Cancer medicines desperately needed by sick children and adults are in short supply, undermining the ability of U.S. doctors to administer treatments, top oncologists warned this week.
Many drugs are scarce because there is no incentive for drugmakers to manufacture low-cost generics, which have slim profit margins for pharmaceutical companies. Doctors do not expect that equation to change any time soon, making them scramble to find acceptable alternatives, or to ration or delay treatment when they cannot.
Generic chemotherapy drugs are in particularly tight supply at the nation's hospitals, including mainstay cancer treatments such as cisplatin, doxorubicin, cytarabine and leucovorin.
"These are chestnuts. These are not old-fashioned drugs. They remain incredibly important drugs which serve as the backbone for treating many of the most common and treatable cancers," said Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston and a past president of American Society of Clinical Oncology (ASCO) which held its annual meeting in Chicago this week.
Cisplatin is used to treat testicular, bladder and ovarian cancers that have spread. The drug, also used to treat lung cancers, is sold under multiple brand names, originally by Bristol-Myers Squibb.
A generic form is sold by Teva Pharmaceutical Industries, among others.
Doxorubicin, also available under multiple brands and as a generic from Teva and others, is used to treat non-Hodgkin's lymphoma, multiple myeloma, acute leukemias and other cancers.
Cytarabine, produced by Hospira and others, is used to treat certain types of leukemia. Leucovorin, also sold by Teva, is used along with certain chemotherapy drugs to treat colorectal, head and neck and other cancers.
Dr. Michael Link, a pediatric oncologist at Lucile Packard Children's Hospital at Stanford and current ASCO president, called it a disheartening crisis.
"Here we have highly effective drugs, they've been shown they work and to think we don't have them available is almost unconscionable," Link said. "We don't see an end in sight."
In some cases, doctors can substitute another drug for one that is in short supply.
"It's still uncomfortable to say that this is ideally what we'd like to do, but unfortunately we don't have it," Link said. "You can imagine the conversation and I'm sure they're going on all over— doctors have to tell their patients or their patients' parents that we can't give them the proven drug because we don't have it."
No Substitute
For some of these medicines in short supply, there may not be acceptable alternatives.
"One could say that substituting Pepsi for Coca-Cola doesn't make a difference. Maybe it does and maybe it doesn't," Mayer said. "But more often it might be substituting 7 Up for Coca-Cola, and that might make a difference."
Leucovorin, a form of folic acid that is used to enhance the effectiveness of other chemotherapy drugs, is one example.
"This is the one that I hear the most about from my colleagues. If you don't have it, you just have to omit it. It certainly isn't in the best interest of patients. It is a very inexpensive drug," Mayer said.
Sophia Parhas, a pharmacy manager at Children's Memorial Hospital in Chicago, said if there is a shortage of the generic, the hospital will often buy the branded product.
"We make some substitutions ... so doctors will go back and forth between daunorubicin and doxorubicin, depending upon which one is short," she said.
Another option is for doctors to flip the order that drugs are given depending on the supply situation. Allen Vaida, executive vice president of the Institute for Safe Medical Practices, which has been tracking the shortage, said doctors have also been forced to delay or ration treatments.
"Patients are started on a therapy and they may go through four or five or six cycles. When a drug becomes short, your cycle may be coming up a month later than planned," he said.
"Oncologists, especially in major cancer centers, are in a quandary. 'Do I start my patient on therapy? Do I save what I have for patients who started two cycles ago?'"
Dr. Richard Schilsky, cancer specialist at the University of Chicago and a past ASCO president, said the shortages have been going on for about nine months with no sign of abating.
"When you talk to the drug companies, they say there are manufacturing problems or they are taking plants offline and then it takes a while to get them back up," he said.
"They point the finger at the FDA (Food and Drug Administration), saying the FDA is under-resourced and they can't get plants inspected to allow resumption of drug production. The drug suppliers are in the middle of this as well," he said.
But underlying all of this, he said, is a dearth of financial incentive to make the lower-cost cancer drugs, especially when new cancer drugs command huge premium prices.
