月別アーカイブ: 2014年10月

ZS Pharma Announces Multiple Presentations From ZS003, a Phase 3 Trial of ZS-9, at the American Society of Nephrology …

COPPELL, Texas, Oct. 30, 2014 (GLOBE NEWSWIRE) — ZS Pharma (ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that data from ZS003, a pivotal Phase 3 trial of ZS-9 (sodium zirconium cyclosilicate), its investigational treatment for hyperkalemia, will be presented in multiple presentations at the American Society of Nephrology (ASN) Annual Meeting in Philadelphia, Pa. which is taking place from November 11 to 16, 2014.

ZS003 was a 753 patient, multicenter, randomized, double-blind, placebo-controlled trial that assessed the safety and efficacy of ZS-9 in treating patients with hyperkalemia, a life-threatening condition that is characterized by higher than normal levels of potassium (K+) in the blood serum.

The presentations listed below describe ZS-9′s ability to control potassium levels in patients with significant renal impairment, multiple comorbidities, and in ethnic subsets. In addition, posters illustrating onset of activity data in patients with severe hyperkalemia (as defined as serum potassium >6 mEq/L) and potentially beneficial changes in bicarbonate and blood urea nitrogen (BUN) will be presented. All ASN presentation details are as follows:

Poster Presentations
Title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Once-Daily ZS-9 for Treatment of Hyperkalemia: Achievement and Maintenance of K+ in Subgroup Analysis of Patients with Significant Renal Impairment
Presenter: Bhupinder Singh, MD, FASN, FNKF, Executive Director, Research and Medical Affairs, ZS Pharma, Inc.
Session: CKD: Epidemiology and Outcomes II (10:00 a.m. to 12:00 p.m. ET)
Date: Friday, November 14, 2014
Title: A Pilot Evaluation of ZS-9 as a Potential Emergency Treatment for Hyperkalemia
Presenter: W. Frank Peacock, MD, FACEP, Professor Associate Chair and Research Director Baylor College of Medicine, Houston, Texas
Session: Dialysis: Epi, Outcomes, Trials – Cardiovascular II (10:00 a.m. to 12:00 p.m. ET)
Date: Saturday, November 15, 2014
Title: ZS-9 Effectively Reduces Potassium Levels in Hyperkalemic Diabetic Patients Who Have Both Renal Impairment and a History of Heart Failure
Presenter: David K. Packham, MBBS(Hons), FRCP, FRACP, MD, Melbourne Renal Research Group, Royal Melbourne Hospital, Australia
Session: Late Breaking Posters (10:00 a.m. to 12:00 p.m. ET)
Date: Saturday, November 15, 2014
Title: Once Daily ZS-9 for Treatment of Hyperkalemia: Achievement and Maintenance of Normokalemia in Black Patients in a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Presenter: Mohamed A. El-Shahawy, MD, MPH, MHA, FASN, Clinical Professor of Medicine, Keck-USC School of Medicine, Director, Academic Medical Research Institute, Los Angeles, Calif.
Session: Fluid, Electrolyte, and Acid-Base Disorders (10:00 a.m. to 12:00 p.m. ET)
Date: Saturday, November 15, 2014
Title: Effect of ZS-9 on Serum Bicarbonate and BUN in a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial
Presenter: Simon D. Roger, MD, FRACP, Department of Renal Medicine, Gosford Hospital, Australia
Session: Fluid, Electrolyte, and Acid-Base Disorders (10:00 a.m. to 12:00 p.m. ET)
Date: Saturday, November 15, 2014

About ZS-9′s Clinical Development Program

The ZS-9 clinical program is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause. ZS Pharma has completed ZS003, a 753-patient Phase 3 study, which showed that ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within the 48-hour Acute Phase and then controlled potassium in the normal range throughout the 12-day Extended Treatment Phase. In addition, the study provided evidence suggesting that ZS-9 is well tolerated with an adverse event profile similar to placebo. HARMONIZE, the Company’s second Phase 3 clinical trial of ZS-9, is a randomized, double-blind, placebo-controlled study that confirmed, over a longer treatment period, the positive results observed in ZS003. In conjunction with HARMONIZE, ZS Pharma is also conducting ZS004E, an extension study that will generate longer-term open-label safety and tolerability data in patients who participated in HARMONIZE. The Company is conducting an additional long-term safety study, ZS005, designed to evaluate the ability of ZS-9 to restore and maintain normal serum potassium levels in patients with hyperkalemia over at least one year of dosing. The Company plans to file a New Drug Application (NDA) with the United States Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency in the first half of 2015.

