FDA Brand Name Review: Finding Predictability in the Process

When it comes to FDA regulation, the top priority of any drug sponsor is finding predictability in the system. Sponsors want to know that if they follow a specified regulatory process, it will result in a predictable (and hopefully positive) outcome.

But that’s precisely what some pharmaceutical companies think is lacking in FDA’s proposed redesign of the brand name approval process.

Right now, the process by which FDA approves proprietary trade names is pretty inefficient: about 40% of brand names proposed by sponsors are rejected by the agency for safety or promotional reasons. (We wrote about this increased rejection rate in a previous story in The RPM Report.)

FDA is hoping to improve things by transferring the responsibility of testing proposed names to drug sponsors, starting with a pilot program negotiated under the last reauthorization of the Prescription Drug User Fee Act. Much like the NDA review process, sponsors would test their preferred names themselves and submit that information to FDA for approval.

The agency held a two-day meeting on the pilot on June 5-6 to gather feedback on a concept paper outlining how the new program might work. One major concern was echoed repeatedly throughout the two-day meeting: that the redesign of the brand name approval program will slow down the process and lead to higher rejection rates.

Novartis VP Trademarks & Copyrights Steven Hartman, one of several industry representatives on the meeting panels, made this point repeatedly. As proposed by FDA, the revised process outlined in the concept paper would require sponsors to do a lot of extra work, he noted. What confidence does a company have that if it finds a name to be acceptably safe, that FDA won’t simply disagree with that conclusion?

Not much, acknowledged Carol Holquist, the director of FDA’s Division of Medication Error Prevention & Technical Support.

“I can’t say that any data that you submit will be rubber-stamped based on your analysis,” she told Hartman. “We would have to evaluate it, just as we would any clinical trials data. We would never be able to officially endorse [a name], and say if you followed the concept paper to the hilt, that we will automatically accept the results verbatim.”

That wasn’t exactly the response Hartman was looking for. “Unless we move toward a scenario in which the agency is willing to place some significant weight on the outcomes that a sponsor submits,” he said, “predictability will decrease.”

Holquist disagreed, arguing that over the long term, the revised approval process will allow FDA to become “more transparent about the reasons why we’re saying no.” If we learn from those reasons,” she said, “the predictability may increase.”

The idea that the revised program “may” increase predictability isn’t likely to offer any immediate comfort to drug sponsors. Luckily for industry, FDA appears quite open to making changes to the program. And given the number of drug company representatives invited to participate in the two-day meeting, industry will have many seats at the table.

image 'Old Faithful' from flickr user James Neeley used under a creative commons license.

Good for Jim Neal

Jim Neal has been about as gracious a loser as you could ever ask for since the Senate primary. Almost immediately once the votes were in he enthusiastically got behind Kay Hagan and pledged to do anything he could to help her get elected. He's shown that he really meant it over the last month by making numerous positive statements about Hagan, and he reports over at BlueNC that he's even hosting a fund raiser for her.

Richard Moore should take a lesson, sooner than later. Bev Perdue is in pretty good shape, but some of the interests that supported Moore in the primary could conceivably move toward Pat McCrory, and if Moore is a good Democrat he'll do what he can to stop that from happening.

Deals of the Week: Industry Spokesperson?

News of Mr. Bill's demise has been greatly exaggerated. The hapless Play-Doh character, an icon from the mid-1970s "Saturday Night Live" episodes, is back, starring in a new MasterCard "Priceless" spot. Recall that despite being mutilated or squashed, the ever optimistic Mr. Bill always came back for more. Now Mastercard's ad agency sees a way to use him to tap into the current “unsureness about what’s going to happen next.” The tag line for the ad, of course, is: “Making it through the day: priceless.”

This got IN VIVO Blog thinking: could the pharma industry find a better pitchman than the Mr. Bill, who suffered the abuse of "friend" Mr. Hands and arch-nemesis Sluggo? Think about it. Vytorin's loss of market share or Chantix's and Lyrica's troubles got you saying "Oh Noooo"? Worried that Teva's got a better take on developing generics--or biologics--than your own stellar and highly paid R&D team? Embrace Mr. Bill.

Hmmm. We aren't sure if Mr. Bill's existing Mastercard contract--or a run-in with a dump-truck loaded with pills (see below)--precludes a deal with the drug industry. And given the state of DTC advertising, would this be the wisest career choice for our yellow friend with big lips? Perhaps it's better to say "Oh Yes" to Deals of the Week.

Ipsen/ Octagen; Ipsen/ Vernalis; Ipsen/ Tercica: Ipsen bulks up its R&D assets with the acquisition of endocrinology, neurology, and hematology projects, adding a bit of US commercial infrastructure to boot. We honored them with their own deals of the week banner yesterday.

Novartis/ Protez Pharmaceuticals: Novartis announced Wednesday that it was buying Protez in a deal that could be worth as much as $400 million if certain clinical milestones and commercial targets are acheived. Protez will become a stand-alone subsidiary of Novartis, maintaining its operations in Malvern, PA. The deal, for which Novartis pays $100 million up-front, is primarily centered around Protez's lead product candidate, PZ-601, an injectable antiobitic belonging to the carbapenem class that is currently in Phase II clinical trials to treat life threatening bacterial infections, including MRSA, and was originally developed by Dainippon Sumitomo Pharma Co. We admit to some head-scratching concerning this tie-up. Protez's other compounds, which are beta-lactamase inhibitors--appear to be in the earliest stages of drug development, so most of the company's value seems tied up in PZ-601. Why then go to the trouble of buying the whole company and ring-fencing it when it seems simpler to license the one drug? Oh, we know antibiotic resistance is on the upswing and that hospital-acquired bacterial infections are a potentially valuable specialist market for Big Pharma. We also know that stand-alones are de rigeur these days. (Sirtris and Millennium will retain their autonomy even though they know report to GSK and Takeda respectively.) But what's the logic behind this structure? Anyone from Protez or Novartis want to clue us in, we are all ears.

Gen-Probe/Innogenetics: It's been a little over four months since Roche succeeded in acquiring Ventana, so it's about time for another battle for a molecular diagnostics player. This time the company in the news is the Belgian diagnostic developer Innogenetics. A little more than a month ago, Solvay announced a friendly tie-up with the company. On Wednesday came news that Gen-Probe was throwing its hat into the aquisition ring, with an all cash offer worth $334 million, a 6% premium to Solvay's original 5.75-euros-per-share offer. Diagnostics used to be viewed as the lowly side-kick to more lucrative drugs, but a changing regulatory climate and a new breed of expensive molecular tests is changing that perception. Gen-Probe seems aiming to build a power-house to rival Roche, given this comment from the company's press release:

The combined entity is expected to be the largest standalone molecular
diagnostics company in the world, with pro forma 2008 sales in excess of $500million. The combined company would offer a broad range of nucleic acid and immunoassay tests to identify bacterial and viral infectious diseases, genetic and neurological disorders,transplant compatibility, and cancer. These tube- and strip-based products could be sold to a diverse group of small, medium and large customers around the world.

Still, as David Hamilton over at bnet writes, it's a risky move for Gen-Probe. The San Diego company, which had 2007 revenue of $403 million and a market valuation of more than $2.83 billion, hasn't done an acquisition since 2003 when it bought Molecular Light Technology for $11 million. And it's offer could trigger Solvay, a much larger outfit with revenues of roughly $15 billion, to up its bid. Given the weakness of the dollar to the euro currently, it's possible Gen-Probe could find itself on the losing end of the bidding war.

