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The only reason that I would think that Mariano and A-rod wouldn't be in the report is because they haven't signed their contracts yet.
With that said, I will repeat what I have said all along. There is NO NAME that would surprise me.
http://sports.espn.go.com/mlb/news/story?id=3153171
It says finalized but I don't see signed. I agree with you though I don't think anyone would surprise me! I think some (many) may get off the hook though just because they are not on the list but that doesn't mean they didn't use steroids or more likely HGH which would be a lot harder for Mitchel to have discovered.
I guess we'll know today if they are lying.
Actually we won't know for sure (unless there was a positive test). Jason Stark pointed out that only about 1-2% of players during the period would comprise the 60-80 figure mentioned and most think it is a lot higher.
Keep in mind Mitchel had limited information. It seems to me the most likely impact would be of former Met players since that is one of the two sources mentioned.
Has anyone check out the busyany website lately? Its not the Yahoo msg board search anymore!
http://www.busyant.com/
I just did (first time in years). I just did a quick search and it may be handy for biotech investors!
I am surprised the players union hasn't sued or done something else to try to stop its public release!
Flolan and Letaris (assuming it gets EU approval) does that count? the third I don't know
WFAN saying 60-80 Current and former players on list.
Good but late.
Quizzes don't seem to last long or maybe it was too easy? Dew answered already.
Answers at #msg-25191427 if you didn't come across it already
Sorry I am not a paying member but I'll reply here hope the moderator isn't upset. I thought your screen name was Preciousone sorry I didn't realize it was Preciouslife1. It took me a while to connect the meaning of the screen name, yes I am slow sometimes :).
So as not to be completely off topic. I am curious if anyone who reads this board is interested in the early Christian Church and the writings of Origen in particular?
I'll beat Preciousone and post the link from Nature :). In the article there is a table of several other inhaled insulin products under development (to me the most interesting aspect of the article).
BTW, appreciate those who discussed CRME/arterial fibrillation. I didn't have anything substantive to add but did appreciate reading the back and forth!
Pfizer dumps Exubera
http://www.nature.com/nbt/journal/v25/n12/pdf/nbt1207-1331.pdf
or
http://www.nature.com/nbt/journal/v25/n12/full/nbt1207-1331.html
After 11 years of development and barely one full year of sales, New York–based Pfizer dumped the much-anticipated inhaled powder insulin product Exubera on 18 October. This was particularly bad news for partner and product originator Nektar Therapeutics, of San Carlos, California. But the question on many minds is: does this represent the death knell for the inhaled-insulin market?
Developing Exubera (recombinant human insulin with particle diameters between 1 and 5 mm) was a massive technical achievement, involving the stabilization of the insulin molecule to make it bioavailable in the dry powder form. It was the first insulin product that did not need to be injected, so when it was approved in January 2006, there were high expectations: analysts estimated annual sales to be from $1 billion to $4 billion, and Nektar envisioned years of royalties. But the product had sales of just $12 million for the first 9 months of 2007, and it cost Pfizer $2.8 billion in pretax charges to walk away—which is rarely done when a drug has no safety or efficacy issues.
So what happened? Some blame Pfizer. The firm is struggling to replace Lipitor (atorvastatin), which loses patent protection in 2011 and accounted for $13 billion in sales last year (27% of total revenue), and observers were shocked to learn that Pfizer did not contact Nektar before issuing the Exubera news—Nektar heard it over the wire like everyone else, and that further fueled acrimony that had already spilled out previously in quarterly earnings conference calls. Others point out that Pfizer was ill-prepared to launch the product in the first place.
"I think Pfizer felt that the drug would sell itself," says specialty pharmaceutical analyst Jami Rubin of Morgan Stanley, in New York, who follows Nektar. Not first alerting its partner "does not speak well of Pfizer's partner-of-choice reputation," she says. "I don't know what's happened. It could be that there's still a lot of dysfunction among the ranks of the senior management team at Pfizer."
The original deal between Pfizer and Nektar was signed in January 1995, three Pfizer CEOs ago. Endocrinologist Paul Norwood of the University of California at San Francisco thinks the pharma firm lost interest before Exubera was launched. "They did a poor job at marketing," he says. "Samples were sparse, the TV ads were late, and they were too benign and not exciting." Rubin also believes Pfizer did not chase the right market. "They did not court the nurses, the certified diabetic educators, who play an even bigger role than physicians in deciding to put patients on insulin," she says. "They ignored them."
"When the product was launched at the American Diabetes Association meeting in June 2006, they didn't have the packaging facility ready in Terre Haut, Indiana, and they weren't ready to ship the product," says specialty pharmaceutical analyst Andrew Foreman, of investment bank W.R. Hambrecht, in San Francisco. "For me, that's the most powerful evidence that within Pfizer, people who were responsible for launching this product dropped the ball because they didn't want anything to do with it."
It's also possible that physicians simply weren't willing to take on something new. "Most physicians are late adopters, waiting to see if someone else is using [a drug] and only then will they try it," says Norwood. He has seven years of experience with Exubera, both in clinical trials and in use as a first-line therapy for diabetics in his private practice. "It's work to understand the mechanism of the device and the way to use it, and [the physicians] just never bothered."
