Friday, July 18, 2008
Congressman Altmire Visits Houston Refinery
United States Congressman Jason Altmire visited an oil refinery in Houston, Texas today. He says he wanted to learn more about the challenges they face. He says he learned that because of the increasing price of gas, demand has slowed down and has forced the refinery to work at less than capacity. Altmire says he would like to see more oil being produced from the United States and says Alaska's National Petroleum Reserve is a good option. The DRILL Act, which would have accelerated development there, was voted down yesterday. House Republicans favor a proposal to drill off the Atlantic and Pacific coasts.
Deals of the Week: All Star Break
In a week when the AL (again) defeated the NL 4-3 in a marathon 15-inning All-Star game at Yankee Stadium (thanks, Billy Wagner, for blowing the save and losing home field advantage for the World Series-bound Phightin' Phils), there were a few all-stars in the pharmaceutical world as well.The buzz word this week was diversification, with health-care behemoths Johnson & Johnson and Abbott Labs posting better-than-expected quarterly results. J&J was buoyed by its consumer products business and Abbott had both stents and Humira to thank for its performance. On the other hand Novartis--an increasingly diversified company--grew in spite of its non-branded Rx divisions: its consumer medicines and Sandoz generics business enjoyed only moderate success thanks to tough times in the key US market, but that didn't stop the Swiss company from posting solid second quarter numbers. (We'll have more to say on Big Pharma business models and the yin and yang of focus and diversification in an upcoming IN VIVO piece.)
Keeping with the baseball theme: we're not a blog to steal signs but we couldn't help but pick up on something earlier this week. On Tuesday we gave you all free access to the denosumab record from Elsevier's Inteleos database and noted that Amgen has suggested it would be open to licensing the project, at least for the primary care indication of post-menopausal osteoporosis (PMO).
The challenge? For all of you expert dealmakers out there to add your two cents regarding the value of the project and potential deal strategies for Amgen. We can only assume that the dearth of comments suggests that all of you are in preliminary or even final-stage negotiations with Amgen and therefore recuse yourselves from the prize-less competition. Wink wink, we get it. Slackers.
You know who hasn't been slacking off? Those intrepid dealmakers responsible for ...
GSK/Actelion: The week started off with a bang when on Monday Glaxo fronted CHF 150 million ($148 million) in a worldwide (ex-Japan) co-development and co-promotion pact with Actelion for the Phase III orexin receptor antagonist almorexant. The Big Pharma pledged an additional CHF 415 million in pre-commercial milestones for the drug’s first indication of primary insomnia and an absolutely filthy figure for total milestones in two additional indications. Reactions to this deal were varied, to say the least. One analyst called it "the largest-ever partnering deal in the history of the industry," while others pronounced themselves decidedly "underwhelmed." Certainly you can't please everyone. But allow us to be the voice of reason, the voice of moderation, the voice of baby bear, when we say that GSK's figure was probably "just right." Why's that? Well forgetting the non-insomnia terms and taking into consideration the fact that GSK will help Actelion get its primary care field force off the ground by paying it to promote an undisclosed GSK drug prior to almorexant, the upfront payment may have been low for a Phase III primary care drug circa 2000-2003, but not anymore. The few primary care drugs available for licensing in Phase III, with novel mechanisms of action designed to treat non-life-threatening diseases, come saddled with higher than ever clinical development hurdles and increased regulatory scrutiny. GSK’s ante for almorexant—though large enough to put the deal in the upper echelon when it comes to guaranteed money—might seem small were it not for those circumstances. The fact that the Big Pharma is only chipping in for a minority of almorexant’s pivotal development program (which aside from the ongoing RESTORA 1 study will include at least two more Phase III trials) is further evidence that GSK is hedging its bets here.
Genzyme/PTC: We'll spare you the "London buses" reference but suffice to say it's unusual to see one $100 million+ upfront licensing deal and to see two in a week--well, that's plain crazy. But score another one for the orphan drug seekers. On Thursday, Genzyme paid $100 million to PTC Therapeutics to enter into a global collaboration to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations. The drug is in Phase IIb trials for Duchenne muscular dystrophy and is scheduled to enter a Phase IIb in cystic fibrosis later this year. PTC will cover the cost of 124's remaining Phase II program--which is slated to include four trials--and from there the parties will split development costs 50/50. PTC is eligible for $165 million in development and approval milestones and $172 in sales milestones. PTC will commercialize in the US and Canada (where it is responsible for all commercialization costs) and Genzyme takes responsibility for marketing and associated costs for the RoW. In addition to Genzyme's up-front contribution PTC pulled in up to $25 million from the non-profit Cystic Fibrosis Foundation the day before the deal was announced to support development of '124 in CF.