Elron/ Given: Elron Electronic Industries aims to buy an additional 1.46 million shares in Given Imaging, upping its stake in the capsule endoscopy company it spun out in 1998 to 48%. Our own Mary Stuart wonders: could this be the prelude to an acquisition? Maybe yes--and not necessarily by Elron, she says. Investment banks like Needham & Co. are positive on Given, and some have suggested that it’s ripe for a takeover, with Boston Scientific, Fujinon, Johnson & Johnson, Olympus, and Pentax named as suspects. Given pioneered capsule endoscopy in 2001 with its creation of an encapsulated color video camera that transmits images of previously inaccessible regions of the small intestine upon swallowing. Capsule endoscopy continues to make incursions upon conventional endoscopy: at the Digestive Disease Week meeting two weeks ago, Given presented clinical studies supporting expanded indications for its diagnostic device. With $130 million in sales projected for 2008 and full US sales and marketing rights for its device (J&J used to have a share), Given might just be at the threshold that large company acquirors like to cross. It's also unencumbered, thanks to the April settlement of patent litigation with Olympus.

Port Authority Gets Bids for North Shore T Station

The Port Authority of Allegheny County received four bids for the new Allegheny T Station on the North Shore ranging from $39 to $42 million. Although a contract will therefore exceed the original estimate of $30 million by about 30%, it could have been worse, according to Winston Simmonds, Rail Operations and Engineering Officer. Concrete and fuel prices are up, he says, and fabricated steel is 50% more costly this year.

Simmonds says the Port Authority is trying to mitigate costs in any way possible, e.g., by allowing a concrete alternative (to steel) for the Allegheny Station bid and by closing the Gateway Station completely during construction so the contractor can save money by having complete access.

The Port Authority will review the low bid of $39.8 million from Brayman Construction of Saxonburg, PA, along with a prior bid for the Gateway Station, with the goal of seeking board approval in July for awarding both contracts. Simmonds says the North Shore Connector will be a valuable regional asset, opening up opportunities for possible northward expansion in the future.

Members of City Council and Mayor Ravenstahl agree to Review of Departmental Goals and Objectives

Pittsburgh City Council and the Mayor have agreed to submit departmental goals and objectives prior to the start of the budget process. All city departments will be required to submit their mission statement along with a list of goals and objectives for the upcoming year. The objectives will be due by July 31st, 2008. Council members Patrick Dowd and Bill Peduto requested the performance statements and have said it will increase transparency during the budget process and allow city council to see exactly what tax payers money will be used for.

DC taking NC seriously this time

It's good news for North Carolina Democrats that Barack Obama is keeping Howard Dean on as chair of the DNC.

Dean has been much reviled by some party insiders for his '50 state strategy,' but it has helped pay clear dividends as Democrats won recent Congressional election in Mississippi and Louisiana districts that they had no business competing in.

The Obama campaign has the same goal of expanding the Democratic map that Dean does, and that makes it more likely that the campaign will be taken seriously in the state all the way through October.

Across the board it appears DC Democrats are giving North Carolina more respect this year. Obama seems to be serious about contesting North Carolina. The DSCC is helping Kay Hagan raise the money she needs to beat Elizabeth Dole. And the DCCC is taking Larry Kissell's bid to knock off Robin Hayes very seriously.

It would be great if they expanded their sights to campaigns like Daniel Johnson's to knock off Patrick McHenry, but it's nevertheless a much better situation than we had at the same time two years ago.

ARCA West Mac's Series race in Regina called due to inclement weather

From Craig Ball of the ARCA West Mac's Series....

"Due to inclement weather, the June 7th ARCA West Mac's Series event in Regina has been canceled."

World of Outlaws Late Models - Thursday June 19th

"Six Nations 50" sponsored by Arrow Express Full point show toward national championship See Rick Eckert, Steve Francis, Tim Fuller and the rest of the stars of the Outlaws battle South Buxton favourites including Jim Dale Jr, Andrew Reaume. Also on the program – Corr/Pak 360 Sprints.

Adult Reserved Seats are $30 with Kids 12 and under $20. Advanced tickets available at 1-888-720-7223.

General admission available race day for Adults at $20 with Kids 12 and under at $10.
Pits open at 2:00PM; Spectator gates at 4:00PM; - Racing at 7:45.
PLUS - Friday, June 20th

Empire Super Sprints plus a complete regular program of Stock Cars Gates open at 5:30PM Admission only $5 with presentation of a Thursday Night WOO Late Model Reserved Seat ticket stub.

Regular Friday admission prices are – Adult - $10; Kids 12 and under – Free; Seniors and Students - $8.

Ohsweken Speedway is located at 1987 Chiefswood Road in Ohsweken Ontario.
For more information see the official website at http://www.ohswekenspeedway.com/

For Ticket info go to - http://www.ohswekenspeedway.com/AdvancedReservedProcedure.htm

FW: DELAWARE SPEEDWAY PR: Litt Ready To Light Up Delaware with the Sprints!

By: John Houghton

 

The Auto Value Bumper to Bumper Super Sprints are set to hit the pavement this Friday at Delaware Speedway for a very special night of racing.  The event will see the homecoming of local favourite Ryan Litt and is also the only Canadian stop for the sprints in the 2008 season!  With anticipation for the event high amongst fans and drivers, local driver Ryan Litt took some time out of his busy schedule to discuss his upcoming visit.

 

“An Auto value Super Sprint is a 1600 lb open-wheel car with a 410 cubic inch all-aluminium small bock motor,” said Litt.  “They have mechanical fuel injection, and are billed as the fastest short track cars in the world.”Delaware Speedway fans are used to the APC Late Models being the fastest car on the track, but AVSS cars certainly give the regular Delaware divisions a run for their money.

 

“The cars are quite a bit different from a Late Model,” said Litt.  “When they go by you’ll know they’re quite a bit faster and noisier then a Late Model.  With the wing, it’s different looking and has big tires on the right rear.  A sprint car is quite a bit different then the average race car.”

 

Delaware Speedway is a race track that will provide some of the fastest speeds on the AVSS circuit this year.

 

“Delaware has long straights, and the corners are a bit tight.  On a long straight we’ll be doing 135-140 mph (225 KPH).  Our fastest speeds at Winchester Speedway are around 165 mph (265 KPH).”

 

Litt himself had a very busy 2007 racing season, but has decided on a new focus in 2008.

 

“Last year we decided to not focus on points racing.  We did a bit of USAC, which is the same car without the wings.  We also did a few Auto Value shows and ISMA shows.  The two highlights that stand out for me were our win at Cayuga, and finishing second at Delaware last year with the ISMA guys.  This year we’re doing the full Auto-Value deal for points.  It lets you get in the swing and find a rhythm instead of moving into a bunch of different cars all the time.”

 

Racing at Delaware is very special to Litt, who considers Delaware Speedway to be his home track.

 

“I grew up around Delaware and raced there when I was younger.  It’s great to see all my friends who I haven’t seen.  My friends and family also get to come out and see the race.  I’ve done a lot of laps around Delaware, it’s familiar so you get to relax and have some fun.”

 

“Over the winter we did a lot of changes to the car.  My crew is my grandfather, Alex Litt, and my dad Wade Litt.  We put our heads together and made some changes to help it with the wing on the car.  It seems to be helping quite a bit so far, there was a noticeable difference.  With BS&B radiator, OTC Tools are back on board we’re shooting for the AVSS championship this year, and working on consistent top 5 finishes, along with some wins of course.  We’ve been fast one week and then miss the setup next week.  This year, we want to perform consistently across all kinds of tracks.” Litt also plans to compete with the ISMA Super Modifieds at Delaware on September 26.

 

“I’ll be back again this year in the Super Modified, so hopefully I can get two top fives or even two wins!  It’s great to have the hometown fans see me in action, I hope it goes well.”

 

Litt also encourages fans to come on down to his trailer after the event to collect and autograph and even pick up the new 2008 Litt Racing t-shirt.

 

So far the Auto-Value Super Sprints have one race under their belts in 2008.  Tom Hartsell, series director for the AVSS took a few minutes to talk about their previous event and to look forward to the only Canadian stop of the year for the AVSS.

