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Alertmeipp, OT - Here's my non-bio virtual portfolio, with some new additions that are owned by Warren Buffett/Berkshire, the most successful investor of our age. The legendary Peter Lynch also goes for these more boring type stocks.
I put considerable emphasis on the 5-10+ year chart, figuring it is one of the more reliable predictors of future performance. There are some incredibly beautiful long term charts here. Warren Buffett has invested in these mundane type stocks with tremendous success. A $10,000 investment in Berkshire Hathaway in 1965 would be worth over $50 million today. That's a compounded 21.5% annualized return. So I figure with returns like that, who needs risky microcap plays, other than for entertainment purposes. BTW, I do have a few riskier stocks on the list, like AeroVironment, since I still have a few remnants of the gunslinger in me -
NON-BIO STOCKS
******************
AEROVIRONMENT -- (AVAV) -- ROBOTIC AIRCRAFT
AMERICAN STANDARD -- (ASD) -- DIVERSE
AMERIPRISE FINANCIAL -- (AMP) -- FINCL PL, ASSET MGT, INSURANCE
AQUA AMERICA --(WTR) --WATER UTILITIES
CAMECO -- (CCJ)-- MINING, URANIUM
CORRECTIONS CORP AMER-- (CXW) --PRISONS
ELBIT -- (ESLT)-- DEFENSE ELECTRONICS
ENERGEN -- (EGN)-- ENERGY
FISERV --(FISV) --FINANCIAL SERVICES
GENERAL ELECTRIC -- (GE) -- DIVERSIFIED
GARMIN -- (GRMN) --NAV/COM ELECTRONICS
HARSCO -- (HSC) --DIVERSE INDUSTRIAL
IDEX -- (IEX) --INDUSTRIAL EQUIPMENT
IRON MOUNTAIN -- (IRM) -- BUS SVCS, DATA PROTECTION
LIFEWAY FOODS --(LWAY) -- HEALTH FOODS
M+T BANK CORP -- (MTB) -- BANK HOLDING CO
MOODYS CORP -- (MCO) -- CREDIT RATINGS, RESEARCH
PENN NATIONAL GAMING --(PENN) -- GAMBLING
POWER SHRS WATER RES --(PHO) --WATER INDEX
PROCTOR & GAMBLE -- (PG) --CONSUMER PRODUCTS
THERMO FISHER SCI -- (TMO) -- ANALYTIC INSTS / RADIATION
TOLL BROS --(TOL) -- HOME BUILDERS
TYCO -- (TYC) -- DIVERSIFIED
UNITED TECHNOLOGIES -- (UTX) -- DIVERSIFIED, AEROSPACE
WACHOVIA BANK -- (WB) -- BANKING
WELLS FARGO -- (WFC) -- FINANCIAL SERVICES
WR BERKLEY CORP -- (BER) -- INSURANCE
Alertmeipp, There are several events beyond the FDA dosing decision that can positively impact Cortex's share price over the longer haul -
1) The high impacts/global neurodegenerative BP deal (I figure by Summer, give or take). The upfronts won't be that big, but the stock should respond favorably, especially if the partner is a high profile BP.
2) A CX-701/ADHD deal - say CX-717 goes down in flames with the FDA (~June), Cortex could just move CX-701 ahead to replace it, run an ADHD Phase 2a in 2008, and then outlicense it to a BP for ADHD. That's the approach I would take rather than the non-Ampakine in-license orphan idea, unless there are sufficient funds to do both.
Concerning my growing preference for more conservative stocks, in addition to the obvious advantages (much less risk/volatility), I noticed that their long term performance can be as good as the very best of the smaller riskier stocks. Just look at the 5-10 years charts for some of the stocks I listed, and you will be amazed at how much money can be made in these more boring/stodgy areas over time, much more reliably than with micro caps. I'll post some additional non-bio names for anyone who might be interested.
iRobot (IRBT) - this probably deserves an honorable mention for the virtual portfolio, though along with AeroVironment it's on the riskier side of the spectrum -
>>> iRobot Corporation engages in the design, development, and sale of robots for the consumer, military, government security, and law enforcement markets. It operates in two segments: Home Robots, and Government and Industrial. The Home Robots segment offers mobile robots used in the maintenance of domestic households sold primarily to retail outlets. The Government and Industrial segment offers robots used by the United States and foreign governments, primarily for reconnaissance and bomb disposal missions. Its products include iRobot PackBot Scout, a mobile robot, designed for military operations in urban terrain and other battle missions; iRobot PackBot Explorer, which is designed for performing real-time targeting and battle damage assessment in inaccessible areas; iRobot PackBot EOD, a rugged robot, designed to conduct explosive ordnance disposal, hazardous materials, search-and-surveillance, and other law enforcement tasks for bomb squads, SWAT teams, military units, and other authorities; and R-Gator: Autonomous Unmanned Ground Vehicle, which is designed to serve as unmanned scout, point man, perimeter guard, and pack/ammunition/supply carrier for soldiers. The company has strategic alliances with Deere & Company and The Clorox Company. It markets its products through sales force, a network of retail businesses in the United States, as well as through distributors internationally. The company was co-founded by Rodney A. Brooks, Colin Angle, and Helen Greiner in 1990. It was formerly known as IS Robotics, Inc. and changed its name to IS Robotics Corporation in 1994. Further, the company changed its name to iRobot Corporation in 2000. iRobot is headquartered in Burlington, Massachusetts.<<<
Updated virtual portfolio, with some new additions from Buffett/Berkshire -
NON-BIO STOCKS
******************
AEROVIRONMENT -- (AVAV) -- ROBOTIC AIRCRAFT
AMERICAN STANDARD -- (ASD) -- DIVERSE
AMERIPRISE FINANCIAL -- (AMP) -- FINCL PL, ASSET MGT, INSUR
AQUA AMERICA --(WTR) --WATER UTILITIES
CAMECO -- (CCJ)-- MINING, URANIUM
CORRECTIONS CORP AMER-- (CXW) --PRISONS
ELBIT -- (ESLT)-- DEFENSE ELECTRONICS
ENERGEN -- (EGN)-- ENERGY
FISERV --(FISV) --FINANCIAL SERVICES
GENERAL ELECTRIC -- (GE) -- DIVERSIFIED
GARMIN -- (GRMN) --NAV/COM ELECTRONICS
HARSCO -- (HSC) --DIVERSE INDUSTRIAL
IDEX -- (IEX) --INDUSTRIAL EQUIPMENT
IRON MOUNTAIN -- (IRM) -- BUS SVCS, DATA PROTECTION
LIFEWAY FOODS --(LWAY) -- HEALTH FOODS
M+T BANK CORP -- (MTB) -- BANK HOLDING CO
MOODYS CORP -- (MCO) -- CREDIT RATINGS, RESEARCH
PENN NATIONAL GAMING --(PENN) -- GAMBLING
POWER SHRS WATER RES --(PHO) --WATER INDEX
PROCTOR & GAMBLE -- (PG) --CONSUMER PRODUCTS
THERMO FISHER SCI -- (TMO) -- ANALYTIC INSTS / RADIATION
TOLL BROS --(TOL) -- HOME BUILDERS
TYCO -- (TYC) -- DIVERSIFIED
UNITED TECHNOLOGIES -- (UTX) -- DIVERSIFIED, AEROSPACE
WACHOVIA BANK -- (WB) -- BANKING
WELLS FARGO -- (WFC) -- FINANCIAL SERVICES
WR BERKLEY CORP -- (BER) -- INSURANCE
Getting back to Cortex, my prediction is that even if CX-717 manages to get the green light from the FDA for ADHD dosing, the BP/pharma who ultimately partners for CX-717/ADHD will probably decide to advance a backup Ampakine instead. CX-717 was only in Phase 2a, so they wouldn't be losing that much time. A backup like CX-701 is not only more potent and longer acting, but it wouldn't have any associated histo finding stigma to come back to haunt it during the approval process.
This isn't to suggest that a favorable FDA ruling on CX-717 won't move the stock up smartly, only that in the end CX-717 may ultimately be viewed by the BP partner as damaged goods. Why take that risk when untainted backup compounds like CX-701 are available?
Blatch, When additional funds become available, these are the type of stocks I personally would like to own. I'm not saying you have to like them too.
With Cortex you're looking at an ultra high risk turnaround stock, while many of the stocks I posted are long term consistent performers in "picks and shovels" areas like CRO's, equipment, diagnostics, etc. Of the companies actually involved in drug development, I've gravitated toward either larger companies with current revenues, generics, or mid cap/smaller companies in lower risk areas like enzyme replacement, antibiotics, a couple higher risk CNS related companies thrown in.
Cortex is easily the riskiest stock on the list, and for me is a sentimental "legacy" pick from my days as a bio gunslinger. With the gunslinger approach, you have the opportunity to get rich fast, though a large amount of luck is required, and the odds are bad. The conservative approach has a high percentage of success, though it is boring and will take a much longer time. To each his own style :o)
Alertmeipp, Yes, good stocks have a habit of doing that :o)
Here's my updated 42 stock virtual portfolio, fwiw. My favorite stock in the sub-$100 mil category is Bio-Imaging Technologies ($86 mil), which is, dare I say it, a slam dunk/sure thing 3-5 bagger over the next 5 years (they don't develop drugs, so I guess it's OK to say "slam dunk") -
BIO / MED RELATED STOCKS
***************************************
Stock Symbol Mkt Cap Description
****************************************************
ACORDA (ACOR)433 m Zanaflex(spast),Fampridine(MS)
ALTUS (ALTU)423 m Enzyme Replacement
AMEDISYS (AMED)719 m Home health care, hospice svcs
ALNYLAM (ALNY)682 m RNAi, Infectious, CNS, other
BECKMAN COULTER (BEC) 4.0B Hospital lab/diag test/equip
BECTON DICKINSON(BDX) 19 B Med supplies, lab equipment
BIO-IMAGING TECH(BITI) 86 m Image mgt for clinical trials
BIO-RAD LABS (BIO) 2.3 B Bio instruments, diagnostics
BIOMARIN (BMRN)1.8 B Enzyme replacement, cardiovasc
BARR LABS (BRL) 5.8 B Generics, proprietary
COMBINATORX (CRXX)246 m Synergistic drug combinations
COVANCE (CVD)4.0 B CRO
CELGENE (CELG) 20 B Cancer - Revlimid, Thalomid
CORTEX (COR) 39 m Ampakines / Neurological
CUBIST (CBST)1.0 B Antibiotics - Cubicin
DURECT (DRRX)304 m Drug Delivery
EXELIXIS (EXEL)962 m Cancer
GENMAB (GNMSF.PK) Cancer, Autoimmune
GENZYME (GENZ) 17 B Enzyme Replacement, others
GILEAD (GILD) 32 B Infectious Diseases, HIV
HALOZYME (HTI)499 m Improved drug penetration
HENRY SCHEIN (HSIC)4.5 B Dental/Med products, vaccines
IDENIX (IDIX)496 m Infectious Disease, Hepatitis
ILLUMINA (ILMN)1.7 B Genetic Variation Equip
MEDAREX (MEDX)1.6 B MAB provider
MERIDIAN (VIVO)766 m Diagnostics, Test Kits
MGI PHARMA (MOGN)1.5 B Chemo related, cancer, other
MYRIAD (MYGN)1.4 B Diagnostics, AD, cancer
NOVAMED (NOVA)178 m Surgical Centers
PDL BIOPHARMA (PDLI)2.4 B MABS, other
PHARMA PR DEV (PPDI)4.1 B CRO
PHARMION (PHRM)1.0 B Cancer
QIAGEN (QGEN)2.6 B Nucleic acid research related
SENOMYX (SNMX)433 m Taste/Flavor Modulators
SEPRACOR (SEPR)6.0 B CNS, Respiratory, other
SIGMA ALDRICH (SIAL)5.0 B Bio Reagents, chemicals
SPECTRUM (SPPI)162 m Cancer, Satraplatin, generics
STERICYCLE (SRCL)3.4 B Medical Waste
TEVA (TEVA) 27 B Generics, proprietary
THERMO FISHER SC (TMO)7.8 B Bio Insts, Radiation detect.
