8:09AM ViroPharma: Analysis of pivotal study data showed routine prevention of Hereditary Angioedema (HAE) attacks with Cinryze (C1 esterase inhibitor [human]) resulted in improved health-related quality of life outcomes compared to acute therapy with C1 inhibitor while on placebo (VPHM) 49.42 : Co announced results of a new quality of life data analysis from the randomized, placebo-controlled pivotal prophylaxis study of Cinryze (C1 esterase inhibitor [human]), the first and only C1 esterase inhibitor therapy approved for routine prevention of angioedema attacks in patients with HAE.

The release of these data marks the first prospective evaluation of the impact of routine preventative treatment on the quality of life of patients with HAE. Quality of life data were specified in the protocol to be collected at the pre-treatment baseline and at the end of each of the two treatment periods but is not included in the prescribing information for Cinryze.

While the burden of HAE and the impact on patients' health-related quality of life (HRQoL) has been previously described, the effect of routine prophylaxis on quality of life has not been evaluated. The objective of this analysis was to evaluate the HRQoL of patients with HAE while they were receiving Cinryze either as routine prophylaxis or for the acute treatment of individual attacks in the absence of prophylaxis during a randomized, placebo-controlled, crossover study. HRQoL was measured by the Short Form-36 V 1.0 (SF-36) questionnaire, the standard patient-reported survey for patient health and quality of life. Cinryze is not approved by the FDA to treat HAE attacks.

More than doubled my money on VPHM this year.

2:05AM ViroPharma to be acquired by Shire (SHPG) for $50 per share (VPHM) 39.38 : Shire (SHPG) and ViroPharma (VPHM) announce that their Boards have unanimously approved, and the companies have entered into, a merger agreement pursuant to which Shire will acquire all the outstanding shares of the rare disease company ViroPharma for $50 per share in cash, for a total consideration of ~$4.2 bln. The $50 per share price in the transaction represents a 27% premium to ViroPharma's closing share price on Friday

Shire transaction highlights:

Expands rare disease portfolio which Shire is strategically committed to strengthen
Adds CINRYZE, with growing sales in the prophylactic treatment of HAE, which complements Shire's FIRAZYR
Enhances Shire's short and long term revenue growth profile
Expected annual cost synergies of ~$150 mln by 2015, over and above the improved operating leverage already being driven by the ongoing One Shire reorganization
Immediately accretive to Shire's Non GAAP EPS following completion and enhances earnings growth profile
Shire expects transaction to deliver ROIC in excess of its weighted average cost of capital
Acquisition to be effected by a tender offer and funded from Shire's cash resources and existing and new bank facilities
Share Buy-back program
Following the announcement of this transaction, Shire intends to terminate its share buyback program. Shire's Board will continue to review Shire's capital structure on an ongoing basis.

Shire to acquire VPHM for $50 a share.

Vphm - ILNS, BUYOUT RUMORS, ILNS VS. PFE, ILNS FROM A PENNY TO DOLLARS, 17 million shares traded on friday, breakout boards rank 30. Sanofi buys Vphm for billions and PFE buys ILNS for hundreds of millions or more, All IMO

@abscgc: $VPHM. Rumor is fake, sorry Longs http://t.co/ASgGOfv219

Wow - VPHM 22% gainer

Earnings highlights

European business delivered $8.3 million in net sales

http://www.earningsimpact.com/Transcript/82559/VPHM/Q2-2013-Earnings-Call

VPHM/ILNS - $120 mm deal
ILNS vs. PFE
Go ILNS

JMP-Securities Conference Presentation

Very insightful... Worth reading...

Read here

3:42AM ViroPharma receives orphan drug designation for Maribavir In Europe (VPHM) 27.79 : Co announces that the European Commission has granted orphan drug designation for maribavir for treatment of cytomegaloviral disease in patients with impaired cell mediated immunity. The "Orphan Medicinal Product Designation" is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as "life-threatening or chronically debilitating" conditions. ViroPharma has previously received orphan drug designation for maribavir in the United States for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

7:32AM ViroPharma: Subgroup analyses of pivotal and open label prevention trials showed effectiveness of co's Cinryze in prevention of angioedema attacks in patients with hereditary angioedema poorly controlled on anabolic androgens (VPHM) 27.04 : Co announced results of new data analyses from the randomized, placebo-controlled and open label clinical trials of Cinryze, the first and only C1 esterase inhibitor therapy approved for routine prevention of angioedema attacks in patients with HAE. Since neither of these clinical trials excluded patients who were on anabolic androgens, analyses were conducted to evaluate how the use of AA impacted the outcome of subjects while on Cinryze. In the randomized, placebo-controlled trial, 36.4 percent of subjects were using AA for prophylaxis with a mean historical attack rate of 13.88 per 12 weeks. Five of these eight patients discontinued AA use prior to randomization. Among these five, the mean number of attacks over the 12-week placebo period was 15, compared to 6.8 attacks during the Cinryze treatment period; this represents a 54.7 percent decrease in attack rate which is similar to the reduction in attack rate (52 percent) from the overall study population.

