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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

VPHM: Jumps +1.14%; Vol +55%; Last 90 Min of Trading
Friday , June 20, 2008 16:21ET

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             $10.50        $10.62        +1.14%
VOLUME           750,988     1,161,332       +54.64%
#TRADES            3,298         4,847       +46.97%
DAY-HI            $10.51        $10.67       LATE-HI
DAY-LO            $10.25        $10.25           N/A


charts:


Ramsburg

Update:

Interesting price development for VPHM.
After a solid consolidation reacting positively near the 50EMA and near the 200EMA, the stock is now gaining upside momentum again with volume catching up.

We are just upgrading our stop level to follow up this positive developments, the new trading plan is:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

la-onda

Who's got Zack's? INCREDIBLY CHEAP

http://biz.yahoo.com/zacks/080624/13369.html?.v=1

We remain confident that ViroPharma Inc.'s (NasdaqGS: VPHM - News)
position is strong. At this level the stock remains incredibly cheap,
and we are optimistic that management will be able to add significant
value in the coming years.

We see several driving forces in 2008 that lead us to believe it will
be another solid year for the Vancocin antibiotic. We see significant
opportunity for Vancocin to gain share in the most severely infected
patients. Clostridium difficile infection is a life-threatening
disease and the data is becoming clear that Vancocin is the best
available option for its treatment.

We are concerned about this generic risk but also remind investors that ViroPharma could be a dramatically different-looking company in 2010 if pipeline antiviral candidate Camvia succeeds in treating cytomegalovirus disease.

The stock will most likely remain in the tight trading range until we get an update from the U.S. Food and Drug Administration/Office of Generic Drugs on generic Vancocin. Positive news will send the shares significantly higher. The launch of a generic product will probably
cause a sell-off, although considering the current market value is $735 million and ViroPharma is sitting on $599 million in cash, we think that is a bet worth taking.

At this level the stock is too attractive to ignore. Our 2008 revenue forecast of $219.9 million yields a price to sales ratio of 3.3x. This is significantly below the biotechnology peer-group average of around 6.5x. We forecast 2008 EPS at $0.90. The price to earnings ratio is only 11.8x. We think Camvia offers a significant growth opportunity over the long-term. As a result, our rating is Buy and our price target of $14 is based on 15.5x our 2008 EPS estimate of
$0.90.

Ramsburg

Update:

VPHM continues to perform well despite the current market mood.

La-Onda already posted about the new Zacks report (thanks la-onda ;)), here you can see the complete 10 pages report:



They added very positive comments and a $14 price target, while Zacks is one of the most respected research departments around (read the report for full details).

Our plan remains the same:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

Update:

Since our last update, VPHM was able to breakout the previous resistance at $11 (now a support), making this move with strong volume and against a broad market tumble at the same time.
This technical behavior shows a lot of relative strength, suggesting upside continuation at anytime soon.

Today, PiperJaffray research department published a note for VPHM regarding some of the themes in Play (they rated VPHM with a BUY recommendation and a $14 price target):

