Product Spotlight: CRC Freeze Off

After a successful launch in the US, CRC Canada announces the much-anticipated release of CRC Freeze Off to the Canadian Automotive Aftermarket.

CRC Freeze OffTM offers a new solution to those rusted and corroded fasteners. CRC Freeze-Off™® is a unique penetrant that uses Freeze Shock Action to FREEZE, PENETRATE & LOOSEN rusted and corroded mechanisms.

This unique formula immediately drops the temperature of the area in direct contact with the spray. The freezing effect cracks rusted surfaces, allowing Freeze-Off® to reach deeper & work more effectively than other penetrants. For use in Automotive, Industrial, Marine, Heavy Duty or Household

CRC Canada Co. • 2-1246 Lorimar Drive • Mississauga, Ontario L5S 1R2 T (905) 670.2291 • F (905) 670.5941 • www.crc-canada.ca

NASCAR Mobil 1 Champion Award Presented to Don Thomson Jr.

TORONTO, ON - Imperial Oil is pleased to announce Don Thomson Jr. and the Home Hardware Chevrolet team as the 2007 recipients of the Pegasus Mobil 1 Champion Award. The annual $5,000 award is presented to the race team achieving the highest cumulative score at the conclusion of the NASCAR Canadian Tire Series. The award marks the conclusion of the 2007 NASCAR race season in Canada.

"We congratulate Don Thomson Jr. and his team for achieving consistently strong results on the Canadian stock car circuit this season," said Jeff Diederichs, marketing manager, lubes and specialties at Imperial Oil. "Mobil 1 has a strong racing heritage in Canada, in the United States and worldwide and is proud to be involved in the new NASCAR Canadian Tire Series."

Imperial Oil's Mobil 1 lubricants are the official motor oil of NASCAR. An industry leader in the development of innovative, problem-solving lubricants, the Mobil 1 line of automotive lubricants includes motor oil, transmission fluid, gear lubricants and greases, and is one of a list of Imperial Oil performance products endorsed by North America's number one motorsport.

From Public Affairs, Imperial Oil Limited

No Titles - But Thomson Jr. Still Nabs Award

Courtesy CNW

TORONTO - Imperial Oil is pleased to announce Don ThomsonJr. and the Home Hardware Chevrolet team as the 2007 recipients of the Pegasus Mobil 1 Champion Award.

The annual $5,000 award is presented to the race team achieving the highest cumulative score at the conclusion of the NASCAR Canadian Tire Series. The award marks the conclusion of the 2007 NASCAR race season in Canada.

"We congratulate Don Thomson Jr. and his team for achieving consistentlystrong results on the Canadian stock car circuit this season," said JeffDiederichs, marketing manager, lubes and specialties at Imperial Oil. "Mobil 1 has a strong racing heritage in Canada, in the United States and worldwide and is proud to be involved in the new NASCAR Canadian Tire Series."

Imperial Oil's Mobil 1 lubricants are the official motor oil of NASCAR. An industry leader in the development of innovative, problem-solving lubricants, the Mobil 1 line of automotive lubricants includes motor oil,transmission fluid, gear lubricants and greases, and is one of a list of Imperial Oil performance products endorsed by North America's number one motorsport.

2008 Knoll Gas Nitro Jam Schedule

Eighth Mile National Event to Open 2008 Knoll Gas Nitro Jam Schedule
 
San Antonio Raceway will be the site of a historical season opener for IHRA as for the first time in history a major drag racing sanctioning body will host a scheduled 1/8th mile national event. The Amalie Oil Texas Nationals will take place April 4-6 in San Antonio, bringing IHRA racing to the 1/8th mile strip for the third time ever. Track conditions caused two events on the '07 Knoll Gas Nitro Jam schedule to be switched from quarter-mile events to the 1/8th mile and the response from fans, sponsors and racers opened IHRA officials' eyes to the possibility of scheduling a race under this format.
 
"Last season we really learned something in San Antonio," IHRA president Aaron Polburn said. "While the quarter-mile has been the standard drag race for a long time, we learned an 1/8th mile national event is a viable, exciting format. The buzz and excitement the Amalie Oil Texas Nationals generated caused us to take a good, hard look at this format. We're very excited to grow this race and build our 1/8th mile national event slate in the future."
 
Polburn was alluding to the 2009 schedule when speaking of more 1/8th mile national events in the future. Pittsburgh Raceway Park in Western Pennsylvania has begun a $2 million facelift and will host a Knoll Gas Nitro Jam 1/8th mile event in June, 2009.
 
"We are very excited about the possibilities in the Pittsburgh market," Polburn said. "It is a great area full of extremely passionate sports fans. The Tedesco's have done an incredible job of turning that track into one of our most treasured venues on the Summit Pro-Am circuit and we want to better utilize Pittsburgh Raceway Park. This is a win-win situation…a national event in a sports-crazy market with track operators who know how to promote."
 
The 2008 Knoll Gas Nitro Jam schedule will kick off April 4-6 with the race in San Antonio. It will then head to North Carolina for the IHRA Spring Nationals, April 18-20 at Rockingham Dragway. The tour then heads north to Michigan for the Motor City Nationals May 23-25 at Milan Dragway. This will be followed by a trip to Western Canada for the July 4-6 Rocky Mountain Nationals at Castrol Raceway in Edmonton. The tour will remain in Canada for the Canadian Nationals at Grand Bend Motorplex July 18-20.
 
After the Canadian Nationals the Knoll Gas tour will head back to Michigan for the Torco Race Fuels Northern Nationals Aug. 1-3 at Knoll Gas Motorsports Park in Martin. This will be followed by a trip to Tulsa, Oklahoma for the Aug. 22-24 Skull Shine Sooner Nationals. The tour will then swing to the Northeast for the Amalie North American Nationals at New England Dragway Sept. 5-7. IHRA will close the Canadian portion of its schedule Sept. 19-21 at the IHRA Canadian Nationals at Toronto Motorsports Park. Oct. 3-5 will be the dates of the Torco President's Cup Nationals at Maryland International Raceway before the Knoll Gas Nitro Jam season wraps up in Rockingham for the World Finals Oct. 17-19.
 
2008 Knoll Gas Nitro Jam National Event Schedule
Date     Market                                  //                                Venue       
            
April 4-6       San Antonio, TX                  //                 San Antonio Raceway
April 18-20     North and South Carolina        //          Rockingham Dragway
May 23-25       Detroit, MI                        //                      Milan Dragway
July 4-6         Edmonton, AB                //                      Castrol Raceway
July 18-20       Grand Bend, ON             //                     Grand Bend Motorplex
Aug. 1-3        Grand Rapids, MI             //                    Knoll Gas Motorsports Park
Aug. 22-24      Tulsa, OK                        //                      Tulsa Raceway Park
Sept. 5-7       Boston, MA                        //                    New England Dragway
Sept. 19-21     Toronto, ON                       //                   Toronto Motorsports Park
Oct. 3-5         Washington, DC                   //               Maryland International Raceway
Oct. 17-19      North and South Carolina       //           Rockingham Dragway

From Mike Perry / IHRA

MOSPORT: Supercars on the Square >> October 22, 2007

MEDIA ADVISORY: Supercars on the SQUARE

Event:           Exclusive Vehicle Display and Pit-Stop Demonstration
Location:       Metro Hall Square, Toronto (220 Wellington St. West)
Date:            Monday, October 22, 2007
Time:            9:00am – 5:00pm (Vehicle Display)
                 11:30am - 1:30pm (Pit-stop demo)

The Princess Margaret Cash & Cars Lottery and Mosport International Raceway are bringing together—for one day only—the hottest vehicles from both road and track. Join car enthusiasts and dreamers alike at Metro Hall Square in downtown Toronto for an up-close display of the world's most sought-after supercars.  

Plus, there will be a pit-stop demonstration from 11:30 am – 1:30 pm from the Castrol Canadian Touring Car Championship and Mosport International Raceway.

Display Vehicles
·         3 show cars from the Canadian Castrol Touring Car Championship and Mosport
·         Ferrari F430 F1 Coupe
·         Aston Martin V8 Vantage
·         Johnny Cool Custom Chopper
·         Porsche Cayenne
·         Mercedes-Benz CLK550 Cabriolet
·         BMW 535xi
·         Ford Mustang
·         Plus the latest hybrids & many more…

Media Contacts:
Pip MacDonald or Ian Eichhorn
Program Coordinators
PMH Cash & Cars Lottery
Tel: 416-450-1817 or 1-866-341-0929

Civitas in Charlotte

The Civitas Institute did a special Charlotte area poll this month. They say the full results will be up on the web Monday, but you can see some of the results now at their blog, Red Clay Citizen.

Chris Hayes in his post touched on the anti-tax sentiment in the poll, but how voters are still supporting the transit tax. See the questions below.

Do you think taxes in Mecklenburg County are:
Much too high - 39%
Somewhat too high - 31%
Just about right - 25%
Somewhat too low - 2%
Much too low - 1%

In 1999, voters in Mecklenburg County approved a 1/2 cent sales tax increase to support a light rail system and mass transit. Will you vote to repeal the 1/2 cent mass transit tax?
Yes - 39%
No - 54%
Not Sure - 7%

Would you support a real estate transfer tax in Mecklenburg County?
Yes - 16%
No - 66%
Not sure - 18%

These questions and results support the pattern on tax questions that I have been repeating for months. If you ask people “do you want this tax increase” (see the third question above) they will say NO. People do not like taxes (see first question)! Yet, if you explain what the tax increase is for, they are willing to support it for schools and education, and to a lesser extent transportation, and maybe a few other things.