TORREY PINES (TPTX) 27 m Neurological, Migraines
VERTEX (VRTX)4.2 B Infectious Disease, Hepatitis
Here's my updated 42 stock virtual portfolio, fwiw. My favorite stock in the sub-$100 mil category is Bio-Imaging Technologies ($86 mil), which is, dare I say it, a slam dunk/sure thing 3-5 bagger over the next 5 years (they don't develop drugs, so I guess it's OK to say "slam dunk") -
BIO / MED RELATED STOCKS
***************************************
Stock Symbol Mkt Cap Description
****************************************************
ACORDA (ACOR)433 m Zanaflex(spast),Fampridine(MS)
ALTUS (ALTU)423 m Enzyme Replacement
AMEDISYS (AMED)719 m Home health care, hospice svcs
ALNYLAM (ALNY)682 m RNAi, Infectious, CNS, other
BECKMAN COULTER (BEC) 4.0B Hospital lab/diag test/equip
BECTON DICKINSON(BDX) 19 B Med supplies, lab equipment
BIO-IMAGING TECH(BITI) 86 m Image mgt for clinical trials
BIO-RAD LABS (BIO) 2.3 B Bio instruments, diagnostics
BIOMARIN (BMRN)1.8 B Enzyme replacement, cardiovasc
BARR LABS (BRL) 5.8 B Generics, proprietary
COMBINATORX (CRXX)246 m Synergistic drug combinations
COVANCE (CVD)4.0 B CRO
CELGENE (CELG) 20 B Cancer - Revlimid, Thalomid
CORTEX (COR) 39 m Ampakines / Neurological
CUBIST (CBST)1.0 B Antibiotics - Cubicin
DURECT (DRRX)304 m Drug Delivery
EXELIXIS (EXEL)962 m Cancer
GENMAB (GNMSF.PK) Cancer, Autoimmune
GENZYME (GENZ) 17 B Enzyme Replacement, others
GILEAD (GILD) 32 B Infectious Diseases, HIV
HALOZYME (HTI)499 m Improved drug penetration
HENRY SCHEIN (HSIC)4.5 B Dental/Med products, vaccines
IDENIX (IDIX)496 m Infectious Disease, Hepatitis
ILLUMINA (ILMN)1.7 B Genetic Variation Equip
MEDAREX (MEDX)1.6 B MAB provider
MERIDIAN (VIVO)766 m Diagnostics, Test Kits
MGI PHARMA (MOGN)1.5 B Chemo related, cancer, other
MYRIAD (MYGN)1.4 B Diagnostics, AD, cancer
NOVAMED (NOVA)178 m Surgical Centers
PDL BIOPHARMA (PDLI)2.4 B MABS, other
PHARMA PR DEV (PPDI)4.1 B CRO
PHARMION (PHRM)1.0 B Cancer
QIAGEN (QGEN)2.6 B Nucleic acid research related
SENOMYX (SNMX)433 m Taste/Flavor Modulators
SEPRACOR (SEPR)6.0 B CNS, Respiratory, other
SIGMA ALDRICH (SIAL)5.0 B Bio Reagents, chemicals
SPECTRUM (SPPI)162 m Cancer, Satraplatin, generics
STERICYCLE (SRCL)3.4 B Medical Waste
TEVA (TEVA) 27 B Generics, proprietary
THERMO FISHER SC (TMO)7.8 B Bio Insts, Radiation detect.
TORREY PINES (TPTX) 27 m Neurological, Migraines
VERTEX (VRTX)4.2 B Infectious Disease, Hepatitis
WMG2, Over the years, I've never been able to stay invested in Cortex for very long, since I was often using borrowed money and was therefore too nervous about it. I would jump in and out a lot, but mostly stayed parked in cash. If it wasn't for that I would have gone down the tubes long ago. So overall I probably broke even on Cortex over the years, even though I still managed to lose money in other ways (getting back into tech related funds too early was my big mistake).
In 2006, I did make some bad calls on Cortex, but luckily stayed out of the stock -
1) ADHD results - I was extremely wary, which turned out to be wrong, though based on that trial design, being wary still seems like the most logical viewpoint to have had.
2) DARPA results - I was very confident, which turned out to be wrong.
3) Clinical hold and aftermath - None of us saw the hold coming, but I was right about the aftermath, so far anyway.
So I guess the moral of the story - if biotech is just a hobby, it doesn't matter how good your individual stock calls are. If I can be a "contrary indicator", I'm glad to be of service :o)
IDEX (2-07) - If the idea of a "17th Annual Pump, Valve, and Motor Symposium" doesn't exactly get your motor revving, IDEX's longer term chart definitely will. Another example of dull is beautiful -
>>> IDEX Corporation To Present at Gabelli & Company's 17th Annual Pump Valve & Motor Symposium
Friday February 2, 8:00 am ET
NORTHBROOK, Ill.--(BUSINESS WIRE)--IDEX Corporation (NYSE: IEX - News) today announced that its management will present at Gabelli & Company's 17th Annual Pump Valve & Motor Symposium in New York on Wednesday, February 7, 2007 The presentation will begin at 10:30 am ET.
Access to the live presentation will be available through a link at www.idexcorp.com. Interested investors may also access the live webcast directly at http://www.wsw.com/webcast/gabelli16/iex/
About IDEX
IDEX Corporation is an applied solutions company specializing in fluid and metering technologies, health and science technologies, dispensing equipment, and fire, safety and other diversified products built to its customers' exacting specifications. Its products are sold in niche markets to a wide range of industries throughout the world. IDEX shares are traded on the New York Stock Exchange and Chicago Stock Exchange under the symbol "IEX".
For further information on IDEX Corporation and its business units, visit the company's Web site at www.idexcorp.com. <<<
With Cortex having to raise $5 mil from vultures just to keep the doors open, I'd be more worried about Cortex surviving as a company than whether you would sell at $20 or $30 in ten years. Not to be overly negative, but let's get real.
Unlike Neuro's rosy 70% estimate for restoring CX-717/ADHD, in my mind I'm finding it hard to justify anything over 20% (and I'm trending more toward 10%). We won't know til June or so, so there's plenty of time to debate the topic. Any additional info Dr. Stoll can provide after all the new data is analyzed may help us estimate the odds. No matter how you slice it though, odds-wise, the FDA decision is going to be a crapshoot at best.
American Standard's Breakup Applauded (2-07) -
>>> Friday February 2, 5:01 am ET
By Jeffrey Gold, AP Business Writer
American Standard to Shed Plumbing and Brake Divisions, Focus on Air Conditioning
NEWARK, N.J. (AP) -- American Standard Cos. Inc. said Thursday it will sell its well-known plumbing fixture business and spin off a unit that makes auto braking systems, then rename the company Trane after its signature brand of air conditioning systems.
Wall Street applauded the breakup, sending the stock rising more than 7 percent to its highest level since the company went public in 1995.
While American Standard, based in Piscataway, N.J., is best known for its kitchen and bath products, the Trane operation brought in $6.8 billion, or 60 percent of its sales in 2006.
Trane is among the leading suppliers of commercial and residential heating, ventilation and air conditioning systems. The new Trane company will retain the right to use the American Standard brand name for such products.
The vehicle control systems business, which posted $2 billion in revenue in 2006, will be spun into a publicly traded company to be called WABCO. American Standard shareholders will be issued one share of WABCO stock for every three American Standard shares currently owned.
American Standard also said it will sell its bath and kitchen business, which generated $2.4 billion in revenue in 2006. The company plans to use proceeds from that sale to pay down debt and buy back Trane common stock.
The breakup, which does not require shareholder approval, is to be completed by early fall.
SunTrust Robinson Humphrey analyst Keith Humphrey said it was not surprising that Wall Street liked the deal.
"It's attractive because the kitchen and bath business, which has been the problem over the last year or so, is no longer going to be part of the entity," Humphrey said. As with others in the industry, its "results have fallen off a cliff" because the price of raw materials has risen.
Because of the American Standard name, however, "I think the private equity firms will line up to buy it," Humphrey said, noting that until recently the segment had performed well. He declined to estimate a selling price, but said it would be "well below" the $2.4 billion in sales for 2006.
The separation of Trane from WABCO also made sense, he said, noting the two businesses had nothing in common.
The company's board decided the restructuring would enhance shareholder value, said Fred Poses, American Standard's chairman and chief executive.
"We feel pretty positive about what we've done, and pretty positive about the future," he said. "Operating separately, the businesses will benefit from greater strategic focus, increased market recognition, improved capital flexibility, and an increased ability to attract, retain and motivate employees."
American Standard now has about 62,000 employees worldwide. Poses said staff cuts are not a focus of the restructuring. "I don't think this is about reductions," he said, but noted that he could not say what the new owner of the bath and kitchen segment would do.
Poses will stay in his posts through 2007, as planned. The company is searching for a successor.
Trane will keep its headquarters in Piscataway and will continue to be traded on the New York Stock Exchange under a new symbol yet to be determined.
Jacques Esculier, president of the vehicle control systems segment, will become CEO of WABCO. Jim Hardymon, currently a director on American Standard's board, will serve as WABCO's non-executive chairman.
WABCO will be a U.S. company, with executive and administrative offices in Brussels, Belgium, as well as Piscataway. It is also expected to be listed on the NYSE.
Dale Elliott, president of American Standard's global bath and kitchen segment, will continue in his role.
The restructuring was announced along with quarterly and annual financial results. The company said its fourth-quarter profit rose 78 percent, helped by strong sales of air conditioning and vehicle control systems.
Quarterly earnings increased to $114.3 million, or 56 cents per share, from $64.4 million, or 30 cents per share during the same period last year.
The results included operational consolidation expenses and benefits from asset sales and taxes. Excluding these items, profit totaled 51 cents per share, matching analyst expectations, according to a Thomson Financial poll.
Revenue grew 6 percent to $2.70 billion from $2.55 billion in the year-ago quarter, but came in just under Wall Street's estimate for $2.74 billion.
For the full fiscal year, American Standard posted a profit of $541 million, or $2.62 per share, a 3 percent decrease from earnings of $556.3 million, or $2.56 per share, in 2005. There was a smaller number of shares outstanding in 2006.
Full-year revenue rose 9 percent to $11.21 billion, from $10.26 billion in 2005.
American Standard stock rose $3.86, or 7.82 percent, to close at $53.25 on the New York Stock Exchange after peaking at $53.83. It had traded from $36.35 to $49.47 over the past year.
On the Net: http://www.americanstandard.com <<<
I'll probably cover my short at .50 cents. Just kidding :o)
Alertmeipp, I'm 51, which is old enough to have at least some CDs/bonds. I'm figuring my target allocation to be around 50% equities/50% fixed income. If you're in your 30s or 40s you should probably be 80-100% in equities. Even at 50 years old, a 50/50 mix is on the conservative side, but I just got tired of losing money every year on bio stocks. 2006 was my first "up" year since 2003, thanks to being out of the bio sector completely. Concentrated bets on bio stocks just hasn't worked for me, so I moved to a more conservative approach.
Warren Buffett / Berkshire's current holdings (see below). He is perhaps the greatest investor of all time. Hmm, but I don't see any biotech microcaps in his portfolio, and no naked options either. I can't have a portfolio like that, it's mind-numbingly boring. He even owns American Standard, the toilet company - how disgusting.
