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

[la-onda]

ViroPharma to Present at Three Upcoming Healthcare Conferences
Thursday , August 30, 2007 13:10ET

EXTON, Pa., Aug. 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that Vincent Milano, vice-president, chief operating officer and chief financial officer of ViroPharma, will present at the Thomas Weisel Partners 2007 Healthcare Conference at 8:00 A.M. ET on Wednesday, September 5, 2007. The conference is being held at the Four Seasons Hotel in Boston, MA.

Mr. Milano will also present at the 14th Annual BioCentury Newsmakers in the Biotech Industry Conference at 1:30 P.M. ET on Thursday, September 6, 2007. The conference is being held at the Millennium Broadway Hotel in New York.

ViroPharma also announced that Michel de Rosen, president and chief executive officer of ViroPharma, will present at the Bear Stearns 20th Annual Healthcare Conference at 3:30 P.M. ET on Monday, September 10, 2007. The conference is being held at the Grand Hyatt in New York.

[BigSully1]

showing some signs of life? I think I have a much better pick. Read about it tommorrow on the members board.

[la-onda]

Melf's update:
http://melfsworkshop.blogspot.com/2007/10/vphm-in-crash-recoveryagain.html

[la-onda]

VPHM update:
ViroPharma Incorporated Reports Third Quarter and Nine-Month 2007 Financial Results
Tuesday , October 30, 2007 07:00ET

EXTON, Pa., Oct. 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) reported today its financial results for the third quarter and nine-months ended September 30, 2007.

Key events since June 30, 2007 include:

    Clinical:

    -- Patient enrollment began in a Phase 3 study of Camvia(TM) (maribavir)
       in liver transplant patients;
    -- Patient enrollment continued to the plan in Phase 3 study of Camvia in
       stem cell transplant patients; study enrollment expanded to European
       sites;
    -- Dosing with HCV-796 was discontinued in an ongoing Phase 2 combination
       study in hepatitis C patients following discovery of elevated liver
       enzyme levels in a subset of patients; trial participants continue to
       receive pegylated interferon and ribavirin in this study; and
    -- New data presented at the 2007 Interscience Conference on Antimicrobial
       Agents and Chemotherapy (ICAAC) meeting by Genzyme Corporation show
       Vancocin(R) is superior in clinical success to metronidazole and
       Genzyme's experimental compound in patients with severe CDAD (Louie et
       al., 2007).

    Operational:

    -- Net sales of Vancocin(R) were $51 million;
    -- Launched new sales and marketing initiatives for Vancocin; and
    -- Research and development expenses increased by 40 percent over the
       third quarter of 2006, primarily driven by investments in Camvia.

    Financial:

    -- Operating income was $27.9 million;
    -- Working capital increased by $31 million to $573 million;
    -- Cash, cash equivalents and short-term investments grew to $552 million;
       and
    -- 11th consecutive quarter of cash flow positivity and profitability
       achieved.

Net sales of Vancocin(R) were $50.9 million for the third quarter of 2007 and $156.1 million for the first nine months of 2007 as compared to $55.1 million and $128.2 million in the respective 2006 periods. Operating income in the third quarter and nine-months ended September 30, 2007 was $27.9 million and $96.7 million, respectively, compared to $34.5 million and $73.7 million in the third quarter and nine months of 2006, respectively. Operating income in the third quarter decreased primarily due to lower sales and increased development costs incurred during the quarter.

"Increased momentum in our Phase 3 Camvia program is of utmost importance to ViroPharma; the third quarter of 2007 reflected this momentum, as shown by the dramatic increase in clinical expenses this period over that of the same quarter in 2006," commented Michel de Rosen, ViroPharma's president and chief executive officer. "For example, we began enrolling into our pivotal Phase 3 trial in liver transplant recipients. There is tremendous global enthusiasm by investigators in this study, as well as in our ongoing pivotal study in stem cell transplant recipients. We also made good progress in elucidating the regulatory and clinical plan for Camvia in Europe. The third quarter was not only a great quarter of clinical execution, but also strong financially. The continued, robust performance of Vancocin helped grow our working capital to $573 million, of which $552 million is in cash, cash equivalents and short- term investments."

Continued de Rosen, "Another company engaged in developing novel therapeutics targeting CDAD, Genzyme Corporation, presented data during the quarter which, among other things, compared clinical success with Vancocin to that of metronidazole and their investigational compound in patients with CDAD. These statistically significant results (p=0.04) showed that in cases of severe disease, patients achieved a higher clinical success rate than patients on metronidazole or the investigational compound. These data confirm the efficacy and safety of Vancocin in patients with severe CDAD and we expect that these data and the IDSA/SHEA guidelines for treatment of CDAD will be strongly considered in treatment recommendations."

