Oct. 10, 2014, 1:43 PM
- The FDA approves Gilead Sciences' (GILD -0.3%) Harvoni for the treatment of chronic hepatitis C genotype 1 infection.
- Harvoni is a combination of ledipasvir and sofosbuvir. It is the first approved regimen that does not require administration with interferon or ribavirin.
- This is the third HCV drug approved in the last 12 months. The agency cleared Janssen's (JNJ +0.3%) Oysio (simeprevir) in November 2013 and Sovaldi in December 2013.
- Price: $94,500/12 weeks, $63,000/8 weeks.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 6, 2014, 1:55 PM
- Privately-held Danbury, CT-based Perosphere enters into a third collaboration agreement with Daiichi Sankyo to study PER977, Perosphere's investigational anticoagulant reversal agent, in Phase 3 trials with edoxaban, Daiichi's investigational oral, once-daily factor Xa-inhibitor.
- In Phase 1 and 2 studies, PER977 showed that it directly binds to heparin as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, it reverses anticoagulant activity after a single IV dose of 100 mg - 300 mg and does not require an extended infusion in order to maintain the reversal.
- Under the terms of the agreement, Perosphere will seek FDA and EMA approval of PER977 to reverse anticoagulant activity of edoxaban and commercialize PER977 in the U.S. and EU. It retains full worldwide commercial rights to PER977. Perosphere will receive an upfront payment from Daiichi Sankyo as well as clinical development-related milestones. It plans to submit an NDA to the FDA by June 2015.
- Related tickers: (JNJ -0.4%)(OTCPK:BAYRY -0.4%)(OTCPK:BAYZF +0.1%)(PFE -0.3%)(BAX)(BMY -0.3%)(ISIS -1.9%)(PTLA)(AZN -0.1%)(MRK -0.6%)
Oct. 2, 2014, 10:35 AM
- Thinly-traded nano cap GeoVax (OTCQB:GOVX +18.5%) announces that it has initiated an Ebola vaccine development program based on its DNA/MVA (modified vaccinia Ankara) platform.
- It will develop GOVX-E301 as a single dose vaccine to the ZEBOV strain of Ebola, which is the strain responsible for the current outbreak, and two-dose GOVX-E302 for routine immunization and protection against the three Ebola strains known to be lethal to humans.
- Related tickers: (TKMR -2.8%)([[SRPT] +2.4%)(BCRX +1.2%)(HEB -7.6%)(INO +0.5%)(NNVC -0.3%)(GSK -0.4%)(JNJ)(OTC:FUJIF)(OTCPK:FUJIY -1.4%)(NLNK -3.2%)(CMRX +0.3%)
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 30, 2014, 8:45 AM
- Johnson & Johnson (NYSE:JNJ) acquires privately-held clinical stage biopharmaceutical firm Alios BioPharma for $1.75B in cash.
- Alios develops therapies for viral diseases. Its lead product is AL-8176, an orally administered antiviral therapy in Phase 2 clinicals for the treatment of infants with respiratory syncytial virus (RSV).
- Janssen Pharmaceuticals R&D Chief William N Hait, M.D., Ph.D. says, "We are excited that this acquisition will enable us to explore treatment options for a number of viral infections, including RSV, the last of the major pediatric diseases with no available preventive therapy."
Sep. 25, 2014, 11:21 AM
- Epirus Biopharmaceuticals (EPRS -0.7%) consummates a collaboration agreement with Guangdong-based Livzon Mabpharm to develop, manufacture and commercialize up to five biosimilar products.
- The first collaboration product is BOW015 (infliximab), a Remicade biosimilar (JNJ -1.1%) that was recently approved in India. Livzon will be responsible for the development work necessary for approval in China and Taiwan. It will the preferred supplier of BOW015 following the transfer of Epirus' manufacturing platform and manage all commercialization activities in its territories.
- Financial terms of the deal are undisclosed.
Sep. 24, 2014, 9:38 AM
- Colgate-Palmolive (NYSE:CL) is an attractive acquisition target with its core products seeing increasing demand in developing nations, reasons Bloomberg.
- Despite the company's large size, its broad distribution network could push a buyer to stretch the wallet a bit.
- A large balance sheet and a global reach would be needed to contemplate a Colgate-Palmolive takeover. Unilever (NYSE:UL) and Johnson & Johnson (NYSE:JNJ) might fit the bill, note analysts.
Sep. 23, 2014, 5:03 PM
Sep. 22, 2014, 11:20 AM
- Under expanded access protocols approved by the FDA and Health Canada, Tekmira Pharmaceuticals (TKMR +12.7%) can now provide TKM-Ebola to patients with confirmed or suspected Ebola virus infections.
- President and CEO Dr. Mark J. Murray says, "Our TKM-Ebola drug supplies are limited, but we will continue to help where we can as we continue to focus on the other important objectives we have to advance therapies to meet the unmet needs of patients."
