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

[la-onda]

FDA update:
Generic Drug Petition In FDA Limbo
Friday , April 21, 2006 01:05 ET

Apr 21, 2006 (financialwire.net via COMTEX) -- April 21, 2006 (FinancialWire) The number of testing hurdles faced by generic drug makers hoping to compete with branded products remains undecided as the Food and Drug Administration ponders the merits of a petition brought by Shire PLC (NASDAQ: SHPGY) that seeks to make them higher.

Branded drug manufacturers such as Shire, ViroPharma Inc. (NASDAQ: VPHM) Salix Pharmaceutical Ltd. (NASDAQ: SLXP) have all recently been involved in legal wrangling over the issue of just how much, and what type of, testing needs to be done before a generic can be marketed as a proper alternative to a branded drug.

Shire's petition concerns attempts by generic drug makers to produce clones of Adderall XR, the company's treatment for attention deficit disorder. Shire wants more comprehensive testing to establish bioequivalence between the generic and branded drugs.

The FDA needs more time to review the complex issues involved before making any decision that would change its testing policies.

http://www.knobias.com/individual/public/news.htm?eid=3.1.86ea430bbc69f316438e094dacca27dba05826b1e8cbb5dc3af8fa87e6176b6b

[peterwangos]

Does vphm chart looks interesting?
http://stockcharts.com/h-sc/ui?s=VPHM&p=D&b=5&g=0&id=p59547409767

[la-onda]

update:
ViroPharma Announces Data Presentations at Two Upcoming Scientific Meetings
Tuesday , April 25, 2006 15:24 ET

EXTON, Pa., April 25, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (Nasdaq: VPHM) announced today that abstracts regarding HCV-796, an orally dosed non-nucleoside viral polymerase inhibitor with the potential to interfere with the replication of hepatitis C virus that is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), will be presented at two upcoming scientific meetings: the 2006 European Association for the Study of the Liver (EASL) meeting, to be held this week in Vienna, Austria (April 26th to 30th, 2006), and at the 2006 Digestive Disease Week (DDW) meeting, to be held in Los Angeles, California (May 20th to 25th, 2006). The abstract contents are available on the EASL (http://www.easl.ch/easl2006) and DDW (http://www.ddw.org) web sites.

Abstract at EASL:

Safety and pharmacokinetics of the non-nucleoside polymerase inhibitor, HCV-796: Results of a randomized, double-blind, placebo-controlled, ascending single-dose study in healthy subjects. Chandra P, Raible D, Moyer L, Harper D, Speth J, Villano S, Fruncillo R

Abstract at DDW:

Antiviral activity of the non-nucleoside polymerase inhibitor, HCV-796, in patients with chronic hepatitis C virus: preliminary results from a randomized, double-blind, placebo-controlled, ascending multiple-dose study. Chandra P, Raible D, Harper D, Speth J, Villano S, Bichier G

HCV-796 is an investigational non-nucleoside polymerase inhibitor compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials in combination with PEG-Interferon by ViroPharma and Wyeth. In previously disclosed results from the phase 1b study of HCV-796 as a monotherapy, the patient cohort with the highest exposure to the compound achieved a peak mean HCV viral load reduction of 1.4 log10, or 96 percent, on day four of a 14-day dosing period. HCV-796 was found to be generally well tolerated, with favorable pharmacokinetics and no dose-limiting toxicities. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events.

&

VPHM: Short Interest UP 66.8% to 7.7M in Apr 2006
Tuesday , April 25, 2006 16:27 ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) INCREASED 66.8% to 7,696,507 shares for the month ended mid-April, 2006.

SYMBOL      MARCH           APRIL          CHANGE       %CHANGE     DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
VPHM           4,613,461       7,696,507      +3,083,046       +66.83%           3

Based on VPHM's 20-day average daily share volume of 3,518,850, it would require approximately 3 day(s) of buying to cover this short interest.


With good 1st Quarter results on May 4th, VPHM will be popping nicely IMO (chekc the latest Vac. numbers posted before)

[la-onda]

just FYI; quotation from VPHM board:

I feel that there is some people here that are not very happy with the current price action on VPHM.  Thats understandable, I am going to offer some opinions and and some charts.  Now please take this as just my view point.  I am not always correct, but I have been succesful as a proffesional trader for some time now.  Keep in mind that everyone here has there own personal situation that they are in.  Some of you were in VPHM when it crashed, some of you got in after the crash,  some of you bought into the phase II results, and some of you are short(trust me they are here).  Since I am offering my opinion, I will disclose that I got into VPHM on crash day.  I think entries are very important, and I managed to get in near the 68% fib.  I also am long a substantial amount of shares.  Maybe not as many as IRC, but in the 6 figures.  I actually picked up another 3k  shares today.  With that said, lets look at things with all emotions aside.

