BCRX - Sector: Healthcare---Industry: Biotechnology

[setravis]

A 'Pandemic' Now Declared, Focus Back on Swine Flu Stocks
On Friday June 12, 2009, 12:00 pm EDT

The H1N1 virus is officially a pandemic, and vaccine stocks are responding.

Swine flu stocks are up again today, with some extending weekly gains to more than 20%. A number of companies released good news to end the week. From small-cap players to multi-billion dollar giants, shares are up big on high volume. Novartis (NYSE: NVS) announced today that it will have a swine flu vaccine ready by this fall. Shares are up by 4% on the news.

On Thursday, the World Health Organization raised its alert level on the virus to "Phase 6," indicating that it has officially become a pandemic.

As a whole the Swine Flu and Bird Flu Stocks Index is up by 2.5%. It is now beating the S&P 500 by 35.5% over the last month.

Generex Biotechnology (NASDAQ: GNBT) is leading the Index today with 10% gains. The company was granted five new patents for its drug delivery systems. The patents were awarded in Canada, Australia, New Zealand, Brazil, and Lebanon. The stock is still in negative territory this week by -3%.

Sinovac Biotech (AMEX: SVA) is adding another 3% to its industry-leading 30% weekly rally. On Monday the company announced that it had begun production of a swine flu vaccine, and noted that it could produce up to 30 million doses per year.

Vical (NASDAQ: VICL) has fallen from earlier highs, and is now trading up fractionally. Thomas Weisel initiated coverage of the company today with an Overweight rating and a $5 price target. The analyst cited Vical's proprietary technology, strategic partnerships, and licensing agreements.

GlaxoSmithKline (NYSE: GSK) and Hemispherx Biopharma (AMEX: HEB) are both ahead by more than 4% today.

Pure Bioscience (NASDAQ: PURE) and AVI Biopharma (NASDAQ: AVII) are industry laggards today, falling by -3% and -6% respectively.

As of this writing the Swine Flu and Bird Flu Stocks Index is a top-three performing tickerspy Index over the last month, gaining 39.5%.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.
http://www.tickerspy.com/index/Swine-Flu-and-Bird-Flu-Stocks?refer=2028Y3
   

[setravis]

Profile: 

 
BioCryst Pharmaceuticals Inc.
2190 Parkway Lake Drive
Birmingham, AL 35244
United States - Map
Phone: 205-444-4600
Fax: 205-444-4640
Web Site: http://www.biocryst.com

DETAILS   
Index Membership: N/A
Sector: Healthcare
Industry: Biotechnology
Full Time Employees: 80


BUSINESS SUMMARY   
BioCryst Pharmaceuticals, Inc., a biotechnology company, engages in the design, optimization, and development of drugs that block key enzymes involved in cancer, viral infections, and autoimmune diseases. It integrates the disciplines of biology, crystallography, medicinal chemistry, and computer modeling to use structure-based drug design to discover and develop small molecule pharmaceuticals. The company’s product candidates include forodesine HCl, a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP), which is in Phase IIb clinical trial for patients with Cutaneous T-cell Lymphoma (CTCL); and in a Phase II trial with an oral formulation in Chronic Lymphocytic Leukemia (CLL). Its Forodesine HCl product is used for three indications: T-cell non-Hodgkin lymphoma, including CTCL; CLL and related leukemias, including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for the treatment of B-cell acute lymphoblastic leukemia. The company also provides peramivir, an inhibitor of influenza neuraminidase, which completed Phase II clinical trial for the treatment of influenza with two parenteral formulations, intramuscular and intravenous. In addition, it offers BCX-4208/R3421, a second generation PNP inhibitor, which is in the Phase IIa clinical trial for the prevention of acute rejection in transplantation and for the treatment of autoimmune diseases. The company has collaborative and other research and development contracts with Shionogi & Co., Ltd.; U.S. Department of Health and Human Services; Green Cross Corporation; Mundipharma International Holdings Limited; F.Hoffmann-La Roche Ltd. and Hoffman-La Roche Inc.; Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd.; The University of Alabama at Birmingham; and Emory University. BioCryst Pharmaceuticals, Inc. was founded in 1986 and is based in Birmingham, Alabama.

