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7:38AM ViroPharma reports Q4 (Dec) results, beats on revs (VPHM) 10.55 : Reports Q4 (Dec) earnings of $0.15 per share, may not be comparable to the First Call consensus of $0.24; revenues rose 75.6% year/year to $87.8 mln vs the $82.5 mln consensus. Co increases 2010 Net Cinryze sales of $150 to $175 million. Global selling, general and administrative (SG&A) and research and development (R&D) 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.
i found this on
www.otcstockreview.com/cpbm.htm
Cyplasin Biomedical Ltd. (OTCBB: CPBM)Human Genome Sciences (NASDAQ: HGSI)Idenix Pharmaceuticals (NASDAQ: IDIX)Intermune (NASDAQ: ITMN)Schering-Plough (NYSE: SGP)ViroPharma (NASDAQ: VPHM)Vertex Pharmaceuticals (NASDAQ: VRTX)
7:32AM ViroPharma provides 2010 Cinryze (C1 Esterase Inhibitor [Human]) outlook; expects sales will be toward high end of previous guidance of $90-$95 mln (VPHM) 8.75 : Co Provides its 2010 Cinryze (C1 Esterase Inhibitor [Human]) outlook. Co states, "In 2009 we successfully launched Cinryze (C1 esterase inhibitor [human]), the first and only drug approved to prevent HAE attacks. Thanks to meticulous execution by our team, we were able to provide Cinryze during 2009 to over 400 patients who are now actively preventing their attacks. We are pleased to announce that for 2009, we expect our net Cinryze sales will be toward the high end of our previous guidance range of $90 to $95 million, placing Cinryze among the best ever launches of an ultra orphan drug product... Further, we recently conducted a successful meeting with the FDA on our industrial scale initiative where we were able to confirm our previous expectations of the path forward for this significantly expanded manufacturing process. As a result, we are announcing 2010 Cinryze net sales guidance of between $145 and $165 mln, which represents tremendous revenue growth over 2009. Although we anticipate that we will be profitable in 2010, we will provide our full guidance later in the first quarter of this year. Finally, I am pleased to announce we have increased our projection of U.S. HAE peak year Cinryze sales to between $350 and $450 mln. Our objective continues to be to ensure that every patient who can benefit from Cinryze will have access to this important drug."
ViroPharma VPHM Oppenheimer upgraded from Perform to Outperform & $13 price target
VIRO ON SALE?
Rumors about a likely Teva bid to acquire ViroPharma started driving up the biotech's share price yesterday, but the developer moved swiftly to squelch the buzz.
"It is certainly not the goal of the management team to be acquired at this point. We are looking to build the company," a spokesperson tells Reuters. Rather than looking for a big company to come along and buy it, ViroPharma says its attention is focused on finding new products that it can acquire.
Still, in a week that has seen market gossip about biotech buyouts hitting fever pitch, some of the analysts were left nodding their heads over the logic of a deal. Zacks Investment Research analyst Jason Napodano told Dow Jones that "ViroPharma would be a good acquisition candidate for a company." And Teva has made it clear that it's interested in getting into the specialty drug business in a big way.
For its part, ViroPharma also insists it is not looking for a partner for either Cinryze, its therapy for hereditary angioedema, or its early-stage therapy for bacterial infection.
UPDATE 1-US panel backs rules for ViroPharma drug copies
Tue Aug 4, 2009
* Advisory panel votes 16-0 in favor of FDA rules
* ViroPharma opposes FDA plan
SILVER SPRING, Md., Aug 4 (Reuters) - U.S. advisers on Tuesday backed Food and Drug Administration testing guidelines for generic versions of the antibiotic Vancocin over the objections of manufacturer ViroPharma Inc (VPHM.O).
ViroPharma argued to the panel that the FDA's proposed criteria for generic rivals were not stringent enough to prove the copycat versions would work the same in the body as the brand-name product.
But panel members said they felt confident in the FDA's proposed methods for evaluating generic versions with the same active and inactive ingredients as Vancocin. The committee voted 16-0 to back the FDA plan.
The drug's generic name is vancomycin. (Reporting by Lisa Richwine; Editing by Leslie Gevirtz)
ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
- Company Delivers $26 Million in Second Quarter Net Sales of Cinryze(TM) C1 Esterase Inhibitor (Human) - - Provides 2009 Cinryze Net Sales Guidance of $80 million to $95 million -
Press Release
Source: ViroPharma Incorporated
On Wednesday July 29, 2009, 7:30 am EDT
Companies:Viropharma inc.
EXTON, Pa., July 29 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) reported today its financial results for the second quarter ended June 30, 2009.
Delivered record $82 million in net product sales including $26 million in net sales of Cinryze(TM) (C1 esterase Inhibitor [human]), of which $2 million was previously classified as deferred revenue;
Grew adjusted net income 19 percent to $34 million for the 2009 second quarter compared to prior year period; GAAP net income reached $16 million;
Improved working capital to $328 million as of the end of the second quarter of 2009, including cash and cash equivalents of $267 million; and
Achieved positive cash flows from operations of $25 million.
Net sales were $81.9 million and $142.1 million for the three and six months ended June 30, 2009, respectively, as compared to $65.4 million and $116.4 million for Vancocin only in the comparative three and six month periods of 2008, respectively. This represents 25 percent growth in the three month period and 22 percent growth for the six month period in net product sales.
The Company is reporting both GAAP net income (loss) and adjusted results for the three and six months ended June 30, 2009. Adjusted net income is GAAP net income excluding (1) non-cash interest expense, (2) amortization related to the acquisition of Lev Pharmaceuticals and Vancocin, and step up in inventory related to purchase accounting arising from the acquisition of Lev Pharmaceuticals, (3) stock compensation expenses, and (4) certain non-recurring events such as the goodwill write off and gain on extinguishment of repurchased bonds. A reconciliation between GAAP and 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 or GAAP net (loss) income. ViroPharma's definition of non-GAAP financial measures may differ from others.
"With the early success of Cinryze - our product used to prevent attacks of hereditary angioedema (HAE) - exceeding our initial expectations, the second quarter of 2009 was among the strongest financial quarters in our history," commented Vincent Milano, ViroPharma's chief executive officer. "During the quarter, the company achieved positive cash flows from operations and achieved a record $82 million in net product sales, including recognizing $26 million of net sales of Cinryze. We are pleased with the early adoption of the product and our focus remains on improving the lives of patients suffering from HAE; and on broadening our ongoing physician education on the debilitating consequences of the disease and the benefits of prophylaxis with Cinryze."
GAAP net income for the second quarter ended June 30, 2009 was $16.1 million compared to $22.8 million for the same period in 2008. GAAP net loss for the six months ended June 30, 2009 was $43.2 million compared to net income of $39.2 million for the same period in 2008. GAAP net income per share for the quarter ended June 30, 2009 was $0.21 per share, basic, and $0.20, diluted, compared to $0.33, basic, and $0.29, diluted, for the same period in 2008. GAAP net loss per share for the six months ended June 30, 2009 was $0.56 per share, basic and diluted, compared to a GAAP net income per share of $0.56, basic, and $0.51, diluted, for the same period in 2008.