"The return on investment of manufacturing generic drugs is pretty low. If something goes wrong, it may be that some manufacturers decide to pull out rather than fix the problem."
Hospira spokesman Dan Rosenberg said shortages arise for many reasons — capacity constraints, commodity shortfalls, or when a competitor withdraws its product for some reason or whencompetitors have shortfalls. It is not always possible for Hospira to ramp up production that quickly, Rosenberg said.
"We are doing everything we can to ensure access to these products for clinicians and patients," he said. "Often, we continue manufacturing products at a loss because we realize there is a critical medical need and we are the only company that provides the medication."
A Teva spokesman said its California plant that makes injectable drugs, which was closed last year due to quality issues, is now back up. But the plant will not reach full capacity until the end of this year.
To address the shortages, U.S. senators Amy Klobuchar, a Democrat from Minnesota, and Robert Casey, a Democrat from Pennsylvania, introduced a bill in February that would make drug companies inform the FDA about supply problems or plans to stop making a drug. The FDA would then have time to work with other suppliers to make the drugs or arrange for imports.
"That is a canary in the coal mine," Schilsky said. "It doesn't really resolve the fundamental problem."
Copyright 2011 Thomson Reuters.
Tech Five: Technology Headlines for June 8 2011 ( Wednesday ) !!
1. Facebook has just committed what Eric Schmidt may consider a privacy sin--it's enabled face recognition in photos for global users (a tech Google has long had, but has not implemented). Facebook says it's making "photo tagging easier" because "many" users said tagging manually was a chore. The code group-suggests images that may be IDd as a particular user, which is one protection, but expect much fuss in the press.
2. In what may go down as one of the most fascinating city council meetings ever, Steve Jobs has just spoken to Cupertino bureaucrats to lay out his planning application for a new Apple campus in the city on former HP land. Jobs spoke with his usual charisma, laying out the design of a 12,000-person "spaceship-shaped" building, heavy on use of curved glass, designed by world's "best" architects, and with great green credentials.
3. AT&T is going to help its clients across the U.S. collect on nearly $1 billion in refunds on incorrectly paid taxes, originally collected as part of mobile Net access fees by AT&T despite a federal moratorium on taxing Net access until 2014. AT&T insists it did nothing wrong, merely passing the fees it thought it was obliged to acquire on to local authorities, but it will now have to spend untold millions of its own money on giving the cash back.
4. Proof that mobile ads are an increasingly hot business comes in this statistic: Mobile ads numbers have risen 128% over the last two years, according to research by Comscore. Most of this growth is driven by smartphones--first the iPhone, and now the growing Android presence--as Comscore notes 82% of smartphone owners use mobile Web browsers and 85% use apps, compared to 19% of feature phone users accessing the mobile web.
5. Enterprising hackers trawling through Apple's developer release of its upcoming iOS refresh have already jailbroken it to release it from Apple's lockdown, but they've also found evidence hidden in the code that refers to two new iPads, "iPad3,1" and "iPad3,2" and two new iPhone models "iPhone4,1" and "iPhone4,2." That is, the iPad 3 and iPhone 5. Previously such handles have turned into real devices several months later. Interestingly there's no reference to a new iPod Touch.
( Source: Fast Company)
Smart-Tek Solutions Inc ( PINK:STTN ), penny stock moving up without specific development news. Stock is trading up more than 42 % and volumes are also abnormal.
Our Call: Cautious call for trade as stock might not see much upside
Our Call: Cautious call for trade as stock might not see much upside
High Plains Gas Inc ( OTC: HPGS ), Stock jumped more than 62 % to $ 1.20 in the morning trade. There was o specific news or announcements relevant to company's developments. Volumes are much stronger and traders might take buy positions as stock might see more upside at this level.
Our Call: Buy positions may be initiated only for intraday trade.
Last news from the company was it has amended a pact with J.M huber corporation on June 1st 2011.