[setravis]

Bingo ! 

[setravis]

JDA, BCRX and AKRX Biggest Small-Cap Winners in Late Rally...
Symmetrical Triangle Breakout...

52wk Range: 0.85 - 6.43
Volume: 5,434,707
Avg Vol (3m): 1,293,150

Technicals
Percentage Gainer

Last Price Quote is:
66.44%above 13-day MA
94.50%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $227.92 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/06/2009
Last Analyst Rating: Average

[setravis]

BIRMINGHAM, Ala., July 17, 2009 /PRNewswire-FirstCall via COMTEX/ -- BioCryst Pharmaceuticals (BCRX, Trade ) today announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza. The studies were sponsored by BioCryst's partner Shionogi & Co., Ltd. of Osaka, Japan and conducted during the 2008-2009 influenza season. Shionogi and Green Cross Corporation, the license holder of peramivir in Korea, co-conducted the portion of the studies in Korea.

In patients with uncomplicated seasonal influenza, Shionogi conducted a three-armed, multi-center, randomized, double-blind, multi-national Phase 3 study of i.v. peramivir that compared the efficacy and safety of a single dose of peramivir (either 300 mg or 600 mg) and treatment with oral oseltamivir phosphate 75 mg (Tamiflu((R))) twice a day for five days. A total of 1,099 patients were enrolled at 146 centers (Japan:100; Korea:25; Taiwan:21). Both the 300 mg and 600 mg single dose peramivir groups demonstrated non-inferiority for the primary endpoint, time to alleviation of symptoms (TTAS), compared to the oseltamivir group. The medians for TTAS for the peramivir 300 mg, peramivir 600 mg and oseltamivir groups were 78.0 hours, 81.0 hours and 81.8 hours, respectively.

Additionally, Shionogi conducted a double-blind, multi-center Phase 3 study of i.v. peramivir with dosing over multiple days. The study enrolled 42 influenza patients at high-risk of serious complications due to one or more qualifying conditions: diagnosis with poorly controlled diabetes mellitus, a chronic respiratory disease requiring pharmacotherapy, or current treatment with any immunosuppressive drug. Peramivir was administered at 300 mg or 600 mg per day, and the duration was adjusted (up to five days) on a case-by-case basis, depending on the patient's temperature and clinical condition. In this study, the median time to alleviation of symptoms in all 37 evaluable patients treated with either 300 mg or 600 mg peramivir daily was 68.6 hours.

i.v. peramivir 300 mg and 600 mg in both single and multiple doses were generally safe and well-tolerated in these trials. Further analyses of the study data, including secondary efficacy endpoints and detailed safety is underway. Additional data will be submitted for presentation at an upcoming medical meeting.

"The clinical outcomes of these Phase 3 studies are important, especially during the declared influenza pandemic, as they indicate the promise of peramivir as a treatment for influenza," commented Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "The need for additional anti-viral treatment options for influenza remains high. BioCryst is currently finalizing its plans for peramivir Phase 3 studies intended to support U.S. regulatory approval, while continuing to support the pre-emergency use authorization review of peramivir by the U.S. Food & Drug Administration."

"This data represents a significant milestone for BioCryst -- the first Phase 3 studies successfully conducted with a drug candidate discovered by BioCryst," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "We congratulate Shionogi on the success of these rapidly completed studies, which have the potential to lead to the first regulatory approval for peramivir."

Shionogi has stated that the Company is making its best effort to file its New Drug Application and to receive a manufacturing approval as soon as possible in Japan.

