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

[la-onda]

FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C Virus Infection
Last update: 6/27/2007 8:30:00 AM

EXTON, Pa., June 27, 2007 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C virus infection. HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (WYE).

Under the FDA Modernization Act of 1997, fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package. However, the designation does not guarantee approval or expedited approval of any application for the product.

"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D, ViroPharma's vice president of global regulatory affairs and quality.

[David Randolph]

FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C Virus Infection
Last update: 6/27/2007 8:30:00 AM

EXTON, Pa., June 27, 2007 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C virus infection. HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (WYE).

Under the FDA Modernization Act of 1997, fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package. However, the designation does not guarantee approval or expedited approval of any application for the product.

"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D, ViroPharma's vice president of global regulatory affairs and quality.

Was the market wrong? This will be interesting

[jorgegr]

Also note this filing at the FDA

Abbreviated New Drug Application (ANDA) for Vancocin Capsules" entered June 21, 2007

http://www.fda.gov/ohrms/dockets/dailys/07/june07/062107/062107.htm

2006P-0124   Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules   

[la-onda]

the boys are back in town 

[la-onda]

ViroPharma initiated with "buy"

Thursday, June 28, 2007 12:51:07 PM ET
Maxim Group


NEW YORK, June 28 (newratings.com) - Analysts at Maxim Group initiate coverage of ViroPharma Incorporated (ticker: VPHM) with a "buy" rating. The target price is set to $18.

[Terliso]

Two  bearish pattern are still in play.

[la-onda]

downtrend broken imho 

news update:
ViroPharma Initiates Phase 3 Study of CAMVIA(TM) (maribavir) in Liver Transplant Patients
Thursday , July 05, 2007 09:00ET

EXTON, Pa., July 5 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the recently initiated second Phase 3 clinical study of CAMVIA(TM) (maribavir) in transplant patients is now open to patient recruitment. This study will evaluate the prophylactic use of CAMVIA in patients undergoing a liver transplant procedure, and will be conducted in up to 60 U.S. transplant centers. The first Phase 3 study of CAMVIA was initiated in September 2006 in patients undergoing a stem cell transplant.

ViroPharma's Phase 3 liver transplant study will compare the efficacy, safety and tolerability of prophylactic use of CAMVIA versus oral ganciclovir when administered for up to 14 weeks for the prevention of cytomegalovirus disease in recipients of orthotopic liver transplants at high risk of developing CMV disease. The study also will evaluate the pharmacokinetics of CAMVIA in this subject population.

"We have made great progress with CAMVIA in the last 12 months; the initiation of this second Phase 3 study is our latest milestone as we work towards our goal of making this important drug available for the more than 120,000 transplant patients throughout the world who are at risk of deadly CMV disease," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "The excellent CAMVIA Phase 2 data presented at the 2006 ASH meeting encourage us as we execute on our comprehensive Phase 3 program in transplant patients."

Phase 3 Liver Transplant Study Design

This Phase 3 study is a randomized, double-blind, multicenter study intended to enroll over 300 subjects who have undergone liver transplantation and are at high-risk of developing CMV disease (i.e., donor CMV seropositive / recipient CMV seronegative). Following transplantation, eligible subjects will be randomized to receive CAMVIA 100mg BID or oral ganciclovir 1,000mg TID in a 1:1 allocation ratio for up to 14 weeks. If CMV disease, defined as symptomatic CMV infection or CMV organ disease, occurs during the study drug administration period, study drug will be discontinued and the subject will be managed according to standard CMV treatment practices at the transplant center.

The primary efficacy endpoint is the incidence of CMV disease (either symptomatic CMV infection or CMV organ disease) within 6 months post transplantation, which is expected to be approximately 12 percent in the oral ganciclovir arm of the study, based on data from published literature. A number of key secondary endpoints have been identified and assessment of these endpoints will play an important part in assessing the clinical benefit of CAMVIA. These secondary endpoints include time to onset of CMV infection and disease; the incidence and time to onset of anti-CMV therapy; and survival without CMV infection or disease; in addition to the incidence of adverse effects that limit the use of current therapies, including suppression of bone marrow function.