About Hyperkalemia

Hyperkalemia, or higher than normal potassium levels (typically defined as a serum potassium level >5 mEq/L), is a potentially life-threatening metabolic condition that can lead to cardiac arrhythmia and sudden cardiac death. Hyperkalemia is characterized by abnormally high concentrations of potassium in the blood resulting from the inability of the kidneys to excrete potassium, impairment of mechanisms that transport potassium into cells, or a combination of both factors. The causes of hyperkalemia vary but the most common are chronic kidney disease (CKD), diabetes, heart failure (HF) and side effects from cardio-renal protective drug therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.

About ZS Pharma

ZS Pharma is a publicly-traded, specialty pharmaceutical company based in Coppell, Texas. ZS Pharma’s lead therapeutic candidate, ZS-9, is an investigational treatment for hyperkalemia that is being evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels. ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology for the treatment of kidney and liver diseases. Additional information is available at www.zspharma.com.

Forward-Looking Statements

ZS Pharma cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward- looking statements include statements regarding the timing of potential regulatory submission and approval of the NDA and/or MAA for ZS-9. Inclusion of forward-looking statements should not be regarded as a representation by ZS Pharma that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the ZS Pharma business, including, without limitation: the potential for clinical data to not meet pre-specified statistical endpoints, regulatory authorities to not approve an application for ZS-9; analysis of ongoing or future potential clinical trials, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with clinical results achieved to date; the therapeutic and commercial value of ZS-9; and other risks described in ZS Pharma’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ZS Pharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ZS Pharma’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission August 14, 2014 and its other reports, which are available from the SEC’s website (http://www.sec.gov) and on ZS Pharma’s website (http://www.zspharma.com) under the heading “Investors”. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source Article from http://finance.yahoo.com/news/zs-pharma-announces-multiple-presentations-200000186.html
ZS Pharma Announces Multiple Presentations From ZS003, a Phase 3 Trial of ZS-9, at the American Society of Nephrology …
http://finance.yahoo.com/news/zs-pharma-announces-multiple-presentations-200000186.html
http://news.search.yahoo.com/news/rss?p=pharma
pharma – Yahoo News Search Results
pharma – Yahoo News Search Results



Perrigo Said in Exclusive Talks to Acquire Omega Pharma

Perrigo Co. (PRGO) has entered exclusive
talks to buy Omega Pharma NV after beating suitors including
Sanofi, Actavis Plc and Boehringer Ingelheim GmbH, people with
knowledge of the matter said.

Perrigo may reach an agreement to buy Omega Pharma, a
Belgian over-the-counter health-care company soon, two of the
people said, asking not to be identified because the
deliberations are private. Omega Pharma may fetch more than 4
billion euros ($5 billion) from the sale, three people said.

Perrigo shares rose as much as 2.8 percent and gained 1.7
percent to $157.59 at 10:19 a.m. in New York.

Representatives for Perrigo, Omega Pharma, Actavis and
Sanofi declined to comment. A representative for Boehringer
Ingelheim did not immediately respond to requests for comment.

Perrigo, which traces its roots back to 1887, develops,
manufactures and distributes over-the-counter and prescription
medicines, nutritional products and pharmaceutical ingredients,
according to its website.

In July 2013, Perrigo agreed to buy Irish drug company Elan
Corp. for $8.6 billion. The deal allowed Perrigo, formerly based
in Allegan, Michigan, to move its address to Ireland, where the
corporate income-tax rate is lower. It also received royalties
from Elan’s multiple sclerosis drug Tysabri.

Omega Pharma, which makes drugs including painkiller
Solpadeine, was valued at 848 million euros when it was taken
private by founder and Chief Executive Officer Marc Coucke with
Waterland Private Equity Investments BV and several co-investors
in February 2012, after 13 years as a public company.