Which brings us to the inhaler itself: the device is rather clunky—about the size of a flashlight, made larger when expanded to the ready position (see photo). The powdered insulin comes in small blister packets and the inhaler is loaded for each dose. The patient triggers a mechanism that disperses the powder into the chamber for inhalation. Although many patients embraced the technology (Box 1), some found it embarrassing to use in public—although a smaller device was in the works, the current inhaler was often compared (humorously) to a marijuana bong. For that, Nektar shoulders the blame: it developed not only the powdered insulin formulation of Exubera but also the inhaler, which was an early design.
Does Exubera's flameout mean the end for inhaled insulin? Wall Street was pleased to see the product abandoned, as Pfizer shares rose on the day of the announcement, but Rubin believes there is a market for inhaled insulin. It's "a niche opportunity," though, and Pfizer was the wrong organization for that, she says.
Researchers and entrepreneurs in this space don't view the fiasco as a failure for all pulmonary insulin products. Richard Pops, chairman of Alkermes, in Cambridge, Massachusetts, says Alkermes is working to develop an inhaled insulin with partner Eli Lilly, in Indianapolis, that is called AIR Insulin and is currently in phase 3 trials. Of Exubera he says, "Even though it worked, it was too cumbersome and difficult for patients in the real world to integrate into their lives."
The Alkermes/Lilly inhaler is much smaller than the one accompanying Exubera. Moreover, it's disposable and patients receive a new one monthly. "We never really saw Exubera as a competing product," says Pops. Alkermes has created powdered insulin with low mass density but high geometric diameter. These particles have the aerodynamic properties of small particles but the physical properties of big particles, which "means that they just didn't aggregate as much," he says. "The particles just fly," making them dispensable from a simple inhaler without requiring a tornado inside to atomize the powder. For Pops, the key to the field is not just clinical efficacy, but also getting a user-friendly device into patients' hands. "We knew we could make a consumer product. Our major generational advantage was based on the simplicity of the device," he says.
Others are also working on the convenience aspect (Table 1). Aradigm, of Hayward, California, is partnered with Novo Nordisk, in Bagsværd, Denmark, to develop a liquid-droplet aerosol for use in a sandwich-sized inhaler that allows fine tuning of the dose, but still requires refrigeration. MannKind, of Valencia, California, has a smaller, palm-sized device to use with its powdered insulin 'Technosphere' formulation, which has been shown to deliver higher blood-insulin concentrations than any of the other powdered products.
Table 1: Selected inhaled-insulin products
Full table
As for the bad feelings between ex-Exubera partners, they were resolved November 13 with Pfizer compensating Nektar through a one-time $135 million payment. Pfizer, concerned that it had been portrayed in the press as high-handed and arrogant toward a small, struggling biotech firm, is also returning all rights to the product, so that Nektar can hunt for a new partner. Hooking up with a fresh, deep-pocketed pharma is critical for Nektar, because it has a much smaller Exubera dispensing device in phase 1 trials. Gaining FDA approval for the new dispenser is going to require the kind of funding that only a mid- to big pharma can provide. Still, there's no way the new device will be approved before 2010 or 2011 when there will be other inhaled insulin on the market.
For the companies still on the sideline, Exubera now can be seen as a sort of pilot program. "The page we took out of their [Pfizer-Exubera] playbook, the one I can literally ascribe to watching Pfizer's development program, was the need for data above and beyond [the fact] that you could reduce glycosylation levels in the blood," says Pops. "You have to provide data that shows payers, physicians and other providers why pulmonary insulin is [the right] treatment for a type 2 [diabetes] patient. Just showing that it reduces glycosylation of hemoglobin was fantastic in the 1990s, when we were proving the principle, but now it's got to fight for its place in a complex treatment environment. And I think Exubera launched without enough of that data to persuade payers, physicians, nurses—and even patients—why they needed Exubera."
Very good! I thought the graphic would make it a little harder for Biowatch to find the answer but you didn't even give her a chance :).
Data on top 15 Biotech companies compiled by Compensia, Inc. as of August 16, 2007. The source of the graphics came from United Therapeutics November CIBC presentation available at http://ir.unither.com/events.cfm [the very small hint was for those wanting to cheat if you were familiar with companies I post about you could have found it. OK I confess the hint was more to try and throw people off].
Revenue / Employee
1. Gilead
2. Genentech
3. Celgene
4. Biogen
5. Amgen
6. MGI
7. Cephalon
8. United Therapeutics
9. OSI Pharma
10. Imclone
11. Millennium
12. Abraxis
13. PDL
14. Amylin
15. Genzyme
Market Capitalization / Employee
1. Celgene
2. Gilead
3. Genentech
4. United Therapeutics
5. Biogen
6. Amylin
7. MGI
8. OSI Pharma
9. Millennium
10. Imclone
11. Amgen
12. PDL
13. Abraxis
14. Genzyme
16. Cephalon
Market Capitalization / Employee
Revenue / Employee
This may be a big hint but...