CAMVIA's antiviral activity and tolerability were elucidated in a Phase 2 study designed to assess the rate of CMV reactivation in patients undergoing allogeneic stem cell transplantation. The press release announcing the presentation of the data at the 2006 American Society of Hematology meeting can be found at the following URL: http://phx.corporate- ir.net/phoenix.zhtml?c=92320&p=irol-researchNewsArticle&ID=941183&highlight= (to ensure proper link, please copy and paste full address into browser)

chart update:

[la-onda]

VPHM: Short Interest UP 13.9% to 11.8M in Jul 2007
Tuesday , July 24, 2007 16:23ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) INCREASED 13.9% to 11,768,013 shares for the month ended mid-July, 2007.

SYMBOL         JUNE            JULY          CHANGE       %CHANGE       DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
VPHM    10,331,811      11,768,013      +1,436,202       +13.90%          10

Based on VPHM's 20-day average daily share volume of 1,231,415, it would require approximately 10 day(s) of buying to cover this short interest.

[Terliso]

Two  bearish pattern are still in play.

Third hit from from upper trendline, looks like a good short here, breaking down the support again.

[la-onda]

have zou shorted VPHM Terliso??

hope not!

ViroPharma's 2Q Profit Beats Wall Street
Wednesday August 1, 9:18 am ET 
ViroPharma's 2nd-Quarter Profit Rises 84 Percent to Eclipse Wall Street Estimates
EXTON, Pa. (AP) -- Drug maker ViroPharma Inc. said Wednesday its second-quarter profit rose 84 percent on higher sales of its gastrointestinal tract infection treatment Vancocin, beating analyst estimates.
Net income grew to $31.6 million, or 39 cents per share, from $17.2 million, or 25 cents per share, a year ago. Revenue rose 28 percent to $56.1 million from $44 million last year.
Analysts surveyed by Thomson Financial expected earnings per share of 26 cents on revenue of $50.6 million. Vancocin posted a 28 percent rise in second-quarter net sales to a record $56 million. Income rose primarily on higher net sales and increased gross product margin rates, offset by costs related to drug development in viral diseases, the company said.



&

ViroPharma Raises 2007 Sales Guidance
Wednesday August 1, 10:37 am ET 
ViroPharma Raises 2007 Revenue Guidance in Line With Wall Street Expectations


EXTON, Pa. (AP) -- Drug maker ViroPharma Inc. revised Wednesday its revenue guidance for 2007 in line with Wall Street's expectations.
The company projects 2007 net product sales between $200 million and $208 million, up from its previous guidance, announced in February, of between $195 million and $205 million.
Analysts surveyed by Thomson Financial on average estimate full-year revenue of $206.2 million. Gross margin rate for Vancocin, the company's treatment for gastrointestinal tract infections, is expected to exceed 90 percent, ViroPharma reiterated. The company said research and development as well as marketing, general and administrative expenses are expected between $71.5 million and $80.5 million, which includes the impact of stock-based compensation expense. Its prior guidance had pegged R&D and MG&A between $67.5 million and $80.5 million. Separately, ViroPharma said its second-quarter profit rose 84 percent on higher sales of its drug Vancocin.

cheers
Oliver

[la-onda]

1)
Zack update:

OUTLOOK
ViroPharma, Inc. is a pharmaceutical company engaged in the development and commercialization of products that address diseases caused by infectious agents such as a
virus or pathogenic bacteria. The company has one approved product, Vancocin Capsules, for the treatment of antibiotic-associated infection, and two mid-stage candidates for viral infections. Recent concerns over a generic alternative to Vancocin have hampered the stock.
This is keeping ViroPharma trading at a significant discount to its peers. The company has filed a Citizens Petition to the FDA-OGD to halt generic entrants.
Outside of Vancocin, clinical-stage candidates Camvia and HCV-796 offer the next substantial growth opportunities. We believe the shares are vastly undervalued. Our target is $22.