The company’s operating profit for the first six months of
2014 was 130.1 million euros, an increase of 60 percent from the
same period last year, according to a statement. Operating
profit for the whole of 2013 was 137.7 million euros, with net
sales of 1.2 billion euros.

Omega Pharma Invest NV, formerly known as Couckinvest NV,
is the main shareholder with an almost 88 percent stake, the
annual report shows. The company holds the rest of the shares as
treasury stock.

To contact the reporters on this story:
Albertina Torsoli in Geneva at
atorsoli@bloomberg.net;
Manuel Baigorri in London at
mbaigorri@bloomberg.net;
David Welch in New York at
dwelch12@bloomberg.net

To contact the editors responsible for this story:
Aaron Kirchfeld at
akirchfeld@bloomberg.net
Elizabeth Fournier

Source Article from http://www.bloomberg.com/news/2014-10-30/perrigo-said-in-exclusive-talks-to-acquire-omega-pharma.html
Perrigo Said in Exclusive Talks to Acquire Omega Pharma
http://www.bloomberg.com/news/2014-10-30/perrigo-said-in-exclusive-talks-to-acquire-omega-pharma.html
http://news.search.yahoo.com/news/rss?p=pharma
pharma – Yahoo News Search Results
pharma – Yahoo News Search Results



Big Pharma Solid Q3 Earnings Put These ETFs in Focus

The healthcare space has emerged relatively unscathed from the biotech meltdown seen early in the year and is clearly outperforming the broad market. This is primarily thanks to strong performances by both biotech and pharma companies and encouraging industry trends. Further, solid corporate earnings are propelling the stocks even higher lately.

Though biotech is leading the health care world from the year-to-date look, Q3 earnings from some of the pharma companies have been inspiring in particular. Though patent expirations and stiff competition took a toll on most of these companies’ revenues and profitability and might continue doing so in the coming months, these have either managed to meet or successfully beat our earnings estimates.

The major outperformer is the world’s largest maker of healthcare products – Johnson & Johnson (JNJ) – which kept its long streak of earnings beat and raised full-year earnings outlook for the third time in a row on growing sales of its new hepatitis C drug. The stock surged about 9% since its earnings announcement on October 14 (read: Healthcare ETFs in Focus on JNJ Earnings Beat).

Other industry primes like Pfizer (PFE), Merck (MRK), Eli Lilly and Company (LLY) and Bristol-Myers Squibb Company (BMY) built up investors’ confidence in this corner of the health care space.

Pfizer Earnings in Focus

Earnings per share came in at 57 cents, a penny ahead of the Zacks Consensus Estimate but 2% below the year-ago earnings. Revenues slipped 2% year over year to $12.36 billion, but topped the Zacks Consensus Estimate of $12.16 billion thanks to growing sales of its cancer medicines and rising demand in emerging markets.  

Despite the earnings beat, the U.S. drug giant narrowed its earnings per share guidance range from $2.20-$2.30 to $2.23-$2.27 and brought down the high end of the revenue guidance from $48.7–$50.7 billion to $48.7–$49.7 billion for the full fiscal year owing to stiff competition. The Zacks Consensus Estimate for earnings and revenues are currently $2.25 per share and $49.51 billion, respectively.

Shares of PFE added 1.6% over the last two days following the earnings announcement on October 28.

Merck Earnings in Focus

The second largest U.S. drug maker reported earnings per share of 90 cents outpacing our estimate by couple of cents but deteriorating 2.2% from the year-ago earnings. Meanwhile, revenues dropped 4.3% to $10.56 billion and fell short of the Zacks Consensus Estimate of $10.69 billion.

Like Pfizer, Merck also reduced its revenue and earnings per share guidance for 2014. It now projects revenues of $42.4-$42.8 billion and earnings per share of $3.46–$3.50 compared with the previous outlook of $42.4-$43.2 billion and $3.43-$3.53, respectively. The Zacks Consensus Estimate for revenue and earnings are currently $42.48 billion and $3.49 per share, respectively (read: Pharma ETF Investing 101).

The stock lost about 2.5% to date after its earnings announcement on October 27.