I am sure that most of you have done your DD, otherwise you would not be here.  I will briefly highlight some of the reasons why I think this is a value.  It might seem redundant since most of you know this, however its good to remind yourself when the pains of emotions cloud our judgement.  The Vancocin generic situation to me is complete B.S.  There still has been no company that has declared any intention to develop it yet.  Many believe that AKN might be developing it.  Has anyone looked into this company?  I would assume that the smart money would be hedging with the purchase of this stock.  Look at the volume of AKN, its pitiful.  The company does not even have the cash to go through clinical trials if they were required.  Now considering it took  2 years for VPHM to make a new supply chain,  who will flip the bill for the manufacturing.  Keep in mind it took 2 years with Lilly's help.  The FDA has also been served with a stay of action.  Look at that recent press release regarding Shire pharma.  They still have not come up with a conclusion on that issue.  The way things are going, it might take longer for a competing vancocin to come out now without the clinical trials.  Another point I wanted to bring up is that VPHM bought vancocin when it was already out of patent.  If it was very easy to make, why wouldn't a huge generic maker like TEVA have done it?  Pure and simple not enough money to be made.

Now we also have  Maribavair.  from the press release that was issued, it could possibly revolutionize the treatments for CMV.  That another potential 500 million market.  Larger than vanco.  The results look good, and we have a sucker like Wei who questions the side effects.  Who is he kidding. "taste disturbances and nasea".  This treats a life threatening disease.  Should we stop chemotherapy because of it side effects? I   think that he has his own agenda also.

We also have the HCV-796.  From what I can see from the preliminary results this could have hugh potential.  We are talking about hepatitis here.  I can't even begin to fathom them drug market worldwide for that drug.

We also have the the current financial situation of VPHM.  The company has sufficient cash to purchase another 3-4 drugs that are in development.  Not to mention that they will probably have about $6-10 a share in cash before there with be any vanco competition.  I understand that stocks trade on future earnings, and that the shorts best defense.  Have they even thought about what the company would do with that much cash?  what about those future earnings?  Most biotechs trade on the hopes that they will get lucky on one of their drugs.

Now technically speaking, VPHM is improving.  It might not seem like it to most people.  Most people relate technicals soley to price and price fluctuations.  To me price is secondary to what the indicators show.  I look primarily at if the indicators are showing either positive divergances or a bullish sign.  We are still weak, and I have never stated that VPHM is a strong stock technically.   TA is similiar to fundamentals.  Eventually the PPS will react to the signs the TA is showing.  The only exception to that is if there is a fundamental change.  In that case TA is trumped by fundamentals.  So far even though some of the indicators have dropped off sometimes.  They have not caused lower lows than the original crash day.  If the RSI, Stochs, MFI, CMF, etc would make a lower peak than crash day.  I would start getting concerned.  Here is a briefly updated Daily chart.

http://stockcharts.com/h-sc/ui?s=VPHM&p=D&b=5&g=0&id=p56927988804&a=74789865

Another technical that we also need to consider is the biotech industry as a whole.  Currently the whole sector has been in correction for a while.  The last time it bounced of its 200 day, and its getting close again.  The institutions have most of their trading set up on auto-pilot.  We are in a day and age were buy and sell programs are a significant force.  This computerized models help them make sure they are in the correct sectors.  The momentum will eventually switch soon, and biotech will be "hot" again.  Until then we have that to consider also.  Here is a chart of the biotech sector.

http://stockcharts.com/h-sc/ui?s=$BTK&p=D&b=5&g=0&id=p26372531562&a=75308040&listNum=-2

Maybe I am just rambling, but my intentions are good.  I really would like all of you guys to make some money.  The worst feeling is seeing a stock that you held for so long take off soon after you sell it.  I posted this link before, I think we could be at #14.

http://www.retro.ms11.net/InvestorMind.gif

Good luck to all you guys.  I hope this would be considered useful.  I annontate my charts to share what I see.  Otherwise I can just look at a chart and get the same ideas in 2 minutes.  BTW, I do have a stop set up for half of my shares at 9.64.  If that is breached, I would be concerned.  Remember there is always another stock to invest in.  Capital preservation is the MOST important thing.

http://finance.groups.yahoo.com/group/VIROPHARMA/message/1961

[basonista]

I agree with you, Oliver.  That is why VPHM is my pick for this contest.  I don't know if it will be enough of a rocket to get towards the top of the standings but earnings next week should be good and hopefully will dissuade some of the fears that have resulted in the PPS getting hammered.

