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VPHM - Sector: Healthcare---Industry: Biotechnology & Drugs

Started by eliteG, June 02, 2005, 08:52:03 PM

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la-onda

I am fucked up with my Feb 08 option call 15$  :-[
minus 80% in 2 days, wow I am a real expert................



ViroPharma, Wyeth stop dosing in study
Friday , August 10, 2007 10:37ET

By Staff Reporter

NEW YORK, Aug 10, 2007 (AP via COMTEX) -- ViroPharma Inc. and partner Wyeth will stop dosing patients in a mid-stage clinical trial of its hepatitis C treatment candidate, citing safety concerns.

The decision on drug candidate HCV-796 follows a review by the joint safety review board of the FDA. The company had found that 8 percent of patients receiving the drug candidate in combination with pegylated interferon and ribavirin had elevated liver enzymes.

Elevated liver enzymes could be an indicator of liver disease. In comparison, only 1 percent of patients in the control arm of the study, who received only pegylated interferon and ribavirin, had elevated liver enzymes.

ViroPharma said patients in the study will have the option to continue therapy, but without HCV-796.

The company did say the drug candidate showed antiviral activity, though those results are preliminary.

"This is a clear disappointment in light of the exciting antiviral activity observed to date in this study. Although this represents a potential setback for hepatitis C patients, we are committed to the health and safety of patients, and this decision was absolutely the right thing to do," said Michel de Rosen, ViroPharma's president and chief executive.

Separately, Wyeth said the FDA denied approval for the its schizophrenia treatment candidate bifeprunox, citing effectiveness and safety concerns.

ViroPharma shares plunged $1.73, or 17 percent, to $8.49 in morning trading. Wyeth shares fell $1.97, or 4 percent, to $47.61.

Terliso

#1066
Quote from: la-onda on August 10, 2007, 11:31:41 AM
I am fucked up with my Feb 08 option call 15$  :-[
minus 80% in 2 days, wow I am a real expert................


I'm sorry for your loss La-onda... but the $9.20 target  is made today, VPHM should bounce and close that gap....

This 3 magic breakdown is crazy, I've seen a lot of this, and they go down fast furious. I'm glad David sold this one too prior to this BIG plunge.


Stocky2000

Quote from: Terliso on August 10, 2007, 12:12:37 PM
Quote from: la-onda on August 10, 2007, 11:31:41 AM
I am fucked up with my Feb 08 option call 15$  :-[
minus 80% in 2 days, wow I am a real expert................


I'm sorry for your loss La-onda... but the $9.20 target  is made today, VPHM should bounce and close that gap....

This 3 magic breakdown is crazy, I've seen a lot of this, and they go down fast furious. I'm glad David sold this one too prior to this BIG plunge.



i think you meant target 10.22 (gap closing)

Terliso

Quote from: ket1390 on August 10, 2007, 01:28:51 PM
i think you meant target 10.22 (gap closing)

$9.20 is the Technical target from Top Head & shoulders pattern... it is roughly around $9.20

18.39 - 13.80 = $4.59
13.80 - 04.59 = $9.21  ;)

la-onda

ViroPharma Whacked by Data
By Brian Lawler August 10, 2007

Hopefully drug developer ViroPharma (Nasdaq: VPHM) was only on everyone's watch list today as shares were down more than 18% following the announcement that it was halting dosing of its hepatitis C antiviral compound in a phase 2 study.
ViroPharma's hepatitis C drug candidate, HCV-796, is being developed with partner Wyeth (NYSE: WYE). Of all the HCV polymerase inhibitor drug candidates it was the furthest along in testing after Idenix Pharmaceuticals' (Nasdaq: IDIX) polymerase inhibitor failed in a phase 2 study two months ago.
What led ViroPharma and Wyeth to end dosing of HCV-796 was that 8% of patients taking the drug in the phase 2 study were experiencing higher liver enzyme levels compared to only 1% of patients in the standard of care arm of the study.

Elevations of liver enzymes are a concern for any drug because they often are an early indicator of liver-related disorders if whatever is causing the raised enzyme levels is not corrected. That this issue didn't show up in earlier human studies of HCV-796 is likely due to the short-term nature of the studies and the fact that hepatitis C is a disease that adversely affects the liver by itself.

If there is a small sliver of hope from the study results announced today, it is that HCV-796 was highly active in eliminating HCV for genotype-1 patients who have previously failed treatment with the standard of care. Twenty-three percent of those null responders (as ViroPharma calls them) had undetectable levels of the virus in their bodies after only 12 weeks of treatment. Undetectable hepatitis C viral loads are a strong indicator of later being declared cured of the disease; currently there are no good treatment options for these non-responder patients.

As the FDA likes to point out, though, raised liver enzyme levels is the number one cause of all drug adverse events and, more worringly, all new drug application rejections. At best, these results suggest that any path forward for HCV-796 would be as a second-line agent for hepatitis C genotype-1 patients failing existing therapies.

There is still a long-shot possibility for the drug if the liver enzyme issues can be corrected or reduced in future studies. Examples of possible solutions include either lowering the dosing of HCV-796 or shortening the treatment duration, but investors shouldn't hold their breath that the drug will remain in development.

These safety issues are definitely a major setback for HCV-796 but it's also worth noting that shares of ViroPharma are at dirt cheap levels right now. The company has a market cap of $580 million with operating income of at least $100 million expected this year and over $260 million in net cash as of the end of the second quarter.

la-onda

Dosing of the company's hepatitis C drug HCV-796 was stopped after patients in an ongoing phase II study developed liver toxicity. Viropharma and its partner Wyeth (WYE) have not permanently shelved the HCV-796 yet, but a drug that causes liver toxicity, especially in hepatitis C patients, is an extremely serious problem.

