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Stock Product Stage Comments
----- --------------- --------------------- -----------------------------
NTII Viprinex Phase 3 Interim analysis January '09. Stroke Drug, high chance of failure.
BPAX Libigel Phase 3 ~2010 Submit Adequate Safety?
EPIX Vasovist PDUFA 12/30/08 FDA initial rejected saying 2 more studies needed. Allowed reread company states
results very positive. Looking to sell outright on approval.
RPRX Proellex Phase 3 Uterine fibroids
Stock Product Stage Comments
----- --------------- --------------------- -----------------------------
NTII Viprinex Phase 3 Interim analysis January '09. Stroke Drug, high chance of failure. Actively said looking for partnership.
BPAX Libigel Phase 3 ~2010 Submit Adequate Safety? Seeking partnership
If you are a bio/pharma company with cash looking to expand your pipeline when do you buy? It seems there is no rush in this market.
JJ Bienaime, (IMO an excellent) CEO of Biomarin, which has been actively looking for a deal has said on recent presentations the prices are getting cheaper and cheaper.
My guess is the first to go would be private companies with near-to-market products.
I wonder if anyone has a list of public (I imagine private are hard to come by) companies with products in Phase 3 or beyond who don't have the resources to bring the product to market. I can think of a couple but don't like them for various reasons.
A disappointing quarter! Maybe they should suspend the dividend and buy back some stock in this market who knows how low it will drop!
SMC Announces Financial Results for the Quarter Ended
September 30, 2008
Friday November 14, 4:03 pm ET
http://biz.yahoo.com/bw/081114/20081114005929.html?.v=1
MIDLAND, Va.--(BUSINESS WIRE)--Smith-Midland Corporation (OTCBB and Boston Stock Exchange:SMID) announced the company reported total revenue of approximately $7.8 million for the three months ended September 30,2008, and total revenue for the nine months ended September 30, 2008 of about $21.5 million. The Company had pre-tax earnings of $97,397 for the three months ended September 30, 2008 and pretax earnings of $529,421 for the nine months ended September 30, 2008.
As of November 7, 2008 the Company's production backlog was approximately $13.4 million as compared to approximately $12.4 million at the same time in 2007.
“Once again, I am pleased that we at Smith-Midland have been able to achieve seven consecutive profitable quarters despite the pressures of increasing raw material and fuel costs,” said Chairman and CEO Rodney Smith. “The Company continues to maintain a very high level of production backlog for the balance of 2008 as well as for the first three quarters of 2009. The Company has been challenged during the first three quarters of 2008 with significant increases in direct materials and fuel costs; however, these costs have begun to moderate and we believe this moderation will be reflected in fourth quarter profits”.
Smith-Midland develops, manufactures, licenses, rents, and sells a broad array of precast concrete products for use primarily in the construction, transportation and utilities Industries.
This announcement contains forward-looking statements, which involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward-looking statements. Factors which might cause such a difference include, but are not limited to, product demand, the impact of competitive products and pricing, capacity and supply constraints or difficulties, general business and economic conditions, the effect of the Company's accounting policies and other risks detailed in the Company's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.
For more complete information on Smith-Midland Corporation, visit the Company’s web site at www.SMITHMIDLAND.com. The “Investor Relations” area will include the Company’s Form 10-K.
Sorry no link
Momenta Claims Teva Gave Conflicting Information On Copaxone
by Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Momenta Pharmaceuticals Inc. (MNTA) is accusing Teva
Pharmaceutical Industries Ltd. (TEVA) of providing conflicting information to
regulators to secure additional patents on its multiple sclerosis blockbuster
Copaxone.
Momenta began the long process of challenging Copaxone's patents over the
summer and is seeking to produce a generic version of the drug, which had 2007
sales of $1.7 billion, before 2014. The allegations, contained in a recent
court filing, add more weight to Momenta's case but also highlight the uphill
challenges faced by the company.
Teva wouldn't comment on the allegations contained in the court filing.
"These claims appear convincing and lead us to believe Momenta and Sandoz may
hold the upper hand in litigation with Teva," said Cowen & Co analyst Eric
Schmidt, the first on Wall Street to highlight the strategy.
Momenta is in a worldwide partnership with Novartis AG (NVS) unit Sandoz for
generic Copaxone, with an even split of profits. They are challenging patents
held by Teva that stretch until 2014.
Copaxone, a vital earnings driver for Teva, was approved in 1996 but its
orphan drug exclusivity expired in 2003, leaving open the possibility of a
generic challenge, though that may not come quickly because of the complexity
of Copaxone's composition.
