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Still believe will close @.0007
NASCOW when the MM are ready to let this run and we get some news soon the volume will be explosve and will run back to .0021 can you say weeeeeeeeeeeeeeeeeeee!
.0007 Will be the last of the cheapies, then everybody will be asking who let the dogs out and will be running to catch any dog we can for the ride of a life time !
$TREET TRADER CURIOUS STILL HOLDING ASAP ?
$treet Trader something in the works for the shell ASAP you still holding ?
Im with you dak77 full speed ahead!
175 million Volume. After blockbuster CC we should see quadruple the volume and full speed ahead !
Share Price after conference call ?.0035 with a bonofide Blockbuster Deal!
JULY 2nd Share Price ? .001
As stated in a previous press release, the Shareholder's Conference Call with the CEO will be announced to the public no later than Friday, July 2, 2010. At that time the exact topics to be discussed will be outlined in detail. Included in the upcoming Press Release concerning the Conference Call will be details addressing the Company's Buyback Share Program which was announced in a previous statement to the shareholders.
BioCryst Pharmaceuticals
Update for Investors
A il62010April 6, 2010
Forward-Looking Statement
BioCryst’s presentation may contain forward-looking statements, including statements regarding future results, unaudited and forward-
looking financial information and company performance or achievements. These statements are subject to known and unknown
risks and uncertainties which may cause our actual results, performance or achievements to be materially different from any future results or
performances expressed or implied in this presentation. You should not place undue reliance on the forward-looking statements. For additional
information, including important risk factors, please refer to BioCryst’s documents filed with the SEC and located at
// / / fhttp://investor.shareholder.com/biocryst/sec.cfm
2
We Have the Key Elements to Build an Enduring, Successful Company
Transformed biotechnology company with product revenue and two late-stage development candidates
Hospitalized seasonal influenza is a sizeable and sustainable opportunity
Emergency intravenous (i.v.) peramivir use offers current revenue and upside to sustainable seasonal flu franchise
PNP ith f ll ll d i t l t i l f CTCL(1) d i ifi tPNP programs with a fully enrolled pivotal trial for CTCL(1) and a significant potential for gout
Nondilutivefinancingmitigatescashburnandallowsinvestment inR&D(2)Non-dilutive financing mitigates cash burn and allows investment in R&D (2)
Experienced and proven team focused on delivering
3
Substantial Progress in Past 12 months
Positive i.v. peramivir Shionogi Phase 3 results, leading to January 2010 approval & launch in Japanpp p
Green Cross filed for peramivir regulatory approval in South Korea
Emergency Use Authorization (EUA) issued
–U.S. Government purchased 10,000 courses of i.v. peramivir ($22.5M order)
Additional $77.2 M in HHS funding awarded for i.v. peramivir development and initiation of Phase 3 studies to support U.S. filing
Forodesine CTCL study fully enrolled
Phase 2 study of BCX4208 initiated in patients with gout
4
Significant Value Creating Events to Come
Clinical EventsClinical Events Regulatory EventsRegulatory Events Commercial EventsCommercial Events
Forodesine data from pivotal CTCL study and
Phase 2 CLL study
Potential approval of peramivir in South
Korea, other countries
Stockpiling partners provide virtually global
coveragey
Data from two Phase 2 studies of BCX4208 in
gout
DatafromPhase3
Potential filing for peramivir approval in
other countries
g
Potential additional government orders for
i.v. peramivir
Potential royaltiesfromData from Phase 3 studies in i.v. peramivir
in hospitalized, seasonal influenza
Potential royalties from ex-U.S. approvals
5
Advancing Late-Stage Pipeline in Multiple Indications
INFECTIOUS DISEASE
PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL FILED APPROVED
Peramivir Outpatient Flu(Seasonal Influenza / i.v.)
Peramivir Inpatient Flu(Acute Influenza / i.v.)
CANCER
PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL FILED APPROVED
Forodesine(CTCL)(CTCL)
Forodesine(CLL)
Forodesine(ALL)(ALL)
INFLAMMATORY DISEASE
PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL FILED APPROVED
BCX4208
6
BCX4208(Gout)
PERAMIVIR FOR INFLUENZA
Peramivir(RAPIACTA) Approved & Launching in Japan
First marketing approval of a BioCryst discovered drug –January 2010g y
Broad Indication
–Seasonal—uncomplicated flu
–Seasonal—patients with high risk factors
One of fastest review periods ever by Japanese authorities
Japan is one of world’s largest markets for influenza anti-virals
–Over 10 million people treated annually
G ’–Gov’tpanel recommendation: grow anti-viral stockpile to cover 60 million citizens
Attractive economics for BioCryst
8
New Influenza Anti-Virals are Needed
Seasonal influenza requiring hospitalization is a serious medical problem
–200,000 hospitalizations
–36,000 deaths in the U.S. annually
No anti-viral is approved for hospitalized influenza patients
Currently approved anti-virals are dosed orally or inhaled
Intravenousdeliveryoftherapyisthepreferredroutetotreat infectionsin
This medical need can be addressed by a potent, rapidly delivered, safe,
Intravenous delivery of therapy is the preferred route to treat infections in the hospital setting
y p , p y , ,effective i.v. anti-viral
9
Key Requirements for U.S. NDA Filing
Task StatusTask Status
Two adequate & well-controlled efficacy studies One completedOne in progress
1,500 subjects for safety data base > 1,000 already complete
Commercial scaleCMC NDAlotscompletedCommercial scale CMC NDA lots completed
Drug product stability Currently > 3 years
Placebo-controlled Shionogi Phase 2 study is 1 of 2 well-controlled studies needed for approval
10
pp
PeramivirPhase 3 Program Enrolling
Parameter Study 301 Study 303
Dose Groups PVR 600mg QD x 5 days + Std of Carevs. PVR 300mg BID x 5 days: orCare vs.
Placebo + Std of Care
orPVR 600mg QD x 5 days
Allocation ratio 2:1 1:1
Power 90% N/A
Hazard ratio 0.67 N/A
Endpoint Time to Clinical Resolution Reduction in viral titer
NTotal Sufficienttoconfirm306inITTI 300NTotal Sufficient to confirm 306 in ITTI (est. 445) 300
Patient Population Requires hospitalization and presence of one or more risk
factors
Broad inclusion
factors
Seasons NH / SH ’09/’10, NH ’10/’11 NH / SH ’09/’10, NH ’10/’11
Additional studies to provide further evidence of efficacy are underdiscussionwithFDA&HHS
11
under discussion with FDA & HHS
Sustainable Revenue Opportunity—Seasonal Flu in the Hospital
Average U.S. flu season: Global flu season:
–200,000 hospitalizations –3-5 million severe illnesses
–36,000 deaths –250-500,000 deaths
The first i.v. anti-viral to market
Pharmacoeconomic benefits in reducing hospital and ICU stays
Base price established through initial Government orders
Patent protection to 2018
Revenue generation for BioCryst from Shionogi
–$7 million milestone for approval in 1Q 2010
–Royalties on net sales of 10-20%
12
–Potential future commercial milestones of up to $95 million
Preparedness for PeramivirDemand
Emergency use authorization issuedOctober 23, 2009
Initial U.S. Government order received November 4
$–10,000 courses at $2,250
–Up to 30,000 additional courses may be ordered under the 2 year
contractcontract
Supply chain capability fully established: API to finished product
Packagedatotal of130000courses–Packaged a total of 130,000 courses
–Additional active pharmaceutical ingredient (API) available to produce up to 350,000 more courses
13
Stockpiling Partners Provide Virtually Global Coverage
14
Near-Term Peramivir Revenue Opportunities
Potential additional orders
fromHHSfrom HHSGovernment
Stockpiling Potential ex-U.S.