 

“Our opener went fairly well.  We were bit light on cars, with fifteen showing up, but many guys were waiting on motor parts and getting things back together,” said Hartsell.  “We’ve gained at least 3-4 cars since then.  We’re thinking there will be around nineteen cars at the Delaware event or even twenty or more.  I’m really excited about this weekend.”

 

The series had an early event at Auto City Speedway but has had a bit of downtime before the Delaware event.  Following Delaware Speedway the series begins a multi-week tour.

 

“We’re rippin’ and rearing to go!” said Hartsell.  “It all kicks off at Delaware.  The Canadian hospitality is great!  Even though there is an imaginary line that separates our two countries, you guys are so welcoming to us it’s just amazing.  We enjoy competing with each other in front of different fans, and just look forward to coming over.  It can be a hassle at the border, but the men and women there are doing a great job.  With the right credentials we do okay - - it’s a bit of an expense but if you love the sport it’s part of the highs and lows in racing!”

 

“The great thing about Delaware is the steps they’re taking in making plans to smooth the surface and take the bumps out of it.  They’re taking good small steps and using good meticulous planning.  In the coming years they’ll be very successful in what they do.”

 

Another local driver, Mike Ling is also rumoured to be part of the action this Friday.  Ling is thought to be driving for Jim Brown.  The AVSS confirmed that Brown has ordered tires for the event.  Also expected to compete is Scott O’Connor, of Delaware Speedway Challenger Motorfreight Truck fame.

 

The Peterbilt of Ontario Super Stocks and POWERADE Open Wheel Modifieds will be competing Friday as well as the sprints.  It’s going to be a full night of exciting Delaware Speedway action!  Gates open at 6:00 PM, Auto Value Super Sprint time trials are at 7:30, and racing starts at 8:00 PM.  You won’t see racing this intense on television - - don’t miss a lap!

Bill to Cut Science Center State Grant Removed

House Bill 2327, a proposal that would have cut an annual $254,000 state grant for the Carnegie Science Center, has been tabled. The legislation was first proposed as leverage to encourage House Democrats to push through House Bill 2299, a measure that would require county officials to approve any exhibit that would show human corpses. According to 2299, organizers would be forced to provide paperwork detailing where the body came from and prior consent from the person that their body may be put on display. State Representative Mike Fleck, a Democrat from Huntingdon County and leading proponent of both bills, says the threat to the Science Center's state grant has diminished now that 2299 is set to come up for vote June 24th. All of this is in response to Premiere Exhibit's controversial "Bodies" display, which ran at Carnegie this spring.

Historical Perspective on Edwards as Running Mate

Survey USA's state by state polls showing how Obama and McCain would fare against each other with various permutations of running mates continue to show that John Edwards is by far the best possible running mate for Obama among the possibilities they are testing (Ed Rendell, Kathleen Sebelius, Chuck Hagel, Edwards.)

This polling might make you think Edwards should be Obama's running mate, but consider some historical perspective:

In late May 2004, a Mason Dixon poll showed George W. Bush leading John Kerry 48-41 in North Carolina. It also showed that with Edwards on the ticket, the margin narrowed to 46-45.

Of course Edwards was chosen- and that seven point deficit turned into a 12 point loss.

The lesson? The Vice Presidential selection is certainly important, because it will line someone up as the leading contender to be our next President- but the running mate is very unlikely to have much of an impact on who actually wins this fall.

Then and now for Dole

Yesterday Kay Hagan released an internal poll showing her trailing Elizabeth Dole by only four points.

In May 2002 Democrats in North Carolina were touting their internal polling as well- showing Erskine Bowles trailing Dole by only 19 points. Other polling out at the time had the margin over 30 points, so even though it showed Bowles getting defeated pretty roundly people were skeptical of his internal poll.

Not only is Hagan doing way better in this month's internal poll, but it's also very much in line with what independent polling is showing.

There's no doubt Dole's in a much worse situation than she was at this same time in the cycle the first time she ran.

State Representative Looks into Voting by Mail

House State Government Committee Chairwoman Babette Josephs recommends that Pennsylvania amend its constitution to allow citizens to vote by absentee ballot without needing an acceptable reason. The Philadelphia County Democrat's suggestion could be the first step on Pennsylvania's way to all-mail voting. Josephs is currently entertaining the idea of universal mail-in ballots. She says that Oregon is the only state with all-mail voting and that process has increased participation, decreased the likelihood of voter fraud, and saved the state money. However, she did concede that mail-in ballots take away the nostalgia of travelling to voting booths. She also said that mail-in ballots did not restrict exit polling in Oregon.

Tree Rivers Arts Fest Opens

The Three Rivers Arts Festival opens Friday at noon with the 80’s and 90’s tribute rock band “Blindsider.” 100-150 artists will be in the artist’s market in gateway center each of the next 17 days. A total of 300 artists will pass through the market at various times. Three stages on Stanwix Street and in Market Square will feature performances each afternoon and evening. This weekend the Artist’s market will play host to “Turning Ideas into Art.” Various artists will show how they create their arts and crafts. Tom Sarver will bring his Art Olympics to market square the next weekend. The Arts Fest is also trying something new. “Container” uses old shipping containers as galleries. Ten of these containers once used on ocean going ships will be set up on Forbes between Stanwix and Market Square.

Ravenstahl warned to not sign campaign finance reform

A campaign finance reform watchdog group has sent Pittsburgh Mayor Luke Ravenstahl a letter encouraging him to veto recently passed legislation that would limit campaign contributions in city races. Center for competitive politics president Sean Parnell says the bill would not take corruption out of politics and it might be unconstitutional. The bill passed this week limits individual contributions to $2,000 and limits political committees to $5,000 per election cycle. There is an exemption for candidates running against candidates who spend more than a quarter of a million dollars of their own money on a campaign. A similar provision in federal law has been argued before the US Supreme Court. Parnell says Pittsburgh ordinance would chill free speech, further entrench incumbents because challengers would not be able to get out their message and it would not limit corruption. He says politicians will still feel the pressure to get endorsements and other special interest group support.

City Controllers office releases audit of Pittsburgh's EMS

City Controller Michael Lamb released an audit of Pittsburgh's Emergency Medical Services (EMS) and found that the city's EMS were meeting desired response times in priority calls at 60% compared to the national standard of 90%. Standard response time is below 9 minutes after the emergency call is placed The audit also found that Unit hour Utilization (UHU), which is the ratio of number of hours spent delivering EMS service as compared to total number of hours a system could deliver is higher that national standards. The acceptable levels for UHU are between .40 Unit hours - .50 Unit hours. The audit found the UHU for the city at .54 in 06, and .56 in 07.

Lamb cited high volume of non emergency calls as the problem for the EMS, and has contacted local health care and service providers with the recommendation of creating and instituting a program that informs the public on what constitutes an emergency health need. Lamb said the city did not need to hire more EMS personnel or have more units available because if non emergency calls decreased then the current number on the force would be appropriate. Pittsburgh's EMS is operating under act 47 guidelines.

UPMC to take Second Shot at Hanging Letters

If you gaze up at the top of the U.S. Steel tower in downtown Pittsburgh, you may notice something "M"issing. The University of Pittsburgh Medical Center's (UPMC) hanging of their signature letters was postponed in early May due to inclement weather leaving the letters U, P, and C, at the top of the 64-story building and the "M" grounded. The first 3 of the 4 letters, which weigh between 2,000 to 3,000 pounds each, were successfully attached to the top of the tower via helicopter. Winds and rain kept the "M" on the ground where it has remained in storage. UPMC will try to hang the "M" again this weekend. Spokesman Paul Wood says that as long as the weather remains nice, it will be put up. Workers saved the "M" for last because it is the letter with the largest surface area and the letter most affected by wind. The project will eventually have the letters "UPMC" hanging from the top of all three sides of the U.S. Steel tower. UPMC leases about one-fifth of the building.