So people don’t mind (as much) more taxes if its going to pay something they support. That’s why the transit tax is going to survive.

Exubera: Fun with the Classics

(With apologies to Joseph Heller.)

… We will courtmartial you if you turn our deal down, even though it would raise a lot of questions and be a terrible black eye for Colonel Cathcart Kindler.

Colonel Cathcart Kindler winced at the words “black eye” and, without any apparent premeditation, hurled his slender onyx-and-ivory cigarette holder Exubera inhaler down viciously on the wooden surface of his desk. “Jesus Christ Hank McKinnel!” he shouted unexpectedly. “I hate this goddam cigarette holder Exubera inhaler!” The cigarette holder Exubera inhaler bounced off the desk to the wall, ricocheted across the window sill to the floor and came to a stop almost where he was standing. Colonel Cathcart Kindler stared down at it with an irascible scowl. “I wonder if it’s really doing me any good.”

“It’s a feather in your cap with General Peckem Pfizer’s ego, but a black eye for you with General Scheisskopf the investors,” Colonel Korn informed him with a mischievous look of innocence.

“Well, which one am I supposed to please?”

“Both.”

“How can I please them both? They hate each other. How am I ever going to get a feather in my cap from General Scheisskopf the investors without getting a black eye from General Peckem Pfizer’s ego?”

“March Biogen.”

“Yeah, March Biogen. That’s the only way to please him Pfizer’s ego. March Biogen. March Biogen.”

Exdoomera: Why Is Sanofi-Aventis Smiling?

Pfizer CEO Jeff Kindler must have been gritting his teeth as he read out loud the costs of the now-terminated Exubera inhaled insulin product.

Pfizer announced pre-tax charges of $2.8 billion related to the Exubera exit, with approximately $1.1 billion of intangible assets, $661 million of inventory, $454 million of fixed assets and $584 million of other exit costs.

That's a lot of zeros. Exubera, along with the now defunct cholesterylester transfer protein (CETP) agent torcetrapib, were supposed to lead Pfizer into an new age of blockbuster products. Now both programs are in rubble.

There has been a lot of buzz about the titanic failure of Exubera to meet expectations, but seeing the numbers in black and white is, nonetheless, staggering.

Less than two years ago, in January 2006, Pfizer paid Sanofi-Aventis a king's ransom--$1.3 billion--for the full rights to Exubera. Then the company brilliantly navigated the product, which had respiratory safety concerns that stalled its development for years, through an FDA advisory committee and US approval by focusing on a comprehensive risk management plan.

At one point, the drug was projected to be a $2 billion-a-year franchise. In the third quarter, Exubera generated $7 million in revenue. Pfizer took one last shot at jump starting the launch by unveiling a national direct-to-consumer ad campaign earlier this year, but that was throwing good money after bad.

Exubera may have failed for any number of reasons: patients were overly concerned about respiratory side effects; the failure of a primary care sales & marketing effort to make a mark in a specialty pharmaceutical category; or it was simply a bad product for the subset of Type 2 diabetic patients it was trying to serve. And it may have been all of those things together.

In the end though, it looks like Sanofi-Aventis pulled a fast one on Pfizer, Gordon Gecko-style (you have to have seen the movie "Wall Street" to understand this reference), giving up its right to a potential blockbuster only if Pfizer paid a huge premium for the French company's troubles. Someone's laughing all the way to the bank. However, that hit may be a tad easier to take if Pfizer chooses to make a significant run at taking a stake in the French drug maker, as rumor would have it.

For Kindler, this hardly seems like a fair shake for his first year as CEO. Will investors view him as a stoic leader making tough decisions to clean up someone else's mess? They may. However, this could be the last time Kindler gets the benefit of the doubt.

Dale Earnhardt Inc. and Steve Hmiel Choose to Part Company

MOORESVILLE, N.C. (Oct. 18, 2007) – Dale Earnhardt Inc. and director of competition Steve Hmiel have parted company.  Hmiel's responsibilities have been redistributed throughout the organization and his replacement will be named soon.
 
"I have enjoyed a wonderful association with Dale Earnhardt Inc. over the past nine years," said Hmiel.  "It is time for me to pursue other endeavors and reestablish new goals for myself.  The management team at Dale Earnhardt Inc. has the company headed in the right direction and it has an exciting future as it continues to fulfill the legacy of Dale Earnhardt."
 
"Steve has been a part of the success of Dale Earnhardt Inc. and we are grateful for his contributions to the company," said John Story, vice president of motorsports.  "We wish him well with his future plans."
 
From Kevin Woods / DEI

Clinton surges ahead, while Thompson drifts behind

From the latest Civitas Poll…

Democratic Presidential Primary
Clinton 31%
Edwards 18%
Obama 18%

Hillary Clinton makes a huge jump in North Carolina, according to the latest Civitas Poll. It’s indicative of her growing lead nationally, and not a good sign for North Carolina’s John Edwards. Of course, Iowa is the ball game for Edwards.

Republican Presidential Primary
Giuliani 21%
Thompson 19%
Romney 16%
McCain 9%

Thompson falls and Giuliani pulls into first.

No gubernatorial primary polls this week.

Civitas on SCHIPs

Do you support the $35 billion expansion of the Children’s Health Insurance Plan that has been approved by Congress but vetoed by President Bush?
Yes 51%
No 32%

Do you think the Children’s Health Insurance Plan should be expanded to cover children from families of four who earn between $62,000 and $82,000?
Yes 26%
No 62%

Obviously the President hasn’t been doing a good job explaining his position.

RALLY AMERICA 2008 SCHEDULE ANNOUNCED

NCATS: Team 3 Red- EHR Headliner at Snap-on Tools Event

STOUFFVILLE, ON - Coming off of a successful NASCAR Canadian Tire Series season, Team 3 Red/EHR will travel this week in support of the Snap-on Tools Nationals Sales Convention in Calgary, Alberta.  The #3 Snap-on Tools Dodge will be the headline attraction for the two day event taking place on Sunday and Monday at the TELUS Convention Centre in downtown Calgary.

     Snap-on Tools'  VP Sales & Marketing  Brian Ross, looks forward to the Team joining the festivities this weekend. "We are very excited to have our driver Jason Hathaway and Team Crew Chief Giulio Montanari a part of our event this year.  They have been great ambassadors of the Snap-on Tools' brand and have had a very successful season.  They will be on hand to open the Snap-on Tool Fair on Saturday night with the race car and Jason and Giulio will be our honorary Grand Marshalls for the event.  It will be a thrill for all of our franchisees and suppliers alike to get along side a true NASCAR Canadian Tire Series racecar."

   The weekend's activities will include a pit box display with all of the Team's Snap-on pit equipment set up to look like a typical day at the races for the Snap-on Tools team.  The Team will also host "The Snap-on Tools Pit Stop Challenge" amongst the attendees .  The Challenge will exemplify the team work necessary for not only a great pit stop on race day to get Jason in and out of the pits quickly, but also the Team work that creates a successful business relationship within the Snap-on Tools Corporation.

    Before the start of the Snap on Tools event the Team will make a stop to visit with long time Team partner Super 8 Motels at the Calgary Super 8 Shawnessy property in southeast Calgary on Friday at 3pm.  The car and team transporter along with Jason and Giulio will be on hand to spend some time with the employees and staff and invited local businesses.  The Super 8 group will get the chance to meet Jason and Giulio and look over the 500 + horsepower racing machine that Jason pilots each weekend with the familiar bright red, yellow and black Super 8 Motels colours.

   "The Super 8 Calgary Shawnessy is excited to welcome Jason and the Team 3 Red/EHR Team to Calgary this week.  We are very proud of our relationship with the Team and look forward to our event on Friday afternoon.  We are pleased to be their host hotel for the weekend's events and look forward to seeing the car and the Team."  said Super 8 Shawnessy General Manager Ed Belanger.

   Team 3 Red/EHR with driver Jason Hathaway behind the wheel of their 2007 Dodge Charger/Avenger competes in the NASCAR Canadian Tire Series.  In the Series' inaugural season, the 12 race schedule took Team 3 Red/EHR to 8 oval track events and 4 road courses or temporary street course events across the country from Vernon British Columbia to Anitgonish, Nova Scotia.  The team finished a solid 9th place in the 41 car field in Driver & Owners Standings and achieved the honour of being the Team to complete the most laps over all of the events throughout the 2007 season. 

     Team 3 Red/EHR is proud to be associated with their great sponsors and supporters. Team 3 Red/EHR thanks Snap-on Tools, Super 8 Motels, Advantex Freight Forwarders, Fast Eddie Racewear and Choko Motorsports, Briggs & Stratton, Castrol, Napoleon Fireplaces & Barbeques, Xilarate Sports Fluid, Praxair, BOSCH Canada and The Busted Knuckle Garage.   For more information on our sponsors please visit our website at www.team3red.com .

###

From Jamie Hakonson // Team 3 Red/Ed Hakonson Racing

Raceline Radio Network Newsletter

Raceline Radio's Tomas Tales... By Erik Tomas

Rules. Can't race with 'em…can't race without 'em.

Most of the awkward moments in this sport are rooted in rule enforcement failure and/or inaccurate rule interpretation.