Government orders th hBi C t dthrough BioCryst and
regional partners
Korea&otherex-U.S.Fll R l t A l Korea & other exU.S. potential approvalsFull Regulatory Approval
15
PNP INHIBITORS
FORODESINE FOR LYMPHOMA/LEUKEMIA
BCX4208 FOR GOUT
PNP Development Strategy Is Advanced and Targeted
CANCER
PRECLINICAL PHASE1 PHASE2 PIVOTAL FILED APPROVEDPRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL FILED APPROVED
Forodesine(CTCL)
Forodesine(CLL)(CLL)
Forodesine(ALL)
GOUTGOUT
PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL FILED APPROVED
BCX4208
Multiple pre-clinical compounds available for near-term development
17
Existing CTCL Treatments Have Significant Limitations
ManypatientswithCTCLhaveaprolongedcourseofillnessandqualityofMany patients with CTCL have a prolonged course of illness and quality of life is an important consideration
–Treatment should be effective, safe, convenient and tolerable for long-term chronic use
Majority of current treatment options have unfavorable side effect profiles and are inconvenient
Approved oral agents have dosing challenges and difficult side effect profilesprofiles
Forodesine profile meets patient needs in the CTCL market
18
oodes epo e eetspate t eeds t eCC a et
Proof of Concept for Forodesine in CTCL
Best mSWATfrom Baseline in All Subjects vs. 80mg/m2 (Blue) Outcome Measure 80 mg/m2N=36
Overall RR 14(39%)
j g ( )
50
100
Percent of Change in mSWAT
Overall RR 14 (39%)
CR 2 (6%)
PR 12 (33%)
0
50 SD 15 (42%)
Time to Response, Days (95% CI) 42 (29.0 –58.0)
Response Duration, Days (95% CI) 127 (71.0, N/A)
(100)
(50)
Duvic, M. et al, ASH 2007 abstract #122
IndividualSubjects
p y ( ) ( )
Long-term treatment data presented at ASCO 2009
demonstratedacceptablesafetyprofileandefficacyin
Solid Phase 1 –2 results support pivotal study
Data from BCX1777-105 study
Individual Subjects
Subjects Not on 80mg/m2 Subjects on 80mg/m2
demonstrated acceptable safety profile and efficacy in
CTCL subjects treated for 12+ months
19
Sod ase esutssuppotp ota study
Forodesine CTCL Pivotal Trial Nearing Completion
Pivotal study is ongoing under special protocol assessment by FDA
Single arm Forodesine 200mg daily
Differentiated profile
Study Design
Intervention & Outcome Measure Commercial Rationale
Stages 1b through 4
Three or more failed treatments
daily
Primary outcome measure is objective
response rate
Market addressable by small sales force
Composition of matter IPthrough2017
Prior therapy must include bexarotene
p IP through 2017
Potential price premium
~$80M sales of approved CTCL
products over the last 12 months
20
Pivotal CTCL study fully enrolled, data expected 2H:10
CLL is an Attractive Indication for Forodesine
MostofthecurrentlyavailableMost of the currently available drugs have significant toxicity
concerns and i.v. dosing
People living with CLL in U.S., 2008: 90,179
Forodesinefor CLL
–Novel mechanism of action
New CLL diagnoses in U.S., 2008: 15,110
–Generally safe and well-tolerated in clinical trials
–Orally administered $35K-$75K /patient spent on CLL therapy annually
–Suitable for combination and potentially synergistic with
existing therapies
21
Incidence data: American Cancer Society
Gout is a Growing Market with Significant Unmet Needs
Gout is now the most common inflammatory arthritis in males
Over last 40 years, the prevalence has increased in most Westernized countries by 200-300%
Growth in prevalence of gout appears to be caused by several factors including:
–Alarming rise in obesityAgingpopulation–Aging population
–Increase in prevalence of kidney failure & hypertension–Widespread use of prescription drugs and alcohol
Issueswithcurrenttherapies:efficacyallergicreactionsandsideeffectsIssues with current therapies: efficacy, allergic reactions and side effects
Phase 2 program initiated in September 2009; Datafrom two studies
22
p g p ;expected in 2010
Phase 2 Psoriasis Study -Rationale for Gout
1
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Uric Acid
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0 1 2 3 4 5 6 7 8 9 10
-4
3
C
h
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Dose of BCX4208, mg/day
0 20 120
C
-4
Dose related reduction in uric acid sustained for the duration of drug exposure
Placebo 20mg/d BCX4208 120mg/d BCX4208
23
Consistent finding in studies of PNP inhibitors
Uric acid elevated in gout and is the cause of the disease
BCX4208 Gout Development Strategy & Commercial Rationale
Gout prevalence in the U.S. and Europe
rangesfrom0814%
Study Design Goal
Primary
Outcome
Measure
Top-line
Data
Expected
3 treatment Dose-Monotherapy
ranges from 0.8-1.4%
U.S. demographic lifestyle trends could
arms
Placebo-
controlled
response
+
Safety
Reduction
in uricacid
2Q:10
Monotherapy
Dose-ranging
Phase 2a
lead to 3.8-5.2M with gout in 2020
~$2000annuallyfor
Controlled
(BCX4208
+/-
Allopurinol)
Dose-
response
+
Safety
Reduction
in uric acid
4Q:10
Combination
therapy
Phase 2b
$2000 annually for current gout therapy
(febuxostat)
N d t fNew products for refractory gout may
price as high as $20,000/yr
24
Phase 2a Gout Study –Dosing Design and Research Goals
Part 1: Parallel GroupN=60 Part 2: Dose EscalationN=60
BCX4208
BCX420840mg/day EligibleSubjects BCX4208160mg/day or PBO
Data Review –Decision to ContinueBCX4208
80mg/day
BCX4208120mg/day
EligibleSubjects R Eligible
Subjects
BCX4208240mg/day or PBO
DataReview–DecisiontoContinue
g y
Placebo
EligibleSubjects BCX4208320mg/day or PBO
Data Review Decision to Continue
Study GoalsDetermine dose response for uric acid reduction (efficacy)
Determinedoseresponseforreductioninlymphocytes(safety)
25
Determine dose response for reduction in lymphocytes (safety)Select a dose(s) for Phase 2b trial
Selectively Investing in our Discovery Platform
Target
Illustrative
Indications
Hepatitis C RNA Ch i H titi C
Management has focused on advancing late-stage products
Successful clinical progressandp
Polymerase
Chronic Hepatitis C
Kallikrein
Hereditary
angioneuroticedema
Successful clinical progress and non-dilutive funding allow the
opportunity to invest in early stage assets
angioneurotic edema
Complement
Age related macular
degeneration
Multiple promising candidates in development
JAK
Psoriasis;
Rheumatoid arthritis
Management is taking a focused and financially disciplined approach
to R&D
26
Financial Summary
Potential revenue opportunities exist from:
–Royalty payments from strategic partnerships–RevenuefromperamivirstockpilingRevenue from peramivir stockpiling
Recent secondary offering & product revenue have significantly strengthened BioCryst’s balance sheet
Current cash allows us to fund clinical development plans for the next 2-3 years
Common shares outstanding 43.9 M as of 12/31/09
C h h i l t & iti $943M f12/31/09Cash, cash equivalents & securities $94.3 M as of 12/31/09
Underlying 2009 cash use* $37.2 M
Anticipated 2010 cash use $25-30 M
27
*Excludes proceeds from equity offering and sale of peramivir to HHS
2010 Events
Additionalstockpilingpartnerscoversmajormarketsglobally
Clinical Events
Additional stockpiling partners covers major markets globally
Update regarding forodesine CLL study
ForodesineCTCL study reaches full enrollment (1Q:10)
Data from Phase 2 monotherapy study of BCX4208 in gout (2Q:10)
Provide update: plans for BCX4208/allopurinolcombo study in gout (mid-10)
Data from pivotal forodesine CTCL study (2H:10)
Data from Phase 2 BCX4208/allopurinol combo study in gout (4Q:10)
Dt f Ph 2CLL t d (2H10)Data from Phase 2 CLL study (2H:10)
R l t dC i lE t
Peramivirmarketing authorization in Japan
Potential for additional regulatory approvals and revenue events
Regulatory and Commercial Events
28
Potential for royalty payment on seasonal sales of peramivir ex-U.S.
