NABI BIOPHARMACEUTICALS : Chute de Trius Therapeutics ( TSRX )

Profil supprimé

14 janvier 2012 •18:21

une petite correction , l'objectif de cours de Ladenburg Thalmann est de 14$

http://content.stockpr.com/lts2/files/researchreport.pdf

Jason Napodano parle d'opportunité, TSRX devrait finir l'année avec plus de 60M en cash, un éventuel partenariat en Europe en 2012

"This may explain the selling pressure in $TSRX:

On January 12, 2012, Sofinnova Venture Partners VII, L.P. distributed 3,615,572 shares of Common Stock without consideration to its partners pro rata pursuant to its partnership agreement and a Rule 10b5-1 Distribution Plan between Sofinnova Venture Partners VII, L.P. and Merrill Lynch, Pierce, Fenner & Smith Incorporated, dated November 29, 2011,
previously filed as an exhibit to Amendment No. 1 to the Schedule 13D (as amended to date, the “Rule 10b5-1 Plan”).

That's a lot of shares given the ADV. Might take a few more days to work through. However, the fundamental story remains in place. I'd use this as an opportunity to get in - if you like the story long-term. "

http://www.twitlonger.com/show/faig1a



"$TSRX: So I have no idea why the stock is down. I know that Rib-x (developing 2 p2 MRSA drugs, including radezolid) was in San Fran hosting meetings around #JPM12. I tried to get a meeting with them but they did not respond (lame).

TSRX should report cash of just over $60 million at year end 2011. That's a nice amount, but clearly they are going to need more prior to commercialization. The plan for 2012 is to move into a 3rd p3 trial (under SPA) for lung infections.

Two ways to raise money - do a secondary or do a deal. I think we see both in 2012. The deal will be centered around EU rights to tedizolid. Remember, Bayer took the Asian rights last year. So when/if they do a secondary offering really depends on when/if they do a deal for Europe and how much they get. Like I said, I think we see both this year. I'd recommend owning the stock ahead of an EU deal. It could be fairly sizable.

As for the U.S. rights, I think management keeps them all the way to the market. The goal is to become the next Cubist. And they have a really interesting preclinial pipeline to boot, so I think they keep tedizolid for themselves and then bring the next drug to market (GyrB/ParE) as a follow-up.

I met with CEO, CFO, CCO, CMO, and VP-Dev earlier in the week. Very good meeting. No change to my investment thesis or $10 target. "


http://www.twitlonger.com/show/fagh4t

Profil supprimé

15 janvier 2012 •11:14

bon, je continue mon monologue...

suis tombé par hasard sur une sorte d'article ( du 1er décembre 2011 ) qui présente les éventuels futurs blockbusters ...

pour les antibiotiques, TSRX est cité parmi d'autres candidats...


"Trius Therapeutics, a San Diego-based biopharma, is now in Phase III testing on a next-in-class oxazolidinone called tedizolid phosphate, or TR-701. If approved, Bayer will sell the drug outside the US. "Data [on TR-701] is coming in early 2012, and I'm very confident that it will be positive," says Selvaraju. "There's activity in this drug not only in skin infections, but also in bacterially associated pneumonia, so it's got a broad spectrum of activity, and I think it will become a very nice commercial opportunity for Trius going forward."



Bourso ne veut pas que je poste l'article dans son intégralité...

j'espère que vous arriverez à ouvrir le lien sans trop de
coupures

http://pharmexec.findpharma.com/
pharmexec/article/articleDetail.
jsp?id=752361&pageID=1&sk=&date=

Profil supprimé

15 janvier 2012 •11:43

parmi les candidats " Minibuster, Blockbuster et Superblockbuster " on trouve notamment:

Pharmasset (VRUS)

Inhibitex (INHX)

ONYX Pharmaceuticals (ONXX)

Clovis Oncology (CLVS)

Celgene (CELG)

Medivation (MDVN)

Amarin Corporation (AMRN)

Aegerion Pharmaceuticals (AEGR)

Cubist Pharmaceuticals (CBST)

Trius Therapeutics (TSRX)

Amylin (AMLN)& Alkermes (ALKS)

Biogen Idec (BIIB)

Biomarin (BMRN)

United Therapeutics (UTHR)

Alnylam Pharmaceuticals (ALNY)

drenan

15 janvier 2012 •12:21

explorer en effet.

drenan

15 janvier 2012 •12:23

l'instant, ça va à 5.

Profil supprimé

15 janvier 2012 •17:23

elo mon doudou !

tu l'auras compris ( ou pas ), elle me plait bien celle-là ...

en plus de leurs 2 phases III avec SPA pour une NDA et une MAA en 2013 ( un partenariat pour l'Europe devrait être annoncé cette année ), je me demande si le plus intéressant ne se situe pas dans le reste de leur
pipe

http://www.triusrx.com/trius-
therapeutics-gyrb-pare.php

http://www. triusrx.com/trius-therapeutics-
marine-natural-products-program.php

si tel est le cas, il y a du buyout dans l'air...

opif1

16 janvier 2012 •22:42

non, tu n'es pas tout seul Sasane !

Juste une précision à t'apporter car je suis Trius depuis 2-3 mois déjà : les résultats de la 1ere phase 3 ont été annoncés (fin décembre de mémoire). Ils sont plutôt bons mais n'ont pas emballé les investisseurs. La 2e phase 3 a débuté maiss ses résultats ne sont attendus qu'au Q1 2013 normalement.

Tout ça pour dire qu'il n'y a pas beaucoup d'éléments tirant à la hausse Trius ces prochains mois.

Le seul catalyseur que j'ai noté, c'est la participation à une grande conférence pour présenter plus en détail leur 1ere phase 3 quelque part en 2012 (sans plus de précision malheureusement).

Pour l'instant, je regarde mais je n'entre pas.

Profil supprimé

26 janvier 2012 •17:46

Trius Therapeutics, Inc. (Nasdaq:TSRX - News) today announced the pricing of an underwritten public offering of 8,600,000 shares of its common stock at a price to the public of $5.25 per share. The gross proceeds to Trius from this offering are expected to be approximately $45.2 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Trius. The offering is expected to close on or about January 31, 2012, subject to customary closing
conditions.

http://finance.yahoo.com/
news/Trius-Therapeutics-Inc-
Prices-p z-2210545768.html?x=0

Profil supprimé

26 janvier 2012 •17:51

http://bionapcfa.blogspot.com/
2012/01/buying-opportunity
-in-trius.html


Monday, January 23, 2012

Buying Opportunity In Trius Therapeutics

By Jason Napodano, CFA

On January 12, 2012, Sofinnova Venture Partners VII, L.P. (SVP) distributed 3,615,572 shares of Trius Therapeutics (TSRX / $5.63 / share) common stock without consideration to its partners pro rata pursuant to its partnership agreement and a Rule 10b5-1 Distribution Plan between Sofinnova Venture Partners VII, L.P. and Merrill Lynch, Pierce, Fenner & Smith Incorporated. In the simplest terms, SVP is a venture capital firm that has been with Trius since before they were public. SVP has a previously agreed upon distribution agreement (AKA - an exit plan) for the shares. As a early investor / venture capital firm, SVP executed its business model perfectly with Trius, i.e. get in early for cheap, and then get out after the IPO lock-up period at (significantly) higher prices. From their point of view, it's time to move on.

With an average daily volume of only 150k shares, working through 3.6 million will take some time. That amount of stock hitting the market caused a meaningful sell-off in the shares, down from $7 before the news to a low of $5.25 last week. Volume over the past week has totaled about 3.0 million shares. This leads us to believe the bulk of the SVP shares have been sold, and are now in the hands of new shareholders. SVP owned over 12% of the stock, so the shares being distributed into the active market is a good thing. It should help increase liquidity for new investors.

...Use Pull-Back As Entry Point...

We remain big fans of Trius. Investors that agree should use this pull-bank on "non-fundamentals" as an entry point. We remind investors that On December 19, 2011, Trius Therapeutics announced results from the company’s 1st phase 3 trial (Study-112) studying 200mg once-daily oral tedizolid (TZD) for 6 days versus 600mg twice-daily oral linezolid (Pfizer’s Zyvox) for 10 days in patients with acute bacterial skin and skin structure infections (ABSSSI). The trial was a non-inferiority design (90% power to detect a 10% non-inferiority margin between the two arms). The trial enrolled a total of 667 patients across sites in North America.
The primary endpoint was cessation of lesion spread and resolution of fever at 48-72 hours after initiation of study drug on an intent-to-treat (ITT) analysis. There were also key secondary endpoints, including sustained clinical response at end-of-treatment (EOT) in the ITT and clinically evaluable (CE) populations and an investigator’s assessment of clinical success in the ITT and CE populations.

The data above look very good. We did not expect tedizolid to achieve superiority to linezolid. To achieve superiority, tedizolid drug would have had to have posted a primary endpoint >7% versus linezolid. Truth be told, linezolid is a highly effective drug. Pfizer would not have sold $1.2 billion of Zyvox in 2010 if the drug didn’t work. We note the rates of methicillin-resistance Staphylococcus aureus (MRSA) infection and outcomes were similar between both arms.

