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

[la-onda]

good news out, tomorrow will be fine:
ViroPharma Announces Positive Phase 2 Results Demonstrating That Maribavir Significantly Reduces CMV Reactivation
Wednesday, March 29, 2006 20:17 ET

EXTON, Pa., March 29, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced positive preliminary results from a Phase 2 study with maribavir, an oral antiviral drug candidate currently being developed to inhibit cytomegalovirus (CMV) reactivation in transplant patients. The data from this study demonstrate that prophylaxis with maribavir displays strong antiviral activity, as measured by significant reduction in the rate of reactivation of CMV in recipients of allogeneic stem cell (bone marrow) transplants, and that administration of maribavir for up to 12 weeks has a favorable tolerability profile in this very sick patient population. The full data set will be presented at a future medical meeting.

"We could not have hoped for better results, as these data show that treatment with maribavir dramatically reduces the incidence of CMV reactivation in these very sick patients. In fact, the only cases of CMV disease in this trial occurred in the placebo group -- there were no cases of CMV disease in subjects who received maribavir," commented Colin Broom, ViroPharma's chief scientific officer. "These results could potentially change the current treatment paradigm in which transplant physicians usually wait until CMV can be detected in the blood, indicating that the virus is multiplying, before initiating treatment. If untreated, there is a high risk that the virus will continue to replicate and lead to potentially lethal CMV disease. The reason physicians are reluctant to use currently available therapies as prophylaxis, particularly in stem cell transplant, is the toxicities associated with available therapies, particularly bone marrow or kidney toxicities. These data from our Phase 2 study suggest that maribavir could be used as prophylaxis to prevent CMV infection and thus prevent CMV disease."

"With these new data now in hand, we can move forward toward pivotal Phase 3 studies," added Broom. "Our plan is to meet with the FDA as soon as possible to discuss the data and reach agreement on the Phase 3 program. Our goal is to initiate a pivotal Phase 3 study in allogeneic stem cell transplant patients mid-year and a subsequent Phase 3 study in solid organ transplant patients by year end."

Study Design

The maribavir Phase 2 clinical trial was a randomized, double blind, placebo-controlled, dose-ranging study at 13 transplant centers across the U.S. involving CMV seropositive subjects who have undergone allogeneic stem cell transplantation. A total of 111 subjects were randomized 3:1 to receive maribavir or placebo in each of three ascending dose groups (100 mg BID, 400 mg QD, 400 mg BID). All subjects were monitored frequently for CMV infection, and if CMV was detected, study drug (maribavir or placebo) was discontinued and the subject was managed according to current standards of care at each transplant center, including starting pre-emptive anti-CMV treatment at the discretion of the investigator.

The objectives of this study included an evaluation of the safety and tolerability of maribavir administered orally for up to 12 weeks, and an evaluation of the prophylactic activity of maribavir in preventing CMV reactivation in CMV seropositive recipients of allogeneic stem cell transplants. The term 'prophylaxis' in this setting refers to therapy given to subjects starting before there is any evidence of CMV replication, to prevent CMV infection and in turn prevent CMV disease.

Antiviral activity of maribavir as measured by reductions in CMV reactivation

Available preliminary data from this Phase 2 clinical study includes all data for subjects through at least 12 weeks after enrollment, and indicated the following:

* In an intent-to-treat analysis of the first 100 days post-transplant,
       the number of subjects who required pre-emptive anti-CMV therapy was
       statistically significantly reduced (p = 0.051 to 0.001) in each of the
       maribavir groups compared to the placebo group (57% for placebo vs.
       15%, 30%, and 15% for maribavir 100 mg BID, 400 mg QD, and 400 mg BID,
       respectively).

     * Separate analyses of the incidence of CMV infection as measured by
       different CMV assays such as CMV pp65 antigenemia or plasma CMV DNA PCR
       were consistent in showing fewer CMV infections in each of the
       maribavir groups compared to placebo.  In most cases, the reduction in
       rates of infection between patients in the maribavir groups and placebo
       were statistically significant.

     * There were no cases of CMV disease in any of the maribavir groups,
       whereas CMV disease was reported in three subjects (11%) in the placebo
       group.

     * There have been no reports of late CMV disease (after the 100 day
       post-transplant period), although patient follow-up remains ongoing for
       some subjects in the study.