High Plains Gas Inc announced the amendment of the Purchase and Sale Agreement between High Plains and J.M. Huber Corporation. The transaction involves certain coalbed methane assets in Wyoming and Montana and has been extended. The amendment expires June 30, 2011, but has provisions which allow the parties to either close or cancel the amendment prior to that date. Details of the transaction were first announced on February 27, 2011. This amendment grants High Plains Gas, Inc. additional time to close the purchase of Huber's Powder River Basin coalbed methane assets as amended. Huber has the right to pursue sales to third parties and may terminate the agreement upon written notice and pursue actions that it deems appropriate. High Plains may notice Huber at anytime of its intentions to close the transaction prior to any termination notice and the transaction may proceed to close. Huber continues to hold non-refundable deposits in the amount of $2 million and 2 million shares of HPGS common stock which may be applied towards the closing price.
Our Call: Buy positions may be initiated only for intraday trade.
Last news from the company was it has amended a pact with J.M huber corporation on June 1st 2011.
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| High Plains Gas Inc |
Following Apple's launch of iCloud, a wireless service that allows users to access their content from any device connected to the Internet, CNBC.com gathered some facts and figures on the growth of the company in recent years.
Led by legendary CEO Steve Jobs, the company's market cap value has gone from $4.8 billion back in the year 2000 to $312.6 billion today, an increase of about 6,413 percent in the past 11 years.
Apple was founded in 1976 by Jobs and partners Steve Wozniak and Ronald Wayne. Less than a year later, Wayne sold his stake to Jobs and Wozniak for only $800.
Since then, Apple has redefined the computer, music, and consumer electronics industries, with products that include the Macintosh, iMac, iPod, iTunes, iPhone, and most recently, the iPad.
When Apple went public in 1980, its initial public offering was the most successful sinceFord [F 13.959 0.049 (+0.35%) ] in 1956. The company has been singled out for innovation and brand loyality among consumers and is also known for a very secretive corporate culture.
Here are some key facts and figures about Apple:
Stock Performance & Valuation
Close on June 6, 2011: $338.04
Median Price Target: $450 (Source: Thomson One)
All-time intraday high: $364.9 on February 16, 2011
All-time closing high: $363.13 on February 16, 2011
Apple's P/E: 16.11
S&P Tech Sector Average P/E: 29.9
Price / Book: 5.31x
TEV / EBITDA (Latest Twelve Months): 11.30x
Percent Change
YTD: 5%
1-Year: 32%
3-Year: 82%
5-Year: 466%
10-Year: 3,161%
20-Year: 2,800%
Revenues:
Revenue LTM (Mar-26-11) : $87.5 billion
Revenue Growth Against the Same 12-Month Period Last Year: 71%
Latest Qtr: $24.5 billion (Q3 2011)
Forecast 2011 Revenue: $103.4 billion
Earnings:
2010 EPS: $15.15
EPS Growth (2009-10): 141%
Latest Qtr: $6.40 (Q3 2011)
Forecast 2011 EPS: $24.74
Analysts' Recommendations:
Strong Buy: 24
Buy: 22
Hold: 3
Sell: 1
Underperform: 0
Three Highest Paid ExecutivesTimothy Cook
Chief Operating Officer since October 2005
Joined Apple Computer Inc. in 1998 as Senior Vice President of worldwide operations
Total Calculated Compensation*: $59.1M
Peter Oppenheimer, Chief Financial Officer and Senior Vice President
Total Annual Compensation: $29.8M
Ronald Johnson, Senior Vice President of Retail
Total Annual Compensation: $29.8M
* Total Calculated compensation figures from Capital IQ include salary, bonuses, estimated stock options and other incentives.
Note: Steve Jobs was reappointed as Chief Executive Officer, Director of Apple Inc. in June 2009. He has been the Director of Apple since 1997. Since 2004, however, Mr. Jobs total annual compensation stands at $1.
Source: CNBC Analytics, Capital IQ and Thomson Reuters
Led by legendary CEO Steve Jobs, the company's market cap value has gone from $4.8 billion back in the year 2000 to $312.6 billion today, an increase of about 6,413 percent in the past 11 years.
Apple was founded in 1976 by Jobs and partners Steve Wozniak and Ronald Wayne. Less than a year later, Wayne sold his stake to Jobs and Wozniak for only $800.