We are surprised that the primary outcome was so close, but we note that the primary endpoint is a composite of both cessation of lesions and absence in fever. According to management, tedizolid offers up numerically better results on the cessation of lesions endpoint – approximately 87% vs. 85%. Both drugs lost efficacy points due to missing temperature data. It becomes difficult to prove in a clinical setting the rapid onset of efficacy when clinicians are not always following the exact FDA guidelines with respect for registration of a new drug application. We think these data are consistent with the clinical profile of the drug demonstrated in early trials.

That being said, what did show a positive trend in the favor for tedizolid was the tolerability. Treatment emergent adverse events were higher for linezolid. Gastrointestinal disorders, which include nausea, vomiting, and diarrhea, were statistically significant in favor of tedizolid. Tedizolid also had less of a detrimental effect on platelet count. Besides better tolerability, we noted the significant administrative and convenience advantages of tedizolid versus linezolid, including a shorter course of treatment (6 days vs. 10 days), once-daily dosing, and bioequivalence between the oral and IV dose.

We think the drug can gain market share from linezolid based on these advantages. With the above marketing advantages on safety and convenience and a superior efficacy claim, we think tedizolid could have best-in-class. Based on the top-line data from Study-112, we still think tedizolid will be a very nice drug for Trius. Paramount is that Trius gets the drug on the market before Zyvox loses patent exclusivity in mid-2015.
…Second Phase 3 Ongoing…

We remind investors that Trius is also testing tedizolid is second phase 3 trial, Study-113, also under a U.S. FDA SPA. Stuyd-113 is an IV-to-Oral step-down trial that will compare the efficacy and safety of 200mg QD tedizolid for 6 days to 600mg BID linezolid (Zyvox) for 10 days. All patients will be initiated on IV dosage form for a minimum of one day and be transitioned to the oral dose form at the discretion of the clinical investigator. We note that having both an IV and oral dosage formulation is a key differentiator to Cubist’s Cubicin (daptomycin). We expect data from this program in early 2013.

…Commercial Potential Is Very Attractive…

We see a significant commercial potential for tedizolid in the U.S. If the second phase 3 program goes as we expect, the drug has peak sales in the $300 million to $350 million range in North America. The current market is dominated by vancomycin and linezolid. The therapeutic window on both is closing. Key for Trius is to gain the cleanest and widest label possible. Expanding the indications into HAP/VAP, pneumonia, and bacteremia provide meaningful upside to our forecast.
This is clearly a large market. U.S. sales for Zyvox, Cubicin, Tygacil, and generic vancomycin eclipsed $1.5 billion in 2010. Vancomycin prescriptions grew by 6% CAGR between 2005 and 2010. Yet, despite the presence of generic vancomycin, branded sales of Zyvox, Cubicin, and Tygacil grew by 20% CAGR. The market is shifting to more effective drugs, and price is becoming less of a factor.

In fact, initial market research conducted by management on formulary acceptance shows that with a non-inferior profile to Zyvox, tedizolid will see broad (~90%) Tier-2 coverage at parity pricing per course of treatment (roughly $1,500) to Zyvox. This includes a range of indications, including skin, HAP/VAP, Bacteremia, and MRSA.

The Trius R&D day in December 2011 offered perspective from two leading physicians with significant experience in treating patients with MRSA: Dr. Ralph Corey, Profession or Medicine and Infectious disease at Duke University and Dr. Jeff Kingsley, CEO of the Southeast Regional Research Group. Both doctors concluded that despite the availability of generic vancomycin and expensive branded products such as Zyvox, Cubicin, and Tygacil, a void remained in the market for a highly effective drug that met all the requirements for success.
Based on data above from the first phase 3 trial and non-clinical history of tedizolid, we see the drug is poised to be “Best-in-Class” with a full label. We are expecting a new drug application (NDA) around the middle of 2013, with FDA approval in 2014. Additional applications for HAP/VAP, pneumonia, and bacteremia should follow in 2014 and beyond. The biggest near-term catalyst for the shares is a deal for the European market, perhaps in 2012. We remind investors that Bayer licensed the Asian rights to the drug in July 2011 for $25 million upfront and $69 million in potential milestones plus double-digit royalties on sales and 25% global development expense reimbursement. Bayer has already paid Trius an additional $7 million in milestones since the initial $25 million upfront last summer.

…Quick Financial Snap-Shot…

We forecast that Trius exited 2011 with roughly $60 million in cash and investments, enough to fund operations through the current phase 3 program. We note the company received a $5 million milestone payment from Bayer in January 2012 for completion of the -112 study. For 2012, we expect Trius will actively seek a European partner for tedizolid. We think this could bring in similar, if not more, cash to the deal done with Bayer in July 2011 for the Asian rights.

Conclusion

In January 2011 we initiated coverage of Trius Inc. with an Outperform rating. We are confident in the outcome of the company’s ongoing phase 3 program testing tedizolid vs. Pfizer’s Zyvox (linezolid) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The first trial, Study-112, offered positive top-line data in December 2011. This trial was run under a U.S. FDA special protocol assessment (SPA). The second trial, Study-113, also under a U.S. FDA SPA, continues on plan, with data expected early 2013. Management is seeking a third SPA for a lung study in 2012. A study in bacteremia could begin in 2013. All-in-all we are very confident in the development program for tedizolid. We believe it represents one of the lowest risk phase 3 assets in biotech.

We see meaningful market share gains for tedizolid over the three market leading products, Zyvox, Cubicin, and Tygacil. The current market cap of only ~$160 million undervalues the story in our view. We think the stock is worth $10 per share based on discounted cash flow (DCF) analysis. Our U.S. peak sales forecast is $350 million. Our global peak sales forecast is $750 million.

Profil supprimé

26 janvier 2012 •17:57

http://bionapcfa.blogspot.
com/2012/01/egg-on-my-face
-with-trius-call.html



Thursday, January 26, 2012

Egg On My Face With Trius Call

By Jason Napodano, CFA

Well I've got a little egg on my face this morning. Three days after I published a blog calling the SVP sell-off in shares of Trius (TSRX / $5.45/share) a "Buying Opportunity", management issued 8.6M shares at $5.25/share in a public offering. Including potential over-allotment of 1.29M, and we could be looking at nearly 10M shares coming to the market by the end of the month. That's 25% dilution for existing shareholders.

I question the timing of the deal. If the SVP sell-off was truly a "non-fundamental" decision, then management should have waited for the stock to recover. The trend was back up since I published the article. The stock was $5.80/share yesterday. I think it would have been above $6 next week. Plus, as noted in my blog published on January 23rd, management just received $5M from Bayer on January 23rd. Including over-allotment, that $55M in new cash in January 2012. I now forecast they will exit the Q1-2012 with $108M in cash.

Whatever the reason, now Trius is sitting on a boat-load of cash. Management will say that this puts them in a stronger negotiating position in seeking a European partner for tedizolid. That's what all management's say. I've been doing this for nearly 15 years. It tells me an EU deal is not likely anytime soon.

...Cash Rich...

Phase 3 #2 is ongoing - that's the IV-to-oral step down trial. Phase 3 #3, a HAP/VAP (lung infection) study, is planned for later in 2012. Management is in talks with the FDA on the SPA for the trial. Management wants phase 3 #4 to be a bacteremia (systemic infection) study. However, plans were to do this trial in 2013. Perhaps with $108 million in the bank, management is considering pushing forward with both these in 2012.


We note that management has been doing some initial market research on tedizolid. Obvious strengths include the shorter course of therapy, the lack of myelosuppression, the easier dosing, and the better tolerability. Acknowledged disadvantages upon launch include less familiarity and a single indication. That single indication being, skin infection (ABSSSI). The figure below is from management's investor presentation.
By raising cash today, management may be looking to wipe-out the disadvantages. A product with four successfully completed phase 3 trials will certainly gain physician attention. Familiarity grows even through conducting the clinical trials. Positive data creates marketing advantages. And if the data is included in the NDA filing, and approved by the FDA, then management may be in position to launch tedizolid with three indications at launch - skin, lung, and bacteremia.

Maybe I'm over-analyzing? Maybe I'm too optimistic? I'm just trying to come up with a logical reason as to why a company already with an Asian parter in Bayer paying 25% of the global development costs and $60M in the bank felt it necessary to raise $50M at depressed prices.

...Catalyst Poor...

As much as we like the Trius story, we acknowledge the stock is lacking catalysts. We're not expecting the phase 3 data from the IV-to-oral step down trial until early 2013. The SVP exit and the massive dilutive offering today is surely to irk current holders. Plus, with Citigroup, Piper Jaffray, Canaccord, and Ladenburg shopping around another 10M shares this week, who's left to buy next week?

Trius stock is looking like dead-money for a while. That's frustrating considering I told people to buy it early in the week. If you're a trader, momentum-player, or catalyst-player, you might find better opportunities elsewhere. Come back to Trius this Fall. If you're a Buy-and-Hold investor, you're fine. Long-term, I still like the story. I see $10 as fair-value based on my DCF model. I'll just have to sit tight until I can be right.