Non-GAAP adjusted net income in the three and six months ended June 30, 2009 was $34.5 million and $46.0 million, respectively, compared to $28.9 million and $51.0 million, respectively, for the same periods in 2008.
The primary drivers of the GAAP net loss in the six months ended June 30, 2009 was the impairment of goodwill for $65.1 million, offset by the gain on our repurchase of our senior convertible notes of $9.1 million. Contributing to this loss were launch costs for Cinryze, increased expenses relating to the development of our product pipeline, and the increase in amortization expense. GAAP net income decreased for the second quarter of 2009 as compared to 2008 due to a decrease in Vancocin sales, increased SG&A costs related to the launch of Cinryze, increased amortization and lower interest income, partially offset by Cinryze sales.
Effective January 1, 2009, the Company adopted Financial Accounting Standards Board's Staff Position No. APB 14-1, "Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)" ("FSP APB 14-1"), which changed the method of accounting for the Company's convertible notes. The Company revised its previously reported financial statements to apply this change in accounting to prior periods. Under this new accounting method, the Company's EPS and net (loss) income calculated in accordance with GAAP have been reduced as a result of recognizing incremental non-cash interest expense. In connection with adopting FSP APB 14-1, the Company recorded $1.7 million and $2.0 million of additional non-cash interest expense in the three months ended June 30, 2009 and 2008, respectively, and $3.7 million and $3.9 million for the six months ended June 30, 2009 and 2008, respectively. In addition, the Company's previously reported net income calculated in accordance with GAAP for the three and six months ended June 30, 2008 has been reduced by $1.3 million and $2.4 million, respectively to $22.8 million and $39.2 million, respectively, with no impact on diluted earnings per share, as a result of adopting this new accounting method.
Operating Highlights
Our net product sales are related to Vancocin and Cinryze. During the second quarter of 2009, we met the revenue recognition criteria to begin recognizing revenue based upon shipment of Cinryze to our specialty pharmacies and specialty distributors (SP/SD's). During the quarter ended June 30, 2009, net sales of Cinryze were $25.6 million, which includes $2.4 million of sales that was previously deferred. Vancocin net sales during the three and six months ended June 30, 2009, decreased 14.0 percent to $56.3 million and 5.6 percent to $109.8 million, respectively due to lower sales volume, partially offset by the price increase in January 2009.
Cost of sales increased over the three and six month periods in the prior year by $11.7 million and $13.7 million, respectively, due to the launch of Cinryze. Included in the second quarter cost of sales is $1.8 million that was previously deferred. In the comparative periods in 2008, the Company only had cost of sales related to Vancocin. As part of our October 2008 purchase of Lev, we acquired Cinryze inventory which was recorded at fair value in purchase accounting. This fair value of inventory will increase cost of sales for Cinryze until all purchased inventory is sold to SP/SD's. At June 30, 2009, the value of the remaining set-up on our balance sheet related to purchase accounting was $0.7 million.
Investment in our commercialization efforts, product pipeline and the company continued to grow as research and development (R&D) and selling, general and administrative (SG&A) expenses in the second quarter 2009 were $36.1 million as compared to $31.2 million in the second quarter of 2008. R&D expenses decreased $2.1 million related primarily to discontinuing the maribavir prophylactic program, offset by costs associated with manufacturing NTCD spores, costs related to the Cinryze open label trial and patient follow-up. For the second quarter of 2009, SG&A increased $7.0 million over the same period in 2008. The largest contributors to this increase were increased compensation costs resulting from expansion of our field force, increased marketing efforts and increased legal and accounting costs. For the six months ended June 30, 2009, R&D expenses increased $3.2 million, driven by the Cinryze open label trial and patient follow-up, manufacturing NTCD spores, and higher compensation costs, offset by decreased costs related to discontinuing the maribavir prophylactic program. For the six month period, the largest contributors to this $18.0 million increase for SG&A over the six month period in 2008 were increased compensation costs from the addition of our field force, increased marketing efforts, increased legal and accounting fees, and increased medical education activities.
The Company's tax expense for the quarter was $5.6 million and $7.8 million for the quarters ended June 30, 2009 and 2008, respectively and $10.6 million and $14.1 million for the six months ended June 30, 2009, respectively. Income tax expense includes federal, state and foreign income tax at statutory rates and the effects of various permanent differences.
Working Capital Highlights
As of June 30, 2009, ViroPharma's working capital was $327.7 million, which represents a $27.2 million increase from March 31, 2009 and a $10.3 million increase from December 31, 2008. The six month increase is primarily the result of net sales, offset by our repurchase of $45 million principal amount of our senior convertible notes. Cash flow provided by operating activities for the six months ended June 30, 2009 was $15.9 million.
Looking ahead in 2009
ViroPharma is revising its guidance for the year 2009. 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 2009, ViroPharma expects the following:
Net Cinryze sales are expected to be $80 to $95 million.
Research and development (R&D) and selling, general and administrative (SG&A) expenses, including the impact of SFAS 123R, are expected to be $135 to $145 million, which includes approximately $18 million of maribavir-related expenses. SFAS 123R expenses are expected to be between $11 and $13 million.
The company is providing Cinryze net sales guidance and withdrawing Vancocin net sales guidance to align the company's guidance with its growth driver and in light of the August 4, 2009 FDA advisory committee regarding proposed bioequivalence recommendations for Vancocin
http://finance.yahoo.com/news/ViroPharma-Incorporated-prnews-3631869798.html?x=0&.v=1
ViroPharma to Release 2009 Second Quarter Financial Results on July 29, 2009
- Conference Call to Discuss Results to Be Held at 9:00 A.M. -
Press Release
Source: ViroPharma Incorporated
On Tuesday July 14, 2009, 3:57 pm EDT
Companies:Viropharma inc.
EXTON, Pa., July 14 /PRNewswire-FirstCall/ -- ViroPharma Incorporated's (Nasdaq: VPHM - News) second quarter financial results for 2009 are expected to be released on Wednesday, July 29, 2009 before the open of the U.S. financial markets.
The company will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on the same day. During the conference call, ViroPharma management will discuss the 2009 second quarter and other business.
The press release and the live webcast of the conference call will be accessible via ViroPharma's corporate website at http://www.viropharma.com. An audio archive will be available at the same address until August 21, 2009. 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.
7:32AM ViroPharma receives complete response letter for Cinryze; FDA has requested an additional clinical study (VPHM) 6.93 : The co announces that it has received a Complete Response letter from the FDA related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The FDA has requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA lacked robustness. In the Complete Response letter, the FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies. In addition, ViroPharma announced that FDA has approved the patient labeling for Cinryze to include self-administration for routine prophylaxis, once patients are properly trained by their healthcare provider. "Though Cinryze is already successfully preventing attacks of HAE in many patients, there remains an unmet medical need for patients suffering from acute laryngeal attacks," said Vincent Milano, ViroPharma's president and chief executive officer. "Despite having a statistically significant result using the most conservative intent-to-treat (ITT) analysis, the FDA feels that the data are not robust enough to support approval at this time. We intend to respond to the FDA about our plans, and we will provide an update on the second quarter financial call."