I think today your guess would be correct on both counts BUT Gilead was #2 on the marketcap per employee list the #1 recently took a big hit in market cap.
[please note the quiz data is as of 8/16/2007]
Maybe I shouldn't have been but I was surprised Gilead was were it was!
As I don't have the exact criteria I am judging by the names on the list.
Does it include companies that make small-molecule drugs?
Yes there are companies that make small molecule drugs. If you mean does a company need only make 1 small molecule drug to qualify I can't answer that but can tell you Pfizer, Merck and other Big Pharma aren't on the list. Hope that helps.
What about medical devices?
No device companies.
I think it is also safe to say market cap > 1 Billion so sorry no Pipex :)
If I can offer a graphic Quiz...
Can you name the top 3 in each of these charts (not necessarily the same companies in each graphic)? Hint [very tiny] the company in Red is the source of these images.
Data on top 15 Biotech companies compiled as of August 16, 2007.
Market Capitalization / Employee
Revenue / Employee
Appreciate the replies.
CRME:
Hi genisi,
Thanks for pointing out that observation.
About the fatality in the IV, the docs day:
It is very likely that the fatality was precipitated by the
subject’s aortic stenosis and heart failure, but there are not enough data in this program that would lend support to this hypothesis.
Do you think there is enough room to speculate the drug may not have been related in that case as well?
I am more interested in the oral program. I would like to see both formulation succeed though. Do you know if the other approved (oral) drugs have had any associated moratility or SAE's?
MNTA -
In the same call they said they were presently conducting 2 additional Phase I's (a MAD study and drug interaction study) so that is where I would imagine the better part of the 100 patient figure you came up with is coming from.
MNTA: the PII M-118 trial enrolling 600 patients in 30 different centers, data should accrue very quickly. I have not seen any company guesstimate for completion and/or mention of interim data.
Granted its before they started it but going back to an old call (Q1 2007) they indicated it would take about a year to complete the study.
I was listening again to some recent InterMune calls and some things I think are worth noting:
1-On a couple of occasions Dr. Porter strongly emphasized that based on what's been seen thus far it was extremely unlikely to have problems here is a quote from the Q3 call:
"I was as confident as I can be after a single-dose study that we were unlikely to have problems from, for example, those GI symptoms at the doses that we plan to study."
2-Sometime in 2008 we will likely hear more about InterMune's preclincal programs in Pulmonology and/or Hepatology. There are atleast 4 programs that have been alluded too (2nd generation Protease Inhibitor-Partnered with Roche with at least two families of compounds, 2nd target in Hepatology and multiple Pulmonology targets)
3-On several of the calls InterMune has made a point that if they generate a 2nd generation candidate to Roche that in addition to a similar package as 191 there would be an up-front payment to be negotiated and should Roche elect not to take the candidate forward InterMune can market it to someone else. My guess is this wouldn't happen. With what has been eluded too as advancing progress we may not be too far (year or so?) from this happening.
4-The Phase 1A had 64 volunteers, Vertex had just 24. One would wonder if InterMune really did a much wider and more thorough dose ranging study to be extra cautious. The 1B is comparable to Vertex (40 for 191 vs 36 for 950).
5-Given that dosing for the 1B was started at the end of September I think it is safe to say the first MAD has been completed and quite possibly the second and we may even already be in the third. Since there has been no PR/8-k I think it is safe to say the study has not been stopped. While this isn't a big deal it is a bit reassuring :).
6-While the company has been vague on when the 1B would be complete they have said a milestone from Roche would be received within 15 month. Since the deal was signed in October '06, 15 month puts it to January '07. What a coincidence :).
I notice that investors tend to think a company is an ideal buyout candidate by company xyz for reasons 1,2,3 when they themselves see it as extremely undervalued. I am certainly guilty of this as well!
I've noticed the next Biotech buyout is rarely one I saw coming and often the acquirer is buying not when the stock is at a (relative) bottom.
If you like the company and your confident in your DD then while it may be frustrating at times (perhaps long periods) to see it appear undervalued the Buffet (or was it Graham?) comment about polling (short-term) vs. weighing (long-term) is good to remember. Of course if your a short-term trader then obviously this is of little consolation.
Finally!
http://sports.espn.go.com/mlb/news/story?id=3145958
Mitchell Report due to be released next week
NEW YORK -- Baseball is about to get its official boxscore on the Steroids Era.
It's the Mitchell Report, the findings of former Senate Majority Leader George Mitchell's 20-month investigation into performance-enhancing drug use that has tarnished some of the game's greatest stars and records.
Several media outlets, including ESPN, have been told it could be released as soon as next Thursday.
While critics are sure to claim it's one-sided and outdated, it has given players and executives cause for pause and led some to fear a modern-day Black Sox scandal.
"Well, it ain't Merry Christmas or Happy New Year for somebody," Cincinnati Reds manager Dusty Baker said.
Shining light into the shadows, the 74-year-old Mitchell brought experience from many fields. The former chairman of The Walt Disney Co., he once was offered a spot on the Supreme Court by President Clinton and famously challenged Lt. Col. Oliver North during the Iran-Contra hearings.