Profil supprimé

14 avril 2012 •08:48

pour l'instant, le calme
plat...

http://finviz.com/chart.ash
x?t=TSRX&ty=c&ta=1&p=d&s =l


http://seekingalpha.com/article/496341-why-trius-therapeutics-is-a-gem-i n-the-innovative-antibiotics-market


Why Trius Therapeutics Is A Gem In The Innovative Antibiotics Market

April 13, 2012


Trius Therapeutics (TSRX) is a biopharmaceutical company that develops and commercializes innovative antibiotics for life-threatening infections. The company announced positive top-line results from their first phase three clinical trial for tedizolid phosphate (TR-701), an IV- and orally-administered, second generation oxazolidinone, for the treatment of serious gram-positive bacterial infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The company is located in San Diego, CA, and run by Jeffrey Stein, Ph.D., President and Chief Executive Officer.

Trius' product offerings are significant because they are well-developed, in a proven market that was already pioneered by big pharmaceutical firms. In addition, competition is actually decreasing due to big pharma's lack of investment and development in this space.

The problem to solve

The company's products address the increasing problem of bacterial resistance to currently marketed drugs. As a result, serious and life threatening infections are in some instances more difficult to treat, and in other instances, impossible. Death by MRSA infection in hospitals, exceeds 19,000 deaths a year. That exceeds the number of deaths due to HIV. So because of declining investment in antibiotic solutions by big pharma, (leading to a leaner pipeline), and the upward trend of bacterial resistance, there is a need for novel therapeutics to treat multi-drug resistant bacterial infections.

Enter Trius' (TR-701,) now in phase three clinical development, and partly addressing the pipeline issue for MRSA indications. The company is expected to complete enrollment of the second phase three trial at the end of 2012.

Revenue base

Not common in many biotech companies is actual revenue. Trius has $60 million in revenues, which are government contract revenues, and which fully front three pre-clinical programs through phase one clinical development. It's developing an (Investigational New Drug) engine of sorts, that is going to be putting drugs into a clinical development pipeline. The most advanced of these is their Gyrase-B program, which is expected to enter the clinic in the first quarter of 2013. That project is funded through a $28 million five-year contract from (the National Institute of Allergy and Infectious Diseases), through Phase I clinical development. The federal government's (Biomedical Advanced Research and Development Authority, is also interested in funding it through phase three.

Gyrase is a broad spectrum drug. According to the company's CEO Jeffrey Stein "it has the potential to be the first truly novel class of broad spectrum antibiotic to enter the clinic in the last 50 years. Its potential value could eclipse the value of the company's late stage product, Tedizolid. This information has not been so visible to investors, but investors should get excited about it."

A significant partner

On the collaboration front, Bayer Pharma (BAYZF.PK) is making $69 million of milestone-based payments to Trius for development of Tedizolid - $25 million of it upfront, half of which will be pre-commercial. Bayer, which will market the drug in Asian territories, is paying 100 percent of their development costs in their territory and 25 percent of development costs in higher value territory, all a pretty solid testimonial to the commercial potential of Tedizolid. If things proceed on schedule, $30-35 million of that will be paid before 2015. The agreement with Bayer does not cover the U.S., Canada, or the European Union, and the company expects to develop similar type agreements for those markets.

Investment Value

This creates the position where investors are paying for the late stage products appropriately, but the company is able to build the full research, clinical, regulatory, commercial capabilities that could then be applied to the earlier stage product once it enters the clinic. This represents an opportunity to enhance investor value, somewhat like a free call option for investors, as they're not paying for it but they will get the end value for it. Essentially, the early stage pre-clinical Phase I and II are funded for Trius.

According to public financial statements referencing the end of Q4 2011, the company reported approximately $59 million in cash on hand, not including the $50 million they netted from a January 2012 public offering. According to company officials, the company is capitalized through NDA filing, which they expect will take place in third quarter of next year.

With relatively low risk from a clinical, regulatory, and financial perspective, a current low cost to enter as an investment ($5.12 per share) and a steady stream of catalyst from news and clinical trials for the next few years to benefit its stock, Trius' value is apparent.

Trius is currently trading at $5.12 per share with a 52wk Range of 4.71 - 9.00, and a Market Cap of $197.82 Million.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72
hours.

--------------------------------------------------



http://seeki ngalpha.com/article/449561-trius-therapeutics-the-calm-before-the-storm


Tri us Therapeutics: The Calm Before The Storm

March 21, 2012


Biotech investing is often an exercise in "hurry up and wait". Once clinical trials are underway, there's not much for investors to do but wait and hope for positive news like partnerships, setbacks at competitors, or new additions to the pipeline. There's a risk that shares of Trius Therapeutics (TSRX) will go to sleep ahead of pivotal data in early 2013, but biotech investors may want to take a serious look at this under-owned name.

A New Antibiotic For A Market That Needs One

Despite the much-publicized rise of methicillin-resistant staphylococcus aureus (MRSA) and its growing threat to public health, antibiotic development is not a major priority for most large drug companies and biotechs. Some of this is due to difficulty (drugs that are very good at killing bacteria are often quite dangerous for the human taking them), but even more may be due to limited revenue prospects - the entire branded antibiotic market in the U.S. is smaller than the market for many individual cancer drugs.

This creates a real opportunity for Trius's lead compound tedizolid. Tedizolid is a 2nd-generation oxadolidinone that Trius is developing as an IV or oral antibiotic for gram-positive bacteria and conditions like acute bacterial skin and skin structure infections (ABSSSI), pneumonia, and bacteremia.

At this point, tedizolid is in a second pivotal Phase III study, with results due in early 2013. Based on the positive results of the first pivotal study, the odds look good for this drug and Trius could be in position to receive FDA approval as early as 2014. While Trius formed a partnership with Bayer (BAYRY.PK) to market the drug in emerging markets, Trius has held on the marketing rights in the U.S. and Europe and seems to be planning on launching the drug itself in the U.S.

The Benefits And Opportunity

Trius is not positioning tedizolid as a more efficacious antibiotic, but rather a safer and more convenient drug that offers no compromise in efficacy. In the first pivotal study, tedizolid showed fewer serious adverse events than Pfizer's (PFE) market-leading Zyvox (24% vs. 31%), substantially lower GI side-effects (16% v. 25%) and lower platelet suppression (9% vs. 15%).

Tedizolid was administered as a once-a-day pill for six days, whereas Zyvox was administered twice a day for 10 days. The measurements of efficacy for the two drugs were virtually indistinguishable.

The company's current pivotal study (#113) is a little different. It's designed as an IV-to-oral step-down study with a slightly different set of endpoints. Under an SPA with the FDA, Trius will be excluding early clinical failures and pain measurements, but the basic aims of the study are the same as in #112. While the #112 results were solid, investors should realize that no trial is risk-free - there is a chance that the FDA could look at reduction in lesion size vs. stoppage of lesion spread, for instance. That said, the efficacy results seen thus far would suggest that the drug should be approvable if the data from this second study is consistent with the first.

If and when approved, I believe that tedizolid will earn a spot as a drug-of-choice in many hospital settings. Doctors will continue to use vancomycin and Zyvox (particularly after it goes off-patent), but the safety and treatment time advantages of tedizolid should earn it significant usage - time is money in hospital stays and tedizolid holds the real prospect of shaving multiple days off of hospital stays. What's more, with its availability as a pill, tedizolid has definite usage advantages over Cubist's (CBST) Cubicin (which is only available intravenously).

I believe that tedizolid could reap $500 million in sales by 2019, with definite potential upside from broader usage in MRSA settings. The company is also looking to put tedizolid into advanced studies in pneumonia and bacteria, and the upside from those indications and broader MRSA usage could double that initial revenue estimate.

Weighing The Risks

Arguably the biggest risks for Trius shareholders right now are that something bizarre and unexpected goes wrong in the 113 study and/or the FDA finds serious nits to pick when the company files its NDA. Beyond that, too, are the normal risks that go with building a salesforce and conducting a product launch - risks that include the likely need for more capital.

Longer term, there are also competitive risks to consider. Despite increasing resistance and potentially serious side-effects, vancomycin still holds about 70% of the antibiotics market. Then there also other drugs on the market like Zyvox and Cubicin that doctors are already familiar with and comfortable using. Tedizolid has real advantages in safety and its administration profile, but these other drugs are not going to vanish.

Despite my initial lead-in about how relatively little antibiotic development there is, there are other companies with experimental antibiotics in trials. Cempra (CEMP) is looking to move Taksta into Phase 3 studies, and Durata and Rib-X also have antibiotics in advanced studies (dalbavancin and delafloxacin, respectively).

Rib-X also boasts Big Pharma support, as it signed an $800 million worldwide licensing deal with Sanofi (SNY) in mid-2011. That said, Rib-X seems to be positioning/preparing delafloxin more as a stronger/better alternative to vancomycin/Zyvox, as opposed to a safer/easier/more convenient antibiotic.

There's certainly room for more than one new antibiotic on the market, but investors should keep these would-be rivals in mind when thinking about the long-term revenue potential for tedizolid.