    Tolerability of maribavir

Administration of maribavir for up to 12 weeks had a favorable tolerability profile in this study in this very sick patient population. The incidence of most adverse events occurred at similar rates in maribavir and placebo groups.

* Consistent with prior clinical studies, the most notable adverse events
       that appeared to be associated with maribavir were taste disturbance
       and nausea.

     * In contrast to a prior Phase 1 study in HIV-infected subjects, skin
       rash was reported at similar rates in maribavir and placebo groups in
       this study, and thus did not appear to be associated with maribavir
       administration.

     * Preliminary analyses of laboratory data did not identify any notable
       differences between maribavir groups and placebo.  In particular, there
       was no adverse impact on neutrophil count or other hematologic
       parameters.

    Conference Call and Webcast

ViroPharma is hosting a live teleconference and webcast with senior management to discuss the clinical results and other business on March 30, 2006 at 9:00 a.m. Eastern Time. To participate in the conference call, please dial (800) 391-2548 (domestic) and (302) 709-8328 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.

Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com. Windows Media or Real Player will be needed to access the webcast. An audio archive will be available at the same address until April 13, 2006.

About Maribavir

Maribavir is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. Maribavir is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.

About Cytomegalovirus

CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50% and 85% of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

[ScottishTrader]

Should be interesting!!!

I see potential resistance at 12.45, 13.40, then not much before 15.50-15.60.  There may be a struggle getting through the 13s and low 14s, as this was where it rebounded after the initial drop before plungiing again.  I expect quite a few people got suckered in (myself included) thinking the first drop was the low, and may want to take this opportunity to get out of what had been an ugly losing situation.

Still, I think this could provide strong momentum for a turnaround in VPHMs woes, and still think I can make a solid profit on my entry at 13.32.  Short to medium term target is to get back into its previous trading range above $16.

GL all

[oicpecnoc]

must say i was not expecting a gap to 13.20 by 830.  Hmmm.  What to do.

[stocks2watch2]

13.06 in pre mkt.

ViroPharma Announces Positive Phase 2 Results Demonstrating That Maribavir Significantly Reduces CMV Reactivation

March 29, 2006 20:17:44 (ET)


EXTON, Pa., March 29, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM, Trade) today announced positive preliminary results from a Phase 2 study with maribavir, an oral antiviral drug candidate currently being developed to inhibit cytomegalovirus (CMV) reactivation in transplant patients. The data from this study demonstrate that prophylaxis with maribavir displays strong antiviral activity, as measured by significant reduction in the rate of reactivation of CMV in recipients of allogeneic stem cell (bone marrow) transplants, and that administration of maribavir for up to 12 weeks has a favorable tolerability profile in this very sick patient population. The full data set will be presented at a future medical meeting.

"We could not have hoped for better results, as these data show that treatment with maribavir dramatically reduces the incidence of CMV reactivation in these very sick patients. In fact, the only cases of CMV disease in this trial occurred in the placebo group -- there were no cases of CMV disease in subjects who received maribavir," commented Colin Broom, ViroPharma's chief scientific officer. "These results could potentially change the current treatment paradigm in which transplant physicians usually wait until CMV can be detected in the blood, indicating that the virus is multiplying, before initiating treatment. If untreated, there is a high risk that the virus will continue to replicate and lead to potentially lethal CMV disease. The reason physicians are reluctant to use currently available therapies as prophylaxis, particularly in stem cell transplant, is the toxicities associated with available therapies, particularly bone marrow or kidney toxicities. These data from our Phase 2 study suggest that maribavir could be used as prophylaxis to prevent CMV infection and thus prevent CMV disease."

"With these new data now in hand, we can move forward toward pivotal Phase 3 studies," added Broom. "Our plan is to meet with the FDA as soon as possible to discuss the data and reach agreement on the Phase 3 program. Our goal is to initiate a pivotal Phase 3 study in allogeneic stem cell transplant patients mid-year and a subsequent Phase 3 study in solid organ transplant patients by year end."