Endnotes
1. CTCL: Cutaneous T-Cell Lymphoma2. Non-dilutive financing sources include HHS, Shionogi and Mundipharmag , g p
29
Press Releases
Reportlinker Adds Global Antivirals Market 2010-2025
NEW YORK, March 30 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Global Antivirals Market 2010-2025
http://www.reportlinker.com/p0184331/Global-Antivirals-Market-2010-2025.html
New report explains how this important anti-infective market will develop
In 2009, the global market for antiviral drugs attained total sales of over $28bn. With hundreds of millions of people worldwide suffering from chronic or acute viral infections, there is enormous need for antiviral drugs. It is only in the past few decades that researchers have begun to find ways of combating viruses. Because viruses mutate rapidly and acquire drug-resistance, the antiviral pipeline needs to be continuously replenished with newer, better therapies, our new market study notes.
Global Antivirals Market 2010-2025 forecasts how the global antivirals market will grow and change over the next 15 years. We predict that the market will continue to expand, driven by significant unmet needs, expanding patient populations, better diagnostics and innovative new drugs, including combination therapies. This report offers detailed and extensive coverage of the principal antiviral drugs, with comprehensive sales forecasting at class and brand levels. We also provide up-to-date assessments of the most-exciting antiviral agents in development.
This new study provides a detailed breakdown of the market by disease area, and forecasts how market shares of the main viral therapy classes will shift from 2010 onwards. More-effective and better-tolerated drugs will bring improved therapies for important diseases, including hepatitis B and C, to many patients in future. How will the global antiviral drug market develop from 2010 onwards? Where will the main revenue gains be made, by market sector and country? What are the most-promising R&D pipeline developments? This new report provides the answers that you require.
Global Antivirals Market 2010-2025 also assesses the leading companies, with their performances in the antivirals market predicted. We cover the leading national markets for antiviral agents separately, with comprehensive forecasts for North America, Europe and Asia. In particular, we examine China and India as expanding antiviral markets with large under-met patient needs at present.
Comprehensive analysis of the antiviral pharmaceuticals market
Global Antivirals Market 2010-2025 critically examines that sector through a comprehensive review of primary and secondary information sources. Our new report provides detailed sales forecasts, market share analyses, discussions of pipeline developments and analyses of commercial drivers and restraints. There are over 75 tables and figures included, as well as two original interviews with relevant experts. The result is a comprehensive market- and industry-centred study, with detailed analyses and informed opinion to benefit your work.
Why you should buy Global Antivirals Market 2010-2025
This report gives you the following benefits in particular:
You will receive a comprehensive analysis of the prospects for antiviral drugs from 2010 to 2025, including predicted revenues, growth rates and other important data
You will find out where the market is heading - both technologically and commercially - from the present onwards, both for the overall world market and for leading national markets
You will discover the prospects for leading companies and disease classes, including sales revenues and market shares from 2010 onwards
You will discover expert opinion from our original survey
You will identify key R&D pipeline developments and up-and-coming products
You will discover the drivers, restraints, competition and opportunities influencing the antivirals market
You will discover prospects for Tamiflu, in light of the recent swine flu outbreak.
Our research shows that new antiviral drugs have strong potential for commercial success if they are well-tolerated and more effective than existing products. The commercial potential and therapeutic expectations are high for R&D pipeline agents, with rapid technological advances.
You can obtain this report today
Nobody with an interest in the antiviral drug sector should overlook this new study. We predict that total revenues will increase over our forecast period, 2010 to 2025. With rising demand for products worldwide and current unmet needs, this market holds significant potential for further revenue growth and technological innovation. Do you want to harness those opportunities? You can stay ahead by ordering this report today.