Net income in the third quarter and nine-months ended September 30, 2007 was $21.3 million and $75.0 million, respectively, compared to a net income of $23.3 million and $48.7 million for the same periods in 2006. Net income per share for the quarter ended September 30, 2007 was $0.30 per share, basic and $0.26 per share, diluted, compared to a net income of $0.34 per share, basic, and $0.33 per share, diluted, for the same period in 2006. Net income per share for the nine-months ended September 30, 2007 was $1.07 per share, basic, and $0.96 per share, diluted, compared to a net income of $0.71 per share, basic, and $0.69 per share, diluted, for the same period in 2006.

The primary drivers of the change in net income for the third quarter were the effects of decreased operating income discussed above, offset by increased interest income and a lower effective tax rate. Net income for the nine month period increased primarily due to higher net sales.

Operating Highlights

During the three and nine months ended September 30, 2007, net sales of Vancocin decreased 7.6 percent and increased 21.8 percent, respectively, compared to the same periods in 2006. The decrease in net sales of 7.6 percent resulted from fewer units sold to wholesalers in the third quarter of 2007 than during the third quarter of 2006 as a result of wholesaler buyer decisions to increase inventory levels in the third quarter of 2006. The nine month increase of 21.8 percent resulted from an increase in units sold to wholesalers and the impact of a price increase in 2007. The gross product margin rate (net product sales less cost of sales as a percent of net product sales) for Vancocin increased to over 95 percent in the 2007 periods as compared to 91 percent and 87 percent for the third quarter and nine months of 2006, respectively. The increase is the result of the price increases and lower cost of sales per unit. This lower cost primarily results from the sale of units during the first half of 2007, which were manufactured by NPI Pharmaceuticals (formerly OSG Norwich) and carried a lower inventory cost than the units sold during the first half of 2006 that were manufactured by Eli Lilly & Co.

The total remaining costs and expenses associated with operating income were $21.0 million and $15.9 million, for the third quarter of 2007 and 2006, respectively, and $52.4 million and $37.9 million, for the nine months of 2007 and 2006, respectively. These increases are primarily due to research and development costs, increased medical education and legal costs as well as an increase in stock compensation expense.

The Company's effective income tax rate was 36.4 percent and 37.3 percent for the quarters ended September 30, 2007 and 2006, respectively, and 32.3 percent and 38.1 percent for the nine months ended September 30, 2007 and 2006, respectively. Income tax expense includes federal, state and foreign income tax at statutory rates and the effects of various permanent differences. The decrease in the 2007 rate as compared to 2006 is primarily due to our current estimate of the impact of orphan drug credit for Camvia. The Company currently anticipates an effective tax rate of approximately 33 percent for the year ended December 31, 2007, which includes an estimate related to Camvia's orphan drug credit based upon estimates of qualified expenses and excludes the impact of discrete items. The Company continues to evaluate our qualified expenses and, to the extent that actual qualified expenses vary significantly from our estimates, our effective tax rate will be impacted.

Regarding additional payments due to Lilly in connection with the Vancocin acquisition, net sales as of September 30, 2007 exceeded the maximum milestone threshold of $65.0 million. As a result, the Company recorded additional purchase price of $6.0 million to intangible assets in June 2007, which was paid to Lilly in the third quarter. No purchase price consideration will be due to Lilly relating to net sales occurring in the remainder of 2007.

Working Capital Highlights

As of September 30, 2007, ViroPharma's working capital was $573.3 million, which represents a $306.9 million increase from December 31, 2006, $31.2 million of which occurred in the third quarter of 2007. The nine month increase is primarily the result of the senior convertible notes issued on March 26, 2007 and cash flows.

Looking ahead in 2007

ViroPharma is updating previously announced guidance for the year 2007 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 2007, ViroPharma anticipates the following:

    -- Net product sales are expected to be between $202 to $208 million;

    -- Gross margin rate for Vancocin is expected to be consistent with our
       actual results in the first nine months of 2007;

    -- Research and development (R&D) and marketing, general and
       administrative (MG&A) expenses, excluding the impact of SFAS 123R, are
       expected to be between $68 to $73 million.

    -- The SFAS 123R impact to the above expenses will be approximately $8
       million.  Including the impact of SFAS 123R, the research and
       development (R&D) and marketing, general and administrative (MG&A)
       expenses are expected to be between $76 and $81 million.

&

VPHM: Short Interest UP 2.8% to 10.5M in Mid Oct 2007
Wednesday, October 24, 2007 16:28ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) INCREASED 2.8% to 10,537,271 shares as reported in mid-October, 2007.

SYMBOL     END SEPTEMBER     MID OCTOBER          CHANGE       %CHANGE  DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
VPHM           10,251,313        10,537,271           +285,958            +2.79%           9

Based on VPHM's 20-day average daily share volume of 1,227,520, it would require approximately 9 day(s) of buying to cover this short interest.

