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

[KCScott]

From the Yahoo:

Maribavir results are good, this is all
by: visxlaserman
Long-Term Sentiment: Strong Buy  03/17/06 10:19 am
Msg: 98775 of 98812

a set up by the ANAList group from Canada. They said that a study would not be needed to get a generic on the market. BULLSHIT. VPHM management is now just waiting for conf. from the FDA to post a statement to the contrary AND have promised me that they will be going after Irridium (or whoever) with both barrels.
If you are margined out of your position due to this action, post it here. We will get together and sue these bastards.

I believe that this was a short attack led by that report. That is criminal. I will get the breakdown of shares owned by whom from the company today and post them.
Hang in there guys,
Laserman- bleeding for nothing!

If true, then the press announcement saying that a generic will need to go through proper testing will send this back up.

At least I hope so

[echo]

No bounce. Where's the floor?

[Jimbo]

filling the gap from August?

Se7en,

hopefully not, but if that's case there still a way to go (down   )


Anyway, there is a support around $13.40 but if that doesn't hold the next one is around $9.70.

[gri64]

Bought today @ $13.425
Am I right? I hope we will see...   

Hold for a short or medium term?
Still undecided 

[la-onda]

here we are 
UPDATE from VPHM:

ViroPharma Comments on Vancocin
Friday March 17, 11:47 am ET

EXTON, Pa., March 17 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today made the following statements about Vancocin®:

We were informed yesterday that the Office of Generic Drugs, Center for Drug Evaluation and Research ("OGD"), may have changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in vivo bioequivalence testing for Vancocin. Specifically, we were informed that a generic applicant may be able to request such a waiver provided that dissolution testing demonstrates that the test product is rapidly dissolving at certain specified conditions. This deviates from our understanding of OGD's practices which would require, for a non- absorbed GI drug, a demonstration of bioequivalence through clinical studies or a demonstration of bioequivalence using an appropriately validated in vitro methodology.

We have attempted to contact OGD, but been unable to confirm this directly with it. Nonetheless, we feel that it is important to note that, if such a change in FDA's approach has occurred:

    -  The change would have been made in the absence of any public
       discussion and, significantly, without seeking input from FDA's own
       expert Advisory Committee on this important issue;

    -  We believe that there are important safety and scientific issues that
       the FDA must consider before making such an important change in its
       requirements for bioequivalence data; and

    -  We strongly disagree with both the manner in which this change in
       approach was developed, as well as the substance of the approach which
       ignores the need to demonstrate bioequivalence for a non-systemically
       absorbed drug. We will vigorously oppose at FDA this attempt to
       radically restrict the data on which FDA would make vancomycin capsule
       bioequivalence decisions. Vancocin combats a serious, and potentially
       life threatening, disease. In this context, we believe that the
       uncertainties of dissolution-only bioequivalence are simply
       unacceptable.

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

[Loffigus]

So what does this news mean for stock price?  can we expect a rebound?

[KCScott]

Just saw that new La Onda - I'm out at 14.07

That's unreal

[Loffigus]

Thinking of going short!

[ncham]

shouldnt AKN be flying on this news??

[KCScott]

shouldnt AKN be flying on this news??

Good call - only up .07 with no volume

Something seems really strange - but with the losses I've piled up this year, I'm not gonna risk a play on either.

AKN bears watching though, if it starts a big move we'll know this OGD thing is real

[ncham]

moral of the story: If Cramer picks a biotech stock, run for the hills (or short it).

http://madmoney.thestreet.com/index.cfm?page=picklists&list=4

[[D] Investor]

VPHM has always been one of my favorite long term stocks but today it took a real beating amid concerns that India's Cipla and Akron will seek to bring a generic Vancocin capsule to the market earlier than expected. In 2005 VPHM shot up over 500% from $2 to $20's+ but today it pluged 24% due to this news alone.

[R]ead it here.

Rather than mourning for VPHM's loss, my immediate reaction was simply that VPHM is on sale! Unfortunately, I was unable to get to my computer until around 8:30 am this morning when VPHM already rebounded from $12 to the $14 and I missed the opportunity to add positions at the low, so I had to setttle with more humble gains instead.