The baseline method around rules is universal.

All you need to do is make your rule book thorough and easy to understand, trying very hard to remove all grey areas. It's not easy, but you need to make certain rules can only be read one way. Black and white, eliminating all "ya but… what if's"

Are you going to hit all areas and all circumstances perfectly right off the bat? Of course not. But if you listen and watch, those adjustments can be made quickly and effectively as required.

If your rules are fair, the fuse you must not ever light is relaxing the rules because drivers badger track management after getting caught violating them. This happens all the time, especially at the local and regional track levels. Johnny Rapid in the # 35 threatens never to come back if his penalty for an illegal carburetor is enforced.

The second you relax the rules and start altering penalties for certain drivers because their violation was unintentional, or you think your entire program hinges on one self-centered driver, it's seen as playing favourites and you've lost all authority and credibility. It's a very slippery slope.

Couple of examples lately at both ends of the sport illustrate what I'm talking about.

Forget all the political crap around "Stepney Gate" in Formula One. Why was McLaren removed from the critical Constructors Championship for allegedly using stolen Ferrari tech secrets on their cars, but were allowed to continue fighting for the Driver's Championship? If McLaren used illegal cars to win races and collect points, why weren't their points wiped out and why weren't Alonso and Hamilton disqualified for the balance of the season?

At Super DIRT Week at Syracuse a few days ago, Brett Hearn was first across the finish line in the 358 modified championship race, but a doctored fuel cell and a strange size fuel log, or fuel connection to the carburetor were discovered in post race tech.

Ready? The rule enforcers decided the rules were broken, but did not give Hearn a performance advantage, so he kept the win, kept the purse money and was fined a laughable one thousand dollars. I would say removing baffling from a fuel cell to up the capacity IS a performance advantage, considering Pete Bicknell and Pat Ward ran out of gas in the end, handing the win to Hearn. Many a race at Syracuse has been won or lost on fuel mileage. That's why teams try to find ways to carry more gas!

DIRT, the sanctioning body, is now guilty of playing in that grey area. They are not enforcing the rules. If you win using an illegal car: NO points, NO money, NO win! Like the Formula One example. So what's to stop other drivers now from altering their fuel cells to carry more gas? It tells other teams you can cheat your brains out in F-1, and you will still be allowed to win a driver's championship. See what I mean by a slippery slope?

NASCAR, though FAR from perfect, did it right in the Carl Edwards case at Dover. One rear corner of his car was too low. Didn't matter HOW, or WHY, or whether not it was intentional, accidental or performance enhancing. NASCAR tech'd the car, and it flunked! They published the rule that was violated, and despite an appeal, stuck to their rule book. Edwards lost 25 driver points, the team lost owner points, and the crew chief was fined. No grey area, no inconsistencies, thereby reducing the temptation to cheat.

No, you will never take that element out of the sport completely, but from Formula One, to NASCAR, to DIRT to the local tracks, proper and unwavering rule enforcement isn't only the RIGHT thing to do, it's the FAIR thing to do.

What do YOU think?

Any suggestions? Opinions? Comments on the show? Better ideas? Keep the E-Mails rolling in for The Raceline E-Mail Bag! The address: erik@raceline.ca  We always invite your feedback!

Miss a show? Go to The TEAM 1040's Vancouver's website www.team1040.ca and click on their pod cast icon and it's all there!

Until next time, talk to ya'll on Raceline Radio! ET

Biosimilars in Europe: Docs Decide

Biosimilars may have won a regulatory pathway in Europe, but they’re having a tough time getting to patients. Last week Spain became the second of Europe’s big five markets, after France, to announce this year that biologic drugs cannot automatically be substituted. Italy is expected to announce a similar decision before year-end.

In many European countries, pharmacists are required—sometimes incented—to dispense a cheaper generic equivalent of whatever brand a doctor has prescribed, if one is available. The rulings in Spain and France mean that this principle won’t hold for biologic drugs—a category for which substitution rules have not, until the advent of biosimilars, been needed at all.

It’s a blow for biosimilar firms, banking on their products’ lower price and perceived equivalence to reference biologicals in order to gain market share.

Doctors will henceforth have to specify which precise brand they want to dispense; if they don’t, “pharmacists will have to check back with the doctor,” according to Thomas Bols, Chair of EuropaBio’s Biosimilar Working Group and Director, Government Affairs, Amgen.

Now granted, for most biologicals we’re talking hospital docs, working in a specialized setting. But the situation still sounds somewhat complex, particularly given biosimilar firms’ apparent victory when Sandoz’s EPO was granted the same international non-proprietary (INN) name as its reference drug, J&J’s Eprex. (Both are epoetin alfa, and you can read more here.)

Same non-proprietary name, same drug, right? Wrong. Bols admits that this particular INN decision from the World Health Organization (in charge of INN naming), came as a surprise to the innovator lobby. But, he adds, any lingering questions over the appropriateness and enforceability of INN rules “only emphasize the need for good rules on automatic substitution.”

For him, a good rule is what’s emerged in France and Spain, as well as in the Netherlands and some Nordic countries: placing the onus on doctors to explicitly prescribe the generic. That means docs need to understand both sides’ arguments. Fine for the innovators—marketing is a big part of what they do. Not so fine for generics firms, for which marketing falls outside of their strategic and financial scope.

Now granted, in countries like Germany, doctors too are incented by budgetary restrictions to prescribe cheap drugs where possible. Similar cost-pressures apply in hospitals. But all doctors also hear innovator lobbyists emphasizing that “approval [of biosimilars] is based on a limited safety package,” as Bols clarified to IN VIVO Blog, and that there are “important therapeutic differences” between biosimilars and innovator drugs. What doctor is going to prescribe a biosimilar for which there’s little or no on-market experience, rather than a branded drug, in particular for chronic conditions?

The European Generics Association, representing biosimilar firms, calls all this scare tactics. According to Suzette Kox, the EGA’s Senior Director of Scientific Affairs, the Spanish decision “won’t impact [doctors’] prescription of biosimilar medicines” but “raises concerns because it is based on perceptions created by certain interested parties, and on a lack of scientific information and knowledge.” She argues, as EGA has all along, that manufacturing changes to any reference drug—a new plant, a new cell line or whatever—introduce variability within innovator products that’s analogous to that between an innovator drug and a biosimilar, yet all batches of innovator drugs like Eprex are assumed to be interchangeable. “The same scientific approach should apply to biosimilar medicines,” she asserts, “as there is no fundamental difference between biosimilar and their respective reference products.”

Some docs will believe that; some, too, might read the EMEA guidelines which state that trials of biosimilar medicines are required to demonstrate that there are “no meaningful differences between the biosimilar and the biological reference medicine in terms of safety or efficacy” before approval is granted.

The fact is that no-one really knows just how similar biosimilars are to reference drugs, and they won’t know until such products have had several years’ worth of market exposure. That’s why the question of how often and how widely these drugs should be prescribed is being passed like a hot potato: EMEA left the substitution decision up to member states, and governments have now passed it on to doctors.

That’s not, fundamentally, a bad situation: why shouldn’t prescribers decide? Brand-specific prescribing also makes pharmacovigilance easier; indeed, this is a key argument that innovators put forward in favor of the approach.

Once such pharmacovigilance data is available, splattered all over the web and in cost-conscious health ministries’ hands, it’s possible—granted no nasty surprises--that some of these rulings on non-substitution may be reversed. (And maybe by then the US will pass biosimilars legislation, too.)
In the meantime, though, biosimilars will be treated with caution--short of any radical new government cost-cutting measures that speak louder to docs’ pockets than clinical scare stories do to their scientific judgment.

AIM Autosport & Camp Boggy Creek

AIM Autosport and the Grand American Road Racing Association offered a fan's dream during the Oct. 12 Champagne Ball auction to benefit Camp Boggy Creek in Eustis, Fla. The Canadian Daytona Prototype team combined with the series to create an honourary crew membership for the 2008 Rolex 24 At Daytona in January, giving the high bidder an inside view of Grand-Am Rolex Sports Car Series racing.

Gene Reed of Charleston, S.C., bid $5000 for the package, which includes track credentials, hot-pit passes and luxury suite access during the 24-hour race. As AIM's guest, he will receive private engineering and technical briefings, attend a driver meeting and enjoy an exclusive behind-the-scenes tour. His race souvenirs will include team clothing and a custom poster signed by Grey's Anatomy star Patrick Dempsey, who also competes in the Rolex Series.

Grand-Am president Roger Edmondson has worked tirelessly to support Camp Boggy Creek. He was excited to team with AIM to present the Rolex 24 package.

"Boggy Creek isn't just a proud charity of Grand-Am. It's a very special place that has become part of our racing community," he said. "It's great to see a young team like AIM Autosport participate in such a meaningful way. The entire crew visited the camp in July to support the Frisselle brothers' mini-golf tournament, and now AIM has joined with us to raise $5000 for the camp. We look forward to continuing this wonderful association."

Ian Willis, co-owner of AIM Autosport, noted Reed's contribution will give two children a memorable week at Camp Boggy Creek, one of the Hole in The Wall Camps founded by actor Paul Newman for children who have chronic or life-threatening illnesses.