Teva sued Momenta and Sandoz in August after the Food and Drug Administration
accepted an application for a generic version of Copaxone. The lawsuit from
Teva automatically triggers a 30-month stay until the FDA can approve the
application.
In the recent court filing, Momenta claims that original patents for the
composition of Copaxone expired in 1991. But Teva asserted that compositions of
the drug with lower molecular weights were less toxic, leading to a new
generation of patents that stretch into 2014.
Momenta, however, says that information submitted by Teva to the FDA
indicates that all molecular weight ranges are equally safe and effective and
that Teva deceived the Patent and Trademark Office to obtain the patents.
The allegation of inequitable conduct could lead to a ruling that the
relevant patents aren't enforceable, but the allegation isn't uncommon in
patent litigation and it must be proved with clear and convincing evidence.
Momenta and Sandoz will have to show that the conflicting information would
actually alter the ability of a patent to be issued, plus they will likely have
to show that Teva actually intended to deceive the patent office.
The legal battle over generic Copaxone is likely to be long - Schmidt doesn't
expect a trial to begin until 2010 - and it remains unclear how the FDA will
evaluate the comparability of a generic with such a complex drug as Copaxone.
Gaining a legal victory is a major hurdle, especially against Teva - the
world's largest generic company and a frequent patent challenger - but gaining
FDA approval could also prove difficult because of the complexity of proving
that the generic version is equivalent to the branded product.
Teva has repeatedly asserted that a "full-fledged clinical study" is needed
to determine the comparability of the drug because of its complexity.
Of course, such clinical trials would be expensive and likely take years to
complete. Momenta previously said it's used "analytic methods" to demonstrate
the equivalence of the two drugs in its application with the FDA.
-By Thomas Gryta; Dow Jones Newswires; 201-938-2053;
thomas.gryta@dowjones.com
> What are the salient differences in trial design? T.i.a.
Genisi had asked that a while back (mabe it was on SI?) I'll try to list them but I may miss something.
Of note while entry criteria differed. Intermune asserts the enrolled patients were incredible similar in terms of baseline characteristics of lung function (vital capacity in Japan and FVC for the CAPACITY). I believe they talk about this is on their call following the ATS presentation if you have access to it or a transcript for more precise details.
1. Japanese patients vs non Japanese. The company has stressed no known difference in metabolism of Pirfenidone in different populations.
2. Weight difference Japanese patients notably lighter.
3. The high dose in the Shionogi study was 1800mg vs. 2400 in CAPACITY (company claims on mg/kg basis equates to the same). Noteable though is the low dose (which should statistical significance in the primary end point of the Shionogi study is the same in both namely 1200mg a day).
4. Primary End point is change in VC in Shionogi vs. Change in FVC in CAPACITY. Company states that pulmonolgists they consult with say as long as obstruction is eliminated (and is part of entry criteria) should be comparable.
5. Treatment duration 52 weeks in Shionogi, 72 in Capacity.
6. Number of patients 250 in Shionogi (randomized 2:2:1 H:P:L) vs. 320 and 400 in the two CAPACITY studies (actually 779 enrolled but don’t know the exact numbers in each trial). Randomization in Capacity 1 is 1:1 H:P and in Capacity 2 is 2:2:1 H:P:L
How can an investor handicap the upcoming Pirfenidone results based on Japanese data?
This is a difficult question to answer and based on the Shionogi data even more so. I think part of the long delay in Japaneese approval was the Shionogi data was not clean. Namely 30% drop outs and O2 saturation (the original end point) did not show significance. To me the main risk is:
1) IPF is a very heterogeneous not well (compared to other diseases) understood disease.
2) Less advanced patients are enrolled may lead to the good old placebo doing better than expected. Where Dan Welch gained some additional respect (in my book) was increasing the study duration to 72 weeks (from 60). The other thing the company has stressed is the identification of patients with confirmation of their IPF through a centralized reading of HRCT before enrolling them.
3) Longer duration could lead to the possibility a treatment benefit is temporary and is lost. I think the companies’ prior failure in 2 Phase 3 Actimmune studies leads this as low probability [i.e. I think Dan is pretty smart and would have reduced the length by 8 weeks to match Shionogi rather than increase it].
Those are the negatives. In my posts various places I have stated reasons for optimism. To me some of the biggest are:
1-Prior success in IPF studies though they are a bit messy (Phase 2 stopped early, Phase 3 noted above). Additional there is an open label phase 2 in advanced patients with very encouraging results when compared to expected outcome and they were in decline.
2-In numerous (granted small) studies of fibrotic disease Pirfenidone has shown efficacy.