Jacques Villeneuve: "NASCAR remains my priority"

He says so here in this SPEED TV story.

(h/t J.R.)

An unusual situation

Pat McCrory has a guy with a 33% approval rating in North Carolina coming to help him raise money next month.

Usually Republicans in North Carolina try to tie state level Democratic candidates to national Democrats. But given McCrory's coziness with the unpopular President Bush, Bev Perdue (or her surrogates) have to give some serious thought to turning the tables this year.

When is the last time Democrats in North Carolina tried to erode an opponent's credibility by tying him to the national Republican party? Sure hasn't happened since I've been down here.

This is a pretty curious move on McCrory's part. Two years ago when Bush showed up in Florida on the eve of the Gubernatorial election, Republican nominee Charlie Crist went out of his way to avoid appearing with him. Bush's popularity has been further eroded since then.

It will be interesting to see whether or not this becomes an issue in the race for Governor.

It's Canadian Grand Prix time... and that means we need more hookers

The Canadian Grand Prix creates big business for several 'industries' in Montreal. Hotels, restarants, taxis.... and prostitution, according to a CP report on CTV.ca.

In fact, the increased demand for young, friendly, willing ladies is so great during the GP weekend that they have to import some, er, 'workers', from outside to satisfy the demand.

"The Canadian Grand Prix weekend means big business for Montreal's sex trade as partying race fans roar into the city on their annual pilgrimage.
Experts say major international sporting events, such as the World Cup and the Olympics, up the demands for young, female prostitutes.
Montreal's annual high-octane extravaganza is no exception, but many of the sex workers who are used to fill the commercial void are unwilling participants, human rights activists say. Sharon DiFruscia, who's part of a Montreal coalition against human trafficking, said most of the women are exploited as sex slaves.
"Not only in Montreal, but for large sporting events, it's a well-known fact that many women are brought in to the city," said DiFruscia, adding it's difficult to estimate just how many.
"Some of these women are from other countries, but some of them are from our own country.""

CTV has the full story here.

p.s. - And you told your wife you were going for the race.....

p.p.s. - Does anyone know if they charge extra to turn the trick while sporting a Nazi costume? I believe it's called a 'Mad Max'.

Ipsen's Own Deals of the Week

Well, Ipsen's sure been a busy beaver.

Late last night the French group announced three separate transactions designed to turn its US foothold into a 'fully fledged presence'. The $9-per-share acquisition of Tercica--an endocrinology specialist and already an important Ipsen partner--is surely the biggest of the three moves, so lets knock the other two out of the way first before we get to that discussion.

All told Ipsen is bulking up its R&D assets with the acquisition of endocrinology, neurology, and hematology projects, adding a bit of US commercial infrastructure to boot, and along the way vandalizing our deals of the week banner:



Ipsen/Octagen: The most straightforward of Ipsen's acquisitions sees the French pharma buying out its partner Octagen's rights to the Phase II recombinant porcine factor VIII haemophilia treatment OBI-1 (love the name). Ipsen will pay Octagen--with whom its been working for ten years on the project--an upfront payment of $10.5 million, potential milestones totalling $26 million and royalties in the low-to-mid single digits.

Ipsen/Vernalis: The Vernalis fire-sale continues. Ipsen's deal with Vernalis is a bit more complex than the Octagen arrangement. For $6.5 million in upfront cash and a $5 million equity investment (at a 20% premium) Ipsen is acquiring Vernalis' US subsidiary Vernalis Pharmaceuticals along with the rights to market its Parkinson's disease treatment Apokyn (Apokyn, an injectible apomorphine treatment for PD flare-ups, was relaunched by Vernalis in 2006 after it acquired the product from Mylan in '05). The deal--which includes milestone payments that could push the total value to $17.5 million--allows Vernalis to avoid spending a few million dollars to shut down that US operation which mainly comprises the company's specialty neurology sales force. A further wrinkle sees Ipsen and Vernalis teaming up to develop certain undisclosed Ipsen neurology R&D programs. When the deal closes Vernalis will look very different compared to only a few months ago: approximately 90 employees, most of which are in R&D, with approximately two years of cash to spend on its early-to-mid-stage pipeline.

Ipsen/Tercica: Finally, on to Tercica. The foundations of this acquisition were laid back in 2006, when the two companies teamed up in the endocrine space. Back in July 2006 we characterized that deal as a "hedged, step-wise acquisition," noting that "Tercica will probably become Ipsen's US arm, providing a commercial presence there for the French group faster and more cheaply than through building one from scratch."

Indeed that's how it turned out (kudos to Melanie Senior for making the call). As part of that original deal Ipsen took a 25% stake in Tercica, with the option to increase that share to 40%. The deal gave Tercica US rights to Ipsen's sustained-release acromegaly drug lanreotide (Somatuline Autogel) and gave Ipsen rights to Tercica's own recombinant human IGF-1 replacement therapy mecasermin (Increlex), for short stature; it also intertwined the companies' futures by calling for collaboration on improved versions of these and other endocrinology products and candidates.

Buying Tercica back then was certainly an affordable option, but one eschewed by Ipsen in order to retain the expertise of Tercica's team. In an interview about six months ago Tercica CEO Chip Scarlett told us that the company should turn a profit by 2010, but played down the idea of a takeout, instead saying Tercica would continue to execute on an alliance and R&D strategy that saw the group team up with Genentech in July 2007. "You cannot remain so firmly fixated on purely commercial growth and success that you turn around in two or three years with nothing to offer" from R&D, he said. "It's a balancing act."

But two years since its original deal with Ipsen the biotech has added little in terms of market capitalization despite making R&D and commercial progress. Yesterday Ipsen excercised its warrants, upping its stake in Tercica to 42.7%, and bought the remaining 44.9 million shares for a total of $404 million--a 104% premium over the day's share price close and a 49% premium over the past six months' volume-weighted price.

Analysts may find the Tercica acquisition expensive--and we don't dispute that the premium is generous--though it is hardly out of step with the deal prices we've seen lately. But all of a sudden Ipsen has a significant US presence with multiple products on the market. And it's hard to see how it could have pulled that off on the cheap.

image 'happy beaver' from flickr user sherseydc used under a creative commons license.

TSN Alert: Canadian Grand Prix, Live this Weekend on TSN

Sophomore sensation Lewis Hamilton leads the biggest names in open wheel racing into Montreal this weekend for Formula 1's Canadian Grand Prix.  TSN has all the live action   beginning Saturday, June 7 at 1 p.m. ET with qualifying on the TSN alternate feed, followed by the race on Sunday, June 8 at 12:30 p.m. ET on TSN.  This marks the 30^th   anniversary of the race being held at the famous circuit Gilles-Villeneuve.

 

TSN will produce a live 30-minute pre-race show on race day (Sunday at 12:30 p.m. ET) with host Todd Lewis from the TSN studio and analyst Gerald Donaldson who will be trackside  in Montreal.  SportsCentre's John Lu will file reports leading up to and following Sunday's race.

 

Coming off of his victory at last month's Monaco Grand Prix, Lewis Hamilton looks to continue his winning ways in his McLaren-Mercedes as he returns to defend his title at the   Canadian Grand Prix.  Hamilton enters this weekend's race atop the standings with 38 points, followed closely by Ferrari drivers Kimi Räikkönen (35) and Felipe Massa (34).  BMW   Sauber's Robert Kubica, who survived a horrifying crash at last year's Canadian Grand Prix, will be back looking to join Hamilton, Räikkönen and Massa as the only drivers to register a  win so far this season.