"AIM is proud to support Camp Boggy Creek and we are very excited that Gene will join our team for an exclusive behind-the-scenes experience at the Rolex 24," Willis said. "We are looking forward to our second year in the series and a continued association with Camp Boggy Creek. Gene will certainly enjoy his prize, but equally important is the joy that two deserving young children will get by visiting the camp courtesy of his generous bid."

Last week's auction raised more than $200,000 for Camp Boggy Creek. Sarah Gurtis, Boggy Creek's vice-president of marketing and corporate development, was thrilled with the racers' support.

"Our largest fundraiser of the year, the Daytona Harley-Davidson Ride For Children, now includes a Champagne Ball. Supporting that event is just one more way that Grand-Am and AIM Autosport have stepped up to help Camp Boggy Creek. Their VIP package for the 2008 Rolex 24 At Daytona will be an experience to remember for a lifetime and we cannot thank them enough," she said.

The Rolex 24 At Daytona is scheduled for Jan. 26 and 27 at Daytona International Speedway in Daytona Beach, Fla.

From Sylvia Proudfoot for AIM Autosport

Cherry Bomb Glasspack turns 40

Loudon, TN (October 15, 2007)…In the development of high performance mufflers there is one name that stands apart ­ the Cherry Bomb® Glasspack.  First introduced in 1968 by the Maremont Corporation, this bright red 2' long straight pipe muffler with a baffled channel lined in fiberglass produced an unmistakable, one-of-a-kind throaty sound and less backpressure for a noticeable improvement in performance.   It's timely introduction occurred at the beginning of one of the most exciting times in the development of hot rods, 1968-1971.  This is when Mopar was king with their development of the Charger, Challenger and Plymouth Roadrunner and GTX.  The Chevelle and Nova were introduced along with the first generation Camaro in response to the growing success of the first generation Mustang.  Relatively inexpensive to own, these cars were easy to modify and packed with power. The Cherry Bomb Glasspack became a standard bolt-on as it embodied in sound, the horsepower under the hood.

Robert Mater, Jr., former marketing director at Maremont responsible for launching the brand, says, "Those were great times. It was the heyday of the hot rod and any muscle car worth its salt had to have a pair of "Bombs. We couldn't manufacture them fast enough. In the 80s that all began to change as there was more calls for a restriction on power, and more emphasis on safety.  This coincided with the EPA's demand for use of a catalytic converter which greatly affected the muscle car industry."

In March 2006, father and son entrepreneurs, Ken and Paul Banks purchased all rights to the Cherry Bomb product line and Maremont's 630,000 square foot manufacturing facility in Loudon, TN. With an acute understanding of the value of brand equity and a long history in the exhaust business as owners of the International Muffler Company (IMCO), the new owners from Schulenburg, TX recognized the value of reinvigorating the brand with improved technology, an expanded product line and increased marketing support.

The original Glasspack had a brightly painted steel housing, a metal baffle interior channel surrounded with a layer of fiberglass insulation. Today's Cherry Bomb Glasspack is produced from high quality cold rolled aluminized tubing, and features a more durable, rust resistant powder coat , still in its characteristic red color. Tuned to perfection in a first class dyno facility, the Cherry Bomb Glasspack still has a throaty sound and is available for most make & model vehicles.

In addition to the Cherry Bomb Glasspack, IMCO/Maremont, the parent company since 2006, now offers five other Cherry Bomb muffler products, each created with their own unique, patented design that provides improved horsepower and a characteristic high performance sound including: Cherry Bomb Pro, Cherry Bomb Elite, Cherry Bomb Extreme, Cherry Bomb Turbo, and the company's top-of-the-line, most technologically advanced product, the Cherry Bomb Vortex. Additionally Cherry Bomb now offers a wide range of cat backs, straight and X pipes, exhaust accessories and a very popular line of apparel including hats, garage jackets, tee shirts and more.

Paul Banks, owner, says, "Chery Bomb is a timeless American classic. It is probably one of the most revered brands in automotive history.  We're having fun keeping this product in the forefront and ensuring its success for the long run."

For more information about the full line of Cherry Bomb mufflers, systems and accessories, visit www.cherrybomb.com, or call 866-869-9704.  For more information about Maremont/IMCO, please contact Leslie Maxwell at 615/952-3917.

SOS: Turford back as club President

The Southern Ontario Sprints (SOS) held their annual Fall Elections and General Meeting on Sunday, October 14th and I'm pleased to introduce the SOS Executive and Board of Directors for the 2008 season.

President ­ Peter Turford // Vice President ­ Dick Mahoney // Secretary ­ Terri Watson // Treasurer ­ Helen Brown // Board of Directors - John Watson, Bob Martin, Warren Lindsay & Mike Ferrell

From Bill Oldroyd:
 
I would personally like to welcome Peter Turford back to the position of President. This is the position Peter held for 5 years prior to me taking over in 2006 and I'm confident that he will once again guide the club in the right direction. During Pete's previous time at the helm, the SOS prospered and with his knowledge of the sport, I have no doubt that he will once again be successful in meeting all the challenges that lie ahead.

I'd also like to welcome Terri Watson, Bob Martin, Warren Lindsay and Mike Ferrell as new members to the Executive/Board. Terri Watson is John's better half and has worked behind the scenes during the last couple of seasons in several areas. Bob Martin is SOS rookie Justin Martin's father and crew chief. Mike Ferrell who was a rookie driver in 2006 will also be joining the Board and the last new member to the Board is SOS Fireman and Tech Inspector, Warren Lindsay. It is pleasing to know that the SOS will be in good hands as I exit my post.

As I reflect back on my time with the SOS (over 5 years), so many great memories come to mind. However, it is easy to pick the one that stands out over all the others; that being all the great people that I was fortunate enough to have been associated with and to have befriended over this time. Also near the top of the list is the knowledge that I've gain about sprint car racing and all the behind the scenes activities. I truly have a much better appreciation of the effort that is expended to make the shows run smoothly. The volunteers that help make this happen are the true heroes.

I'd be remiss if I didn't talk about the drivers and crews. The SOS is very fortunate to have such a great bunch of people associated with the race teams. I can't tell you how many times I saw people helping each other when there was a need. This is not something that takes place in every organization. You should all be very proud of this fact and work hard to maintain this atmosphere, regardless of how big the club gets.

Other things that I enjoyed were the record car counts, tons of rookies joining the SOS and the Yearbook. All of these were very gratifying to me. Going forward, I've decided to step back for a while to do some camping and to spend more time with Jenny, my better half. However, that doesn't mean that I'll be a stranger. I will be out supporting the SOS whenever the opportunity presents itself. I also want to spend some time going to other tracks such as Eldora, that I was not able to do with my commitment to the SOS.

I truly wish the SOS all the best in the future and hope that your new Executive/Board gets your support. The SOS is facing some real challenges but I'm confident that the right decisions will be made to keep the SOS strong.

Thanks so much to everyone for your support over the past few years and I'll see you at the track.

Bill Oldroyd

A1GP: F1 Legend Fittipaldi To Return To The Track

London, Great Britain - Emerson Fittipaldi has vowed to come out of retirement to test the new Ferrari-powered A1GP World Cup of Motorsport car next season.

The 60-year-old A1 Team Brazil boss is so excited about A1GP's involvement with Ferrari that he has confirmed he will get back behind the wheel to test the contemporary single-seater.

Following last week's historic announcement that the Italian sports car manufacturer will supply all engines to A1GP from next season, Fittipaldi, who never drove for Ferrari in his Formula One career, will not race the car but instead will look to get behind the wheel at the earliest opportunity.

"When I was told about the possibility of Ferrari coming on board I thought it was brilliant," Fittipaldi said.

"The Ferrari name alone is incredible and people are going to give A1GP more respect and we are going to be much bigger. When Ferrari's people visited us in Zandvoort they loved our A1GP weekend and they are very enthusiastic to get involved with A1GP.

"Ferrari will help design a beautiful car. I always wanted to drive for Ferrari and now I can! I will at least test the car. I won't race it, but I want to test the car. I'm very excited about it.

"The partnership with Ferrari will make more drivers want to get involved in A1GP too. It will be an exciting formula for the racing."

From A1GP

PMRA: Como's in Niagara Falls to host banquet

CAYUGA, ONTARIO (October 17, 2007) - The upcoming PMRA Champions Banquet is fast approaching, and is promising to be the best yet to honor the winners of this Pro Modified series.

"Interest and ticket sales for our banquet have been excellent," said PMRA Director of Operations Bruce Mehlenbacher. "Over one-third of our teams are based in the United States, and having our banquet this year at Como's in New York State will add to the PMRA's international flavor."

This year's season-ending festivities will be held at the Como's Francesco Hall in Niagara Falls, New York, Saturday, November 10.

Receiving top honors this year will be Bruce Boland of Hamilton, Ontario. The veteran competitor took his first PMRA Points Championship sponsored by Wix Filtration Products, Valvoline, Uni-Select, and Moen Incorporated in 2007 with the B & B Racing 1953 Corvette.

Taking second was a tie in the series this year between PMRA rookies Matt Guenther of Livonia, New York in the Guenther Racing Team 1941 Willys, the only nitrous-powered Pro Modified in the series and Scott Wildgust of Stratford, Ontario, in the Ajax Engines 1957 Chevy. Next was Ike Maier of Tottenham, Ontario, in his 1967 Camaro, and Sam Andreacchi of Toronto, Ontario placed fifth with his 1969 Chevrolet Nova.