But he is also a director with the World Series champion Boston Red Sox, a role players say makes him hopelessly conflicted and an agent of commissioner Bud Selig, who appointed him. Players also claim Mitchell refused to show those accused the evidence against them, denying them a chance to refute the allegations.
For now, Selig claims not to know what's inside the report. Suffice to say, midway between Boston wrapping up the Fall Classic and the start of spring training, there are plenty of jittery people around the majors.
"Obviously, it can't be really good," New York Mets manager Willie Randolph said. "If there's some really, really big names I'm sure it's going to be a real impact in some ways."
Outfielders Jose Guillen and Jay Gibbons, linked in media reports to receiving human growth hormone, were suspended Thursday for the first 15 days of next season. The penalties are an indication how baseball might treat any players named by Mitchell.
Although some say Barry Bonds' home run record -- and milestone ball -- should be marked with an asterisk, Mitchell noted the Hall of Fame vote in which Mark McGwire was picked on just 23.5 percent of ballots, nowhere near the 75 percent needed for induction.
That election in January was considered the first test on how history will view a period when bulked-up stars amassed bulked-up stats.
"If nothing else, the results of the Hall of Fame voting last week, and the reaction to it, offer fresh evidence that this issue will not just fade away," Mitchell said then. "Whether you think it fair or not, whether you think it justified or not, Major League Baseball has a cloud over its head, and that cloud will not just go away."
To some, the drumbeat of suspicion is falling on deaf ears.
"Now when it comes out, more people seem to be numb to it," former New York Yankees star Don Mattingly said this week. "If it's not some huge name, they don't even pay attention anymore."
Said Milwaukee Brewers manager Ned Yost: "I don't care one way or the other, to be honest with you."
Hired by Selig in March 2006, Mitchell and his staff spent millions of dollars interviewing people and collecting evidence. Their task: Provide a history of what happened off the diamond during a time when home run marks that had lasted for decades fell as suddenly strong sluggers changed the balance between pitchers and hitters.
Previously undisclosed names could be tied to steroids and HGH, thanks to the cooperation of former Mets clubhouse attendant Kirk Radomski. A national investigation led by the Albany, N.Y., district attorney's office is also believed to have provided evidence to Mitchell.
Active players have largely resisted cooperating -- the Yankees' Jason Giambi is the only one known to have spoken to the inquiry. However, retired players have spoken with Mitchell, who did not have subpoena power.
Selig's decision to launch an official investigation followed the release of "Game of Shadows," in which San Francisco Chronicle reporters Mark Fainaru-Wada and Lance Williams said Bonds used performance-enhancing drugs for at least five seasons beginning in 1998.
Bonds, who broke Hank Aaron's career home run record in August, pleaded not guilty Friday to charges he lied to federal investigators about using performance-enhancing drugs.
The home run king was arraigned in U.S. District Court on four counts of perjury and one of obstruction of justice stemming from a Nov. 15 indictment. If convicted, he could spend more than two years in prison.
Bonds, currently a free agent who hopes to play in 2008, has denied knowingly using illegal performance-enhancers. He nonetheless became the face of steroid allegations while dozens of other major- and minor-leaguers tested positive.
"I think we're all eager to get this era behind us and to get steroids out of this game, growth hormone out of the game, get things that change the competitive balance other than hard work and a desire to be the best ballplayer you can be," Los Angeles Angels manager Mike Scioscia said.
To former World Anti-Doping Agency leader Dick Pound, baseball is an outlaw sport, refusing to agree to WADA's standards for testing and discipline.
But athletes in U.S. team sports, protected by collective bargaining agreements and American labor laws, have no interest in international standards.
"I think if you look at attendance, if you look at the health of the game right now, that would suggest that fans have digested what information exists and perhaps assumed that the problem has been addressed, at least for the moment," San Diego Padres chief executive officer Sandy Alderson said.
While cycling has been hurt by doping allegations, Selig repeatedly says this is a golden age for baseball. The sport drew a record average of 32,785 fans to games this year, breaking the previous mark of 31,423 that was set in 1994 -- before a 7½-month players' strike caused a steep drop.
The major leagues set a total attendance mark for the fourth straight season, drawing 79.5 million, up 4.5 percent from last year's 76 million. Performance, thus far, has been what has largely determined players' reputations, not whether they are clean.
"That may unfortunately be the case," Alderson said.
By hiring Mitchell, Selig gave himself time to see what other information would emerge. Sensitive to what's written about baseball and himself in newspapers and what is said on the airwaves, Selig acts at a deliberate pace.
Selig has maintained he didn't realize performance-enhancing drugs were an issue until 1998, when The Associated Press reported McGwire used androstenedione, a testosterone-producing pill that baseball did not ban until 2004.
When players showed up with bigger biceps and hat sizes at spring training in those years, many in baseball suspected something was going on, but no one could prove it. Once the games started, attention turned to the field.
Even now, with the Mitchell report looming, many fans are more focused on what moves their favorite teams are making.
"We're all kind of desensitized," Randolph said. "There will be a reaction, but I think that's really kind of always short-lived and you've got to pick up and move on."