 

TSN's Canadian Grand Prix broadcast schedule is as follows:

Saturday, June 7

Qualifying – live at 1 p.m. ET on TSN alternate feed (encore June 8 at 1 a.m. ET on TSN)

Sunday, June 8

Canadian Grand Prix Race – live at 1 p.m. ET on TSN (pre-race at 12:30 p.m. ET)

 

TSN, a division of CTVglobemedia, is Canada's Sports Leader.  Setting the Canadian sports broadcasting standard, TSN was voted the No. 1 source for sports coverage and news by sports fans across the country.*  TSN's comprehensive broadcast schedule features SportsCentre, the NHL and first three rounds of the Stanley Cup Playoffs; International Hockey including the IIHF World Junior Championship; the Olympic Games through 2012; CFL including Friday Night Football; NFL including Sunday and Monday Night Football; PGA TOUR and all four golf Majors; Blue Jays baseball; Raptors basketball and the NBA Finals; Season of Champions Curling; Auto Racing including NASCAR, Formula One and IRL; Tennis and all four Grand Slam events; EURO 2008 and UEFA Champions League Soccer; and HBO World Championship boxing.  TSN HD offers more sports coverage, more hours and more events in High Definition than any other network in Canada.  TSN is available in 9 million households. TSN's programming and news content is also available online at TSN.ca.

*2007/2008 Roper Reports Canada 

 

From TSN

FDA's Next Steps on Epilepsy Drugs and Suicide

Man, we hate to say we told you so.

Today, the Wall Street Journal reported that several manufacturers of anti-epileptic medications met with FDA officials in New York to try and convince the agency not to add warnings to product labeling on an increased risk if suicidality.

During the closed-door meeting, three drug manufacturers—GlaxoSmithKline (which markets the epilepsy drug Lamictal), Pfizer (Neurontin and Lyrica) and UCB (Keppra)—made presentations to FDA, according to the Journal. Despite best efforts, the companies left the meeting “convinced” that the agency would revise labeling.

That was probably a foregone conclusion. Given that FDA believes that a two-fold increased risk of suicidality is a problem with all 11 anti-epilepsy medications, the agency is quite likely to ask for class labeling as a result. Indeed, FDA already issued a MedWatch alert on the risk in January; class labeling was just a matter of time.

But that won’t be all that FDA will be asking of drug sponsors. The agency is also interested in asking sponsors of new anti-epileptic medications to use the prospective Columbia Suicide Severity Rating Scale (C-SSRS) to predict whether the investigational drug might carry a higher risk of suicidality.

As Office of New Drugs director John Jenkins said in an interview in the April issue of The RPM Report, “it wouldn’t be illogical for us, now that we have observed this finding, to ask future anti-epileptic trials to include a C-SSRS-type of rating scale.” FDA already routinely asks antidepressant manufacturers to use a prospective scale like C-SSRS, and has started asking manufacturers of certain centrally-acting weight loss products (read: Merck’s taranabant) to use it as well.

Finding a link to psychiatric adverse events isn’t usually good for product sales—look no further than Pfizer’s smoking cessation drug Chantix (and our earlier blog post). But over the long term, manufacturers would be wise to take a cautious approach to psychiatric drug safety. FDA certainly is.

ARCA Returns to Canada; Cayuga Motor Speedway to Host June 28, 29

ARCA RE/MAX Series Returns to Canada; Cayuga Motor Speedway to Host ARCA Double-Header June 28 & 29

 

NELLES CORNERS, ON (6-4-08) – For the first time since 1992, the ARCA RE/MAX Series is headed north of the border.

Cayuga Motor Speedway, a .625-mile paved short-track in Nelles Corners, Ontario, will host the 56-year-old tour with the Cayuga ARCA RE/MAX 250 Sunday afternoon, June 29^th.  In addition, the ARCA Lincoln Welders Truck Series will join the ARCA RE/MAX Series for an ARCA double-header weekend kicking off with the ARCA Lincoln Welders 50 Saturday afternoon, June 28^th.

Expected entries for the Cayuga ARCA RE/MAX 250 include Roush Fenway Racing development driver Ricky Stenhouse, Jr., Formula 1 veteran Scott Speed in the Red Bull Toyota, three-time series winner Justin Allgaier, Denver, North Carolina’s Matt Carter and Cherry Hill, New Jersey’s Tom Hessert III.

After seven events so far in 2008, there have been no repeat winners. Series victors include Michael Annett at Daytona Int’l Speedway, Justin Allgaier at Salem Speedway, Matt Hawkins at Iowa Speedway, Scott Speed at Kansas Speedway, Joey Logano at Rockingham Speedway, Ricky Stenhouse, Jr. at Kentucky Speedway and Matt Carter at Toledo Speedway.

The ARCA RE/MAX Series has been long regarded as one of the most versatile touring series in the world regularly competing on superspeedways, short-tracks, on both dirt and pavement, and road courses.

The race will mark the eighth appearance of the ARCA RE/MAX Series in Canada since 1967. The ARCA RE/MAX Series first traveled into Canada in July of 1967 to Capital City Speedway in Ottawa, Ontario where Bill Clemens earned the victory in the 100-lap main event.

After a 20-year hiatus, the series return to Canada on May 22, 1987 at Delaware Speedway in Delaware, Ontario where Bill Venturini won the 125-lap race. The next five ARCA RE/MAX Series appearances in Canada were all at Delaware where winners included Tracy Leslie (August 12, 1988), Bob Keselowski (August 11, 1989, July 7, 1991 & July 11, 1992) and Bob Strait (September 29, 1990).

 The ARCA Lincoln Welders Truck Series is building its own presence in Canada having already competed at Delaware on three occasions and at Sauble Speedway twice. ALWTS winners in Canada include Brett Rowe (Delaware 2005), Paul Hahn (Delaware 2006 and Sauble 2006 & 2007) and Nick Gullatta (Delaware 2007).

Cayuga Motor Speedway, just over a half-mile in length, is wide with relatively flat and sweeping corners, ideal for close, competitive short-track racing – the kind that puts much of the outcome back into the driver’s hands.

Set on nearly 300 acres, Cayuga offers fans a full range of amenities including 1,500 campsites, refreshment and souvenir booths and free supervised parking. There is also a covered pavilion, which often serves as a gathering spot to enjoy all the festivities. 

Practice for the ARCA RE/MAX Series is scheduled for Saturday, June 28^th from 12:30-2:00 PM followed by SIM Factory Pole Qualifying at 3:30. The ARCA Lincoln Welders Truck Series race follows ARCA RE/MAX Series qualifying Saturday afternoon. The Cayuga ARCA RE/MAX 250 is set for 1:30 PM Sunday afternoon, June 29^th.

For ticket and general information, visit http://www.cayugamotorspeedway.com.

 From ARCA

Cyber School Reform Bill Would Benefit Allegheny Co.

State Representative Karen Beyer wants to lower the rate at which public schools would reimburse cyber schools in their geographic area. The Republican Lehigh County lawmaker says her bill would save school districts statewide roughly $20 million dollars with Allegheny County districts benefiting from the biggest savings at $5 million. The bill was approved by the House Education Committee and has been "held up" in the Appropriations Committee. Beyer says she hopes the measure will reach a floor vote by the end of the month.

Three Rivers Regatta Returns

The Three Rivers Regatta will be held this year from July 3rd to the 4th. The festivities will be on the north shore this year with the Pittsburgh pirates having their kid zone set up at the entrance to the Clemente bridge. There will be a concert on a barge in front of Heinz field, and for the first time in a couple years the F-1 Champboat series will return to Pittsburgh. There will also be fireworks and a laser show to end the two day festival. This will be the 31st year for the Regatta. Heinz field and PNC Park are partners with the Regatta this year.

PA Has Green Job Future

Pennsylvania's job market future looks...green. A Natural Resources Defense Council (NRDC) report outlined the future of green jobs within the state. The report took into account the current level of green job opportunities and the potential for future green jobs. It determined that the creation of green jobs in Pennsylvania would not necessarily mean a shift from its staple industries--steel and manufacturing--but would change what these industries produce. Clean Air Council Executive Director Joseph Minott says that these industries will be producing the materials for wind power, solar power, energy efficient cars, building retrofitting, and a variety of other environmentally-friendly products. Wind power giant Gamesa has already yielded over 1,000 green jobs.