&

NWI quotation:
ViroPharma (VPHM) reported $50.9 million in sales and 26 cents a share, compared with the consensus expectation for $52.6 million in sales and 28 cents. Revenues were a bit light because sales of Vancocin fell $4.2 million or 7.6% from last year's artificially high level, due to wholesaler stocking in the 2006 third quarter. The company is also accelerating its R&D investment in Camvia for transplant patients.

Vancocin sales are up 22% for the nine months, so I think this decline is a one-quarter problem. Management said that the market for Vancocin's class of therapies is maturing, but they then raised the bottom of their sales forecast for 2007 to $202 million, keeping the top of the range at $208 million. They also pointed out that during the quarter, Genzyme's competing drug in Phase III trials failed to show non-inferiority against Vancocin. And, of course, no one has filed for generic Vancocin yet. At this point no one could get a product into the marketplace earlier than ViroPharma management has expected all along.

The consensus for the December quarter is $51.9 million and 24 cents, and I think that's too low. They have $552 million in cash, and the stock trades with a total market capitalization of only $563 million, with $250 million in convertible debt. It's as if Vancocin and Camvia are near-worthless, which is ridiculous.

They will use some of the cash to do an acquisition or in-licensing deal. It could happen any day, and the stock will go up on the news. How do I know that? Because this management is very smart, they won't overpay, and they will have strategic plans in place for anything that they buy that they can talk about right from the first conference call that announces the deal.

I've been doing some work on methicillin-resistant Staphylococcus aureus (MRSA), the disastrous mutation that is wreaking havoc in Southeastern hospitals. Vancomycin remains the reference standard for treating this systemic infection. Buy VPHM up to $12 for my $25 target or better.

Chart:

[David Randolph]

It's interesting to note how ASPV (remember this one?) was so cheap, yet the market didn't push the price up ... this until it was taken over for $26 a share:



VPHM is another very cheap biotechnology stock (trading at 7 times 2007 EPS), I want to keep it under the radar.

[la-onda]

just fyi (quotation):
This successfully defended the 8.25 support level from last week and turned up creating another higher low as this is now prepared to test the 9.15 resistance and the top of the symetrical triangle.  What timing, with Christmas next week and only 3 1/2 days of trading.  It sure doesn't help that the hourly oscillators are very oversold also.   Not really an ideal time to be taking on a tough resistance level.  The chart is getting a more bullish feel to it though and the accumulation and money flow indicators are turning bullish and volume picked up the last couple days.  There hasn't been a high volume down day for a good month and the up days reflect distinctly higher volume.  The lack of price movement reflects accumulation taking place.  I think it will be real interesting to see what the short interest is when those numbers come out later this month. With bullish volume increasing and bearish volume decreasing I just wonder if there is some short covering slowly taking place.  With the 50ema soundly taken out today and with the RSI doing the jig with the 50 for about a month now (rather than dropping back down into oversold) and the Bollinger bands squeezing, I think a strong move will be coming soon.  Perhaps not next week, but soon and I think the odds are favoring the bulls.

[la-onda]

why 2008 will be a good year for VPHM (from irc)

A generic will not be approved in 2007. The burden of proof will then switch from VPHM to AKRX as AKRX will have lost its credibility. The fact of the matter is FDA will not approve a generic Vancocin without clinical trials to prove BE. The safety risks exceed any perceived benefits of allowing dissolution testing to replace clinical trials. The market is not that big. CDI is a deadly infection. The heat is on the FDA to ensure the safety of drugs. They would be absolute idiots
to require anything less than clinical trials to prove BE.

This stock is getting ready to take off. I have not looked at the prospectus lately, but I believe the bond owners can convert at a price equal to 130% of the quarter ending price. (Can anyone verify this?) When the bondholders converted the last time convertible bonds
were issued, the stock rose from around $3 to $24 in six months.
This event also coincided with a decreasing short interest.

As the notes are converted, the net cash per share goes up significantly. Fully diluted earnings per share is already being calculated as if the bonds have been converted so there will not be
any further dilution upon conversion. Because of the call that VPHM owns and the warrants, actual dilution may be less than what has been reflected in the EPS calculations.

Look for no generic Vancocin in the forseeable future, a path forward for HCV-796 announced shortly, and a Camvia teach in in February with new positive data/developments being announced about Phase III. We are about to see some excitng positive develpoments both in terms of the company and its share price. These developments should make the
mediocre earnings (due to increased Camvia R&D expenses) of the fourth quarter irrelevant in terms of share price.

2008 will be a great year for all VPHM longs with positive cash flow, a debt free balance sheet with cash approach 3/4 of a billion dollars and Camvia about to be approved as a prophylactic for CMV disease and graft host disease. Camvia will also be approved to be used in those cases where the patient gets CMV disease thus replacing to a significant extent, the black box treatments currently used.