Eight subjects continued on a stable dose of AA during open label treatment. The attack frequency/month of those subjects went from 3.5 (2.75, 4) at study entry to 0.26 (0.06, 0.71) after treatment with open label Cinryze. The other 11 subjects reduced but did not stop using AA; their median monthly attack frequency went from 2 (2, 3) to 0.24 (0, 0.67) at study completion. No drug interaction studies of Cinryze and AA have been conducted.

7:31AM ViroPharma: Treatment with VP20621 in a Phase 2 study resulted in high rates of colonization and statistically significant reductions in recurrence of C. difficile Infection (VPHM) 26.01 : Co announced the results of a Phase 2 study of VP20621 (non-toxigenic Clostridium difficile; NTCD) a novel treatment approach for preventing recurrent C. difficile infections (CDI). In this study of 168 patients who were randomized and dosed following antibiotic treatment for CDI, VP20621 was well tolerated, with mild-moderate headache the only notable associated adverse event reported by 10 percent of subjects compared to 2 percent on placebo. Viable non-toxigenic C. difficile was detected in stool culture (the primary endpoint of the study) in 54 percent of subjects treated with the low dose of VP20621 and up to 79 percent of those receiving the high dose. In addition, across all dose groups, VP20621 reduced the incidence of CDI recurrence (a secondary endpoint of the study) by greater than or equal to 50 percent vs. placebo, with a similar reduction in antibacterial treatment for CDI vs. placebo in this study. The CDI recurrence rate was two percent (2/86) in the subgroup of patients successfully colonized with VP20621.

http://www.secform4.com/insider-trading/946840.htm

ViroPharma To Participate In Two December Healthcare Investor Conferences
PR NewswirePress Release: ViroPharma Incorporated – Thu, Nov 29, 2012 4:30 PM EST

EXTON, Pa., Nov. 29, 2012 /PRNewswire/ -- ViroPharma Incorporated (VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will present at the Deutsche Bank dbAccess BioFest 2012 Conference at 9:00 AM ET on Monday, December 3, 2012. The conference is being held at the Four Seasons Hotel in Boston.

ViroPharma also announced that Charles Rowland, vice president and chief financial officer of ViroPharma, will present at the Oppenheimer 23rd Annual Healthcare Conference at 1:35 PM ET on Thursday, December 13, 2012. The conference is being held at the Waldorf=Astoria Hotel in New York City.

ViroPharma's presentations will be webcast live for investors through www.viropharma.com and available for a period of 14 days following the conferences.

About ViroPharma Incorporated

ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options. ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich's Ataxia, and adrenal insufficiency; and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at www.viropharma.com.

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

$40 before X-mas.

7:03AM ViroPharma and Halozyme Therapeutics (HALO) provide update on clinical development of subcutaneous Cinryze (C1 esterase inhibitor [human]) with recombinant human hyaluronidase (rHuPH20); FDA has advised ViroPharma to amend the study protocol (VPHM) 6.41 : ViroPharma and Halozyme Therapeutics (HALO) announced that the FDA has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. The FDA informed ViroPharma that based upon their ongoing assessment, the FDA believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical development program of another company's product are limited to that specific program. According to Halozyme, the detected antibodies were non-neutralizing and not associated with any clinical adverse events. The FDA has advised ViroPharma to amend the study protocol, allowing for increased laboratory sampling to monitor rHuPH20 antibody levels, and keep the Agency informed of elevated antibody levels during the treatment phase of the study. ViroPharma intends to provide additional commentary on next steps and timing at ViroPharma's analyst day event scheduled to begin at 9:00 A.M. E.T. today..... both VPHM and HALO shares are halted.

9:31AM ViroPharma 's Cinryze (C1 esterase inhibitor [human]) open label prophylaxis study showed up to 2.6 years of effectiveness in majority of subjects with hereditary angioedema (VPHM) 22.67 +0.25 : Co announced the publication of data demonstrating that routine prophylactic use of Cinryze (C1 esterase inhibitor [human]) provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with hereditary angioedema. The paper entitled Safety and Efficacy of Prophylactic Nanofiltered C1-inhibitor in Hereditary Angioedema by Drs. Bruce L. Zuraw and Ira N. Kalfus describes the maintenance of effectiveness and the safety profile of Cinryze as continuing prophylactic therapy in a large cohort of subjects with HAE. These data have been published in the July 14th online edition of The American Journal of Medicine. The co expects the data to appear in the Sept print issue. According to the publication, subjects were to be treated with Cinryze 1000 units every 3 to 7 days based on the decision of the investigator; subjects in the study experienced a 93.7 percent reduction in attacks while taking prophylactic Cinryze (median of 0.19 attacks per month) compared with the median historical rate at baseline (3 attacks per month). Some 87.7 percent reported an attack frequency of one or less attack per month during prophylactic Cinryze and 34.9 percent had no attacks during the study. Some 7.5 percent of subjects experienced relatively frequent attacks despite twice-weekly Cinryze. Additionally, though 18 subjects (12.3 percent) had an overall attack rate of more than 1 per month on Cinryze, only 4 subjects (2.7 percent) failed to achieve an attack rate of one or less per month when treated with Cinryze at the recommended twice per week schedule.