One final risk worth mentioning with Trius is the virtually non-existent pipeline behind tedizolid. While the company has some sponsored research activities aimed at developing more potential gram-positive and gram-negative antibiotics, the cupboard is currently bare. Antibiotics take less time to advance through trials than many other kinds of drugs, but the inability to find promising follow-on drugs will create some dis-economies of scale if Trius stays independent and builds out a U.S. salesforce.

The Bottom Line

Tedizolid has clean IP, a well-understood mechanism of action, and what looks like a clean efficacy and safety profile. What's more, it raises the very real prospect of an effective alternative for resistant hospital-acquired infections, as well as a means of shortening hospital stays and reducing overall treatment costs.

On the basis of $500 million in potential sales in 2019, a 30% discount rate, and some assumed future dilution, Trius shares could be worth nearly $12 today. This analysis assumes a future revenue multiple of 7x, which is arguably aggressive. The good news is that even using the much lower multiple of rival Cubist (3.6x) results in a target fair value north of $6 - certainly not so exciting, but still supportive of the idea that Trius is undervalued.

With the results seen to date in tedizolid, the need for new, better antibiotics, and the potential for a significant licensing agreement for European rights, Trius shares seem worthy of serious due diligence from biotech investors.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Profil supprimé

14 avril 2012 •08:57

April 9, 2012

Piper Jaffray Sees Increased Chance of Trius (TSRX) Partnering in Europe Following Tedizolid Data

The analyst suggested recent data on tedizolid could strengthen Trius' chances of partnering with a European company. The analyst maintains an Overweight rating and a $13 price target on shares of Trius.

drenan

14 avril 2012 •11:09

comment va ? t'as plus de biotechs en ptf ?

Ca m'arrangerait bien qu'elle décolle car j'en ai un paquet ;-)

Profil supprimé

14 avril 2012 •11:49

oui, j'ai pris du recul avec la bourse, j'y reviendrai quand je pourrai vraiment me le permettre...

si j'avais pu, j'aurais mis aussi un beau paquet sur TSRX, c'est sans doute la seule qui m'attire actuellement, j'espère que tu te les feras en or avec elle ;-)

jazmin

14 avril 2012 •15:49

Salut,

J'avais également repéré TRIUS car en matière de nouveaux antibiotiques, c'est zéro.
Mais je crains , si admis par la FDA, qu'il ne soit réservé qu'à des cas bien précis, comme les entérocoques résistants à la vancomycine et le staphylo doré résistant à la meticiline, afin qu'il ne devienne lui-même très vite résistant si galvaudé.

Il existe déjà une oxazolidinone sur le marché, le linézolide de Pfizer (ZYVOCID(R)) qui déjà n'est déjà administré que dans ces deux cas précis et pas plus de 4 semaines, vu les effets secondaires importants.

Profil supprimé

15 avril 2012 •13:11

à priori le seul catalyseur à court terme serait l'annonce d'un partenariat pour la diffusion de Tedizolid en Europe. Un autre partenariat est envisageable pour les USA, mais quand ? ...

mais il faut bien avoir conscience que Tedizolid appartient aussi à Donga Pharmaceutical ! et que Trius doit verser des paiements d'étapes à cette boite coréenne.

----------------------------------------------------

Milestone payments: USD8.6m—USD3.4m upon completion of US phase III clinical trials in 2012, USD1.7m upon FDA approval in 2013, and USD3.4m upon market
release in 2014 ... + Royalties: 7% of net sales

Global sales of super antibiotics effective at treating methicillin-resistant staphylococcus
aureus (MRSA) totaled USD 2.6b in 2011, and have been growing at a 10% clip for several years.

Pfizer’s Zyvox accounts for half the global market, with 2011 sales of USD 1.3b , and 38% of a US market worth USD 1.68b , with 2011 sales of USD 0.64b .

We estimate that DA-7218 ( Tedizolid ), which has proven faster and safer than Zyvox, will take 25% of Zyvox’s share ... applying a 90% success probability

Sales of DA-7218 ( Tedizolid )for the treatment of acute-bacterial and skin-structure infections to start in 2014 in the US, 2017 in the EU, and 2019 in emerging markets. Approval of pneumonia and bacteremia treatments (phase II trials are now occurring) to boost the drug's global market share from 3% in 2014 to 25% by 2019

Global market for Zyvox, annual growth in sales of which we expect to decline from 5% to 2%. Donga to sell DA-7218 ( Tedizolid ) for 10% less than Zyvox

voir le document
ci-dessous:

http://equity.co.kr/upfile/issue/
2012/04/06/1333686635374.pdf

-----------------------------------------------------

ça calme ... quel intérêt alors de se placer sur Trius ?
si c'est pour faire de la pv à CT, il y a sans doute mieux ailleurs, par contre sur le LT Trius semble offrir certaines garanties
elle me fait un peu penser à AIS ...( je n'ai jamais pu faire une grosse pv sur elle car trop impatient , alors que si j'avais su la garder , elle me l'aurait bien rendu...)

quelles sont ces garanties ? c'est sans doute subjectif , mais le partenariat avec Bayer où la présence de Wellington qui détient plus de 16% des titres peuvent inspirer confiance.

----------------------------------------------------

mais c'est surtout le management qui peut inspirer confiance, en particulier la présence du Dr Philippe G. Prokocimer comme chef médical


"Dr. Prokocimer, formerly a Vice President for Johnson & Johnson Pharmaceuticals and, before that Vice President of Anti-infectives Clinical Research with Aventis Pharmaceuticals, has been developing anti-infective drugs for the past 20 years and has been involved with the filing of five New Drug Applications (NDAs) including the antibiotics Doripenem, Synercid, Zagam (sparfloxacin) and Biaxin."


http://www.firstwordplus.com/Fws.do?articleid=610FFEB299
004DAEAE960B1B1769 0207

"Postes précédents:
-VP Drug Evaluation chez Johnson & Johnson Pharmaceutical Research & Development
-Vice President Clinical/Regulatory chez Aventis Pharmaceuticals, Inc
-Vice president Anti-Infective Clinical Research chez Aventis
-Vice President Anti-Infectives chez Rhone-Poulenc Rorer (became Aventis)
-Vice President A-I Clinical Research chez Rhone-Poulenc Rorer
-Vice president Anti-Infective Clinical Research chez Rhone-Poulenc Rorer, Aventis, Aventis Behring
Medical Director chez Abbott Laboratories
Formation: Université Pierre et Marie Curie
(Paris)"

http://www.linkedin.com/pub/
philippe-prokocimer/8/62/80

-- ---------------------------------------------------

le marché des antibios est à renouveler, l'équipe de Trius l'a bien compris, seulement huit nouveaux antibiotiques ont été approuvés depuis 2003 alors que les bactéries deviennent de plus en plus résistantes

ce qui pourrait être intéressant c'est ce qu'ils font en amont, au stade pré-clinique

"Trius Therapeutics initiated IND-enabling studies in December 2011 for a Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and
Pseudomonas."

http://investor.triusrx.com/releasedetail.cfm?ReleaseID=65 6785

ou leur programme de recherche de nouveaux antibios grâce aux
algues

http://www.triusrx.com/trius
-therapeutics-marine-natural
-products- program.php

si du jour au lendemain ils nous annoncent la découverte d'un nouvel agent antibio très prometteur suite à des essais sur des animaux, ça peut très bien booster le cours de l'action

"Antibiotics are also attractive because, unlike in other therapeutic areas, the results of preclinical efficacy and safety studies are highly predictive of clinical success. In other words, if an antibiotic effectively kills bacteria and is determined to be safe in animal models, it has a high likelihood of performing similarly in humans in clinical
trials."

http://info.agscientific.com/blog
/bid/108104/Trius-grows-as-l ead
-antibiotic-moves-forward

en extrapolant un peu, leurs potentielles découvertes pourraient susciter la convoitise d'autres biopharmas telles que Cubist Pharmaceuticals ou même de plus gros groupes...


mais bon, c'est vraiment subjectif...
je me souviens avoir eu un bon à priori sur CYCC, alors que par la suite j'ai pu me rendre compte qu'elle avait tout d'une "zombie biotech" comme dirait Sacha ...
ou même Adeona ( qui a encore changé de nom ;-))) pour devenir Synthetic Biologics , tout un progamme...) que j'ai toujours considéré comme une coquille vide, ce qui ne l'a pas empêché de monter ces derniers temps de 0.50 à plus de 2.50$...


donc tout est relatif ...

je perçois Trius comme un gage de sécurité pour un investissement LT mais il se pourrait bien que ce soit qu'une boite d'opportunistes qui profitent d'être sur le marché pour s'en mettre plein les poches...

http://www.secform4.com/
insider-trading/1356857.htm


l'avenir plus ou moins proche nous dira ce qu'il en est réellement...


en complément, vous pouvez regarder leur dernière présentation et la dernière note de Napodano sur
Trius:


http://investor.tri
usrx.com/events.cfm


http://www.wall-street .
com/wp-content/uploads/
2011/12/TSRX_SCIR.pdf


bon dimanche ...