Buffett has an annualized return of 21.5% per year since 1965. THAT'S 21.5 PERCENT COMPOUNDED EVERY YEAR. Do the math - if you had invested $10,000 in Berkshire Hathaway when he took control in 1965, your holdings would be worth more than $50 million today. That's FIFTY MILLION DOLLARS. Dull is beautiful baby :o) --
USG (NYSE: USG - News)
Costco (NasdaqGS: COST)
General Electric (NYSE: GE - News)
Ameriprise Financial (NYSE: AMP - News)
Tyco (NYSE: TYC - News)
Target (NYSE: TGT - News)
Nike (NYSE: NKE - News)
Iron Mountain Inc. (NYSE: IRM - News)
Coca-Cola (NYSE: KO - News)
Comcast (NasdaqGS: CMCSK)
Proctor & Gamble (NYSE: PG - News)
Moody's Corporation (NYSE: MCO - News)
Westco Financial (AMEX: WSC - News)
Johnson & Johnson (NYSE: JNJ - News)
Anheuser-Busch (NYSE: BUD - News)
American Express (NYSE: AXP - News)
Wells Fargo Company (NYSE: WFC - News)
Walmart (NYSE: WMT - News)
ConocoPhillips (NYSE: COP - News)
M&T Bank Corporation (NYSE: MTB - News)
American Standard (NYSE: ASD - News)
United Parcel Service (NYSE: UPS - News)
Western Union (NYSE: WU - News)
Lowe's (NYSE: LOW - News)
H & R Block (NYSE: HRB - News)
Sanofi-Aventis (NYSE: SNY - News)
<<<
Meixatech, I would define it as someone who invests in biotech :o) But seriously, I think the author just meant stocks that don't perform well over time - the perennial dogs. The tendency is for investors to quickly take profits in their winners, and double down on their losers, which is the opposite of what should be done for good results. It's like a gardener watering the weeds while pulling all the flowers out by the roots. Unfortunately, we've all done it.
OT - Excerpt from a MF article -
>>> "Your emotions are costing you money. Ever heard of loss aversion? It's the practice of holding onto losers in the hopes they'll turn.
In another study, Professor Terrance Odean found that while investors held losing stocks for a median of 124 days, they held winning stocks for just 102 days. Moreover, investors were 1.7 times as likely to sell their winner.
In other words, investors are cutting winners off early and letting losers ride. That's the antithesis of a successful investment formula.
Alas, this madness can be explained. As master fund manager Ron Muhlenkamp puts it, "For most people 'The Game of the Stock Market' is a distraction which prevents them from making money in 'The Business of Investing.'"
That's why you only hear your buddies talk about their winners at cocktail parties. In the "The Game of the Stock Market," losers don't exist. But in "The Business of Investing," they're the reason why those same buddies haven't yet retired.
Small consolation: The pros aren't immune
Professional investors suffer from loss aversion, too, according to research from Andrea Frazzini. Pros were 1.2 times as likely to sell a winning stock rather than a losing stock. While not quite as bad as the 1.7 of the average Joe, these guys and gals supposedly earn their paychecks staying calm, cool, and collected! " <<<
So, the moral of the story is -- dump the losers, and let the winners ride. Simple right? But not always easy to do.
Fearfrost, Do yourself a big favor and forget the whole options thing. Also, NEVER open a margin account under any circumstances. NEVER buy stocks with borrowed money. If you have the choice of paying down your car loan, student loan, mortgage, etc, do that before buying some screwball bio stocks or options (and believe me, they're all screwball).
Don't learn these vital lessons via the school of hard knocks like the rest of us have. Biotech and options are just like going to Vegas. They are gambling, pure and simple, and gambling is for chumps and losers.
Remember the old maxims, they may sound corny but they're as true today as they were 3000 years ago -
1) Know Thyself -- know your strengths/limitations and don't delude yourself.
2) Moderation/Nothing to Excess -- when applied to investing = Diversification.
3) Hubris begets Nemesis -- arrogance/pride will be one's undoing.
American Standard (2-07) - to split into 3 different units -
>>> American Standard profit surges, to split company
By Shawn Langlois, MarketWatch
Last Update: 10:25 AM ET Feb 1, 2007
SAN FRANCISCO (MarketWatch) -- American Standard shares roared to a record high on Thursday after the company reported a 77% surge in fourth-quarter profit and announced it will split into three different businesses.
At last check, American Standard's (ASD ) stock was up 7.5% at $53.11, pulling back slightly from a record high of $53.70 notched earlier in the session.
The Piscataway, N.J.-based company said its board has voted to spin off its vehicle control business systems unit into a publicly traded entity called WABCO, sell its bath and kitchen business, and retain its air conditioning systems and services unit.
The latter unit will be renamed Trane.
"It is difficult to argue with the strategic logic of this move,"
— Deutsche Bank analyst Nigel Coe
"The board has concluded that separating American Standard into three focused, better understood companies will create greater shareowner value than the current structure," Chairman and CEO Fred Poses said in a statement.
For every three shares of American Standard held, a stockholder will get one WABCO shares in a tax-free spinoff. Jacques Esculier, president of Vehicle Control Systems for the past three years, will become CEO of WABCO.
Deutsche Bank analyst Nigel Coe, who carries a hold rating on the stock, gave the move a nod of approval.
"The continuous under-performance of the [bath & kitchen] businesses has over-shadowed top-tier performances from Trane and WABCO; as such, it is difficult to argue with the strategic logic of this move," he told clients in a note.
Also fanning buyer interest, American Standard posted earnings of $114.3 million, or 56 cents a share, up from a year-ago profit of $64.4 million, or 30 cents a share.
On an adjusted basis, excluding certain items, the company earned $104.5 million, or 51 cents a share, in the latest quarter. Sales rose to $2.7 billion in the three months ended Dec. 31 from $2.55 billion in the same period a year earlier.
Analysts polled by Thomson Financial had expected a profit of 51 cents a share.
"Earnings for the air conditioning and vehicle control systems businesses were powerful enough to overcome lower earnings in our bath and kitchen business," Poses said.
"We did fall short of our cash goals because of the timing of receipts and some inventory build-up in air conditioning, but expect to recover much of the cash in the year ahead," he added.
For 2007, the company forecast adjusted earnings of $3.15 to $3.25 a share on sales growth of about 8%. For the first quarter, American Standard said it sees adjusted earnings of 48 to 52 cents a share with sales rising about 6%.
Wall Street's current consensus estimate is for a profit of $3.08 a share for the year and 48 cents a share in the March period. <<<
Alnylam - (2-07) >>> Presents Pre-clinical Results from Hypercholesterolemia, Huntington's Disease and Neuropathic Pain Programs at Keystone Symposium on RNAi
Thursday February 1, 8:00 am ET
- New Results Expand In Vivo Efficacy Data for Direct and Systemic RNAi Therapeutic Applications -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, announced today that it presented new pre-clinical data at the "RNAi for Target Validation and as a Therapeutic" Keystone Symposium held January 28 - February 2, 2007 in Keystone, Colorado. The new results were presented from Alnylam's RNAi therapeutics program targeting PCSK9 for the treatment of hypercholesterolemia and from Alnylam collaborations in Huntington's disease and neuropathic pain. The data demonstrate that small interfering RNAs (siRNAs), the molecules that mediate RNAi, can be administered in animal models to achieve therapeutic silencing of disease-causing genes, and that effective and clinically relevant delivery can be achieved with both direct and systemic RNAi applications.
"Alnylam scientists and our collaborators continue to make significant progress in achieving delivery for RNAi therapeutics and in demonstrating in vivo efficacy in animal models of human disease. Indeed, the new data presented this week further extend Alnylam's scientific leadership in advancing RNAi therapeutics as a new class of innovative medicines," said Victor Kotelianski, M.D., Ph.D., Vice President, Research at Alnylam. "We are especially encouraged by the new findings in our PCSK9 program for hypercholesterolemia that show considerable potency and durability in a mouse model after a single dose of our RNAi therapeutic. These new data support ongoing efforts to advance our PCSK9 program toward a planned IND filing in 2007."
Hypercholesterolemia
Alnylam is developing a systemically delivered RNAi therapeutic for the treatment of hypercholesterolemia targeting PCSK9, a key gene involved in the metabolism of LDL cholesterol. In a talk titled "Achieving Therapeutic Gene Silencing in vivo with RNAi," results were presented on ALN-PCS01, Alnylam's RNAi therapeutic targeting PCSK9 which comprises an optimized siRNA formulated in a liposomal nanoparticle.
Data presented include the following.
In vivo systemic administration of ALN-PCS01 in mice was associated with dose-dependent and rapid silencing of the PCSK9 messenger RNA to more than 70 percent of control levels, with peak silencing effects observed as soon as 48 hours after dosing.
After a single intravenous injection, the RNAi therapeutic showed a durable biological effect with more than 50 percent silencing of PCSK9 maintained through two weeks, and full recovery of PCSK9 to normal levels at 23 days after dosing.
Therapeutic efficacy for ALN-PCS01 was demonstrated with up to 30 percent reduction in total cholesterol levels at doses that were well tolerated.
Alnylam intends to file an investigational new drug (IND) application for ALN-PCS01 in 2007.
Huntington's Disease
In a talk titled "Advances in the use of Synthetic siRNAs in the Treatment of Huntington's Disease Models," Alnylam collaborator Dr. Neil Aronin, Professor of Medicine and Cell Biology and Director of Endocrinology and Metabolism at the University of Massachusetts Medical School presented in vivo data demonstrating that an siRNA targeting the huntingtin gene inhibited the progression of Huntington's disease in a mouse model. These results showed both a reduction of neuronal pathology and an improvement in abnormal behavior in the disease model with administration of a cholesterol-conjugated siRNA. Pathological protein aggregates in the neuropil were decreased by about 70 percent. Two types of abnormal behavior - clasping and footslips - were ameliorated by approximately 50 percent and 70 percent, respectively. In addition, levels of the huntingtin messenger RNA, which encodes the protein that mediates Huntington's disease, were reduced by about 70 percent. Alnylam believes these findings support further studies of RNAi therapeutics for the treatment of Huntington's disease.
Neuropathic Pain
In a poster titled "RNAi of Neuropeptide Y for Neuropathic Pain," Alnylam collaborator Dr. Josephine Lai, Professor of Pharmacology at the University of Arizona, presented results showing that intrathecal injection of an siRNA targeting neuropeptide Y (NPY) prevented the development of neuropathic pain in a rat model. A more effective siRNA, designed by Alnylam, has been identified from in vitro studies and will be tested in vivo for enhanced activity. Further, in a talk titled "Treating Neuropathic Pain with RNA Interference," Dr. Lai presented results demonstrating that a single intraparenchymal injection of a very small dose of siRNA targeting the receptor of NPY in a lipid formulation was efficacious against neuropathic pain in a rat model. Alnylam believes these findings further support the use of RNAi as a highly potent therapeutic approach for the treatment of disorders of the nervous system.
About RNA Interference (RNAi)
RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. The discovery of RNAi has been widely acknowledged as a major breakthrough in biology, and the technology was recognized for its potential broad impact in medicine with the award of the 2006 Nobel Prize for Physiology or Medicine. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause targeted gene silencing.
About Alnylam
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is building a pipeline of RNAi therapeutics; its lead program is in Phase I human clinical trials for the treatment of respiratory syncytial virus (RSV) infection, which is the leading cause of hospitalization in infants in the U.S. The company's leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, and Biogen Idec. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts, and has an additional operating unit in Kulmbach, Germany. For more information, visit www.alnylam.com. <<<
Gilead article - (2-07) -
>>> Gilead Sciences Revs Growth Engine
By Adam Feuerstein
Senior Writer
2/1/2007 8:49 AM EST
URL: http://www.thestreet.com/newsanalysis/biotech/10336190.html
Gilead Sciences (GILD) is keeping the pedal to the metal on its HIV drug growth engine, which contributed mightily to a fourth-quarter earnings report Wednesday that easily topped estimates.
The Foster City, Calif.-based biotech firm posted adjusted net income of $372.8 million, or 78 cents a share, compared with net income of $256.5 million, or 54 cents a share, in the year-ago quarter.
Gilead lost $1.67 billion, or $3.62 a share, due to a one-time charge related to last year's $2.5 billion acquisition of Myogen.
Analysts were expecting Gilead to earn 62 cents on an adjusted basis, according to Thomson Financial.
