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AMARILLO, TX--(Marketwire - 11/16/10) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) today announced that it has signed a supply agreement with Zydus Cadila, the fifth largest pharmaceutical company in India, with projected worldwide sales of $1 billion in fiscal year 2010 and $3 billion in 2015. Under this agreement, Zydus will market ABI's dietary supplement Maxisal in India and Nepal. Maxisal enhances salivary function, promotes oral comfort and helps relieve dry mouth.
ABI initially launched Maxisal in the United States after clinical studies in subjects with Sjögren's syndrome (characterized by dry eyes and dry mouth) found that the active ingredient in Maxisal significantly improved mouth comfort and decreased mouth and throat dryness. Maxisal is marketed in Germany by ABI's licensee Egofocus OHG based in Darmstadt.
"Based on the favorable reception Maxisal has met in the U.S., -- which we attribute to the product's clinical benefits and reasonable cost -- we fully expect that it will be successful in India. We are delighted that Zydus Cadila has agreed to market Maxisal and are hopeful that success in India and Nepal will lead them to expand Maxisal into some of the more than 50 other countries in which they currently market products," said Dr. Joseph Cummins, President and CEO, ABI.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.
About Zydus Cadila
Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group's operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 11,000 employees worldwide, a world-class research and development centre dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving people's lives. Additional information is available on the web at http://www.zyduscadila.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.
Contact:
Investor Relations:
Philippe Niemetz
PAN Consultants, Ltd.
e-mail: p.niemetz@panconsultants.com
Tel: 800-477-7570; 212-344-6464
Fax: 212-618-1276
Joseph M. Cummins, DVM, PhD
Amarillo Biosciences, Inc.
e-mail: jcummins@amarbio.com
Tel: 806-376-1741 x 13
Fax: 806-376-9301
http://finance.yahoo.com/news/...s-to-iw-3050834167.html?x=0&.v=1
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BS Reporter | 2010-11-18 01:11:00
Ahmedabad based pharma major Zydus Cadila has entered into an agreement with US based Amarillo Biosciences Inc(ABI to market ABI's dietary supplement Maxisal in India and Nepal.
Nasdaq listed ABI has informed the stock exchange in this regard. Maxisal enhances salivary function,promotes oral comfort and helps relieve dry mouth. Amarillo had initially launched Maxisal in the US market after clinical studies in subjects with gren's syndrome (characterised by dry eyes and dry mouth) found that the active ingredient in Maxisal significantly improved mouth comfort and decreased mouth and throat dryness.
Maxisal is marketed in Germany by ABI's licensee Egofocus OHG based in Darmstadt.
"Based on the favorable reception Maxisal has met in the US, which we attribute to the product's clinical benefits and reasonable cost, we fully expect that it will be successful in India. We are delighted that Zydus Cadila has agreed to market Maxisal and are hopeful that success in India and Nepal will lead them to expand Maxisal into some of the more than 50 other countries in which they currently market products," Joseph Cummins, President and CEO, ABI said in a statement. Pankaj Patel, chairman and managing director of Zydus Cadila was unavailable for a comment. Amarillo Biosciences, Inc. is a US based biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4 per cent of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. Ahmedabad based Intas Pharmaceuticals Limited (Intas) had entered into a strategic partnership with Amarillo Biosciences, Inc (ABI) in December last year, whereby Intas will sponsor clinical trials of ABI's orally administered interferon-alpha lozenges for influenza, and could also be used in combating the H1N1 virus for swine flu. Intas will pay ABI a royalty on net sales after marketing approval is obtained in India.
