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ProShares UltraShort Nasdaq Biotechnology ETF (BIS)

  • Thu, Nov. 12, 11:59 AM
    • A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
    • Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
    • The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
    • Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
    • BI is in the process of expanding its rankings to include other years.
    • On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
    | Thu, Nov. 12, 11:59 AM | 61 Comments
  • Wed, Oct. 21, 1:22 PM
    • As if anyone following biotechs needs reminding, sellers are overwhelming the space. The iShares Nasdaq Biotechnology ETF (IBB -2.8%) is down 6% since Monday.
    • Key tickers: (BIB -6.5%)(BIS +6.3%)(VRX -38.5%)(AGN -5.9%)(BIIB -0.1%)(AMGN -1.7%)(GILD -1%)(CELG -2%)
    | Wed, Oct. 21, 1:22 PM | 66 Comments
  • Mon, Oct. 5, 5:41 PM
    • Top gainers, as of 5.25 p.m.: ARNA +6.1%. DD +5.3%. RKUS +4.0%. BIS +3.5%. JCP +1.4%.
    • Top losers, as of 5.25p.m.: ILMN -14.0%. HAE -12.1%. TCS -10.0%. ABY -5.3%. RIG -4.1%.
    | Mon, Oct. 5, 5:41 PM | 10 Comments
  • Tue, Sep. 22, 2:07 AM
    • Democratic presidential candidate Hillary Clinton is scheduled to outline a plan to rein in prescription drug costs in Iowa later today, after vowing on Twitter to go after "price-gouging" by drug companies.
    • The tweet brought down the biotech sector yesterday, with the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) plunging 4.5%.
    • Several details of the new plan have been provided by the Clinton campaign ahead of the speech: A $250 monthly cap on the amount chronic pain patients would have to pay for prescription medications, approving more generic/imported drugs, forcing pharmaceutical companies to reinvest their profits into R&D and ending their ability to write off consumer advertising as a business expense.
    • Previously: Biotechs take it on the chin after Hillary tweet about plan to address drug price gouging; IBB down 5% (Sep. 21 2015)
    | Tue, Sep. 22, 2:07 AM | 49 Comments
  • Fri, Jul. 31, 7:52 AM
    • According to Reuters, the value of merger and acquisition deals through July 30 was $436.4B, including 14 deals worth over $5B apiece. Although down from June's torrid pace of $546.8B, it still ranks as the seventh busiest month on record. Leading the pack was Teva's $40.5B purchase of Allergan's generic drugs business.
    • The top investment bank in terms of the total value of transactions was Goldman Sachs (NYSE:GS), involved in 35 deals worth $148.8B, including half of the top ten. JP Morgan (NYSE:JPM) was second with 30 deals worth $116.1B while Morgan Stanley (NYSE:MS) was third with 33 deals valued at $95.9B.
    • Global M&A so far this year is $2.64T, up 41% from last year. The action in the U.S. is up 66%.
    • Energy and healthcare are the leading sectors. There have been 1,557 deals in energy worth $407B. Healthcare is close behind with 1,577 deals worth $395B.
    | Fri, Jul. 31, 7:52 AM | 1 Comment
  • Tue, Jun. 23, 9:22 AM
    | Tue, Jun. 23, 9:22 AM | 11 Comments
  • Thu, May 7, 11:13 AM
    • Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
    • Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
    • The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
    • Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
    • Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
    • Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
    • Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
    | Thu, May 7, 11:13 AM | 6 Comments
  • Wed, Apr. 29, 12:42 PM
    • The biotech sector heads south again today, continuing the move that began in earnest on Monday. The iShares Biotechnology ETF, for example, is down over 8% from the March 29 high of 374.97 and down almost 7% from the intermediate high of 368.25 on April 23. This phase of the down move is particularly bearish considering the high volume driving the drops on Monday and Tuesday (2.3x normal volume both days).
    • A correction is not that surprising in light of the uninterrupted one-year uptrend. On a technical basis, IBB longs should look for support at 320.
    • ETFs: IBB, BIB, BIS
    | Wed, Apr. 29, 12:42 PM | 5 Comments
  • Mon, Apr. 27, 11:19 AM
    • Drug manufacturers have long defended their pricing by citing the need to recoup ultra-high development costs. Now another price-raising scheme is drawing attention. In a report by the Wall Street Journal, there are a growing number of examples where companies acquire drugs they perceive as undervalued and then significantly raise the prices.
    • In February, Valeant Pharmaceuticals (VRX -1.5%) purchased the rights to two heart drugs, Isuprel and Nitropress, from privately-held Marathon Pharmaceuticals for an undisclosed sum. It then immediately raised the prices 525% and 212%, respectively, based on the recommendations of a consultant who researched the price/benefit of each. According to Truven Health Analytics, the cost of a 1mL vial of Isuprel went from $215.46 to $1,346.62 while a 2mL vial of Nitropress went from $257.80 to $805.61.
    • Last year, Mallinckrodt (MNK -0.7%) bought Cadence Pharmaceuticals to gain access to its Ofirmev pain meds. A short time later, the list price for a package of 24 vials jumped 2.5-fold to over $1,019.52.
    • In 2013, Horizon Pharma increased the price of Vimovo pain tablets, after acquiring the rights from AstraZeneca, almost 600% to $959.04.