KEY POINTS
The near-term future of ViroPharma is heavily dependant on sales of Vancocin Capsules. Guidance for 2007 is for sales between $200 and $208 million. Our estimate is above guidance at $210.1 million, growth of 26% over 2006 driven by strong demand and price increases.
Generic manufacturers, including an Akorn-Strides JV, have announced their intent to bring a generic Vancocin (oral vancomycin) to the market. Guideline changes at the Office of Generic Drugs (OGD) in early 2006 have seemingly facilitated the application process for a locally acting GI drug such as Vancocin, removing the necessity for human clinical trials before approval. This could allow for ANDA approvals for generic oral vancomycin in 2008 two years earlier than previously expected given the old guidelines. The company has filed a Citizen s Petition to the OGD with two formal letters outlining the legal protocol and scientific merits to halt an early generic alternative on May 31, 2006 and June 30, 2006, respectively. The company is also conducting an exploratory study to characterize the intestinal track of patients infected with C.
difficile. ViroPharma will now wait for OGD responses to the two letters or the GI data.
We believe the company is making great progress with the pipeline and both HCV-796 and Camvia offer the next wave of growth for shareholders. Investor concern is too focused on the generic Vancocin risk. ViroPharma will be a significantly more diversified company once these two drugs are on the market.
Our Buy Call: Sales of Vancocin were very strong in the second quarter 2007. Sales growth grew 28% in the quarter and remains very strong. We are also very excited about the potential for Camvia. Camvia is significantly under-appreciated in our view. Finally, as far as the legal and scientific petition to the OGD, we believe that ViroPharma s position is strong. The risk of a generic product before 2009 is low in our view.

INVESTMENT OUTLOOK
No ANDAs have yet been approved on Vancocin. Akorn-Strides commented recently that they expect a decision by the FDA before year-end 2007. We do not know the current status of Akorn or Strides BE testing. However, we have long said that gaining approval for generic Vancocin will be difficult given the manufacturing challenges. We had previously believed even if Cipla started today, they would not gain approval until late 2008 based on the manufacturing validation necessary to product a Vancocin capsule. It took ViroPharma over a year to get validation from the third party manufacturer in the first quarter of 2006. The legal and scientific arguments submitted by ViroPharma are rock solid in our view. We do not believe the FDA would approve an ANDA without addressing the Citizen s Petition , or CP. This has yet to occur. We think the exploratory study being conducted by ViroPharma will further add to the solid view of the scientific argument pertaining to the CP. We are concerned about this generic risk but also remind investors that ViroPharma could be a dramatically different looking company in 2010 if pipeline candidates such as Camvia or HCV-796 succeed. So far the data on Camvia and HCV-796 looks very encouraging. Based on the recent very positive phase II Camvia data, this
candidate may be the driving force of the future. Peak sales estimates for Camvia could quadruple that of Vancocin. Likewise, we are excited about HCV-796 and please to see the FDA grant Fast Track development status to the drug in June 2007. Additionally, we expect ViroPharma to seek to in-license one or two more products over the next few quarters. And, despite generic risk and emerging competition, Vancocin Capsules will probably remain the industry standard for at least the next 18 months. Management guidance for 2007 seems conservative given the lack of immediate competition for the drug and another expected price increase shortly.