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More HeadlinesAll About: Zydus Cadila, Pharma sector, Amarillo Biosciences Inc, Joseph Cummins, Maxisal, ABI, Alpha, Biotechnology, Intas Pharmaceuticals Limited, Hayashibara Group, Amarillo Biosciences Inc., Egofocus OHG
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Amarillo Biosciences Announces Completion of Patient Enrollment in Phase 2 Hepatitis C Trial
AMARILLO, TX--(Marketwire - 12/14/10) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) today announced that enrollment in a Phase 2 clinical trial of 165 patients with chronic hepatitis C virus infection is now complete. The clinical trial is being conducted in Taiwan and funded by ABI's strategic partner, CytoPharm, Inc. The aim of the study is to reduce the virologic relapse rate for those patients who have successfully completed standard combination therapy for hepatitis C, which consists of injectable interferon alpha and Ribavirin.
Many patients with hepatitis C are found to be virus-free at the end of standard therapy, but up to half of those with certain viral genotypes relapse in the six months following treatment, once again becoming positive for hepatitis C virus. There are currently no FDA-approved medications shown to reduce the relapse rate for hepatitis C patients, so there is a clear medical need for effective new therapies.
All patients enrolled in this trial first completed standard therapy and were found to be negative for hepatitis C virus. The patients were then assigned to one of two different daily doses of ABI's human interferon alpha lozenges or placebo for 24 weeks, followed by untreated observation for 24 weeks to check for relapse. All patients are scheduled to complete the untreated observation phase by December 2011, and final results from this important study are expected to be available by the end of next year.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.
http://finance.yahoo.com/news/...nces-iw-3725040897.html?x=0&.v=1
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Companies:
- Press Release Source: Amarillo Biosciences, Inc. On Monday December 20, 2010, 9:40 am EST
AMARILLO, TX--(Marketwire - 12/20/10) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) today announced that a clinical trial of ABI's interferon-alpha lozenges for the treatment of influenza will be launched in Taiwan in 2011. The pilot study, approved by the Taiwanese Department of Health, will enroll the first of 60 planned subjects in January. Half of the patients with confirmed influenza A infection will be assigned to 5 days of twice daily treatment with interferon lozenges and half will receive placebo. All of the patients will also receive standard, 5-day treatment with Tamiflu. The aim of the study is to explore the possible benefits of combining oral interferon with Tamiflu in the treatment of influenza. Final study results are expected to be available in July 2011.
This new study is expected to add to the body of evidence that oral interferon is safe and effective in treating and preventing flu. A 200-subject study completed in Perth, Australia last year found that healthy volunteers who took oral interferon once a day during the winter cold and flu season had significantly fewer episodes of moderate to severe acute febrile respiratory illness (cold/flu with a fever), compared to volunteers who took placebo. Previously, human studies in the former Soviet Union, Bulgaria, Japan and China reported that oral interferon is a safe and effective treatment for influenza.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.
http://finance.yahoo.com/news/...nces-iw-1916973722.html?x=0&.v=1
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AMARILLO, TX--(Marketwire - 01/14/11) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) and Oasis Diagnostics® Corporation today announced that they have entered into an agreement under which Oasis will exclusively market Maxisal®, ABI's dietary supplement for enhancement of salivary function, promotion of oral comfort and relief of dry mouth, in North, Central and South America, China and Taiwan.
Oasis, a salivary diagnostics and genomics company based in Vancouver, WA, plans to expand on ABI's current marketing efforts by exploring new potential markets for Maxisal® in patients undergoing kidney dialysis and chemotherapy, those with dryness-related sexual dysfunction, and individuals with burning-mouth syndrome and other dryness-related conditions. Current estimates put the number of dry mouth sufferers in the US at 25 million.
Maxisal® is currently marketed by ABI's licensees Egofocus OHG in Germany and Zydus Cadila in India. The first target market in Germany and India is cancer patients. There are over 400 medications, including some oncology drugs that cause dry mouth as a severe side effect. By taking Maxisal®, cancer patients may be able to relieve at least one of the unpleasant side effects associated with cancer therapy.
Maxisal® was first offered for sale in the US after clinical studies in subjects with Sjogren's syndrome (characterized by dry eyes and dry mouth) reported that the active ingredient in Maxisal® significantly improved mouth comfort and decreased mouth and throat dryness.