About Peramivir

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. Peramivir has demonstrated clinical activity and safety in prior human studies. In laboratory tests, peramivir has shown activity against various viral strains, including the novel influenza A (H1N1) virus. In the U.S., BioCryst is preparing plans for additional Phase 3 studies of i.v. peramivir to support product registration. Additionally, i.v. peramivir is currently undergoing a pre-emergency use authorization (EUA) review.

About the Shionogi & Co., Ltd. Partnership

In February 2007, BioCryst & Shionogi & Co., Ltd. entered into an exclusive license agreement under which Shionogi obtained rights to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening influenza. In 2008, Shionogi's rights were extended to include Taiwan. Under the terms of the agreement, BioCryst may receive future clinical and commercial event milestone payments up to $116 million, as well as double digit royalty payments on product sales of peramivir. BioCryst retains its rights to commercialize peramivir in countries outside of Japan, Taiwan and South Korea.

About BioCryst

BioCryst is a biopharmaceutical company that has developed a diverse pipeline of novel therapeutics targeting major illnesses by employing crystallography and structure-based drug design. BioCryst is currently advancing investigational new drugs discovered in-house in late-stage clinical trials for influenza and lymphoma. In addition, the Company has a pre-clinical portfolio of novel compounds, directed against infectious, cardiovascular and autoimmune disease targets, to create long-term sustainable value. The Company's strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Ltd. validate its scientific foundation and the utility of its product candidates. For more information, please visit the Company's Web site at www.biocryst.com .

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that peramivir may not receive emergency use authorization; that the U.S. government may choose not to ship peramivir to the CDC Strategic National Stockpile; that to the extent peramivir is used as a treatment for H1N1 flu (or other strains of flu), there can be no assurance that it will prove effective; that HHS may further condition, reduce or eliminate future funding of the peramivir program; that ongoing peramivir clinical trials or our peramivir program in general may not be successful; that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed; that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates; that peramivir or our other product candidates may not receive required regulatory clearances from the FDA or other regulatory agencies; that ongoing and future preclinical and clinical development may not have positive results; that we or our licensees may not be able to continue future development of our current and future development programs; that our development programs may never result in future product, license or royalty payments being received by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates; that our actual burn rate may not be consistent with our expectations; that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, most recent Registration Statement on Form S-3 (filed November 28, 2008 and subsequently amended Jan 23, 2009), Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in our projections and forward-looking statements.

SOURCE BioCryst Pharmaceuticals


   

[setravis]

UPDATE 1-Shares of flu drugmakers rise on latest WHO stats
Mon Jul 27, 2009 4:23pm EDT

BANGALORE, July 27 (Reuters) - Shares of companies that make vaccines and drugs for flu rose on Monday after the World Health Organization said more than 20 countries and overseas territories confirmed their first cases of the H1N1 swine flu virus.

Analysts believe the headlines have spurred investors to turn their attention to a basket of drugmakers developing novel therapeutics to combat a potential flu pandemic, as these companies stand a chance of benefiting from government funding or stock-piling grants.

"Anytime that kind of news hits the air, these companies tend to respond," Rodman & Renshaw analyst Reni Benjamin said.

Shares of small viral vaccine maker Novavax Inc (NVAX.O) touched a two-year high of $4.40, while DNA-based vaccines maker Vical Inc (VICL.O) rose to a new 52-week high of $3.96 on Nasdaq.

Flu drug maker Biocryst Pharmaceuticals Inc's (BCRX.O) shares rose as much as 18 percent to a two-year high of $11.20. Biopharmaceutical company AVI BioPharma Inc's (AVII.O) shares rose 18 percent to a 19-month high of $2.26.

"As long as flu vaccine stays in the news (the trend of shares rising) is possible," Cowen and Co analyst Eric Schmidt said.

"I think it's all about news flow rather than fundamentals."

According to the latest WHO figures, H1N1 pandemic flu has spread to the most remote parts of the planet, including popular island getaways. An estimated 816 people have died from infection to date, according to the WHO's latest tally. [ID:nLR353672]

Patients suffering from the H1N1 influenza -- which is a genetic mix of human, bird and swine viruses -- display symptoms such as fever and vomiting.