I don't know if this is going up or down before next Thursday but I've started building my own position in case it builds into earnings.

[la-onda]

thursday will be very interesting.... 

VIROPHARMA INC (RT-ECN)    
Symbol:    VPHM
Last Trade:    11.75 4:00PM ET
After Hours Change:    N/A
Today's Change:    Up 0.51 (4.54%)
Bid:    10.62
Ask:    11.30

news out:
yaoo board quotation:
From: "irc203" <irc203@...>
Date: Mon May 1, 2006  3:16 pm
Subject: IMS Health Weekly Prescriptions

Prescriptions for the week ended 4/21 totaled 2,311. Prior week total
was 2,393. The weekly prescription total is very strong although down
from the prior week. It may be that Easter Sunday caused the decrease.
We will see next week. Regardless, the news is very good. April
scripts will be a new record. Remember, the trend is your friend.

&

ViroPharma Announces Presentation of Pharmacokinetic Data From HCV-796 Phase 1a Study
Monday May 1, 3:20 pm ET

EXTON, Pa., May 1 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that pharmacokinetic (PK) data from a Phase 1a trial of HCV-796, an orally dosed non-nucleoside viral polymerase inhibitor with the potential to interfere with the replication of hepatitis C virus, that is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), were presented at the 2006 European Association for the Study of the Liver (EASL) meeting in Vienna, Austria, which concluded yesterday. These data concluded that the safety and PK profile of the compound supported additional clinical evaluation. HCV-796 is currently in Phase 1b testing in combination with PEG-interferon.

"These initial Phase 1a data were the first set of data from our human clinical analyses of HCV-796, and important in that they set the stage for our ongoing multiple dose studies," commented Steve Villano, ViroPharma's vice president of clinical research and development. "Overall, the findings demonstrate that the absorption and elimination profile, distribution, half life, and tolerability of HCV-796 are acceptable, and supportive of our ongoing clinical development."

Trial Description

This Phase 1a study was an ascending single dose, placebo-controlled trial designed to assess the safety and tolerability of HCV-796 in healthy adult volunteers. Fasting healthy subjects were randomly assigned to receive 25, 50, 100, 250, 500, 1000, or 2000 mg oral doses of HCV-796 or placebo (six active, two placebo per dose group). Subjects in the 100-mg dose cohort received HCV-796 in a fasting and fed state.

Results

The safety profile from this study indicates that single oral doses of HCV-796 are generally well tolerated with no serious treatment-emergent adverse events. Mild to moderate headache was the most frequently reported adverse event. There were no apparent dose-related increases in frequency for any adverse event. There were no significant differences in the rate of adverse events between patients on drug compared to placebo. The PK data showed that the maximum concentration (Cmax) and drug exposure as measured by the area under the curve (AUC) increased less than proportionally with increasing dose, and appeared to reach a plateau at the 1000 mg cohort. HCV- 796 displayed a long half life. When dosed with food at the 100 mg dose level, drug exposure as measured by AUC increased approximately 1.4 fold, providing the first evidence that systemic exposure to the drug may be increased by dosing with food and leading to an additional study designed to specifically assess the potential enhancement of drug exposure when dosed with food.

HCV-796 is an investigational non-nucleoside polymerase inhibitor compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials in combination with PEG-Interferon by ViroPharma and Wyeth. In previously disclosed results from the Phase 1b study of HCV-796 as a monotherapy, the patient cohort with the highest exposure to drug achieved a peak mean HCV viral load reduction of 1.4 log10, or 96 percent, on day four of a 14-day dosing period. HCV-796 was found to be generally well tolerated, with favorable pharmacokinetics and no dose-limiting toxicities. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events.

About Hepatitis C

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon (IFN) products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of IFN can lead to discontinuation of therapy in approximately 20% of patients.

[la-onda]

TA chart from alimovstock  (yahoo board) 

http://stockcharts.com/h-sc/ui?s=VPHM&p=W&yr=2&mn=0&dy=0&id=p66123533398&a=75853137

[basonista]

I'm surprised no one is talking about VPHM.    The stock tanks because of the future threat of generics arriving but the near future fundamental picture hasn't changed - it appears to be strengthening!  VPHM was a value favorite of Michael's for a long time.  This seems almost as predictable as buying KOMG before earnings.  Has everyone abandoned ship!?!

Hanging out around $11 waiting for earnings tomorrow morning....

[la-onda]

I am still invested and earnings are out:

ViroPharma Incorporated Reports First Quarter 2006 Financial Results and Reiterates Full Year Vancocin Sales Guidance
Thursday May 4, 7:00 am ET

EXTON, Pa., May 4 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) reported today its financial results for the first quarter ended March 31, 2006.