3-There is no approved therapy. While steroids, NAC and some other agents are used none is a solution and the ultimate (in the near-mid term) solution is likely some cocktail. So the hurdle should be low.
PS I'll dig up some slides and e-mail them to you
By all means you do a better job at it and I am impressed with how up-to-date you keep them :)
Let me know if there is any additional info you need.
For what its worth I bought more BMRN yesterday and today. I have a few year horizon so I can't say what the market may do to the stock in the short term but I think the stock is dirt cheap looking out a few years on what type of EPS they could have from just their 3 current drugs and they have a descent chance of having a couple more in late stage trials in 2-3 years plus I think their is a descent chance JJ turns some of the cash sitting on their balance sheet into a nice additional income stream. Now that they are profitable and look to continue being so their is less of a need for 600 million sitting paying almost no interest.
UTHR:
Based on the stock moving on heavier volume yesterday and to some degree today I would suspect at yesterday's Confab Dr. Jeff's must have given a pretty optimistic view of how the FREEDOM-C study would do (results probably next day or two). I think this trial has a lot more risk then the monotherapy for what its worth but the drug could be a bigger blockbuster then the market may think especially if the tolerability is much improved with the lower dose titration as the company reports.
Interestingly on some patient message boards there have been some anictodal reports of 25% or so drop in blood pressure as a "side-effect" of using the Oral drug. Perhaps another blockbuster indication down the road?
You did a very nice job summarizing the INFORM study. I got the same impression on interest in it (based on the battery of initial questions on that study at the start of the call). I would add that Dan Welch said if things progress on schedule and the data look promising full SVR data from a phase 2 study would be available before telaprevir is launched which could make for interesting market dynamics. Also, the INFORM-1 study would likely be followed by several other INFORM studies upon completion. Though he did not specifically indicate what they may be he did disclose trying regimes with and without PEG (though at least in some keeping Ribavirin).
There were several notable remarks on Pirfenidone in the call (I really like the pure Q&A format of that conference and in general found the questions more substantive then other conferences for all presenting companies I heard not just ITMN).
I am really impressed thus far with Dan Welch. I liked him from early on but his past few conferences and what he's done with the hand he has been dealt has been to more than my satisfaction. Now we just need positive Pirfenidone data!
I am not sure I will update the ReadMeFirst but I would be happy to elaborate on any questions people may have and I will post a few updates below:
Up Coming Milestones
--------------------
Q4 ’08: Report Top-line data on at least 5 cohorts in the 191 Combo study.
Jan-Feb ’09: Report Top-line data on CAPACITY study of Pirfenidone
1H ’09: INFORM-1 study results
1H ’09: Initiate Phase 2B R7227 (ITMN-191) Combination study with Pegasys/Copegasys
HCV Programs
-------------
Phase 1 results
Phase 1A #msg-33270294
Phase 1B #msg-33270341 and #msg-33270355
R7227 (ITMN-191) Phase 2B program likely to:
1. Test both 2x and 3x regimens of R7227.
2. International
3. SVR will be the end point
4. Expect similar to other protease inhibitor studies
. R7227 will be lead by Roche going forward.
. 12 week tox studies longest animal studies that we are aware of being successfully completed (longer studies are likely in progress and perhaps recently completed but not disclosed)
Other HCV Work
1. ITMN-5489 (non-macrocyclic) #msg-33270262
2. 2nd generation (macrocyclic) described as VERY interesting are in earlier stages of development
3. Preclinical work combining R7227 and R1626 or R7128 #msg-33270382
4. Helicase Program #msg-33270432
IPF/Pulmonary
-------------
1. Pirfenidone results January/February ’09. FVC of 40-50% reduction in rate of decline compared to placebo is primary end point. Main secondary end point PFS (FVC is part of composite defining this).
2. Japanese approval 10/16/08 marketed as Pirespa
3. Early stage programs for Pirfenidone analogs as well as other Pulmonology targets
Financials at end of Q3 2008
. 185 millions cash and securities
. 170 million in 2 convertible notes (half due 2011 $21.63 conversion and .25 interest, half 2015 $18.88 conversion and 5% interest) total 8.4 million shares for both
. A number of (IMO) nuisance suits have been filed in the past couple months regarding Actimmune use. My expectation is that this will take a year or so to drag on before settling.