1) ViroPharma Inc. (VPHM)
Sector: Healthcare
Industry: Biotechnology
Market Cap: $1.66B
Beta: 1.36

ViroPharma Inc. has a Operating Profit Margin of 36.59%, a Earnings Per Share Growth Rate of 14.14%, a Current Ratio of 6.12, and a Quick Ratio of 5.57. The short interest was 13.45% as of 07/03/2012. ViroPharma Incorporated, a biotechnology company, develops and commercializes therapeutic products that address serious diseases in the United States and internationally. It focuses on developing products used by physician specialists or in hospital settings. The company markets and sells Cinryze, a C1 esterase inhibitor therapy for the routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, a life-threatening genetic disorder; and Vancocin HCl capsule, an oral capsule formulation for the treatment of C. difficile-associated diarrhea (CDAD) and to treat enterocolitis caused by staphylococcus aureus, including methicillin-resistant strains.

http://seekingalpha.com/article/701981-3-cash-hoarding-biotech-stocks-with-solid-profits?source=yahoo

ViroPharma VPHM Oppenheimer Outperform $34 » $27

Here comes generic version; 20 percent off.
ViroPharma drops 20% after Vancocin generic approvals, FTC investigation
Theflyonthewall.comTheflyonthewall.com – 1 hour 11 minutes ago
Companies:

ViroPharma Inc.

RELATED QUOTES
Symbol Price Change
VPHM 28.61 0.00

08:37 EDT ViroPharma drops 20% after Vancocin generic approvals, FTC investigation..
source: the flyonthewall



"ViroPharma announces that the FDA has denied its citizen petition regarding bioequivalence and exclusivity for Vancocin capsules; FTC conducting investigation (VPHM) 28.61 : Co announced the FDA denied the citizen petition filed by ViroPharma on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of abbreviated new drug applications referencing Vancocin (vancomycin hydrochloride, USP) Capsules. In the FDA's response to the citizen petition, the agency denied ViroPharma's citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA's citizen petition response is forthcoming. The FDA also informed ViroPharma in the same correspondence that the recent supplemental new drug application for Vancocin approved December 14, 2011 would not qualify for three additional years of exclusivity based on the agency's assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication. FDA also indicated that it is approving three ANDA's for generic vancomycin capsules. ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to set aside the FDA's approval of ANDA's for generic versions of Vancocin. In addition, the company has received a notification that the Federal Trade Commission is conducting an investigation into whether the company has engaged in unfair methods of competition with respect to Vancocin."
Briefing
"

~ Monday! $VPHM ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $VPHM ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








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http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

7:34AM ViroPharma data demonstrating efficacy of Plenadren in adrenal insufficiency published in the Journal of Clinical Endocrinology and Metabolism (VPHM) 31.55 : Co announced that data from the pivotal study for their orphan drug Plenadren (hydrocortisone, modified release tablet) were published in the Journal of Clinical Endocrinology and Metabolism. Plenadren was recently granted European Marketing Authorization for treatment of adrenal insufficiency in adults. The authors described results showing that the once daily dual-release tablet provided a more circadian-based serum cortisol profile, and that reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during once daily treatment, compared to treatment with immediate release hydrocortisone three times per day. In particular, the authors noted glucose metabolism improved in patients with concomitant diabetes mellitus. In addition, the preference of once daily versus three times per day treatment was assessed to be large or very large by 85 percent of patients at 12 weeks. Plenadren is not approved in the United State

7:32AM ViroPharma Provides Update on Industrial Scale Supplement for Cinryze (C1 Esterase Inhibitor [Human]); says the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity (VPHM) 30.50 : Co announced the FDA issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. Specifically, the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. The company expects that the additional activity required to address this comment can be completed in a short time frame. The FDA also noted that it has not yet completed the review of ViroPharma's January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility. There are no remaining technical comments posed by FDA in the complete response letter. The company intends to provide an update to shareholders on specific timing of resubmission and expected action dates during the 2011 Financial Results conference call to be held later this month.