ViroPharma/Lev: Specialty pharma outfit ViroPharma announced it was entering the hereditary angioedema (HAE) space with its $443 million acquisition of Lev Pharmaceuticals. The linchpin of the deal is Lev's C-1 esterase inhibitor Cinryze, a biologic that has been available in Europe for 35 years to treat this rare and life-threatening condition, which causes inflammation of the larynx, abdomen, face, and extremities. Lev filed a BLA for Cinryze in July 2007, seeking approval for both prophylaxis and acute treatment of HAE. The product faces competition from CSL Behring's C1 inhibitor Berinert and Jerini's Firazyr. Our sister publication Pink Sheet Daily has more on the HAE market and Cinryze's chances of success. For ViroPharma, the deal marks a shift away from the antiviral space, which has long been its focus, into the hospital/ transplant arena. And with the addition of a soon-to-be marketed product, it continues the company's trend of playing to an investor base attracted to fully-baked and largely derisked assets. Recall this is the company that made a tidy profit on Vancocin, a decades old product it inlicensed from Eli Lilly, to treat Clostridium difficile outbreaks. ViroPharma's timing on Vancocin was exquisite. It brought in the product just when very nasty strains of the bacterium were causing large scale hospital outbreaks of the disease; given the market forces, ViroPharma was able to raise prices of the drug considerably. It is currently working on a follow-on to Vancocin, NTCD. Meantime, there's little information available about ViroPharma's hepatitis C program: ViroPharma discontinued its HCV-796 program, partnered with Wyeth, earlier in the year. According to ViroPharma's website, the two companies continue to exlore follow-on molecules to treat the disease.--Ellen Foster Licking
MacroGenics/Raven: Raven Biotechnologies finally found a buyer in MacroGenics. Last November, Raven announced a tie-up with VaxGen worth about $39 million. But VaxGen's shareholders revolted and scuppered the deal this past spring. MacroGenics, in turn, has been working to build a fully integrated biopharmaceutical company (how quaint) around its Fc antibody engineering and dual affinity re-targeting (DART) programs. It has a large deal with Lilly to develop and commercialize its anti-CD3 mAB for use in the treatment of autoimmune diseases, icluding recent onset-type 1 diabetes. On July 17, MacroGenics and Raven announced their tie-up. Financial terms weren't disclosed but it seems unlikely that Raven got more than what VaxGen originally offered. For MacroGenics, the acquisition provides additional preclinical assets, including more than 1300 monoclonal antibodies that Scott Koenig, CEO of MacroGenics, claims can rapidly be developed using their optimization platforms. In addition, the deal gives MacroGenics access to a portfolio of proprietary cancer stem cells from many types of primary tumors that could be an important addition to MacroGenics R&D capabilities. --EFL
Teva/Barr: What's $7.6 billion buy these days? Maybe a top-five starting pitcher, but those are hard to come by. No, this week it was Barr Laboratories. This late-breaking deal of the week is the latest chapter in the ongoing consolidation of the generics sector, but the bigger story here is the combination of Teva and Barr's biologics programs. Teva also noted Barr's legal prowess and at-risk launch capabilities. Under the terms of the deal, each share of Barr common stock will be converted into $39.90 in cash and 0.6272 Teva ADRs and Teva will assume Barr's $1.5 billion in debt, to boot. In other generics news, Czech generics play Zentiva is now telling investors to reject Sanofi-Aventis' attempt to up its stake in the company, saying the $2 billion play is a lowball offer.
photo by flickr user mori claudia used under a creative commons license.
County Council Could Have Multiple Referendums On Novembers Ballot
Allegheny County may see multiple referendum questions on this years ballot all revolving around the same issue, the port authority and the controversial drink and car rental taxes county council's committee on government reform has approved two bills that would put referendums on the November ballot. One calls for the reduction of the drink tax from 10% to .5%, and the car rental tax to be reduced from $2 dollars to 50 cents a day. The second bill sponsored by councilman Chuck McCullough calls for the elimination of the port authority, and the privatization of mass transit. McCullough says that move would bring much revenue to the county because the current land owned by the port authority is worth $1 billion and is not taxable, but would be if privatized. Council president Rich Fitzgerald is also proposing a bill that would require a raise in property taxes as a result of any reduction in the drink and car rental taxes. Council will discuss those bills during a special meeting Tuesday.