    Recent operational highlights include:

    -- Underlying prescription demand for Vancocin, measured by IMS, grew 39
       percent over the first quarter of 2005;
    -- A portion of prescription demand was met by a reduction in wholesaler
       inventory;
    -- Net product sales grew 39 percent compared to the first quarter of
       2005;
    -- Working capital grew $12 million to $179 million;
    -- Fast track designation for maribavir received from U.S. Food and Drug
       Administration (FDA);
    -- Maribavir shown in phase 2 study to be well tolerated and to
       significantly reduce incidence of CMV reactivation in stem cell
       transplant patients;
    -- Third party manufacturing and supply chain for Vancocin approved; and
    -- Petition filed with FDA to stay approval of generic versions of
       Vancocin in the absence of appropriate standards.

Net sales of Vancocin® were $29.2 million for the first quarter of 2006, representing a 38.8 percent increase from $21.1 million for the first quarter of 2005.

Operating income in the first quarter of 2006 was $13.4 million compared to $17.4 million operating income in the first quarter of 2005. Factors that reduced operating income included the fact that 2006 does not include any license fee revenue, whereas 2005 included $6.0 million license fee revenue and that other operating expenses increased $4.1 million as compared to the first quarter of 2005, including $0.9 million of share-based compensation. Partially offsetting the reductions to operating income was the increase in gross margin of $6.1 million related to sales of Vancocin.

"Prescription demand for Vancocin as reported by IMS during the first quarter of 2006 continued to grow to its highest point in the history of this product, though our product sales were significantly impacted by a reduction in product inventory levels in the wholesaler channel," commented Vincent Milano, ViroPharma's chief operating officer and chief financial officer. "We believe that our sales of Vancocin have been impacted by changes in wholesaler inventory levels every quarter since we acquired Vancocin; however, the first quarter of 2006 represents the first time wholesalers have chosen to reduce their inventory levels of the product to this degree. Despite this recent change in wholesaler levels, underlying prescription demand remains very strong; as such we are reiterating the guidance we last gave for net sales of Vancocin of $160 to $170 million for the full-year 2006."

"From an operations perspective, the beginning of 2006 was marked by some significant successes and challenges," commented Michel de Rosen, ViroPharma's Chief Executive Officer. "Of course, we were thrilled by the Phase 2 data for maribavir showing that maribavir not only met its primary end point, it was also well tolerated, and showed extraordinary results in reducing the incidence of CMV reactivation in these very sick patients at every dose group. We also completed the full approval of our third party supply chain for Vancocin, which will, among other things, improve our already strong product margins as we head toward the end of this year."

Continued de Rosen, "A significant event occurred on March 16th and 17th when we were surprised by an apparent change in opinion at the Office of Generic Drugs (OGD) regarding what had previously been their approach requiring generic competitors to demonstrate bioequivalence to Vancocin through clinical studies or appropriately validated in vitro methodology. At that point we made our first filing with the FDA, a petition for a stay of action regarding the use of dissolution data as the premise for granting bioequivalence waivers, which we do not consider to be an appropriate standard. We believe that only through adequate and well-controlled human clinical trials can the efficacy, and perhaps most importantly the safety, of a generic version of oral Vancocin be confirmed. For a life-saving product such as Vancocin this issue is exceptionally important to the healthcare community and the patients we serve."

The adoption of SFAS 123R, "Share-based Payments," resulted in $0.9 million of expense, excluding the impact of income taxes. This results in a $0.01 per share impact for basic and diluted earnings per share.

Net income in the first quarter of 2006 was $8.2 million, compared to $17.4 million in the first quarter of 2005. Net income per share for the quarter ended March 31, 2006 was $0.12 per share, basic and diluted, compared to a net income of $0.64 per share, basic, and $0.36 per share, diluted, for the same period in 2005.

The primary drivers of the lower results were the effects of lower operating income discussed above and income tax expense of $5.5 million in the first quarter of 2006, while no income tax was recorded in the first quarter of 2005.

Operating Highlights

During the quarter ended March 31, 2006, net sales of Vancocin increased 38.8 percent compared to the same period in 2005 due to the impact of price increases, partially offset by lower unit sales. The Company believes, based upon data reported by IMS Health Incorporated, that prescriptions in the 2006 period exceeded prescriptions in the 2005 period by 39 percent. Since the Company does not acquire precise inventory data from wholesalers, the Company is required to estimate the inventory at wholesalers. The Company believes the lower unit sales reflect a decrease in wholesalers' inventory levels during the first quarter of 2006 compared to an increase in wholesalers' inventory levels during the first quarter of 2005.