[la-onda]

 VPHM: Short Interest DN 5.9% to 10.1M in Mid Dec 2007
Wednesday, December 26, 2007 16:22ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) DECREASED 5.9% to 10,075,890 shares as reported in mid-December, 2007.
Based on VPHM's 20-day average daily share volume of 1,067,545, it would require approximately 10 day(s) of buying to cover this short interest.

[la-onda]

COMPUSTAT for Price and Volume, TheStreet.com Ratings, Inc. for Rating History

RECOMMENDATION

We rate VIROPHARMA INC (VPHM) a HOLD. The primary factors that have impacted our rating are mixed - some indicating strength, some showing weaknesses, with little evidence to justify the expectation of either a positive or negative performance for this stock relative to most
other stocks. The company's strengths can be seen in multiple areas, such as its attractive valuation levels, expanding profit margins and largely solid financial position with reasonable debt levels by most measures.
However, as a counter to these strengths, we also find weaknesses including deteriorating net income, weak operating cash flow and a generally disappointing performance in the stock itself.

HIGHLIGHTS

The gross profit margin for VIROPHARMA INC is currently very high, coming in at 96.50%. It has increased from the same quarter the previous year. Along with this, the net profit margin of 41.80% significantly outperformed against the industry average.
Despite currently having a low debt-to-equity ratio of 0.53, it is higher than that of the industry average, inferring that management of debt levels may need to be evaluated further. Even though the debt-to-equity ratio shows mixed results, the company's quick ratio of 26.62 is very
high and demonstrates very strong liquidity.
The company, on the basis of change in net income from the same quarter one year ago, has underperformed when compared to that of the S&P 500 and greatly underperformed compared to the Pharmaceuticals industry average. The net income has decreased by 8.5% when compared to the same quarter one year ago, dropping from $23.28 million to $21.29 million.
Net operating cash flow has declined marginally to $40.36 million or 4.61% when compared to the same quarter last year. In addition, when comparing the cash generation rate to the industry average, the firm's growth is significantly lower.

[la-onda]

ViroPharma "market perform"

Monday, December 31, 2007 6:22:47 AM ET
Rodman & Renshaw
NEW YORK, December 31 (newratings.com) - Analyst Michael G King Jr of Rodman & Renshaw maintains his "market perform" rating on ViroPharma Incorporated (ticker: VPHM).

In a research note published this morning, the analyst mentions that sales of the company's Vancocin drug declined by 3.4% m/m in November. Vancocin's sales are tracking in-line with the estimates for 4Q07, the analyst says.

[la-onda]

 
good update:
ViroPharma Provides Update on Vancocin(R)
Tuesday , January 08, 2008 07:53ET

EXTON, Pa., Jan. 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided the following update on its petition to the U.S. Food and Drug Administration (FDA) regarding Vancocin(R) (vancomycin hydrochloride capsules).

As part of the company's continuing efforts to assure the safety of patients afflicted with Clostridium difficile infection, ViroPharma yesterday presented its views on the in vitro dissolution bioequivalence method proposed by OGD, as well as important related health and safety information, to officials in the FDA's Office of Pharmaceutical Sciences (OPS), Office of Generic Drugs (OGD) and FDA legal counsel. ViroPharma appreciates the FDA's time and attention to this matter.

Consistent with the eventual availability of the slides presented by ViroPharma at the meeting in the FDA Docket for ViroPharma's petition on this matter, ViroPharma has posted these slides to its corporate website (http://www.viropharma.com/OGDpetition/).

Additionally, the company notes that the FDA's website docket at times experiences a delay in making Citizens Petition and supplement submissions available for public review through the internet. In the interest of transparency, ViroPharma also has posted to its website the following supplement submissions previously filed by ViroPharma, but which are not yet available on the FDA's website:

    -- December 2007 Docket submission by ViroPharma detailing how ViroPharma
       believes the OGD's actions regarding Vancocin are illustrative of
       larger systemic problems at the OGD, and amending the company's
       petition to request that the FDA take appropriate additional corrective
       actions;
    -- August 2007 Docket submission by ViroPharma providing comments on the
       FDA's Draft Guidance for Industry on Bioequivalence Recommendations for
       Specific Products; and
    -- May 2007 Docket submission by ViroPharma discussing the bioequivalence
       issue in more detail and clarifying the types of testing ViroPharma
       believes are required to demonstrate bioequivalence and to provide an
       adequate basis for determining whether a BCS-based biowaiver to
       establish bioequivalence for Vancocin results in an acceptable level of
       risk to patients and public health.

ViroPharma remains committed to assuring the safety of patients suffering from C. difficile infection and continues to oppose vigorously any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods developed through public process to demonstrate bioequivalence. The company is committed to ensuring safety and efficacy of the drug consistent with good medicine, science, and the law.

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. Without proper treatment, the associated complications of the disease can be deadly. 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 U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004 data.