Total revenue for the quarter increased 48% to $899.2 million. This included $768.1 million in product sales, which were up 56% from the year-ago quarter.
Buoyed by the strong earnings report, shares rallied nearly 5% in after-hours trading to $67.45.
Once again, Gilead's HIV drug franchise was a powerhouse. Truvada sales were $337.1 million for the quarter, up 76% from the year-ago quarter. U.S. sales of Truvada were $196.3 million, a scant 2.5% sequential drop.
The strong domestic performance of Truvada continues to defy Gilead skeptics who believed Truvada sales would be cannibalized by the July 2006 launch of Atripla, a once-daily, single-pill treatment for HIV that combines Gilead's Truvada with Bristol-Myers Squibb's (BMY) Sustiva.
Atripla sales in the quarter totaled $137.4 million, up 101% sequentially. The drug has broad appeal to patients because of its simplicity. For the first time, treating HIV with a single pill has become as easy as popping a morning vitamin. When combination drug therapy was first introduced into the HIV drug market 10 years ago, patients were forced to take a bowlful of pills each day.
One good way to gauge the earnings power of Gilead's HIV drug franchise is to combine sales of Truvada with the Truvada component of Atripla (equal to about two-thirds of total Atripla sales, with one-third of sales being passed on to Bristol-Myers). During the fourth quarter, this "total Truvada" revenue was $283 million, a 16% sequential jump.
According to data collected by Gilead, 67% of new HIV patients starting treatment are now on a Truvada-containing regimen. Among HIV patients already on therapy, Truvada continues to steal market share from Combivir, a competing regimen marketed by GlaxoSmithKline (GSK) .
On its conference call Wednesday night, Gilead said it expects total product revenue in 2007 to be in the range of $3.4 billion to $3.5 billion -- a 30% to 35% increase over 2006 product revenue.
This revenue guidance excludes royalty revenue, which totaled just under $438 million in 2006. Royalty revenue hinges primarily on sales of the flu drug Tamiflu, marketed by Roche. Tamiflu sales have been on a global upswing due to government stockpiling as a defense against the threat from the bird flu virus.
Gilead did forecast higher spending for 2007 now that it has digested Myogen, which it acquired last October. But investor concerns going into Gilead's quarterly report that expense guidance would be higher than expected, and therefore cut deep into earnings growth, appear to be allayed.
On the pipeline front, Gilead said it will present phase II clinical data on its experimental HIV drug GS9137 at an HIV meeting in February. A phase III study of GS9137 is expected to start soon.
Clinical data from a phase I study of experimental hepatitis C drug candidate GS9132 will be ready in the second quarter. Another HIV drug candidate in Gilead's pipeline, GS9224, was discontinued due to problems with dosing. <<<
iRobot / robotics article (1-07) -
>>> Park 'n' Save With Robots
http://www.fool.com/investing/high-growth/2007/01/31/park-n-save-with-robots.aspx
Jack Uldrich
January 31, 2007
If you have ever lived in, worked in, or visited New York City, and had to get around by car, you understand what a hassle parking in the city can be. So I was considerably intrigued the other day to read an article heralding the opening of a new robotic parking garage in the Big Apple.
Don't worry -- the system doesn't demand that you turn your keys over to a robot.. Instead, your car is placed on a pallet, and a robotic contraption efficiently whisks the automobile away for safe storage.
As cool as that is, it's not what caught my attention. Instead, I was surprised to learn that the robotic system, built by Automation Parking Systems, is so efficient that it can fit 67 cars in a space that normally only holds 24. It is able to do this not only by packing cars closer to one another (there is no need to leave space to open a car door) but also because it can do away with ramps and other superfluous maneuvering space.
When you consider that it costs roughly $25 a day to park in New York City, then multiply that figure by the number of additional cars such a system can handle, you get some idea of how robots might possibly make a solid long-term investment.
All across the emerging field of robotics, similar opportunities for cost savings are emerging. It's well-known (at least on these pages) that Intuitive Surgical's (Nasdaq: ISRG) da Vinci system is now performing almost 40% of all prostatectomies. Less common is the knowledge that the robots perform these operations so well that patients often have significantly shorter recovery times.
In more practical terms, this means shorter hospital stays and fewer nurses to watch over the patients. It also suggests that the hospital can make more doctors (and beds) available to serve other patients.
The same is true of other robots. For instance, iRobot's (Nasdaq: IRBT) Roomba and Scooba could help building maintenance companies cut down on janitorial costs. Similarly, on the military side, iRobot's and Foster-Miller's robots can cut down on the number of soldiers needed to disarm roadside bombs and patrol dangerous areas.
My recommendation: Consider some modest investments in the emerging field of robotics, then park those investments away. By helping other businesses "do more with less," they themselves are likely to prosper. In so doing, they could end up helping you squeeze a little more out of your portfolio. For assistance in analyzing such companies, check out a free 30-day trial of Motley Fool Rule Breakers, where we are always looking at innovative companies in emerging technologies.
Interested in other robotic foolishness? Check out these articles:
The Circle of Life, With Robots
Small Visions of the Future
Robots on the Brain
Are Intuitive Surgical and iRobot Just Babies? <<<
Pharmion / Vidaza (IV approval) (1-07) -
>>> SeekingAlpha
Pharmion's New Vidaza Approval Sends Stock Soaring
Tuesday January 30, 4:50 am ET
Anthony Payne submits: Pharmion (NasdaqGM: PHRM) announced FDA approval yesterday for its NDA supplement to add intravenous [IV] use as a new route of administration to the instructions in the approved prescribing information for its DNA demethylating agent Vidaza. In May 2004, Vidaza became the first drug approved by the FDA for the treatment of patients with Myelodysplastic Syndromes [MDS] a serious cancer like blood disorder. The FDA approved Vidaza, the first in a new class of drugs called demethylation agents, for treatment of all five MDS subtypes, which include both low-risk and high-risk patients. MDS are a group of diseases in which the blood cells produced by the bone marrow is disrupted. As compared to leukemia’s where the white cells are produced in extremely large quantities.
According to the press release issued yesterday:
“With IV administration, the dosing for Vidaza remains the same as the previously approved subcutaneous [SC] administration at 75 mg/m2 daily, for seven days, every four weeks. Since this approval is for an alternative administration of the existing formulation, Pharmion will begin promoting this IV route of administration immediately.”
The stock rose almost 5% on the news and it at its 52 week high.
PHRM 1-yr chart
As I reported earlier, there are a significant number of catalysts for PHRM expected in 2007 and even though the valuation is high at present, these events should move the stock even higher in 2007. The catalysts expected in 2007 are repeated below.
The filing in Europe for Satraplatin for hormone refractory prostate cancer [HRPC]
The filing in Europe for Vidaza for the treatment of high-risk myelodysplastic syndromes [MDS]
Data from the randomized controlled Phase 3 survival study for Vidaza in high-risk MDS, which is expected to be complete in the third quarter of 2007
Phase 3 Satraplatin survival data in HRPC
Phase 2 Amrubicin data in small cell lung cancer [SCLC]
Oral Vidaza bioavailability data
Phase 2 MGCD0103 data in a variety of indications
Initiation of a pivotal registration trial for MGCD0103 in a hematologic malignancy
Initiation of a pivotal registration trial for Amrubicin in second-line SCLC Disclosure: Author has no position in PHRM.<<<
Gilead (1-07) Q4-06 -
>>> Gilead swings to quarterly loss; revenue jumps 48%
By Carolyn Pritchard, MarketWatch
Last Update: 5:38 PM ET Jan 31, 2007
SAN FRANCISCO (MarketWatch) -- Gilead Sciences Inc. late Wednesday swung to a loss in the latest three-month period due to costs associated with recent acquisitions, but it posted a 48% surge in fourth-quarter revenue that was powered by its HIV treatments.
Shares of Gilead surged more than 4% in after-hours trading, to $67.
Results and outlook
After the closing bell, the Foster City, Calif.-based Gilead (GILD ) said it lost $1.67 billion, or $3.62 a share, in the latest three-month period. That compares with a profit of $281.6 million, or 59 cents a share, in the same quarter the year before. The latest results include a $2.04 billion charge for purchased in-process research and development acquired through its buyouts of Corus Pharma Inc. and Myogen Inc., Gilead said.
Excluding onetime charges, Gilead posted a per-share profit of 78 cents. Revenue rose to $899.2 million from $609.3 million. Analysts polled by Thomson Financial had been looking for a per-share profit of 68 cents and revenue of $850.9 million, on average.
Gilead also issued a 2007 product sales forecast of $3.4 billion to $3.5 billion, a 31% to 35% rise over the full-year 2006 period. It sees research & development costs ranging from $510 million to $530 million for the year, Chief Financial Officer John Milligan said on a conference call, which would be a 54% to 60% rise over 2006 R&D expenses excluding the impact of stock-based compensation costs.
Product details
Fourth-quarter product sales rose 56% year-over-year, to $768.1 million, with HIV product sales rising 67% to $642.4 million. Royalty, contract and other revenue came in 13% above last year, at $131.1 million, with $113.2 million in Tamiflu royalties from F. Hoffmann-La Roche Ltd.
Sales of the first once-a-day treatment for HIV treatment Atripla, which Gilead jointly developed with Bristol-Myers Squibb Co. (BMY) , rose to $137.4 million from $68.4 million in the third quarter. The FDA approved Atripla, which contains Bristol-Myers' Sustiva and Gilead's Truvada, which itself consists of the company's drugs Viread and Emtriva, for sale last summer. Gilead expects Atripla will be approved for sale in the European Union sometime in the second half of the year, Chief Executive John Martin said on the conference call.
Sales of Truvada soared to $337.1 million in the latest quarter, from $191.1 million the year before and $309 million in the third quarter.
But sales of Viread and Emtriva both fell, to $159.5 million $8.5 million, respectively. That compares with Viread sales of $182.4 million last year and $170.6 milllion in the third quarter; Emtriva sales fell from $11.2 million in the fourth quarter of 2005 and $9.3 million from the third quarter of 2006.
Hepsera, used to treat chronic hepatitis B, saw its sales rise 29% to $51.2 million, while sales of fungal infection treatment
AmBiosome were up 5% over the same period last year, at $58.3 million.
Gilead in mid-December submitted an application to the Food and Drug Administration seeking approval for ambrisentan, a once-daily treatment of pulmonary arterial hypertension that Gilead acquired the rights to through its $2.5 billion purchase of Myogen.
Ambrisentan has been granted orphan drug designation for such an indication in the U.S. and in the European Union. The company has requested the FDA give priority review to the application; it expects the FDA to decide whether or not to do so by the middle of February.
GlaxoSmithKline Plc (GSK) holds the rights to sell ambrisentan outside of the U.S. Early in December, Gilead was subpoenaed by the Justice Department in relation to how its sells Viread and Emtriva and Truvada. The DOJ didn't request information related to Atripla. See full story. <<<
Sepracor mentioned as attractive takeover target (1-07) -
>>> Sepracor Falls on 2007 Outlook
Wednesday January 31, 4:14 pm ET
Sepracor Shares Tumble on 2007 Forecast, Weakness of Sleep Aid Lunesta Sales
NEW YORK (AP) -- Shares of Sepracor Inc. moved lower Wednesday after the drug maker's 2007 earnings forecast fell short of Wall Street estimates despite a strong fourth-quarter.
Shares of Sepracor lost $3.15, or 5.2 percent, to close at $57.06 on the Nasdaq at nearly five times their average volume. Shares have traded between $42.29 and $63.24 over the past 52 weeks.
The company reported its fourth-quarter profit nearly tripled to $99.1 million, or 85 cents per share, on revenue of $357.2 million, a 15 percent increase. Analysts surveyed by Thomson Financial expected more modest earnings per share of 62 cents on revenue of $341.4 million.
However, the company later forecast 2007 earnings per share of $2.25 on sales of $1.46 billion, compared with a Wall Street consensus of $2.40 per share on sales of $1.44 billion.