10:56AM ViroPharma announces meeting of FDA Advisory Committee for pharmaceutical science and clinical pharmacology on bioequivalence recommendations for oral vancomycin hydrochloride products (VPHM) 6.99 +0.17 : Co announces that the FDA announced that it will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. The meeting is scheduled for August 4, 2009. FDA will make background material available to the public no later than two days before the meeting. "ViroPharma views the convening of the advisory committee as a positive step towards open dialogue to discuss this very serious public health issue. ViroPharma will have an opportunity to address the Committee, and we look forward to what we hope will be a robust discussion of the many important issues raised by the Office of Generic Drugs' in vitro approach to bioequivalence for Vancocin."
Buying ViroPharma Ahead of June 3rd FDA Decision
Is it just me or does it seem like the good old days of biotech are back? With monster moves from Dendreon (DNDN) and Map Pharma (MAPP) based on positive phase 3 data, buyouts of IDM Pharma (IDMI) by Takeda and Cougar Biotech (CGRB) by JNJ and FDA approvals for Vanda Pharma (VNDA) and United Therapeutics (UTHR), it looks like a good time to start buying ahead of important news flow.
One stock that I think has the potential to move higher is ViroPharma (VPHM). On June 3, 2009 the FDA is scheduled to make a decision whether or not to approve ViroPharma's orphan drug Cinryze for acute attacks of hereditary angioedema (HAE).
In October of 2008, Cinryze was approved for routine prophylaxis (prevention) against HAE attacks in adults and adolescents, which I believe makes the chances for approval in acute setting of HAE much more probable. One other point that makes this approval even more important is the fact that the orphan drug status that Cinryze would carry with FDA approval would also keep a competing drug from CSL Behring off the market for seven years, the length of time a company benefits from orphan drug status .
That's why I'm looking for $10 a share with approval, but back to $5 with a non approval.
Disclosure: The author is long VPHM
http://seekingalpha.com/article/140056-buying-viropharma-ahead-of-june-3rd-fda-decision?source=yahoo
Check out that intraday chart...nice 45 degree angle ;)
VPHM is finally back over the 10 SMA and appears to be headed for the 20 SMA. A break over that would be very encouraging.
Those who bought in the $4 area are up at least 10% on this beaten down stock.
ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
- Conference Call at 10:00 A.M. Today to Discuss Results -
EXTON, Pa., Feb. 9 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (NASDAQ:VPHM) today announced that its Phase 3 trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant (SCT) patients did not achieve its primary endpoint. In the primary analysis, there was no statistically significant difference between maribavir and placebo in reducing the rate of CMV disease. In addition, the study failed to meet its key secondary endpoints. Maribavir was generally well tolerated in this clinical study.
"We are extremely disappointed by the outcome of this pivotal study," said Vincent J. Milano, ViroPharma's president and chief executive officer. "We just received these data and there are far more questions than answers; we still have a significant amount of work to do to fully understand this outcome and its impact on the overall program. Our disappointment is no doubt shared by physicians and transplant patients, who must today contend with CMV disease."
The primary endpoint of this Phase 3 study was the incidence of CMV disease, confirmed by an independent endpoint committee, within 6 months post-transplant. The incidence of CMV disease within 6 months was 4.4 percent for maribavir compared to 4.8 percent for placebo (P=0.79). The first of four key secondary endpoints was the rate of initiation of anti-CMV treatment within 6 months, which was 37.9 percent for maribavir compared to 40.5 percent for placebo (P=0.49). In addition, the incidence of graft-versus-host disease, mortality and CMV disease-free survival was comparable between the groups.
Conference Call and Webcast
ViroPharma is hosting a live teleconference and webcast with senior management at 10:00 A.M. this morning to discuss the results of this Phase 3 study. 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 February 23, 2009.
SCT Phase 3 Study Design
This study is a randomized, double-blind, placebo-controlled, multicenter pivotal Phase 3 study in 681 patients who have undergone allogeneic stem cell transplantation. Following transplantation and transplant engraftment, eligible patients were randomized to receive maribavir or matching placebo in a 2:1 randomization ratio. All patients received maribavir 100 mg BID or placebo for a maximum duration of 12 weeks, and followed for an additional 12 weeks to reach the 6-month post-transplant analyses for regulatory filing purposes. All patients were then followed for an additional 24 weeks.
Enrolled subjects underwent testing for CMV infection at least weekly. CMV surveillance included weekly testing at a central laboratory for the presence of CMV pp65 antigenemia and for the presence of CMV DNA in plasma using a polymerase chain reaction (PCR). If CMV infection was detected during the study drug administration period (or if CMV organ disease was diagnosed), study drug was discontinued and the subject was managed according to standard CMV treatment practices at the transplant center.
The primary efficacy endpoint was the incidence of CMV disease within six months post-transplant. Following extensive dialogue with FDA, a number of key secondary endpoints associated with CMV infection were identified and assessment of these endpoints was essential in assessing the clinical benefit of maribavir. These key secondary endpoints include incidence of initiation of preemptive anti-CMV therapy, incidence of graft-versus-host disease, mortality and CMV disease-free survival.
About maribavir
Maribavir is a selective, orally bioavailable Phase 3 antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable clinical safety profile to date, including no evidence of renal toxicities or myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets). Maribavir is a member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and egress of viral capsids from the nucleus of infected cells. Maribavir also has demonstrated activity in vitro against strains of CMV that are resistant to current anti-CMV therapies.
About Cytomegalovirus
CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpes viruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV disease can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, and Cinryze(TM) (C1 inhibitor (human)) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency (for prescribing information on ViroPharma's commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV), HAE and C. difficile.
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, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. Forward looking statements in this press release include statements regarding our clinical development programs, including those relating to the future of our CMV clinical development program and our hope of advancing our product candidate, maribavir, as a potential therapeutic agent in the future. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. The data that are described in this press release is preliminary and additional safety and antiviral data will become available in the future. Full analysis of the existing and future data may not support any or all of the statements in this press release. There can be no assurance that we will continue existing CMV studies or conduct additional CMV studies in the future. The FDA or other regulatory authorities may either prohibit the continuation of existing studies with maribavir, prohibit any future studies with maribavir or alternatively may require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval. The can be no guarantee that ViroPharma will be successful in gaining regulatory approval of maribavir for any indications. These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. We do not assume any responsibility for updating any forward-looking statements.