[la-onda]

VPHM and DNDN related long research article:
http://www.scoop.co.nz/stories/print.html?path=HL0801/S00062.htm

VPHM part:

Another case of leaking occurred on March 1, 2006, when the FDA sent a letter to the Canadian investment firm, Infinium Capital, that said the agency would allow testing for a generic version of Vancocin, marketed by ViroPharma, to be conducted in a test tube.

Two weeks later, after allowing plenty of time for persons with the inside information to position themselves to make a killing in the stock market, Infinium issued a report on ViroPharma stating, "Generics . . . sooner than you think".

According to an SEC filing by ViroPharma, Infinium's report was the first public disclosure of the new testing standard and:

      "ViroPharma itself had not previously heard that OGD had lowered its BE standard for Vancocin. Nor it would seem, except those to whom OGD had privately communicated, had anyone else."

ViroPharma's filing went on to note that Infinium's report stated:

      ""Our recent communications with the FDA regarding the approval process for a potential generic competitor to Vancocin lead us to believe a generic could enter the market 1-2 years sooner than current expectations."

What ""recent communications with FDA" might mean, the filing states, beyond the March 1, 2006 letter to Infinium, is unclear to ViroPharma. On March 16, 2006, Medindia.com dropped a bombshell when it informed the public of the news by quoting analysts at Infinium as saying it could mean a generic version would be available by early 2008.

"Previously, generic manufacturers may not have been interested in developing this therapeutic due to its low revenue potential; however, with the recent sales growth of 133 percent in 2005, Vancocin is now on the radar screen," an Infinium analyst told Medindia.

Infinium's announcement caused shares of ViroPharma "to dip by about 33 percent," according to Medindia. But in fact, Infinium's report triggered a multi-day stock sell-off that cut the company's market capitalization by 40%, or roughly $500,000,000.

The approval process prior to the FDA's unexpected announcement required trials to be conducted on humans. ViroPharma has filed a Petition to stop the approval of generic versions with allegations that the FDA violated the Freedom of Information Act, the Data Quality Act, the Administrative Procedure Act, and its own Standards of Conduct.

Vancocin is used to treat hospital-acquired bacterial infections in the lower gastrointestinal tract caused by the bacterium Clostridium difficile. In order to be effective, the drug must be released in one specific section of the intestines, making its release mechanism far more difficult to replicate than other drugs.

The release of an ineffective version of Vancocin at this point in time would be especially dangerous because recent studies have shown that cases of Clostridium difficile-associated disease (CDAD) are increasing world-world. The disease causes 400,000 cases of diarrhea and colitis each year in the US, according to the US Department of Veterans Affairs.

In addition, a paper by Michel Warney, et al., entitled, "Toxin Production by an Emerging Strain of Clostridium difficile Associated with Outbreaks of Severe Disease in North America and Europe," in the September 2005 Lancet medical journal, reported a new strain of C difficile that produces up to 23 times more toxins than previous strains; this strain has been implicated as the cause of a more severe form of the disease

A May 11, 2007, report by the Pennsylvania Health Care Cost Containment Council said that in 2005, patients with CDAD were hospitalized 2-and-a-half times longer, charged over twice as much, and were 4 times as likely to die as patients without the disease.

On average, the report notes, patients with CDAD remain in the hospital almost 7 days longer at a cost of $73,576, verses the average charge of $30,833 for patients without the disease. A November 2007 report entitled, "The Emerging Infectious Challenge of Clostridium difficile-Associated Disease in Massachusetts Hospitals: Clinical and Economic Consequences," cites a "conservative estimate" of the annual cost for CDAD management in the US as $3.2 billion.

People treated with antibiotics are at the highest risk because antibiotics disrupt the balance of bacteria in the GI tract, which allows C difficile bacteria to multiply. CDAD is highly infectious and can spread by contact with patients or touching surfaces contaminated with C difficile spores. The severity of the disease ranges from mild cases of diarrhea to painful colitis, bloodstream infections or death.

Years ago, CDAD was almost exclusively limited to patients in hospital or long-term care settings where infectious diseases spread easily. But there are now widespread reports of patients developing CDAD outside hospital settings, referred to as "community-acquired" CDAD, and with no antibiotic exposure.

Recent studies indicate that many cases may be caused by proton pump inhibitor drugs which inhibit the production of gastric acid in the stomach that acts as a defense against bacteria and spores, widely used by persons with ulcers and other GI illnesses.

The December 21, 2005, Journal of American Medical Association published a report by Canadian researchers based on studies that determined that gastric acid-suppressant drugs were associated with the rising cases of community-acquired CDAD.

The researchers used the United Kingdom General Practice Research Database and identified all 1,672 cases of CDAD recorded between 1994 and 2004 and found that 1,233, or 74%, of the patients had not been hospitalized in the year prior to the diagnosis and were considered community-acquired.

The study showed the increase in community-acquired cases rose from less than 1 per 100,000 in 1994 to 22 per 100,000 in 2004 and during this same period, prescriptions for antibiotics had decreased while prescriptions for proton pump inhibitors had increased.