- Related tickers: (SRPT -5.1%)(NLNK -7.2%)(BCRX -5.1%)(NNVC -1.4%)(INO -1.8%)(OTC:FUJIF)(OTCPK:FUJIY -0.6%)(JNJ)(GSK)(HEB -7.2%)
Sep. 15, 2014, 4:36 PM
- India's Drug Controller General approves Epirus Biopharmaceuticals' (EPRS +1.7%) Remicade (infliximab) biosimilar, BOW015. It is the first infliximab biosimilar approved for sale in that country.
- The company and commercialization partner Ranbaxy Laboratories expect to launch the product by Q1 2015 under the brand name Infimab.
- Under the terms of their January 2014 license agreement, Epirus will develop and supply BOW015 and Ranbaxy will register and commercialize BOW015 in India and other territories in Southeast Asia, North Africa and selected other markets.
- Related ticker: (JNJ +0.1%)
Sep. 12, 2014, 12:30 PM
- When the FDA finally opens the door for biosimiars in the U.S. it could save as much as $250B per year by 2024 according to Express Scripts (ESRX -1.3%). There are 14 biotech meds being targeted by pharmaceutical firms who want to sell cheaper versions. Novartis (NVS -0.7%) submitted the first filing with the FDA in July for its version of Amgen's (AMGN -0.9%) Neupogen (filgrastim). Regulatory clearance could happen as early as March 2015.
- Drug companies have sought at least 76 meetings with the FDA to discuss the requirements to bring 14 different biosimilar drugs to market. Nothing will happen quickly, though. Work remains on how to name generics that are a little different from the branded versions due to different cell lines used to create them and how to design clinical studies the prove they can be safely swapped with the originals.
- The U.S. is far behind Europe. The EC began approving biosimilars in 2006. A generic version of Neupogen was cleared in 2008.
- A second biosimilar approved by the FDA may be Celltrion's version of J&J's (JNJ -0.2%) arthritis drug Remicade (infliximab). It filed its application last month.
- ETFs: DRGS
Sep. 11, 2014, 7:08 PM
- After moving back above the $100/share level, Apple (NASDAQ:AAPL) is back over the $600B mark in market cap, pushing it nearly $200B above Exxon Mobil (NYSE:XOM), the next largest company in the U.S.
- XOM is still valued at more than $400B, but Google (NASDAQ:GOOG) at $397B and Microsoft (NASDAQ:MSFT) - which has surged in 2014, adding $74B in market cap to $386B - are closing the gap.
- Berkshire Hathaway (NYSE:BRK.B) completes the top five with a $339B market cap; no other companies are worth more than $300B.
- Rounding out the top 20 market caps: JNJ, WFC, GE, WMT, CVX, PG, JPM, FB, VZ, IBM, PFE, KO, ORCL, T, MRK.
Sep. 9, 2014, 7:20 AM
- The World Health Organization says Liberia's Ebola outbreak is spreading exponentially with thousands of new cases coming. It believes that up to 20,000 people may eventually be infected and that it may take six to nine months to contain the disease.
- Fourteen of Liberia's fifteen counties have reported cases. As soon as a new treatment center opens, it is overwhelmed with patients.
- The government extends a nationwide nighttime curfew to help curb the spread of the disease.
- There is just one doctor per 100,000 citizens. 152 health care workers have been infected to date with 79 deaths.
- Sierra Leone orders a four-day countrywide "lockdown" beginning September 18 to halt the spread of Ebola within its borders.
- Related tickers: (NASDAQ:TKMR) (NASDAQ:SRPT) (NASDAQ:NLNK) (NASDAQ:BCRX) (NYSEMKT:NNVC) (NYSEMKT:INO) (OTC:FUJIF) (OTCPK:FUJIY) (NYSE:JNJ) (NYSE:GSK) (NYSEMKT:HEB)
Sep. 4, 2014, 7:02 AM
- Johnson & Johnson (NYSE:JNJ) announces that it will fast track the development of its new combination vaccine regimen against Ebola and collaborate with its partners in global health to deliver relief aid to help combat the current outbreak.
- Its vaccine candidate is a prime-boost regimen where one vector primes the immune system and the other boosts it. The product features two components based on the AdVac technology from Crucell N.V. (part of Janssen) and the MVA-BN technology from the Danish biotech firm Bavarian Nordic. The National Institute of Allergy and Infectious Diseases (NIAID) is providing direct funding and preclinical services to bring the program forward. Human clinical trials may start as soon as early 2015.
- Crucell and Bavarian Nordic are both developing preventative vaccines against filoviruses, including Ebola, with the aforementioned support from NIAID. More than 1,000 humans have received Crucell's adeno-platform-based vaccine in clinical trials. Bavarian Nordic's MVA-BN platform is the basis for the smallpox vaccine registered in Canada and Europe with a safety record of use in more than 7,300 people.
JNJ vs. ETF Alternatives
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of a range of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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