Since then, Apple has redefined the computer, music, and consumer electronics industries, with products that include the Macintosh, iMac, iPod, iTunes, iPhone, and most recently, the iPad.
When Apple went public in 1980, its initial public offering was the most successful sinceFord [F 13.959 0.049 (+0.35%) ] in 1956. The company has been singled out for innovation and brand loyality among consumers and is also known for a very secretive corporate culture.
Here are some key facts and figures about Apple:
Stock Performance & Valuation
Close on June 6, 2011: $338.04
Median Price Target: $450 (Source: Thomson One)
All-time intraday high: $364.9 on February 16, 2011
All-time closing high: $363.13 on February 16, 2011
Apple's P/E: 16.11
S&P Tech Sector Average P/E: 29.9
Price / Book: 5.31x
TEV / EBITDA (Latest Twelve Months): 11.30x
Percent Change
YTD: 5%
1-Year: 32%
3-Year: 82%
5-Year: 466%
10-Year: 3,161%
20-Year: 2,800%
 |
Revenues:
Revenue LTM (Mar-26-11) : $87.5 billion
Revenue Growth Against the Same 12-Month Period Last Year: 71%
Latest Qtr: $24.5 billion (Q3 2011)
Forecast 2011 Revenue: $103.4 billion
Earnings:
2010 EPS: $15.15
EPS Growth (2009-10): 141%
Latest Qtr: $6.40 (Q3 2011)
Forecast 2011 EPS: $24.74
Analysts' Recommendations:
Strong Buy: 24
Buy: 22
Hold: 3
Sell: 1
Underperform: 0
Three Highest Paid ExecutivesTimothy Cook
Chief Operating Officer since October 2005
Joined Apple Computer Inc. in 1998 as Senior Vice President of worldwide operations
Total Calculated Compensation*: $59.1M
Peter Oppenheimer, Chief Financial Officer and Senior Vice President
Total Annual Compensation: $29.8M
Ronald Johnson, Senior Vice President of Retail
Total Annual Compensation: $29.8M
* Total Calculated compensation figures from Capital IQ include salary, bonuses, estimated stock options and other incentives.
Note: Steve Jobs was reappointed as Chief Executive Officer, Director of Apple Inc. in June 2009. He has been the Director of Apple since 1997. Since 2004, however, Mr. Jobs total annual compensation stands at $1.
Source: CNBC Analytics, Capital IQ and Thomson Reuters
General Electric and Capital One Financial have submitted bids for ING's U.S. online banking operations in a deal worth about $9 billion, Bloomberg reported on Tuesday.
ING may reach an agreement to sell ING Direct USA this month, Bloomberg reported, citing sources familiar with the matter.
It said GE has submitted an all-cash bid, while Capital One's bid would be partly in shares.
GE is a minority stakeholder in NBC Universal, which owns CNBC and CNBC.com.
ING was forced to split its insurance and bank operations and agreed to divest ING Direct USA by 2013 to obtain European Commission approval for 10 billion euros of Dutch state aid received in 2008 during the financial crisis.
Proceeds from the sale would be used to repay the state.
A spokesman for ING in Amsterdam declined to comment on whether GE and Capital One had submitted bids.
"I can confirm that the process to prepare the sale of ING Direct USA is ongoing," Raymond Vermeulen said on Tuesday.
The Netherlands paid nearly 40 billion euros to rescue the domestic financial sector in 2008 when it was forced to nationalize ABN AMRO and provide capital injections for Aegon and SNS Reaal as well as ING.
ING has already announced several divestments and has paid back part of the state aid. It said it would repay the remaining 3 billion euros by May 2012.
( Source: Reuters )
( Source: Reuters )
Tech Five: Technology Headlines for June 7 2011 ( Tuesday ) !!
1. The ongoing spat between Google and China has now pushed upward to political levels--and Secretary of State Hilary Clinton has chosen to respond with a public comment on the matter. Google "believes" the attacks originated in China, they're being treated very seriously in an "ongoing investigation" that wraps in the FBI.