Profil supprimé

18 avril 2012 •12:43

au sujet de leur programme pré-clinique GyrB/ParE:

"This could be the first truly novel class of broad-spectrum antibiotics that are active against all known resistant strains" ... ( dixit le boss
)


http://www.genengnews.com/gen-articles/tackling-drug-resistant-bacterial- infections/4068/


Tackling Drug-Resistant Bacterial Infections

Carol Potera

Trius Therapeutics’ Second-Generation Oxazolidinone Targeted at MRSA


New antibiotics are desperately needed to treat serious drug-resistant gram-positive bacterial infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which place an increasing burden on healthcare resources. To address this need, Trius Therapeutics is testing a second-generation oxazolidinone antibiotic, called tedizolid phosphate, in Phase III clinical trials. Pfizer’s Zyvox® (linezolid) is a first-generation oxazolidinone approved to treat MRSA, and it is the only marketed oxazolidinone.

Previous clinical and nonclinical testing showed that tedizolid has better potency and safety profiles than Zyvox, according to Trius. In fact, the firm claims that tedizolid is four to eight times more potent than Zyvox against both MRSA and vancomycin-resistant enterococci. Other advantages Trius notes for tedizolid include highly efficient oral absorption, rapid in vivo bactericidal activity, and once-daily oral or intravenous (IV) administration. Hospitalized patients treated with the IV drug can be transitioned to the oral form when they are discharged from the hospital.

“It’s unusual in the antibacterial marketplace to have only one member of a drug class,” says Jeffrey Stein, Ph.D., president and CEO. Starting in 2005, Dr. Stein searched worldwide for 18 months to find antibacterial compounds with compelling preclinical efficacy and safety data. He discovered tedizolid at Dong-A Pharmaceutical in South Korea and licensed the compound in 2007.

A Phase I trial in 2008 conducted by Trius compared tedizolid to Zyvox and the results confirmed the potential of Trius’ new drug, Dr. Stein reports. “We were prepared to terminate the development of tedizolid if it did not demonstrate a potential safety advantage over Zyvox in this 21-day study,” he says.
Selective Modifications

Oxazolidinones are small molecule drugs that bind to 23S ribosomal RNA in a specific location and inhibit protein translation. Unlike Zyvox, tedizolid lacks an acetamide group, long assumed to be essential for oxazolidinones to bind to their targets. Strains of MRSA become resistant to oxazolidinones due to mutations at the acetamide site.

“Eliminating the acetamide group minimizes the ability of pathogens to evolve resistance mutations,” says Dr. Stein. Pathogens become resistant to tedizolid 10 times more slowly than to Zyvox, he remarks.

Scientists at Dong-A made tedizolid even better by replacing the acetamide group with a smaller hydroxy methyl group and then adding a phosphate. This makes tedizolid a highly soluble, yet inactive prodrug. The body’s natural serum phosphatases cleave the phosphate ester bond, releasing a highly soluble and active molecule. The highly soluble phosphate group also allows for IV formulation and improves oral bioavailability.

In general, when oxazolidinones are modified to improve potency, they become less soluble and more difficult to formulate as IV drugs. The Korean scientists found “a very clever solution to a problem facing those trying to develop second-generation oxazolidinones,” says Dr. Stein.

Trius Therapeutics announced results of its Phase II trial in June 2009. Patients with complicated skin infections were treated orally with tedizolid for five to seven days. The overall cure rate was 98% for the 200 milligram dose, and patients with MRSA skin infections had a 100% cure rate.

Trius is running two Phase III trials. Top-line data from the first Phase III trial was released in December 2011. The primary endpoint of efficacy noninferiority to Zyvox was met, and noninferiority for safety was also demonstrated, Dr. Stein reports. The second trial is an IV-to-oral transition study, which is still ongoing.
Marine Microbes Next

The preclinical program at Trius focuses on GyrB and ParE, both targets of gram-negative bacteria. GyrB and ParE are needed for DNA replication. They are part of macromolecular complexes that are targeted by the well-known quinolone class of antibiotics. “Our GyrB compounds are hitting the same macromolecular targets as quinolones, but at different binding sites. This makes our lead compounds active against quinolone-resistant pathogens,” says Dr. Stein.

Trius researchers engineered compounds with broad-spectrum activity against gram-negative pathogens like Pseudomonas and Klebsiella as well as gram-positive pathogens like MRSA. A lead series of compounds show good potency in animal efficacy studies, Dr. Stein reports. “This could be the first truly novel class of broad-spectrum antibiotics that are active against all known resistant strains,” he says.

A second preclinical program focuses on a collection of molecules being developed at the Scripps Institute of Oceanography. The antimicrobial agents are derived from marine strains of Streptomyces, a common soil microbe and previously a rich source of antibiotics. However, “Streptomyces in soil has been tapped out with respect to chemical diversity,” says Dr. Stein. The Scripps scientists discovered marine strains with complex metabolic processes and novel chemical diversity. They are screening libraries to identify candidates with potent antimicrobial activity.

Trius Therapeutics benefits from a two-tiered funding structure. The development of tedizolid is backed by private and public investors, whereas federal grants support investigations of the early-stage broad-spectrum antibiotics and marine microorganisms.

The National Institute of Allergy and Infectious Diseases has awarded Trius $27.7 million, and the Defense Threat Reduction Agency has given $29.5 million to identify and develop novel antibiotics or countermeasures for biodefense threats.

“With this structure, our investors’ dollars are focused on our late-stage programs. Yet they can benefit from the potential upside of our early-stage programs if any of them progress into the clinic,” says Dr. Stein.

Profil supprimé

20 avril 2012 •09:58

alors que les analystes la voit environ à 12-13$ ...
c'est à se demander ce qu'elle attend pour y aller , une petite annonce peut-être ?

05/12/11 - Oppenheimer initiates coverage on Trius Therapeutics with an Outperform. PT $12.00

17/01/12 - Canaccord Genuity Analysts Reaffirm a 'Buy' Rating on Trius Therapeutics. PT $12.00

26/01/12 - Robert W. Baird Analysts Reaffirm an 'Outperform' Rating on Trius Therapeutics. PT $13.00

12/03/12 - Ladenburg Thalmann maintains its Buy rating on Trius Therapeutics. PT $14.00

09/04/12 - Piper Jaffray says Trius Therapeutics remains a top small-cap pick for 2012 and reiterates an Overweight rating. PT $13.00

Profil supprimé

20 avril 2012 •12:51

les analystes la voit entre 3 et 5$...

21-Dec-11 MLV & Co $4
27-sept-11 Oppenheimer $4
12-sept-11 Canaccord Genuity $3
07-Jul-11 Rodman & Renshaw $5
05-Jul-11 Oppenheimer $4
25-mars-11 JMP Securities $5

..et aussi Wedbush 5$ (2012)

moi je fais gaffe avec les analystes. ça vient appuyer mon sentiment. mais j'ai un manque de confiance marqué envers eux

Profil supprimé

20 avril 2012 •13:19

en effet, impressionnant leurs objectifs sur ZLCS

ce qui soulève une autre question: quels critères utilisez-vous pour vous placer sur une biotech ?

certains utiliseront l'analyse technique, d'autres tenteront de se placer avant une décision FDA ou l'annonce de résultats

en ce qui me concerne, j'essaie de soupeser tout ce que je peux trouver sur la boite mais c'est clair que ce qu'il en résulte n'est qu'une question de feeling

pas facile d'investir sur une biotech, la part d'incertitude et de risque y est énorme, mais le gain peut être bien supérieur à ceux des autres secteurs, c'est sans doute pour ça que nous sommes là...

Profil supprimé

21 avril 2012 •09:01

"19th annual Future Leaders in the Biotech Industry"

vous la trouverez sur cette page:

http://investor.triusrx.com/events.cfm


voir page 10 et 11 : efficacité sur la cellulite


page 37 : partenariat européen est situé au T2 2012


page 40 et 41 : performances de Gyrase / Gram -

Profil supprimé

01 juin 2012 •13:37

Trius: Tedizolid Prospects In MRSA Lead To Initiation With A Buy

June 1, 2012

Introduction

Trius Therapeutics (TSRX) is in late stage clinical development of its new antibiotic, tedizolid, for treatment of MRSA infections that have increased to epidemic levels in both the hospital and community settings. There are a number of companies competing in this market and a host of new products in development, but I see tedizolid as the most promising of the new products.

This report is a summary of a more detailed report that I have published on my website. It contains tables that support projections presented in this report.

Investment Thesis

I project that tedizolid will be approved and launched commercially in the US and Europe in 2H, 2014. I have projected a launch that produces US sales of $39 million in 2015, $137 million in 2016 and $625 million in 2020; international sales should be comparable. I think that the valuation based on 2020 worldwide sales of $1.2 billion could be 3x revenues (or more) reflecting the long patent life (through 2029) and continuing strong growth potential beyond 2020; this would result in a market capitalization of $3+ billion and a stock price of $60+ around the 2020 timeframe.