The Associated Press contributed to this report.
Copyright 2007 by The Associated Press
SMID:
I think it is dirt cheap here! Obviously people are labeling them as a construction (housing) play and discounting earnings.
What people may be overlooking is that the past few quarters a good chunk of their revenue is non housing such as J-J hooks which not only shouldn't be impacted but should remain strong. Their construction slender wall and the link is mainly bigger orders too so really commercial.
The fact that they have 3 straight positive EPS quarters to me is a good sign that perhaps management has straightened up a bit and we won't have those big right-offs on projects that have been happening at least once or twice each year for several years!
I wish management wasn't looking to expand though and the beach prisms and H2Out products though they sound nice are a way off from generating meaningful revenue.
I really like the licensing/royalty model and the barrier rental. Don't forget with next year being an election year if we get the two conventions and inaguration (which we always get) the following year we should get a real boost in EPS!!
Thanks for the comments. I'll read this weekend. I am more curious on if there is something in the package which will have negative implications on their Oral drug.
I do remember Cardiome management remarking about why a panel was requested and they said they believed it was more related to the other drug and to contrast.
Didn't see anyone comment on the Cardiome Docs. I didn't read them yet they are at:
http://www.fda.gov/ohrms/dockets/ac/cder07.htm#CardiovascularRenal
Saw Jon and some others on SI negative. The stock seems to have had a big swing today.
>I couldn't think of another major city that depends on one company as much as Indy depends on Lilly.<
Hershey/Hershey :)
Tony has been in denial over a few things. What else is new?
At least not everything...
Research Report for Allon Therapeutics / Transition Therapeutics
Got this from the iVillage Board for Transition anyone interested here is the link for the report:
http://www.vmbl.ca/Actions/1/Neurology_20071022_FINAL.pdf
Writers cite conflicts, vote to get out of award-bonus business
It'll be interesting to see if Agents/Teams get more creative in bonus or just do away with this type of bonus completely
http://www.sportsline.com/mlb/story/10514218
Dec. 5, 2007
CBSSports.com wire reports
NASHVILLE, Tenn. -- Baseball players no longer would receive bonuses for winning the Most Valuable Player, Cy Young or rookie awards bestowed by the Baseball Writers' Association of America under a rule passed Wednesday.
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Starting in 2013, players with such bonus clauses in their contracts will be banned from receiving votes for any BBWAA awards. The lag time is designed to give agents and teams an opportunity to adapt to the ban; only a handful of players are already under contract for 2013.
Hall of Fame voting is not affected, nor are manager of the year or non-BBWAA awards such as the World Series MVP or Gold Glove.
"When we first started giving out these awards it was just to honor somebody. You got a trophy, there was no monetary reward that went with it," BBWAA secretary-treasurer Jack O'Connell said. "I honestly don't think people vote with that in mind. But the attachment of a bonus to these awards creates a perception that we're trying to make these guys rich."
The vote was 41-21 on the rule, which was brought up by The Associated Press two years ago. The BBWAA appointed a committee to discuss the rule with the commissioner's office and the players' association.
"We've been on record for the past 20 years as being opposed to bonus clauses related to these awards," O'Connell said. "The idea behind this was to toughen our stance against these clauses."
Gene Orza, the chief operating officer of the players' association, declined to comment. Rob Manfred, baseball's executive vice president for labor relations, did not immediately respond to an e-mail seeking comment.
Many veterans have award clauses in their contracts, some for honors bestowed by the Sporting News and Baseball America, others for postseason awards given by Major League Baseball, such as World Series MVP. Some are small -- at least relative to the multimillion dollar salaries -- but others are worth millions.
New York Yankees third baseman Alex Rodriguez earned a $1.5 million bonus for winning the AL MVP in 2007, and Boston Red Sox pitcher Curt Schilling has a clause in his agreement for next year that would pay him $1 million if he receives even a single third-place vote for the Cy Young Award.
"The Schilling thing is disturbing because he doesn't even have to win," said O'Connell, noting that Schilling joked about a kickback to the voter if he collected the bonus. "That's something that none of us finds very funny."
Although the policy was first floated two years ago, Schilling responded with a 1,000-word, four-font, two-color posting on his blog, 38pitches.com.
"To think that these guys ever approached this as anything other than them being touted as the 'experts' on who wins what is (untrue)," he wrote. "Add to that I seriously doubt anyone ever looked at this from a perception standpoint and thought wow, they are making this guy rich. I would disagree.
"The only step that hasn't happened yet is to stop them from voting on awards altogether. They shouldn't do it. Anytime someone is allowed to vote on this, on the Hall of Fame ballot, and that person injects personal bias into their vote, they should lose the privelage (sic)."
David Schwartz, whose clients include Rudy Seanez and Josh Paul, said the rule would benefit the owners and hurt mid- or low-level players who perform better than expected.
"It seems like ownership put the writers up to this," Schwartz said. "It seems like the real beneficiaries here are owners who don't have to pay bonuses to players who've had good years. Players who have award-winning seasons ought to be rewarded for it."