Why running against Jim Black isn't effective
In 2006 Republican legislative candidates tried to make Democratic ethical issues the focus of the election. It didn't work. Democrats made gains in both the House and the Senate.
Today's new Civitas poll may give the reason why. Only 49% of North Carolina voters know that Democrats control the House, an even smaller 40% know Democrats control the Senate, and only 61% even know that we have a Democratic Governor.
Voters are unhappy with their elected officials pretty much across the board right now. But it looks like a lot of them don't know who to blame if they're unhappy with what's going on in Raleigh. I bet upwards of 90% know what the party the President of the United States represents.
Pat McCrory and other Republican candidates can rail on corruption all they want this fall, but I think voters are much more likely to associate that term with Republicans in Washington than Democrats in Raleigh.
Today's new Civitas poll may give the reason why. Only 49% of North Carolina voters know that Democrats control the House, an even smaller 40% know Democrats control the Senate, and only 61% even know that we have a Democratic Governor.
Voters are unhappy with their elected officials pretty much across the board right now. But it looks like a lot of them don't know who to blame if they're unhappy with what's going on in Raleigh. I bet upwards of 90% know what the party the President of the United States represents.
Pat McCrory and other Republican candidates can rail on corruption all they want this fall, but I think voters are much more likely to associate that term with Republicans in Washington than Democrats in Raleigh.
David Ostella FBMW Lime Rock Report
“I think this past weekend was the best so far since I finished both races without problems,” Ostella said upon his return to Canada. “The track was a very fast one, and I figured out how to reach the ultimate pace more quickly, but I still have to get better at it going forward. I’ve just got to put it all together!”
The data once again supports his words as Ostella produced times of 59.839 seconds and 59.374 seconds in back-to-back qualifying sessions on Friday, improving by very nearly a half-second. Returning to the track early Saturday morning for race eight of the Championship, the teenager from Maple, Ontario, then had a quick time of 58.560 seconds on his way to running from eighth on the grid to sixth, eight-tenths better than his qualifying pace. “In the race I had a good start, lost one position on the second lap but then incidents happened on the track and I ended up sixth,” he said. “I was the fifth fastest car, which was encouraging.”
In the second start Saturday Ostella had truly found the zone as he turned the second quickest lap in the field and climbed all the way to fifth from tenth on the grid. “Off the start I gained one position and then we had a red flag when a driver hit the wall,” he said of race nine of the Championship. “At the same time a driver drove off and I was able to take seventh, and on the restart I stayed in my position until another driver had an off to give me sixth. I passed my teammate for fifth-place, and was still gaining time until the checker came out.”
Gaining time indeed. Racing in a three-pack for positions second through fourth, Ricardo Favoretto and Mikael Grenier were the quickest pair and set personal best laps on lap 21 at 58.70 seconds. Ostella set his best time on the same tour, a 58.38 second lap! It was a consistent pattern, with the young racer nearly reaching Grenier’s rear wing when the checkered flag waved. The checker also brought to a close the first half of the season, and overall Ostella says he is having the time of his life.
“I am having the greatest time in the world racing cars, Montreal was just incredible,” he said in summing up the first half events. “Overall though, the first half wasn’t as good as I would have liked, but I’m taking it all as a learning experience and staying positive about everything involved with the racing. I’ve got a great support team, a great race team, and just can’t wait to get back at it in the second half of the season.”
Next up for the Formula BMW Americas Championship is an official test session at Putnam Park before all head to famed Road America for three races early in August. David will once again be racing with support from Global Precast Motorsports, Alpinestars, and RAW Integrated Ltd. For more information visit www.davidostella.com
From Jason Holland
Representative Mike Turzai introduces new gaming legislation
Representative Mike Turzai (R-Allegheny) has introduced legislation to help bring integrity, honesty and accountability to the Pennsylvania Gaming Control Board's (PGCB) awarding of gaming licenses taking over licenses, if need be.
"Whats the remedy when someone you gave a license to proves to be unsuitable?" Turzai asked a former New Jersey gaming regulator. "[He] said a trusteeship was the remedy most often used in New Jersey."
Turzai added this was something that is simply putting language into law. It has been done in the state before, but it is not a regulated law.
"Whats the remedy when someone you gave a license to proves to be unsuitable?" Turzai asked a former New Jersey gaming regulator. "[He] said a trusteeship was the remedy most often used in New Jersey."
Turzai added this was something that is simply putting language into law. It has been done in the state before, but it is not a regulated law.
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