I know that this argument arouses skepticism in some investors who want to know what is going to happen to the stock in the next year or month or nanosecond and would point out the inherent inaccuracies in long term forecasting. I understand this, but my purpose in doing such a long term projection is to show the value in the franchise that a potential pharmaceutical partner or acquiror or long term investor might see in the franchise.

The stock does face headwinds and uncertainties over the next three years. The outcome of the second phase 3 trial that will be reported in early 2013 will be a critical binary event and while the success of this trial is made highly probable by the safety and efficacy shown in the first phase 3 trial, there is never a guarantee of success. Trials can sometimes fail for execution reasons even though the drug may be effective. Failure would cause a sharp decline in the stock price.

Even if the results of the trial are successful, the company still faces the challenge of gaining approval. In response to the majority of newly submitted NDAs, the FDA frequently issues Complete Response Letters which are often related to non-clinical sections of the NDA such as chemistry, manufacturing and control. A CRL usually delays approval by a year or two. It has also been the case that recent new product launches have been disappointing (at least initially) and investors will be wary of the initial launch phase. It could be 2016 before the outcome of all of these issues are known and put behind the company, a time frame that is forever in the current short term focused market.

The trial uncertainty and the potential for a CRL at the probable PDUFA date in mid-2014, is likely to restrain investors' near term enthusiasm toward the stock. However, there are other aspects to the investment equation that are compelling. Tedizolid has the potential to be one of the most important antibiotics for treating the MRSA epidemic over the next decade. While impatient investors focusing on day to day events may not find this particularly compelling, potential pharmaceutical partners or potential pharmaceutical acquirors could.

I think that there is a high probability for a partnering deal for Europe alone or perhaps the US, Canada and Europe later this year or in early 2013 that would bring in a significant upfront payment. Bayer has already licensed tedizolid for all other countries of the world for an upfront payment of $25 million. Another large upfront fee later this year from a licensee could cause a significant move in the stock.

However, the most upside potential for Trius in the short term comes from the possibility of an outright acquisition by a big pharma company. The prospect of acquiring a product that appears to be a meaningful improvement on Zyvox, which is in late stage development and has a strong patent position, would be a compelling investment opportunity for many big pharma companies. I think that there is a reasonable possibility that this will occur. Turning the product over to a bigger company would produce an excellent return for shareholders and avoid the time and risk involved in commercializing tedizolid. I think that a takeover bid on the order of $12 to $15 is possible (market capitalization of $450 to $570 million).

I am recommending the stock on the basis of these arguments. The current market capitalization of $200 million is not much more than is sometimes accorded to venture capital investments with far less probability of success. I think that patient investors can buy the stock and over the next five to ten years it could be a very rewarding investment. This is made more interesting by the potential for a partnering deal that could cause a meaningful bounce in the stock or an outright acquisition that could double or triple the stock overnight. I think that the most reasonable risk in the risk reward equation is that the stock will be boring over the next year or two or three, particularly if the company receives a CRL. I recognize that there is very significant downside risk down to the $1 to $2 level if the second Phase 3 trial fails, but I think the probability is small.

Perspective on the MRSA Antibiotic Market

Staphylococcus aureus is arguably one of the greatest bacterial threats to mankind. It is a rapidly growing and particularly virulent bacterium that is often involved in infections involving the skin and skin structure tissues, lungs, blood stream (bacteremia) and other organ systems. Each copy of Staphylococcus aureus can reproduce itself every half hour so that one bacterium can produce over 1 trillion copies in just 20 hours. This rapid reproduction rate enables frequent genetic mutations that through natural selection results in strains of Staphylococcus aureus resistant to antibiotics that could once effectively treat them.

Resistant strains of Staphylococcus aureus are referred to as methicillin resistant Staphylococcus aureus or MRSA as opposed to methicillin susceptible (MSSA) strains. Methicillin in the late 1960s was the preferred antibiotic but due to the emergence of resistance, it is no longer effective or in in use. The term MRSA is now broadly applied to Staphylococcus aureus strains that are resistant not only to methicillin, but to many antibiotics of the important penicillin and cephalosporin classes.

A healthy human immune system can generally deal with bacterial infections, but for MRSA or MSSA infections even people with healthy immune systems are still vulnerable to these extremely aggressive pathogens. When Staphylococcus aureus gains access to the interior of the body through open wounds, cuts, burns or intravenous catheters, its rapid replication can overwhelm the immune system and antibiotic support becomes critical. Without effective antibiotic therapy, the outcome can be devastating. Both MRSA and MSSA cause very dangerous infections, but the antibiotic options for MSSA are less making it a greater problem.

There are currently six drugs approved for MRSA: generic vancomycin, Pfizer's (PFE) Zyvox, Cubist's (CBST) Cubicin, Forest Laboratories' (FRX) Teflaro, Pfizer's Tygacil and Theravance's (THRX)Vibativ. The pharmaceutical industry has responded aggressively to the medical need for new drugs effective against MRSA as there are at least 9 new drugs in phase 2 or 3 development. Two of these, Durata's (privately held) dalbavancin and The Medicine Company's (MDCO) oritavancin are as far along in regulatory development as tedizolid. Both have promise, but tedizolid, in my opinion, is the most promising new agent in late stage development.

The most widely used drug for treating MRSA is vancomycin, which was first introduced in 1958 and has been the "go to" drug for MRSA ever since. Because of increased vancomycin usage, strains of Staphylococcus aureus are becoming less susceptible. In 2005, 3% of MRSA strains displayed intermediate resistance to vancomycin and this number increased to 11% by 2009. US sales of the six approved drugs reached $1.8 billion in 2011 led by Cubicin with $699 million, Zyvox $640 million and vancomycin $289 million. The sales figures are not representative of unit usage because Cubicin is priced at about $252, Zyvox at $200 for oral and $225 for IV and vancomycin at $15 per patient day, respectively. I estimate that there were 28 million patient days of therapy in 2011 with vancomycin accounting for 74%, Zyvox 11% and Cubicin 11%.

If vancomycin were priced at $225 per patient day of therapy or midway between Cubicin and Zyvox, it would be a $4.6 billion product. Looked at in this way, the market addressed by tedizolid is a $5.8 billion opportunity. Assuming pricing of $235 per day for tedizolid, each 1% of market share that it gains in the US is roughly $65 million of sales and worldwide could be about double that or $130 million.

The Potential Role of Tedizolid in MRSA

Tedizolid is the second drug from the oxazolidinone class of antibiotics in which Zyvox was the first. Tedizolid offers major improvements over Zyvox even though Zyvox is a very effective drug that is generally considered superior to vancomycin. Tedizolid is bactericidal in vivo while Zyvox is bacteriostatic. In vitro, it is 4 to 16 times as potent against MRSA and MSSA. Tedizolid is dosed once a day versus twice a day and requires a shorter length of therapy. It offers improved tolerability in short term usage and doesn't appear to have certain drug interactions associated with Zyvox. For longer term therapy, it does not appear to depress blood platelets, which is a concern with Zyvox. As with Zyvox, patients can easily be switched from an intravenous to oral dose.

I think that tedizolid has a very significant commercial and medical opportunity, but as is always the case there are investment concerns. Upon the introduction of each new antibiotic, the argument always arises that it should be used sparingly and only after other antibiotics have been tried and fail. The premise is that exposure of a new antibiotic to bacteria will inevitably lead to the emergence of resistance and exposure in the early years should be kept to a minimum so that there will be a drug of last resort. If this were to be widely accepted by the medical community, tedizolid would only be used after vancomycin, Zyvox and Cubicin have been judged to be ineffective either through clinical use or laboratory tests.

A second concern is that the Zyvox patent expires in May 2015 in the U.S. and Cubist has reached a settlement that allows Teva to introduce a generic to Cubicin in 2018. Investors have seen that when major products in other therapeutic categories went generic, it switched usage from other branded products to the newly generic agents. Cost conscious hospital formularies and health care plans jump on the opportunity to reduce costs by incenting generic prescribing.

I think these issues, while legitimate, will not prevent tedizolid from becoming a very successful drug. MRSA is different from many diseases in that it can become life threatening within days of the patient presenting at an emergency room or developing an infection in a hospital. Such infections require aggressive and effective intervention. This is not like treating a slowly progressing chronic disease such as hypertension. Physicians don't have the time to try the least expensive generic first and then switch to a branded product. They need to prescribe the drug which their experience suggests will have the best immediate chance of curing their patient. The concern about overuse of a new antibiotic and its cost are not at the top of the physician's prescribing check list.

The experiences with Zyvox and Cubicin support my point; both were accepted into widespread clinical practice even though vancomycin is generic. This is not to say that physicians should or will use new drugs promiscuously and ignore the "hold in reserve" argument or any price consideration in their prescribing decision. Indeed, vancomycin still accounts for 74% of patient days in the MRSA antibiotic market. It is just that these issues aren't so dominant that they preclude the potential for tedizolid's success. When the chips are down and the physician is faced with a life threatening Staphylococcus aureus infection, he will choose the antibiotic that he thinks has the best immediate chance of curing the patient.