Event organizers are excited about this year's banquet venue, the famous and popular Como Restaurant, a Niagara Falls landmark since 1927, specializing in the best in Italian cuisine.

A limited number of tickets are available on a first come, first serve basis.

Entering its fourth year of operation, The Pro Modified Racing Association continues to enjoy strong fan popularity and for 2007 presented some of the best in Pro Modified drag racing in North America.

The PMRA traveled to several drag strips in 2007, including two dates at Toronto Motorsports Park in Cayuga, Ontario, Lancaster Raceway Park in New York State, Sanair in Quebec, and a season-closer at the Southwestern Ontario track of the Grand Bend Motorplex.

About the Pro Modified Racing Association (PMRA):
The Pro Modified Racing Association, http://www.promodifiedracing.com/, was organized late in 2004, started racing operations in 2005, and is entering its fourth year of operation. The PMRA is a self-governing organization with input from its teams. The series abides to the technical and safety rules as outlined by the International Hot Rod Association (IHRA) and the National Hot Rod Association (NHRA). The series has event venues in Ontario, Quebec, and New York State.
Cars in the PMRA capture the true spirit of hot rodding, and the class is one of drag racing's most exciting and volatile classes, offering a diverse group of race cars with different types of 2,500-horsepower engines.
Combining classic body styles and modern equipment, constructors are permitted, within established rules and parameters, to modify and enhance the cars in both appearance and performance. The cars are fuelled by gasoline or methanol, propelling them down the quarter-mile in low six-second times at over 200 miles per hour. The PMRA provides drag race fans the opportunity to see, hear, and experience the popular Pro Modifieds, known as "the world's fastest door slammers".

From the PMRA

MOTO-ST: Go Big Racing Ready To Beat The Heat With New Sponsor For Daytona

The SunTrust Moto-ST Endurance Series finale is set to take place this weekend at the historic Daytona International Speedway and Ross Millson (Hamilton, ON), Paul Glenn (Keene, ON) of Go Big Racing and fellow Canadian rider Karl Daigle (Granby, ON), are ready to make a run at the ST Class Championship during the final 8 hour endurance race with the addition of AVAcore Technologies Inc. (http://www.avacore.com/) as a sponsor for the Daytona race.

Go Big Racing will be using AVAcore's CoreControl powered by RTX (Rapid Thermal eXchange) system in the pits to assist the three rider team and crew to beat the heat during the 8 hour test of endurance and strategy. The CoreControl system will be monitored by team trainers Angie and Mike Hallman of New Hamburg, ON.

The CoreControl, powered by RTX, is cutting edge technology developed at Stanford University for core body heat extraction. CoreControl enhances the natural heat dissipation system of the body through a combined application of optimal temperature and a slight vacuum. Heat extraction is beneficial for maintaining peak mental and physical performance, or in accelerating recovery from heat stress. It has been field-tested by many collegiate and professional athletes, industrial workers, Military personnel, and Multiple Sclerosis sufferers who are heat sensitive. Studies involving athletes, firefighters and electrical workers have validated the effectiveness of this new cooling method and demonstrated remarkable results.

"The quickest and most effective way to cool down is from cooling your blood. Our hand-held CoreControl units are designed to take the most direct path through the specialized blood vessels in the palm of your hand and work to cool your body from the inside out" explains Mark Smith, AVAcore Vice President of research and technology. "This technology is a natural fit with the high temperatures on the track and in the pits of an 8 hour endurance race and we are pleased to be able to showcase our product with the Go Big Racing team."

"We are looking to capitalize on every advantage that will put us in a position to win and we feel the CoreControl system will help us combat the temperature at the track" commented Glenn on the reasoning behind the partnership with AVAcore.

"In addition to helping us at the track, Go Big Racing hopes to showcase the CoreControl system to the competitive motorcycle racing market" added Millson.

The past few weeks have been extremely busy for the Go BIG Racing team. Besides developing the recent partnerships with AVAcore and Ready Fastener for Daytona, the team have been feverishly preparing the #79 Summit Gearworks/Ready Fastener/Infinet Designs sponsored Suzuki SV650 for the final race.

"We have to thank Ultimate Cycle, Scott Laidman and Blaine Groves for their tireless help in getting the bike in top shape." commented Millson "…we also need to thank the crew from JD Graphics for making sure all our sponsors get exposure on the bike and in the paddock.

In other news, live video from the SunTrust Moto-ST 8 Hours of Daytona will be broadcast over the Internet on Hello World TV at: www.helloworld.com/motorcycleracing (Click on Watch TV) where Brett Ray will be shooting pit stops and getting rider perspectives throughout the race.

Speed TV will broadcast of all 6 rounds of the SunTrust MOTO-ST Endurance Series with The 8-hour finale from Daytona airing January 8, 2008. Visit http://www.speedtv.com/ for complete broadcast details.

Visit: http://www.gobigracing.ca/. for additional information and to learn more about the sponsors that support the team, including Suzuki dealer - Milton Motorsports, Summit Gearworks, Infinet Designs, Ready Fastener, AVAcore Technologies Inc., MotorcycleCourse.com, JD Graphics, Turn 2 Sportbike Rentals, Mimic Industries, Ultimate Cycle, Bickle Tire Warmers, Accelerated Technologies, Bagshaw Performance Inc and Corner 2 Racing.

From Go Big Racing

NASCAR Toyota All-Star Showdown News & Notes 10/17/07

Ranger, Lopez Add International Flavor

The Race: NASCAR Toyota All-Star Showdown
The Place: Irwindale (Calif.) Speedway
The Event: 150-lap Super Late Model race and 250-lap Grand National Division race
The Date: Friday, Oct. 19 and Saturday, Oct. 20
TV: SPEED (live)
Track Layout: half-mile oval
Race Purse: $467,980
Schedule:
Friday: Super Late Model Practice, 10-10:45 a.m. Grand National Practice, 10:55-11:55 a.m. Super Late Model Practice, 12-12:45 p.m. Grand National Practice, 12:50-1:50 p.m. Super Late Model Time Trials, 2:30 p.m. Grand National Time Trials, 5 p.m. Super Late Model Race, 6:15 p.m. Grand National Open Qualifier (50 laps), 7:30 p.m.
Saturday: Grand National Division Race, 7:30 p.m.
Track Contact:
Kevin O'Brien (626) 358-1100; kobrien@irwindalespeedway.com

International Flare
Fresh Off Canadian Tire Series Title, Ranger Heads To The Toyota All-Star Showdown
Andrew Ranger is a special talent behind the wheel of a racecar – any racecar. And he heads to Irwindale this weekend looking to showcase that talent which earned him the 2007 NASCAR Canadian Tire Series presented by Sirius Satellite Radio championship.
He came into the 2007 NASCAR Canadian Tire Series season with just one stock car race under his belt, but that wasn't enough to deter the talented 20 year-old from Roxton Pond, Quebec. He made the move to NASCAR last winter from the ranks of the CHAMP Car World Series in which he finished 10th in points for both the 2005 and 2006 seasons. In 2005, at just 18 years of age, he became the youngest driver in series history to notch a podium finish.
That's ancient history, though, for Ranger. His move to the heavier cars of NASCAR has been seamless. He picked up his first NASCAR win in the season's second race of the year – his third start in a stock car. En route to his championship, he posted seven top-five and 10 top-10 finishes throughout the 12-race schedule.
The NASCAR Grand National Division cars that will be used in the NASCAR Toyota All-Star Showdown are different from those used in the Canadian Tire Series, but Ranger does not foresee any difficulty in adjusting.
He will be driving a car owned by fellow Canadian Dick Midgley, owner of Midgley Motorsports of Victoria, B.C.
"Andrew is NASCAR's Canadian national champion and with our base of operations in Canada, it seemed like a natural fit," said Midgley.
Travis Bennett drove a Midgley car to a fourth-place finish in a NASCAR Grand National Division, West Series event at Evergreen Speedway in Monroe, Wash., this season.
"The cars are just a little heavier and have a few more horsepower," said Ranger. "I really don't think it will be that hard to get used to."
On the track by himself, the adjustment may be easy, but he'll have to do it with other drivers on the speedy 1/2-mile oval, most of which have plenty of experience in their equipment, as well as at Irwindale Speedway itself.
"That was the case all season long in the Canadian Tire Series," Ranger said. "I've heard nothing but great things about the track. This is a great chance to compete against top drivers and an opportunity to showcase your talent in front of a people of influence in NASCAR."