Table of Contents
1. Executive Summary
1.1 Aims and Methods of this Report
1.2 Synopsis of Report
2. Introduction
2.1 What is a Virus?
2.2 Viruses and Disease
2.3 History of Virology
2.3.1 Origin of Viruses
2.3.2 Historical Developments in Virology
2.4 Know Your Enemy: Classifying Viruses
2.4.1 DNA Viruses
2.4.2 RNA Viruses
2.4.3. Reverse Transcribing Viruses
2.5 Introducing Antiviral Drugs
2.5.1. Antivirals Versus Vaccines
2.6 The Viral Life Cycle and How to Stop It
2.6.1 Cell Entry
2.6.2 Viral Particles Synthesis
2.6.3 Maturation and Release
2.6.4 Immune System Modulating
2.7 Antivirals Battle Highly Mutational Viral Genomes
2.8 The Antiviral Class in the World Anti-Infective Market
3. The Global Market for Antiviral Drugs, 2010-2025
3.1 The Global Antiviral Market was Worth Over $28bn in 2009
3.2 The Major Targets for Antiviral Drugs
3.2.1 HIV Dominates the Market
3.2.2 Hepatitis, Influenza and Herpes Markets
3.3 The Main Methods of Targeting Viruses
3.3.1 Reverse Transcriptase Inhibitors
3.3.2 Protease Inhibitors
3.3.3 Newer Anti-HIV Drug Classes
3.3.4 Nucleoside Analogues
3.3.5 Neuraminidase Inhibitors
3.3.6 Immunoglobulin
3.4 Global Antiviral Forecast 2010-2025
3.5 Global Antiviral Market by Disease Area, 2010-2025
3.6 The Rise of the Hepatitis Class from 2010-2025
3.6.1 Hepatitis' Unique Market Strengths
3.7 Trouble in the HIV Market
3.7.1 Patent Expiry
3.7.2 Problems with Developing World Markets
3.7.2.1 Low Purchasing Power in Many African Countries
3.7.2.2 Conflicts with Governments
3.7.2.3 Premature Generics
3.7.2.4 Compromise is Unavoidable in the Developing World
3.7.3 The Outlook for The HIV Market
3.8 Influenza and Patent Rights
3.8.1 Pandemic Protection
3.8.2 Generics Will Meet the Market Need
3.9 Forecast for the Leading Antiviral Brands, 2010-2025
3.9.1. Will Tamiflu Retain its Leadership Position?
3.9.2 The Global Antivirals Market will Undergo Major Power Shift by 2015
3.9.3 Commercial Future Lies in Combination Therapies
3.9.4 Decline of the Pegasys-Ribavirin Combination Therapy?
3.9.5 Atripla will Dominate the Antivirals Market
3.10 Growing Investment in the Antivirals Market
4. Factors Affecting the World Antiviral Market 2010-2025
4.1 Strengths
4.1.1 Resistance is Useful to the Market
4.1.2 Chronic and Acute Indications Ensure Long-Term Demand for Antivirals
4.1.3 Global Scope of the Viral Threat to Public Health
4.1.4 Joint Public and Private Efforts to Facilitate Greater Accessibility are a Positive Step
4.2 Weaknesses
4.2.1 Demography
4.2.1.1 Discounting Drugs for the Developing World
4.2.2 High Drug Toxicity, Low Patient Compliance
4.2.3 The Cost of Antiviral Treatments Forces Market Exclusivity and Limits Market Growth
4.2.4. The Low Prevalence of Treatable Viral Diseases
4.3 Opportunities
4.3.1 Diagnostic Improvements
4.3.1.1 The Advantages of Early Diagnosis
4.3.1.2 The Majority of Patients Did Not Know They Were Infected
4.3.2 Novel Targets and Mechanisms Constitute an Important Market Driver
4.4 Threats
4.4.1 Generic Penetration Threatens Leading Brands
4.4.2 Does the R&D Pipeline Have Enough Potential to Replace the Ageing Brands?
4.4.3. Problems with Patents
4.4.4 Production Rate Unable to Meet Demand
4.4.5 Vaccines – a Commercial Threat to Antiviral Drugs?
4.4.5.1 What Will Happen?
5. Leading Companies and Brands in the Antivirals Market, Forecast and Analysis 2010-2025
5.1 The Big Three: GlaxoSmithKline, Gilead Sciences and Roche Dominate the Antivirals Market
5.2 How Long Will GSK Stay on Top?
5.2.1 GSK's Antiviral Drug Portfolio: Herpes and Influenza
5.2.2 GSK and the HIV Market
5.3 Gilead Sciences Carves into the HIV Market
5.4 Roche and Biotechnology
5.5 The Top 15 Antiviral Drugs of 2009
5.6 Tamiflu (Roche)
5.6.1 Tamiflu Dominates the Influenza Market
5.6.2 Tamiflu's Market Performance Heavily Affected by Swine Flu
5.7 Truvada (Gilead) – Market Prospects
5.8 Atripla (Gilead) – Market Prospects
5.8.1 Atripla Poised for HIV Market Hegemony?
5.8.2. Potential Threats for Atripla
5.9 Valtrex (GlaxoSmithKline) – Market Prospects
5.10 Pegasys (Roche) – Market Prospects
5.11 Reyataz (Bristol-Myers-Squibb) – Market Prospects
5.12 Kaletra (Abbott) – Market Prospects
5.13 Synagis (MedImmune/AstraZeneca) – Market Prospects
5.14 Relenza (GlaxoSmithKline) – Market Prospects
5.15 Epzicom (GlaxoSmithKline) – Market Prospects
5.16 Pegintron (Schering-Plough) – Market Prospects
5.17 Baraclude (Bristol-Myers-Squibb) – Market Prospects
5.18 Prezista (Johnson & Johnson) – Market Prospects
5.19 Combivir (GlaxoSmithKline – Market Prospects
5.20 Isentress (Merck & Co) – Market Prospects
6. Antivirals in the Leading Pharmaceutical Markets 2010-2025
6.1 Sales of Antivirals in the Leading Pharmaceutical Markets in 2009
6.2 Performance of Antivirals in the Leading National Markets, 2010-2025
6.3 The US Dominance of the Antivirals Market
6.4 Other Industrialised Country Markets to Achieve Steady Growth
6.5 How Will the Leading Developing Countries Fare in the Global Antivirals Market?
6.5.1 Relevant Healthcare Issues in China and India
7. Antivirals Technology: The Future
7.1 HIV Targets and Candidates
7.2 New Reverse Transcriptase Inhibitors
7.2.1 NRTI: Apricitabine (Shire)
7.2.2 NNRTI: Rilipivirine (Johnson & Johnson; Tibotec-Virco)
7.3 Integrase Inhibitors
7.3.1 Elvitegravir (Gilead)
7.3.2 The Quad Pill (Gilead)
7.3.3 Other Integrase Inhibitors
7.4 Entry Inhibitors
7.4.1 The Potential Advantages of Host Targeting
7.4.2 Stopping Viral Entry: Attachment, Entry and Fusion Inhibitors
7.4.3 Vicrivoc (Schering-Plough)
7.5 Maturation Inhibitors
7.5.1 Bevirimat (Myriad)
7.6 Other HIV Pipeline Products
7.7 Hepatitis Pipeline Development
7.8 Interferons and Other Immunomodulators
7.8.1 Albuferon (Novartis; Human Genome Sciences)
7.9 Protease Inhibitors for Hepatitis C
7.9.1 Telaprevir (Vertex; Johnson & Johnson; Mitsubishi)
7.9.2 Boceprevir (Schering-Plough)
7.10 Polymerase Inhibitors
7.10.1 R7128 (Roche; Pharmassett)
7.11 New Frontiers in Antivirals
7.11.1 Can Monoclonal Antibodies Compete with Small Molecules?
7.11.2 Advantages of Monoclonal Antibodies
7.11.3 RNA Interference Technology Raises Fervent Investment Interest
7.11.4 Some RNA Interference Pipeline Products
8. Interviews with Experts
8.1 Interview 1: Professor Raymond F. Schinazi, Francis Winship Walters Professor of Pediatrics and Chemistry and Director of the Laboratory of Biochemical Pharmacology, Emory University and VA Medical Center
8.1.1 On the Importance of Hepatitis C in the Next Decade
8.1.2 On the New Treatments for Hepatitis C
8.1.3 On the Challenge of Viral Mutation
8.1.4 On HIV Treatment in the Next Decade
8.1.5 On the Failure of Vaccines
8.1.6 On the Cost of Antivirals
8.1.7 On the Main Drivers of the Antivirals Market
8.1.8 On Influenza Treatments
8.1.9 On Host Targeting
8.2 Interview 2: Dr. Michael Kinch, Vice President, Research and Development, Functional Genetics, Maryland, USA
8.2.1 On Promising Sub-Markets
8.2.2 On Market Drivers and Restraints
8.2.3 On the Arguments for a Host-Oriented Therapeutic Approach
8.2.4 On the Potential of Biologicals
9. Conclusions
9.1 The Antivirals Market Set to Grow
9.2 The Next Market Leader
9.3 The Rise of the Hepatitis Segment