Cowen & Co. analyst Ian Sanderson used the opportunity to downgrade the company to "Underperform," stating that sluggish sales of the sleep aid Lunesta were hidden by lower marketing costs and a boost in sales of Xopenex asthma medication sales.
While Xopenex sales accounted for $200.8 million in revenue, Lunesta sales only rose 2 percent to $148 million in the latest quarter. Total sales and marketing costs fell by 16 percent to $167.9 million from the year-ago period.
The company's earnings forecast for 2007 will need a 21 percent rise in Lunesta sales, but Sanderson only sees Sepracor growing sales by 15 percent to 17 percent because of generic competition.
Investors were less likely to listen to Merrill Lynch's Gregg Gilbert and Baird & Co.'s Lawrence H. Neibor, who held onto their Buy-grade ratings, optimistic of strong revenue growth and Sepracor's attractiveness as a takeover candidate. <<<
Generic related legislation (1-07) -
>>> Mylan on the Generic Attack
http://www.fool.com/investing/general/2007/01/31/mylan-on-the-generic-attack.aspx
Brian Lawler
January 31, 2007
It was a busy day for generic drugmaker Mylan Laboratories (NYSE: MYL), which announced four separate news releases today. First came news of a management shakeup in conjunction with its acquisition of Indian generic drugmaker Matrix Laboratories. Mylan followed that up with two more approvals -- one to market a generic version of GlaxoSmithKline's (NYSE: GSK) antiviral herpes treatment Valtrex, and another to market a generic version of Alza's Duragesic pain patch. (Alza is a subsidiary of Johnson & Johnson (NYSE: JNJ).)
But it is the news that a piece of legislation was introduced in the Senate yesterday that might have the biggest effect on Mylan and competitors like Barr Pharmaceuticals (NYSE: BRL), and the future of the generic-drug industry as a whole. This legislation would outlaw the practice of pharmaceutical companies launching authorized generic versions of their branded drugs.
When a generic drugmaker becomes the first to successfully challenge the validity of a branded drug's patents, the FDA gives it a 180-day exclusivity period where it may be the only competitor against its branded counterpart. Gaining this exclusivity period is worth hundreds of millions of dollars on some drugs, and this is one of the main ways that generic drug companies make their profits. Congress passed a law giving generic companies this lucrative 180-day duopoly to encourage them to challenge what can be shaky patents that big-pharma tries to attach to their drugs to extend their patent protection.
The problem has been that pharmaceutical companies have been trying to get around this exclusivity period and squeeze out extra profits for themselves by willingly letting a second generic drug company market an "authorized generic" version of their product when the exclusivity period starts up. This kneecaps the profits of generic drugmakers who take the risk and spend years and millions of dollars fighting the invalid branded-drug patents in court in order to get that exclusivity period.
In fact, when a second generic copy of a drug enters the market, the price of the first generic falls from 94% of the branded drug's price all the way down to 54% of its price on average, and causes generic drugmaker profits to decline. Less profits on a generic drug means a huge disincentive to fight against branded-drug patents in the future. This is what Sens. Schumer, Leahy, Kohl, and Rockefeller want to fix with their bill.
It's a simple rule of economics that the less competition there is, the higher the profits from selling a product could potentially be. Investors interested in any of the generic drugmakers should pay close attention as this piece of legislation moves its way through Congress -- it could have a hugely positive effect on Mylan and the whole generic-drug industry if it eventually becomes law. <<<
>>> MGI Pharma (1-07) - cited by FDA for "misleading" advertising -
Wednesday January 31, 3:41 pm ET
The U.S. Food and Drug Administration cited MGI Pharma Inc. for what it calls a "misleading" advertisement for the company's implanted therapy to treat brain tumors, according to a letter released on Wednesday.
The FDA said a two-page promotional ad for the product, called Gliadel Wafer, "fails to disclose its full indication and presents unsubstantiated claims".
The agency also said that claims in the ad that "Gliadel wafer works at day 1," was misleading because it didn't include the information that the claim was based on animal trials, not human studies.
The agency requested that MGI Pharma immediately stop using the ad and any similar ads.
Officials at Shakopee-based biopharmaceutical company MGI Pharma (NASDAQ: MOGN - News) could not be immediately reached for comment. <<<
Sepracor article (1-07) -
>>> No Snoozing for Sepracor
http://www.fool.com/investing/high-growth/2007/01/31/no-snoozing-for-sepracor.aspx
Brian Lawler
January 31, 2007
Last year proved to be a wild one for shareholders of pharmaceutical company Sepracor (Nasdaq: SEPR). Shares fluctuated wildly over concern and then relief that more competition was not imminently coming -- namely from Neurocrine Biosciences (Nasdaq: NBIX) -- against Lunesta in its key insomnia market.
Today Sepracor released its fourth-quarter financial results. Sales gained 15% versus the fourth quarter last year. While this is still strong growth, it's not nearly as heady as the year-over-year sales expansion that Sepracor experienced earlier in the year. The main cause of the sales slowdown was the complete lack of growth in Lunesta sales, which came in at $148 million for the quarter. The lack of growth was most likely due to a 15% scaling down of sales and marketing expenses. The future Lunesta sales trend as we start 2007 is something investors should pay attention to.
Total Product Sales*
Y-O-Y Growth
Q4 2006
$349
15%
Q3 2006
$280
47%
Q2 2006
$256
54%
Q1 2006
$278
160%
*In millions
Sepracor will try to combat this slowing growth starting in the second quarter, when it launches the recently approved Brovana to treat chronic obstructive pulmonary disease. Now that Brovana is on the market, Sepracor's pipeline is pretty threadbare, although it does plan on moving both of its depression treatments into phase 2 studies later this year.
It's nice to see Sepracor get its share count under control after diluting shareholders 28% in 2005. It also plans to get rid of over a third of that $1.2 billion convertible debt liability hanging over its head this quarter.
While the Brovana launch will reignite sales growth in the second quarter, it's a little disconcerting to see Lunesta sales stop expanding on the small cutback in marketing and sales expenses. All last year, some investors were clamoring for Sepracor to sell itself to a larger pharma that could better market Lunesta. If the sales growth doesn't return to this key product, maybe it's time for Sepracor to start shopping itself around -- if it can find a bidder for the right price. <<<
Exelixis article (1-07) -
>>> Exelixis Sticks With the Plan
http://www.fool.com/investing/high-growth/2007/01/31/exelixis-sticks-with-the-plan.aspx
Brian Lawler
January 31, 2007
In drug development, delays and missed timelines can be maddening for biotech investors. That's especially true for people who buy shares of drugmakers with early-stage pipelines, since the drug-development process can take years even without delays. One way to minimize the impact of such drug-development holdups is to buy shares of biotechs with multiple drug candidates in the clinic. To that end, Rule Breakers pick Exelixis (Nasdaq: EXEL) has done a great job of keeping its promise to stock its pipeline with three new drug candidates each year.
Continuing with this annual goal, Exelixis yesterday filed another investigational new drug (IND) application to bring a new compound into the clinic for further testing. This move brings Exelixis' pipeline up to eleven drug candidates that are either in clinical testing or about to begin it. That's two more compounds in development than Exelixis had by the end of 2005, even including the failed XL119 phase 3 program that was discontinued last year.
Even better, Exelixis expects to surpass its annual goal of three new IND applications and bring a fourth new compound into clinical development this year. Considering that, on average, only one out of five drugs entering the clinic crosses the finish line and gains marketing approval, Exelixis is smart to stock up its pipeline and to have made partnerships with so many of the leading pharmaceutical and biotech companies, including Genentech (NYSE: DNA), GlaxoSmithKline (NYSE: GSK), and Wyeth (NYSE: WYE).
It's refreshing to follow a development-stage biotechnology company such as Exelixis that sticks with its goals, even if the path forward is not always perfectly flat. As Rule Breakers biotech analyst Charly Travers laid out in his recommendation for the company, this magnitude of clinical development is unmatched for a biotech the size of Exelixis. Even if a few of the shots on goal go astray, as XL119 did, Exelixis is ensuring that investors are given multiple chances for success. <<<
American Standard (ASD) - Just added to my virtual portfolio. You may know the name from their toilets. Dull you say? Disgusting you say? Just look at their 10 year chart and you will see something else -- exciting and beautiful. (BTW, "dull and disgusting" are among the key criteria used by investment icon Peter Lynch for evaluating prospective stocks) -
>>> American Standard Companies, Inc. manufactures air conditioning systems, bath and kitchen fixtures and fittings, and vehicle control systems (VCS). The company offers commercial and residential heating, ventilation, and air conditioning (HVAC) equipment, systems, and controls, as well as related services for commercial, institutional, and residential buildings. Its HVAC equipment include commercial systems, such as chillers, air handlers, and terminal devices; commercial unitary systems; and split-system and packaged residential systems, including condensing units, furnaces, air handlers, heat pumps, coils, and air filtration devices. American Standard Companies sells its HVAC products primarily through company-owned and independent agents, and distributors principally in North America and Europe. The company also offers bath and kitchen products, including toilets, sinks, tubs, faucets, accessories, and related products through retail and wholesale sales channels to residential and commercial markets in Europe, the United States, central America, and Asia. In addition, it manufactures and sells braking, stability, suspension, and transmission control systems for commercial truck, trailer, bus, and passenger car manufacturers. American Standard Companies sells its VCS products directly to vehicle and component manufacturers worldwide. The company was founded in 1929 and is headquartered in Piscataway, New Jersey. <<<
Bio-Rad / Siemens (1-07) -
Bio-Rad and Siemens Medical Solutions Diagnostics Enter Into Joint Marketing Agreement to Offer Products to Optimize Clinical Laboratory Test Systems
Wednesday January 31, 8:00 am ET
HERCULES, CA and TARRYTOWN, NY--(MARKET WIRE)--Jan 31, 2007 -- Bio-Rad Laboratories, Inc. (AMEX:BIO - News) (AMEX:BIO-B - News), a multinational manufacturer and distributor of life science research and clinical diagnostics products, and Siemens Medical Solutions Diagnostics, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., today announced a joint marketing agreement under which Bio-Rad will provide its quality control products and Unity(TM) QC data management solutions for use on Siemens Diagnostics' ADVIA® Chemistry and ADVIA Centaur® Immunoassay Systems. The combination of the quality control products and data management solutions will help ensure Siemens Diagnostics customers of the reliability and precision of their clinical laboratory test systems.
"This is an ideal pairing," said John Goetz, Bio-Rad Vice President and Group Manager Clinical Diagnostics. "Customers will not only gain access to a greater breadth of quality control products, but they also will have online access to quality control data provided by thousands of laboratories worldwide for peer group interlaboratory comparison."
"Ensuring the reliability of patient data is crucial to overall laboratory performance," said Anthony Bihl, CEO of Siemens Medical Solutions Diagnostics. "Our agreement with Bio-Rad is an important step in providing our customers with the tools they need to generate the best and most reliable data possible."
Laboratories using Bio-Rad and certain Siemens Diagnostics' controls may submit their quality control data to Bio-Rad's Unity(TM) Interlaboratory Program and use one of Bio-Rad's Unity(TM) product options. The Unity products offer varying levels of QC data management functionality ranging from basic QC data submission and participation in significant worldwide peer groups to advanced QC data management and analysis and reports in real time, providing laboratories with increased confidence in their test systems and proficiency survey outcomes. Siemens Diagnostics Chemistry Systems are part of the ADVIA® family of products. For additional product information, visit www.siemens.com/diagnostics.
About Bio-Rad
Bio-Rad Laboratories, Inc. (AMEX:BIO - News) (AMEX:BIO-B - News) has remained at the center of scientific discovery for more than 50 years, manufacturing and distributing a broad range of products for the life science research and clinical diagnostics markets. The company is renowned worldwide among hospitals, universities, major research institutions as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 85,000 research and industry customers worldwide through its global network of operations. The company employs over 5,000 people globally and had revenues of $1.1 billion in 2005. For more information, visit www.bio-rad.com.