DATASOURCE: ViroPharma Incorporated
ViroPharma Inc. Sees FY Vancocin Sales $235M-$245M>VPHM
3rd Qtr EPS .33
Holding up well here in the 9's
$15.00 on the horizon
Short Interest drastically reduced
ViroPharma Inc. $ 14.20
VPHM 0.37
Short Interest (Shares Short) 10,218,900
Days To Cover (Short Interest Ratio) 5.2
Short Percent of Float 14.79 %
Short Interest - Prior 12,149,700
Short % Increase / Decrease -15.89 %
Short Squeeze Ranking™ 38
% From 52-Wk High ($ 14.70 ) -3.52 %
% From 52-Wk Low ($ 7.11 ) 49.93 %
% From 200-Day MA ($ 10.10 ) 28.87 %
% From 50-Day MA ($ 11.99 ) 15.56 %
Price % Change (52-Week) 49.40 %
Shares Float 69,100,000
Total Shares Outstanding 69,960,218
% Owned by Insiders 1.21 %
% Owned by Institutions 93.10 %
Market Cap. $ 993,435,096
Trading Volume - Today 1,019,243
Trading Volume - Average 1,948,700
Trading Volume - Today vs. Average 52.30 %
Earnings Per Share 1.03
PE Ratio 13.40
Record Date 2008-AugA
Sector Healthcare
Industry Biotechnology
Shares of ViroPharma pass 52-week high
Wednesday August 13, 4:41 pm ET
By The Associated Press
Shares of ViroPharma pass 52-week high, thanks in part to strong biotech index
ViroPharma Inc. shares passed a 52-week high in trading Wednesday, recovering to levels approached before the company's announcement last month of a deal to buy Lev Pharmaceuticals Inc.
Exton, Pa.-based ViroPharma's stock traded for $13.39 Wednesday afternoon, up 15 cents or 1 percent from the previous close and higher than a 52-week high of $13.36.
Stanford Group. Co. analyst Biren Amin said in a phone interview he thinks the stock is up in part because investors may have grown more comfortable with the Lev Pharmaceuticals purchase.
He also noted that analysts have "a lack of information" from the U.S. Food and Drug Administration on requirements for generic competition for ViroPharma's only marketed treatment, Vancocin, which treats gastrointestinal tract infections.
"The third factor being the biotech general index has been fairly strong over the last six weeks or so," he said.
Cowen and Co. analyst Rachel McMinn said a ViroPharma stock recovery is likely following a generic Vancocin approval.
ViroPharma's shares dropped shortly after its July 15 announcement of the acquisition.
Lev Pharmaceuticals Inc. is a biopharmaceutical company that focuses on developing treatments for inflammatory diseases. ViroPharma agreed to buy it for up to $617.5 million in cash and stock, with the final price depending on whether Lev Pharmaceuticals drug candidate Cinryze meets certain milestones.
McMinn noted ViroPharma could continue to benefit from near-term possibilities like an FDA approval of Cinryze and solid initial demand for the drug.
ViroPharma Cheap and Promising
Friday August 1, 12:06 pm ET
By Jason Napodano, CFA
ViroPharma, Inc. (NasdaqGS: VPHM - News) made a bold move earlier in July to acquire Lev Pharmaceuticals and with it, Cinryze, a potential $250 million product for hereditary angioedema (HAE). HAE is an ultra-rare genetic disorder and a highly attractive market given the significant unmet medical need.
Thus, we are positive on the deal, but acknowledge that significant questions remain. Nevertheless, the move works to greatly diversify the product portfolio and ease investor concern that a generic Vancocin would be devastating to the financial results.
On the contrary, we think both Cinryze (under regulatory review) and antiviral maribavir (in phase III) could be on the market by 2010 and generating positive income. Couple this with an estimated $300 million in cash still to be on hand after the Lev deal closes, and still at least another year of exclusive Vancocin sales, and the company's fundamental position is rock solid. We are maintaining our Buy rating.
At this level ViroPharma stock is too attractive to ignore. Second quarter results handily beat our expectations. Our 2008 revenue forecast of $233.3 million yields a price to sales ratio of only 3.5x. This is significantly below the biotechnology peer-group average of around 6.5x. We forecast 2008 EPS at $0.90. The price to earnings ratio is only 13.1x.
Our model will likely undergo significant revisions once the Lev deal closes in the fourth quarter, but as of now we see $1.32 per share in EPS in 2012 without Lev. Our initial projections show that Cinryze could add as much as a dollar of EPS to that figure by 2012. As such, we have moved our price target to $16 per share.
ViroPharma Incorporated Reports Second Quarter 2008 Financial Results
Wednesday July 30, 7:46 am ET
- Company Achieves Record Vancocin(R) Net Sales; Increases Full Year Guidance for 2008 -
EXTON, Pa., July 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) reported today its financial results for the second quarter and six-months ended June 30, 2008.
Key events since March 31, 2008 include:
Development:
-- Completed enrollment in Phase 3 study of maribavir in stem cell transplant (SCT) patients;
-- Announced intent to present top-line maribavir Phase 3 SCT data in the first quarter of 2009;
-- Announced intent to file the initial New Drug Application (NDA) in the U.S., Marketing Authorization Application (MAA) in Europe, and New Drug Submission (NDS) in Canada for maribavir in SCT patients in the third quarter of 2009;
-- Complete clinical trial results from maribavir Phase 2 study in stem cell transplant patients were published in the June 1 issue of the scientific journal Blood; and
-- Patient enrollment continued in Phase 3 study of maribavir in solid organ (liver) transplant patients.
Operational:
-- Net sales of Vancocin achieved a record $65 million;
-- Research and development expenses increased by 106 percent over the second quarter of 2007, primarily driven by investments in maribavir and NTCD; and
-- Selling, general and administrative expenses increased 94 percent over the second quarter of 2007 due to increased investments in our European operations, our Vancocin sales force, additional medical education activities and increased marketing efforts.
Business Development:
http://biz.yahoo.com/prnews/080730/new042a.html?.v=1
I read that VPHM has still mo cash left. where did they find this cash? Any block buster drug?
ViroPharma to Acquire Lev Pharmacueticals
Tuesday July 15, 9:17 am ET
- Acquisition Adds Late Stage Product Targeting Life-threatening Hereditary Angioedema Disease with Limited Treatment Options -
- Companies to Host Conference Call at 10:30 A.M Eastern Today to Discuss Transaction -
EXTON, Pa.--(BUSINESS WIRE)--ViroPharma Incorporated (Nasdaq: VPHM - News) and Lev Pharmaceuticals, Inc. (OTCBB: LEVP - News) today announced that the companies have signed a definitive merger agreement under which ViroPharma will acquire Lev, a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases, for $442.9 million of upfront consideration, or $2.75 per Lev share, comprised of $2.25 per share in cash and $0.50 per share in ViroPharma common stock (subject to a collar). Contingent consideration of up to $1.00 per share may be paid on achievement of certain regulatory and commercial milestones. The transaction with a potential net aggregate value of up to $617.5 million has been unanimously approved by the boards of directors of both companies. The companies expect the transaction to be completed by the end of 2008. In addition, concurrently with the execution of the merger agreement, ViroPharma purchased $20 million of Lev common stock.