QuoteViroPharma (VPHM - $11.21)
Company Note - June 27, 2008

Buy | Volatility: Medium

Mylan's Response To VPHM's Petition Flawed

KEY POINTS:
• New finding: Mylan discloses its generic Vancocin
• Mylan's response to VPHM's petition contains flawed arguments
• Buyer on weakness on generic Vancocin fears - Camvia can make up downside
• New Surprise: Mylan Has A Generic Vancocin. As a reminder, VPHM
originally filed a petition in March 2006 to prevent the FDA from allowing
dissolution testing to replace a clinical study for determining bioequivalence for
Vancocin. While we knew that Akorn (AKRX) had submitted an ANDA for a
generic Vancocin, Mylan has also posted a response to VPHM's petition for its
own generic vancomycin capsule. Mylan's key arguments are: 1) its vancomycin
capsules are rapidly dissolving in contrast to VPHM's assertion that Vancocin
does not meet the criteria for rapid dissolution required for dissolution studies;
and 2) there is no data to support that the GI tract differences in C. difficile
patients would limit the effectiveness of a generic approved under dissolution
studies. Secondary arguments include: vancomycin's low absorption, high
solubility, and a 1987 paper showing little difference in fecal concentrations
when vancomycin was delivered by capsule or by solution.
• Mylan's Arguments May Fall Short. Mylan's key argument is that Vancocin is
rapidly dissolving, a requirement for the dissolution studies to be used in lieu of
clinical studies. The discrepancy between Mylan and VPHM lies in the
dissolution apparatus used: Mylan used USP Apparatus II while VPHM used
USP Apparatus I. While both are options in the BCS waiver guidance document,
Apparatus I is recommended for capsules like Vancocin, whereas Apparatus II is
preferred for tablets (see p. 2). Mylan offers no rationale for its choice of
Apparatus II. Separately, we find the argument that there is no known data
suggesting that the perturbed GI motility or pH range of CDI patients would limit
the effectiveness of oral vancomycin to be a flawed argument and the very reason
why VPHM petitioned in the first place. VPHM is conducting a study to explore
this question and whether perturbations in gastric motility and pH in CDI falls
outside the scope of dissolution studies to mimic.
• Buy On Weakness – Value In Camvia Offsets Generic Risk. More insight into
the prospects and timing of a Vancocin generic may come from a FDA panel
meeting on July 23 on bioequivalence methods for locally acting GI drugs.
However, it is unclear if there will be specific debate of Vancocin at this meeting.
Any weakness in the stock from this panel meeting could be a good buying
opportunity given the prospects for Camvia in late-stage development. We are
using this opportunity to shift our generic assumption from 3Q08 to 4Q08. Even
in this worst case scenario for VPHM, our price target is $14 and already
assumed two near-term generic competitors, and thus, the new discovery of
Mylan's filing does not affect our valuation.

INVESTMENT RECOMMENDATION:
ViroPharma is rated Buy. Our price target of $14 is based on a sum-of-the-parts
valuation: $7 cash + $3 Vancocin + $4 Camvia.

RISKS TO ACHIEVEMENT OF TARGET PRICE:
Risks include but are not limited to: 1) Vancocin generic competition, 2) failure in
Camvia program; and 3) failure to develop a pipeline beyond Camvia.

Our plan remains the same:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

Update:

Despite the current market slide, VPHM is holding up above the $11 breakout level. It would be normal to watch some consolidation though, but for now this is a powerful relative strength signal.
The 50EMA just crossed above the 200EMA, which is a standard long term bullish signal (not important for short term, but a good technical input), these moving averages are located a little below $10.

PiperJaffray just published another note, this time commenting May's IMS sales:

QuoteMay IMS Sales Update
Company Note - July 1, 2008

KEY POINTS:

• Vancocin prescription sales trends for May suggest upside to our 2Q08 estimate
of $57.9 million; Raising estimate to $65.0 million

• Price target remains $14

• May Monthly Vancocin Sales Data. The IMS audit for the month of May
recorded $20.6 million in Vancocin sales, up 2.6% from April sales of $20.1
million. Relative to the prior-year, Vancocin sales for May are up 11.6% Y/Y and
up 6.7% comparing April/May of 2008 to the same time period in 2007. Of note,
historical patterns of Vancocin use have shown a yearly peak around the month
of June, lagging the season of peak antibiotic use during the winter. We also
remind investors that IMS monthly sales are reported on a 4-4-5 calendar,
which—assuming consistent demand for the rest of the quarter—points to
$66.1m in Vancocin sales for 2Q08. Our 2Q08 Vancocin sales estimate of
$57.9m assumes an extra 0.4 weeks of inventory relative to 2Q07, a 5.6% Y/Y
decrease in end-user demand, and a 9.4% price increase effective February 5 for
an overall 3.3% increase in Y/Y sales. Based on the discrepancy between the
6.7% increase in IMS Vancocin sales seen for April-May 2008 over the same
time period in 2007 and our modeling assumption of a 5.6% Y/Y decrease in
end-user demand, we are raising our 2Q08 Vancocin sales estimate from $57.9m
to $65m. Q/Q sales trends could also be helped by the relatively recent launch of
the first Vancocin promotional efforts with a small sales force in the Northeast
and medical education grants. We continue to believe that IMS monthly sales
have the best correlation with end-user demand, and we will continue to closely
monitor IMS monthly prescription and sales data.