It's unfortunate because HCV-796 appears to have a strong antiviral effect against the hepatitis C virus, but I have a hard time envisioning a scenario where HCV-796 survives this setback.

When Jimmy emailed me his question, HCV-796 was still a viable and promising drug in Viropharma's pipeline. In fact, I wrote this column on Thursday, so I had to revise it when the HCV-796 news hit Friday.

I can understand how Jimmy viewed Viropharma as undervalued prior to this recent setback. Second-quarter earnings easily topped Wall Street estimates and the company raised 2007 sales guidance for Vancocin, its treatment for gastrointestinal tract infections.

At Thursday's closing price of $10.22, Viropharma was trading at a price-to-earnings ratio of just 12 times estimated 2008 earnings, or 4 times estimated 2008 sales.

Cheap, right? Well, not exactly. The reason that investors were discounting Viropharma's valuation is because of worries that Vancocin would face generic competition next year. Vancocin gross margins are in the 90%-plus range and because of that the drug generates a good amount of cash flow for Viropharma.

That's great, but if a cheaper generic version of Vancocin is launched, Viropharma's operating business takes a big hit. You can see that playing out in the current analyst estimates: They have Viropharma earning $1.17 per share this year but only 86 cents per share in 2008.

Viropharma is fighting efforts by Akorn (AKRX) to launch a generic Vancocin by late this year/early next year. At this point, it's not clear who will win, but even if Viropharma can delay a generic launch, competition for Vancocin is coming eventually. This explains, partially, why the stock seemed undervalued.

It also explains why Viropharma's ability to advance its drug pipeline is so important to the investment thesis. HCV-796 was a linchpin in that effort, but now it's probably gone. At the very least, whatever value ascribed to the drug by investors will be all but erased.

That leaves Camvia as the most important drug in Viropharma's pipeline. The antiviral drug is being developed to protect stem cell transplant and liver transplant patients from infection with cytomegalovirus - a common virus but one that can cause serious health problems for people with weakened immune systems.

Two phase III studies of Camvia are currently enrolling, with data from the first, in stem call transplant patients, due in the second half of 2008.

As I write this Friday morning, Viropharma is down $2.42, or 24%, to $7.80 per share. Unfortunately, generic Vancocin concerns plus the blow-up of HCV-796 are likely to outweigh any enthusiasm for Camvia in the near term.

David Randolph

Clearly VPHM had some kind of problem, that's why its valuation was so low. In fact, there were two problems, one is the probable generic competition to Vancocin, but everybody knew about that, and the second was publicly known on Friday:

• Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
PR Newswire (Fri, Aug 10)

I think this is a setback for this Hepatitis C treatment, but not at all the end of it. They'll just have to correct some issues and then get back to testing.

In the meantime VPHM's results have been superb and the cash pile is mounting, currently to an excess of $516 M (there's also $273 M in liabilities) - and the market cap is just $607 M.

I think VPHM will have EPS of about $1.4 in 2007, so the stock is trading at just 6.2 times earnings, all due to fears of generic competition for Vancocin (but the company is fighting this and there's no assurance doctors will start prescribing the generic drug when and if it becomes available) - and now this setback in HCV-796.

But, beyond Vancocin and HCB-796, there's Maribavir, which may represent $400 M in annual revenue when it's fully approved and commercialized.

Anyway, I just feel VPHM's bad news were already discounted by the market and Friday's sell off was an exaggeration. I expect the stock to bounce strongly over the next few days, to at least close the gap at $10.15.

This will be a trade, not an investment.

The trading plan is:

Buy 6.66% of capital in VPHM, at the open and if the open is below $8.9 (pass the trade if the stock opens above $8.9).

David Randolph

QuoteBuy 6.66% of capital in VPHM, at the open and if the open is below $8.9 (pass the trade if the stock opens above $8.9).

The open was too high, I've passed the trade, as planned. Good luck if you bought.

la-onda

ViroPharma "buy," target price reduced

Monday, August 13, 2007 8:30:15 AM ET
Lazard Capital Markets

NEW YORK, August 13 (newratings.com) - Analysts at Lazard Capital maintain their "buy" rating on ViroPharma Incorporated (ticker: VPHM), while reducing their estimates for the company. The target price has been reduced from $24 to $18.

In a research note published on August 10, the analysts mention that a rise in the incidence of liver enzymes has resulted in the termination of the Phase II trial dosing of HCV-796 in patients with hepatitis-C virus by the company and its partner Wyeth. ViroPharma is expected to continue to incur R&D expenses through 2010, since it is likely to explore further treatment options with the drug, the analysts say. The fully-diluted EPS estimate for 2012 has been reduced from $1.69 to $1.25.

Stocky2000

#1074
should run bought today 8.38 >:D

Stocky2000

lets see if the break out continues  >:D....in case we are prepared stop loss 8.12

tokyopua

Jumped in at 8.76, now lets fill that gap!
Chance favors the prepared mind


Terliso

Quote from: Terliso on August 10, 2007, 12:12:37 PM
I'm sorry for your loss La-onda... but the $9.20 target  is made today, VPHM should bounce and close that gap....

The gap is almost close. ;D .... I expect VPHM to test the resistance, prior support, around $12.50.

mitchjas

Knocked it's head on the 10.15 resistance but pulled back on low volume.  Maybe a chance to break it.