9.4 Pipeline Developments
9.5 Antivirals: Summing up the Market's Prospects
List of Tables
Table 2.1, Major Events in History of Virology
Table 2.2, Classification of Clinically-Significant Viruses
Table 2.3, The Viral Life Cycle and Antiviral Drugs
Table 2.4, The World Anti-Infectives Market: Sales ($bn), 2009
Table 3.1, Blockbuster Antiviral Drugs: Sales ($m) and Market Shares (%), 2009
Table 3.2, Significant NRTIs and NNRTIs, 2010
Table 3.3, Global Antivirals Market: Sales ($bn), and Growth (%), 2009-2015, 2020, 2025
Table 3.4, Global Antivirals Market by Disease Area, 2009
Table 3.5, Global Antivirals Market Disease Areas: Sales ($bn), Growth (%), 2009-2015
Table 3.6, Market Performance of Hepatitis Segment: Sales ($bn), Growth Rate (%), CAGR (%), Market Shares (%), 2009-2015
Table 3.7, Top Marketed Antiviral Therapies: Sales ($bn) and Patent Expiry Dates, 2009
Table 3.8, Market Performance of HIV Segment: Sales ($bn), Growth Rate (%), CAGR (%), Market Shares (%), 2009-2015
Table 3.9, Market Performance of Influenza Segment: Sales ($bn), Growth Rate (%), CAGR (%), Market Shares (%), 2009-2015
Table 3.10, Top 15 Antiviral Brands: Sales ($m) and Growth (%), 2009
Table 4.1, SWOT Analysis of the Antivirals Market, 2010
Table 5.1, Leading Companies in the Antivirals Market: Sales ($bn), Market Shares (%), 2009
Table 5.2, Tamiflu Sales ($m), 2009-2025
Table 5.3, Truvada Sales ($m), 2009-2025
Table 5.4, Atripla Sales ($m), 2009-2015
Table 5.5, Valtrex Sales ($m), 2009-2025
Table 5.6, Pegasys Sales ($m), 2009-2025
Table 5.7, Reyataz Sales ($m), 2009-2025
Table 5.8, Leading Protease Inhibitors: Sales ($m), 2009-2025
Table 5.9, Kaletra Sales ($m), 2009-2025
Table 5.10, Synagis Sales ($m), 2009-2025
Table 5.11, Relenza Sales ($m), 2009-2025
Table 5.12, Epzicom Sales ($m), 2009-2025
Table 5.13, Pegintron Sales ($m), 2009-2025
Table 5.14, Baraclude Sales ($m), 2009-2025
Table 5.15, Prezista Sales ($m), 2009-2025
Table 5.16, Combivir Sales ($m), 2009-2025
Table 5.17, Isentress Sales ($m), 2009-2025
Table 6.1, Antivirals in the Leading Pharmaceuticals Markets: Sales ($m), Market Shares (%), Growth (%), 2009
Table 6.2, Antivirals in the Leading Pharmaceutical Markets: Sales ($m), 2009-2015, 2020, 2025
Table 6.3, Antivirals in the Leading Pharmaceutical Markets: Sales ($m), Market Shares (%) and CAGR (%), 2009 and 2015
Table 6.4, Number of HIV Patients in Key Countries, 2010
Table 7.1, HIV Life Cycle and Relevant Drug Classes, 2010
Table 7.2, NNRTIs Currently in Development, 2010
Table 7.3, Selected Products for HIV Treatment in Phase II Development, 2010
Table 7.4, Selected Products for Hepatitis C Treatment in Phase II Development, 2010
Table 9.1, Global Antivirals Market: Sales ($bn), 2009-2025
List of Figures
Figure 2.1, The World Anti-Infectives Market: Sales ($m), 2009
Figure 3.1, Leading Disease Areas in the Antivirals Market: Sales ($m), 2009
Figure 3.2, Leading Drug Classes in the Antivirals Market: Sales ($bn), 2009
Figure 3.3, Drug Classes: Market Shares (%), 2009
Figure 3.4, Drug Classes in the HIV Disease Area: Sales ($bn), 2009
Figure 3.5, Global Antivirals Market: Sales ($bn), 2009-2015
Figure 3.6, Global Antivirals Market by Disease Area: Sales ($bn), Market Shares (%), 2009
Figure 3.7, Global Antivirals Market by Disease Area: Sales ($bn), 2009-2015
Figure 3.8, Global Hepatitis Market: Sales ($bn), 2009-2025
Figure 3.9, Global HIV Market: Sales ($bn), 2009-2015
Figure 3.10, Global Influenza Market: Sales ($bn), 2009-2015
Figure 3.11, Market Shares (%) of the Leading Antiviral Drugs, 2009
Figure 5.1, Leading Companies in the Antivirals Market: Market Shares (%), 2009
Figure 5.2, Top 15 Marketed Antiviral Drugs, Sales ($m), 2009
Figure 5.3, Top 15 Marketed Antiviral Drugs, Growth (%), 2009
Figure 5.4, Tamiflu Sales ($m), 2009-2015
Figure 5.5, Truvada Sales ($m), 2009-2015
Figure 5.6, Atripla Sales ($m), 2009-2015
Figure 5.7, Valtrex Sales ($m), 2009-2015
Figure 5.8, Pegasys Sales ($m), 2009-2015
Figure 5.9, Reyataz Sales ($m), 2009-2015
Figure 5.10, Kaletra Sales ($m), 2009-2015
Figure 5.11, Synagis Sales ($m), 2009-2015
Figure 5.12, Relenza Sales ($m), 2009-2015
Figure 5.13, Epzicom Sales ($m), 2009-2015
Figure 5.14, Pegintron Sales ($m), 2009-2015
Figure 5.15, Baraclude Sales ($m), 2009-2015
Figure 5.16, Prezista Sales ($m), 2009-2015
Figure 5.17, Combivir Sales ($m), 2009-2015
Figure 5.18, Isentress Sales ($m), 2009-2015
Figure 6.1, Antivirals in the Leading Pharmaceuticals Markets: Sales ($m), 2009
Figure 6.2, Antivirals in the Leading Pharmaceuticals Markets: Market Shares (%), 2009
Figure 6.3, Antivirals in the US Market: Sales ($m), 2009-2015
Figure 6.4, Antivirals in Other Leading Industrialised Countries: Sales ($m), 2010-2025
Figure 6.5, Antivirals in China and India: Sales ($m), 2009-2015
Companies Listed
Abbott
Alnylam Pharmaceuticals
American Association for the Study of Liver Diseases
Anadys
Ardea
AstraZeneca
Aurobindo
Beijing Mefuvir Medicinal Technology; Medivir
Benitec
Bill and Melinda Gates Foundation
BioChem Pharma
BioCryst Pharmaceuticals
Boehringer Ingelheim
Bristol-Myers Squibb
Cipla
Conatus
CytoDyn
Debiopharm
EMEA
Enzo Biochem
FDA
Gilead Sciences
GlaxoSmithKline
Heidelberg Pharma
Idenix
Innate Therapeutics
Intermune
International AIDS Vaccine Initiative (NIAID)
Johnson & Johnson
Medecins Sans Frontieres
MedImmune
Merck & Co
Microbiocides (USA)
MIGENIX
Mitsubishi
Myriad
Novartis
PDL BioPharma
Pfizer
Pharmasset
Progenics
Roche
InterMune
Sanofi-Aventis
Schering-Plough
Shionogi
Shire
Tacere
Takeda
Tibotec-Virco
Tobira
Trellis Bioscience
Unitaid
US Department of Health and Human Services (HHS)
Valeant
Vertex
ViiV Healthcare
Virogen
ViroStatics
VIRxSYS
World Bank
World Health Organisation (WHO)
To order this report:
Pharmaceutical Industry: Global Antivirals Market 2010-2025
More Market Research Report
Check our Company Profile, SWOT and Revenue Analysis!
Contact:
Nicolas Bombourg
Reportlinker
Email: nbo@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
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A16
Helen Branswell
THE CANADIAN PRESS
SPEAK UP (Read in full DR Memoli states we need to think about using Peramivir sooner! Seriously sick patients Need Peramivir First!)
TORONTO - American scientists have reported the first known case of H1N1 viruses that are resistant to the newest flu drug to hit the market, peramivir.
The case involved a person with H1N1 flu who first developed resistance to oseltamivir or Tamiflu. Because of similarities in the drugs' chemical structures, it was expected that viruses resistant to Tamiflu would be resistant to the new drug as well.
But the confirmation makes it clear doctors treating severely ill flu patients need to try to maximize the benefits of the few flu drugs available and minimize the risk of resistance developing, said Dr. Matthew Memoli, a physician and researcher at the National Institute of Allergy and Infectious Diseases and first author of the report.
Memoli suggested doctors can do that by giving more thought to the order in which they use flu drugs when treating seriously sick patients or those who seem at risk of becoming gravely ill because they suffer from other medical conditions.