The first course of treatment for CDAD caused by antibiotics is to stop the antibiotics. But if diarrhea continues and becomes severe, Vancocin is a treatment of last resort for very sick patients which means there is no room for error.

The FDA claims that dissolution testing for the generic version can be done by creating a test tube solution that replicates the environment in the lower intestine. But experts say it would be next to impossible to replicate the GI tracts of very ill and elderly patients to determine whether the generic version will work the same in the targeted area.

Experts also point out that drug interactions, such as those in patients on proton pump inhibitors would make it hard to develop a solution that would replicate the GI tract.

The approval of an ineffective generic version of Vancocin, will subject millions of people to potentially fatal risks because the patients who end up being treated with this medication will have no second chances if it fails.

The FDA is currently under attack for doing the exact same thing by not requiring adequate testing for the generic version of the antidepressant Wellbutrin. The FDA approved the generic in 2006 and after a steady stream of patients reported that they were experiencing serious side effects, testing by ConsumerLabs, revealed that the time release rate of the active ingredient was much faster than the release rate in the original drug.

The consumer-product testing group, ConsumerLab began investigating the drug after Joe and Terry Graedon, authors of The People's Pharmacy column, came to the group with complaints received from readers of their column. While the Graedons had received complaints about generic drugs before, "we had never received this volume of response," Joe Graedon, a pharmacologist, told MSNBC on October 12, 2007.

"In almost all cases people were saying their depression returned," he said. Users also complained about severe headaches, digestive problems, insomnia, anxiety, and tremors.

ConsumerLab performed dissolution testing on 6 samples of each medication and found that even though both contained the same amount of the active ingredient, the generic released nearly 50% of the ingredient in the first 4 hours verses 25% by Wellbutrin.

"It's been an eye-opener for everyone," ConsumerLab President, Dr Tod Cooperman, told MSNBC. "It makes you question whether generics are always going to be equivalent to the original product."

"If these things are releasing at such different rates," he advised, ""it's hard to believe they'd be acting the same way in your body."

"It would seem very difficult to imagine that the results we saw would be acceptable results," Dr Cooperman told MSNBC.

He pointed out that the release of the active ingredient more quickly could mean there is less medication available to the patient later, and may explain why patients experienced a return of their depression.

He said a time-release problem might also explain why patients experienced more side effects, such as headache, irritability and nausea, if they received a high dose of the medicine upfront. "Too much Wellbutrin can cause side effects, even the potential for seizure," he told MSNBC.

The Canadian firm Biovial filed a petition with the FDA in 2005, asking the agency to require generic makers to conduct more rigorous testing of generic versions of Wellbutrin prior to their approval but apparently the agency ignored the request.

An agency spokesperson told MSNBC that the FDA does not require generic makers to do clinical trials on hundreds or thousands of people as required for name brand drugs. It only requires lab data and "bioequivalence" testing in about 24 to 36 healthy volunteers showing that the drug enters the bloodstream in a similar manner to the original product.

Since the generic version was approved, millions of consumers have switched to the drug to save money which means a high number of patients may be experiencing serious side effects without knowledge of the cause. Experts say this whole problem could have been avoided had testing on humans been conducted to check the release mechanism before millions of scripts were written.

"Sustained release mechanisms are not that easy to develop, and they tend to be proprietary in nature," Michael Katz, clinical associate professor of pharmacy practice and science at the University of Arizona College of Pharmacy told MSNBC.

"It would be difficult for a generic manufacturer to reproduce the same release characteristics as the brand-name product," he stated.

"Such differences clearly could have an impact on patients," he said, "and my view is that sustained-release products are among the relatively short list of products that should not be switched."

Experts say the time release characteristics would be even more difficult to replicate in a generic version of Vancocin, where the concern is not just about how much of the drug is released into the blood stream but rather in one specific section of the GI tract.

The leaking of information in the Vancocin case is reminiscent of a major scandal that erupted during the first Bush Administration in 1989, when FDA officials were charged with taking bribes from generic makers and sharing insider information. On August 28, 1989, Time magazine reported that an investigation by the Justice Department had uncovered evidence that "some makers of generic pharmaceuticals falsified laboratory test results and paid off FDA chemists to gain quick Government approval for their products."
In that case, Charles Chang the head of the FDA's generic division and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment for certain generic makers in July 1989, according to the Time report.
In the end, the generic scandal during the first Bush Administration landed Mr Chang in federal prison and caused 42 others and 10 companies to be convicted on charges of fraud and corruption and the FDA Commissioner Frank Young resigned in November 1989.
The crooks in the current Bush Administration's FDA deserve the same fate.

