Saturday, August 31, 2013
Pros and Cons of Alkaline Diets
Acid alkaline diet and the alkaline ash diet exist after the foods are digested. Said diet leaves an ash that can be acidic, alkaline or neutral depending on the mineral content. Overconsumption of meat and dairy products promote an acidic pH balance in the body that can lead to serious ...
'Legal high' bans must be 'faster'
Mandela still in hospital, not discharged - S. Africa government
JOHANNESBURG (Reuters) - Former South African President Nelson Mandela, who has been receiving medical treatment for three months for a lung ailment, is still in hospital in Pretoria in a critical but stable condition, the government said on Saturday. The presidency said reports by some international media that the revered anti-apartheid leader, who is 95, had been discharged and returned to his home were "incorrect". ...
Source
Dr. Roach: Alzheimer's disease does have some genetic link
Dear Dr. Roach: My wife and her two siblings all have Alzheimer's disease. My wife is 81 and now lives in a nursing home. Her sister is 86 and in hospice, and their brother died at age 80.
Friday, August 30, 2013
All Natural Garcinia Cambogia Is a Weight Loss Pill That Works
Do you thrive on Facebook likes?
The more popular people are on Facebook, the more they love the social media platform, a new study has found.
Healthy Brownie Recipes That Make a Diet Seem Decadent
Not quite a cookie, but not yet a cake, there's something so satisfying about a brownie. Whether you like them dense and fudgy or light and cakey, there's a healthy recipe for you here. And we've thought of everything; look for recipes that are vegan, raw, gluten-free, and absent of refined sugars, too.
View Slideshow › Read the full article.Thursday, August 29, 2013
Gut bacteria affect health and obesity
For the Rest of 2013, Mold Inspection Sciences of San Francisco is...
San Francisco, California residents may contact Mold Inspection Sciences by phone or email to discuss, for free, their concerns about indoor mold and moisture problems. The company's competitors...
(PRWeb August 29, 2013)
Read the full story at http://www.prweb.com/releases/free_mold_inspection/consultation/prweb11070158.htm
For complete story, click here.Greatist Workout of the Day: Thursday August 29th
Greatist Workout of the Day: Thursday August 29th
Welcome to the cycle of GWODs designed by Kelvin Gary and Katherine Simmons of Body Space Fitness! Note: Exercise descriptions with video links are included below the image.
Have thoughts on the new graphic design of Greatist's Workouts of the Day? Email us at gwod [at] greatist.com!
· Walkouts are an advanced ab exercise, so make sure you’re ready for it with this great post about walkouts, and walkout modifications.
· Step it up with Step ups! This simple exercise is great for your glutes, hamstrings, and quads.
· A rear foot elevated slip squat is more commonly known as a Bulgarian split squat. Learn about the Bulgarian Split Squat here.
· Skaters are a great conditioning exercise. Learn how to do skaters with this video demo.
China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2013 Financial Results
SHENZHEN, China, Aug. 29, 2013 /PRNewswire-FirstCall/ -- China Nepstar Chain Drugstore Ltd. (NYSE: NPD) ("Nepstar" or the "Company"), the largest retail drugstore chain in China based on the number of directly operated stores, today announced its unaudited financial results for the second quarter ended June 30, 2013.
Financial Highlights
For the quarter ended June 30, 2013:
- Same store sales increased by 8.6% compared with the second quarter of 2012
- Revenue increased to RMB638.8 million (US$104.1 million) compared with RMB617.6 million for second quarter 2012
- Loss from operations was RMB1.0 million (US$0.2 million), compared with income from operations of RMB 3.9 million for the second quarter 2012.
- Net cash-flow from operating activities was RMB14.6 million (US$2.4 million), compared to RMB30.2 million in second quarter 2012
Mr. Fuxiang Zhang, Chief Executive Officer of Nepstar, commented, "During the second quarter, we adopted a more proactive marketing strategy to propel growth in revenue and to improve our store productivity. As a result, our average daily store traffic increased by eleven visits and same store sales grew by 8.6%, with fewer operating stores compared with the second quarter of 2012. While this promotional strategy has impacted our near-term gross margin and profitability, we believe the longer-term benefit of increased store traffic and participation in our loyalty programs will provide sustainable growth in margin over time and will ultimately enhance our competitiveness."