2. Meanwhile Sony has, yet again, suffered its own hack attack--seemingly hitting the news headlines as Sony's execs presented live onstage at E3. The hack was again performed by LulzSec (which yesterday "kindly" hacked Nintendo to prove a security hole exists) and the team has posted files relating to the Sony Computer Entertainment Developer Network online as proof.
3. RSA Security, supposedly relying on encrypted hardware "keys" to provide super-protected access to computers, has admitted its systems were compromised for "virtually every customer" it has by hackers who broke its security. RSA has admitted its violated code keys were involved in the hack at Lockheed Martin, although apparently no data was stolen from the system. RSA is replacing or monitoring every code key it's issued.
4. Internet history, of sorts, was made last night when Rep. Anthony Weiner admitted he did send pictures of his bulging underpants to a young girl on Twitter. It was part of a "joke" that was meant to be a direct message, a tearful and genuinely shaken Weiner revealed. He's learned his lesson. The news highlights two things: Twitter has become so powerful a news entity it can bring down a politician. And Twitter needs to brush up its interface to make DMs more identifiable versus public messages.
5. Sony has now officially announced its next-generation handheld games machine, the successor to the PSP: It's re-dubbed the PS Vita, and it'll hit shelves late in 2011. The price is $249, which pitches it directly in competition with the iPod Touch (everyone's surprise gaming champion) and the Nintendo 3DS. In terms of raw computing power, the Vita has plenty more than its peers--but it's not as flexible as the Touch and may be too complex for gamers the 3DS appeals to.
Talbots Inc ( NYSE: TLB ), company has reported quarterly earnings with a net profit of 1 cent a share compared with 12 cents a share same quarter last year. Company's net profit continued declined YoY and stock took a hit of more than 37 %.
Below is the quarterly earnings report
Earnings Per Share of $0.01; Adjusted Earnings Per Share of $0.08
Operating Income of $3.2M; Adjusted Operating Income of $7.6M
Company Comments on Second Quarter
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| Talbots Inc |
The Talbots, Inc. (NYSE:TLB) today reported results for the quarter ended April 30, 2011.
First quarter income from continuing operations was $0.9 million, or $0.01 per share, compared to last year’s loss from continuing operations of $7.1 million, or $0.12 per share.
Adjusted first quarter income from continuing operations was $5.3 million, or $0.08 per share, excluding special items of $4.4 million, or $0.07 per share, compared to last year’s adjusted income from continuing operations of $21.7 million, or $0.38 per share.
A full reconciliation of GAAP to non-GAAP (“adjusted”) items is included with this release.
Trudy F. Sullivan, Talbots President and Chief Executive Officer, commented, “Our first quarter performance reflects an inconsistent customer response to our merchandise assortments, a challenging competitive environment and high levels of promotional activity. Although we did see a positive customer reaction to our March brand moment, our February and April brand moments underperformed and sales in each month of the quarter decreased year over year.”
“We have been vigorously addressing our challenges, while continuing with the implementation of our key long-term initiatives. Our focus has been on directing our merchandise strategies to deliver a stronger balance of classic versus fashion forward styles in our assortments and implementing broader based marketing initiatives that better connect with our core and target customers to drive top-line growth.”
First Quarter 2011 Operating Results:
Operating income was approximately $3.2 million, compared to prior year’s operating income of $2.9 million.
Adjusted operating income, excluding special items of $4.4 million, was $7.6 million, a decrease of $24.1 million, compared to prior year’s adjusted operating income of $31.7 million.
Net sales decreased 6.0% to $301.3 million, compared to $320.7 million in the same period last year.
Consolidated comparable sales decreased 7.7%. Beginning with the first quarter 2011, the Company will report consolidated comparable sales inclusive of its direct marketing channel, which includes Internet, catalog and red-line sales. Consolidated comparable sales exclude stores scheduled to close under the Company’s store rationalization plan. Two years of comparable prior year periods have been prepared and are available on the Company’s website under “Investor Relations/Financial Highlights.”
Store sales decreased 6.5% to $240.8 million, compared to $257.6 million in the same period last year. Comparable store sales decreased 8.2% in the first quarter of 2011, excluding stores scheduled to close under the Company’s store rationalization plan.