"If you have someone who's very sick "¦ and you're very worried about them, maybe they're on their way to the ICU or you think they could be heading that way "¦ maybe we need to go straight to peramivir," he said from Bethesda, Md.
The report, published in the journal Clinical Infectious Diseases, also suggests resistance to these drugs in immunocompromised patients may arise more rapidly than might have been previously thought.
Two immunocompromised patients, both of whom had undergone stem cell transplants, developed resistance to Tamiflu quickly after being put on the drug. In one patient, resistance developed somewhere between Day 5 and Day 9 of treatment while in the other it occurred sometime before Day 14.
About 22 per cent of the 267 reported cases of oseltamivir-resistant H1N1 flu worldwide have been seen in people who are immunocompromised.
These patients have a harder time fighting off their infection, so they are kept on flu drugs for substantially longer than is normally the case - sometimes weeks. The patient who developed resistance to peramivir, for instance, was given 24 days of Tamiflu treatment before being switched to peramivir.
The prolonged treatment creates a situation where the viruses that are vulnerable to the drugs die off, but those that can survive the attack replicate and flourish. This paper suggests that process can happen pretty quickly.
"While the emergence of drug-resistant influenza virus is not in itself surprising, these cases demonstrate that resistant strains can emerge after only a brief period of drug therapy," NIAID Director Dr. Anthony Fauci said in a release.
Using peramivir right from the start might be more effective, Memoli said. The drug is administered intravenously, a delivery mode that is more effective with severely ill patients because it gets more of the drug into the system. Tamiflu is administered in pill form; pills are not always fully absorbed in severe cases.
Hitting the infection with an intravenous drug from the start might vanquish the virus before resistance can develop, Memoli said, adding more study will be needed to see if this is a more effective regimen.
"Once the patient has developed resistance to oseltamivir, peramivir is unlikely to work," he said. "It's possible what we need is to think about using peramivir "¦ sooner."
So far all H1N1 viruses resistant to Tamiflu and peramivir have been susceptible to zanamivir (sold as Relenza). But that drug is inhaled. Inhalation is not a workable delivery mode for severely ill flu patients, especially those who are on a machine to help them breathe.
Fauci said the cases also underscore the need for more pharmaceutical weapons with which to fight flu.
"We have a limited number of drugs available for treating influenza and these findings provide additional urgency to efforts to develop antivirals that attack influenza virus in novel ways."
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message continues... 11-Mar-10 11:26 pm Per Maphere YMB
it's time to get in (or cover as it may be) before BCRX takes off, the news doesn't stand still:
____________________
11 March 2010
Pandemic H1N1 Persists as Avian Flu Claims Lives in Three Nations
World Health Organization confirms increase in West African H1N1 cases
Washington — A global pandemic is still under way according to the World Health Organization (WHO), 12 months after more than half the population of La Gloria in the Mexican state of Veracruz were sickened by a respiratory disease later identified as type A influenza, subtype H1N1.
And in at least three countries where H1N1 is circulating ? Egypt, Indonesia and Vietnam ? highly pathogenic H5N1 avian flu is infecting poultry and sickening and sometimes killing people who come into close contact with ill or dead birds.
The latest human H5N1 cases have come from nations where H1N1 is also circulating. On February 12, the Ministry of Health of Indonesia announced a new case of human infection of H5N1. The infected 25-year-old female from Jakarta province died January 25.
On March 4, the Ministry of Health of Egypt confirmed five new cases of H5N1, with all of the victims reported in critical to stable condition in February. On the same date, the Ministry of Health of Vietnam confirmed three new cases, including one death.
With pandemic H1N1 and highly pathogenic H5N1 circulating among people in some of the same countries, scientists fear that the viruses’ genetic components could mix, creating a new virus that spreads easily from person to person, as does pandemic H1N1 virus, and that kills nearly 60 percent of the people it infects, as does H5N1.
...On April 19–21, high-level government officials responsible for animal and human health from many nations will meet in Hanoi, Vietnam, to participate in the International Ministerial Conference on Animal and Pandemic Influenza, whose theme is “The Way Forward.”
This is the seventh international meeting since 2005 on the topic of pandemic flu, held to advance cooperation among health and agriculture ministers to confront the global threat.
http://www.america.gov/st/scitech-englis...
____________________________-
The way to make BIG money is to know what's going on before it becomes mainstream...now you know.
________________
Feb. 11, 2010
I sit here and wonder why BCRX management is so quiet. Confidential treatment order ? Could this be that Swiss Roche and Glaxosmithkline both interested in taking over BCRX for their BCX4208. Could this be why Charles A Sanders MD is on BCRX Board who served as CEO for Glaxo, insiders know! if this becomes a fact who will win takeover of BCRX and at what Price ?
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A 90% Cure Rate For the Flu at 4X Earnings
March 15, 2010
By Michael Murphy, Editor, New World Investor
Michael Murphy
As editor of New World Investor, Michael is one of the nation's leading experts in exciting technology industries. He began his career in the industry's infancy, first as COBOL programmer and mainframe systems analyst, then as the technology stock analyst for American Express in 1970, and later as the CEO of two software companies.
More about this Expert
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Every year, seasonal flu puts about 200,000 Americans in the hospital and kills 36,000 of them, mostly the elderly. Worldwide, the numbers are more than triple the U.S. statistics -- and that's not even counting the swine flu deaths now that this strain is sweeping the globe. With this illness causing so much trouble around the globe, it's no wonder that biotech stocks are racing for a cure.
The swine flu, H1N1, was less than half as deadly in the flu season now ending, killing perhaps 11,000 people in the U.S. and double or triple that worldwide -- the final count won't be known for months. But instead of the elderly, it preferentially attacked young adults and children. It also did not follow the usual flu pattern of getting worse as the weather got colder. The swine flu pandemic started early in Mexico, kicking off last spring, No one knows what will happen this year.
For the sickest patients that wind up in the Intensive Care Unit, the Food & Drug Administration gave emergency use authorization (EUA) under the Bioterrorism Act to use Tamiflu, a five-day antiviral pill treatment, or Relenza, an inhaled antiviral. They also went to BioCryst Pharmaceuticals (BCRX) last March to request data for an emergency use authorization of peramivir, an intravenous antiviral that is in clinical trials funded by Health & Human Services. When a flu patient is sick enough to be admitted to the ICU, they often can't take an inhaled drug, and they might not have five days to build up a drug load in their bloodstream. Intravenous administration of drugs is standard procedure in the ICU, where lives hang in the balance.
In mid-June, the FDA decided peramivir was safe and likely to be effective. But instead of issuing an EUA, they issued an Emergency IND (Investigational New Drug). Doctors had to apply on a case-by-case basis to get the drug. BioCryst was not allowed to tell doctors the drug was available, and the Centers for Disease Control did not change their antiviral guidelines to mention the drug. It was not until mid-October that the EUA was granted. In the interim, only 32 patients were treated with peramivir, all at death's door. They ranged from three months to 80 years old, including some pregnant women. Twenty-nine of them survived and walked out of the hospital, a remarkable 90% cure rate. Sadly, during the four months between the E-IND and EUA, several thousand Americans died, mostly young people and children.
After the FDA granted the EUA, the Centers for Disease Control still did not allow peramivir to be stocked in hospitals, and made doctors apply for it on a case-by-case basis. They bought 10,000 courses of treatment (five days of doses) for the National Stockpile, but still did not let BioCryst educate doctors or talk about the 90% cure rate. They did change their antiviral guidelines to admit peramivir exists, but surrounded it with enough cautions and incorrect advice to scare off many doctors. During the rest of the epidemic in the U.S., only about 1,100 patients were treated with peramivir, again all at death's door. Over 1,000 survived, again a 90% or better cure rate.