Second Quarter Results
During the second quarter of 2013, the Company opened 25 new stores and closed 48 stores. As of June 30, 2013, the Company had 2,071 directly operated stores in total.
Revenue for the second quarter of 2013 increased by 3.4% to RMB638.8 million (US$104.1 million) from RMB617.6 million for the same period in 2012. Same store sales (for the 1,969 stores opened before December 31, 2011 and were still operating) for the second quarter of 2013 increased by 8.6% compared with the same period in 2012. The increase in same store sales was primarily due to promotional initiatives aimed at increasing store traffic.
Second quarter revenue contribution by product category was 22.3% from prescription drugs; 38.2% from over-the-counter ("OTC") drugs; 14.8% from nutritional supplements; 4.0% from herbal products; and 20.7% from convenience and other products.
Second quarter gross profit was RMB280.8 million (US$45.7 million), a slight decrease from RMB287.5 million for the same period in 2012. Gross margin in the second quarter of 2013 was 44.0% compared with 46.5% for the same period of 2012. This decrease in gross margin was primarily the result of a more proactive marketing strategy for promoting the convenience and other products category.
The Company's portfolio of private label products was expanded to 2,069 types of products as of June 30, 2013. Sales of private label products represented approximately 25.0% of the Company's revenue and 33.8% of gross profit for the second quarter of 2013.
Sales, marketing and other operating expenses, as a percentage of revenue, in the second quarter of 2013 decreased to 38.9% from 40.8% in the same period of 2012. This decrease was primarily due to growth in same store sales and closure of underperforming stores.
General and administrative expenses as a percentage of revenue in the current quarter was 4.6%, compared with 5.1% for the same period in 2012. This decrease was mainly due to the continued implementation of rigorous cost control measures.
During the second quarter, we recognized impairment loss of RMB 3.4 million, which represents the reduction of the carrying amount of the property and equipment of certain underperforming stores.
Loss from operations in the second quarter of 2013 was RMB1.0 million (US$0.2 million), compared with income from operations of RMB3.9 million in the same period in 2012. The loss from operations in the second quarter of 2013 was mainly due to lower gross margin and the impairment loss. Excluding the impairment charge, income from operations was RMB 2.3 million (US$0.4 million).
Interest income for the second quarter of 2013 was RMB4.2 million (US$0.7 million) compared with RMB3.9 million in the same period in 2012.
Dividend income from cost method investments was RMB0.4 million (US$0.1 million) in the second quarter of 2013, compared with RMB3.1 million in the same period of 2012. On December 28, 2012, the Company completed the sale of its entire 40% equity interests in Yunnan Jianzhijia Chain Drugstore Ltd. for a total cash consideration of approximately RMB 81.5 million. Equity in income of an equity method investee was nil in the second quarter of 2013, compared with a loss of RMB1.0 million in the same period in 2012.
The Company's effective tax rate was 208.0% for the second quarter of 2013, compared with 74.9% for the same period in 2012. The Company's income tax expense was RMB 7.5 million for the second quarter of 2013, compared with RMB 7.4 million for the same period in 2012. The amounts of income tax expense were stable compared with the same period last year, and the higher effective rate for the current quarter was mainly due to the effect of operating losses from certain of our loss-making subsidiaries, for which full valuation allowances were made on their deferred tax assets.
Net loss for the second quarter of 2013 was RMB3.9 million (US$0.6 million), which represented RMB0.04 (US$0.01) basic and diluted loss per ADS. Net income for the second quarter of 2012 was RMB2.5 million, which represented RMB0.02 basic and diluted earnings per ADS.
Net cash-flow from operating activities in the second quarter of 2013 was RMB14.6 million (US$2.4 million), compared with RMB30.2 million for the same period in 2012.
As of June 30, 2013, the Company's total cash, cash equivalents, bank deposits and restricted cash were RMB666.0 million (US$108.5 million) and its shareholders' equity was RMB1.03 billion (US$167.6 million). This compares with total cash, cash equivalents, bank deposits and restricted cash of RMB664.4 million and shareholders' equity of RMB1.03 billion as of December 31, 2012.
Business Outlook
"Going forward, our focus remains on optimization of our product mix and maintaining momentum in store traffic and sales to stabilize and regain growth in margin and profitability," Mr. Zhang concluded. "Looking to the second half of the year, we expect same store sales and also the daily store traffic growth to continue."