AP NEWS
The Associated Press News Service
RPRX -
Wasn't their call supposed to be archived on their website? I haven't seen it http://www.reprosrx.com/presentations.htm
Anyone know if it'll be up?
The 4th quarter has always been lower (then the 3rd) since I've followed them [last year with the sales ramp it was flat but that is basically down per rep given the sales force addition]. With the steady growth though we'll obviously do better this year but here is some data over the past few years:
Net sales and rental income 2007 2006 2005 2004
Q1 $1,336,731.00 $505,091.00 $544,943.00 $262,941.00
Q2 $1,505,207.00 $560,860.00 $589,483.00 $336,705.00
Q3 $2,104,446.00 $743,787.00 $604,141.00 $366,784.00
Q4 $747,071.00 $359,841.00 $290,246.00
There were some flags aside from the study being based on a retrospective subset. Maurie Markman published a paper on baseline CA-125 level that sunk it in for me (though being long UTHR I obviously hoped for success in the IMPACT Studies).
I was a bit (happily) surprised to see United didn't take much of a hit. I know most didn't hold out much up but with the recent run-up with TRIUMPH results I thought there could be a bit of an over reaction.
I found it interesting that United reacted quickly to complete drop the whole MAB program. They had Phase 2 results in Front-line patients that could have at least had them spin the results as perhaps in combo with chemo the treatment will work. I guess there are many ways to take that. I took it as perhaps they want to clean up the company. If they are to be sold my guess is before the Oral program gets near trial results.
REX's new management basically bet the company on the results. They have some other products (Hep-B Vaccine, Uterine Fibroid) but no cash what-so-ever. I don't know much about there other products but none-the-less I wouldn't even consider looking further into them even with a market cap < 10 million.
What about ENCY (Thelin)?
A couple of additional thoughts on United/OvaRex.
1-When the dust settles (my guess is United drops 10 or so) United may be more "in play" as a take over since the picture is clearer an a valuation could be more easily set.
2-Its interesting that United is cutting the program completely. They reported encouraging Phase 2 front-line findings and there is a NIH trial recently started.
3-I imagine DNDN longs will not see any relevance to them but I would be more cautious seeing another Immunotherapy fail [though the end point was TTR and survival].
Clinical / Regulatory / Litigation Calendar
[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: UTHR (OvaRex results out, No Interim analysis in Oral Remodulin studies per Q)
ACHN – See GILD
ADLR – Entereg FDA advisory panel: 1/23/08
AMLN – Byetta monotherapy results: any day.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
CRME - IV version of RSD1235: FDA advisory panel 12/11/07.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
DDSS – Tramadol NDA: second approvable letter received 5/31/07. New clinical trial likely. Ph III Trazodone results 2nd qtr/08
DNA – Avastin sBLA in breast cancer action date: 2/08; Avastin adjuvant CRC interim look Q4 07; Rituxan in Primary Progressive MS Ph III Results Q1 08.
DNDN – Provenge 9902b study: interim analysis (~180 deaths) 2H08; final analysis (360 deaths) 2010.
ELN – AAB-001: Start phase-3 program 4Q07.
start Phase II clinical trial in ELND005 for AD by the end of 2007 or early 2008; new PDUFA date for Tysabri Chron's Jan 15, 2008
GILD – Viread NDA submission for HBV: 4Q07. (MAA submitted to EU 10/11/07.)
GILD – GS9190 polymerase inhibitor for HCV: new phase-1 trial to test QT-prolongation announced 10/18/2007; no start date yet.
GTCB – US Atryn partnership announcement: late 2007.
GTCB – ATryn phase-3 for HD in US: report top-line data 4Q07, submit BLA mid 2008.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete end 2008.
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: late 2007.
GTOP – Final MyVax results Dec 07.
HGSI – Phase-3 Albuferon: report data spring 2009, submit BLA fall 2009.
IDIX – Tyzeka vs Baraclude phase-4 (12 weeks PK): report data 3Q08 (Dew’s estimate)
IDIX – Tyzeka ph3 data in decompensated liver disease: enrollment completed 1Q07, reporting date unknown.
IDIX – IDX899 in HIV: Phase-1b monotherapy in treatment-naïve patients (7 days): start dosing Oct 2007; report preliminary results Dec 2007; report full results Feb 2008 at CROI conference. Phase-2 in combination with SoC therapy: begin recruitment in 2008.
IDIX – IDX102/IDX184, 2nd generation HCV nucleosides: submit IND 4Q07.
ISA.TO-European psoriasis P3 results 2008. Phase 2B 6&12 month renal results 2008. Phase II/III Uveitis results 2008.
ITMN – ITMN-191 Phase-1B initial PK data from perhaps 1st 3 cohorts: Q1 2008
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Late 2008 (72 week treatment period). No interim analysis planned, though monitored for safety.
JNJ – TMC125 for HIV: FDA action date 1/18/08.
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients, one of the largest trials in Canadian History.
Full enrollment completed Sept. 14 with Top Line Data expected by Late February /08 or Mid March at the latest.
No Partner as of yet and Tons of Cash in the Bank.
Merrimack: see GTCB
MNTA – Meeting with FDA re Lovenox ANDA: date not specified, but soon.