The gross margin rate was 80 percent for the quarter ended March 31, 2006 and 83 percent for the first quarter of 2005. The decrease is primarily the result of units carrying an increased inventory cost as they were manufactured pursuant to the November 2005 amendment to the manufacturing agreement with Lilly, offset by the effects of price increases.

The total costs and expenses associated with operating income were $15.9 million and $9.8 million, for the first quarter of 2006 and 2005, respectively. In addition to the $2.1 million increase in cost of sales, research and development increased $1.3 million as the Company continued to support its CMV and HCV development programs and marketing, general and administrative increased $2.6 million related to commercial and other personnel related expenses, share-based compensation, and legal and consulting costs, $0.4 million of which related to the Company's opposition to the attempt by the OGD to change the approach towards making vancomycin hydrochloride capsules bioequivalence decisions.

The Company's effective income tax expense rate was 40.1 percent for the quarter ended March 31, 2006, while the 2005 quarter does not include any income tax expense. Income tax expense includes federal and state income tax at statutory rates and the effects of various permanent differences. The Company anticipates that the annual effective tax rate will be 38.2 percent.

link:
http://biz.yahoo.com/prnews/060504/nyth060.html?.v=51&printer=1


OUTLOOK:
Looking ahead to 2006

ViroPharma is commenting upon previously announced guidance for the year 2006 as a convenience to investors. The following guidance provided by ViroPharma are projections, based upon numerous assumptions, all of which are subject to certain risks and uncertainties. For a discussion of the risks and uncertainties associated with these forward looking statements, please see the Disclosure Notice below.

    For the year 2006, ViroPharma expects the following:

    -- Net sales are expected to be $160 to $170 million, representing growth
       of 27 percent to 35 percent over 2005;

    -- Operating income (without the SFAS 123R impact) is expected to grow 10
       percent to 20 percent over 2005;

    -- SFAS 123R impact to operating income in the range of $3.5 to $4.5
       million is not reflected in operating income growth above. Operating
       income growth including the impact of SFAS 123R is expected to grow 5
       percent to 15 percent over 2005.

[basonista]

Some good news but huge drop in eps.  Not too good....

[Lucas Scott]

Bas - that depends. I sold my position yesterday at $10.97 (was long from $12.01) and immediately went short. I got lucky.

[Melf Elf]

I'm curious if anyone saw VPHM trade at 7.69 near the open.  I saw it trade only as low as 8.32, which Scottrade also showed as the low, but the tick chart showed a low of 7.70 at 9:31 and a low of 7.69 at 9:31.  Later on, Scottrade changed the low to 7.69.

That seems fishy.      

Reason that I ask is that I have Target: 7.76 IN PLAY from the Double Top.  While I don't ascribe to "knife catching," I was ready to day trade it if the 7.76 target hit.  "Evidently" it did, but I never got the chance to play it.

VPHM has had a nice bounce, currently BID 9.24...ASK 9.25 which would have been a nice, quick profit off 7.69.

 

Thanks in advance if anyone has any information on the 7.69 print.

[la-onda]

thanks MelfElf 

analyst update:

VPHM: SG Cowen Ups to Neutral from Underperform; Analyst Notes
Thursday , May 04, 2006 10:19 ET
Issuer: Viropharma, Incorporated (NasdaqNM: VPHM)
Analyst Firm:  SG Cowen & Co.
Ratings Action: UPGRADE
Current Rating: Neutral (from Underperform)
Analyst Comments: The firm sees risk/reward as favorable here.

7.69 $ day low:

Viropharma, Incorporated  (nasdaqnm: VPHM)     Stock Symbol:

Last Trade:    9.310    Change:    -1.660 ( -15.132 %)
Previous Close:    10.970    Today's Open:    8.640
# of Trades:    12,065    Volume:    8,771,700
Avg. # of Trades:    3,225    Avg. Daily Volume:    1,709,430 

Bid:    9.310    Bid Size:    1
Ask:    9.310    Ask Size:    1
Day High:    9.370    Day Low:    7.690
52 Week High:    24.360    52 Week Low:    2.070
Market Cap:    638.53M    Dividend:    N/A
EPS:    1.94    P/E Ratio:    5.600

[Melf Elf]

7.69 $ day low:

Oliver,

I guess 7.69 was the low, but you had not to blink, to see it.  I sure would like to see that on the time & sales.  I saw only 8.32, the it rallied into the 8.40s...8.50s...8.60s and on above 9.00.

Thanks.

[calven]

Would not be buying VPHM anytime soon...

This chart looks brutal.