Conference Call Information
The Company will host a conference call and a simultaneous webcast, on Thursday, August 29, 2013 at 8:00 a.m. Eastern Time / 8:00 p.m. Beijing Time. Interested parties may participate in the conference call by dialing in approximately five minutes before the appointed starting time at +1-877-407-9210 (North America) or +1-201-689-8049 (International). A live web cast of the conference call will be available on the Company's website at http://www.nepstar.cn.
A replay of the call will be available shortly after the conclusion of the conference call through September 5, 2013 at 11:59 p.m. Eastern Time. An archived web cast of the conference call will be available on the Company's website at http://www.nepstar.cn. Interested parties may access the replay by dialing +1-877-660-6853 (North America) or +1-201-612-7415 (International) and entering conference ID number 419160.
About China Nepstar Chain Drugstore Ltd.
China Nepstar Chain Drugstore Ltd. (NYSE: NPD) is the largest retail drugstore chain in China based on the number of directly operated stores. As of June 30 2013, the Company had 2,071 stores across 75 cities, one headquarter distribution center and 16 regional distribution centers in China. Nepstar uses directly operated stores, centralized procurement and a network of distribution centers to provide its customers with high-quality, professional and convenient pharmaceutical products and services and a wide variety of other merchandise, including OTC drugs, nutritional supplements, herbal products, personal care products, family care products, and convenience products. Nepstar's strategy of centralized procurement, competitive pricing, customer loyalty programs and private label offerings has enabled it to capitalize on the continuing economic growth in China and to take advantage of the demographic trend in China to achieve a strong brand and leading market position. For further information, please go to http://www.nepstar.cn.
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the quotations from management in this press release and the Company's strategic operational plans and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in the Company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
Exchange Rate Information
The United States dollar (US$) amounts disclosed in this press release are presented solely for the convenience of the reader. Translations of amounts from RMB into United States dollars were calculated at the certified exchange rate of US$1.00 = RMB6.1374 on June 28, 2013 as set forth in the H.10 weekly statistical release of the Federal Reserve Board. No representation is made that the RMB amounts could have been, or could be, converted into US$ at that rate on June 28, 2013, or at any other date. The percentages stated are calculated based on RMB amounts.
Contacts
Zixin Shao
China Nepstar Chain Drugstore Ltd.
Chief Financial Officer
+86-755-2641-4065
ir@nepstar.cn
Dixon Chen
Grayling
Investor Relations
+1-646-284-9403
dixon.chen@grayling.com
Ivette Almeida
Grayling
Media Relations
+1-646-284-9455
ivette.almeida@grayling.com
Tables follow
China Nepstar Chain Drugstore Ltd. | |||
Unaudited Condensed Consolidated Statements of Comprehensive Income/(Loss) | |||
(amounts in thousands – except per-share and per-ADS data) | |||
Three-month period ended | |||
June 30, | |||
2012 | 2013 | 2013 | |
RMB | RMB | USD | |
Revenue | 617,606 | 638,758 | 104,076 |
Cost of goods sold | (330,148) | (358,000) | (58,331) |
Gross profit | 287,458 | 280,758 | 45,745 |
Sales, marketing and other operating expenses | (252,289) | (248,719) | (40,525) |
General and administrative expenses | (31,272) | (29,698) | (4,839) |
Impairment losses | - | (3,380) | (551) |
Income/(loss) from operations | 3,897 | (1,039) | (170) |
Interest income | 3,917 | 4,218 | 687 |
Dividend income from cost method investments | 3,124 | 436 | 71 |
Equity in income of an equity method investee | (995) | - | - |
Income before income tax expense | 9,943 | 3,615 | 588 |
Income tax expense | (7,445) | (7,520) | (1,225) |
Net income/(loss) | 2,498 | (3,905) | (637) |