MNTA — Lovenox patent appeal (Sanofi v Amphastar): arguments begin 1/8/08.
MNTA – M118 phase-2 data in stable angina to be presented at unspecified medical conference in 2008.
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NBIX - Indiplon IR PDUFA date December 12, 2007
NBIX - Indiplon IR Product launch, indiplon IR 1Q08
NBIX - NBI-56418 Complete enrollment, 6-month phase 2b endometriosis trial 4Q07
NBIX - NBI-56418 Topline data, 6-month phase 2b endometriosis trial 2Q08
Novocell – see SRDX
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
Pharming (PHAR.as) – Rhucin for HAE: EMEA action on MAA by year-end 2007; FDA BLA submission by year-end 2007.
PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.
PPHM -
Bavituximab (anti-viral): phase 1B HCV top-line info released 3/07. Final data at AALSD Nov.
Bavituximab (anti-viral): phase 1 trial in HCV/HIV coinfected patients initiated 7/07.
Bavituximab (anti-cancer): phase 2 breast cancer trial protocol submitted to reg. board 9/07
Bavituximab (anti-cancer): phase 2 lung cancer trial protocol submitted to reg. board 7/07
Bavituximab (anti-cancer): phase 1B solid tumor top-line info released 5/07.
PPHM – Cotara: phase 2 glioblastoma multiforme Indian trial patient enrollment initiated 6/07.
Cotara: glioblastoma multiforme US trial sites expanded to include MUSC 6/07.
RPRX– Proellex
*Initiate US PII Endometriosis trial (Enrollment Oct 2007)
*One year extension data (Q1 2008)
*Initiate Fibroids Pivotal PIII trials (YE2007)
*Initiate Anemia Pivotal PIII trial(s) (YE2007)
RPRX – Androxal
*Initiate Pivotal PIII trials (Q4 2007)
RPRX – Other: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: 12-week data reported on 10/18/07 (#msg-23788779); end-of-treatment data due in 2008 and SVR data in late 2008 or early 2009.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: any day (enrollment complete 8/30/06).
SYMD- Synthemed-Circulatory System Devices Advisory Panel has been scheduled for September 19, 2007 for Repel CV.
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
UTHR - Oral Treprostinil (FREEDOM-C). 16 week combination study.
UTHR - Oral Treprostinil (FREEDOM-M). 12 week monotherapy study.
VRUS – Preliminary phase-1, 28-day data for R7128 with HCV SoC: 1Q08.
ZGEN – rThrombin FDA response date: 1/17/08 (was extended by 3 months.).
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When management indicated it would take three months to get top-line results [as opposed to just 3 weeks for the TRIUMPH study] I took that as an additional negative indicator though I am long UTHR.
http://biz.yahoo.com/prnews/071205/new046.html?.v=33
Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primary Endpoint
Wednesday December 5, 4:30 am ET
Preliminary Analysis Demonstrates Studies Failed to Reach Statistical Significance
SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR - News) and its wholly- owned subsidiary, Unither Pharmaceuticals, Inc., announced today the completion of their two pivotal trials of OvaRex® MAb for the treatment of advanced ovarian cancer. Preliminary analysis demonstrates that the studies failed to reach statistical significance.
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The identical studies, known as IMPACT I and II (IMunotherapy Pivotal ovArian Cancer Trial), were randomized, double-blind, placebo-controlled trials conducted at over 60 centers across the United States. The studies enrolled 367 ovarian cancer patients and assessed the efficacy of OvaRex mono- immunotherapy during the so-called "watchful waiting" period following front- line carboplatin-paclitaxel based chemotherapy. The program sought to confirm data observed in a subset analysis of a prior randomized phase II study, which suggested the potential of OvaRex to extend the time to disease relapse among patients who had successfully completed front-line therapy. The studies were well balanced in terms of patient demographics and the safety profile was similar between active and control populations. The studies demonstrated no difference between active (standard of care followed by OvaRex) and control (standard of care followed by placebo) populations. The results of IMPACT I and II were consistent with each other. There were no statistically significant differences in safety profiles and the quality of life between the active and control groups.
Further review and analysis of the IMPACT I and II preliminary results is ongoing and full data from the IMPACT trials is expected to be presented at an upcoming medical meeting and published in a peer-reviewed journal.
OvaRex MAb-B43.13 (oregovomab) is one of five investigational immunotherapeutic monoclonal antibodies which Unither Pharmaceuticals licensed in April 2002 from AltaRex Medical Corp., a wholly-owned subsidiary of ViRexx Medical Corp. Based on the preliminary results from the IMPACT trials, Unither Pharmaceuticals intends to terminate the license agreement and intends to cease further development of the entire platform of antibodies. United Therapeutics is currently determining the amount of exit costs associated with termination of this program. While a precise estimate of write-down charges is not yet known, United Therapeutics has approximately $7 million in assets related to this program that are subject to write-down during the fourth quarter of 2007.