Here's why VPHM is on sale:

• Even with clinical trials of the generic Vancocin, the product WILL NOT enter the market until at least 2010 given the timeframe required for FDA review. (Source)
• VPHM has positive FY 2005 4Q net income of $72.7 million and the value is expected to grow to $160+ million in 2006. (Source)
• VPHM currently has ZERO long term debt and as a result has high cash flow. (Source)
  Phase II data for cytomegalovirus (CMV) candidate Maribavir is to be released at the end of VPHM's FY 2006 1Q. (Source)
• HCV-796 is still another major value driver in their clinical pipeline with huge market potential. (Source)
• VPHM is ranked as a top company by top analysts. (Source)

The Bottom Line: VPHM is going to be shaky in the short term as it attempts to stabilize and recover from the panic sell-off. However, VPHM's long term prospects remain extremely attractive for the following reasons:

• There's no way for Vancocin's generic competitor to receive FDA approval until post-2009.
• VPHM has other value drivers that may be commercialized prior to the entrance of the generic drug.
• It has a solid financial state with high cash flow which may be potentially used to speed up the R+D efforts for it's value drivers.

My [2] cents.

[la-onda]

update part 2:
ViroPharma Falls on Vancocin Anxiety
Friday March 17, 12:45 pm ET
ViroPharma Shares Fall Over Uncertainty of FDA Stance on Generic Vancocin

NEW YORK (AP) -- Shares of antibiotics company ViroPharma Inc. fell Friday on concern over the possibility that the Food and Drug Administration may allow drug makers an easier path to sell a generic version of the company's major revenue driver.

ViroPharma shares fell $3.19, or 20 percent, to $13.05 in midday trading on the Nasdaq at more than 10 times their average volume. Shares have climbed from a 52-week low of $1.67 in April to a 52-week high of $24.36 in November.

Vancocin sales accounted for $125.9 million of the company's $132.4 million in total revenue in 2005. The company bought U.S. rights for Vancocin from drug maker Eli Lilly & Co. in 2004 for $116 million plus royalties. Vancocin is an antibiotic for treating inflammation of the intestines.

ViroPharma acknowledged in a statement hearing that the FDA's Office of Generic Drugs may be changing its approach for establishing bioequivalence for Vancocin. The company has yet to confirm the change directly with the FDA, but said it will fight the change if it does materialize.

Piper Jaffray analyst Thomas Wei, who rates ViroPharma an "Outperform," considers news coming out of the FDA about the possibility of generic Vancocin mixed and contradictory.

On the one hand, the agency has stated that clinical trials would be required to show that a generic version of Vancocin was similar to the branded one, an expensive and unprofitable proposition for a generic drug maker.
On the other hand, Wei said that recent panel meetings on gastrointestinal drugs have suggested the possibility that much simpler studies could be used to show bioequivalence of highly soluble, rapidly dissolving drugs like Vancocin. Wei noted that even if simpler studies were allowed, the drug is difficult to make.

"Nonetheless, the elimination of the requirement to run large clinical studies could substantially shorten the time line to generic Vancocin approval," Wei said in a research note.

Lazard Capital analyst Joel Sendek, who rates the stock a "Buy," was more skeptical of the easier path. While the FDA indicates the possibility that bioequivalence data could be used in place of clinical trial data, Sendek told investors he views the easier route as a risky proposition given the increasing incidence and severity of GI infections.

&
yahoo board quotation:
I just spoke with the FDA
by: cjtwantstoknow    03/17/06 01:36 pm
Msg: 99492 of 99511

I just spoke with a person at the FDA regarding this matter. Apparently, the FDA's changes will ONLY affect the bio-equivalency testing and will shorten this particular aspect by 3 to 6 months. THERE ARE NO OTHER CHANGES. Drug manufacturers are still subjected to other testing and requirements such as chemistry, labeling, etc. The person on the phone indicated that the chemistry testing is typically a significant portion of the approval and that it continues to consume a considerable amount of time. This FDA change is factual but the impact is very minimal. The generic drug is not around the corner!

The FDA said that they received many calls regarding this topic. They are somewhat surprised because they are only making changes to streamline their own internal processes.

[eliteG]

Oliver asked for some quick comments on VPHM, even though it is not in the portfolio, and I'll give it a shot.

VPHM - Its a viscious move guys but VPHM may have found support.  Here are the charts I did and I hope they help out with a trading plan.  .

[ScottishTrader]

Applaud DInvestor, though I know there are some other VPHM threads elsewhere.  Man talk about a shakey day though - just unbelievable.  At this stage I have no idea where it will settle, but as I am looking to move my portfolio to a longger term (less stressful???) position, this seems to be an ideal buying opp.  In at 13.32 today.  I fully expect that after a bit of turbulence (and the intraday chart still looks weak) it should make back some of these losses.  After all, as you said, they are making loads of money from Vancocin NOW, and any generics will be a long way off.

Maybe I will just not look at it for a week and see what happens???