Basic earnings/(losses) per ordinary share | 0.012 | (0.020) | (0.003) |
Basic earnings/(losses) per ADS | 0.024 | (0.040) | (0.006) |
Diluted earnings/(losses) per ordinary share | 0.012 | (0.020) | (0.003) |
Diluted earnings/(losses) per ADS | 0.024 | (0.040) | (0.006) |
Net income/(loss) | 2,498 | (3,905) | (637) |
Other comprehensive loss, net of tax: | |||
Foreign currency translation adjustments | (496) | (512) | (83) |
Comprehensive income/(loss) | 2,002 | (4,417) | (720) |
China Nepstar Chain Drugstore Ltd. | |||||
Unaudited Condensed Consolidated Balance Sheets | |||||
(amounts in thousands) | |||||
As of | As of | As of | |||
December 31, | June 30, | June 30, | |||
2012 | 2013 | 2013 | |||
RMB | RMB | USD | |||
ASSETS | |||||
Current assets | |||||
Cash and cash equivalents | 371,256 | 357,540 | 58,256 | ||
Short-term bank time deposits | 237,100 | 272,440 | 44,390 | ||
Restricted cash | 36,000 | 36,000 | 5,866 | ||
Accounts receivable, net of allowance for doubtful | 114,601 | 114,720 | 18,692 | ||
Amounts due from related parties | 8,254 | 10,705 | 1,744 | ||
Prepaid expenses, deposits and other current assets | 147,252 | 161,002 | 26,233 | ||
Inventories | 478,483 | 452,514 | 73,731 | ||
Deferred tax assets | 1,704 | 2,450 | 399 | ||
Total current assets | 1,394,650 | 1,407,371 | 229,311 | ||
Non-current assets | |||||
Long-term bank time deposits | 20,000 | - | - | ||
Property and equipment, net | 120,237 | 114,643 | 18,679 | ||
Rental deposits | 38,236 | 40,101 | 6,534 | ||
Cost method investments | 12,638 | 12,638 | 2,059 | ||
Intangible assets, net | 2,868 | 2,868 | 467 | ||
Goodwill | 51,819 | 51,819 | 8,443 | ||
Deferred tax assets | 3,056 | 7,500 | 1,223 | ||
Accrued interest income | 507 | - | - | ||
Total non-current assets | 249,361 | 229,569 | 37,405 | ||
Total assets | 1,644,011 | 1,636,940 | 266,716 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||
Current liabilities | |||||
Accounts payable | 356,095 | 346,401 | 56,441 | ||
Bills payable | 20,534 | 24,063 | 3,921 | ||
Amounts due to related parties | 18,381 | 23,199 | 3,780 | ||
Accrued expenses and other payables | 105,503 | 104,914 | 17,094 | ||
Income tax payable | 40,967 | 29,805 | 4,856 | ||
Deferred income | 14,327 | 17,355 | 2,828 | ||
Total current liabilities | 555,807 | 545,737 | 88,920 | ||
Non-current liabilities | |||||
Deferred income | 18,365 | 17,145 | 2,794 | ||
Deferred tax liabilities | 7,499 | 7,695 | 1,254 | ||
Other non-current liabilities | 36,237 | 37,700 | 6,142 | ||
Total non-current liabilities | 62,101 | 62,540 | 10,190 | ||
Total liabilities | 617,908 | 608,277 | 99,110 | ||
Shareholders' equity | |||||
Share capital | 158 | 158 | 26 | ||
Additional paid-in capital | 832,811 | 832,811 | 135,694 | ||
Accumulated other comprehensive loss | (41,688) | (42,337) | (6,898) | ||
Retained earnings | 234,822 | 238,031 | 38,784 | ||
Total shareholders' equity | 1,026,103 | 1,028,663 | 167,606 | ||
Total liabilities and shareholders' equity | 1,644,011 | 1,636,940 | 266,716 |
SOURCE China Nepstar Chain Drugstore Ltd.
RELATED LINKS
http://www.nepstar.cn
Source: www.prnewswire.com
Use of sleeping pills highest among older Americans: CDC
Should everyone over 65 take a statin?
Tuesday, August 27, 2013
Deadline for finalizing Obamacare health plans delayed
By David Morgan and Caroline Humer WASHINGTON (Reuters) - The Obama administration has delayed a step crucial to the launch of the new healthcare law, the signing of final agreements with insurance plans to be sold on federal health insurance exchanges starting October 1. The U.S. Department of Health and Human Services (HHS) notified insurance companies on Tuesday that it would not sign final agreements with the plans between September 5 and 9, as originally anticipated, but would wait until mid-September instead, according to insurance industry sources. ...
Calgary Home Care Company and Dr. Leslie Martin to Host Educational...
The next installment in Home Care Assistance’s Healthy Longevity Webinar Series will be presented by leading psychologist and award-winning author, Dr. Leslie Martin, on September 4th at 11 AM PST/ 2...