This could help keep in mind Pennsylvania is one of the states in need of bridge repair which is one of the regions serviced by the Moro companies.
http://news.yahoo.com/s/ap/20081106/ap_on_el_pr/meltdown_obama
Obama has called for about $175 billion in new stimulus spending, including money for roads, bridges and aid to hard-pressed states
Conference link don't know if it will be webcast or not (currently no active link for iec's presentation)
http://www.wnyinvest.org/schedule.cfm
Here is a link to the slides
http://www.iec-electronics.com/documents/investor/WNY%20Investor%20Presentation%20Nov%205th%20Final%20Pdf.pdf
This likely was not in the backlog since the PR is 7/9
http://www.jjhooks.com/press/soundwall.html
Update Holdings from 11/4/08 DEF14A
Dr. Donald R. Spink, Sr. 1,353,070 8.3%
Edward F. Spink 1,176,968 7.2%
Egbert Q. van Everdingen 366,120 2.2%
Richard H. Hurd 106,673 **
Julien J. Hradecky 244,423 1.5%
Glen O. Wright 60,000 **
Andrew T. Meikle 60,000 **
Ken Kivenko 47,000 **
Raymond L. Alarie 150,000 **
Dr. F. Eugene Deszca -- --
Richard C. Gimpel 35,625 **
Heartland Advisors, Inc. 1,250,000 7.6%
Bard Associates, Inc. 1,544,475 9.4%
From their R&D Day presentation (Slides 111-125)
M6P Content 18% 3.5% 4 fold better
M6PR Uptake 2.1 nM 30 nM 15 fold better
CONCLUSIONS:
BMN 103 An Improved GAA Enzyme; May Be
Better Treatment for Pompe Disease
• Novel production system in modified CHO cells
• Secretion of highly phosphorylated GAA enzyme
• 4 fold higher levels of bis-mannose 6-phosphate
• 15 fold more efficient uptake in cells
• Tissue distribution is superior
• Glycogen reduction is superior
Emil (and in the slides) pointed out in one of the conferences that one benefit seen was in the diapragm (also Heart) and since many patients are on respirators that could turn out to be significant. I believe the dose is significantly lower too and I thought Pompe ERT was dosed much higher then others.
For what its worth I bought back some of my bmrn in the past few weeks (though I wish I would have gotten more before the recent move up).
Someone seems to want out at .7 (yesterday and today) but how many shares? I seriously doubt it is one of the Smith's and AL-Frank is a value fund who have owned for many years so I doubt they are unloading any significant amount. Curious to know how many shares they have left.
MRCR:
Moro came in with a solid quarter .11
board_id-8604
http://investorshub.advfn.com/boards/board.aspx?board_id=8604
Moro came in with a solid quarter .11
#board_id-8604
Moro came in with a solid quarter .11
#board_id=8604
Moro Corporation Reports 3rd Quarter 2008 Sales Increase of 28% over Year Ago Period; Nine Month Book Value Per Share up 9%
http://biz.yahoo.com/bw/081104/20081104005948.html?.v=1
Tuesday November 4, 12:14 pm ET
WAYNE, Pa.--(BUSINESS WIRE)--Moro Corporation (OTC:MRCR - News) today announced that financial results for the three and nine months ended September 30, 2008 were as follows:
Three Months Ended
Nine Months Ended
September 30
September 30
2008
2007
2008
2007
Revenue $ 22,777,000 $ 17,784,000 $ 55,095,000 $ 47,916,000
Net income $ 695,000 $ 795,000 $ 769,000 $ 1,548,000
Earnings per share $ .11 $ .13 $ .12 $ .25
Average number of common shares outstanding
6,369,643 6,282,143 6,369,643 6,282,143
Revenue for the third quarter of 2008 of $22,777,000 was 28% greater than for the year-ago period. The Construction Materials Division (mainly concrete reinforcing steel) represented 45% of total revenue and the Mechanical Contracting Division (mainly HVAC products and services) accounted for 55% of total revenue for the third quarter.
Net income for the third quarter was $695,000. Earnings per share for the third quarter were $.11. Both the Mechanical Contracting Division and the Construction Materials Division were strong contributors to profits.
Revenue for the first nine months of $55,095,000 was 15% greater than for the year-ago period. The Construction Materials Division represented 48% of total revenue and the Mechanical Contracting Division accounted for 52% of total revenue for the nine-month period.
Net income and earnings per share for the nine-month period of $769,000 and $.12, respectively, were below the results reported for the year-ago period. The Mechanical Contracting Division reported a revenue increase of 20% over the prior year period. However, profits were substantially less than those reported for the prior year for the following reasons: (a) the commercial segment of this Division did not have contracts that were as profitable as those for the previous year, and (b) the residential segment experienced a wide gap between selling prices and labor and operating expenses due to the turmoil in overall housing and financial markets. The Construction Materials Division reported an 11% revenue increase and net income that was 93% greater than for the prior year period. This division benefitted from higher profit margins caused by an increase in the difference between selling prices and the cost of purchased steel and operating costs.
