expand their partnership to include the development and commercialization of the once-daily regimen of Gilead's tenofovir alafenamide (TAF) and emtricitabine and Janssen's rilpivirine for the treatment of HIV infection. Gilead will initiate a Phase 3 trial in the coming months and be responsible for the manufacturing, registration, distribution and commercialization in most markets. Janssen will distribute in 17 markets.
- TAF is a nucleotide reverse transcriptase inhibitor that has demonstrated efficacy at a 10x lower dose than Gilead's Viread (tenofovir disoproxil fumarate) with a better renal and bone safety profile.
Dec. 22, 2014, 12:08 PM
- MacroGenics (MGNX +11%) enters into a global collaboration and license agreement with Janssen Biotech (JNJ +0.8%) for MGD011, a humanized CD19 x CD3 DART protein, for the potential treatment of B-cell malignancies. MGD011 is based on MacroGenics' proprietary platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3.
- Under the terms of the agreement, MacroGenics will receive an upfront license fee of $50M, up to $575M in various milestones and double-digit royalties on net sales as well as the option to co-promote the product with Janssen in the U.S.
- Janssen will invest $75M in MacroGenics via the purchase of 1,923,077 shares of common stock at $39 per share and will be fully responsible for developing MGD011. It expects to submit an Investigational New Drug (IND) application to the FDA in 2015.
- MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies.
Dec. 22, 2014, 2:09 AM
- The price war over hepatitis C drugs continues, after Express Scripts (NASDAQ:ESRX) announced that it will only cover AbbVie's (NYSE:ABBV) newly approved Viekira Pak, which received clearance from the FDA on Friday.
- The move will help the drug maker take market share away from Gilead Sciences (NASDAQ:GILD) and J&J (NYSE:JNJ), which make blockbuster hep C drugs, including Sovaldi, Harvoni and Olysio.
- AbbVie's Viekira Pak will have a price of $83,319, although the agreement with Express Scripts involves a significant discount to that price.
- Previously: FDA clears AbbVie HCV combo (Dec. 19 2014)
Dec. 18, 2014, 10:34 AM
- Antitrust regulators in France have fined 11 companies a combined $1.17B on price-rigging charges.
- Companies hit by the action include L'Oreal (OTCPK:LRLCF), Unilever (NYSE:UL), Colgate-Palmolive (NYSE:CL), Hillshire Brands (NYSE:HSH), Johnson & Johnson's (NYSE:JNJ) French business, and Reckitt Benckiser Group (OTCPK:RBGLY).
- Statements from the consumer products sellers expressed some outrage over the sanctions due to the limited impact on consumers.
Dec. 17, 2014, 11:30 AM
Dec. 17, 2014, 9:30 AM
- Halozyme Therapeutics (NASDAQ:HALO) and Janssen Biotech (NYSE:JNJ) enter into a worldwide Collaboration and License Agreement to develop and commercialize products based on Halozyme's Enhanze technology, which is based on HALO's proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily modifies hyaluronan, a component of the extracellular matrix, to aid in the dispersion and absorption of injected therapeutic drugs.
- Under the terms of the contract, Halozyme grants Janssen a global license to develop and commercialize products for up to five targets combining rHuPH20 with Janssen's proprietary compounds. Halozyme will receive an upfront payment of $15M and up to $566M in development, regulatory and sales milestones plus royalties on commercial sales.
Dec. 16, 2014, 7:48 AM
- Belgian biotech Galapagos NV (OTCPK:GLPYY) and Janssen Pharmaceutica NV (NYSE:JNJ) terminate their collaboration to develop the GPR84 inhibitor GLPG1205 for inflammatory bowel diseases. Full and unencumbered rights to the GPR84 program have now been transferred back to Galapagos. It plans to initiate a Phase 2 trial before the end of December.
- The reasons for the move are not disclosed.
Dec. 12, 2014, 8:14 AM
- U.S. District Court Joseph Goodwin took the unusual step of advising C.R. Bard (NYSE:BCR) to settle more than 12,000 vaginal mesh lawsuits it faces in light of the large verdicts to date. "I can't imagine a corporation facing potentially billions of dollars in verdicts wouldn't find it advisable to try to achieve a settlement for a much lesser sum," he says. "I base that billions of dollars business on some of the rather large verdicts that we've had." The judge is overseeing all federal court litigation involving the products. More than 30,000 cases have been consolidated before him.