Other companies that make flu vaccines include Sanofi Pasteur (SASY.PA), Australia's CSL Ltd (CSL.AX), GlaxoSmithKline Plc (GSK.L), Novartis AG (NOVN.VX), Baxter (BAX.N) and nasal spray maker MedImmune, which was acquired by AstraZeneca Plc (AZN.L).

[setravis]

updated chart look...
 

[setravis]

Updated chart look...
BreakOut...

[setravis]

Could be a Double Bottom put in...
Oversold...Bottom fishing
Closed above the 13-Day MA, let's see if it can pop through the 50-Day MA

24-Feb-11 17:14 ET In Play BioCryst awarded additional $55.0 mln by the U.S. Dept of Health & Human Services to complete peramivir phase 3 program (3.99 +0.04) : Co announced that it has been awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services (HHS) intended to fund to completion the Phase 3 development of its neuraminidase inhibitor, intravenous (i.v.) peramivir, for the treatment of patients hospitalized with influenza. This contract modification brings the total award from HHS to $234.8 million, providing funding through completion of Phase 3 development and the filing of a new drug application (NDA) for i.v. peramivir in the U.S.

Day's Range: 4.17 - 4.36
52wk Range: 3.87 - 8.37
Volume: 817,561
Avg Vol (3m): 325,389
Market Cap: 192.72M
P/E (ttm): N/A
EPS (ttm): -0.73
Div & Yield: N/A (N/A)

Technicals
Close Above the 13-day EMA
Gap Up

Last Price Quote is:
3.09%above 13-day EMA
-4.72%below 50-day EMA
RS Rating: 15 

[setravis]

BCRX  BioCryst Awarded Additional $55.0 Million by the U.S....  by Business Wire  Feb 24 2011 5:14PM 

RESEARCH TRIANGLE PARK, N.C., Feb 24, 2011 (BUSINESS WIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) today announced that it has been awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services (HHS) intended to fund to completion the Phase 3 development of its neuraminidase inhibitor, intravenous (i.v.) peramivir, for the treatment of patients hospitalized with influenza.

"The shared goal of HHS/BARDA and BioCryst is to achieve approval for peramivir for seriously-ill influenza patients. We value our long-standing relationship with HHS and their continued support," said Jon P. Stonehouse, President and Chief Executive Officer, BioCryst Pharmaceuticals. "This contract modification allows us to significantly increase the number of enrolling sites for our ongoing efficacy study and to drive it to completion. Additionally, the FDA and HHS have agreed to changes in the study that we believe greatly improve the likelihood of demonstrating an improvement over standard of care. Our first priority is to complete the Phase 3 program and we believe these changes should help us reach that goal."

This contract modification brings the total award from HHS to $234.8 million, providing funding through completion of Phase 3 development and the filing of a new drug application (NDA) for i.v. peramivir in the U.S. It also extends the contract term by 24 months through December 31, 2013. A change of indirect rates for prior years resulting from the contract modification has led to adjustments to BioCryst's financial results for 2010, as explained in detail below. In January 2007, BioCryst was originally awarded a $102.6 million, four-year contract from HHS to develop peramivir for the treatment of influenza. During 2009, peramivir clinical development for U.S. registration shifted to focus on intravenous delivery and the treatment of hospitalized influenza patients. To support this focus, a September 2009 contract modification was awarded to extend the program by 12 months and to increase funding by $77.2 million. Through December 31, 2010, $157.6 million has been recognized as revenue under the contract with HHS to support activities related to the peramivir development program.

