Mon, Feb. 23, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Fri, Feb. 20, 5:56 PM
- Bloomberg reports Johnson & Johnson (NYSE:JNJ) is exploring the sale of its Cordis medical device unit to Cardinal Health (NYSE:CAH) for as much as $2B.
- The WSJ reported last August J&J is seeking a buyer for Cordis, whose products include stents, guidewires, and catheters, and that it could get $1.5B-$2B for the business.
- CAH +1.5% AH to $88.34.
Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Wed, Feb. 18, 1:54 PM
- The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meets Friday, February 20 to discuss the Premarket Approval Application (PMA) from privately-held San Clemente, CA-based VertiFlex for its Superion InterSpinous Spacer for the treatment of moderate lumbar stenosis (narrowing of the openings for the spinal cord and nerve roots).
- The device, CE marked in Europe since 2007, alleviates back pain via insertion in the lumbar area which decompresses the spine and relieves the pressure. Its value proposition is a one-piece expandable, reversible and motion preserving implant that is easily inserted via a small incision in the back under local anesthesia in the outpatient setting.
- Executive Summary, Panel Questions
- Related tickers: (NYSE:ABT) (NYSE:MDT) (NYSE:JNJ)
Tue, Feb. 17, 5:58 PM
- Boston Scientific (NYSE:BSX) +11.8% AH after settling the $7.2B lawsuit brought by Johnson & Johnson (NYSE:JNJ) for $600M, ending litigation that has nagged BSX since its 2006 acquisition of Guidant.
- JNJ had sought damages after accusing Guidant of breaching their merger agreement by going with the higher offer from BSX.
- BSX says it admits no liability in the settlement, and will record a $600M charge in its Q4 2014 financial results.
Thu, Feb. 12, 1:18 PM
- Novavax (NVAX +1.7%) commences patient enrollment in a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M. The study, being conducted in Australia, involves 230 healthy subjects between the ages of 18 and 50. Each person will receive two intramuscular injections, one on Day 0 and one on Day 21.
- The trial will also evaluate immunogenicity as measured by serum concentrations of IgG antibodies to the Ebola Makona strain glycoprotein.
- According to CEO Stanley C. Erck, the company now has the capability to rapidly scale up manufacturing to produce millions of doses of Ebola vaccine.
- Related tickers: (GSK -1%)(JNJ -1.8%)(OTCPK:BVNRY)(MRK +0.1%)(NLNK +5.3%)
- Previously: Johnson & Johnson announces Ebola vaccine development consortia (Jan. 16)
- Previously: First Glaxo Ebola vaccine to arrive in Liberia (Jan. 23)
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Wed, Feb. 11, 3:38 AM
- President Obama is expected to announce plans today to withdraw most of the U.S. troops assigned to combat the Ebola outbreak in West Africa, where they had been deployed to assist with supply logistics, construction and training.
- The return of the troops comes as the number of new infections drops in the region - from 1,000 new suspected, probable and confirmed Ebola cases a week in October to about 150 a week in recent reports.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR -0.5% AH
Tue, Feb. 3, 1:07 PM
- The FDA grants Priority Review for the New Drug Application (NDA) for Janssen Research & Development's (JNJ +0.7%) Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma (STS). Priority Review status shortens the review clock to six months from the usual ten. The FDA's decision date is, therefore, on or around August 3.
- Trabectadin is a synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. It works by preventing cancer cells from multiplying.
- Yondelis is approved in 77 countries for the treatment of advanced STS as a single agent and in 70 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection). It has had a rough time in the U.S., however. The FDA rejected it for the treatment of ovarian cancer in 2009.
Fri, Jan. 30, 7:39 AM
- The FDA approves Janssen's (NYSE:JNJ) Prezcobix (darunavir/cobicistat) for the treatment, in combination with other antivirals, of adults patients with HIV-1 infection. Darunavir is protease inhibitor (sold as a single agent under the brand name Prezista by Janssen) and cobicistat is a CYP3A4 inhibitor (sold as a single agent under the brand name Tybost by Gilead (NASDAQ:GILD) Sciences).