The acquisition of Lev Pharmaceuticals further enhances ViroPharma’s pipeline with Cinryze™ (C1 inhibitor (human)), which is currently under regulatory review for approval by the U.S. Food and Drug Administration as a replacement therapy for patients with hereditary angioedema (HAE), also known as C1 esterase inhibitor (C1-INH) deficiency. The use of replacement therapy in patients with C1-INH deficiency is supported by more than 35 years of clinical practice experience in Europe. C1-INH depletion is also implicated in a number of other serious inflammatory disorders.
Hereditary angioedema, or C1-INH deficiency, is a dangerous and potentially deadly inflammatory disease affecting up to 10,000 patients in the United States, caused by a genetic deficiency in an essential protein called C1 esterase inhibitor. Clinical studies have shown that prophylactic C1 inhibitor replacement therapy with Cinryze can significantly reduce the severity, duration and frequency of HAE attacks.
“This transaction is consistent with ViroPharma’s stated objective of broadening our portfolio of therapies for serious life-threatening conditions in selected specialty markets,” commented Vincent Milano, ViroPharma’s president and chief executive officer. “Lev’s orphan drug Cinryze™ is a life-saving therapy treating a very dangerous disease. This opportunity provides a clear strategic fit with ViroPharma: Cinryze targets a market that is addressable with modest additional infrastructure and further serves patients suffering from a disease with few treatment options. We are very pleased to add the expertise of Lev to our organization, and Cinryze to our growing portfolio of options for underserved patient populations with critical and urgent needs.”
“We believe this transaction recognizes the value we have created at Lev and provides our shareholders with attractive financial terms, through the upfront payment and the opportunity to continue to share in the success of Cinryze™ through the ownership of ViroPharma shares and the contingent value rights,” commented Judson Cooper, Lev’s chairman of the board. “Leveraging the combined resources of both companies not only strengthens our C1 inhibitor development platform, but also underscores our commitment to serving patients with critical unmet medical needs.”
Transaction Terms
Under the terms of the merger agreement, ViroPharma will acquire the outstanding common stock of Lev for $2.25 per share in cash and $0.50 per share in stock (“Upfront Consideration”), subject to a collar. The Upfront Consideration value could be lower or higher if the ViroPharma average common share price is lower than $10.03 or higher than $15.68 per share during the twenty trading day period prior to closing. In addition, Lev shareholders will receive the non-transferrable contractual right to two contingent payments (“CVR Payments”) of $0.50 each that could deliver up to an additional $174.6 million, or $1.00 per share in cash, if the Company meets certain targets. The first CVR payment of $0.50 per share would become payable when either (i) Cinryze is approved by the FDA for acute treatment of HAE and the FDA grants orphan exclusivity for Cinryze encompassing the acute treatment of HAE to the exclusion of all other human C1 inhibitor products or, (ii) orphan exclusivity for the acute treatment of HAE has not become effective for any third party’s human C1 inhibitor product for two years from the later of the date of closing and the date that orphan exclusivity for Cinryze for the prophylaxis of HAE becomes effective. The second CVR payment of $0.50 per share would become payable when Cinryze reaches at least $600 million in cumulative net product sales within 10 years of closing. The Upfront Consideration of $2.75 per share and the potential for a total value of $3.75 per share represent premiums of 49% and 103%, respectively, over Lev’s closing stock price on July 14, 2008.
Closing is subject to certain conditions including approval under the Hart-Scott-Rodino Act, the approval of Lev’s shareholders and other customary closing conditions. Mr. Judson Cooper, Lev’s chairman of the board, and Dr. Joshua Schein, Lev’s chief executive officer, respectively, and their affiliates, who collectively hold an aggregate of approximately 23% of the outstanding Lev shares, have agreed to vote their shares in favor of the transaction.
Additionally, ViroPharma agreed to make a $20 million investment in Lev, at signing, by purchasing 9,661,836 shares of Lev common stock at a 10 percent premium to the five day average closing price of Lev’s shares for the period ending Friday, July 11, 2008, sold pursuant to Lev’s effective registration statement on Form S-3.
J.P. Morgan Securities Inc. advised ViroPharma and DLA Piper acted as legal counsel. In addition, Piper Jaffray & Co. provided a fairness opinion to ViroPharma’s board of directors. J.P. Morgan Securities Inc., as successor to Bear, Stearns & Co. Inc., advised Lev and provided a fairness opinion to Lev’s board of directors. Willkie Farr & Gallagher LLP and Becker & Poliakoff, LLP acted as legal counsel to Lev.
ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Tuesday July 8, 9:00 am ET
EXTON, Pa., July 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin® (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.
Based on FDA's statements to ViroPharma regarding the purpose of this meeting, made by both Committee staff and FDA's Office of Chief Counsel, ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting GI drugs. Among other things, ViroPharma's letter notes important issues that must be addressed in this complex area of bioequivalence method development, and attaches for the Committee's review a letter sent to FDA last year by the Infectious Diseases Society of America (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.
FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."
ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.
ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.
ViroPharma Value Excellent
Tuesday June 24, 3:13 pm ET
By Jason Napodano, CFA
We remain confident that ViroPharma Inc.'s (NasdaqGS: VPHM - News) position is strong. At this level the stock remains incredibly cheap, and we are optimistic that management will be able to add significant value in the coming years.
We see several driving forces in 2008 that lead us to believe it will be another solid year for the Vancocin antibiotic. We see significant opportunity for Vancocin to gain share in the most severely infected patients. Clostridium difficile infection is a life-threatening disease and the data is becoming clear that Vancocin is the best available option for its treatment.
We are concerned about this generic risk but also remind investors that ViroPharma could be a dramatically different-looking company in 2010 if pipeline antiviral candidate Camvia succeeds in treating cytomegalovirus disease.
The stock will most likely remain in the tight trading range until we get an update from the U.S. Food and Drug Administration/Office of Generic Drugs on generic Vancocin. Positive news will send the shares significantly higher. The launch of a generic product will probably cause a sell-off, although considering the current market value is $735 million and ViroPharma is sitting on $599 million in cash, we think that is a bet worth taking.
At this level the stock is too attractive to ignore. Our 2008 revenue forecast of $219.9 million yields a price to sales ratio of 3.3x. This is significantly below the biotechnology peer-group average of around 6.5x. We forecast 2008 EPS at $0.90. The price to earnings ratio is only 11.8x. We think Camvia offers a significant growth opportunity over the long-term. As a result, our rating is Buy and our price target of $14 is based on 15.5x our 2008 EPS estimate of $0.90.
this thing looks like it's goin back t0 15 soon
12 million "die hard" shorts can do that to a stock(when they cover)
Stock's goin to pluto!!!!
Viropharma Comments On Upcoming FDA Advisory Committee Meeting
Thursday June 5, 9:20 am ET
EXTON, Pa., June 5 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) notes that FDA has published a notice of a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to be held on July 23, 2008. The Committee will address several issues at this meeting, including a discussion of:
" ... presentations from the Office of Generic Drugs (OGD) on the
bioequivalence methods for locally acting drugs that treat
gastrointestinal (GI) conditions ... "
For over two years, ViroPharma has called for a deliberative public discussion that would include input from clinicians as well as biopharmaceutics and dissolution experts. Bioequivalence determinations for locally acting GI drugs, particularly drugs like Vancocin® that treat a serious and potentially life threatening disease, are complex. Clostridium difficile infection results in significant morbidity and mortality, and has developed into a national health issue. The risk to patients of a product that is not bioequivalent to Vancocin in this setting is high.