"Clinical data has confirmed the beneficial effects of Maxisal in people experiencing dry mouth. With its widespread knowledge and expertise in salivary diagnosis and treatment, and its expansive network of contacts in the oral health arena, I fully expect Oasis to be successful at marketing Maxisal for individuals experiencing the unpleasant and potentially dangerous symptom of dry mouth," said Dr. Joseph Cummins, President and CEO of ABI.
"We are extremely happy and excited to have executed this license agreement with ABI. We feel that Maxisal® fits extremely well into our portfolio of novel tools for oral health and will open up new windows of opportunity for our growing company and its partners," said Dr. Paul Slowey, CEO of Oasis Diagnostics® Corporation.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 6% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.
About Oasis Diagnostics
Oasis Diagnostics® Corporation is an emerging Company focused on two core areas of the in vitro diagnostic market -- saliva based diagnostics and genomics. Over the past eight years the Company has assembled a portfolio of proprietary devices and tools for the standardized collection of saliva, immediate disease testing from saliva and the collection of DNA from saliva specimens. Oasis' non-invasive collection and testing technologies address the three main segments of the IVD market -- molecular diagnostics, rapid, point-of-care testing and diagnostics performed in the laboratory, and may be applied to a variety of areas including infectious diseases [including tuberculosis and HIV], steroid hormones for general wellness, oncology, immune response, cardiovascular disease and many others. Additional information is available on the web at http://www.4saliva.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.
http://finance.yahoo.com/news/...s-and-iw-549387673.html?x=0&.v=1
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Amarillo Biosciences' CEO Does Live Interview on ChartPoppers.com
AMARILLO, TX--(Marketwire - 01/17/11) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) -- ABI announced today that a new audio interview with ChartPoppers.com (http://chartpoppers.com) is now available. The interview can be viewed at http://ChartPoppers.com/iReports.
Amarillo Biosciences, Inc. (OTC.BB:AMAR - News) is developing low-dose oral interferon for human and animal health. The product is safe, inexpensive, stable at room temperature, easy-to-administer and modulates the immune system by helping regulate interferon sensitive genes. The company asserts that low dose oral interferon can achieve many of the benefits of high dose injectable interferon without the toxicity reported by most patients given high dose injectable interferon.
In the interview, the CEO notes: "Our new license and supply agreement with Oasis Diagnostics is expected to generate revenues this year." To listen to the entire interview visit: http://ChartPoppers.com/iReports.
About ChartPoppers
ChartPoppers.com is a small-cap research and investment commentary provider. ChartPoppers.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on ChartPoppers, please visit http://ChartPoppers.com/ireports.
ChartPoppers.com Disclosure
ChartPoppers.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. ChartPoppers.com is a Web site wholly owned by Seo Freisin, Inc. ChartPoppers.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, ChartPoppers.com, for complete risks and disclosures.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 6% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2009.
http://finance.yahoo.com/news/...Does-iw-1804694085.html?x=0&.v=1
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362.699 stück
Es scheint das bald gute News kommen..
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Herpes, Genital Warts, COPD, IPF all had no cure available till now. The herpes/genital warts angle will generate 20-50 mil in sales for Amar within a year or two.
FAQ's .
.
Frequently Asked Questions
Q. What is Virapress?
A. Virapress is a proprietary formulation of naturally occurring immunomodulation agents, known as cytokines, such as interleukins and interferon that are produced by all healthy animals. These cytokines, classified as proteins, regulate the body’s immune response to viral outbreaks and autoimmune illnesses.
Q. Is Virapress safe to take?
A. Yes. The effectiveness of Virapress against viral-based and autoimmune illnesses has been tested in studies over a 30 year period and while the product has been found to be effective, no cases of adverse side effects have been reported. Since Virapress is comprised of immunomodulation agents found in meat, as detailed above, the body accepts the Virapress formulation and therefore no adverse side effects are produced.