Thu, Jan. 29, 12:22 PM
- The FDA approves the use of Janssen's (JNJ -0.5%) and Pharmacyclics' (PCYC +0.6%) Imbruvica (ibrutinib) for the treatment of patients with Waldenstrom's macroglobulinemia (WM), a rare blood cancer also called lymphoplasmacytic lymphoma.
- Imbruvica is an Orphan Drug for the treatment of WM so it will have a seven-year period of market exclusivity for this indication.
- It is also approved for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.
Thu, Jan. 22, 3:45 AM
- After lawyers for both companies made final presentations on Wednesday, Johnson & Johnson's (NYSE:JNJ) multibillion-dollar trial with Boston Scientific (NYSE:BSX) over its purchase of device maker Guidant now lies in the hands of a federal judge.
- As Guidant’s successor, J&J is seeking more than $7.2B in damages and interest from Boston Scientific for violating clauses included under their agreement to combine in 2004.
- Previously: J&J, Boston Scientific $5B trial to begin Thursday (Nov. 19 2014)
Tue, Jan. 20, 8:44 AM
- Johnson & Johnson (NYSE:JNJ) notable changes in Q4 by segment ($M):
- Consumer (-3.9%): Women's Health (-11.5%); Baby Care: (-10.4%); Wound Care: (-6.2%).
- Pharmaceutical (+9.6%); Immunology (+7.3%), Simponi/Simponi Aria: 346 (+36.2%), Stelara: 545 (+30.7%), Remicade: 1,672 (-2.3%).
- Infectious Diseases (+13.9%); Olysio/Sovriad: 321 (+999%), Edurant: 90 (+23.3%), Prezista: 448 (-2.8%), Other: 212 (-24.6%), Incivo: 5 (-95.3%).
- Neuroscience: 1,651 (unch); Invega Sustenna/Xeplion: 418 (+19.4%), Invega: 161 (+4.5%), Other: 609 (-7.3%), Risperda Consta: 294 (-8.4%).
- Oncology: 1,212 (+8.9%); Other: 199 (+111.7%), Zytiga: 595 (+20.2%), Velcade: 418 (-20.2%).
- Other: 1,482 (+28.1%), Xarelto: 428 (+57.9%), Other: 752 (+29.9%), Procrit/Eprex: 302 (-1.6%).
- Med Devices & Diag: 6,649 (-9.0%); Specialty Surgery/Other: 904 (+32.4%), Cardiovascular Care: 558 (+4.5%), Orthopedics: 2,441 (-0.6%), Surgical Care: 1,572 (-4.1%), Diabetes Care: 514 (-8.7%), Vision Care: 646 (-10.2%), Diagnostics: 14 (-97.0%).
Tue, Jan. 20, 8:21 AM
- Johnson & Johnson (NYSE:JNJ) Q4 results ($M): Total Revenues: 18,254 (-0.6%), Consumer: 3,606 (-3.9%), Pharmaceutical: 7,999 (+9.6%), Medical Devices & Diagnostics: 6,649 (-9.0%).
- Revenue by region: U.S.: 8,604 (+7.4%), Europe: 4,560 (-8.2%), W. Hemisphere ex. U.S.: 1,782 (-5.8%), Asia Pacific & Africa: 3,308 (-5.0%).
- COGS: 5,853 (-1.7%); R&D Expense: 2,635 (+9.3%); SG&A Expense: 5,822 (-1.6%); Net Income: 2,521 (-28.4%); EPS: 0.89 (-27.6%); Gross Profit: 12,401 (unch); COGS: 32.1% (-1.2%); Gross Margin: 67.9% (+0.6%); Operating Income: 3,944 (-3.1%); Operating Income Yield: 21.6% (-2.6%); Net Earnings Yield: 13.8% (-28.0%).
- 2015 non-GAAP EPS guidance: $6.12 - 6.27.
Tue, Jan. 20, 7:51 AM| 2 Comments
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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