NCATS: Cayuga Motor Speedway 'Crown Jewel 200' TSN TV Times

Due to the fact that the Basketball game on Friday May 30th went late on TSN the NASCAR Canadian Tire Series race - The Crown Jewel 200 from Cayuga Motor Speedway - will be replayed on : SUNDAY JUNE 15th @12:00PM EST

Replays: Monday June 16th @1:00PM and Sunday June 22nd @12:30AM

Rendell says Clinton will concede soon

Pennsylvania Governor Ed Rendell says he thinks Senator Hillary Clinton will concede later this week. He says he does not think she will heed the call of some supporters that she suspend her campaign and then mount a fight on the floor of the convention in August. Rendell thinks Clinton is still the best nominee and he points to her victories in the last few months of the campaign including her ability to capture about 55-percent of the vote in the later primaries. However, he says she will now put her support behind Sen. Barack Obama and he thinks the same will be true of 90-95 percent of the democratic primary voters. To the Clinton supporters who say they will not vote for Obama, Rendell reminds them that the next president may name as many as three supreme court justices and that should not be left to Sen. John Mc Cain.

CDER Hiring Frenzy: More Reviewers Means Faster Reviews

Anyone concerned about today’s troubled economy and their own future employment prospects should submit a job application to FDA’s Office of New Drugs. They’re hiring.

Indeed, OND is on a virtual hiring frenzy to bulk up long-understaffed review divisions. As we reported in an earlier blog post, the Center for Drugs Evaluation & Research will hire 663 employees—helped in large part by new money into FDA, as well as CDER director Janet Woodcock’s successful efforts to gain direct-hiring procedures from HHS.

Now, according to new information released by FDA to The RPM Report, CDER is nearly halfway through that hiring goal, having brought on 309 new employees so far this fiscal year (ending September 30). That's not an insignificant number for CDER to swallow: the center for drugs employed 2,252 individuals as of May 13.

But there’s good news for drug sponsors: at 108 employees, new hires into the Office of New Drugs have far outstripped any other CDER office. (That's to be expected, given that OND is the largest office in CDER, but it is still worth mentioning.) Plus, most of the hiring is within the divisions themselves, with few, if any, additions at the immediate office level. That means more division-level medical reviewers, and more time spent on new drug applications.

Some review divisions are benefiting from the hiring frenzy more than others, depending on the previous level of understaffing. Divisions with the most new hires are Gastroenterology Products, which has hired 16 employees so far this fiscal year, followed by Cardiovascular & Renal Products (9) and Neurology Products (8). All divisions, with the exception of Anti-Infective and Ophthalmology Products, has hired at least one new employee.

(For a handy chart with a division-by-division breakdown, click here. You can also access a summary breakdown of new hires across CDER by clicking here.)

While the hiring process itself is going quite well, CDER is also fighting attrition, as long-time FDA employees leave the agency, either for retirement or for more lucrative jobs in industry and academia. "We’re making progress, and we’re getting our head count up, but a miracle hasn’t occurred," Woodcock said in a recent interview with The RPM Report.

Indeed, several top-level FDA scientists have left for industry, including Robert Meyer, the former head of the Office of Drug Evaluation II, for Merck, and Mark Goldberger, the former director of the Office of Antimicrobial Products, for Abbott. Both departures came just weeks after the announcement that CDER director Steve Galson would be leaving to become surgeon general.

As USA Today reports in an article today, when companies siphon off FDA's most experienced scientists, they leave a leaner, less confident staff that is hesitant to approve new drugs. "What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely," Steve Brozak, an analyst with WBB Securities, told USA Today. "This cannot have any positive effect whatsoever."

We have a slightly more optimistic outlook: In addition to the new hires, two other recent developments will help improve the regulatory environment for drug sponsors: 1) Woodcock's return to CDER; and 2) FDA's new REMS authorities. It won't happen overnight, but like Woodcock says, it's slow and steady progress.

F1200 report from the Shannonville Shootout

From Gerry Merz / TLM Racing

CRDA - Shannonville Shootout

2008 F1200 SEASON OPENS IN HARD CHARGING STYLE!

Judging by the results of the recent Shannonville Shootout event, the driver who will be crowned the 2008 F1200 Champion will be anyone's guess. The season opener saw 3 different race winners, 2 fast paced rookies, and a batch of veterans all looking like they have an equal shot at this year's title.

2007 Champion Randy Smith, 2007 Rookie of the Year Andrew McMurray, and 2006 Champion Guy Bellingham, along with the hard charging 2007 rookie Michael Iamundi were likely very surprised to be amidst, if not behind, two unknown rookies as the weekend progressed; team mates Alex Ellis and Dylan Gibson.

Stormy skies and lightning caused a 30-minute rain delay for race one. The race was finally underway in very wet and miserable conditions when the green flag finally dropped but this didn't hinder the drivers from putting on a show for the fans the usual F1200 hard charging and exciting style!

Pole sitter Mike Iamundi managed to hold his lead for the first lap, only to slip back to 5th by mid race. The surprise of the day was rookie Alex Ellis. Ellis, after qualifying 4th, completely dominated the race after gaining the lead by lap 2 and driving away with a win by a margin of 18 seconds. Rookie Dylan Gibson, Andrew McMurray, Michael Iamundi, and Randy Smith, all of who traded positions on numerous occasions, pursued Ellis to the finish line but were never close enough to challenge.

The mid pack battles were very close and comprised of Bellingham, Rob Tronchi, and Phil Wang, with Greg Brenzil and Mike Rogers, a minute behind, and the balance of the field up to 2 minutes behind the hard charging Ellis who took the checkered on his inaugural F1200 race.

All bets were off for race two on Saturday morning as the tire killing track was dry and everyone knew that the series veterans were going to put pressure to rookies Ellis and Gibson on the front row. Veterans Smith and McMurray very quickly pulled out front but were unable to shake Ellis and Gibson. On lap 3 McMurray took the lead as Smith and Gibson swapped positions and Ellis began to drop back slightly while battling with Bellingham, who worked his way all through the field after going off track early in the race to create a two car mid pack battle that had the fans attention.

As the race progressed McMurray held ground and fended off attacks by not only the reigning 2007 Champ, but also the young Gibson. It looked as if McMurray was going to post his first win when coming into the last lap the very seasoned and crafty Smith pulled out in front, followed
closely by Gibson. At the flag it was Smith taking the win followed right behind by Gibson and McMurray, and Ellis overtaking Bellingham in a breathtaking move just two corners from the checkered flag. Rounding out the top 8 were Rogers, Eric Barrett, and Greg Brenzil.

The trophy race started at a frantic pace with Smith, McMurray, and the rookies Gibson and Ellis edging away from the mid pack on the back straight on lap 1. Ellis made a driving error into turn 15 on the first lap, spinning out after braking too deep into the corner. Ellis's spin allowed McMurray, Smith and Gibson to break away to put some distance between them and the rest of the field.

By mid race, McMurray's car had hooked up and in lap 7, challenged for the lead going into turn two, successfully overtaking both Smith and Gibson. Gibson would fight back and retake the lead into turn 7, only to lose his lead again to McMurray on corner 12. McMurray would drive a tidy race to the end, retaining the lead for the last laps of the race for his first ever F1200 win.

The hard charger award would go to Mike Iamundi who, after starting from the back of the grid would race his way to challenge for 4th place, setting the fastest lap of the weekend in the process.

Andrew McMurray - Winner Trophy Race
"I'm so happy to get my first ever win in the trophy race following up on our 2007 Rookie of the Year performance", said McMurray. "As a team we've improved in all areas and this win would not be possible without my father Tom McMurray and brother Jason McMurray making sure the car was in top condition. It's a great way to introduce our new sponsors for the 2008 season Hiker Enterprises and Warbo Thermal Products. Their equipment and support are already paying off."