Peramivir was been approved in Japan in January for seasonal flu, as Shionogi Pharmaceuticals, BioCryst's partner, fast-tracked it through Phase III trials and the Japanese FDA approved it in a record 2 ½ months. BioCryst receives milestone payments and 10% to 20% royalties on Shionogi's sales in Japan and Taiwan. Green Cross, BioCryst's partner in Korea, should get their FDA approval shortly.
In the U.S., peramivir is in two Phase III trials now for seasonal flu, which will conclude after the 2010-2011 flu season ends. The drug also works against bird flu, H1N5, which is still circulating in Asia and the Middle East, as well as the deadly swine flu mutation that recently killed so many people in Ukraine. It is available now for purchase by other countries, and small amounts have been sold to Australia, Mexico and Israel. Brazil and China will probably be the next countries to order it, at approximately $2,250 for a course of treatment. With one day in the ICU costing around $30,000, peramivir saves money as well as lives.
Morgan Stanley (MS), BioCryst's investment banker, has the highest earnings estimate on the Street at $1.80 for this year. BioCryst is a heavily shorted stock, with naked shortsellers and paid message board bashers making it difficult for investors. There have been fake "research reports" predicting a course of treatment would cost $15, and at least one brokerage firm is publishing extremely low revenue and earnings estimates to keep the average consensus estimate at a low level. But I think Morgan Stanley has it right, and all the pressure from the often-wrong naked shortsellers gives us the opportunity to buy a drug with a 90% cure rate for a worldwide pandemic at around 4X earnings. That's a remarkable opportunity that makes BCRX my #1 stock right now.
Tell us what you think here.
Perspective: BCRX: PPS 10-Mar-10 09:54 pm
Regardless of pps these things are not arguable:
1. Influenza is global and happens every year rotates around the globe so it's basically always in season.
2. Antivirals are frontline medicine for infected persons.
3. Influenzas mutate every year, this year is especially dangerous with H1N1 still the dominate strain and H5N1 popping back up in Asia and Middle East. It's a potential nuclear bomb that could hit any country hard and fast and spread to other countries in 3 months with a kill rate of 60%.
4. H1N1 was moderate and US and others were only partially prepared. Had it been more severe people's reactions would be Katrina to the 10th power. The US will not be caught with their hands in their pockets this time.
5. Prepareation and stockpiling are the ONLY alternatives to fight off a fast spreading pandemic. Time and time again the experts say it's not if it's when and right now the influenza ingredients are active.
6. There are not enough manufactures of all antiviral producers combined to even meet 2% of the global demand.
7. BCRX has the only approved IV antiviral (japan), EUA IV antiviral and PH3 IV antivral.
8. Hospitals prefer IV delivery to critical ICU patients...end of story!
__________________
On the company side:
1. No debt
2. Govt. funded trials.
3. Cash rich, done with secondary.
4. 5 countries using their unapproved drug, S. Korea filed for approval, Japan P is approved and filed for pediactric use.
5. I have a strong inclination there have been more small lots ordered of P since the last conference in Jan. and there are more countries with EUA approval.
6. BCRX is basically estatic waiting for Gout clinical trials 2nd qrt. Big market!
7. BCRX has an outstanding order of 30,000 courses waiting to be plucked by the US govt. as they prepare for 2010 winter = $67,500,000.
8. Top 5 execs took advantage of large option positions last week.
__________________________
So, who cares if shorts put on their war paint and cap every post with their boogey-man tactics...in the end BCRX is a solid investment and you're safer here then trying to jump in and out of the market...
________________________
Conclusion:
The documented relevant signature features can help health authorities
prioritize national strategies and aid international collaborators in
addressing the initial and successive waves of illnesses and deaths.
The recent H1N1 Influenza outbreak raised concerns about our ability
to handle the current and future pandemic threats. Our systems for
surveillance, reporting, infection control, and antiviral drug
distribution showed strain and could potentially be overwhelmed. In
the brief time we have to prepare for our next wave, we must step back
and evaluate where improvements need to be made. Preparations must
continue to be improved and fine-tuned to ensure that the impact of the
future influenza pandemic is minimized as much as possible. It is
important to plan for the constant evolution of H1N1 virus. H1N1 may
transform into a deadly global threat at some point, debilitating normal
life across the world. Countries must heed the lessons of this scare and
recognize that preparedness in the present is essential. By
implementing comprehensive policies and investigating the strengths
and weaknesses before any real crisis hits, we can ensure a relatively
smooth transition into a state of emergency, should they be faced with
the worst. Though the rapidity of transmission of influenza virus
during pandemics necessitates immediate action, it can be hoped that
close collaborations and lessons drawn from the recent H1N1
pandemic will contribute to reducing national and global mortality.
http://www.bioinformation.net/004/007100...
Sentiment : Strong Buy
This was posted by Maphere on yahoo BCRX message board, Believe he is right on Target, we have a winner here folks!
SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012 (Federal Register March 5, 2010)
Therefore, pursuant to section 319F-3(b) of the Act, I have
determined there is a credible risk that the spread of pandemic
influenza A viruses and those with pandemic potential and resulting
disease does or could constitute a public health emergency.
...and extends
through February 28, 2012.
http://www.theflucase.com/index.php?opti...
and here for the fuller version:
http://satellite.tmcnet.com/emergency-re...
See more news releases in: Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Trade Show News
BioCryst to Speak at RBC Healthcare Conference
BIRMINGHAM, Ala., Feb. 18 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that Stuart Grant, Senior Vice President and Chief Financial Officer of BioCryst, plans to speak as a participant on the Biodefense Panel at RBC Capital Market's Healthcare Conference in New York on Tuesday, March 2, 2010 at 3:35 to 4:30 p.m. Eastern Time.
Links to a live audio Web cast and replay of the panel discussion may be accessed on the BioCryst Web site at www.biocryst.com.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds that are in late-stage pivotal trials; peramivir, a neuraminidase inhibitor for the treatment of influenza, and forodesine, an orally-available purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Additionally, BioCryst has a third product candidate, BCX4208—a next generation PNP inhibitor—in mid-stage trials for the treatment of gout. 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.
This press release contains forward-looking statements, including statements regarding future results and 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. Please refer to the documents BioCryst files periodically with the SEC and located at http://investor.shareholder.com/biocryst/sec.cfm.
Patiently waiting on orders to be announced, very soon imo .
Priz, Maphere is right on target, Peramivir will be needed for quite sometime with H1N1,mutations there of and bird flu along with influenza period.
500K here! Ready for a penny next week!
Priz thats is exactly what ive been hearing,shorts are going to get a spiritual experience next 9 days.
CEO Jon Stonehouse awesome Conference,listen to whats in their pipeline, What a steal at this price imo.
BCRX will gets LOTS OF LOVE EPS @$1.80 @20 times earnings is $36.00 per share, short squeeze is starting IMO.
Krays nice timing on your buy! Listen to these Biocryst Web Page
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Flu death rate above epidemic threshold in U.S. for 3 weeks
HOUSTON, Feb. 5 (Xinhua) -- The proportion of deaths attributed to pneumonia and influenza (P&I) in the United States remained above the epidemic threshold for three weeks running following a short decrease since the beginning of 2010, the federal Centers for Disease Control and Prevention (CDC) said on Friday.