ViroPharma Is Poised For Gain

http://seekingalpha.com/article/316888-viropharma-is-poised-for-gain?source=yahoo

ViroPharma's antibiotic Vancocin gets new label
ViroPharma says FDA approved new label for Vancocin; says change could block generic versions
APAP – 4 hours ago


RELATED QUOTES
Symbol Price Change
VPHM 27.80 +4.21

EXTON, Pa. (AP) -- ViroPharma Inc. said Wednesday that regulators approved a new label for its antibiotic Vancocin with data on its safety and effectiveness, and the company believes the change will keep generic versions of the drug off the market for the next 3 years.

Shares of ViroPharma jumped $4.21, or 17.9 percent, to close Wednesday at $27.80. The stock was unchanged in aftermarket trading.

ViroPharma said the new label includes data on the safety and effectiveness of Vancocin as a treatment for Clostridium difficile, an intestinal infection that can cause symptoms ranging from diarrhea to potentially life-threatening inflammation of the colon. The drug is approved as a treatment for diarrhea associated with C. difficile and for gastrointestinal infections caused by Staphylococcus aureus.

The company said it believes the new labeling will prevent the approval for generic versions of Vancocin, or vancomycin, for another three years. In the third quarter, sales of the drug rose 13 percent to $76.6 million.

The information used in the new label comes from studies of Vancocin and an experimental drug being studied by Sanofi's Genzyme unit. ViroPharma said it bought the rights to use the studies. It will pay Genzyme royalties of 10 percent on net Vancocin sales over the next two years, and 16 percent the year after that.

ViroPharma Announces Approval of Modernized Labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules



Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201112141430pr_news_usprx____ph22743&title=viropharma-announces-approval-of-modernized-labeling-for-vancocin-vancomycin-hydrochloride-usp-capsules#ixzz1gY8hkEu9

http://www.insidercow.com/history/company.jsp?company=vphm&B1=Search%21

9:26AM ViroPharma's Buccolam granted European Marketing Authorization for treatment of acute seizures (VPHM) 18.61 : Co announces the European Commission has granted a Centralized Pediatric Use Marketing Authorization for Buccolam, for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age. This action by the European Commission represents the first product approval through the centralized PUMA procedure since its inception. In connection with the approval of Buccolam, co will make an additional payment of 10 mln Pounds Sterling (~$16.3 mln) to the former owners of Auralis

ViroPharma Incorporated Reports Second Quarter 2011 Financial Results
- Quarter Highlighted by Record Net Product Sales and European Approval of Cinryze® (C1 Inhibitor [human]) -

Press Release Source: ViroPharma Incorporated On Thursday July 28, 2011, 7:30 am EDT

EXTON, Pa., July 28, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq:VPHM - News) reported today its financial results for the second quarter ended June 30, 2011.

In the second quarter of 2011, we:

Achieved a record $129 million in net product sales, including $62.5 million in net sales of Cinryze® (C1 esterase inhibitor [human]) representing Cinryze growth of 55 percent over the same period in 2010;
Realized non-GAAP adjusted net income of $36 million; GAAP net income reached $23 million;
Delivered positive cash flows from operations of $29 million;
Improved working capital to $585 million as of June 30, 2011, including cash, cash equivalents and short-term investments of $518 million;
Attained centralized European approval for Cinryze in adults, and adolescents with HAE for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks;
Entered into a collaboration with Halozyme initially focused on a novel subcutaneous formulation of Cinryze, resulting in a charge of $9 million; and
Received positive CHMP opinion recommending approval of Buccolam® (midazolam, oromucosal solution) for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents.


"Execution and achievement are the terms that best describe our second quarter," stated Vincent Milano, ViroPharma's president and chief executive officer. "Our team continues to design and execute new ways to meet patient needs, which are generating significant growth opportunities. For example, almost half of our new patient adds during the first half of the year formerly used steroids for their HAE. Also we have achieved our goal of having a commercial organization in Europe, as we launch Cinryze, our first product in Europe, and approach the European Commission decision regarding Buccolam, following the positive CHMP opinion we received last month."

Milano continued, "And while we can look back on the second quarter as a period of great execution and achievement, our focus remains on the future and on continuously meeting the evolving needs of our patients. Looking forward to the upcoming months and quarters, we are very excited about our clinical development efforts to advance our various C1 esterase inhibitor programs as well as our novel approach to addressing recurrence of C. difficile through VP-20621."

Net sales were $128.8 million and $255.8 million for the three and six months ended June 30, 2011, compared to $109.0 million and $199.6 million in the comparative periods of 2010, respectively. This represents an 18 percent increase for the three month period and 28 percent increase for the six month period.

Our GAAP net income was $22.8 million in the second quarter of 2011 compared to $28.5 million in the 2010 quarter. For the six month period in 2011, GAAP net income was $59.2 million, a 19 percent increase over the $49.8 million of GAAP net income during the first six months in 2010.