"While the notice does not specifically identify Vancocin, ViroPharma intends to take every opportunity to ensure the points we've raised through our submissions will be brought forward to this committee," commented Thomas F. Doyle, ViroPharma's vice president, strategic initiatives.
ViroPharma is encouraged that FDA is taking this first step to allow a critique of OGD's bioequivalence proposals. As the company noted in a letter that it sent to FDA earlier this year (newly available on the company's website at http://www.viropharma.com/OGDpetition/), bioequivalence for Vancocin is deserving of "at least the same level of process and scientific discussion it has previously afforded locally acting GI drugs used to treat far less serious disease where the consequence associated with getting it wrong do not pose as great a risk to patients."
About Clostridium difficile
One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most common and devastating HAIs. The incidence of C. difficile observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-term care patients, or those that have a serious underlying illness, are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea, fever, nausea and abdominal pain and dehydration, though cases can lead to life threatening complications such as megacolon, peritonitis and perforation of the colon.
stock seems to be breaking out of its recent trading range...looks like blue skies til 15
New Publication of Phase 2 Data Shows Maribavir Markedly Reduced the Rate of Cytomegalovirus Infection and Disease in Bone Marrow Transplant Patients
Monday June 2, 8:00 am ET
- Prevalent in Immunosuppressed Patients, Cytomegalovirus Infection and Disease is Associated with a Range of Life Threatening Complications -
EXTON, Pa., June 2 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced the publication of results of its previously described Phase 2 study showing that maribavir, when used as prophylaxis, reduced the rate of cytomegalovirus (CMV) reactivation and was well tolerated when compared to placebo in allogeneic stem cell, or bone marrow, transplant patients. These results were published in the June 1 issue of Blood, the official journal of the American Society of Hematology (ASH) and previously presented in 2006 at the annual ASH meeting in Orlando, Fl.
CMV is among the most important infectious causes of significant morbidity and mortality in transplant patients. Approximately 60 percent of all at-risk allogeneic stem cell (bone marrow) transplant patients will show evidence of CMV infection in the first 100 days post transplant and despite treatment with currently available therapies approximately 10 percent of these patients will progress to develop CMV disease, which may manifest as deadly complications such as pneumonia or gastrointestinal disease. CMV infection is also associated with indirect effects in transplant recipients, including adverse immunologic effects (graft versus host disease (GvHD) after bone marrow transplantation and graft rejection after solid organ transplantation), serious bacterial and fungal infections, and reduced overall survival rates.
In a 111 subject study, maribavir significantly reduced the rate of CMV infection requiring treatment across all dose ranges (15 percent, p=0.001; 30 percent, p=0.051 and 15 percent, p=0.002 in 100 mg BID, 400 mg QD, 400 mg BID doses respectively), compared to placebo (57 percent). No patients taking maribavir at any dose developed CMV disease, compared to the placebo group in which three subjects (11 percent) developed the disease. Moreover, there were no reports of late CMV disease across any treatment groups with a maximum follow up period of five months post-transplant.
"These results are important because they suggest that maribavir has the potential to shift the CMV management strategy in stem cell transplant from pre-emptive therapy to prophylaxis," said Drew J. Winston, M.D., University of California, Los Angeles Medical Center. "It is clear that maribavir has the potential to offer an important new and safer option for clinicians to prevent CMV disease in transplant patients."
Among other observations, GvHD of grade 2 or higher, a common complication in bone marrow transplants, also was found to be less common in the three maribavir treatment arms (14 percent; 29 percent; 23 percent) than in the placebo group (46 percent).
"While this dose-ranging study evaluated the safety and the ability of maribavir to prevent viral reactivation in bone marrow transplant patients, we are particularly encouraged by the possibility that maribavir may help reduce the rate of CMV disease and associated morbidity, something we are investigating in our current Phase 3 study," said Stephen Villano, M.D., vice president, clinical research and development at ViroPharma.
The most common adverse events in the maribavir treatment groups were taste disturbance, nausea and vomiting. Maribavir did not cause renal toxicities or myelosuppression.
ViroPharma is currently conducting two pivotal Phase 3 studies with maribavir, one in allogeneic stem cell transplant recipients and the other in liver transplant recipients. The company expects to file its initial NDA and MAA for maribavir in SCT patients in the third quarter of 2009.
Study Design
The maribavir Phase 2 clinical trial was a randomized, double blind, placebo-controlled, dose-ranging study conducted at 13 transplant centers across the U.S. involving CMV-seropositive subjects who had undergone allogeneic stem cell transplantation. A total of 111 subjects were randomized 3:1 to receive placebo or maribavir in each of three ascending dose groups (100 mg BID, 400 mg QD, 400 mg BID). All subjects were monitored frequently for CMV infection, and if CMV infection was detected, study drug (maribavir or placebo) was discontinued and the subject was managed according to current standards of care at each transplant center, including starting pre-emptive anti-CMV treatment at the discretion of the investigator.
The objectives of this study included an evaluation of the safety and tolerability of maribavir administered orally for up to 12 weeks, and an evaluation of the prophylactic activity of maribavir in preventing CMV reactivation in CMV seropositive recipients of allogeneic stem cell transplants.
About maribavir
Maribavir is a potent and selective, orally bioavailable Phase 3 antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable clinical safety profile to date, including no evidence of renal toxicities or myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets). Maribavir is a member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and egress of viral capsids from the nucleus of infected cells. Maribavir also has demonstrated activity in vitro against strains of CMV that are resistant to current anti-CMV therapies.
About Cytomegalovirus
CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV disease can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.
ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
Thursday May 29, 8:00 am ET
- Phase 3 Study in 681 Stem Cell Transplant Patients Represents First Pivotal Study on a New Antiviral CMV Therapy in Stem Cell Transplant in Over a Decade -
- Company Also Provides Timing of Phase 3 Data Disclosure and Regulatory Submissions -
EXTON, Pa., May 29 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that it completed enrollment in its pivotal Phase 3 study of maribavir in stem cell transplant patients. This international Phase 3 study is evaluating the efficacy, safety and tolerability of prophylactic use of maribavir administered orally for up to 12 weeks for the prevention of cytomegalovirus (CMV) disease in recipients of allogeneic stem cell transplants (SCT). The study also will evaluate the pharmacokinetics of maribavir in this subject population. It is being conducted in 90 transplant centers in the U.S., Canada, and Europe.
"Maribavir may mark the first new advancement in CMV therapeutics for transplant recipients in many years," stated Stephen Villano, M.D., vice president, clinical research and development at ViroPharma. "CMV can cause significant and potentially deadly clinical manifestations among transplant recipients, and maribavir represents the opportunity for a shift in CMV treatment paradigm toward prophylaxis against CMV, thus preventing CMV viral infection and disease and allowing for enhanced focus on other aspects of patient outcome following transplantation."