Former NASCAR Mexico Champion Lopez Is Making His Move
Former NASCAR Mexico Series champion Rogelio Lopez heads to Irwindale following his first full season in the NASCAR Busch East Series, where he has become a force to be reckoned with.
Lopez, 27, of Aquascalientes, Mexico scored his first career NASCAR Busch East Series victory at the fabled Music City Motorplex fairgrounds oval in Nashville, Tenn., midway through the season. As if punctuating his 2007 campaign, Lopez won his first career Budweiser Pole Award at New Hampshire International Speedway in September, and converted the start to a third-place finish. He finished the season seventh in series points with a record of five top-5s and six top-10s in 13 starts.
Lopez has the whole package needed for success, and he's proven he's for real. He's also a bonifide star entering the NASCAR Toyota All-Star Showdown at Irwindale (Calif.) Speedway Friday and Saturday, Oct. 19 and 20. By virtue of his Music City win, Lopez also won a guaranteed starting position in the 250-lap all star race.
"We're looking forward to the Toyota Showdown and we're in pretty good shape," Lopez said. "We have a good car. To win that race would be very important to me and for my sponsors and the team. It would be nice to end the season like that. We tested the car at Caraway Speedway (in Asheboro, N.C.) and I think we have a pretty good set-up. We've been strong on short tracks like Music City, and on big tracks like New Hampshire, so we're looking forward to going to California.
"Our focus will be on running for the NASCAR Busch East Series championship next year. I think we have everything we need to do that."
Lopez won the 2006 NASCAR Mexico Series championship. In 2007, he joined up with NASCAR Busch East Series team owner Dave Davis, crew chief Freddy Skaff, and promptly became a contender in the No. 03 Telmex/Lucas Oil Chevrolet. Lopez also has a place in NASCAR history as the first driver from Mexico to compete in a NASCAR Touring event with the series in 2005.
Like most of the tracks the NASCAR Busch East Series visited in 2007, Lopez has never laid eyes on Irwindale Speedway.
"I've never been to Irwindale Speedway, but I've talked to a lot of drivers who've been there," Lopez said. "I think I've gotten some good advice, and I'm going to follow some guys who have been there like Sean Caisse in practice to see what they do."
Lopez also takes a big picture of his racing career, hoping to use NASCAR's ladder system to work his way up.
"Look at guys like Kevin Harvick and Martin Truex. They came up through the NASCAR Grand National Division, and they're winning in the Cup Series now," Lopez said. "Sean Caisse looks like he's the next guy who is moving up. I'm hoping I can do the same. The NASCAR Busch East Series is very competitive. Teams like Joe Gibbs and DEI compete in our series. They are here because they know they can take drivers to the next level from here. It's a great place for teams, drivers and sponsors. I hope we can move up, too. We want to prove ourselves next year. We'll be working really, really hard to do that."

Showdown stats
All-Star experience: Eight drivers have competed in all four previous Toyota All-Star Showdown events. Two of those drivers – Mike Duncan and Matt Kobyluck – have already secured a spot in this year's event by virtue of winning a Grand National Division race this season. In addition to Duncan and Kobyluck, others to compete in all four previous events were Bryan Chew, Scott Gaylord, Mike Johnson, Joey McCarthy, Mike Olsen and Jack Sellers.
Four races, four winners: None of the first four winners in Toyota All-Star Showdown competition have been able to repeat. The four post-season events featured four different winners – Austin Cameron (2003), Mike Johnson (2004), David Gilliland (2005) and Matt Kobyluck (2006).
Finishing up front: Matt Kobyluck has the most top-five finishes in Showdown competition, with three. He is tied with Brian Hoar and Joey McCarthy for the most top-10 finishes, with three each.
Best average finish: Matt Kobyluck has the best average finish of 4.25, among drivers with three or more starts in Toyota All-Star Showdown competitition. His win last year and runner-up finishes in 2004 and 2005, followed a 12th-place finish in the inaugural event in 2003.
Leading the way: David Gilliland has led the most laps in Toyota All-Star Showdown competition. The Riverside, Calif., competitor – who since graduated to the NASCAR NEXTEL Cup Series – led a total of 133 laps, 91 circuits in 2004 and 42 in 2005.
Race distance: The race distance for the NASCAR Toyota All-Star Showdown has varied. The inaugural event in 2003 was 125 laps. The race distance for events from 2004 to 2006 were 150 laps. This year's event is slated for 250 laps.
Last to lock in: Eric Holmes was the last driver to lock in a spot to this year's event by winning a Grand National West Series race, taking the victory in the season finale. Holmes won the Elite portion of the Showdown in 2004.

Home Field Advantage: Track Champ Michels Ready
To Take On All Challengers In Super Late Model 150
The only thing left for Rip Michels to accomplish in 2007 is to win Friday's NASCAR TOYOTA All-Star Showdown King Taco 150 NASCAR Whelen All-American Super Late Model race at Irwindale Speedway. The 42-year-old resident of San Fernando, Calif., has enjoyed a dominant year at his "home track", Irwindale Speedway, winning his fourth track division title, and the ACDelco Super Late Model series crown on Sept. 22.
"Winning any championship is awesome," Michels said. "Winning the 2006 NASCAR Southwest Tour title was sweet, but winning this year's Super Late Model title is cool and hopefully winning Friday's Showdown race will cap a special year. But the competition in Friday night's race will be tough!"
Michels won 11 races, and his 55 career victories on the half-mile variable banked track are more than any other Irwindale Speedway competitor.
At one point in time, Michels was considering not racing at Irwindale Speedway this year.
He had spent the past three years racing on the NASCAR Elite Division, Southwest Series winning last year's title and his only win which was the race at Irwindale. NASCAR realigned its short-track racing program, eliminating the Southwest Series from its development ranks.
Michels spent the off-season looking for another team and right after Christmas of last year, Michels agreed to a deal with long-time Irwindale Speedway competitor Lee Ladd and team owner Bob Bruncati to race one of Bruncati's Super Late Model cars at the Speedway.
"I've had a great racing career and have accomplished more than I ever dreamed I could," said Michels. "The accomplishments I have reached are because of great people like the late great Jim Kent, who taught me how to build my first street stock, to Lee Ladd, Rick Smith and, of course, my team owners Bob and Maureen Bruncati."
"It takes the whole package to win and without the support of these people, including my crew members and a supporting wife, you will not be successful."

D.W. Will Oversee Festivities As Showdown Grand Marshal
Eighteen years after finally reaching Victory lane in the Daytona 500, three-time NASCAR NEXTEL Cup Series champion Darrell Waltrip will serve as the Grand Marshal for the race that has become the 'Daytona 500' of the NASCAR Developmental Series: the 2007 NASCAR Toyota All-Star Showdown.
Waltrip – who had championships in 1981, 1982 and 1985, along with 84 wins in NASCAR's premier series – will serve as the dignitary for what has become the pinnacle of short-track racing. Known for its tight three-wide or sometimes four-wide competition and dramatic finishes.
After his racing career, in which he had more than 800 career starts in NASCAR's Cup Series between 1972 and 1999, Waltrip became a television commentator. The Owensboro, Ky., native serves as an analyst on FOX's NASCAR broadcasts.

Showdown coverage on TV
SPEED's coverage of the NASCAR Grand National Division this season culminates with live coverage of the NASCAR Toyota All-Star Showdown for a fifth consecutive year.
The cable network televised 22 Grand National events this season as part of its Racing Across America series.
About SPEED
SPEED is the nation's first and foremost cable television network dedicated to motor sports and the passion for everything automotive. From racing to restoration, motorcycles to movies, SPEED delivers quality programming from the track to the garage. Now available in more than 74 million homes in North America, SPEED is among the fastest-growing sports cable networks in the country.

TICKET INFORMATION
Tickets for the 2007 NASCAR Toyota All-Star Showdown, which will take place Oct. 19-20 at Irwindale (Calif.) Speedway, are available for purchase at the Irwindale Speedway ticket office, by calling (626) 358-1100 and online at http://www.irwindalespeedway.com/.

From NASCAR

Musical Chairs at Novartis, Except When the Music Stops, 1250 Fewer Chairs

Novartis posted its third quarter results this morning and missed its profit guidance. Genericization, delays to Galvus, and the withdrawal of Zelnorm all contributed to a 12% decline in earnings. And so out comes the axe. Oddly enough, the press release was titled "Novartis delivers record earnings in first nine months of 2007 thanks to strong operational performance and divestment gains." Is it time to revive IN VIVO Blog's 'press release of the week' feature?

Novartis is cutting 1250 jobs (mostly in sales, and including 510 'third-party' sales positions) in the US, a move cheered by analysts and expected to result in savings of about $230 million in 2008. The layoffs are part of a restructuring of its pharma development and commercialization organization.

Most conspicuously Thomas Ebeling, the current head of pharma, will be shuffled over to Novartis' consumer business--a position perhaps more suited to his background: he came to Novartis from Pepsi a decade ago. At pharma he'll be replaced by American Joe Jimenez, the current head of the consumer business who joined Novartis earlier this year (and was until 2006 European president and CEO of the food giant Heinz), effective immediately, "to expand management experience and provide fresh impetus." That might be a new euphemism, we're not sure.

Less surprisingly, the company is also establishing Novartis Biologics "as a focused unit to accelerate and optimize the potential of research and development of innovative biologic medicines." We've noted before (and discuss at length here) certain pharma's need to bulk up in large molecules. Novartis says:

This unit will unify and expand the expertise within Novartis by bringing together the key elements necessary for fast and high-quality R&D activities and to help attract top talent. Biologics comprise 25% of the pre-clinical research pipeline at Novartis and are increasingly a priority in R&D activities.

It will be interesting to see whether Novartis feels the need to augment its internal biologics capabilities with the kind of external moves being pondered by Sanofi-Aventis and Pfizer. The company has inked some 22 deals in large molecules over the past five years and most impressively has bulked up in vaccines (through the full acquisition of Chiron) and in RNAi, though a first-mover deal with Alnylam.

But back to the layoffs for a moment. Novartis' cutbacks don't approach the level of some of the other Big Pharma that have cut back this year--see the chart below from the September issue of IN VIVO--and will mainly be executed by not filling vacant positions, the company says.