A third issue to consider is that tedizolid will initially be approved only for use in skin and soft tissue infections (ABSSSI) which accounts for about 30% of infections caused by Staphylococcus aureus. The approval in "skin" could come in 2014. It is not likely to be approved for pneumonia until 2016 and bacteremia will be somewhat later. Skin and soft tissue infections, while quite serious, are easier to treat and the competitive advantages of tedizolid are less compelling.

It is in pneumonia, bacteremia and other infections requiring long-term treatment in which tedizolid may offer the most significant therapeutic advantages. While it will take two or more years after tedizolid's initial approval to gain these additional indications, physicians can use a drug off-label and I think there will be considerable off-label prescribing of tedizolid. In 2004 and 2005 during the early days of the Cubicin launch, it was only approved for skin and soft tissue infections, but Cubist reported that about 50% of its use was off-label. Importantly, Cubicin is not effective in lung infections so that most of this off label usage was in bacteremia and endocarditis. The off-label usage has now dropped to about 25% with the approval of Cubicin in bacteremia.

Zyvox achieves about 40% of current sales in off-label indications, primarily in bacteremia and infections requiring long-term therapy. This is importantly due to its being available in an oral dosage form; vancomycin and Cubicin can only be given IV. Zyvox failed to reach its primary endpoint in a bacteremia trial, but it is estimated that 15% of its use still occurs in bacteremia.

Sophisticated physicians will weigh the advantages shown by tedizolid against Zyvox indicated by in vitro, animal and clinical studies and will make their prescribing decisions almost as much on these factors as the label. I expect meaningful off-label prescribing in pneumonia and bacteremia before tedizolid is formally approved for these indications. This will usually be in infections not responding to vancomycin, Cubicin or Zyvox or infections requiring long-term therapy in which oral dosing provides a significant benefit. Because of its potential superiority to Zyvox and because Cubicin is ineffective in lung infections, I see considerable potential in pneumonia.

Development of New Antibiotics for MRSA is Intense

If there is caution by investors about the commercial potential for new antibiotics effective against MRSA, it is not shared by the pharmaceutical industry. There are a large number of companies that are developing MRSA antibiotics and I am aware of 9 drugs in phase 2 or 3 development. This competitive onslaught will also be part of the investment discussion around Trius and tedizolid.

I find three new products to be of the most interest. The privately held company Durata (just filed an S-1) is developing dalbavancin and The Medicines Company is developing oritavancin. Both belong to the glycopeptide class of antibiotics of which vancomycin is the charter member. They are on the same development timeline as tedizolid and both will be revealing topline data from phase 3 trials in 2013 and depending on the outcomes could be filing NDAs in 2013 at about the same time as tedizolid. The third product is Forest Laboratories' Teflaro (ceftaroline), a fifth generation cephalosporin antibiotic with good activity against MRSA that was introduced in 2010; Forest is guiding for sales on $65 million for the year ending March 2013.

Both dalbavancin and oritavancin have previously had NDAs submitted that were not approved by the FDA. Based on my research, I am inclined to think that these rejections were due to trial design. My working view is that both are effective agents, but this can only be determined when phase 3 data is released in early 2013. The major differentiating point for both of these drugs is their administration. Dalbavancin requires an initial IV infusion followed by a second infusion seven days later. Oritavancin requires just one infusion.

Durata and The Medicines Company argue that these drugs will be highly cost effective. A patient showing up at the emergency room can be given an injection and sent home without the need for costly hospitalization. Tedizolid would require an initial IV infusion or oral dosage followed by five days of once-a-day oral therapy in this setting. The assured compliance of dalbavancin and oritavancin could be preferred in some cases.

The dosing advantage of dalbavancin and oritavancin would be most meaningful for the least severe skin and soft tissue infections caused by MRSA. This is not an insignificant market as recent reports indicate that about 60% of the patients showing up at emergency departments with skin and soft tissue infections have MRSA. Of these, about 25% of patients are admitted to the hospital. There are significant cost advantages and health benefits in keeping patients out of the hospital. The hospital is no place to be sick because of the risk of acquiring a new infection.

Patients presenting at an emergency room with the most severe skin and soft tissue infections, pneumonia and bacteremia would almost certainly be admitted to the hospital for medical management of their conditions and observation. Patients with less severe skin and soft tissue infections might receive dalbavancin or oritavancin. I have seen no estimates on how much of vancomycin, Zyvox and Cubicin use is currently in this patient population that can potentially be treated in the emergency room and sent home. My guess is that it is significant and growing rapidly. This market segment is also being treated with generic agents that have activity against community-acquired MRSA, such as clindamycin and trimethroprim combined with sulfamethoxazole. These are unapproved usages.

Patients who show up at the emergency room and who are then admitted are usually treated by an emergency room physician who would likely prescribe vancomycin if MRSA is suspected or a cephalosporin like Keflex if MSSA is believed to be the causative agent. The emergency room physician treats empirically without knowing the cause of the infection might be. Accurate identification requires that a culture be taken and sent to the laboratory which reports back in 24 to 48 hours on what the bacteria is. If the results come back as MRSA, the infectious disease physician or other physician assuming care of the patient would choose to continue vancomycin if already prescribed or if not, shift to vancomycin, Zyvox or Cubicin depending on their judgment and the epidemiology in the hospital. It is unlikely that a patient who is going to be admitted to the hospital would be started on dalbavancin or oritavancin.

Both of these drugs have certain reimbursement issues. Zyvox and Cubicin are priced at about $2,000 per course of therapy. If dalbavancin were priced equivalently each infusion would cost $1,000 and oritavancin would be priced at $2,000 for its only infusion. The cost per course of therapy is the same, but there might be sticker shock at the price of these drugs versus $225 per day for Zyvox and about $252 for a Cubicin infusion.

The hospital might also have another subtle reimbursement issue that could give it pause on these two drugs. In the case of a patient who is admitted to the hospital for say one day, the cost of treating with oritavancin is $2,000 per the previous example and $1,000 for dalbavancin versus $225 for Zyvox and $250 for Cubicin. In the case of Zyvox and Cubicin the remaining cost of therapy would be the responsibility of the patient's health insurance plan. The cost of drug therapy is probably only 10% to 20% of the total cost of a stay in a hospital for a MRSA infection, but a savings of $600 to $1,600 is not insignificant.

I see other issues that have to be addressed by these two drugs. I think that they have the potential to carve out meaningful market niches, but I don't see the dosing advantage as being profound. There will be questions on pharmacokinetics with these long acting drugs and how they might be administered in more severe infections in which the doctor might want to increase the dose. Also in long-term infections requiring 10 to 60 days of therapy there might be a difficulty in scheduling doses.

Teflaro is a different therapeutic consideration. It is quite effective in infections in patients who have or are suspected of having a mixed infection caused by both gram positive and gram negative infections such as occur in severe skin and soft tissue infections, pneumonia and bacteremia and particularly in intra-abdominal infections. Currently in these types of infections with MRSA involvement suspected, the patient is treated with vancomycin, Cubicin (except in pneumonia) and Zyvox in combination with a drug that protects against gram negative bacteria; aztreonam is often used.

Using one drug instead of two is an advantage. However, Teflaro loses this advantage if Pseudomonas aeruginosa is involved and it is frequently involved or suspected of being involved when therapy is started; Teflaro is not active against Pseudomonas aeruginosa. Physicians also avoid using broad spectrum antibiotics if possible due to the side effects inherent in wiping out large elements of bacteria in the bowel. I see Teflaro as having a meaningful niche in mixed infections with MRSA involvement, but its niche is somewhat different from vancomycin, Cubicin, Zyvox and tedizolid. Teflaro also is hampered by the requirement for twice a day IV infusions for 5 to 14 days.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72
hours.


http://seekingalpha.com/article/630141-trius-tedizolid-prospects-in- mrsa-lead-to-initiation-with-a-buy

http://smithonstocks.com/component/content /article/3/261-trius-therapeuticsarsquo-tedizolid-has-blockbuster-potential-for- mrsa-infections-tsrx-505

drenan

18 juin 2012 •18:03

signer un partenariat d'ici la fin du S2 ... On y arrive !

Profil supprimé

24 juin 2012 •10:15

-SunTrust initiates on TSRX (Buy / 13$)

-In Vitro activity data shows high potency of tedizolid vs. linezolid (Zyvox) for MSSA and MSRA

http://bit.ly/LJi5dQ

-study showed that tedizolid was 4-fold more potent against PRSP isolates in vitro than linezolid and that tedizolid phosphate administered orally or intravenously to mice was effective in vivo against systemic infection with PRSP isolates.

Oral tedizolid phosphate was also effective in vivo against pneumonia induced with a PSSP strain.

These results warrant further investigation into the pharmacodynamics of tedizolid phosphate in the respiratory tract, as well as clinical evaluation of tedizolid phosphate for the treatment of pneumococcal
infections.

http://bit.ly/MNUfyF

Profil supprimé

03 août 2012 •19:47

inutile d'insister; belle perte...

je ne la sens pas trop cette hausse ( bull trap ? ) sur les indices

prisuttu

06 septembre 2012 •19:09

je sens qu il y en a un qui va encore se faire couil lonner ..............

prisuttu

17 septembre 2012 •18:19

no comment ......