Eli Lilly Earnings in Focus

Earnings of 66 cents at Eli Lilly met the Zacks Consensus Estimate but declined 41% from the year-ago earnings. Revenues also fell 16% to $4.88 billion but were slightly above our estimate of $4.83 billion. The company reiterated its full-year earnings per share guidance of $2.72–$2.80 on revenues of $19.4–$20.0 billion. The Zacks Consensus Estimate for earnings and revenue are currently of $2.78 and $19.69 billion, respectively.

Shares of LLY are up 1.2% post earnings announcement on October 23.

Bristol-Myers Earnings in Focus

Though Bristol-Myers topped the Zacks Consensus Estimate both on top and bottom lines, the numbers are weaker than the year-ago levels. Earnings per share of 45 cents and revenues of $3.88 were ahead of our earnings estimate respectively by four cents and $0.13 billion. Notably, earnings per share fell 2% and revenue slid 4% year over year.
 
The company maintained its 2014 revenue guidance of $15.2–$15.8 billion and earnings per share guidance of $1.70-$1.80. The Zacks Consensus Estimate for revenue and earnings are currently of $15.57 billion and $1.78, respectively.

Shares of BMY are up 1% post its earnings announcement on October 24.

ETF Angle

While these firms have given mixed performances depending on their specific fundamentals, pharma ETFs have been surging over the past one week. It is worth noting that BMY currently holds a Zacks Rank #2 (Buy) while the other four bellwethers mentioned have a Zacks Rank #3 (Hold). This suggests some profitable trading for these stocks in the coming days.

Given this, we have highlighted three pharma ETFs having the largest allocation to these drug makers. Investors should closely monitor the movement in these funds and could catch the opportunity from any surge in the stock prices (see: all the Healthcare ETFs here).

PowerShares Dynamic Pharmaceuticals Fund (PJP)

This is by far the most popular choice in the pharma space that follows the Dynamic Pharmaceuticals Intellidex Index. The product has AUM of about $1.4 billion and sees good volume of about 140,000 shares a day. The fund charges 58 bps in fees and expenses from investors.

Holding 27 stocks, the fund invests nearly 19% of total assets in the in-focus four firms, which are among the top 10 holdings while LLY accounts for 3% share. The ETF gained 5.2% in the past five days and touched a new 52-week high of $67.19 on October 29. It has a Zacks ETF Rank of 4 or ‘Sell’ rating with a Medium risk outlook.

iShares U.S. Pharmaceuticals ETF (IHE)

This ETF provides exposure to 42 pharma stocks by tracking the Dow Jones U.S. Select Pharmaceuticals Index. The in-focus five firms are among the top six holdings accounting for 36.2% of total assets, suggesting heavy concentration (read: Healthcare ETFs for your Portfolio’s Wellness).

The product has $791.9 million in AUM and charges 43 bps in fees and expense. Volume is light as it exchanges about 31,000 shares a day. The fund has added about 3% over the past five trading sessions and hit the new 52-week high of $144.22 on October 28. IHE has a Zacks ETF Rank of 4 with a Medium risk outlook.

Market Vectors Pharmaceutical ETF (PPH)

This ETF follows the Market Vectors US Listed Pharmaceutical 25 Index and holds 26 stocks in its basket. JNJ, PFE, MRK and BMY are among the top five holdings and make up for a combined 29.16% share while LLY takes the twelfth spot at 4.47%.

The product has amassed $375.4 million in its asset base and trades in a moderate volume of more than 102,000 shares a day. Expense ratio came in at 0.35%. The fund is up 1.9% over the past week and has a Zacks ETF Rank of 3 or ‘Hold’ rating with a Medium risk outlook.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Read the analyst report on PJP

Read the analyst report on IHE

Read the analyst report on PPH

Read the analyst report on JNJ

Read the analyst report on MRK

Read the analyst report on LLY

Read the analyst report on BMY

Zacks Investment Research

 
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Source Article from http://finance.yahoo.com/news/big-pharma-solid-q3-earnings-133529915.html
Big Pharma Solid Q3 Earnings Put These ETFs in Focus
http://finance.yahoo.com/news/big-pharma-solid-q3-earnings-133529915.html
http://news.search.yahoo.com/news/rss?p=pharma
pharma – Yahoo News Search Results
pharma – Yahoo News Search Results