VALUATION
We are maintaining our buy rating on shares of ViroPharma heading into the second half of the year. We are pleased to see sales of Vancocin on tract with our yearly forecasts. Management increased guidance over the previous range of $195 to $205 million to $200 to $208 million for 2007. Our forecast of $210.1 million for Vancocin Capsules sales in 2007 is just above management s guidance on our belief that the remainder of the year will continue the strength seen in the first half. We also feel the recent 9.4% price increase and now under-control
inventory situation will help management meet or exceed their guidance. Camvia looks like a big winner given the recent very positive phase II results. Other candidates such as HCV-796
also look very solid given the positive phase Ib data recently presented at EASL. Both these candidates are progressing forward with the next stage of clinical work as we head into the fall of 2007. Management expects to add one or two additional value drivers to the portfolio over the next several quarters. In 2006 we saw the company in-license a pre-clinical Non-Tox C. difficile candidate from the Hines VA Hospital. ViroPharma held $517 million in cash on hand at the end of the first quarter. This amount includes $37 million in cash generated during the
quarter and $219 million in net proceeds from the recent 2% senior convertible 2017 notes in March. We note the company is very well capitalized, generating cash, and actively seeking opportunities. In our view, ViroPharma is one of the best managed companies in biotech. We are very confident in the financial and strategic position of the company it is key to our Buy recommendation. At this level ViroPharma stock is too attractive to ignore. Over half the market capitalization is cash. Our 2007 revenue forecast of $210.5 million yields a price to sales ratio of 5.1x. This is significantly below the biotechnology peer-group average of around 8.5x. We forecast 2007 EPS at $1.25 (including option expense). The price to earnings ratio of 10.2x is so far below peer-group we can t help but wonder whether a company like GlaxoSmithKline, Bristol-Myers, or Wyeth would be interested in acquiring ViroPharma. ViroPharma s stock sank in March 2006 on fears of generic Vancocin. Since that time the company has progressed with Camvia and HCV-796 to the point where we now include both candiates in our long-term model. We have recently expanded our model to include 2011 EPS. Investors concerned with generic Vancocin should begin to pay attention to sales of Camvia for CMV. We think the candidate offers a much more significant growth opportunity over the long-term.
We think the market is too focused on the generic risk to Vancocin. We see the Citizens Petition as solid and the recently initiated exploratory study to characterize the GI track of healthy vs. infected patients will only help add to the scientific validity of management s claim. The two letters made public outlining the legal and scientific merits for a judgment stay are rather convincing in our view. The OGD clearly violated a number of laws and its own standard
of conduct with its bioequivalencey testing guideline change apparently made in February 2006. Additionally, Vancocin clearly does not meet several of the OGD s own instituted criteria for in vitro dissolution testing. We expect the ODG to respond favorably to ViroPharma s actions.
Volatility acknowledged, we would be buyers of the stock at this level.
Our $22 price target is based on 17.5x our 2007 EPS estimate of $1.25. This 17.5x is a discount to the peer-group s 26.5x based on the risk of generic Vancocin. A positive response by the OGD and we believe the stock could easily eclipse our target.

2)
BUYINS.NET: (VPHM) SqueezeTrigger Price is $13.889. There is $164,516,640.00 That Short Sellers Still Need To Cover
Wednesday, August 01, 2007 12:53ET

Aug 01, 2007 (M2 PRESSWIRE via COMTEX) -- BUYINS.NET / www.squeezetrigger.com is monitoring VIROPHARMA INC (NASDAQ:VPHM) in real time and just received an alert that is crossing above its primary SqueezeTrigger Price, the price that a short squeeze can start in any stock. There are 11768000 shares that have been shorted at the volume weighted average SqueezeTrigger Price of $13.889. To access SqueezeTrigger Prices ahead of potential short squeezes beginning, visit http://www.squeezetrigger.com. From January 2005 to July 2007, an aggregate amount of 303198222 shares of VPHM have been shorted for a total dollar value of $3,941,576,886.00. The VPHM SqueezeTrigger price of $13.889 is the volume weighted average price that all shorts are short in shares of VPHM. There is still approximately $164,516,640.00 of potential short covering in shares of VPHM.

Charts & Zack Report for downloading (nice details about the awesome pipeline  )

[la-onda]

fyi:

Don't Discount ViroPharma
By Brian Lawler August 6, 2007

Last week, exciting biopharma ViroPharma (Nasdaq: VPHM) announced its second-quarter financial results and updated investors on what's ahead for the rest of the year.

Sales of ViroPharma's only marketed product, the oral antibiotic Vancocin, were up 28% year over year in the second quarter to $56 million. Net income was up more than 80% to $31.6 million, or $0.39 per share on a diluted basis.

Because of two ongoing phase 3 studies for its transplant drug maribavir and other R&D expenditures, the second half of the year won't be as strong financially as the first half was. But even on the low end of its guidance, ViroPharma expects to bring in approximately $100 million in net income for the year, or about $1.18 in diluted earnings per share for 2007, at today's share count.

Potential competitor Idenix Pharmaceuticals (Nasdaq: IDIX) had development of its hepatitis C polymerase inhibitor put on hold by the FDA last month. This puts ViroPharma and partner Wyeth (NYSE: WYE) in the lead to develop the first HCV polymerase inhibitor with their compound, dubbed HCV-796.