(PRWeb August 27, 2013)
Read the full story at http://www.prweb.com/releases/2013/8/prweb11058798.htm
Get the whole story here.Marathon Training Tips for College Students
While I’m away on vacation, I asked you guys to submit topics for blog posts. Today’s features Shannon Mulcahy, a junior in college who is training for the NYC Marathon! I can’t imagine what it must be like finding the time for long runs with class work and busy social calendar so I asked her to share her tips for my college readers who are thinking of doing the same. Enjoy. Follow Shannon’s blog, twitter and Instagram if you too are training for a marathon this semester.
As I’m sure you all know fall is right around the corner which means that schools are already back in session or starting within the next few weeks. I have always loved the start of a new school year because it represents fresh starts, plus I love back to school shopping. My biggest challenge this semester is going to be fitting in a full course load (17 credits) with training for the New York City Marathon on November 3rd.
I was a competitive swimmer growing up so juggling training and school has always been a part of my life. There were times where I was training 18+ hours a week plus taking AP classes! In high school it was much easier though because swim practice was always at the same time. I saw my friends at school during the day and then went to practice every evening. Week to week everything pretty much looked the same.
In college, however, there is so much more freedom. You get to pick your class schedule, unless you run for your school you have to decide when you are going to train, you even get to decide if you even want to go to class each day (I recommend you go).
For me the hardest part about training for such a time consuming event plus going to school is figuring out how to have a social life as well. I never want to feel like I am missing out on something, which can lead to going out with friends to a party instead of writing that psychology paper or doing that 7 mile run on my training plan. An important thing to remember is that everybody has (or at least should) do homework and study for exams. If you have to miss out on one social event the chances are that your friends probably also have to miss one at some point during the semester.
Since none of my friends are endurance athletes I have to be creative to be able to get in my training while not missing out on too much fun. This means doing my weekly long runs on Fridays. I may not be able to go out on Thursday night but lets face it, the parties are always better on the weekends anyways, right? I also live by myself (which is not for everyone but I totally love it), which makes waking up early to go for a run a whole lot easier. I often hang out with friends in between classes or in the evenings so heading out running in the morning works out great.
But who wants to get up early to run in college, you might ask. Well it’s all relative because for me waking up early to go for a run means heading out around 8:00-8:30. This might still seem early but compared to waking up at 5:00 to run before heading to work it’s not so bad.
Something else I really like doing is inviting friends to run with me. While none of my friends are training for a marathon, a few of them do like to run. When I have shorter easier runs on the schedule I’ll invite a friend along to make the time go by faster. This way I get to see my friends plus they get a firsthand look at how important training is to me. The friends that have run with me are much more supportive and rarely try to get me to skip a run to hang out with them.
The best advice I have is just to figure out what works for you. My first semester at school that I trained for a half marathon it took me a few weeks to figure out how to make everything work. Experiment a little and don’t be afraid to get creative. Do your long run on a weekday if you need to so you can still go out with your friends on the weekend. Maybe join your school’s running club if they have one. Figure out what works for you and roll with it. Don’t be intimidated if it doesn’t look like everybody else’s schedule. It’s yours for a reason.
Why do haters have to hate?
Research has delved into the reasons why some people seem to dislike everything and others like everything.
Zane Benefits Publishes New Information on Utah Health Insurance...
Utah's Health Insurance Exchange released rates for individual plans and small groups.
(PRWeb August 26, 2013)
Read the full story at http://www.prweb.com/releases/2013/8/prweb11061087.htm
For full post, click here.Bayer and Onyx Pharmaceuticals Announce FDA Priority Review Designation of Nexavar® (sorafenib) Supplemental New Drug Application for the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer
WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 27, 2013 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental New Drug Application (sNDA) for the oral multi-kinase inhibitor Nexavar® (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The FDA grants priority review status to drug candidates that may offer a significant improvement in treatment over existing options. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the sNDA is December 25, 2013.
"We are very pleased that the FDA has chosen to grant Priority Review to sorafenib," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This is an important milestone for sorafenib and the designation highlights the urgent need for new treatments for patients with this type of thyroid cancer who have limited or no treatment options."
"Sorafenib could offer an FDA-approved treatment option for patients with this type of thyroid cancer," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.
DECISION Trial Design
The submission is based on the DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study. A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer were randomized to receive 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). Ninety-six percent of randomized patients had metastatic disease.