"Given what appeared to be the promising clinical activity observed in a subset of patients from an earlier phase II trial, we are very surprised by these findings. The IMPACT trials, which were well designed and rigorously conducted, indicate that the approach of triggering tumor-specific immunity using a murine monoclonal antibody has its challenges," said Christopher Nicodemus, MD, Unither Pharmaceuticals' Senior Vice President Clinical Research & Development.
"We are all disappointed that OvaRex did not make it to the finish line as a new therapeutic for ovarian cancer, and we owe a huge debt of gratitude to the women and physicians who participated in the studies," said Peter Gonze, Unither Pharmaceuticals' Chief Operating Officer.
About Ovarian Cancer
Ovarian cancer is the fifth leading cause of cancer deaths among women in the United States. The American Cancer Society estimates that in the United States this year, there will be over 20,000 new cases of ovarian cancer diagnosed and over 15,000 women will die from the disease. Overall, the five- year survival rate for women with distant disease is estimated to be 29%. Although most patients initially respond to surgery and chemotherapy, the relapse rate is high and once relapse occurs, there is no known curative therapy.
About United Therapeutics
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life- threatening cardiovascular, cancer and infectious diseases.
Forward-looking Statements
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. Forward-looking statements include our expectation that full data from the trial will be presented at an upcoming medical meeting and will also be available in peer-reviewed journal articles, our intention to terminate the April 2002 license agreement with AltaRex Medical Corp., our intention to cease further development of the entire platform of antibodies, the prospects of triggering tumor-specific immunity using a murine monoclonal antibody, and our expectation relating to the amount of the write-down during the fourth quarter of 2007 relating to termination of the monoclonal antibody program. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, which could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Reform Act of 1995 for forward-looking statements. We are providing this information as of December 5, 2007, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g]
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed Old entries, Add 2 Conferences, Numerous company R&D/Investor-Analysts's Days
Conferences
NYSSA Presents 11th Annual Biotech/Specialty Pharma Conference
December 11-12, 2007
NYC
http://cf.us.biz.yahoo.com/bw/071129/20071129005603.html?.v=1 (PR of Presenters)
http://www.nyssa.org/Biotech2007 (Website)
RBC Capital Markets
2007 Healthcare Conference
December 12-13, 2007
The Westin New York at Times Square New York
http://www.wsw.com/webcast/rbc84/
Company Events
Amicus Therapeutics
R&D Day
December 19, 2007 4:30pm-7:00pm ET
http://ir.amicustherapeutics.com/eventdetail.cfm?eventid=46617
Exelixis
Third Annual R&D Day
December 5, 2007 10:00am-2:00pm ET
http://ir.exelixis.com/phoenix.zhtml?p=irol-eventDetails&c=120923&eventID=1694993
Exelixis
Analyst and Investor Briefing in Conjunction With The American Society of Hematology 48th Annual Meeting
December 10, 2007 8:00pm-9:00pm ET
http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-calendar
Javelin Pharmaceuticals, Inc
2007 Analyst and Institutional Investor Day
December 13, 2007 3:00pm-6:00 pm
http://ir.javelinpharmaceuticals.com/eventdetail.cfm?eventid=47117
Pharmion Corporation
Investor and Analyst Event at ASH 2007
December 10, 2007 7:30pm-9:00pm ET
http://www.pharmion.com/investors.casts.php?id=1705554&step=2
Sangamo BioSciences
Investor and Analyst Briefing
December 5, 2007 4:30pm-6:30pm ET
http://investor.sangamo.com/eventdetail.cfm?EventID=47143
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Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
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Anyone interested here is the list of presenters at that conference (not much biotech) http://ca.news.finance.yahoo.com/s/20112007/31/link-finance-news-media-advisory-best-ideas-mid-small-cap-companies.html
and the code from the article is "broadway"
Anyone know the code or a list of who presented at the CIBC World Markets 3rd Annual Mid & Small Cap 'Best Ideas' Conference?
http://www.veracast.com/cibcwm/bestideas07/index.cfm
Just heard the vertex presentation after seeing this post on iVillage
http://www.investorvillage.com/smbd.asp?mb=4017&mn=2426&pt=msg&mid=3578157
They did say that they think the best chance for an early approval may be if the non-responder data due 2nd half next year is very good.
How was LM a head case?
There are a few things here (funny how quick it gets update the trade is already mentioned!
http://en.wikipedia.org/wiki/Lastings_Milledge
Lastings Milledge is a stud and this trade is going to bite the mets again big time...
I don't know if I am as confident as you but if I am Washington I do the trade too! You give up so-so players for a chance at a star. Your a bottom team looking for marque players its a pretty much a no-brainer. Even if he doesn't live to his potential he'll add interest.
I hope so (I'm long one on that list and looking at others) but a contrarian may go with the bottom list. I was noticing the charity picking board (on SI) some of the picks that made the majority of the lists didn't do so well.
Don't get me wrong the bottom list scares me (of those I am familiar with I only see 1 of them with a chance and even that is risky).
Thanks! Here is the link for those not in the (radio) listening area
http://cbsplayer.streamtheworld.com/index.php?CALLSIGN=WFANAM
Thanks for clarifying my post and Yes your right by list I was referring to steroids/Mitchel Report.