Nevertheless, can the decision be seen in the broader context of the general shrinkage of Big Pharma sales forces, thanks to a variety of factors including but not limited to the rise of biologics and a shift toward specialist medicines? Which brings us back to the pharma/consumer reshuffle; both execs' backgrounds are more grounded in consumer marketing than pharmaceuticals. To say the least appointing Jimenez to the pharma post goes against the grain of the specialist marketing trend.

Have conservatives lost the debate on health care?

Civitas released their October poll today. Click here for results. I will be discussing it over the next couple of days. First I’ll talk about health care. Civitas had a quite a few questions on the subject.

When you think about health care, which of the following is your major concern:
Cost of health insurance 43%
Number of poor w/o insurance 31%
Quality of health care 10%
Access to quality care 6%
Inability to qualify for ins 5%

Do you support a state mandate requiring all health insurance policies to include mental health coverage even if it causes a 5-10% increase in the cost of your insurance?
Yes 59%
No 29%

Do you think Medicare adequately provides health insurance for older Americans?
No 46%
Yes 42%

Should all businesses in North Carolina with more than five employees be required to provide health insurance for their employees?
Yes 57%
No 36%

Do you think the quality of health care you receive in North Carolina is:
Excellent 29%
Good 48%
Fair 17%
Poor 6%

Do you support universal health care coverage where the federal government would insure that every American receives some type of health insurance coverage even if it means an increase in taxes?
Yes 56%
No 36%

At this point in Jack Hawke’s presentation of the survey results during the Civitas luncheon this afternoon, my friend Dallas Woodhouse of Americans for Prosperity blurted out that “the conservatives have lost the debate” on health care. In a lot of ways he’s right. Public opinion is moving towards acceptance of universal health care. But if conservatives have lost the debate they have no one to blame but themselves.

Almost all, if not all, the Democratic Presidential candidates supports some sort of universal health coverage and they talk about it often. Democrats in Congress and at the state level are trying to expand coverage through programs like SCHIPs (more on that later). What are the Republican’s plans for health care? I don’t know. I don’t hear them talk about it. All I hear is “let the free market decide.” Unfortunately for them, the American people have decided that the free market isn’t working in our health care system.

Mitt Romney, as governor of Massachusetts, did implement a universal health care plan in his state. Why doesn’t he talk about that more? That would be a start.

Doug Polen To Ride For Touring Sport Ducati In 8 Hours At Daytona

DAYTONA BEACH, Fla. -- Could there be an encore of the magical 1992 Daytona 200 By Honda photo finish between Scott Russell and Doug Polen in the upcoming SunTrust MOTO-ST Series 8 Hours At Daytona Finale on Saturday, Oct. 20?
 
Motorcycle fans can only hope.
 
Polen is adding his name to the list of motorcycle legends, which includes five-time Daytona 200 By Honda winner Russell, which will be competing in the season-ending endurance race. Polen, a four-time World champion, will team with Frank Shockley and Pete Friedland on the No. 77 Touring Sport Ducati SS1000 in the GST class.
 
Polen, who won two straight World Superbike Championships in 1991 and 1992 and earned Ducati's first AMA Championship in 1993, has six top-five runs in the Daytona 200 By Honda and two runner-up finishes, including 1992 when he finished second to Russell by a margin of .182 seconds.
 
Touring Sport Ducati and Shockley are in a tight points battle for the GST season championship. Touring Sport Ducati is second in class, just seven points behind Richie Morris Racing and Shockley is 10 points out of the lead in rider points behind Shawn Higbee.
 
Shockley needed a veteran rider for this weekend's race. He immediately thought of Doug Polen, who still has a relationship with Ducati North America. After a phone call to Ducati North America, Shockley had secured the former World Superbike Champion as a teammate for the 8 Hours At Daytona.
 
"I was looking for a ringer, somebody who could help propel us to the win, and I got to thinking about Doug," Shockley said. "It'll be tremendous. His reputation is world wide. I don't know anybody that I would have rather had. He's a pretty cool guy. I've followed his career myself. I'm just excited. I can't believe he said yes."
 
The 8 Hours At Daytona will boast an international field of top riders from the United States, Europe, South America and Canada in three classes – The Buell Motorcycle Company SuperSport class (SST) which includes motorcycles producing between 90-118 horsepower, the BMW GrandSport Twins class (GST) covering motorcycles producing 75-90 horsepower and Sport Twins (ST) for machines under 75 horsepower.
 
Included in the $100,000 purse is $7,500 to the overall winner of the 8 Hours At Daytona and $7,500 to the SuperSport Twins class winner, $5,000 to the GrandSport Twins winner and $3,500 to the Sport Twins Bonus.
 
The SunTrust MOTO-ST Series 8 Hours At Daytona finale is scheduled to go green at 1 p.m. on Saturday, Oct. 20 and is part of Fall Cycle Scene. Tickets are available online at www.racetickets.com or by calling 1-800-PITSHOP.
 
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From Grand-Am / MOTO-ST
 

INDY PRO SERIES: Brian Stewart helps Canadian golfer qualify

Brian Stewart helps Canadian golfer qualify for tourney: Indy Pro Series team owner Brian Stewart spends nearly as much time on golf courses as he does at racetracks.

Earlier this week, Brian Stewart took time away from chasing his own golf balls to caddy for fellow Canadian Dan Payton in Chattanooga, Tenn., as the young golfer qualified for this weekend�s Nationwide Tour event at Black Creek Club.

�Dan is a good kid,� Stewart said of Payton, who regularly golfs on the Great Lakes Tour, Canada�s developmental golf circuit. �He works at the club where I belong, and we had a chance to talk and play a couple of times, so I decided to back his efforts.�

Payton, who ranks third on the Great Lakes Tour, will compete for part of a $475,000 purse. Stewart, who caddied �in the blazing hot sun� Monday and Tuesday, departed for Iowa Speedway where the team will conduct some off-season testing.

From IndyCar

The Biogen Idec Sale: It’s About Revenues – Not Biologics

Last week, IN VIVO Blog broke the news that Biogen Idec had hired bankers to explore a sale.

Now, we know that companies, like people, don’t always act in their economic best interests. And there are plenty of revenue-desperate Big Pharmas (much speculation surrounds Pfizer, as the Wall Street Journal notes here and here) who might let desperation get the better of common sense. One banker peripherally involved in the transaction noted that there was “so much panic [among Big Pharma] about generating revenues they’ll rationalize as much as they need to about cost-cutting to justify the price. If I was at Biogen, I’d be out looking for a job right now.”

But let’s be clear: buying Biogen at this price doesn’t make sense. First, by contract Genentech/Roche will soon be upping their share of Rituxan revenues (from 60% US and greater ex-US to 70% US). And then there’s Elan’s change-in-control option on jointly marketed Tysabri – which could soon be providing a quarter of Biogen’s revenues (or more: it’s likely that Tysabri sales are already beginning to cannibalize sales from Biogen’s other MS drug, Avonex).

It’s possible, perhaps, that Elan and Biogen have reached some sort of understanding over Tysabri. But unless that understanding is worth a ton of money to Elan (which an acquirer would end up paying for), we think it would be hugely stupid for Elan to leave Tysabri in any Biogen-acquiror’s hands without extracting a huge fee (the huge fee they didn’t get when, in 2000, they signed the original deal with Biogen) and probably a far better ex-US royalty rate (we think they now get about 13%).

And Elan would have no trouble – zero – raising the money to buy out Tysabri: investors (who could smell high-profit re-sale to any number of large companies) would jam Elan’s offices with their checkbooks. Imagine what product-poor Novartis would pay for a drug to spearhead its efforts in developing an MS portfolio? “For Elan, this is the best thing since sliced bread,” says a banker. In any event, Elan’s hired Lehman Brothers to advise on the issue – and we’re pretty sure Lehman agrees with us.

So are there non-crazy reasons to buy Biogen at something north of $90/share? If you were intent on stretching a point, you could argue that senior management could use the necessity of making such a big bet pay off to bomb a primary-care mindset into the new world of specialty-care product development and marketing. And a small-molecule Big Pharma could suddenly acquire the rare soup-to-nuts biologics capabilities required to make a go of large molecules. For an in-depth discussion, see this October IN VIVO story.

But there are certainly more sensible compromises an acquirer should make if indeed biologics is the primary goal. For a lot less money, an acquirer could buy PDL, Genmab, MicroMet, Seattle Genetics, Human Genome Sciences or Xoma, each of which would bring some of the requisite capabilities. Certainly there’s plenty of hair on each of these companies—none of them have ever marketed a biological, so they lack proven development and regulatory expertise. None of them are free from management challenges. And they don’t all have the manufacturing capacity some buyers might want. But each of them has far more freedom than virtually any Big Pharma to operate within the IP constraints of the antibody world; they all have at least some of the expertise needed…and the rest can probably be acquired piecemeal.

But we don’t think a biologics business is the goal. The goal is revenues. And what Icahn hopes is that growth-starved, cash-rich Pharmas will be willing to pay an exorbitant exchange rate to trade balance sheet dollars for sales.

Incidentally, while Genzyme stock is up about 20% thanks to the Icahn put-them-in-play treatment, we’re also leery of a sale. To our eyes, Biogen CEO Jim Mullen looks pretty eager to cash out. Our bet is that Henri Termeer, Genzyme’s boss, probably wants to stay right where he is – the grand old man of biotech – and that he’d put up a significant fight to stay independent.

UPDATE: Be sure to vote in our highly unscientific poll on the top-left of the IN VIVO Blog. Who do you think Pfizer and its ilk will take out next?

