Fri, Jan. 16, 8:54 AM
- A consortia of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals (NYSE:JNJ) to accelerate the development of its Ebola vaccine. The Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The project is delineated into three areas or topics:
- Topic 1: Vaccine development, Phases 1, 2 and 3. Consortia members: Janssen, London School of Hygiene and Tropical Medicine, Oxford University, Insititut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz.
- Topic 2: Manufacturing capability: Janssen, Bavarian Nordic A/S, Vibalogics.
- Topic 3: Deployment and compliance of vaccination regimens: Janssen, London School of Hygiene and Tropical Medicine, Grameen Foundation, World Vision of Ireland.
- A recently-started Phase 1 trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Janssen, in partnership with Bavarian Nordic A/S (OTCPK:BVNRY), has produced more than 400K regimens of the prime-boost vaccine for use in large-scale trials that could begin as early as April.
- Ebola vaccine-related tickers: (NASDAQ:NLNK) (NYSE:MRK) (NYSE:GSK)
Thu, Jan. 15, 5:52 PM
- DepoMed (NASDAQ:DEPO) +3.7% AH after agreeing to acquire the U.S. license rights to the painkiller Nucynta from Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for $1.05B.
- DEPO says it plans to reintroduce the drug, expand its sales force and promote Nucynta for both chronic pain and nerve damage caused by diabetes; DEPO says Nucynta has patent protection until 2022.
- DEPO, which previously projected 2014 sales of $232M-$242M, says the deal will increase its 2014 pro forma net product revenue guidance by ~2.5x.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Tue, Jan. 13, 8:24 AM
- Janssen Biotech (NYSE:JNJ) enters into a license agreement with Vedanta Biosciences for the development and commercialization of VE202, a human microbiome modulator, that has demonstrated efficacy in preclinical models of autoimmune disease. Janssen will focus on the indication of inflammatory bowel disease (IBD).
- Under the terms of the agreement, Vedanta will receive an upfront payment and various milestones potentially up to $241M plus additional consideration related to commercialization. Vedanta may continue to explore other indications and licensing deals. Janssen may elect to expand its work into new areas under terms similar to the IBD indication.
Mon, Jan. 12, 9:46 AM
- Hospira (HSP) submits its Biologics License Application (BLA) to the FDA for Retacrit, a biosimilar to Amgen's (AMGN +1.3%) Epogen (epoetin alfa) and Janssen's (JNJ +0.5%) Procrit (epoetin alfa). The submission was actually made on December 16 under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.
- Last week, an FDA advisory committee voted in favor of the approval of Sandoz's BLA for its biosimilar to Amgen's Neupogen (filgrastim).
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
Mon, Jan. 12, 4:18 AM
- Boosting its Alzheimer's research efforts, Johnson & Johnson (NYSE:JNJ) has struck an up to $509M deal with Swiss biotech firm AC Immune to develop so-called anti-tau vaccines to treat Alzheimer's patients earlier in the disease.
- Tau is a protein known for forming tangles inside brain cells and is linked to cell death.
Fri, Jan. 9, 8:24 AM
- A Phase 3 trial evaluating the safety and efficacy of Portola Pharmaceuticals' (NASDAQ:PTLA) Breakthrough Therapy-designated anticoagulant antidote, andexanet alfa, met its primary primary endpoint of significantly and immediately reversing the steady-state anticoagulation activity of the Factor Xa inhibitor Xarelto (rivaroxaban) (NYSE:JNJ) when administered as an intravenous bolus.
- The second part of the trial assessing the safety and efficacy of a bolus plus continuous infusion of andexanet alfa to sustain reversal, is ongoing.
- Portola is developing the product for patients on Factor Xa inhibitors who are experiencing a major bleeding episode or who need emergency surgery.
- The company will present the full data set on Monday, March 16 at the American College of Cardiology's Annual Scientific Session in San Diego.
- PTLA is up 11% premarket on modest volume.
Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
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)
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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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