Profil supprimé

18 janvier 2013 •16:49

déjà 3.5M de titres échangés après 1 heure de cotation... sans doute le volume d'échange le plus élevé depuis que Trius est en bourse, mais que faut-il en conclure ? à chacun son interprétation...

Profil supprimé

19 janvier 2013 •07:56

environ 20% des titres en circulation qui changent de main...
le plus étonnant c'est que certains en ont pris à 5$ et que presque tous les échanges se sont fait au-dessus des 4.75$ de l'AK...
va comprendre ...

Profil supprimé

19 janvier 2013 •10:38

je lis ici et là " wouais s'ils font une AK c'est qu'ils n'ont pas trouvés de partenaires " ... " les résultats de leur seconde phase III ESTABLISH-2 seront mauvais " ... " pourquoi lever que 29M$ ? ils devront refaire une AK d'ici fin 2013 "... et blablabla et blablabla...

et si, tout simplement, cette AK servait juste à financer leurs études en cours ou futures ?

pipeline:

bitly.com/U8qeyf

présentation du 07/01/2013:

bit.ly/XL8wAr

un article intéressant de Napodano:

bit.ly/XLa5hR

zachari

21 janvier 2013 •16:27

bon, dèjà attention à la petite : A très court terme, ce sera du +60% ... ou du -60% cette histoire

mon avis suite à AK TSRX - 18 janv. (Il y a 3 jours):

>SITUATION

Hier, TSRX a annoncé le 17/01/2013 envisager lever du Cash. Cette levée de Cash m'a étonné car la société disposait de 76 Millions $ en Cash au 30/09, suffisant pour tenir théoriquement durant 6 trimestres - soit jusque Mars 2014.

Mais souvent une biotech cherche à lever du Cash 2 ou 3 trimestres avant qu'elle ne soit en manque. Pour TSRX, la levée de Cash est étonnante car:

Mars 2014 - 2 trimestres = levée de Cash théorique au mois de Septembre 2013
Mars 2014 - 3 trimestres = levée de Cash théorique au mois de Juin 2013

La date théorique de levée de Cash aurait donc été autour de mi-2013..

Qu’est-ce qui justifie cette levée de Cash maintenant ?

Je pense que la société a en fait souhaité lever du Cash :
1-pour sécuriser son financement en cas de mauvais résultats cliniques (il aurait fallu diluer davantage, d’autant que le cours avait entamé une progression de +15% depuis le début 2013);
2-pour pouvoir avoir assez de Cash en vue de démarrer de nouvelles études cliniques.

>AUGMENTATION DE CAPITAL

La plupart des sociétés Small Caps ont un Cash flow négatif. Elles ne peuvent bien souvent éviter de procéder à des Augmentations de Capital qui sont la plupart du temps dillutives pour les actionnaires - sauf si ce sont des filiales ou bien des sociétés qui ont un contrat de partenariat. Dans tous les cas, il est toujours difficile de savoir quand une société fera une Augmentation de capital.

Hier, après l’annonce de la société de vouloir le ver du Cash (via publication auprès de la SEC d’un formulaire de PUBLIC OFFERING :
http://files.shareholder.com/downloads/ABEA-43S70D/2276594344x0xS1193125-13-1604 8/1356857/filing.pdf

On ne savait pas le montant qui sera levé ni à quel cours.. C'est simplement un document de référence remis auprès de la SEC qui indique que la société s’apprête à lever du Cash. Aujourd’hui, TSRX annonce plus de Détails sur sa levée de Cash via un PRICING PUBLIC OFFERING : http://investor.triusrx.com/releasedetail.cfm?ReleaseID=734346

6,3 millions de titres vont être créés à un cours de 4,75$ ; C’est une dilution d’environ -10%. C’est pour cela que le titre devrait être en baisse de -10% aujourd’hui avec un cours proche des 4,75$ à l’ouverture. Le montant brut levé ressort à 29,9 millions $.

Quelques exemples récents d’Augmentations de capital sur des biotechs:

1/ SRPT
Le 12/12/12, SRPT avait annoncé une Augmentation de capital (public offering) et le 13/12/12, SRPT annonçait le montant : 4,95 millions de titres à un cours de 25,25$:
http://investorrelations.sareptatherapeutics.com/phoenix.zhtml?c=64231&p=iro l-news&nyo=1
Le cours de SRPT n'avait pas baissé dans les séances qui ont suivi parcequ'il n'y avait pas de dilution..

2/SCMP
SCMP par exemple a fait la même chose il y a 1 semaine et le titre n'a pas baissé.. Le 11/01/13, la société a publié un document en prévision d'une éventuelle levée de Cash (S-3) de 150 Millions $:
http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-SECText&TEXT=a HR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTg2NTMyNDgmRFNFUT0wJlNFU T0wJlNRREVTQz1TRUNUSU9OX0VOVElSRSZzdWJzaWQ9NTc%3d
Le titre SCMP a peu bougé suite à cette annonce..

3/AVEO,ALNY,ITMN,ONXX,THRX
La semaine dernière, 5 autres biotechs ont annoncé lever du Cash;
la réaction à ces annonces a été différente selon les titres :
http://finviz.com/screener.ashx?v=211&t=AVEO,ALNY,ITMN,ONXX,THRX

>PLAN DE TRADING

Au final, pour TSRX : le nombre de titres créés est important, mais c’est généralement ce qui est observé (c’est même dans le bas de la fourchette de 10 à 20% de nouveaux titres créés).. pour le moment, pas d'autre choix de conserver ma Position en attente du prochain catalyseur (résu phase 3 ESTABLISH). Le marché a bien réagi avec cette annonce (clout > cours d'AK); J'aurai bien aimé renforcer de 200 à 300 titres entre 4,5 et 4,75$ pour abaisser mon prix de revient (5,3$)..

NB : voici une sélection de titres biotechs qui pourraient bien se comporter prochainement et sur lesquels j'envisage de prendre position à TCT >>

-ARRY : Achat sous les 4$ (Newsflow très favorable et pipeline avancé) ... POTENTIEL DE +20% SELON MOI ; POTENTIEL DE BAISSE DE -20%;
-ADXN : Achat proche des 10 CHF (Partenariat attendu au T1 2013) ... POTENTIEL DE HAUSSE DE +50% SELON MOI ; POTENTIEL DE BAISSE DE -20%;
-ALHYG : Achat proche des 0,90€ (Résultats Phase 2 dans la LLC avant Mars 2013)... POTENTIEL DE HAUSSE DE +30 A +50% SELON MOI ; POTENTIEL DE BAISSE DE -20% à -30%.

à suivre,
Sacha

Profil supprimé

26 janvier 2013 •18:46

oui Sacha, je pense aussi qu'en cas de résultats décevants de leur phase III ESTABLISH-2 ce sera du -60%
par contre s'ils sont bons, cette affaire peut aller beaucoup plus haut qu'un simple +60%, pas en une seule journée mais d'ici fin 2013 je la verrais bien dans une fourchette située entre 10$ et 14$, si et seulement si les résultats attendus sont bons, c'est ce qui conditionne tout, le ou les partenariats qui en découleraient , les objectifs des analystes revus à la hausse... bref, cela débriderait TSRX et plus grand chose à part la FDA ;-) ne pourrait l'arrêter...

actuellement je n'ai pas de TSRX, je me la tâte pour jouer les résultats, j'ai toujours pas compris pourquoi 20% des titres ont changé de main en une journée, c'est ce qui me retient un peu, même si ça c'est fait au-dessus des 4.75$ de l'AK.
Si les résultats sont bons, il ne sera pas trop tard pour rentrer car je pense que la hausse sera graduelle d'ici 2014

Profil supprimé

23 juillet 2013 •10:27

salut les loulous !

bon ! je viens de vous écrire un roman mais la censure bourso na pas voulu que vous le lisiez...

je faisais le point sur mes 10 convictions 2013
http://pacman.nerim.net/thebull/?q=jtb/cj/2013/7

j expliquais les raisons de mon absentéisme, tout en me livrant à un plaidoyer pour que le forum continue à vivre... ce qui est paradoxal voir même absurde ;-)

TSRX est au zénith, Oppenheimer & co avaient raison, mais avec une CB proche des 580M$, la marche de progression semble plus que limitée maintenant, sauf si deal hors norme...

bon été a toutes et tous !

kiss love gode

prisuttu

31 juillet 2013 •18:35

http://www.reuters.com/article/2013/07/30/cubist-deal-idUSL4N0G04RL20130730?feed Type=RSS&feedName=industrialsSector&rpc=43

Profil supprimé

31 juillet 2013 •18:55

Salut

CBST semble décidé a gober TSRX... pas cher payé pour certains, mais la petite a pris + de 160% depuis début 2013

Cipher Pharmaceuticals Inc. (DND) va bien aussi après la publication de ses résultats trimestriels

avec çà, Tutu va devoir se contenter de la 2eme place au classement de The Bull... comme poulidor ;-)

http://pacman.nerim.net/thebull/?q=jtb/cj/2013/7