The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included overall survival, time to progression, response rate and duration of response. Safety and tolerability were also evaluated.
About Thyroid Cancer
Thyroid cancer has become the fastest-increasing cancer in the world in recent years and is the sixth most common cancer in women.1,2 There are more than 213,000 new cases of thyroid cancer annually and approximately 35,000 people die from thyroid cancer worldwide each year.3
Papillary, follicular, HĆ¼rthle cell and poorly differentiated types of thyroid cancer are classified as "differentiated thyroid cancer" and account for approximately 94 percent of all thyroid cancers.4 While the majority of differentiated thyroid cancers are treatable, RAI-refractory locally advanced or metastatic disease, is more difficult to treat and is associated with a lower patient survival rate.4,5
About Nexavar® (sorafenib) Tablets
Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. Nexavar is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 100 countries. Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.
Important Safety Considerations For Nexavar® (sorafenib) Tablets
Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.
Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.
An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar.
Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, if required.
Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Nexavar should be discontinued if Stevens-Johnson Syndrome or toxic epidermal necrolysis are suspected as these may be life threatening.
Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar. Discontinue Nexavar in the event of a gastrointestinal perforation.
Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time (PT), International Normalized Ratio (INR) or clinical bleeding episodes.
Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.
Nexavar in combination with gemcitabine/cisplatin is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of Nexavar has not been established in patients with non-small cell lung cancer.
Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.
Drug-induced hepatitis with Nexavar may result in hepatic failure and death. Liver function tests should be monitored regularly and in cases of increased transaminases without alternative explanation Nexavar should be discontinued.
Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while on Nexavar and female patients should also be advised against breastfeeding while receiving Nexavar.
Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar.
Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of Nexavar. Nexavar exposure decreases when coadministered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.
Most common adverse reactions reported for Nexavar-treated patients vs. placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs. 25%), fatigue (46% vs. 45%), abdominal pain (31% vs. 26%), weight loss (30% vs. 10%), anorexia (29% vs. 18%), nausea (24% vs. 20%), and hand-foot skin reaction (21% vs. 3%). Grade 3/4 adverse reactions were 45% vs. 32%.
Most common adverse reactions reported for Nexavar-treated patients vs. placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs. 13%), rash/desquamation (40% vs. 16%), fatigue (37% vs. 28%), hand-foot skin reaction (30% vs. 7%), alopecia (27% vs. 3%), and nausea (23% vs. 19%). Grade 3/4 adverse reactions were 38% vs. 28%.
For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar-us.com or call 1.866.NEXAVAR (1.866.639.2827).
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
Forward Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013, filed with the Securities and Exchange Commission under the heading "Risk Factors" for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
Nexavar® is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
Contacts: | |
Media | Investors |
Rose Talarico | Amy Figueroa |
Bayer HealthCare Pharmaceuticals | Onyx Pharmaceuticals, Inc. |
(862) 404-5302 | (650) 266-2398 |
Danielle Bertrand | |
Onyx Pharmaceuticals, Inc. | |
(650) 266-2114 |
References:
1. Raghunandan Venkat and Marlon A. Guerrero, "Recent Advances in the Surgical Treatment of Differentiated Thyroid Cancer: A Comprehensive Review," The Scientific World Journal, vol. 2013. http://www.hindawi.com/journals/tswj/2013/425136/. Accessed April 11, 2013.
2. Brown RL, de Souza JA, Cohen EEW. Thyroid Cancer: Burden of Illness and Management of Disease. J Cancer 2011; 2:193-199. http://www.jcancer.org/v02p0193.htm. Accessed April 11, 2013.
3. World Health Organization: GLOBOCAN 2008. Cancer Incidence and Mortality Worldwide in 2008. http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900. Accessed October 16, 2012.
4. Naifa Lamki Busaidy and Maria E. Cabanillas, "Differentiated Thyroid Cancer: Management of Patients with Radioiodine Nonresponsive Disease," Journal of Thyroid Research, vol. 2012. http://www.hindawi.com/journals/jtr/2012/618985/cta/. Accessed April 11, 2013.
5. Lucia Brilli, Furio Pacini. Future Oncology. Targeted Therapy in Refractory Thyroid Cancer. 2011;7(5):657-668. http://www.medscape.com/viewarticle/742987. Accessed April 22, 2013.
SOURCE Bayer HealthCare and Onyx Pharmaceuticals
RELATED LINKS
http://www.onyx.com
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