Non-GAAP adjusted net income for the three and six months ended June 30, 2011 was $36.2 million and $81.3 million, respectively, compared to $36.0 million and $64.6 million for the same periods in 2010.

Operating Highlights

Our net sales of Cinryze during the three and six months ended June 30, 2011 increased to $62.5 million and $119.1 million, respectively, from sales of $40.3 million and $75.2 million, respectively, during the same periods in the prior year due to the increase in the number of patients receiving commercial product. During the three months ended June 30, 2011, net sales of Vancocin were $65.2 million which is a decrease from $68.4 million in the same period in 2010 due to reduced volumes partly offset by the effect by net realized price growth. During the six months ended June 30, 2011, net sales of Vancocin increased to $134.5 million from $124.1 million in the same period in 2010 primarily due to net realized price growth.

Research and development costs increased in the both the three and six month period of 2011 compared to the same period in 2010 primarily due to the $9.0 million upfront payment made to Halozyme. The increase in selling, general and administrative expenses in both periods of 2011 compared to the same period of 2010 is driven by higher spending related to our European commercialization efforts and new Cinryze marketing programs.

We also incurred other operating expenses of approximately $5.5 million and $6.0 million during the three and six months ended June 30, 2011 respectively, including costs to expand Cinryze manufacturing capacity at Sanquin and the increase in the fair value of the contingent consideration related to the acquisition of Buccolam.

Working Capital Highlights

At June 30, 2011 our working capital was $585.3 million compared to $561.0 million at the end of 2010 as we generated $68.5 million in cash flow from operations during the first six months of 2011, offset by the $50 million cash outlay associated with the accelerated share repurchase agreement under which we repurchased 2.7 million shares.

Looking ahead in 2011

ViroPharma is updating its guidance for the year 2011 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 2011, ViroPharma expects the following:

Net Cinryze sales are expected to be between $250 and $260 million.


Research and development (R&D) and selling, general and administrative (SG&A) expenses are expected to be between $180 and $190 million.


Non-GAAP Disclosures

The Company is reporting both GAAP net income and non-GAAP adjusted results for the three and six month periods ending June 30, 2011. Non-GAAP adjusted net income is GAAP net income excluding (1) non-cash interest expense, (2) amortization related intangible assets acquired, (3) stock compensation expenses, and (4) certain non-recurring events. A reconciliation between GAAP and non-GAAP adjusted net income is provided in the Selected Financial Information - Reconciliation of GAAP Net Income to Adjusted Net Income table included with this release.

The Company believes it is important to share these non-GAAP financial measures with shareholders as they better represent the ongoing economics of the business and reflect how we manage the business. Accordingly, management believes investors' understanding of the Company's financial performance is enhanced as a result of our disclosing these non-GAAP financial measures. Non-GAAP adjusted net income should not be viewed in isolation, or as a substitute for or superior to reported GAAP net income. ViroPharma's definition of non-GAAP financial measures may differ from others.

Conference Call and Webcast

ViroPharma is hosting a live teleconference and webcast with senior management to discuss the financial announcement, guidance, and other business results on July 28, 2011 at 9:00 a.m. Eastern. 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.

Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com. Windows Media or Real Player will be needed to access the webcast. An audio archive will be available at the same address until August 18, 2011.

6:11AM ViroPharma announces positive CHMP opinion for Buccolam in the European Union (VPHM) 17.95 : Co announced that The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization for Buccolam, for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years. If approved by the European Commission, Buccolam would be the first product approved through the centralized PUMA procedure.

ViroPharma receives European OK for Cinryze
ViroPharma receives European approval for angioedema treatment Cinryze

On Wednesday June 15, 2011, 1:29 pm EDT

EXTON, Pa. (AP) -- Biotechnology company ViroPharma Inc. said Wednesday it received European approval for the Cinryze, an intravenous treatment for a genetic disease that can cause dangerous swelling in the throat and extremities.

The Exton, Pa., company said the European Commission approved Cinryze for the prevention and treatment of angioedema attacks in adults and adolescents. The commission also authorized properly trained patients to administer Cinryze to themselves.

Hereditary angioedema affects at least 10,000 people in Europe. Patients with it can experience unpredictable and potentially deadly swelling attacks that can affect the larynx, abdomen and face.

Cinryze is already approved in the United States and generated $57 million in sales during the first quarter.

Shares of ViroPharma fell 49 cents, or 2.7 percent, to $17.56 in afternoon trading.

http://www.form4oracle.com/company/viropharma-inc-vphm/company-transactions?id=6230

10:30AM ViroPharma announced that the European Commission has granted ViroPharma Centralized Marketing Authorization for Cinryze (VPHM) 18.11 +0.06 : Co announced that the European Commission has granted ViroPharma Centralized Marketing Authorization for Cinryze in adults and adolescents with hereditary angioedema for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks. The approval also includes a self administration option for appropriately trained patients included in the Summary of Product Characteristics. HAE is a rare, debilitating and potentially life-threatening genetic disorder that affects at least 10,000 people in Europe.