Late last year, the partners announced positive phase 1b study results for HCV-796. In May, ViroPharma completed enrollment of the initial treatment groups for a phase 2 study of the drug. Data from four weeks of dosing is expected this quarter, which will give an initial idea of whether the drug is reducing hepatitis C viral load as expected. Vital 12-week patient dosing of the drug will come in the fourth quarter, which should give investors a better idea of how HCV-796 compares with existing treatments in eliminating the hepatitis C virus from the body.

ViroPharma has an enterprise value of nearly $700 million. Considering that its lead drug is highly profitable and has two strong pipeline candidates in development, shares of ViroPharma don't look expensive.

ViroPharma guided for a potential maribavir FDA regulatory filing in 2009 and a similar timeframe for a European Union marketing application as well. All it would take is for one success with its pipeline, or the failure of a generic Vancocin to appear, and shares of ViroPharma would look like a steal at today's prices. Investors might not get to wait that long, though; ViroPharma would be a perfect fit for an acquirer such as Gilead Sciences (Nasdaq: GILD) or Genzyme (Nasdaq: GENZ). 

[la-onda]

Cowen update:
We Downgrade ViroPharma; Investor Opinion Mixed On Interim Phase 2
Data For HCV-796 - Cowen Comments



(RTTNews) - Wednesday, Cowen downgraded ViroPharma, Inc. (VPHM)
shares to Neutral from Outperform. The brokerage raised its 2007 EPS estimate to $1.23 from $1.15, while lowering its 2008 estimate to $1.16 from $1.25.

Analyst Rachel McMinn said that the investor opinion is mixed on what to expect from interim Phase 2 data for VPHM's HCV-796 for hepatitis C virus. Additionally, investors are split on whether VPHM's cash cow Vancocin will be impacted as early as 2008 by generic competition and how dramatic the impact would be.

The analyst believes investors will need to gain additional confidence in both Vancocin and HCV-796 for VPHM shares to outperform over the next 12 months. Expectations for an upcoming Phase 2 interim analysis for '796 are set well below those for Vertex Pharmaceuticals
Inc.'s (VRTX) telaprevir, which the analyst views as appropriate, and it appears investors are generally looking to gain comfort in the potential combinability of '796 with telaprevir or Schering-Plough Corp.'s (SGP) boceprevir.
The analyst sees 3 key '796 risks: potential failure for '796 to suppress HCV levels below detection in at least 40-60% of patients at 4-weeks, a minimum threshold that will give us confidence '796 can be developed independent of other HCV agents; potential delay in
starting Phase 3 and increasing visibility of competing non- nucleoside products.

Separately, the analyst expects generic Vancocin concerns to remain an overhang for VPHM until there is clarity around the timelines for generic approval. Phase 2 data for VPHM's anti-CMV product Camvia suggest a promising profile. However, given limited news flow on
Camvia until the second half of 2008, the analyst expects Vancocin and '796 news to drive investor interest. The analyst's analysis suggests shares are fairly valued given the uncertainties that lie ahead for Vancocin and '796.
The analyst noted that VPHM shares are undervalued on the basis of current and near term cash flow and the pipeline assets. Camvia could be a $500 million+ product and '796, while not as impressive as telaprevir, will ultimately be incorporated into a new standard of care for HCV and thus is underappreciated.

Currently, the stock is down $0.16 or 1.23% and trading at $12.84.

THIS DOWNGRADE IS BULLSHIT IMHO, I have bought some Feb08 15$ calls today 

[Terliso]

Two  bearish pattern are still in play.

Third hit from from upper trendline, looks like a good short here, breaking down the support again.

There you go (3 Magic Breakdown for VPHM)..... the bearish patterns are kicking in and the chart now is too ugly to ignore.

[la-onda]

Two  bearish pattern are still in play.

Third hit from from upper trendline, looks like a good short here, breaking down the support again.

There you go (3 Magic Breakdown for VPHM)..... the bearish patterns are kicking in and the chart now is too ugly to ignore.

I must admit that your analysis was wright, my was wrong 
Now I have to pay for it....   

Applause Terliso
cheers
Oliver