David W. Menard, President and CEO, commented: “These are tough times for businesses serving the construction industry. I feel fortunate that Moro, on an overall basis, is doing reasonably well. We continue to expand our topline (revenue), by broadening our program’s reach and opening new branches, and searching for expansion opportunities including possible acquisitions and joint ventures.”
Moro is a profitable and financially strong and multi-subsidiary eleven-location construction products and services company engaged in the (a) fabrication of concrete reinforcing steel (rebar), sheet metal (duct work), and process piping, (b) distribution of construction steel, miscellaneous steel and construction accessories, and (c) mechanical contracting services (HVAC, plumbing, and piping).
For more information, contact David W. Menard, President and CEO, at 484-367-0300, fax 484-367-0305.
Statement under the Private Securities Litigation Reform Act: This press release contains certain forward-looking statements regarding, among other things, the anticipated profitability and continued growth of the company. Those statements are subject to known and unknown risks, uncertainties and other factors that could cause the actual results to differ materially from those contemplated by the statements, including the continued ability of the company to generate operation profits, the lack of continued demand for the company’s products, the ability to locate and acquire suitable acquisition opportunities, and if acquired, the failure of any such businesses to generate operating profits.
Contact:
Moro Corporation
David W. Menard
President and CEO
484-367-0300
Fax: 484-367-0305
I imagine we will find out in 2009 whether BMN-103 is viable or not even if it isn't quite ready for clinical trials. If 2220 preclinical studies look favorable Amicus said in 2009 they would initiate combination studies with Myozyme.
Forgot to post the link
http://www.easiset.com/news.shtml
The PR's are July 20-22, 2008
Thanks for clarifying.
Would you venture a guess as to whether there is a Pompe enzyme in development? I know in the Crowley book they took about all sorts of problems developing one at Novazyme before Genzyme took them over. And Genzyme seems to have had no shortage of problems. Other then cost and getting around patents does the plant technology offer something to producing a better or more potent enzyme?
As always appreciate your comments 'I' :).
Budget-conscious baseball GMs meet at posh resort
The headline sure makes it sound like a sign of the times lets see how long that lasts though, the being budget consciousness not the staying in posh resorts :)
http://sports.yahoo.com/mlb/news?slug=ap-gmmeetings&prov=ap&type=lgns
DANA POINT, Calif. (AP)—The annual schmoozing of baseball executives and agents began in style—at the same resort where AIG executives convened following the company’s government bailout in September, drawing criticism from Rep. Henry Waxman.
Walking past a circular lobby area with sculpted plants, intricate stone floors and glass artwork at the St. Regis Monarch Beach Resort, the GMs started face-to-face trade talks in uncertain economic times. While baseball is coming off a season of record $6.5 billion revenue, some teams are worried the go-go years might be over and still have not set final payroll budgets for next season.
“I know we’re sensitive to the softness of the economy and frankly are taking it into account as we do our planning for next season,” Arizona Diamondbacks chief executive officer Jeff Moorad said Monday. “We’re bullish about next season on the one hand, but we recognize that especially on the corporate partnership side, that there could be some direct impact.”
Just five days after the Philadelphia Phillies defeated the Tampa Bay Rays for the World Series title, the other 28 GMs were plotting overtaking them to win next year’s pennants. They can’t start talking with free agents from other teams until Nov. 14, and the offseason maneuvering is unlikely to pick up speed until the winter meetings in Las Vegas from Dec. 8-11.
CC Sabathia, A.J. Burnett and Francisco Rodriguez highlight the potential free-agent pitchers, and Manny Ramirez and Mark Teixeira top the available hitters. San Diego is shopping ace Jake Peavy in the lobbies of the hotel, where a bagel goes for $5.50 and a kobe burger with truffle cheese fetches $28.
Peavy is guaranteed $63 million over the next four seasons, and Padres GM Kevin Towers said he had talked exclusively with one unidentified team about a trade before enlarging the field. Towers would like two major league players plus prospects in return.
“His preference is still the National League. He likes that part of the game,” Towers said. “I’ve got maybe a handful of clubs right now I’m going to focus on. A lot of those clubs we’ve already had quite a bit of dialogue.”
Towers also said the Padres probably will exercise outfielder Brian Giles’ $9 million option by Saturday’s deadline and are trying to work out an agreement to keep closer Trevor Hoffman.
Ramirez, whose $20 million team options were voided when the Los Angeles Dodgers acquired him from Boston on July 31, expects a bull market for his services.