7:29AM Halozyme Therapeutics and ViroPharma (VPHM) announce $83 million global licensing agreement to develop subcutaneous cinryze (HALO) 6.67 : Halozyme Therapeutics ( HALO) and ViroPharma Incorporated (VPHM) announce the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 (recombinant human hyaluronidase) in the development of a subcutaneous formulation of Cinryze. Under terms of the agreement, Halozyme may receive up to $83 million, commencing with an upfront payment of $9 million and total potential future milestone payments of $74 million dependent upon the achievement of clinical and regulatory targets, plus a 10% royalty on future sales of the combination of Cinryze with rHuPH20. The license provides ViroPharma with exclusivity to C1 esterase inhibition and to the hereditary angioedema indication, along with three additional orphan indications. ViroPharma will fund all development and commercialization expenses for the program. Additional terms of the transaction have not been disclosed.

strong quarter
Strong Quarter for ViroPharma
.
ViroPharma Inc..

Zacks Equity Research,

ViroPharma Inc. (NasdaqGS: VPHM - News) posted third-quarter earnings of 48 cents per share, beating the Zacks Consensus Estimate by 17 cents and the year-ago figure by 20 cents. Increased product sales helped boost third quarter 2010 earnings.

Revenues

Quarterly revenue of $117.8 million was well above the Zacks Consensus Estimate of $106 million and 46% above the year-ago revenue of $80.6 million. Revenues were spurred by higher sales of Cinryze and Vancocin.

While Cinryze sales increased 69% to $49.1 million, Vancocin sales came in at $67.6 million, up 31%.

Sales of Cinryze increased during the quarter due to higher patient demand, while sales of Vancocin went up due to price increases.

Expenses

Selling, general and administrative (SG&A) expenses and research and development (R&D) expenses, taken together, increased during the quarter to $35.2 million from $31.2 million in the year-ago period.

Quarterly SG&A expenses increased 24.0% year over year as a result of a rise in compensation expense and marketing activities related to Cinryze, while quarterly R&D expenses declined 7.4% due to the discontinuation of the maribavir prophylactic program.

Outlook

For fiscal 2010, ViroPharma raised its Cinryze sales guidance to $170–$180 million from $165–$175 million.

Expenses, both R&D and SG&A taken together, are expected to range from $140–$145 million, up from the previous guidance range of $135–$145 million.

Our View

We currently have a Neutral recommendation on ViroPharma, which is supported by a Zacks #3 Rank (short-term Hold rating). We are pleased with the company’s third quarter results. ViroPharma expects the European approval and launch of Cinryze to take place in the first half of 2011.

However, Vancocin, which is one of the primary revenue contributors at ViroPharma, is not protected by any patent. Vancocin generics are yet to hit the market with the FDA requiring generic companies to conduct a bioequivalence study to gain approval for their versions. We note that a proposed bioequivalence method for Vancocin is filed for approval with the FDA. If the method gets the regulatory body’s nod, the time required for a generic manufacturer to get a copycat version of Vancocin approved will be reduced and multiple generics may enter the market, thereby leading to significant sales erosion of the drug.


Zacks Investment Research

The bottom line is that the company is making decent money without the expaneded production, and as we get closer to expanded production, which eventually should happen, this stock should get a lot of attention. I intend to hold this stock into the $20's.

mlkr: What is wrong here. Good news out and no one posts it here: Oct 22 (Reuters) - ViroPharma Inc (VPHM.O), a specialty pharmaceutical company, said U.S. health regulators declined to approve industrial-scale manufacturing of its genetic disorder drug Cinryze, sending its shares down 17 percent.

In a complete response letter to ViroPharma, the U.S. Food and Drug Administration (FDA) sought additional information related to observations from the pre-approval inspection and review of the technical processes, the company said.

ViroPharma said it will respond to the FDA and plans to start manufacturing industrial scale lots at risk in the first quarter of 2011.

The company however, expects its currently approved manufacturing process alone to yield up to 60,000 doses annually.

Cinryze is the company's approved treatment for a fatal genetic disorder called hereditary angioedema and is expected to generate full-year revenue of $165-$175 million.