About Siemens Medical Solutions
Siemens Medical Solutions of Siemens AG (NYSE:SI - News) is one of the world's largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics -- such as Diagnostic Products Corporation and Bayer Diagnostics -- mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing more than 41,000 people worldwide and operating in over 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (Sept. 30). Further information can be found by visiting www.usa.siemens.com/medical-pressroom. <<<
Sepracor (1-07) -
Sepracor 4Q Profit Nearly Triples
>>> Sepracor Announces Fourth Quarter and Full Year 2006 Results
Wednesday January 31, 7:00 am ET
2006 Product Revenues Increased by 51% Over 2005
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced its consolidated financial results for the fourth quarter and full year 2006.
For the three months ended December 31, 2006, Sepracor's consolidated revenues were approximately $357.2 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $348.8 million (XOPENEX® brand levalbuterol HCl Inhalation Solution revenues were $179.9 million, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol MDI revenues were $20.9 million and LUNESTA® brand eszopiclone revenues were $148.0 million). Net income for the fourth quarter of 2006 was approximately $99.1 million, or $0.85 per diluted share. Reported results for the fourth quarter of 2006 included charges of $13.8 million, or $0.12 per diluted share, for stock-based compensation due to Sepracor's adoption in January 2006 of Statement of Financial Accounting Standards, or SFAS No. 123R. These consolidated results compare with consolidated revenues of $311.1 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $302.9 million (XOPENEX Inhalation Solution revenues were $146.0 million, XOPENEX HFA revenues were $12.0 million and LUNESTA revenues were $144.9 million), and a net income of $36.9 million, or $0.31 per diluted share, for the three months ended December 31, 2005.
For the year ended December 31, 2006, Sepracor's consolidated revenues were approximately $1,196.5 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $1,162.8 million (XOPENEX Inhalation Solution revenues were $555.0 million, XOPENEX HFA revenues were $41.0 million and LUNESTA revenues were $566.8 million). Net income for the year ended December 31, 2006 was approximately $184.6 million, or $1.60 per diluted share. Reported results for the full year 2006 included charges of $45.2 million, or $0.39 per diluted share, for stock-based compensation due to Sepracor's adoption of SFAS No. 123R. These consolidated results compare with consolidated revenues of $820.9 million, of which Sepracor's pharmaceutical product sales were approximately $769.7 million (XOPENEX Inhalation Solution revenues were $428.5 million, XOPENEX HFA revenues were $12.0 million and LUNESTA revenues were $329.2 million) and a net income of $3.9 million, or $0.03 per diluted share, for the year ended December 31, 2005.
As of December 31, 2006, Sepracor had approximately $1,166 million in cash and short- and long-term investments. Sepracor expects to spend approximately $451 million, including $11 million in interest, to repay all of its outstanding 5% convertible subordinated debentures when they come due on February 15, 2007.
2006 Highlights
"The year 2006 was a year of significant achievement for Sepracor and its stakeholders. It marks our first full year of operating profits and the first year that revenues exceeded one billion dollars," said Timothy J. Barberich, Chairman and Chief Executive Officer of Sepracor." Other highlights in 2006, discussed in more detail below, include:
Published and/or Presented at Scientific Meetings: LUNESTA Co-Morbidity Data, XOPENEX Inhalation Solution Data, XOPENEX HFA Data and BROVANA Phase III Data
BROVANA(TM) (arformoterol tartrate) Inhalation Solution First-Cycle U.S. Food and Drug Administration (FDA) Approval
Advanced Serotonin and Norepinephrine Reuptake Inhibitor for Treatment of Depression
Advanced Triple Reuptake Inhibitor for Treatment of Depression
Commercialized Products
LUNESTA® brand eszopiclone -- LUNESTA is indicated for the treatment of sleep onset and/or sleep maintenance insomnia and is available by prescription in 1 mg, 2 mg and 3 mg dosage strengths. Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night.
An estimated 36 percent of adult Americans reported suffering from either chronic or occasional insomnia in the last year.(1) Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.
LUNESTA Geographic Expansion Update
In December 2006, Sepracor submitted the equivalent of an Investigational New Drug Application (IND) for LUNESTA for the treatment of insomnia, to regulatory authorities in Japan and has begun a Phase I clinical trial in Japan. In Europe, Sepracor is preparing to submit a Marketing Authorization Application (the equivalent of a New Drug Application) for LUNESTA for the treatment of insomnia to the European Union regulatory agency during the second half of 2007.
Recent LUNESTA Publications and Clinical Data Presentations
Insomnia-Perimenopause Study Publication
In December 2006, Sepracor announced the publication of results from its Phase IIIB/IV, 410-patient, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of LUNESTA for the treatment of insomnia in perimenopausal and menopausal women suffering from insomnia. The results of this study were published in the December 2006 issue of the Journal of Obstetrics and Gynecology.
In this study, perimenopausal or early menopausal women experiencing insomnia according to DSM-IV®2 criteria were randomized to LUNESTA 3 mg or matching placebo nightly for four weeks. This four-week, double-blind treatment period was followed by a one-week discontinuation phase during which all patients received single-blind placebo. Patients treated with LUNESTA demonstrated statistically significant improvement (pless than0.01) compared with placebo in patient-reported measures of sleep latency (onset of sleep), wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep) and total sleep time for each week of the study. Secondary measures of sleep quality, depth of sleep, daytime alertness, ability to function, ability to concentrate and physical well-being were also statistically significantly (pless than0.05) improved over the double-blind period for patients administered LUNESTA versus those administered placebo. Additionally, insomnia severity index-assessed sleep quality, feeling refreshed/rested, daytime fatigue, attention/concentration, and relationship enjoyment parameters were statistically significantly (pless than0.05) improved with LUNESTA compared with placebo. There was no evidence of rebound insomnia or other withdrawal phenomena during the discontinuation phase in the patients who had received 28 days of nightly dosing with LUNESTA 3 mg.
Measures of other menopausal symptoms including mood, quality of life, and impairment in daily activities were also assessed in this study using the Greene Climacteric Scale (GCS), Montgomery Asberg Depression Rating Scale, the Menopause Quality of Life questionnaire (MENQoL), the Sheehan Disability Scale (SDS), as well as the physician global assessment of menopausal symptoms. As compared with placebo, patients administered LUNESTA for 4 weeks demonstrated a statistically significantly (pless than0.05) greater reduction from baseline at the end of the 4-week period in nighttime awakenings due to hot flashes and a significant improvement in mood as measured by the Montgomery Asberg Depression Rating Scale. Statistically significantly (pless than0.05) greater changes from baseline were noted with LUNESTA on the GCS (total score, psychological and vasomotor domains), MENQoL (vasomotor and physical domains), and the SDS (family/home domain). A physician global assessment, which evaluated the overall improvement in menopausal symptoms at the end of the four-week period, demonstrated that more patients (pless than0.001) administered LUNESTA were "very much improved" or "much improved" in menopausal symptoms versus those patients administered placebo. No significant difference was observed between treatment groups in number or severity of daytime hot flashes at each week or over the four-week treatment period. LUNESTA was well tolerated in the study.
Insomnia in Patients with Co-Existing Generalized Anxiety Disorder Study Results Presented
In December 2006, results from a Phase IV, 595-patient study were presented at the annual meeting of the American College of Neuropsychopharmacology. This placebo-controlled, double-blind, ten-week study evaluated the efficacy and safety of LUNESTA in patients with insomnia and co-existing Generalized Anxiety Disorder (GAD).
Patients with insomnia and GAD were randomized to receive nightly LEXAPRO® brand escitalopram oxalate 10 mg, which is approved for the treatment of GAD, and either LUNESTA 3 mg (n=294) or placebo (n=301) for the first eight weeks, followed by a two-week period in which patients discontinued study drug but continued receiving escitalopram and placebo. As compared with patients in the placebo-escitalopram treatment group, patients in the LUNESTA-escitalopram treatment group showed statistically significant (pless than0.05) improvements from baseline in sleep onset, total sleep time (TST), wake time after sleep onset (WASO) and number of awakenings, during each double-blind assessment week and when averaged over the 8-week, double-blind treatment period.
The LUNESTA-escitalopram group demonstrated reductions from baseline in HAM-A (Hamilton Anxiety Rating Scale, a standard scale used to assess anxiety in clinical trials and consisting of a list of symptoms commonly associated with anxiety) and HAM-D17 (Hamilton Depression Rating Scale, a standard scale used to assess depression in clinical trials and consists of a list of symptoms commonly associated with depression) scores that were statistically significantly greater (pless than0.05) than those seen in the placebo-escitalopram group during each assessment week of the 8-week, double-blind treatment period. LUNESTA was well tolerated over the treatment period.
LUNESTA Elderly Study Publication
The results of a large, randomized, double-blind, placebo-controlled, two-week study of LUNESTA for the treatment of insomnia in elderly patients were published in the September 2006 edition of the journal, Current Medical Research and Opinion. The study was conducted in 49 centers across the United States and included elderly patients (64-86 years of age; n=264) who met DSM-IV criteria for primary insomnia and screening polysomnographic (PSG; a type of study conducted in a sleep laboratory) criteria. Patients were randomized to two weeks of nightly treatment with either LUNESTA 2 mg or placebo. Efficacy and safety were assessed at overnight sleep laboratory visits using PSG measures and Interactive Voice Response System (IVRS) morning and evening questionnaires, and through patient-reported IVRS morning and evening questionnaires at home.
The study showed that elderly patients with chronic primary insomnia who were administered LUNESTA 2 mg experienced statistically significant (pless than0.05) improvements in measures of sleep maintenance (ability to sleep through the night), sleep induction (time to fall asleep) and sleep duration (total sleep time), as assessed by both PSG objective measurements and patient-reported subjective measures, versus those patients administered placebo. In this study, LUNESTA was generally well tolerated with the most frequently reported adverse events being pain, dry mouth, dizziness, somnolence and unpleasant taste.
Important Safety Information - LUNESTA
LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of depression, GAD or menopause. LUNESTA works quickly and should only be taken immediately before bedtime. Patients should have at least eight hours to devote to sleep before becoming active. Patients should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. Patients should use extreme care when engaging in these activities the morning after taking LUNESTA. Patients should not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. Patients should not use sleep medicines for extended periods without first talking to their doctor. Patients should see their doctor if they experience unusual changes in thinking or behavior, or if sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
XOPENEX® brand levalbuterol HCl Inhalation Solution -- XOPENEX Inhalation Solution is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma.
Asthma is a chronic lung disorder characterized by reversible airway obstruction and a pathologic finding of airway inflammation. According to the 2002 National Health Interview Survey conducted by the Centers for Disease Control and Prevention, nearly 31 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects nearly 9 million children in the U.S. under the age of 18. Short-acting bronchodilators are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information.
Recent XOPENEX Inhalation Solution Clinical Data Presentation
XOPENEX Inhalation Solution Clinical Outcomes and Cost-Effectiveness Study Results Presented
In October 2006, results of a randomized, prospective, open-label, multi-center study assessing clinical outcomes and cost-effectiveness of the use of XOPENEX Inhalation Solution in hospitalized patients were presented at CHEST 2006, the annual meeting of the American College of Chest Physicians (ACCP). In this study, patients were administered either XOPENEX Inhalation Solution (n=241) or racemic albuterol (n=238) by nebulization.
Patients administered XOPENEX Inhalation Solution received fewer total nebulizations during their hospital stay versus patients administered albuterol (median 10 for XOPENEX, 12 for albuterol; p=0.03). No significant differences were observed between the two groups in measures of FEV1 (forced expiratory volume in one second), duration of hospital stay, relapse rate, total hospital costs or respiratory costs.
The results of this study confirmed that less frequent administration of XOPENEX Inhalation Solution maintained comparable efficacy compared with albuterol without increasing the cost of therapy and may be cost effective when compared to the use of albuterol. XOPENEX Inhalation Solution was generally well tolerated in this study.
XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol MDI -- XOPENEX HFA is a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), which is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medication is inhaled. Indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease, XOPENEX HFA complements the XOPENEX Inhalation Solution product line and provides patients with a portable means of administering XOPENEX.
Recent XOPENEX HFA Clinical Data Presentations
XOPENEX HFA Long-Term Safety and Tolerability Study Results Presented
In October 2006, results of a randomized, open-label, active-controlled, multi-center, parallel-group safety study were presented at CHEST 2006. The study evaluated patients 12 years of age and older with stable asthma who were treated four times daily with either XOPENEX HFA (n=496) or PROVENTIL® HFA (albuterol; n=250) over 12 months.
In the study, the overall incidence of adverse events in the XOPENEX HFA (72%) and PROVENTIL HFA (76.8%) groups was similar. The rate of adverse events with the potential to be related to the specific pharmacologic action of these drugs, including tachycardia, palpitation, chest pain, arrhythmia, hypertension, dyspepsia, nausea, leg cramps, dizziness, insomnia, nervousness, anxiety and tremor, was 13.3% in patients administered XOPENEX HFA, and 18.4% in patients administered PROVENTIL HFA. Asthma-related adverse events were similar between treatment groups: 18.3% for the XOPENEX HFA treatment group and 19.6% for the PROVENTIL HFA treatment group.
Lung function with chronic dosing was also assessed in this study. The mean percent change in FEV1 one hour after the first dose was 18.1% for patients treated with XOPENEX HFA and 16.3% for patients treated with PROVENTIL HFA. At Week 52, the mean percent change in FEV1 was 12.7% for patients treated with XOPENEX HFA and 11.6% for patients treated with PROVENTIL HFA. XOPENEX HFA was generally well tolerated in this study.
XOPENEX HFA Exercise-Induced Bronchospasm Study Results Presented
Also presented at CHEST were the results of a double-blind, randomized, placebo-controlled crossover study of 15 adult mild-to-moderate asthmatic patients with exercise-induced bronchospasm (EIB) who were administered either XOPENEX HFA or placebo pre-exercise to evaluate the ability to prevent EIB. The study evaluated the maximum decrease in FEV1 post-exercise. In the study, patients treated with XOPENEX HFA demonstrated a statistically significantly smaller (pless than0.001) decrease in post-exercise FEV1 compared with patients treated with placebo (5.82% decrease for patients treated with XOPENEX HFA and 21.8% decrease for patients administered placebo; p=0.0002). A statistically significantly higher percentage of patients administered XOPENEX HFA were protected from EIB compared with patients treated with placebo (93.3% for patients treated with XOPENEX HFA compared with 53.3% patients administered placebo; (p=0.0143). XOPENEX HFA was generally well tolerated in this study.
XOPENEX HFA is not indicated for prevention of EIB and this study was not specifically designed to support such an indication.
XOPENEX HFA Safety and Tolerability Study Results Presented
In November 2006, clinical data for XOPENEX HFA were presented at the American College of Allergy, Asthma and Immunology annual meeting. This study compared safety and tolerability of cumulative doses of XOPENEX HFA MDI with those from a racemic albuterol HFA MDI in a group of asthmatic subjects.
Asthmatic patients who met randomization criteria were administered either 16 cumulative puffs of XOPENEX HFA (45 mcg) (n=22) or racemic albuterol HFA MDI (90 mcg) (n=27) during the first dosing visit (Visit 4). Following a seven-day washout period, they were crossed-over and received a total of 16 puffs of the other treatment. Measures of heart rate, blood pressure, serum potassium and glucose concentrations were obtained pre-dose, after each dose, and up to eight hours after the final dose.
Changes in mean heart rate following one and two cumulative puffs did not differ significantly between the XOPENEX HFA and racemic albuterol HFA groups. However, changes in mean heart rate after 4, 8, and 16 cumulative puffs were significantly higher for racemic albuterol compared to XOPENEX HFA. Median ®-albuterol concentrations appeared to increase proportionally with dose for both treatments. Median plasma concentrations of ®-albuterol following each dose of XOPENEX HFA were approximately 10% to 28% lower than those observed following the corresponding doses of racemic albuterol HFA, and this difference in ®-albuterol levels became more pronounced with increased doses. When subjects received racemic albuterol HFA, median (S)-albuterol concentrations were consistently two-to-five-times higher than ®-albuterol concentrations. Improvement in FEV1 was comparable between treatment groups, as were changes in serum potassium, glucose concentrations and blood pressure.
Important Safety Information - XOPENEX
XOPENEX HFA Inhalation Aerosol and XOPENEX Inhalation Solution are contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol or any other component of XOPENEX HFA Inhalation Aerosol or XOPENEX Inhalation Solution. XOPENEX HFA Inhalation Aerosol and XOPENEX Inhalation Solution and other beta-agonists can produce paradoxical bronchospasm, which may be life threatening. If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with beta-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias and hypertension), diabetes, hyperthyroidism, or convulsive disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics, digoxin or MAOI and tricyclic antidepressants.
BROVANA(TM) brand arformoterol tartrate Inhalation Solution -- Approved by the FDA on October 6, 2006, BROVANA is a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.
BROVANA is the first long-acting bronchodilator to be approved as an inhalation solution for use with a nebulizer, which is a machine that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask.
According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S., and in 2004, approximately 12 million adults in the U.S. were reported to have COPD. Approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute (NHLBI). COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function. According to the NHLBI, COPD includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions.
BROVANA Launch Update
Sepracor plans to complete launch preparations and commercially introduce BROVANA during the second quarter of 2007. Upon launch, Sepracor's sales force will promote BROVANA in hospitals and to primary care physicians and pulmonologists who treat patients with COPD.
Recent BROVANA Clinical Data Presentation
BROVANA Phase III Study Results Presented
In October 2006, results of a double-blind, randomized, placebo-controlled, multi-center Phase III study that included 739 adult patients with COPD were presented at CHEST 2006. The study evaluated airway function improvement with BROVANA and salmeterol (SEREVENT®) MDI compared with placebo over a period of 12 weeks in patients with COPD.
Patients treated with BROVANA demonstrated clinically meaningful and statistically significant improvement in morning trough FEV1 throughout the 12-week study period versus patients administered placebo. At Week 0, representing the first day of treatment, patients treated with BROVANA 15 mcg demonstrated mean percent improvement in morning trough FEV1 change from baseline of 21.8% versus 6.3% for those administered placebo (pless than0.001). At Week 12, patients treated with BROVANA 15 mcg showed a mean percent improvement in morning trough FEV1 change from baseline of 14% versus 4.7% for those administered placebo (p=0.003).
In the study, the percentage of patients in the BROVANA 15 mcg treatment group who achieved improvement in FEV1 that was greater than or equal to 10% from predose was 88.3% versus 55.1% for patients administered placebo, at Week 0. The median time to achieve this response was 3.3 minutes in the BROVANA 15 mcg group and 213.7 minutes for those administered placebo. At Week 12, 84.3% of patients administered BROVANA 15 mcg demonstrated a 10% or greater increase in FEV1 while 40.7% of patients in the placebo group achieved a 10% or greater improvement in FEV1. At Week 12, the median time to achieve this response was 10.0 minutes for the BROVANA 15 mcg group and not applicable for the placebo treatment group, given that less than 50% of subjects responded. BROVANA was well tolerated in this study.
BROVANA has not been demonstrated to have an impact on the progression of disease or the survival of patients with COPD.
Important Safety Information - BROVANA
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to arformoterol (a long-acting beta2-adrenergic agonist), the active ingredient in BROVANA.
Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists. BROVANA is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e. rescue therapy. BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted. BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of BROVANA at the recommended dose, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTC interval and ST segment depression. The clinical significance of these findings is unknown. BROVANA, as with other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.
In clinical studies, the numbers and percent of patients who reported adverse events were comparable in the BROVANA 15 mcg twice daily and placebo groups. The most frequent adverse events reported in patients taking BROVANA that were greater than the frequency reported in patients taking placebo were pain (8%), chest pain (7%), back pain (6%), diarrhea (6%) and sinusitis (5%). BROVANA, as with other long-acting beta2-adrenergic agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTC interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.
Phase I and Preclinical Development
The following is a summary of some of Sepracor's products under development.
SEP-225289 Update -- SEP-225289 is a serotonin, norepinephrine and dopamine reuptake inhibitor (SNDRI), for the treatment of major depressive disorder and is currently in Phase I. Sepracor plans to advance SEP-225289 into a Phase II proof-of-concept study during 2007. Based on preclinical data, SEP-225289 appears to be a highly potent reuptake inhibitor with a mechanism that has a balanced action across the three neurotransmitters.
According to the National Institutes of Health, major depression is one of the most common chronic conditions as approximately 18 million Americans have a depressive disorder in any given year. Major depression is described as when five or more symptoms of depression are present for at least two weeks.
These symptoms include feeling sad, hopeless, worthless or pessimistic. In addition, people with major depression often have behavior changes, such as new eating and sleeping patterns. Evidence suggests that between 29 percent and 46 percent of depressed patients fail to fully respond to antidepressant treatment with marketed drugs.(3) According to IMS Health information, the U.S. market for prescription antidepressants was approximately $10.1 billion in 2005.
SEP-227162 Update -- SEP-227162 is a serotonin and norepinephrine reuptake inhibitor (SNRI) for the treatment of depression and is currently in Phase I. Sepracor plans to advance SEP-227162 into a Phase II proof-of-concept study during 2007.
Partnered Programs
Sepracor continues to earn royalties on sales of out-licensed antihistamine products. These include:
ALLEGRA® brand fexofenadine HCl - Marketed by sanofi-aventis, Sepracor earns royalties in countries outside the U.S. where Sepracor holds patents relating to fexofenadine, including Japan, Europe, Canada and Australia;
CLARINEX® brand desloratadine HCl - Marketed by Schering-Plough Corporation, Sepracor earns royalties on sales of all formulations of CLARINEX in the U.S. and other countries where Sepracor holds patents relating to desloratadine; and
XYZAL®/XUSAL(TM) brand levocetirizine - Marketed by UCB, Sepracor earns royalties on sales of levocetirizine in European countries in which the product is sold and will be entitled to receive royalties on product sales of levocetirizine in the U.S. if and when it is approved.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the expected commercial launch of BROVANA brand arformoterol tartrate Inhalation Solution and the successful development and commercialization of the company's other pharmaceuticals under development; the safety, efficacy, potential benefits, possible uses and commercial success of LUNESTA brand eszopiclone, XOPENEX brand levalbuterol HCl Inhalation Solution, XOPENEX HFA brand levalbuterol tartrate and BROVANA, and all of the company's pharmaceutical candidates; and expectations with respect to collaborative agreements, the FDA approval process, and Sepracor's future growth and profitability. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected delays in commercial introduction of BROVANA and other Sepracor products; Sepracor's ability to fund and the results of further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor's patents and the patents of others and the success of challenges by others of Sepracor's patents; the clinical benefits of the company's products; the commercial success of Sepracor's products; changes in the use and/or label of LUNESTA or Sepracor's other products; the outcome of litigation and regulatory decisions relating to Sepracor's patents, products and product candidates; the outcome of two class action lawsuits pending against Sepracor; the effects and outcome of the SEC's inquiry into Sepracor's stock option granting practices; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees and other collaboration partners and its ability to enter into new licenses and collaborations; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2006 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
(1) Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353
(2 )Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition
(3 )Data Monitor, October 2004
Brovana is a trademark and Lunesta, Xopenex and Xopenex HFA are registered trademarks of Sepracor Inc. Lexapro is a registered trademark of American Home Products Corporation. Clarinex and Proventil are registered trademarks of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal is a registered trademark of UCB, Societe Anonyme. Serevent is a registered trademark of Glaxo Group Limited. DSM-IV is a registered trademark of the American Psychiatric Association.