“I want to see who is the highest bidder. Gas is up and so am I,” he said last month after the Phillies eliminated the Dodgers from the playoffs.
Perhaps Ramirez didn’t notice, but the average price for a regular gallon of gas dropped to $2.41 nationally on Monday, down more than 30 percent from last month, according to auto club AAA, the Oil Price Information Service and Wright Express.
“We’ll have to check the gas market, I guess, before I go and speak with him,” Dodgers general manager Ned Colletti said. “I know how the fans feel and how we feel. It’s obvious. I mean, what he did for 10 weeks—regular season and postseason—was as good as anybody can do. I’ve been at it long enough to tell you that I’m not going to tell you what my gut feeling is.”
Ramirez is represented by Scott Boras, who last year persuaded Colletti to give Andruw Jones a $36.2 million, two-year contract. Jones then hit .158 with three homers and 14 RBIs.
Colletti said the Dodgers haven’t made an offer yet to Ramirez and it would be difficult to afford both Ramirez and Sabathia.
“You can’t let one player stand in the way of everything else you need to do,” he said. “Every player’s got their own timeline and their own rhythm to their thought process. So when you have other needs that you need to address, you can’t really hold them up waiting for somebody to make a decision, unless it’s a very unique situation.”
Milwaukee said it made an offer to Sabathia last weekend, hoping to sign him before other clubs can offer megabucks.
“It’s in their hands,” general manager Doug Melvin said. “He hasn’t really had a chance to talk with other teams.”
Free-agent contract demands won’t slow because of the economy. That could cause negotiations to drag out even longer than usual because budgets may be in flux.
“I think in some places it may very well have an effect,” Houston Astros president of baseball operations Tal Smith said. “From the standpoint of free agents, it’s something clubs will probably take a look at.”
Some high-revenue teams, relatively certain that they will sell close to 100 percent of their tickets, don’t have to worry as much.
“I think as long as we win, we’ll have revenue certainty,” said Red Sox GM Theo Epstein, who just received a new contract.
It looks like 5 more licenses were added in the quarter. While they may not produce revenue right away (though the Seminole deal sounds very nice and I suspect was done to get access to JJ hooks for the order!) unless they were given some deal we should get a licensee fee that I believe is between 25 and 50k each!
While we didn't get the convention rental but we did do the 4th of July
http://www.jjhooks.com/releases/capitol.shtml
and I believe we are entitled to a royalty on this not sure if it is a full 4-5% or less but it sounds like a huge order
http://www.jjhooks.com/releases/seminole.shtml
FYI maybe this is old news to those who follow the company closely but they disclosed at the Oppenheimer conference they have a Fabry program (currently in animals). They also have a number of others in animals (see slide 25 of todays presentation.
FYI,
The password for the Oppenheimer conference is
astoria
SMID:
Huge volume today on no news (that I could find). To answer a question posted on the mother board no they did not get either convention barrier rental contract.
BTW, there is a board now
http://investorshub.advfn.com/boards/board.aspx?board_id=14077
Huge volume today! I thought we got rid of most of the selling a couple weeks ago. Today should have gotten rid of any leftovers.
Just what do you consider a small amount anyway :)
In the past I've noticed that when I put in a bid it either shows up a few pennies below what I actually placed it, their is a fill at my bid (but not mine) immediately or some other similar type of behavior.
On heavy volume days though I did get fills at my price (I never had a 5 share fill on this stock so I wouldn't worry about that maybe a 100 though :)).
This stock has less then 5 million shares outstanding so with a buck fifty drop in gas it doesn't take much to add up to significant savings and translate to a few pennies on the EPS line! Granted in Q3 not much of that would be seen.
As cheap as this stock is now if they put in a good quarter say .05+ this could be well over a buck quickly so if you believe in it I don't know that I would quible about .01 - .02 on the bid. That being said the management has produced inconsistent results but I am cautiously optimistic for good results the next few quarters at least.
The results look very impressive at this stage and the doses seem remarkably low!
HCV was a not my primary reason for investing in ITMN and the landscape seems more and more competitive with each passing day (not the type of market I tend to invest in). That being said ITMN still has a couple advantages one of the strongest remaining is its partnership with Roche and them having a polymerase to potentially combine with InterMune's Proteases. While its still early, the selectivity of 191 may still be a factor as safety and tolerability become more of an issue. I don't think Vertex/SGP will get the entire boatload of patients in 1-2 years. Plus the rash issue is understated by Vertex longs IMO. Yes it is a severe disease and the trade off may be a small factor, however if there is a choice of two (or three) therapies one with and others without if all other things are equal I think they lose quite a lot of market share.