In June, ViroPharma approached the FDA, seeking approval to commercialize Cinryze manufactured using the industrial scale process. [ID:nWNAB9826]

The company's shares, which had plunged 18 percent since it expressed doubts over the drug's production capability in October last year, fell to $13.51 pre-market trade on Friday. They closed at $16.19 Thursday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopaku

UPDATE 1-FDA denies ViroPharma's higher genetic-drug production

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ViroPharma Incorporated
VPHM.O
$15.20
-0.99-6.11%7:25pm UTC+0300
Fri Oct 22, 2010 9:25am EDT

* Co says FDA seeks more information

* Co says to go ahead with manufacturing at risk

* Says approved process to yield 60,000 doses annually

* Shares fall as much as 17 pct before the bell

Oct 22 (Reuters) - ViroPharma Inc (VPHM.O), a specialty pharmaceutical company, said U.S. health regulators declined to approve industrial-scale manufacturing of its genetic disorder drug Cinryze, sending its shares down 17 percent.

In a complete response letter to ViroPharma, the U.S. Food and Drug Administration (FDA) sought additional information related to observations from the pre-approval inspection and review of the technical processes, the company said.

ViroPharma said it will respond to the FDA and plans to start manufacturing industrial scale lots at risk in the first quarter of 2011.

The company however, expects its currently approved manufacturing process alone to yield up to 60,000 doses annually.

Cinryze is the company's approved treatment for a fatal genetic disorder called hereditary angioedema and is expected to generate full-year revenue of $165-$175 million.

In June, ViroPharma approached the FDA, seeking approval to commercialize Cinryze manufactured using the industrial scale process. [ID:nWNAB9826]

The company's shares, which had plunged 18 percent since it expressed doubts over the drug's production capability in October last year, fell to $13.51 pre-market trade on Friday. They closed at $16.19 Thursday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier)

ViroPharma VPHM Caris & Company Buy $18

ViroPharma Announces Presentation of Data from Non-Toxigenic Clostridium difficile (VP20621) Phase 1 Study
- New Data Validating VP20621 Clinical Proof of Concept Presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) -

http://finance.yahoo.com/news/ViroPharma-Announces-prnews-3079600362.html?x=0&.v=1

$13 in more than a year!

8:42AM ViroPharma announces publication of Cinryze Phase 3 trial results in Hereditary Angioedema (VPHM) 13.61 : Co announced that data from Phase 3 studies of Cinryze have been published in New England Journal of Medicine. The paper describes the safety and efficacy of Cinryze in treating and preventing attacks of hereditary angioedema. Cinryze is the first and only FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease; it is not approved by the FDA to treat acute angioedema attacks.

7:32AM ViroPharma beats by $0.02, beats on revs (VPHM) 11.37 : Reports Q2 (Jun) earnings of $0.34 per share, $0.02 better than the Thomson Reuters consensus of $0.32; revenues rose 33.1% year/year to $109 mln vs the $99 mln consensus. Co reports Cinryze sales of $40 mln vs. $39 mln consensus; reports Vancocin sales of $68.4 mln vs. $60 mln consensus. For the year 2010, ViroPharma expects the following: Net Cinryze sales are expected to be $165 to $175 mln. Research and development and selling, general and administrative expenses, including the impact of stock compensation expense,are expected to be $135 to $145 mln. Stock compensation expenses are expected to be between $10 and $12 mln.

6:57AM ViroPharma files prior approval supplement for Cinryze industrial scale manufacturing (VPHM) 12.19 : Co provided an update on recent progress in Cinryze manufacturing expansion activities. ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE. The addition of the industrial scale project is expected to significantly increase capacity for Cinryze, providing adequate supply to meet the company's projected demand growth for prophylaxis against attacks of HAE.

ViroPharma Announces Availability of Cinryze(TM) (C1 Esterase Inhibitor [Human]) Final Open-Label Data
- Experience Highlights Effectiveness of Cinryze in Preventing Attacks of Hereditary Angioedema -

Press Release Source: ViroPharma Incorporated On Monday May 17, 2010, 8:10 am EDT
EXTON, Pa., May 17 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq:VPHM - News) today announced the availability of final data from Open-Label studies of Cinryze™ (C1 Esterase Inhibitor [Human]) in preventing and treating attacks of hereditary angioedema (HAE) on the U.S. National Institutes of Health's online clinical trial registry, www.clinicaltrials.gov. The data from the CHANGE 3 prophylaxis study are available now; the data from the CHANGE 2 acute treatment study will be available at the same website in the coming weeks. The company expects the complete data set to be presented at a scientific meeting later this year and in subsequent publications in peer-reviewed journals.

Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. Cinryze is not approved in the U.S. for acute treatment of attacks.

"We are excited about the strength of these data in support of the efficacy and safety of Cinryze, and are happy to see them available online," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "Our open label experience with the therapy, outside the confines of controlled pivotal clinical studies, has shown that Cinryze therapy can change the lives of HAE patients and their families. For example, prophylaxis with Cinryze in the open label prevention study dramatically reduced the median frequency of attacks from three times per month to less than three attacks per year. Our goal as a company is to improve the lives of the patients suffering from HAE, and it is clear that Cinryze accomplishes that goal for patients who choose prophylaxis against their HAE attacks as their means to regain control of their lives."