UPDATE II: Poll is closed. Big winner? Biogen Idec, with more than 50% of the vote!

Champ Car: RuSport "closing down"

TSN has a story quoting RuSport Champ Car driver Justing Wilson saying that the team won't be back in the series in 2008.

"The future of the RuSport team in Champ Car is very much in doubt after reports surfaced from Australia that the team would fold at the end of this season.
"They (RuSport) have just announced they are closing down," driver Justin Wilson tells goldcoast.com.au. "They have just told me and the crew. They don't want to carry on. This weekend I will just have to see what my options are for next year."

In the wake of high-profile driver defections and event cancellations, Champ Car is starting to look like Rocky Balboa... taking a beating but still somehow standing. How long can it last?

Story continued at the link above.

UPDATE: As requested (see the comments). The names on the limbs could be updated, but the sentiment still fits. Originally released in March 2007.

FDA Sides With CMS in EPO Battle; Labeling Change Next

Rep. Stark is smiling; Amgen isn't

Amgen Inc.’s uphill climb to reverse restrictive coverage policies for darbepoetin (Aranesp) just got a little steeper.

The Centers for Medicare & Medicaid Services’ position that it will not pay for use of Aranesp or Johnson & Johnson’s competing EPO brand epoetin (Procrit) in patients with hemoglobin levels above 10 g/dL “is generally consistent with the available data and the published scientific literature.” So says the Food & Drug Administration in a letter sent to two prominent House Democrats: Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) and Ways & Means/Health Subcommittee Chairman Pete Stark (D-Calif.).

The letter, signed by acting Assistant Commissioner for Legislation Stephen Mason, gives CMS a vote of support the agency desperately wanted. It looks like CMS is making its position stick—and that is a development that should matter to companies across the industry, not just Amgen and J&J. (Why? We have written extensively about that in The RPM Report—including this article just going to press. Not a subscriber? Click here to register for a free trial and check out our coverage.)

FDA’s letter ends any lingering hopes for a quick reversal of the coverage policy, despite an all-out campaign by Amgen and J&J to enlist support in Congress. Amgen seemed to have gained a lot of traction on Capitol Hill, especially in the Senate, where a non-binding resolution urging CMS to reconsider the policy passed at the start of September, and where many Hill watchers expected a binding resolution to be included in a Medicare bill this year.

But one of the critical arguments underpinning the Senate legislation has been the contention that CMS’ policy is consistent with the FDA approved directions for use for EPO. As currently written, FDA’s label says EPO should be used to maintain hemoglobin levels at the lowest level sufficient to avoid the need for transfusions, and not be used once hemoglobin rises above 12 g/dL. Amgen, J&J, and a whole bunch of oncologists think that means CMS’ policy—refusing to pay for use above 10—is inconsistent with the labeling.

CMS has stuck by its position despite the political pressure. But no one knew for sure what FDA thought or what it would say when it finalizes new labeling for the drugs to reflect advice from two advisory committees convened in May and September. (Here is our recap of the situation, including a nifty picture of Commissioner von Eschenbach holding the PDR.)

So Waxman and Stark asked. FDA still hasn’t finalized the labeling, but it did answer the critical question. “The current labeling advises that the hemoglobin not exceed 12 g/dL,” Mason wrote. “FDA considers this to be an upper safety limit for ESA dosing, not a target for therapy. FDA is aware that there has been some confusion about the dosing recommendations in the current approved labeling and will work to clarify that confusion as we complete labeling changes that we are currently discussing with Amgen.” (Amgen is the license holder for both Aranesp and Procrit, so J&J is not directly involved in the labeling discussions.)

“Transfusions are not normally given to patients whose hemoglobin is 10 g/dL or higher,” FDA said. So I guess we know what the new labeling will say--not that it matters anymore, since FDA's letter of support is far more important to the future of the anemia therapies than anything the labeling ultimately says.

Oh, and FDA didn’t stop there. “There is no evidence that ESAs result in improved survival, tumor control, health-related quality of life at any hemoglobin level in cancer patients undergoing chemotherapy,” the agency wrote. “ESAs were approved based on their effectiveness in reducing the need for red blood cell transfusions.”

Don’t expect Amgen to take that answer lying down. But the company has an even tougher road ahead if it hopes to change CMS' mind.

SunTrust MOTO-ST Series: News & Notes Update

DAYTONA BEACH, Fla. - Heading into this weekend�s 8 Hours At Daytona SunTrust MOTO-ST Series race at Daytona International Speedway, the sixth and final round of the 2007 schedule, here are some pre-race notes, story angles and interesting trends to follow:
 
DRESSED TO THE NINES: Pair-A-Nines Racing is a Hall of Fame effort in every sense of the word. The team is managed by Motorcycle Hall of Famer Gary Nixon, with the full season ST class effort piloted by Hall of Famers Jay Springsteen and Jimmy Filice. Springsteen and Filice currently hold a 29-point advantage in the ST (Sport Twins) class, earning wins on the road courses at Homestead-Miami Speedway, Iowa Speedway and the season-opener at Daytona last March.
 
Before his team manager days, Nixon won the 1967 and 1968 Grand National Championships, comprised of road racing and flat track events, but his specialty was the pavement. Springsteen captured three Grand National Championships and is known as one of the greatest flat trackers of all time, capturing 43 Grand National dirt track victories in a career that spanned over 30 years. Nixon and �Springer� both wore the number nine plate throughout their careers.
 
Filice was one of the fastest American riders ever to ride a 250cc motorcycle, and in 1988 became one of only four Americans to win a World Championship 250 Grand Prix race.
 
Springsteen and Filice will be joined on the No. 9 Pair-A-Nines Kawasaki EX650 for the 8 Hours At Daytona by Filice�s son, Justin.
 
MR. DAYTONA COMES HOME: Scott Russell, nicknamed �Mr. Daytona� for his five wins in the Daytona 200, will make his motorcycle racing return this weekend at the 8 Hours At Daytona. The Conyers, Ga. native hasn�t raced professionally since suffering injuries in a 2001 accident.
 
Not only fast at Daytona, Russell captured the 1992 AMA Superbike Championship and the 1993 World Superbike Championship. Russell also captured a win at the famous Suzuka Eight Hours endurance race.
 
Mr. Daytona will ride the No. 92 Pair-A-Nines Kawasaki 650 VERSYS this weekend with other riders to be named.
 
SBK AT DIS: Two-time Superbike World Champion Doug Polen makes his return to racing at this weekend�s 8 Hours At Daytona, riding the No. 77 Touring Sport Ducati SS1000 with Pete Friedland and Frank Shockley. Polen was World Champion in 1991 and 1992 before returning home to capture the Superbike National Championship in 1993.
 
RUSSELL VS. POLEN, PART 2: The 8 Hours At Daytona SunTrust MOTO-ST race could shape up as a rematch of one of the most exciting Daytona 200 races of all time. Both Russell and Polen are competing in the GST (Grand Sport Twins) class this weekend.
 
In 1992, Russell scored his first of five wins in a photo finish at the famed race by making a slingshot move on his Kawasaki past Polen�s Ducati to the checkered flag at the �World Center of Racing.�
 
CHAMPIONSHIP BUSTERS: Two riders making their SunTrust MOTO-ST debut this weekend have an excellent shot of leaving with a win. Colombian Martin Cardenas and Venezuelan Robertino Pietri will ride the No. 3 Roadracingworld.com Suzuki SV1000S in the SST class, after successful summers of road racing.
 
The 26-year-old Cardenas established himself as one of the top motorcycle riders in the United States this summer after beginning the season riding an essentially stock motorcycle to a 12^th place finish at Daytona in the Superbike class. Cardenas capitalized on a mid-season opportunity to earn a new ride and record four podium finishes late in the summer, competing for wins on a number of occasions. In 2005, Cardenas became the first Colombian to ever compete in a World Championship motorcycle race, recording two top-10s in two years in the highly competitive 250cc class.
 
Second-generation racer Pietri is the son of former Superbike racer Roberto Pietri and recorded a number of top-10 finishes in the 1000cc class this summer.
 
Cardenas and Pietri should have the equipment to compete for a win, as teammate Chris Ulrich finished second at the season-opener at Daytona and recorded a win at Homestead-Miami Speedway.
 
MANY HAPPY RETURNS: SunTrust MOTO-ST Series riders Shawn Higbee and Brian Kcraget will return to action this weekend after an exciting finish to the last round at Iowa Speedway in July.
 
Both riders were involved in a fiery accident in Turn 2 late in that race and have made fast and full recoveries to return to action this weekend at Daytona. Higbee leads the GST class points battle by two points over Brad Phillips.
 
PROMOTIONAL PUSH: The off-the-track activities for the SunTrust MOTO-ST Series and the 8 Hours At Daytona kick into high gear this week with spectacular events at two local hot spots during the local scene�s fall bike week.
 
Daytona Beach�s famed Ocean Deck hosts Wednesday night�s festivities, including SunTrust MOTO-ST competitors from Richie Morris Racing - among others - on hand to give away tickets and merchandise from 8 to 11 p.m.
 
On Thursday, the festivities will head to Hooligan�s at Destination Daytona from 5 to 11 p.m. Riders from Team Rightsforbikers.com and Richie Morris Racing will give away gifts and prizes to those in attendance.
 
From Grand-Am / MOTO-ST