VRUS:
I hadn't heard the VRUS presentation till today but did read Adam's column after which I expected the stock would be down in the $5-$10 range today (currently down .20). I should have known better though as his bias towards VRTX has been quite evident.
They (VRUS) indicated that the kidney tox did not show up in the 28 day monkey studies and since they are not sacrificed during the study could not say when in the 13 weeks it starts to occur. They believe it is dose dependent (did not elaborate to a great deal on what specific doses). They also said 6 month tox studies (sorry I didn't catch what doses) are going well and currently at month 5 (these studies are not needed to proceed to Phase 2). My impression is that the 7128 is far from dead and Phase 2 trials should proceed shortly.
I wish I would have bought more. Unless they hit a hiccup with one their trials or people get more scared about Kuvan uptake (I think it was at a maximium a few weeks ago and one reason I bought some then) I think we head back up. I don't claim to be able to time the market one thing BMRN could be substantially higher before too long:
1) We have some trial successes (Bh4, PEG-PAL, PAH) not to mention Kuvan EU approval.
2) Kuvan uptake increases (I'ld be happy for remaining steady at around the 4 referrals a day)
3) What I think is more likely then not if the general bio/pharm sector remains flat is a fair sized deal for a marketed/near market product. This could give a dramatic uptake to EPS (much better then whatever interest we get on the near 600 million)
Thanks for the info.
I thought we would be getting a lot more PR's and company calls. I only saw Pharmasset with a call today. Perhaps with most of the posters presented on the 4th they'll come later.
http://investor.pharmasset.com/eventdetail.cfm?eventid=61317
Does anyone know the significance of the 4 week lead in? I thought I heard Vertex at an earlier conference claim that they are using that period to prescreen patients. But isn't Vertex trying a similar thing? If that is not the case anyone care to speculate on why the response would be better.
Just a note on this compound. While the results are very impressive I don't believe it is the most promising compound in development. Dan Welch indicated that that their are several macrocyclic compounds in early stages that looked quite impressive (granted at extremely early stage).
BMS-790052 is a First-in-class Potent Hepatitis C Virus (HCV) NS5A Inhibitor for Patients with Chronic HCV Infection: Results from a Proof-of-concept Study
R. Nettles1; C. Chien1; E. Chung1; A. Persson2; M. Gao3; M. Belema3; N. A. Meanwell3; M. p. DeMicco4; T. C. Marbury5; R. Goldwater6; P. Northup7; J. Coumbis8; W. K. Kraft9; M. R. Charlton10; J. C. Lopez-Talavera3; D. Grasela1
1. Research and Development, Bristol-Myers Squibb, Hopewell, NJ, USA.
2. Research and Development, Bristol-Myers Squibb, Princeton, NJ, USA.
3. Research and Development, Bristol-Myers Squibb, Wallingford, CT, USA.
4. Advanced Clinical Research Institute, Anaheim, CA, USA.
5. Orlando Clinical Research Center, Orlando, FL, USA.
6. PAREXEL International, Baltimore, MD, USA.
7. University of Virginia, Charlottesville, VA, USA.
8. Research and Development, Bristol-Myers Squibb, Hamilton, NJ, USA.
9. Thomas Jefferson University, Philidelphia, PA, USA.
10. Mayo Clinic, Rochester, MN, USA.
BMS-790052 is a first in class and highly selective HCV NS5A inhibitor with in picomolar vitro potency against genotypes 1a and 1b. In a single ascending dose study with healthy subjects, BMS-790052 was shown to be safe, well tolerated, and had a pharmacokinetic profile suggestive of once daily dosing.
The objectives of this randomized, double blind, placebo-controlled, single ascending-dose study were to evaluate the safety, tolerability, antiviral effect and pharmacokinetics of BMS-790052 in patients with genotype 1 chronic hepatitis C (CHC). Patients were randomized to receive 1, 10, or 100mg of BMS-790052 or placebo (6 patients per dose; active:placebo=5:1) and could be treatment-naive or experienced men or women, 18 to 49 years of age with HCV RNA ≥105 IU/mL with non-cirrhotic compensated liver disease.