In conjunction with this fourth quarter and full-year 2006 results press release, Sepracor will host a conference call and live audio webcast beginning at 8:30 a.m. ET on January 31, 2007. To participate via telephone, dial 973-582-2749, referring to access code 8292745. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A PDF of the slides will be available in the For Investors section of the web site as well as in the left-hand navigation menu of the webcast viewer just prior to the start of the call. A replay of the call will be accessible by telephone after 11:00 a.m. ET and will be available for approximately one week. To replay the call, dial 973-341-3080, access code 8292745. A replay of the webcast will be archived on the Sepracor web site in the For Investors section.
Condensed, consolidated statements of operations and consolidated
balance sheets follow.
Sepracor Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per
share amounts)
Three months ended Twelve months ended
December 31, December 31,
2006 2005 2006 2005
--------- --------- ----------- ---------
Revenues:
Product sales $348,758 $302,937 $1,162,775 $769,685
Royalties and other 8,397 8,162 33,759 51,243
--------- --------- ----------- ---------
Total revenues 357,155 311,099 1,196,534 820,928
Cost of revenue 33,187 26,820 104,736 67,431
--------- --------- ----------- ---------
Gross margin 323,968 284,279 1,091,798 753,497
Operating expenses:
Research and
development 42,340 40,431 163,488 144,504
Sales and marketing 167,899 199,650 691,650 585,771
General and
administrative and
patent costs 20,263 10,961 72,143 40,839
--------- --------- ----------- ---------
Total operating
expenses 230,502 251,042 927,281 771,114
--------- --------- ----------- ---------
Income (loss)
from operations 93,466 33,237 164,517 (17,617)
Other income (expense):
Interest income 13,486 9,016 46,589 27,462
Interest expense (5,534) (5,840) (22,166) (23,368)
Other income
(expense), net 20 601 (300) (79)
Gain on sale of equity
investments (A) - - - 18,345
--------- --------- ----------- ---------
Total other
income 7,972 3,777 24,123 22,360
Equity in investee
gain (loss) 143 44 (422) (665)
--------- --------- ----------- ---------
Income before income taxes $101,581 $37,058 $188,218 $4,078
--------- --------- ----------- ---------
Income taxes 2,531 151 3,656 151
--------- --------- ----------- ---------
Net income (B) $99,050 $36,907 $184,562 $3,927
========= ========= =========== =========
Net income per common share
- basic (B) $0.94 $0.35 $1.76 $0.04
========= ========= =========== =========
Net income per common share
- diluted (B) $0.85 $0.31 $1.60 $0.03
========= ========= =========== =========
Weighted average shares
outstanding - basic 105,340 105,669 104,943 104,839
Weighted average shares
outstanding - diluted 116,023 117,985 115,508 118,162
(A) Gain on sale of Vicuron shares resulting from Pfizer acquisition
of Vicuron.
(B) Effective January 1, 2006, the Company adopted SFAS No. 123R using
the modified-prospective method. In accordance with this adoption
method, the Company is not adjusting its historical financial
statements to reflect the impact of stock-based compensation. Based
on the pro-forma application of SFAS No. 123 for the calculation of
employee stock-based compensation expense prior to January 1, 2006
(as previously disclosed in the Company's consolidated financial
statements), pro-forma employee stock-based compensation for the
three and twelve months ended December 31, 2005 was $11.2 million and
$46.7 million, or $0.11 per basic share and $0.09 per diluted share
for the three month period ended December 31, 2005 and $0.45 per
basic share and $0.39 per diluted share for the twelve month period
ended December 31, 2005.
Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
December 31,December 31,
ASSETS 2006 2005
----------- ------------
Cash, short and long-term investments $1,166,324 $976,201
Accounts receivable, net 175,103 140,465
Inventory, net 37,087 38,951
Property, plant and equipment, net 72,811 72,467
Investment in affiliate 5,107 5,829
Other assets 37,361 40,584
----------- ------------
Total assets $1,493,793 $1,274,497
=========== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
Accounts payable and accrued expenses $123,850 $198,953
Other liabilities 115,877 76,923
Debt payable 1,078 3,290
Convertible subordinated debt 1,160,820 1,160,820
Total stockholders' equity (deficit) 92,168 (165,489)
----------- ------------
Total liabilities and stockholders' equity
(deficit) $1,493,793 $1,274,497
=========== ============
<<<
Fearfrost, Truthfully, I would just stick with an index fund, and forget the whole biotech and options thing. You'll save yourself a lot of grief (and money) in the end. If you're interested in biotech, follow it as a hobby.
Fearfrost, We were all planning a trip to Vegas when the stock hit 100. Then it was 50. Now, well maybe 5 would do :o)
As you hang around the biotech space more you'll find a lot more stories like Cortex's. The ranks of bio investors needs to be constantly replenished with naive newcomers, since the burnout rate is so high. Fools and their money are soon parted, and so it goes in bioland.
Daviddal, Yes, a sad chapter, but just as you love to gamble, I'm a born collector - coins, stamps, records, guns, guitars, gems/minerals, books, even sea shells, you name it. In the tech mania of the late 1990's, I had "collected" 30 different tech stocks and 30 different tech mutual funds. Now I have over 40 bio stocks in my virtual portfolio, and 20 or so non-bios. So 25 notebooks on Cortex wasn't that surprising I guess, not that it did me any good financially ..
Fearfrost, MarketFest is right, but it's actually been much longer than 11 months of pain. With very few exceptions, this stock has been a perpetual downer from the beginning. But to fully appreciate that, you really had to live through it. It's been one frustration after another, and I've only been following the company for maybe 4 years or so (since the Shire debacle / sub-dollar days). Some of the longest suffering folks on this thread have been around here for 10 years or more. Oh, the humanity..
It's painful to discuss, but a brief review - the company never had any money, and was whipping a dead horse (CX-516) for year after year. Man, it was pathetic. Shire/ADHD bombed out. Servier/MCI/CX-516 bombed out. Cortex did 2 partnerships under duress (Organon and Servier), but these European companies seemed to have only 3 speeds - slow, stop, and reverse. Finally, with less than $500,000 left, the CEO was forced out, and Dr. Stoll came in, raised some money (4 times, and counting), and got the potent CX-717 into the clinic, and what do you know -- it sailed right through
Phase 1 with flying colors, and then, laud and huzzah, it showed good activity for Sleep Deprivation (UK), and then tremendous activity for ADHD. Holy cow, finally - the big payday was here. BUT not so fast, ye undeserving mortals - the gods of biotech quickly intervened, and the long nightmare we thought was finally over got even worse. The drug did "something" funny, to some cells "somewhere", which pretty much brings you up to date. The years of us COR-heads endlessly speculating, theorizing, tea leaf reading, and slicing and dicing this stock has gotten old, to say the least. My 25 notebooks full of Cortex info now rest in some distant landfill somewhere for some future generations of archaelogists to puzzle at -- hmm, these earthlings were peculiar creatures, with way too much free time.. But I digress ..
MarketFest, I think there's a good chance the stock will drift higher over the coming months - it seems like the path of least resistance. There will be some PIPE overhang, but I could see it back to $1.25-1.50 or so between now and the FDA decision. That decision is probably going to be in the June time frame (Dr. Stoll estimated mid May). A gradual move up to $1.50 would provide plenty of room for still another 50% haircut after the FDA decision :o) How's that for positive thinking? LOL.
If I was playing this stock with real money instead of imaginary/virtual money, I would probably ride the gradual rebound over the next 3-4 months, then either dump (or hedge with puts) prior to the actual FDA decision.
Thanks Dew. I also thought Alnylam looked particularly good, though as you said it isn't cheap. I merely put it into a "virtual" portfolio, so I'm not so concerned about the current valuation but more the longer term prospects. Inex is the Canadian company that did the recent deal with Alnylam. Thanks for your insights :o)
>>> Alnylam, CytRx Gain by Moving into RNAi
Wednesday January 10, 2:34 am ET
H.S. Ayoub submits: The Nasdaq Biotechnology Index [^NBI] gained slightly on Tuesday, ending the trading session at $807.34. Alnylam Pharmaceuticals (NASDAQ: ALNY - News) gained almost 9% on the day after the company announced it has taken a worldwide exclusive license to use Inex Pharmaceuticals' [IEX.TO] liposomal delivery formulation technology, for discovery and development of RNA Interference [RNAi] products. The deal also allows Inex to develop its own RNAi based products.
Not to be outdone, CytRx Corp (NASDAQ: CYTR - News) jumped more than 15% as the company announced it had established a new subsidiary dedicated to RNAi technology research. RXi Pharmaceuticals will be lead by top notch scientists including Nobel Prize winner, for his work on RNAi research, Dr. Craig C. Mello. <<<
Inex (12-06) - interesting company -
>>> INEX Data Shows INX-0167 Potential for Cancer Treatment in Combination with Monoclonal Antibody Therapies
Monday December 11, 5:34 pm ET
VANCOUVER, Dec. 11 /PRNewswire-FirstCall/ - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) today presented pre-clinical data confirming earlier studies that its proprietary lead product candidate INX-0167 provides a strong immune response that translates into a dramatic enhancement in the anti-tumor activity of the monoclonal antibodies Rituxan® or Herceptin®.
The INEX data, presented at the annual meeting of the American Society of Hematology in Orlando, Florida, also showed that INX-0167 was able to stimulate higher levels of immune response in a study of non-human primates than CpG7909 (ProMune®), an immune system stimulating drug in late-stage clinical trials as a treatment for lung cancer.
The primate study compared INX-0167 with CpG7909 (ProMune®), a toll-like receptor agonist compound being evaluated by Pfizer, Inc. in Phase III trials as a treatment for advanced non-small cell lung cancer. The compound was developed by Coley Pharmaceutical Group, Inc. and licensed to Pfizer.
The ability of INX-0167 to induce immune responses in non-human primates as judged by enhanced plasma cytokine, chemokine and growth factor levels in cynomolgus monkeys was assessed compared to the primate optimized CpG7909. Treatment with INX-0167 induced higher levels of a number of cytokines and chemokines, including IL1Ra, IL-6 and MCP1, than produced by CpG7909. INX-0167 also increased the number of activated immune cells, including NK cells and T- lymphocytes, as compared to CpG7909.
The ability of INX-0167 to enhance the anti-tumour activity of Rituxan® was evaluated in a human B-cell lymphoma xenograft model. Treatment with Rituxan® alone had little effect on median survival (19-31% increase) while INX-0167 alone prolonged survival by 110%. However, combining both INX-0167 and Rituxan® resulted in a synergistic response, increasing life span of treated animals by more than 500%.
The ability of INX-0167 to enhance the anti-tumor activity of Herceptin® was evaluated in a murine tumor model expressing Her2/neu. Treatment with Herceptin® alone had no effect while INX-0167 alone prolonged survival by only 60%. However, a combination of both resulted in a synergistic response, increasing life span by more than 600%.
Timothy M. Ruane, President and Chief Executive Officer of INEX, said the data provides the scientific basis for INEX's plan to take INX-0167 into human clinical trials. Ruane said the commercial potential of INX-0167 is significant given the large and growing use of monoclonal antibodies to treat cancer.
"There are a number of monoclonal antibodies approved for the treatment of cancer with more than 100 others under clinical investigation. We believe that INX-0167 is well positioned to improve the use of monoclonal antibodies in this multi-billion dollar market," Ruane said.
About INX-0167
INX-0167 stimulates the immune system to fight cancer. INX-067 is the encapsulation of oligonucleotides in INEX's liposomal technology and combines the immunostimulatory properties of oligonucleotides into a single synthetic particle. INX-0167 enhances the number and potency of certain immune cells, including natural killer (NK) cells. The resultant increase in NK cell activity is important for the enhancement of the potency of monoclonal antibodies through a mechanism known as antibody-dependent cell mediated cytotoxicity.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about INEX and this news release can be found at www.inexpharm.com.
Forward Looking Statements
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, Inex's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Inex's products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol "IEX".
Rituxan is a registered trademark of Biogen Idec, Inc.
Herceptin is a registered trademark of Genentech, Inc.<<<