The company also provided the timing of future milestones in the development of maribavir in SCT. These include:
-- Data collection for the 6-month assessments will continue through the
end of November 2008;
-- Top line Phase 3 clinical data is expected to be announced in the first
quarter of 2009;
-- Filing of the initial NDA (New Drug Application) in the U.S., MAA
(Marketing Authorization Application) in Europe, and NDS (New Drug
Submission) in Canada for maribavir in SCT patients based on the
6-month assessments is expected in the third quarter of 2009;
-- The company will announce the timelines for the ongoing Phase 3 study
in liver transplant at a later date, including completion of enrollment
and top line data. The company intends to file its supplemental NDA,
NDS and MAA variation for this additional opportunity as soon as
possible following receipt of initial marketing approvals in SCT.
"These are significant milestones for the development of this important drug, and we are excited by the global interest and support for maribavir among transplant physicians throughout the U.S., Europe and Canada," commented Vincent Milano, ViroPharma's president and chief executive officer.
CMV is among the most important infectious causes of significant morbidity and mortality in transplant patients. Approximately 60 percent of all at-risk allogeneic stem cell (bone marrow) transplant patients will show evidence of CMV infection in the first 100 days post transplant and despite treatment with currently available therapies approximately 10 percent of these patients will progress to develop CMV disease, which may manifest as deadly complications such as pneumonia or gastrointestinal disease. CMV infection is also associated with indirect effects in transplant recipients, including adverse immunologic effects (graft versus host disease (GvHD) after bone marrow transplantation and graft rejection after solid organ transplantation), serious bacterial and fungal infections, and reduced overall survival rates.
SCT Phase 3 Study Design
This study is a randomized, double-blind, placebo-controlled, multicenter pivotal Phase 3 study in 681 patients who have undergone allogeneic stem cell transplantation. Following transplantation and transplant engraftment, eligible patients have been randomized to receive maribavir or matching placebo in a 2:1 randomization ratio. All patients will receive maribavir 100 mg BID or placebo for a maximum duration of 12 weeks, and will then be followed for an additional 12 weeks to reach the 6-month post-transplant analyses for regulatory filing purposes. All patients will then be followed for an additional 24 weeks.
Enrolled subjects will undergo testing for CMV infection at least weekly. CMV surveillance includes weekly testing at a central laboratory for the presence of CMV pp65 antigenemia and for the presence of CMV DNA in plasma using a polymerase chain reaction (PCR). If CMV infection is detected during the study drug administration period (or if CMV organ disease is diagnosed), study drug will be discontinued and the subject will be managed according to standard CMV treatment practices at the transplant center.
The primary efficacy endpoint will be the incidence of CMV disease within six months post-transplant, which is predicted to be approximately nine percent in the placebo (current standard of care) arm based on data from the Phase 2 study, data from published literature, and information from transplant center databases. Following extensive dialogue with FDA, a number of key secondary endpoints associated with CMV infection have been identified and assessment of these endpoints will be essential in assessing the clinical benefit of maribavir. These key secondary endpoints include incidence of initiation of preemptive anti-CMV therapy, incidence of graft-versus-host disease, mortality and CMV disease-free survival.
ViroPharma Announces Discontinuation of HCV-796 Development
Wednesday April 16, 6:02 pm ET
EXTON, Pa., April 16 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) announced today that ViroPharma and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), have jointly discontinued the development of HCV-796 due to the previously announced safety issue that emerged in the ongoing Phase 2 trial in patients with hepatitis C.
"Clearly, this is a disappointing outcome for patients suffering from this difficult disease," commented Vincent Milano, ViroPharma's president and chief executive officer. "Significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development."
The companies will ensure that patients enrolled in the ongoing Phase 2 study will continue to receive the current standard of care. ViroPharma also announced that ViroPharma and Wyeth do not expect to continue to collaborate on future development of hepatitis C treatment candidates.
Forecast for ViroPharma's Pipeline: Mostly Shiny
http://www.seekingalpha.com/article/59878-forecast-for-viropharma-s-pipeline-mostly-shiny
ViroPharma Provides 2008 Outlook
Wednesday January 9, 8:30 am ET
2008 Focus on Pipeline Advancement; CAMVIA Momentum Building Toward 2009 NDA
EXTON, Pa., Jan. 9 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) 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.
http://biz.yahoo.com/prnews/080109/new005b.html?.v=1
ViroPharma Provides Update on Vancocin(R)
Tuesday January 8, 7:53 am ET
EXTON, Pa., Jan. 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today provided the following update on its petition to the U.S. Food and Drug Administration (FDA) regarding Vancocin® (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:
http://biz.yahoo.com/prnews/080108/netu035.html?.v=38
Baker Brothers Life Sciences Capital, LLC have been back in buying VPHM stock in the past month:
http://www.form4oracle.com/company?cik=0000946840&ticker=VPHM
ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
EXTON, Pa., Nov. 12 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has granted orphan drug designation for CAMVIA for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell-mediated immunity. The EMEA's 'Orphan Medicinal Product Designation' is designed to promote the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as 'life-threatening or very serious conditions.'
Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant. Finally, when a Pediatric Investigation Plan is completed, an additional two years of exclusivity could be granted for a product with orphan medicinal product designation.
'We are very pleased to receive orphan designation for CAMVIA from the EMEA,' commented Thierry Darcis, M.D., ViroPharma's vice president and general manager, Europe. 'This designation clearly recognizes the potential to address great unmet medical needs with CAMVIA as we work to maximize the global value of the drug. This designation from the EMEA adds additional momentum as we continue to develop CAMVIA for transplant-related cytomegalovirus disease. We commend the European Commission for providing incentives for the development of drugs for rare and life threatening diseases.'
'ViroPharma is in a period of great global progress with CAMVIA,' added Michel de Rosen, ViroPharma's chief executive officer. ' We initiated one pivotal Phase 3 study in stem cell transplant patients in late 2006; presented excellent and unequivocal Phase 2 data at the 2006 meeting of the American Society of Hematology; were granted Orphan Drug Designation from the U.S. Food and Drug Administration this year; and began dosing in our second pivotal phase 3 study in solid organ liver transplant patients in September. We are generating strong excitement from US and European transplant physicians and this European designation marks yet another important positive step as we move diligently toward our goal of regulatory filings in the US and Europe in 2009.'
About CAMVIA
CAMVIA(TM) (maribavir) is a potent and selective, orally bioavailable Phase 3 antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, CAMVIA inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. CAMVIA is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.
About Cytomegalovirus
CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.
ViroPharma Incorporated Reports Third Quarter and Nine-Month 2007 Financial Results
Tuesday October 30, 7:00 am ET
EXTON, Pa., Oct. 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) 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® 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® 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® 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.
As the table shows, all these stocks are still very well-regarded by the CAPS community despite their underperformance over the past month. While these are not formal recommendations, they could be a great place to kick off further research. I'll even get you started with some thoughts on ViroPharma.