Randy Smith - Winner Race 2
"For our first weekend out of the 2008 Season, the Head To Hoof Equine Supplement, Chemsynergy RTJ exceeded our expectations. We were running with a brand new aerodynamic body this year so we had been planning to work out some bugs. First event in the rain proved very exciting and conditions changed drastically throughout the race. The rookies, Alex Ellis and Dylan Gibson of TLM put on a driving clinic regarding car control in the wet. Race two proved to be a far more successful for the more patient amongst us. Andrew McMurray drove superb but seemed to loose grip in the later stages of the race which afforded me to take advantage and pull off my first win of 2008"

"Rookie" Alex Ellis - Winner Race 1
"It was a great weekend, I got my first win in my first open wheel race and that's more than I could ever have hoped for. The wet conditions in which I took the win were terrible, but I felt I stayed calm and composed in bringing the car around for the win. I know there were some unfortunate problems and mistakes in races 2 and 3, but I was still able to manage a 4th and that's more than enough for my rookie race. A big thanks to TLM Racing, my driving coach Randy Smith, and my tech Devan Matkovich for helping put a great car under me and to understand what I needed to do for my first F1200 race, as well as Ellis Engineering, Art Craft Kitchens, and Grote in guiding me into my maiden win."

"Rookie" Dylan Gibson - (3)- 2nd place finishes
"I would like to thank TLM Racing and my driving coach Randy Smith for a fast car, and clear strategy that produced consistent results all weekend. A special thanks to my tech Aaron Lang who helped me all the way through to the end and set up a podium car. A big thanks to Fasada Home Renovations, The Door Dude, and Grote for their contributions towards my 2008 season.

The F1200 series appears next at Mosport International Raceway on June 28 - 29.

PHOTOS COURTESY: Photo Arts International - Teresa Matkovich

Empringham joins Zogaib and Dalziel at SAMAX Motorsport

Empringham joins Zogaib and Dalziel at SAMAX Motorsport

Daytona Prototype’s first-ever winner joins the newest names on DP win list

(Pompano Beach, FL) 4 June 2008--Already packing the hottest 1-2 punch in Rolex Sports Car Series competition with the series’ newest race winners Henri Zogaib and Ryan Dalziel, SAMAX Motorsport announced on Wednesday another powerful addition to the combination as David Empringham has been signed to join the squad for this weekend’s Sahlen’s Six Hours at the Glen.

The Indy Lights and two-time Atlantics Champion is no stranger to Daytona Prototype competition, having inscribed his name in the history books as the first-ever winner in the category.  This weekend will see him join up with the two newest additions to that list with Zogaib and Dalziel in the No. 2 SAMAX Motorsports Dinan-BMW Riley combination as the duo look to take their Laguna Seca-winning momentum to Upstate New York this weekend.

“This is a great opportunity for me and I’m really excited to get back into Daytona Prototype competition with SAMAX,” said Empringham, who scored fifth in the 2007 Rolex 24 at Daytona in his last DP start. “Obviously this team is really clicking with Henri and Ryan taking the win at Laguna, and I’m happy to be a part of such a competitive situation. I’ve been working with the team the last few races and I’m just looking forward to getting going this weekend at the Glen.”

Based in Toronto, Empringham brings a lot to the team from both inside and out of the cockpit.

“I couldn’t be more pleased to have David on board as one of my co-drivers,” said Zogaib, who will look to put his previous racing experience to good use on the 3.4-mile  Watkins Glen circuit this weekend. “He has been a fantastic coach and I know that he will do an excellent job in the car this weekend as well.  The team has been doing an amazing job and we have a lot of momentum from the last two races, so we just want to keep that level of performance up again this weekend at the Glen.”

The addition marks another step forward for the Pompano Beach, Florida-based team, which has rapidly grown strength during the 2008 season. After a challenging start to the year in the Rolex 24, SAMAX team owner Peter Baron made the move to Dinan-BMW power as he teamed Ryan Dalziel with Henri Zogaib, and the combination has proven effective, taking three top tens in four races including second place at VIR and then a thrilling race victory at Mazda Raceway Laguna Seca.

“We are excited to have David (Empringham) get in the car for us this weekend at the Glen,” said Baron. “I raced against him in Atlantics and have followed him ever since.  David  worked with Phil (LePan) when he won the Lights Championship and he was key as our spotter at Laguna.  He already knows most of the guys on the team so it’s a great fit.  He also brings a lot to the team as a coach, so we are happy to be able to bring him on board and are looking forward to getting off to a good start here at the Glen.”

The Sahlen’s Six Hour event weekend is a Friday-Saturday schedule, with practice and qualifying slated for Friday as Saturday will open with an 11:15 AM race start.

David Empringham Fast Facts:

Atlantic Champion (1993+1994, Runner-up 1995)
Firestone Indy Lights Champion+Rookie of the Year (1996)
KONI Challenge Champion (2005, 2002)

For additional information: www.samaxmotorsport.com

 From Sunday Group Management.com/HZ

More on Barr's supporters

Digging deeper into our poll from Monday:

-Supporters of Bob Barr go for Elizabeth Dole 51-34 in the Senate race, and for Pat McCrory 45-22 in the Gubernatorial race, with Michael Munger right behind Bev Perdue at 21%. That's just more confirmation that even if the poll made it look like Barr was pulling equally from self identified Democrats and Republicans, the voters he's earning support from are Republican leaning voters even if that's not what they call themselves.

-The Libertarians may be the male party. 63% of respondents who support Munger are men, compared with 53% for McCrory and 38% for Perdue. 58% of Barr's supporters are men, compared with 52% for John McCain and 39% for Barack Obama.

-Quite a sign of how Hillary Clinton has antagonized African Americans- 29% of Barr's supporters are black and just 19% of hers are.

Venture Round: The BEAT Goes On

When we wrote about CardioNet's IPO back in March, we had no idea it would hold such historical importance.

CardioNet, trading under the symbol BEAT, remains the last venture capital-backed company to go public this year, including both life sciences and technology plays. And we have to admit its doing the VC-crowd proud.

But the company is doing so well one could argue it may have sold more shares than it had to.

You may recall the cardiac monitoring company entered into a unique structure with investors back in spring 2007 when it raised $110 million in a Series E. Investors were given stock that converted into common shares during the IPO. The company's management took a bit of a gamble as there were repercussions if the company didn't get out in a timely manner.

Well, it did go out at the lowest price allowed by the deal--$18 per share. As we noted back in March, the conversion of those shares depended upon the IPO price. Had CardioNet gone out at $23 per share, which it initially had hoped to do, those Series E investors would have held 5.9 million shares.

But if CardioNet went out anywhere between $18-$20, the Series E shares converted to 7.2 million shares.

Today, CardioNet shares are trading at $27.50, making it a darling among IPO stock pickers, with a nearly 53% gain in three months.

It's interesting that if CardioNet priced its IPO at $23, more than four dollars below where it's trading today, the company would have had to hand over one million fewer shares to its Series E investors.

We're being a bit facetious, of course. CardioNet's stock didn't really take off until the company posted better than expected numbers in mid-April. So this is the case of a company doing what it needed to do to go public, and then going out and proving its value to shareholders.

At the time, the company clearly wasn't getting traction at $23 per share. In fact, $18 per share seemed rather generous. It apparently wasn't.

While we're engaging in some 20-20 hindsight, Boston Scientific--which acquired a sizable stake in CardioNet through its purchase of Guidant--sold off 1.5 million shares at the time of the IPO, recouping $27 million.

Had it held on, its stake would be worth more than $41 million today.

***

Edmund de Rothschild Investment Partners more than doubled its assets under management for life sciences by closing on €150 million last week for its third life sciences fund. The Paris-based firm previously raised €80 million and €26 million for its second and first funds, respectively, according to VentureWire Lifescience.