Study Design

The maribavir Phase 2 clinical trial was a randomized, double blind, placebo-controlled, dose-ranging study at 13 transplant centers across the U.S. involving CMV seropositive subjects who have undergone allogeneic stem cell transplantation. A total of 111 subjects were randomized 3:1 to receive maribavir or placebo in each of three ascending dose groups (100 mg BID, 400 mg QD, 400 mg BID). All subjects were monitored frequently for CMV infection, and if CMV was detected, study drug (maribavir or placebo) was discontinued and the subject was managed according to current standards of care at each transplant center, including starting pre-emptive anti-CMV treatment at the discretion of the investigator.

The objectives of this study included an evaluation of the safety and tolerability of maribavir administered orally for up to 12 weeks, and an evaluation of the prophylactic activity of maribavir in preventing CMV reactivation in CMV seropositive recipients of allogeneic stem cell transplants. The term 'prophylaxis' in this setting refers to therapy given to subjects starting before there is any evidence of CMV replication, to prevent CMV infection and in turn prevent CMV disease.

[Lucas Scott]

What to do? I sold the gap up 13.05. Actually the first bounce - it dipped to 12.90 and bounced and then I sold. Just in time it seems but the day is young. 13.13 puts me back in. All I need is $2 profit on a trade either long or short and I'll be in the green with VPHM. That's what it takes for me to collect on the debt VPHM put me in.

[la-onda]

update:
JAGfn Rumors
Wednesday, March 29, 2006 10:42 ET
Mar 29, 2006 (JAGfn.com via COMTEX) -- (VPHM) Rumor that ViroPharma (VPHM) may be the target of a larger pharmaceutical company.

&

VPHM: Infinium Ups to Neutral from Underperform; Keeps Tgt @ $15; Analyst Notes
Thursday , March 30, 2006 15:14 ET

Issuer: Viropharma, Incorporated (NasdaqNM: VPHM)
Analyst Firm:  Infinium Capital
Ratings Action: UPGRADE
Current Rating: Neutral (from Underperform)
Target Price Action: MAINTAIN
Target Price: $15.00
Analyst Comments: The firm cites valuation as basis for their upgrade.

I will hold this baby

[AussieTrader]

There seems so much dodgyness to this collapse that any positive news regarding the FDA ruling will likely pop VPHM a decent percentage upwards.

Now the dust has settled and a bottom found I decided to get some options, so I purchased Aug  $15 Calls ( +DUZHC ), paid $85 per contract (contract being 100 options).

Reason for options? As I'm looking for a recovery play, the returns from options give me a better risk reward here. Aug calls gives me a few weeks /months for recovery to play out.

What about the risk I here people say? Well with options I only buy as many contracts as I would actual shares e.g. if my normal position size for VPHM (at $11 each) is 1000 shares, then I buy 10 contracts. So I control 1000 shares but only pay $850.

Last price on these calls was $100 per contract

I am currently travelling in the UK, but as I had expected news and speculation are starting to drive the VPHM train. My Aug calls are 50% up on entry price a few days ago. I'll let this run some more I think as something interesting seems to be plyaying out.

[effigy235]

Any opinions? in at 11.88 average.

[ScottishTrader]

Effigy,

PLEASE can you post on one of the existing VPHM threads instead of making a new one - there are so many already here!!

If you are having trouble finding one, use the search bar twice (i.e. search for VPHM and then hit search again).  Dunno why but the first search doesn't always pick up all the threads.

Cheers,

Scotsman

[la-onda]

Weekly Prescriptions - Record Levels
by: irc203
Long-Term Sentiment: Strong Buy    04/03/06 10:56 am
Msg: 115479 of 115480

The weekly prescription totals for the first four weeks of March are: 3/3 - 2,299; 3/10 - 2,291; 3/17 - 2,322; 3/24 - 2,479.

There has never been 4 sequential weeks that even come close to the weekly totals we are seeing. What is truly remarkable about this is the four weeks are trending higher as we are about to go into the high season. April through June will be spectacular as will the rest of the year.

As the more virulent strain of CDAD continues to spread through out the USA and as VPHM's educational efforts continue, we will see ever increasing prescription numbers.

It is obvious the Zack's analyst was wrong regarding the growth of Vancocin sales.