C ViroPharma fall
When a biopharma company like ViroPharma takes a tumble, it's usually a safe guess that testing of a new drug went poorly. And this was the case with ViroPharma's early August dive.
On Aug. 10, ViroPharma's stock dropped as much as 27% before shoring up a bit and closing down 15% from the prior day. The reason was the announcement that the company was discontinuing the phase 2 trial of its hepatitis C drug, dubbed HCV-796, which ViroPharma had been working on in conjunction with Wyeth (NYSE: WYE). The drug trial revealed that patients being treated with HCV-796 had higher levels of liver enzymes -- typically a warning sign that something is going wrong in the liver.
Though a single drug can be the whole story in some young biopharma companies, this isn't the case with ViroPharma. The company is profitable thanks to the drug Vancocin, a treatment for pseudomembranous colitis that it acquired from Eli Lilly (NYSE: LLY). It also has another drug in phase 3 trials -- Maribavir, which treats cytomegalovirus. And let's not overlook the fact that ViroPharma is sitting on a combined $517 million of cash and short-term investments, and it has made it known that it will be looking at acquisitions.
Of 157 CAPS All-Stars -- players ranked in the top 20% of all 60,000-plus CAPS players -- to weigh in on ViroPharma, 155 expect the stock to outperform the market. One of those All-Stars, nickinglis, slapped on the thumbs-up a few days after the HCV-796 report came out, saying there had been a "market over-reaction on bad news" and that a correction is still on the way.
So, does the drop create a good buying opportunity? Or does the HCV-796 disappointment warrant the new, lower price? Let the community know what you think -- head over to CAPS and share your thoughts. Even if you'd prefer to pass on ViroPharma, you can check out a couple of the other stocks listed above or any of the 4,900 stocks that are rated on CAPS. (If you were waiting, consider this your engraved invitation to join CAPS.)
Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
- Early Antiviral Activity with HCV-796 Supports Follow-up with Standard of Care Including Evaluation of Sustained Virologic Response (SVR) -
- Company to Host Conference Call at 10:00 AM ET Today -
EXTON, Pa., Aug. 10 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) announced today the decision made with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), to discontinue dosing with HCV-796 in combination with pegylated interferon and ribavirin in its current Phase 2 study. All subjects, following consultation with the principal investigators at each site, will have the option of continuing on the combination therapy of pegylated interferon and ribavirin, the standard of care. This decision follows yesterday's review by the joint safety review board of safety data accumulated to date, which show elevated liver enzyme levels in some patients after 8 weeks or more of therapy with HCV-796 with pegylated interferon and ribavirin.
The companies conducted a thorough safety review of liver enzyme levels in all patients. Clinically significant elevations of liver enzymes were observed in approximately eight percent of patients receiving HCV-796, including two patients who experienced serious adverse events leading to withdrawal from active therapy with HCV-796, pegylated interferon and ribavirin. In contrast, elevated liver enzymes were seen in only one percent of patients on standard of care. Elevations of liver enzymes appear to be transient in some patients. The U.S. Food and Drug Administration has been notified that all patients on triple therapy will now be maintained on only pegylated interferon and ribavirin for the remainder of the clinical study.
'While substantial efforts are ongoing to continue analysis of these data, we consider it to be in the best interests of patients to discontinue dosing with HCV-796 at this time,' commented Dr. Colin Broom, ViroPharma's chief scientific officer. 'We and Wyeth are focused on patient safety. We are acting quickly and with the best interests of patients in mind. '
'This is a clear disappointment in light of the exciting antiviral activity observed to date in this study. Although this represents a potential setback for hepatitis C patients, we are committed to the health and safety of patients, and this decision was absolutely the right thing to do,' commented Michel de Rosen, ViroPharma's president and chief executive officer. 'We are committed to understanding the observations that led to this decision in the hope of advancing this potential therapeutic agent in the future.'
Clinical trial investigators are being notified of the current data and the change in clinical plans. ViroPharma and Wyeth will continue to analyze the efficacy and safety data from this ongoing study in order to make a benefit risk assessment for the future development of HCV-796.
Phase 2 Preliminary Antiviral Data
All patients currently in the study have received at least 8 weeks of dosing. We have not completed a full analysis of all data, including discontinuations and withdrawals. Preliminary analysis of antiviral data has been performed on patients who have completed 4 weeks and a portion of patients who have completed 12 weeks of therapy. Not all patients who have completed 12 weeks of therapy have data available at this time.
For Patients On-therapy at Week 4:
Treatment Naive Patients Null Responders
Peg-Intron + ribavirin HCV-796 + Peg-Intron + HCV-796 +
(control therapy) ribavirin Peg-Intron +
ribavirin
Percent of
patients with 7% 45% 4%
undetectable HCV (5 of 75) (34 of 75) (3 of 78)
levels (<10 IU/ml)
For Patients On-therapy at Week 12:
Treatment Naive Patients Null Responders
Peg-Intron + ribavirin HCV-796 + Peg-Intron + HCV-796 +
(control therapy) ribavirin Peg-Intron +
ribavirin
Percent of
patients with 39% 73% 23%
undetectable HCV (15 of 38) (27 of 37) (17 of 73)
levels (<10 IU/ml)
The above data are based on a randomized, open-label study of the safety, tolerability, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin (standard of care) in HCV genotype 1-infected subjects who are naive to treatment. The combination of HCV-796, pegylated interferon and ribavirin was also assessed in a group of HCV genotype 1 patients who had previously failed treatment (null-responders). The number of subjects enrolled and dosed in each of the three treatment groups ranged from 78 to 84.
Individual subjects in all dose cohorts will continue to be eligible for treatment for up to 48 weeks with standard of care, provided that, sufficient antiviral responses are observed at interim time points (12 and 24 weeks of treatment). Subjects will continue to be followed for an additional 24-week period to assess sustained virological response (SVR).
Conference Call and Webcast
ViroPharma is hosting a live teleconference and webcast with senior management to discuss these matters on August 10, 2007 at 10:00 a.m. Eastern Time. To participate in the conference call, please dial (877) 366-0713 (domestic) and (302) 607-2000 (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 RealPlayer will be needed to access the webcast. An audio archive will be available at the same address until August 24, 2007.
Old gap filled in VPHM this morning buying some stock today(spank it)
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http://www.viropharma.com/
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ViroPharma Incorporated, a biopharmaceutical company, engages in the development and commercialization of products that address serious infectious diseases, with a focus on products used by physician specialists or in hospital settings in the United States. Its principal product includes Vancocin for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The company also develops Maribavir, which is in Phase III clinical development stage for the treatment of cytomegalovirus disease; HCV-796 that is in Phase II clinical development stage for the treatment of hepatitis C virus infection; and Intranasal pleconaril, which is in Phase II clinical development stage for the treatment of common cold and asthma exacerbations. ViroPharma serves pharmacies, hospitals, clinics, and other facilities licensed to dispense prescription medications. The company was founded in 1994 and is based in Exton, Pennsylvania.
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