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ViroPharma Provides 2008 Outlook
2008 Focus on Pipeline Advancement; CAMVIA Momentum Building Toward 2009 NDA

EXTON, Pa., Jan. 9 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced Michel de Rosen, ViroPharma's president and chief executive officer, will provide an overview of the company's business and present a financial update during the 26th Annual JPMorgan Healthcare Conference. As previously announced, this presentation will be webcast live at 2:00 P.M. Pacific Time on Wednesday, January 9, 2008 and may be accessed via the company's website at www.viropharma.com. The company expects to release full-year 2007 financial results and further discuss 2008 guidance later in the first quarter of 2008.

"We are in the midst of a period of great momentum and promise," said Michel de Rosen, ViroPharma's Chief Executive Officer. "For example, we expect to build on the great clinical progress we are currently experiencing in our ongoing Phase 3 program with CAMVIA(TM)(maribavir) as we move toward our goal of a 2009 NDA filing. We also continue to work diligently in our pre-launch activities for CAMVIA to refine our plans for medical education, marketing and communications, and ensure a successful launch. We also are extremely excited about moving our unique non-toxigenic C. difficile (NTCD) program into humans during the year; we believe that this novel approach could one day be the therapy of choice for recurrent C. difficile infection (CDI), which remains a significant medical need in CDI patients. As a reminder, we along with Wyeth continue to work diligently to elucidate the path forward for our HCV program which we hope will reinvigorate it this year. And, of course, our strong balance sheet puts us in a position to evaluate and potentially execute upon acquisitions and in-licensing opportunities. Finally, we remain confident in our efforts to preserve safety for CDI patients and accordingly will be investing in both medical education for CDI and promoting Vancocin to drive growth for the product; Obviously, the decision on whether to approve generic versions of the drug on the basis of anything less than clinical endpoint bioequivalence studies for this serious disease ultimately rests with FDA."

"Looking back on 2007, ViroPharma saw a tremendous amount of momentum throughout our organization, in terms of financial performance and staffing for continued growth," commented Mr. de Rosen. "Organizationally, we launched ViroPharma Europe in the first half of 2007, and throughout the year nearly doubled overall the size of the global team supporting the development of CAMVIA and preparing for its commercial launch. Financially, I can confirm that we expect Vancocin(R) sales in 2007 to be within our guidance range of $202 to $208 million, representing growth of at least 21 percent over that of 2006."

Looking ahead in 2008

ViroPharma is commenting upon future guidance for the year 2008 as a convenience to investors. The following elements of 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.

    - Net product sales are expected to be $210 to $235 million;

    - Research and development (R&D) and sales, general and administrative
      (SG&A) expenses are expected to be a combined $105 to $115 million.

    - The SFAS 123R impact to the above expenses will be between $9 and $11
      million.  Including the impact of SFAS 123R, the research and
      development (R&D) and selling, general and administrative (SG&A)
      expenses are expected to be between $114 and $126 million.


This press release includes non-GAAP financial information as the our projected combined R&D and SG&A expenses has been presented including and excluding the effect of stock option expense resulting from the application of SFAS 123R. We believe that presenting our R&D expense and SG&A expense in this release both with and without the impact of share-based compensation will allow investors to better understand our financial results and how such results compare with our prior results and current guidance.

Further discussion of 2008 guidance will be provided along with the full- year 2007 financial results later in the first quarter of 2008.

&

Bullish Events:
Close Above 13 Day EMA, Close Above 50 Day EMA, Percentage Gainer   Trending Up

VPHM closed above its 13-day EMA on --. This signal tends to have bullish implications that the near-term trend of the stock is higher.
VPHM closed above its 50-day EMA on --. This signal tends to have bullish implications that the near-term trend of the stock is higher.
On --, VPHM was one of the biggest percentage gainers on the NASDAQ as it rallied by +0.68 or (+7.91%).

On --, the MACD swung to bullish when it closed above the signal line, a 9-period EMA of the MACD. This means that the underlying moving averages are converging and implies positive action for this stock's future trend.

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insider buying:
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5382922
&
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5382905

shorts update:
VPHM: Short Interest DN 2.9% to 9.8M at the End of Dec 2007
Thursday , January 10, 2008 16:52ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) DECREASED 2.9% to 9,782,224 shares as reported at month-end December, 2007. Based on VPHM's 20-day average daily share volume of 1,213,670, it would require approximately 9 day(s) of buying to cover this short interest.

JP Morgan update:
JP Morgan Update: ViroPharma back on the Upside
January 10, 2008 · No Comments

At the JP Morgan Healthcare Conference yesterday, Michel de Rosen, CEO of Viropharma (NASDAQ:VPHM) presented a very attractive update on the company:

1. ViroPharma is advancing his late stage asset, Canvia for the treatment of Cytomegalovirus (CMV) infections, toward a 2009 NDA. CMV infections are the most frequent illness in transplant patients. Other groups at risk include HIV/AIDS patients, certain oncology patients and neonates. Sales expectations for Canvia are in excess of $ 500 million.