The firm expects to invest the new fund in 15 to 20 life science companies across all stages of development, including biopharmaceutical, medical device and diagnostic companies, mostly in Europe.

According to the firm, its investors include most of Edmond de Rothschild Investment Partners' life science existing investor base, including La Compagnie Financière Edmond de Rothschild, La Caisse des Dépôts and Amgen. Other investors include health insurance companies, public pension funds, social institutions and institutional investors.

***

Attention any other venture firms in the market with new funds, save the postage. Washington State Investment Board isn't interested, according to a recent post on Private Equity Hub.

***

Three Arch Partners, still investing its 2004 vintage fund, probably won't be in the market for a new one until next year.

***

Fresh from the "I made a seven minute presentation to a bunch of lawyers and investors, and all I got was a lousy...." file.

As always, if you have any private suggestions, tips, or if you really, really, really hate the idea that we'll be running this column on Wednesdays instead of Fridays email me here.

(Image courtesy of Flickr user RWK through a Creative Commons license.)

Mosley wins vote to stay on

From TSN

The FIA has voted to keep Max Mosley, but some of the major federations are threatening to "freeze all world federation activities in protest" of the result, which reportedly came about thanks to the support (for Mosley) of several "smaller clubs."

More at the link above.

Shaw Motorsports: Weekend Update

From Ken Spira for Shaw Motorsports

Dark clouds and rain gave way to sunshine and warm temperatures as the Shaw crew made their way south to Flamboro Speedway. Only 13 late models made the trip as some teams headed north to Sauble Speedway for the Margarita Ice Strawberry 150 or were still repairing their cars from damage inflicted the previous weekend.
The first practice produced a good handling car, thanks to the work the crew put into testing during the week, and after the crew put on two new tires to scuff during the second practice, the lap times picked up even more as a result. The only adjustment made by chassis expert, Dave Meades was a small adjustment to the anti-roll bar for a small push that was felt by the driver.
Jason lined up the #82 Georgetown Printing Ford on the outside pole for the heat race beside the #52 who had the pole position. On the first lap, the #52 got sideways in turn 2 bringing out the caution, allowing Jason to try maintaining the lead for the shortened 8 lap heat race. Jason restarted beside the #3 and after running side by side for two laps, the #82 pulled into the lead where Jason was able to take the win by a commanding 4 car length lead.
The smaller than normal field lined up in front of the somewhat sparse crowd as they readied for the feature. The #82 Del Metals Ford was lined up 8th for the 20 lap feature beside the #42 and on the first lap, the #3 would exit turn two and hit the backstretch wall, breaking the rear end housing in the process. Shortly after the #3 made contact, the field checked up after registering the first lap, sending Jason back two positions before the caution came out when the #3 came to a stop in turn one. Jason was now at the back of the pack in 10th were he would restart beside the #42. On lap 6, Jason made the move forward by getting past the #42 into 9th and then past the #99 into 8th, two laps later. At the half way mark, the leaders pulled away as the rest of the pack remained in a tight group where they slugged it out for position. Despite the large amount of stay-dry on the high side of the track from the thunder car feature, Jason ventured up and passed the #52 and #3x just prior to the caution that came out for the #8 who lost a wheel on the backstretch. Thankfully the wheel got caught up in the safety fence in turn 3/4 as it cleared the wall threatening the safety of the fans including most of the Shaw crew who were standing in the area. Under the following caution, Jason found himself now in the 5th position behind the #37, #34, #86 and #27. Two laps later it was the #27 that would bring out the caution by spinning into the infield with a little help by the 3x. Jason picked up a spot as a result and was running in 4th when the caution came out again with just two laps to go for the #42 who spun out in turn 2. The #37 lead the field to the green for the final restart and despite Jason getting a good run on the outside of the #86 to challenge for the third position, the #37 of David Elliot would hang on for the win and Jason would not be able to get past the #86 to take the checkered flag in 4th.
In other racing news, the #88 Spira Racing mini-stock continued their struggle to get back into the top 10 as driver, Dave Hagedorn after an eventful night of contact throughout the qualifying and main event, would finish 11th after a 12th place start in the 25 lap feature.
Next up for the Shaw team is a return trip to Flamboro Speedway for the first of three Grisdale Triple Crown events. The 50 lap special is to run on Saturday June 7th were the pit gates are to open at 3:00pm, the main gates at 5:00 and racing is scheduled to begin at 6:00.

CCAC Nursing Program Receives $984,275 Grant

Community College of Allegheny County received over $980,000 in federal grant money from the Health Resources and Services Administration to go toward its RN Achievement nursing program. RN Achievement encourages and recruits high school students to enter the CCAC nursing school. The grant will promote recruitment efforts, help disadvantaged students enter and complete the program through academic and financial aid, increase nursing program retention, and provide cultural diversity training to faculty and students. CCAC Vice President for Institutional Advancement and External Relations Nanci Lee Burzachechi says there was strong competition for the funds and that CCAC received the grant from within a pool of 90 applicants. CCAC has $225,000 of the money slated for financial aid alone.

Domestic Partner Registry legislation introduced

City Councilman Bruce Kraus introduced legislation today that would create a domestic partner registry to assist domestic partners is obtaining benefits available to them by their employers. The city already offers benefits to domestic partners but does not have anyway of verifying and maintaining records of those couples. The registry would be mutually exclusive to the city but would allow domestic partners who register to obtain the proper paperwork to take to their employer that would verify their relationship status. The legislation was modeled after that of Urbana, ILL. The idea for this registry came after council president Doug Shields was auctioned off for charity. The winning couple won dinner at the Council Presidents house where the idea was introduced.

Councilman Disapproves of Committee-Passed Smoking Ban

Allegheny County Councilman Rich Fitzgerald agrees with State Senator Robert Mellow of Lackawanna County--that a smoking ban bill, passed by a House-Senate Conference Committee, is unfair to Allegheny County. The bill which was approved by 5-1 vote (Mellow being the only dissenting vote) banned smoking in most workplaces and public places, including restaurants and office buildings. The measure also grandfathered in the Philadelphia smoking ban which took effect in September 2006 on top of the state ban. Fitzgerald feels that it is unfair that Philadelphia can enact its own smoking ban, but Allegheny County cannot. Allegheny County's smoking ban was overturned in court last year.

Working America hits Altmire's district

A grassroots organization affiliated with the AFL-CIO is upping its membership drive efforts in key congressional districts across the country including Pennsylvania’s 4th. The group “Working America” focuses on issues it feels are important to working families including minimum wage, better access to health care and the right to organize. The group says it fights for “workers who do not have a union on the job.” Members will be canvassing in Congressman Altmire’s district and other neighborhoods in southwestern Pennsylvania. Jen Jannon is the state director of working America. She says they often get people to sign up on the spot and write letters or make a call before they leave the porch. Jannon says nation wide the organization has 2 million members and 400-thousand of them are in Pennsylvania. She says people are yearning to have their voices heard in Washington and by gathering under one organization they feel they have that power.

City Council adopts Campaign Finance Reforms

Pittsburgh City Council today approved new campaign finance rules. With a 5-4 vote the bill has been sent to Mayor Luke Ravenstahl. The bill bars candidates for city office from taking more than $2,000 per election from any individual or partnership and no more than $5,000 from any political action campaign.

Voting yes on the bill were, Bill Peduto, Doug Shields, Bruce Kraus, Patrick Dowd, and Ricky Burgess.

Voting no were Tonya Payne, Jim Motznik, Darlene Harris, and Dan Deasy.

All members of council voiced support for the reform bill but also made sure to express their own feelings regarding the fact that Pennsylvania does not have any statewide limitations or reforms coming. Members who voted in the negative said they would support a statewide reform bill that places everyone on an even playing field.