All BMS-790052 single doses were well tolerated and had a safety profile similar to that of placebo. Following oral administration, BMS-790052 was readily absorbed with dose proportional exposures over the studied dose range which were comparable to those observed in a previous study of healthy subjects. The mean terminal half-life of BMS-790052 was approximately 12 hours. The figure below shows the decline in HCV RNA for all doses from time of administration to 144 hours. Mean decline in HCV RNA 24 hours after a single 1, 10 and 100 mg dose of BMS790052 was 1.8 log10 (range 0.18 to 3.0 log10), 3.2 log10 (range 2.9 to 4.0 log10) and 3.3 log10 (range 2.7 to 3.6 log10), respectively. Furthermore, the 100 mg dose resulted in a mean decline of 3.6 log10 (range 3.0 to 4.1 log10) observed at 48 hours after dosing, which was maintained at 144 hours.
BMS-790052 is a potent NS5A inhibitor that produces a robust decline in HCV RNA following a single dose in patients chronically infected with HCV genotype 1. BMS-790052 was safe and well tolerated in single doses of up to 100 mg and has a pharmacokinetic profile that potentially supports once-daily dosing. Multiple dose trials are ongoing.
Phase 2 Study of Telaprevir Administered q8h or q12h with Peginterferon-Alfa-2a or -Alfa-2b and Ribavirin in Treatment-Naïve Subjects with Genotype 1 Hepatitis C: Week 4 Interim Results
X. Forns1; P. Marcellin2; T. Goeser3; P. Ferenci4; F. Nevens5; G. Carosi6; J. P. Drenth7; K. De Backer8; R. van Heeswijk8; T. J. Vangeneugden8; G. Picchio9; M. Beumont-Mauviel8
1. Liver Unit, University of Barcelona, Barcelona, Spain.
2. Hôpital Beaujon, Clichy, France.
3. Klinikum der Universität zu Köln, Köln, Germany.
4. Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria.
5. Department of Hepatology, University Hospital Gasthuisberg, Leuven, Belgium.
6. Clinic of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy.
7. Radboud University Nijmegen Medical Center, Nijmegen, Netherlands.
8. Tibotec BVBA, Mechelen, Belgium.
9. Tibotec Inc., Yardley, PA, USA.
Background: Study C208 is an ongoing open-label, randomized Phase 2 study of telaprevir (TVR) administered q8h or q12h in combination with peginterferon-alfa-2a (Peg-IFN-alfa-2a) or Peg-IFN-alfa-2b and ribavirin (T/PR) in treatment-naïve subjects with HCV genotype 1 infection. We report the results of an interim analysis conducted at week 4 of treatment.
Methods: 161 subjects were randomized into 4 arms (table). Subjects in all arms received T/PR treatment for 12 weeks, and will subsequently receive either 12 or 36 additional weeks of PR based on rapid virologic response (RVR) criterion. Subjects who met the definition of viral breakthrough (≥1-log increase in HCV RNA above nadir) discontinued TVR dosing and will complete 48 weeks of PR. An intent-to-treat analysis was performed when all treated subjects had completed week 4 of treatment or had discontinued earlier than week 4. The analysis also assessed all treatment or TVR dosing discontinuations including subjects who discontinued beyond week 4, up to the time of data cutoff. The proportion of subjects with HCV RNA below the limit of detection (TaqMan assay LOD 10 IU/mL) at week 4 (RVR) is reported.
Results: Baseline characteristics were balanced across arms. Although differences did not reach statistical significance, a higher rate of HCV RNA clearance was observed at week 4 in arms A and C compared with arms B and D. The proportion of subjects with undetectable HCV RNA at week 4 was 82% and 85% for arms A and C, respectively; and 71% and 68% for arms B and D, respectively. Up to week 4, the number of subjects with viral breakthrough was 0 and 2 in arms A and C, respectively; and 2 and 1 in arms B and D, respectively. The overall proportion of TVR discontinuations for any reason was 12% (n=19). Similar discontinuation rates were observed in each of the arms.
Conclusions: In the context of the two currently available standard-of-care regimens, TVR 750 mg q8h or 1125 mg q12h in combination with PR yielded high rates of virological response and low viral breakthrough at week 4. Differences in the proportion of subjects with undetectable HCV RNA were observed between arms receiving different PR regimens. Future results from a week 12 interim analysis will further assess the therapeutic potential of TVR q12h dosing, as well as potential differences in efficacy related to the combination of TVR with either Peg-IFN-alfa-2a or Peg-IFN-alfa-2b and ribavirin.
N Peg-IFN TVR Ribavirin
A 40 alfa-2a (180 μg/wk) 750 mg q8h 1000–1200 mg/d
B 42 alfa-2b (1.5 μg/kg/wk) 750 mg q8h 800–1200 mg/d
C 40 alfa-2a (180 μg/wk) 1125 mg q12h 1000–1200 mg/d
D 39 alfa-2b (1.5 μg/kg/wk) 1125 mg q12h 800–1200 mg/d