    • Valeant is apparently leading the price-raising pack. It has boosted list prices by at least 20% about 122 times since early 2011.
    | Mon, Apr. 27, 11:19 AM | 12 Comments
  • Tue, Apr. 14, 7:28 AM
    • According to the IMS Institute for Healthcare Informatics, U.S. spending for prescription drugs rose 13% last year to $374B, driven by manufacturer price hikes, pricey breakthrough medicines and millions of newly insured individuals under the Affordable Care Act. The increase was the largest since 2001. Total spending rose by $43.4B, including $10B from price increases and $20.3B from new drugs. led by Gilead Sciences' hepatitis C drug Sovaldi. Specialty medicines, those for complex, chronic disorders, accounted for one third of spending.
    • A record 4.3B prescriptions were filled last year. Those covered by Medicaid rose by almost 17% which accounted for 70% of the growth in prescriptions filled at retail pharmacies. 8.4M fewer prescriptions were filled at retail pharmacies compared to 2013 for patients with commercial insurance due to high out-of-pocket costs.
    • The number of novel medicines launched in 2014 was 42, including 18 for rare diseases. Ten were designated as Breakthrough Therapies by the FDA.
    • Generic drugs reduced spending by only $11.9B.
    • The IMS data is based on list prices for branded drugs. Wholesalers usually get discounts of ~6%.
    | Tue, Apr. 14, 7:28 AM | 9 Comments
  • Wed, Mar. 25, 12:13 PM
    • The Nasdaq's down move notwithstanding, the biotech sector is selling off on higher-than-normal volume today. On a technical basis, a correction (or at least a pause) is due. Prices pierced their upper price channel last week on robust volume. This is classic pre-correction behavior at the end of a long uninterrupted bull run, which began for biotechs almost a year ago. Look for more near-term weakness before prices consolidate.
    • ETFs: IBB, BIB, BIS
    | Wed, Mar. 25, 12:13 PM | 23 Comments
  • Tue, Mar. 24, 4:42 PM
    • The FDA will hold a public hearing April 20 - 21 seeking information and comment on the use of products labeled "homeopathic" and the agency's regulatory framework for such products. The hearing will cover prescription drugs, biological products and over-the-counter (OTC) medicines labeled homeopathic, a multi-billion dollar industry in the U.S.
    • There has been considerable debate over the years concerning whether homeopathic medicines actually work. Recently, an Australian government study concluded that they do not. Last week, the FDA issued a warning about the potential health risks of homeopathic OTC asthma products considering they have not been evaluated for safety and effectiveness.
    • Homeopathy is considered pseudoscience. No remedy has ever been proven to be more effective than placebo.
    | Tue, Mar. 24, 4:42 PM | 11 Comments
  • Thu, Mar. 19, 11:45 AM
    • In a report published by EP Vantage (the editorial arm of market intelligence firm Evaluate), 2014 was the year of biotech. Highlights include:
    • $212B in M&A transactions, eclipsing 2009's $152B; 87 IPOs that raised $6.3B (almost double the floats done in 2013 and more than 2x money raised); $6.5B in venture funding (+33%).
    • FDA approved a record 50 new drugs.
    • So far in 2015, ~$3B has been raised through secondary offerings.
    | Thu, Mar. 19, 11:45 AM | 7 Comments
  • Dec. 23, 2014, 10:40 AM
    | Dec. 23, 2014, 10:40 AM | 28 Comments
  • Nov. 28, 2014, 9:23 AM
    • The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
    • Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
    • Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
    • Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
    • Previously: BI begins enrollment in Phase 3 CRC trial
    | Nov. 28, 2014, 9:23 AM | 1 Comment
  • Nov. 26, 2014, 3:33 PM
    • Dutch biotech UniQure (QURE +22.6%) catapults into uncharted territory with the pricing of its gene therapy drug Glybera (alipogene tiparvovec). It is set to debut in Germany at €1.1M ($1.4M).
    • Glybera treats an ultra-rare disease called lipoprotein lipase deficiency (LPLD), a condition that clogs the blood with fat. The European Commission approved it in November 2012 but the launch was delayed because the company needed to collect six-year follow up data on its benefits.
    • UniQure's commercial partner, Italian firm Chiesi, has filed a pricing dossier with German regulators, who will issue an assessment of the drug's benefits by April 2015. Chiesi seeks a retail price of €53,000 per vial. Under German rules, the launch price will be valid for 12 months.
    • At this price, the full regimen cost will be €1.1M for a typical LPLD patient weighing 62.5 kg, who will require 42 injections from 21 vials. The number of eligible patients is tiny, only 150 - 200 across Europe.
    • Former #1 Soliris (eculizumab), made by Alexion Pharmaceuticals (ALXN +0.7%) is now a distant second at ~$540,000.
    • ETFs: IBB, BIB, BIS
    | Nov. 26, 2014, 3:33 PM | 5 Comments
BIS Description
ProShares UltraShort Nasdaq Biotechnology seeks daily investment results, before fees and expenses, that correspond to twice (200%) the inverse (opposite) of the daily performance of the NASDAQ Biotechnology® Index.
See more details on sponsor's website
Sector: Healthcare
Country: United States
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