"During week four (Jan. 24 to 30), 8.1 percent of all deaths reported through the 122-Cities Mortality Reporting System were due to P&I. This percentage was above the epidemic threshold of 7. 8 percent for week four," the CDC said on its web site, adding that "this is the third consecutive week that the percentage of P& I deaths has been above the epidemic threshold."
Since last October, when the A/H1N1 pandemic peaked and as many as 48 states had widespread activity of the new virus, the proportion of deaths attributed to P&I based on the 122 Cities Report had been above the epidemic threshold for 11 weeks running.
As the A/H1N1 flu began to wane in December, the proportion of deaths linked to P&I based on the 122 Cities Report was dipping below the epidemic threshold in week 50 of 2009, but bouncing back in week 51. After that, it remained below the epidemic threshold for two more weeks, but bounced back again during the second week of 2010.
The epidemic threshold is the point at which the observed proportion of deaths attributed to pneumonia or influenza is significantly higher than would be expected at that time of the year in the absence of substantial influenza-related mortality.
The latest statistics released by the CDC show that, from August 30, 2009 to January 30, 2010, there were 39,794 laboratory- confirmed influenza-associated hospitalizations and 1,905 laboratory-confirmed influenza-associated deaths, including 257 of young patients under age of 18, that have been reported to the federal agency.
But health officials believe the actual death toll have been much higher than the figures of laboratory-confirmed influenza- associated deaths.
The CDC estimated 55 million Americans became ill from the A/ H1N1 flu between last April and mid-December -- the first eight months of the pandemic. About 246,000 Americans were hospitalized and 11,160 killed.
"The estimates are actually much more accurate than the confirmed numbers," the CDC director Dr. Thomas Frieden said. "The number of confirmed deaths is really just a small proportion of the number of total deaths," he explained.
On the whole, the CDC reported on Friday that the A/H1N1 flu infections continue to be on the wane nationally and there had been no states reporting widespread activity across the country for the first month of 2010.
Although the A/H1N1 flu infections are declining, But CDC spokesman Tom Skinner warned that it would be too early to say the virus has disappeared.
"We're still seeing (regional, local and sporadic) activity across the country. It's certainly not at the levels of late October, early November, but activity is still going on, and we have many weeks left in our flu season," he stated.
Awesome earnings, major analyst up grades this coming week. Flu season is just getting started again. Orders will be strong for Peramivir if we get in pandemic panic mode. Great CC today!
Holding all BCRX SHARES with an IRON FIST!. All BCRX shareholders patience will be rewarded,its not if anymore its when. When all the info i mean everything about peramivir in the USA comes to light we will be rewarded. Legally right now BCRX management cannot disclose much of anything material, because its not yet approved in USA, though we will hear more complete info about peramivir in japan and mexico and where ever else it becomes approved. When the people hear all the facts about Peramivir and all the life saving benefits all across this world for the seriously ill from H1N1 and the use for regular influenza in the world, people will come to realize how peramivir came just at the right time. BCRX shareholders will get their reward when all this comes about, be it this week or when it gets FDA approval!
GOOD MORNING! PRIZ Dog is right on i believe. Market is very very slow to understand what this means. Im holding for the big dollars, shorts are you waking up now the odds are in our favor for 2010 baby.
January 11 news release
BOSTON (MarketWatch) -- German drugmaker Merck KGaA and U.K. firm Hikma Pharmaceuticals have entered into a deal with BioCryst Pharmaceuticals /quotes/comstock/15*!bcrx/quotes/nls/bcrx (BCRX 8.15, -0.01, -0.12%) to help market BioCryst's H1N1 treatment peramivir in various territories outside the U.S., according to BioCryst. Merck KGaA will represent the product in Europe, Russia, Canada and Singapore, while Hikma will promote the product in various nations of the Middle East and North Africa. "Each of these companies has strong commercial infrastructures and established regulatory contacts in their respective territories, making them attractive partners for peramivir within these important markets," said Jon Stonehouse, BioCryst's chief executive officer, in a statement. "BioCryst has received peramivir emergency use inquiries from various countries in these regions, and we look forward to working with Merck Serono and Hikma to make peramivir available during the ongoing influenza pandemic
BioCryst, BCRX, $7.81 Market Outperform, $15 Price Target
· A busy week of announcements headed by the first global approval of peramivir. In our view the most important announcement last week was that of the approval of peramivir in Japan. The news came well ahead of our timing assumption of mid-2010 approval and represents upside to our projections for worldwide peramivir sales in the seasonal flu setting. More importantly, in our view, this rapid approval (less than three months review period) enhances our conviction for the drug both in the US and globally and, we believe, could reduce both regulatory and commercial risk in the US and Europe. The company also announced partnerships in several geographies, for example with Merck Serono in Europe, Russia and Canada, which indicates to us the ongoing potential demand for peramivir as an emergency use rescue medicine in the ongoing H1N1 swine flu pandemic. Additionally, BioCryst announced the completion of enrollment in the pivotal trial for forodesine in CTCL. We view this news as important, as it should remind investors that the company is “more than just a flu company”. We believe BioCryst’s pipeline programs and platform technology can further attract attention from investors, both institutional and strategic. Data from the CTCL trial are expected to be available in 2H10. Further catalysts in 2010 include continued enrollment in to US Phase III program for peramivir, potential emergency use orders in partnered and non-partnered countries, forodesine data in CLL by YE10, and data from BCX-4208 both as a monotherapy treatment for gout in 2Q10 and in combination with allopurinol in 4Q10. Our $15 price target is derived from both a risk-adjusted sum-of-the parts analysis of peramivir and forodesine revenue as well as by relative valuations of comparable companies. JPM Securities 01-21-10
Patiently waiting. Should hear News On NHI PRICE LISTING AND ORDERS this week!
National Health Insurance Price Listing for Shionogi Pharmaceuticals Rapiacta has not i repeat has not been officially reported by Shionogi or BCRX. We should hear Official news by Friday with crystal clear clarity IMO.
Japan's pricing News! $127 per dose for estimated 6 Million patients Is HUGEEEEEEEEE! plus 10% to 20 % RoyaltiesTo BCRX. Japan doesn't mess around. Are you Ready for Conference Call BCRX PRES/CEO Stonehouse, wanna hear your view! Lets be looking for one by today not later than friday!
BCRX, Japan got rapid approval for its peramivir. Now look for NHI price listing to get rapid response, this train is ready to leave the station ALL ABOARD! FULL STEAM AHEAD !
Jon P Stonehouse gave a great! presentation at the JPMorgan Health Care Conference today. A Must Listen and View of Slides Presentation. I must say i believe more now than ever, we have a real winner here folks! its go! go! go! BCRX the trend is up! up! up ! We should hear the real numbers next week sometime on orders and pricing from the National Health insurance price listing in Japan. I believe this will with out a shadow of doubt start the fireworks that we all been waiting patiently for. Patience is a Virtue i have Patience !
Prisoner im buying more at this price too! Patience is a virtue. JP Morgan Health Conference is tomorrow morning,lets see if this lights the fire to start the fireworks!. IMO orders will get the most attention plus we should get the real numbers milestone and royalties from CEO StoneHouse tomorrow, cant always believe all the numbers that you read in the media . Some one is giving the shorts one more day to cover. Long & Strong BCRX, JAG626
Good Morning Prisoner And Happy New Year BCRX Longs Japan Approval!! weeeeeeeeeeeeeeeeeeeeee 8.55 pre market believe we will run with all this love, 100 % on this Hugh News! and another 100 % with world-wide orders and analyst upgrades soon!. Fireworks! Galore Today! Weeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee!
Priz Mexico approval, Japan approval should be next! niceeeeeeeeeeeeeeeeeeeeeeee!