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)
Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Dec. 3, 2014, 10:01 AM
Dec. 2, 2014, 8:30 AM
- The European Medicines Agency accepts for review a Type II variation application for Imbruvica (ibrutinib) filed by Pharmacyclics (NASDAQ:PCYC) strategic partner Janssen-Cilag International NV (NYSE:JNJ) for a potential label expansion covering the treatment of adult patients with Waldenstrom's macroglobulinemia (WM), a rare type of B-cell lymphoma.
- The acceptance of the filing triggers a $20M milestone payment to Pharmacyclics from collaboration partner Janssen Biotech.
- A supplemental NDA was filed with the FDA for WM in October.
- Imbruvica is currently approved for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.
Nov. 25, 2014, 4:47 PM
- Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
- 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
- All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
- Previously: Positive Phase 3 results for brodalumab
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial
Nov. 25, 2014, 11:10 AM
- Johnson & Johnson's (JNJ +0.1%) Janssen Research & Development, LLC submits a New Drug Application (NDA) with the FDA for Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
- Soft tissue sarcomas are cancers of the soft tissues that connect, support and surround other body structures such as muscle, fat, blood vessels and nerves.
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 3:43 PM
- Twenty-two spinoffs have been completed in 2014, the most in a decade, and another 28 have been announced. Among the catalysts are activist investors, so Credit Suisse screened for companies with multiple business segments, slow growth, and stocks trading for lower multiples than peers, in other words, "good, quality companies that are struggling to grow."
- The list is heavy on big media names like Time Warner (NYSE:TWX) and Twenty-First Century Fox (NASDAQ:FOXA), big tech like Oracle (NYSE:ORCL), Symantec (NASDAQ:SYMC), and IBM, and big industry like Lockheed Martin (NYSE:LMT), Ingersoll-Rand (NYSE:IR), and Raytheon (NYSE:RTN), but just two financial names - Travelers (NYSE:TRV) and Torchmark (NYSE:TMK).
- The rest: MO, CA, WU, DPS, PBI, SJM, HRS, SWK, EMR, WLP, MAT, GE, SNA, LLL, ITW, STJ, PDCO, HPQ, DLPH, HAS, NAVI, GME, CBS, JNJ, SLB.
Nov. 24, 2014, 12:52 PM
- Privately-held Transposagen Biopharmaceuticals enters into a research collaboration and worldwide license agreement with J&J's (JNJ -0.9%) Janssen Biotech to develop allogeneic Chimeric Antigen Receptor T-cells (CAR-T).
- CAR-T therapies have shown promise in early clinical trials for the treatment of blood cancers. They have the potential to be used "off the shelf" without the need to match donor with recipient.
- Under the terms of the agreement, Janssen will pay Transposagen up to $292M which includes an undisclosed upfront fee and development-, regulatory- and commercial-related milestones. It will also pay tiered royalties on net sales of any allogeneic CAR-T products commercialized by Janssen.
- Transposagen will enter into a three-year research collaboration with Janssen focused on preclinical research. Janssen will be responsible for the manufacturing and commercialization of allogeneic CAR-T therapies.
Nov. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Nov. 20, 2014, 12:48 PM
- Johnson and Johnson (JNJ -0.8%) unit Janssen Research & Development, LLC submits its NDA for three-month atypical antipsychotic paliperidone palmitate for the treatment of schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic with a 4x/year dosing schedule.
- The FDA approved once-monthly paliperidone palmitate (Invega Sustenna) in July 2009. It is cleared for sale in over 80 countries.
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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