Direct marketing sales, including Internet, catalog and red-line, decreased 4.0% in the quarter to $60.5 million, compared to $63.1 million in the same period last year.
Cost of sales, buying and occupancy as a percent of net sales increased 800 basis points to 64.4% compared to 56.4% last year. This increase is primarily due to an 880 basis point deterioration in merchandise margin, resulting from higher levels of markdowns and promotional activity. The increase was partially offset by an 80 basis point improvement in buying and occupancy expenses as a percent of net sales.
Selling, general & administrative (SG&A) expenses as a percent of net sales decreased 60 basis points to 33.1%, reflecting an $8.3 million decrease in SG&A expenses over the prior year period. This dollar decrease was due primarily to the reduction of certain components of performance-based management incentive compensation.
Total inventory increased 13.1% to $177.1 million, compared to $156.7 million in the same period last year, due to lower than anticipated sales volume in the quarter and a planned increase in spring receipts.
Total outstanding debt was $86.8 million, a decrease of $7.3 million compared to $94.1 million in the same period last year.
In the first quarter, the Company opened 6 Talbots upscale outlets, closed 6 Talbots stores and ended the period with 568 stores, including 34 Talbots upscale outlet stores.
In line with its previously announced plans to close approximately 90 to 100 stores and to consolidate and/or downsize approximately 15 to 20 stores over two years, the Company announced that it plans to close approximately 110 stores in total, including 13 consolidations. Approximately 83 stores are expected to close in fiscal 2011, approximately 25 stores are planned for closure in fiscal 2012 and approximately 2 stores are planned to close in fiscal 2013. The 110 stores that are planned for closure contributed approximately $21.0 million in sales and $4.0 million in operating loss in the first quarter of 2011, including $2.0 million in restructuring charges and $1.2 million in impairment of store assets. This compares to last year’s first quarter contribution of approximately $22.9 million in sales and approximately $2.5 million in operating income. There were no restructuring and impairment charges attributable to these stores in the first quarter of 2010.
For its first group of stores that are scheduled to close by the end of August, the Company has commenced its enhanced targeted marketing program designed to support the transfer of customer spend to other stores in the same markets or to its direct channel.
Second Quarter 2011 Comments
Second quarter-to-date sales and customer traffic continue to trend negative, with top-line sales to date down approximately low-teens compared to the same period last year. The Company expects high levels of promotional and markdown activity to continue throughout the second quarter, resulting in an expected increase in cost of sales, buying and occupancy as a percent of net sales of approximately 1,000 basis points compared to the same period last year. Selling, general and administrative expenses on a dollar basis are expected to increase slightly from the prior year second quarter, due in-part to continued incremental marketing investments.
Ms. Sullivan concluded, “We expect second quarter sales and gross margin will be significantly below last year, resulting from high promotional and markdown activity as we work to clear slower moving goods and better position ourselves for fall. As previously stated, fiscal 2011 will be a transition year and as we move forward in our turnaround efforts this year, our financial flexibility and liquidity are expected to fully enable us to support our anticipated working capital needs and the implementation of our strategic initiatives.”
The above outlook is based on the Company’s internal assumptions and estimates, is subject to its accompanying forward-looking statement and is not a guarantee of future performance or financial condition.
Brinx Resources Ltd ( PINK: BNXR ) stock jumped 34% without any specific news or announcements. Volumes are more than 2.5 millions shares. Stock move might be consider a technical breakout and high risk traders might consider trading the stock for intraday gains. Open positions might not carry forward.
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| Brinx Resources Ltd |
Our Call: High risk trade, very cautious on buying for intraday gains.
As per our last alert on the stock Westinghouse Solar Inc ( NASDAQ: WEST ) on June 1st to trade the stock for intraday gains ( Read Here ). Stock has logged 99% upside during the trading session. Today stock exploded to another 31% to close to $ 2.50. What to do now?
Our Call: Small buy positions for intraday trade purpose may be initiated but cautious call as stock might see profit booking later today or tomorrow. Don't consider as investment positions.