[bigdogs99999]

Drug stocks have long been a favorite of mine.  I do not think VPHM a long term holding; I think it fully valued.  VPHM has one product, an antibiotic, for which it paid $116 million to Lilly.  An antibiotic is not a bet the farm type of drug.  The company has a $1.1 billion market cap based on selling about $100 million per year in that product.  That gives it a price to sales ratio of about 10.  VERY VERY high.  The big drug cos (like a Pfizer) is only 3 or 4 these days, and even Amgen is about 8.  Trailing EPS is about 20 times, and guesstimate for 2006 is 18 times ... not a small number these days for a drug stock.  The development pipeline is not particularly impressive, and only one product has hit phase two.  Finding this stock when it got the rights to Vancocin was a great find and congratulations to all who profited (I never bought in - found it too late).  But I think that this stock has had its run and will essentially be dead money for awhile.   

Hi Big Dog,

Before I start to abuse you let me just say that I in general like dogs - especially big dogs 

Well I don't know if I would bet my farm on VPHM (or any stock for that matter) but I have earned enough on VPHM to buy a small farm. You might want to do a little DD before you take your final decision on Viropharma.

Now that Michael is "the man," how can I resist the old Wrath of Khan line that revenge is a dish best served cold?  Lol.  Okay, on to something useful.  VPHM fundamentals are looking somewhat better ... on dips below $11, there seems to be enough value based on ttm sales/earnings and 1 and 2 year projections to make this an interesting pick, particularly as a trading pick on 8-10% swings.  Given the trading volumes in March, most everyone who wants out of the stock is probably out....

[Lucas Scott]

I'm back in at 12.00. Gap filled Monday and Tuesday. Turning back up and it has upside to $14.50 to complete a 38.2 Fib retrace. If it stalls in the low 13's again, we'll have an ascending triangle in the making.

[la-onda]

Nice Link:
http://stockcharts.com/h-sc/ui?s=VPHM&p=30&b=5&g=0&id=p90852411420&a=74300158



VPHM: Jumps +1.16%; Vol +52%; Last 90 Min of Trading
Wednesday, April 12, 2006 16:21 ET

During the last 90 minutes of today's session, shares of Viropharma, Incorporated (NasdaqNM: VPHM) demonstrated a strong UPWARD close relative to its 13:30 ET statistics. "Strong Closers" are determined by proprietary Knobias calculations performed during the last segment of each trading day.

sym: VPHM      @13:30 ET        @CLOSE      % CHANGE
----------   -----------   -----------  ------------
PRICE             $11.22        $11.35        +1.16%
VOLUME         1,114,800     1,698,000       +52.31%
#TRADES            1,922         2,665       +38.66%
DAY-HI            $11.26        $11.36       LATE-HI
DAY-LO            $11.00        $11.00           N/A

[la-onda]

Weekly prescriptions totaled 2,424 for the week ended 4/7/06 which is the second highest weekly total on record!! The highest weekly total occurred for the week ended 3/24/06 and totaled 2,479. We are off to a spectacular year and second quarter. Management will be forced to raise Vancocin sales guidance upward.

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=7077380&tid=vphm&sid=7077380&mid=120485

[la-onda]

ViroPharma Announces Approval of Third Party Manufacturing and Supply Chain for Vancocin
Wednesday April 19, 4:30 pm ET

EXTON, Pa., April 19 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced the successful completion of the finished goods technology transfer from Eli Lilly and Company to OSG Norwich Pharmaceuticals, Inc., the company's third party Vancocin® manufacturer. Norwich has begun manufacturing batches of product for release into the market. ViroPharma has also reached an agreement with, and validated, Alpharma Inc., the company's third party supplier of the active pharmaceutical ingredient for Vancocin. With this, the company has now completed validation of its third party supply chain for Vancocin, which is indicated for the treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile.

"This is a great step forward for ViroPharma and the patients we serve," commented Josh Tarnoff, ViroPharma's Chief Commercial Officer. "Vancocin is a product that addresses a life-threatening condition, and is a difficult product to manufacture to necessary specifications to ensure stability and potency. The validation of the supply chain represents the successful conclusion of nearly two years of diligent work by ViroPharma, Eli Lilly and Norwich."

As previously described, ViroPharma anticipates improvements in gross margins, due to the qualification of this third party supply chain, beginning in the second half of 2006, as product manufactured in the Lilly facility is pulled through the channel.

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year; 15 to 25 percent are caused by C. difficile.