2. ViroPharma has a strong Balance Sheet, with $552 million in cash, which supports an agressive Business Development strategy.

3. Vancomicin, which ViroPharma acquired from Eli Lilly in 2004 when sales were $54 million, continue to grow. The company gave guidance of  $ 202-208 million Vancocin net sales for 2007 and $210-235 million for 2008. The new guidelines from the Infectious Disease Society of America (IDSA) support the leadership position of Vancocin in the treatemnt of Clostridium dificile infections (CDI).

Viropharma was up 7.9% yesterday to $9.28 a share. We believe that the company has been unfairly punished by investors in the past year. With a Market Cap of under $650 million, ViroPharma has definitely a very strong upside potential.

chart:

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Seeking Alpha update:
Forecast for ViroPharma's Pipeline: Mostly Shiny
posted on: January 14, 2008 | about stocks: VPHM   

ViroPharma (VPHM) had a big week with its stock climbing 20% after the company announced better-than-anticipated guidance for 2008 sales of its bacterial infection drug Vancocin. The company expects that 2007 sales of Vancocin were in the guided range of $202-208 million and that 2008 sales will fall in the range of $210-235 million. This guidance greatly out-paces what analysts were projecting. Consensus 2008 estimates had ViroPharma with $182 million in sales.

Analysts, for a couple of years now, have feared generic competition to Vancocin, which could eliminate 50% of the product's sales in the first year of an available generic. However, a generic form of Vancocin is not available yet, and it appears from ViroPharma's guidance that it does not feel one will be available this year.

However, that does not mean the threat of generic competition is gone. A generic form of Vancocin will be available at some point, and investors need to look beyond Vancocin to see if ViroPharma is a viable investment choice.

VPHM is a small ($700 million market cap), but highly profitable biotech. The company has a clean balance sheet; approximately $6 per share in cash and short-term investments; and has strong operating cash flows ($121 million in the trailing twelve months). These traits could give ViroPharma some room to seek acquisitions or partnerships. Or could make VPHM a strong buyout candidate.

For VPHM to be a buyout candidate, or for it to be a viable investment choice, we must look further and into the pipeline. ViroPharma currently has four projects that it or its partners are working on. However, I'm only accounting for one of those projects becoming financially viable at this point.

ViroPharma and Wyeth (WYE) decided to discontinue Phase II dosing for HCV-796, a Hepatitis C drug because of safety concerns in August. The companies continue to pursue ways to use the drug, but I'm not counting on anything. VPHM also has a compound that could treat C. difficile-associated disease [CDAD], but it has not moved into human trials yet.

Last, I'm not accounting for pleconaril, a nasal spray to treat the common cold, which is being developed by Schering-Plough (SGP). Pleconaril has been a part of ViroPharma since the 1990s. The company filed an NDA for an oral form of the drug in 2001, but it was rejected by the FDA. SGP licensed the drug in 2003, and has been working on the nasal form since. ViroPharma is due to potentially receive another $65 million from SGP, as well as royalties if the drug makes it to market. However, the clinical trial process has been slow. The drug is currently in Phase II. And when I looked on Clinicaltrials.gov, it showed that a Phase II trial had been completed, but neither company has said anything about it. I would be willing to think that data from that trial should be expected sometime soon, but I have no definite timetable for that announcement. So, until we do hear something from that trial, I'm not going to account for pleconaril in ViroPharma's future earnings.

With all that said, ViroPharma does have one very promising drug, that could earn more in peak sales than Vancocin. Camvia (maribavir) is in Phase III trials for the treatment of cytomegalovirus [CMV]. The company projects that a market is available for peak sales of $500 million. That would provide significant growth for VPHM. The company says it is on track for a 2009 NDA. Using my rNPV template, I feel that Camvia is worth $4.37 currently to the company. It would be worth around $8 to the company if Phase III trials are successful.

As I see it, there are two wildcards that are holding me back from calling ViroPharma a strong buy. First, what will happen with generic Vancocin. If the company can continue to get the FDA to hold back allowing a generic Vancocin, the drug should continue to grow its sales and I feel is worth at least $10 per share, which is slightly above the current trading price alone. However, if generic competition gets in as early as next year, I feel that Vancocin is only worth $5 going forward and the stock is probably fairly valued, at best.

The second wildcard that I'm looking at is pleconaril. If Schering gets this drug moving, it has the potential to be a blockbuster, and ViroPharma would reap those benefits. However, there is currently no telling if that will happen, and we'll just have to keep our eye out for news.

To conclude, I like ViroPharma. It is a good company, with a couple of good products. However, there is a lot of uncertainty here in 2008 and its long-term picture is a little blurry. My opinion is that this is a buy for the long-term, but I think a lot is riding on the Phase III trials of Camvia. Camvia should be able to replace Vancocin and keep the company growing for its shareholders. Although, this stock could really go places if the two wildcards fall into place for VPHM.