INVESTMENT RECOMMENDATION:
ViroPharma is rated Buy. Our price target of $14 is based on a sum-of-the-parts
valuation: $7 cash + $3 Vancocin + $4 Camvia.

RISKS TO ACHIEVEMENT OF TARGET PRICE:
Risks include but are not limited to: 1) Vancocin generic competition, 2) failure in
Camvia program; and 3) failure to develop a pipeline beyond Camvia.

Our plan remains the same, but probably after a consolidation or another upside breakout we'll increase our stop level:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

la-onda

VPHM: Jumps +2.32%; Vol +55%; Last 90 Min of Trading
Tuesday , July 01, 2008 16:21ET

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             $11.21        $11.47        +2.32%
VOLUME           944,787     1,468,902       +55.47%
#TRADES            4,403         7,113       +61.55%
DAY-HI            $11.28        $11.52       LATE-HI
DAY-LO            $10.84        $10.84           N/A

Ramsburg

Update:

VPHM again with interesting technical developments... Another new high for this upswing, closing near $11.50 and suggesting continuation. We are half the way to our target now.

Our plan remains the same:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

la-onda

very nice update  >:D

ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Tuesday , July 08, 2008 09:00ET

EXTON, Pa., July 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.

Based on FDA's statements to ViroPharma regarding the purpose of this meeting, made by both Committee staff and FDA's Office of Chief Counsel, ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting GI drugs. Among other things, ViroPharma's letter notes important issues that must be addressed in this complex area of bioequivalence method development, and attaches for the Committee's review a letter sent to FDA last year by the Infectious Diseases Society of America (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.

FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."

ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.

ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.

Ramsburg

Update:

Interesting developments for VPHM's chart, once again the stock manage to reach new relative highs while the board market was tumbling. This situation gives us a nice relative strength for VPHM right now, and that could mean increasing the upside momentum at anytime.

In Play during the last session was some FDA news. Yesterday, the analysts at Goldman Sachs published this research note:



Our plan remains the same:

Trading Plan:
Sell @ $13.00, Stop @ $9.45
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

la-onda

ViroPharma: Increasing Q2 Vancocin estimate - Cowen (11.95 )

Cowen is increasing their Q2 sales ests on VPHM's Vancocin based on IMS (accounting for their typical sales over-estimation) data to $62.1 mln ahead of consensus of $58.3 mln. Firm says additional upside to their and consensus 2H08 sales ests is possible if current organic growth expands with VPHM's pilot marketing initiative, although they don't expect 2008 sales to exceed the current co guidance of $210-235 mln. Firm adds that at this point, it is unclear if the growth in organic sales is sustainable over 2H08, or merely a one-time seasonal event.

Chart:

la-onda

sold 30% @ 12.89

ViroPharma to Release 2008 Second Quarter Financial Results on July 30, 2008
Monday , July 14, 2008 16:30ET

EXTON, Pa., July 14 /PRNewswire-FirstCall/ -- ViroPharma Incorporated's (Nasdaq: VPHM) second quarter financial results for 2008 are expected to be released on Wednesday, July 30, 2008 before the open of the U.S. financial markets.

The company will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on the same day. During the conference call, ViroPharma management will discuss the 2008 second quarter financial results and other business.