Phase 3 Development of Peramivir

To improve the likelihood of a positive clinical outcome, BioCryst has amended the primary efficacy analysis of its multi-center, randomized, double-blind, controlled study to evaluate the efficacy and safety of 600 mg i.v. peramivir administered once-daily for five days in addition to standard of care (SOC), compared to SOC alone, in adults and adolescents who are hospitalized due to serious influenza. Implementation of the following is supported by the HHS contract modification announced today:

Changing the primary efficacy analysis of the study to focus on a subset of approximately 160 patients not treated with neuraminidase inhibitors as SOC, in order to provide the greatest opportunity to demonstrate a statistically significant peramivir treatment effect Increasing the total study target enrollment up to 600 subjects from the current target of 445 subjects Adding at least 45 more clinical site locations in additional countries

The actual time to reach completion of enrollment will depend on the prevalence and severity of influenza, as well as the ability of the more than 265 investigator sites to successfully enroll patients. Further details regarding this Phase 3 study is available at: http://clinicaltrials.gov/ct2/show/NCT00958776

Resulting Adjustment to 2010 Financial Results

In connection with the contract modification, HHS and BioCryst agreed to settle on final indirect rates for years 2007, 2008 and 2009. As a result, BioCryst will receive a $4.9 million cash payment from HHS related to the difference between the actual indirect costs incurred against the contract and the indirect costs that were invoiced at a provisional billing rate during those years. In order to reach agreement regarding the modification, the Company agreed to reductions of approximately $1.1 million of indirect costs relating to 2008 and 2009. As this subsequent event occurred after BioCryst's release of fourth quarter and full year 2010 financial results but prior to issuance of its annual financial statements to be included in Form 10-K, the Company will adjust the financial results previously reported in its February 10, 2011 press release. Accordingly, collaborative and other research and development revenues for the three and twelve months ended December 31, 2010 will be reduced to $17.4 million and $62.1 million, respectively. Net loss and loss per share for the three months ended December 31, 2010 will increase to $10.2 million and $0.23 per share. Net loss and loss per share for the twelve months ended December 31, 2010 will increase to $33.9 million and $0.76 per share. Receivables from collaborations, total assets, and stockholders' equity as of December 31, 2010 will be reduced to $30.2 million, $109.4 million and $65.5 million, respectively. Accumulated deficit as of December 31, 2010 will increase to $296.6 million. An adjusted financial table is available at: http://investor.shareholder.com/biocryst/releases.cfm

Conference Call and Webcast

BioCryst's management team will host a conference call and webcast on Friday, February 25, 2011 at 8:30 a.m. Eastern time to discuss the contract modification and clinical program changes. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.biocryst.com . Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About peramivir

Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including pandemic H1N1 swine origin flu viral strains. In January 2010, Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name RAPIACTA(R) to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir please visit BioCryst's Web site at www.biocryst.com/peramivir .

About BioCryst

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst currently has three novel late-stage compounds in development: peramivir, a neuraminidase inhibitor for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company's Web site at www.biocryst.com .

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that there can be no assurance that our compounds will prove effective in clinical studies; that development and commercialization of our compounds may not be successful; that HHS may further condition, reduce or eliminate future funding of the peramivir program; that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates; that our product candidates may not receive required regulatory clearances from the FDA; that ongoing and future pre-clinical and clinical development may not have positive results; that we or our licensees may not be able to continue future development of our current and future development programs; that our development programs may never result in future product, license or royalty payments being received by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates; that our actual cash burn rate may not be consistent with our expectations; that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in our projections and forward-looking statements.

BCRXW

SOURCE: BioCryst Pharmaceuticals, Inc.


BioCryst Pharmaceuticals
Robert Bennett, 919-859-7910 (investors)
or
WCG
Catherine Collier Kyroulis, 212-301-7174 (media)

[setravis]

BCRX - Momentum

[setravis]

For now, great potential...because they have a pipeline...

Day's Range: 3.96 - 4.07
52wk Range: 3.17 - 6.88
Volume: 425,830
Avg Vol (3m): 215,525

Technicals
Last Price Quote is:
8.02%above 13-day EMA
10.75%above 50-day EMA
RS Rating: 88