Open-Label C1 Esterase Inhibitor for the Prevention of Acute HAE Attacks

The CHANGE 3 study was performed to evaluate the safety and efficacy of prophylactic use of Cinryze for the prevention of attacks of HAE. One hundred forty six (146) HAE patients were enrolled in this study and were included in the analysis of the primary efficacy outcome measure. The vast majority of the patients enrolled in the study have transitioned to commercial Cinryze. Seventy-nine (79) patients completed the study; most of those not completing the study did so because they transitioned to commercial Cinryze before the end of the study. Per protocol, patients received 1,000U of Cinryze administered intravenously every three to seven days.

The primary efficacy outcome measure was the frequency of all HAE attacks that occurred during prophylaxis with Cinryze. Prior to initiating prophylactic therapy with Cinryze, patients enrolled in the study had a median of 3.00 HAE attacks per month. During prophylaxis with Cinryze, over a median of 244 days, enrolled patients had a median of 0.21 HAE attacks per month.

For patients that received Cinryze prophylaxis for at least one year, the degree of protection from HAE attacks was maintained over the one year period.

In this study, there were no serious adverse events (SAEs) considered related to Cinryze. No subjects were discontinued from Cinryze due to an adverse event, and there were no adverse trends observed in vital signs. Among the 74 subjects tested, there were no subjects who had detectable anti-C1-INH antibodies following Cinryze administration.

Open-Label C1 Esterase Inhibitor for the Treatment of Acute HAE Attacks

The CHANGE 2 study was performed to evaluate the safety and efficacy of repeat use of Cinryze for treatment of attacks of HAE. A total of 113 subjects were enrolled in the study; 101 subjects received Cinryze for treatment of one or more HAE attacks and were analyzed for efficacy. Forty three (43) patients completed the study; the majority of the patients not completing the study did so because they transferred to the open-label prophylaxis study. Per protocol, patients received 1,000U of Cinryze administered intravenously for treatment of HAE attacks. If there was inadequate response to treatment within one hour after the first dose, a second 1,000U dose could be administered.

The primary efficacy outcome measure was the proportion of HAE attacks with substantial relief of the defining symptom within four hours of initial treatment with Cinryze. Substantial relief was attained in eighty seven (87) percent of attacks, when a conservative definition of response was applied so that all patients with incomplete data were considered treatment failures. Using a less conservative definition of substantial relief as either three consecutive reports of symptom improvement or improvement of the defining symptom followed by cessation of symptom assessments, ninety five (95) percent of HAE attacks were substantially relieved within four hours of initial treatment. Eighty-four (84) laryngeal attacks occurred during this study; none required intubation following treatment with Cinryze.

Data were also analyzed for patients who received Cinryze treatment for multiple attacks of HAE; there was no loss of effectiveness of Cinryze with subsequent repeat administration.

In this study, there were no serious adverse events (SAEs) considered related to Cinryze. No subjects were discontinued from Cinryze due to an adverse event, and there were no adverse trends observed in vital signs. There was no evidence for the development of anti-C1-INH antibodies following repeated Cinryze administration.

About Cinryze™ (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency. A Medicinal Authorization Application (MAA) for Cinryze for acute treatment and routine prophylaxis of acute attacks in patients with HAE has been accepted for filing by the European Medicines Agency (EMA) and currently is undergoing review.

The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 esterase inhibitor therapy well above the approved treatment dosage regimen. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening plasma donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.

Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.

About Hereditary Angioedema (HAE)

HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,000 people with HAE in the United States.

For more information on HAE, visit the U.S. HAE Association's website at: http://www.haea.org/.

Baker Bro. Buys $25M Worth of Viropharma

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7:34AM ViroPharma misses by $0.06, misses on revs (VPHM) 13.90 : Reports Q1 (Mar) earnings of $0.26 per share, $0.06 worse than the Thomson Reuters consensus of $0.32; revenues rose 50.5% year/year to $90.6 mln vs the $92.5 mln consensus. ViroPharma is increasing the bottom of its Cinryze net sales guidance range and reiterating our expense guidance for the year 2010. For the year 2010, ViroPharma expects the following: Net Cinryze sales are expected to be $155 to $175 million. Research and development (R&D) and selling, general and administrative (SG&A) expenses, including the impact of SFAS 123R,are expected to be $125 to $140 million. SFAS 123R expenses are expected to be between $10 and $12 million.

8:00AM ViroPharma announces initiation of Phase 2 study of Cinryze (C1 Estersase Inhibitor [Human]) in pediatric patients (VPHM) 13.95 : Co announces that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema. Cinryze was approved by the FDA in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. Cinryze is not approved in the US for acute treatment of attacks or in pediatric patients below the age of 12 years.

ViroPharma VPHM Oppenheimer Outperform $15 » $19