The press release and the live webcast of the conference call will be accessible via ViroPharma's corporate website at http://www.viropharma.com. An audio archive will be available at the same address until August 15, 2008. To participate in the conference call, please dial (888) 299-4099 (domestic) and (302) 709-8337 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.

AussieTrader

Update:

VPHM continues to aggresively outpace the market. Applaud La-onda for the information and the news updates with VPHM.

Yesterdays high got to within a few cents of our profit target, some of you (like La-onda) may have taken profit in that area, well done if that is the case. As the intraday price action got so close I will take the following actions; 1) Lower the profit target to $12.90 (just below yesterdays high, I don't want that high to act as resistance) 2) Raise our stop to a more logical level at $10.40 just below July 9th pivot low.

Trade Plan:

Sell at $12.90 Stop at $10.40
AussieTrader
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

la-onda

ViroPharma To Acquire Lev Pharmaceuticals
- Acquisition Adds Late Stage Product Targeting Life-threatening Hereditary Angioedema Disease with Limited Treatment Options
- Company to Host Conference Call at 10:30 A.M. Eastern Today to Discuss Transaction

EXTON, Pa., July 15 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) and Lev Pharmaceuticals, Inc. (OTC Bulletin Board: LEVP) today announced that the companies have signed a definitive merger agreement under which ViroPharma will acquire Lev, a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases, for $442.9 million of upfront consideration, or $2.75 per Lev share, comprised of $2.25 per share in cash and $0.50 per share in ViroPharma common stock (subject to a collar). Contingent consideration of up to $1.00 per share may be paid on achievement of certain regulatory and commercial milestones. The transaction with a potential net aggregate value of up to $617.5 million has been unanimously approved by the boards of directors of both companies. The companies expect the transaction to be completed by the end of 2008. In addition, concurrently with the execution of the merger agreement, ViroPharma purchased $20 million of Lev common stock.

The acquisition of Lev Pharmaceuticals further enhances ViroPharma's pipeline with Cinryze(TM) (C1 inhibitor (human)), which is currently under regulatory review for approval by the U.S. Food and Drug Administration as a replacement therapy for patients with hereditary angioedema (HAE), also known as C1 esterase inhibitor (C1-INH) deficiency. The use of replacement therapy in patients with C1-INH deficiency is supported by more than 35 years of clinical practice experience in Europe. C1-INH depletion is also implicated in a number of other serious inflammatory disorders.

Hereditary angioedema, or C1-INH deficiency, is a dangerous and potentially deadly inflammatory disease affecting up to 10,000 patients in the United States, caused by a genetic deficiency in an essential protein called C1 esterase inhibitor. Clinical studies have shown that prophylactic C1 inhibitor replacement therapy with Cinryze can significantly reduce the severity, duration and frequency of HAE attacks.

"This transaction is consistent with ViroPharma's stated objective of broadening our portfolio of therapies for serious life-threatening conditions in selected specialty markets," commented Vincent Milano, ViroPharma's president and chief executive officer. "Lev's orphan drug Cinryze(TM) is a life-saving therapy treating a very dangerous disease. This opportunity provides a clear strategic fit with ViroPharma: Cinryze targets a market that is addressable with modest additional infrastructure and further serves patients suffering from a disease with few treatment options. We are very pleased to add the expertise of Lev to our organization, and Cinryze to our growing portfolio of options for underserved patient populations with critical and urgent needs."

"We believe this transaction recognizes the value we have created at Lev and provides our shareholders with attractive financial terms, through the upfront payment and the opportunity to continue to share in the success of Cinryze(TM) through the ownership of ViroPharma shares and the contingent value rights," commented Judson Cooper, Lev's chairman of the board. "Leveraging the combined resources of both companies not only strengthens our C1 inhibitor development platform, but also underscores our commitment to serving patients with critical unmet medical needs."

basanlas

Just like that it wipes away our profits and hits the stops!