- Women who have had the products implanted for the treatment of incontinence or to support internal organs claim that the devices erode over time causing organ damage and pain. Jury decisions so far have found the devices defectively designed or the manufacturers failed to adequately warn physicians and patients of the risks.
- In October, Bard agreed to settle 500 suits for $21M. In August, the company lost a case in West Virginia and was ordered to pay a woman $2M in damages.
- Bard is not the only company mired in litigation. Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) have recently lost jury verdicts. In September, a jury in West Virginia ordered JNJ to pay $3.27M to a woman who received the implant. Juries in Texas and Florida ordered BSX to pay $45.2M to eight women and $73M to one woman, respectively.
- The FDA ordered the three manufacturers to study the rates of organ damage and complications linked to the devices.
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
Dec. 12, 2014, 7:34 AM
- In a Phase 3b study, Novartis' (NYSE:NVS) IL-17A inhibitor Cosentyx (secukinumab) demonstrated superiority to Janssen's (NYSE:JNJ) Stelara (ustekinumab) in psoriasis patients. The study met its primary endpoint of PASI 90 at week 16 as well as its secondary endpoint of PASI 75 at week 4. The results from the 679-patient study will be presented at a medical conference next year.
- In an earlier trial, Cosentyx demonstrated superiority to Amgen's Enbrel (etanercept).
- Regulatory approvals of secukinumab for the treatment of moderate-to-severe plaque psoriasis are pending.
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
Dec. 11, 2014, 11:58 AM
- The Global Alliance for Vaccines and Immunisation, Gavi, plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. An additional $90M could be used to support countries that introduce the vaccine and to rebuild devastated health systems and restore immunisation services in Ebola-stricken countries.
- Gavi is funded by governments and the Bill & Melinda Gates Foundation.
- Two vaccine candidates are currently being tested in humans in Phase 1 trials. The first trial, assessing Merck (MRK +0.8%) and NewLink Genetics' (NLNK -0.8%) candidate, experienced a hiccup recently when four volunteers complained of joint pain in their hands and feet. The trial is on hold as a precaution, but will restart on January 15 contingent on no further adverse events. The second trial, assessing the combination of GlaxoSmithKline's (GSK +0.4%) monovalent cAd3-EBO Z Ebola vaccine candidate with Bavarian Nordic's MVA-BN Filo booster vaccine, has experienced no adverse events to date.
- Johnson & Johnson (JNJ +0.8%) will begin testing its Ebola vaccine candidate in January and says it will have 250K doses for clinical study by May.
- Previously: Merck-NewLink Ebola vaccine trial interrupted (Dec. 11, 2014)
- Previously: Phase 1 underway for Ebola booster vaccine regimen (Dec. 4, 2014)
- Previously: J&J to begin testing Ebola vaccine in January; expects 250K doses ready by May (Oct. 22, 2014)
Dec. 5, 2014, 1:57 PM
- As expected, the Biotechnology Industry Organization (BIO) gives a resounding thumbs up in support of adding Ebola to the FDA Priority Review Voucher Program Act. Under the act, developers of a vaccine or treatment for a qualified tropical disease receive a voucher for FDA priority review for another product of its choice.
- Late Wednesday, the U.S. House of Representatives voted unanimously to add Ebola to the Act. Additional refinements to the legislation include making it easier for the Secretary of Health and Human Services to add to the list of qualified diseases, allowing the vouchers to be sold and transferred multiple times and shortening the timeline for notifying the FDA of the intention to use a priority review voucher.
- The changes bring the tropical diseases priority review voucher program more in line with the rare pediatric disease priority review voucher program.
- Ebola-related tickers: (GSK +0.2%)(JNJ +0.5%)(MRK +1%)(NLNK +2.2%)(TKMR -1.4%)(HEB +0.6%)(SRPT -0.8%)(BCRX +0.8%)(CMRX +3.2%)
Dec. 5, 2014, 7:19 AM
- Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work. Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
- The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
- ETFs: IRY, IXJ
- Ebola-related tickers: (NYSE:GSK) (NYSE:JNJ) (NYSE:MRK) (NASDAQ:NLNK) (OTCQB:AEMD) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:SRPT) (NASDAQ:BCRX)
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