Q. How do I know that Virapress has the desired active ingredients?
A. The exclusive supplier of active immunomodulation agents for Virapress is Amarillo Biosciences, run by Dr. Joseph Cummings, the undisputed scientific expert on low-dose alpha interferon. All batches of bovine extract supplied to produce Virapress are tested and documented to be safe from impurities and to have the desired strength of active ingredients.
Q. How can Virapress help me?
A. If you suffer from any viral based illness such as Idiopathic Pulmonary Fibrosis, Shingles, Oral or Genital Warts, or Mononucleosis, to name a few, Virapress may improve or even eliminate your symptoms. The ingredients in Virapress work by stimulating the body’s immune system sufficiently so the body is able to naturally combat the virus.
Q. Is Virapress only for combating viruses?
A. No! Virapress is also effective against autoimmune disorders such as IPF, COPD, Asthma, Emphysema, Bechet’s Disease, and Sjogren ’s syndrome, to name a few. In these cases, Virapress regulates the body’s immune response to the invading illness, thus reducing or eliminating the illness which has been caused by an overactive immune system attacking healthy cells.
Q. Does Virapress work the same for everyone?
A. Results may vary depending on several factors, such as the severity and/or longevity of the disorder, as well as other health issues, such as lifestyle, that may exacerbate the disease. However, Virapress has either lessened symptoms or stopped the progression of the disease in the vast majority of people who have taken the product. Before deciding to try Virapress, we encourage you to refer to our web site, www.virapress.com and also the website featuring our product, www.healthnewslink.com , and familiarize yourself with the product case studies and also read testimonials of real people who have taken the product, and then decide if Virapress is right for you.
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Form 8-K for AMARILLO BIOSCIENCES INC
4-Feb-2011
Other Events
Item 8.01 Other Events.
Amarillo Biosciences, Inc. (ABI) has license and supply agreements with Hayashibara Biochemical Laboratories (HBL), the sole supplier of human interferon alpha (IFN?) and anhydrous crystalline maltose (ACM) to the Company. HBL is part of the Hayashibara Group of companies, which announced on February 2, 2011 on its website in Japan that it had filed a petition for corporate reorganization with the Tokyo District Court.
In a letter to customers dated February 2, 2011, Mr. Hideki Matsushima, who has been appointed by the Tokyo District Court to be the provisional administrator of HBL, made the following statements, "�I would like to inform you that we will endeavor to supply our products to our customers in a stable fashion. We believe that we will be able to ensure a stable supply of our products, since we have been permitted by the Tokyo District Court to pay our debts to our suppliers related to the purchase of raw materials for our products, on the condition that our suppliers will continue to do business with us under the pre-existing payment terms and conditions."
Based on these statements from Mr. Matsushima, ABI does not expect any disruption in the supply of IFN? or ACM from HBL.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
DATE: February 4, 2011.
AMARILLO BIOSCIENCES, INC.
By: /s/ Joseph M. Cummins
Joseph M. Cummins, Chairman of the Board, President and Chief Executive Officer
http://biz.yahoo.com/e/110204/amar.ob8-k.html
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© Reportlinker PRWire 2011 - By Roger Miller
15.02.2011 11:24:24
More information regarding this report:Idiopathic Pulmonary Fibrosis - Pipeline Assessment and Market Forecasts to 2017
http://www.reportlinker.com/p0240277/Idiopathic-Pulmonary-Fibrosis-Pipeline-Assessment-and-Market-Forecasts-to-2017.html#utm_source=LivePR&utm_medium=pr&utm_campaign=LivePR
Idiopathic Pulmonary
http://www.youtube.com/...79739&kw=market%20research%20interviews
Fibrosis - Pipeline Assessment and Market Forecasts to 2017
Summary
GlobalData’s pharmaceutical and healthcare report, “Idiopathic Pulmonary Fibrosis - Pipeline Assessment and Market Forecasts to 2017” is an essential source of information and analysis on the global idiopathic pulmonary fibrosis market. The report identifies the key trends shaping and driving the global idiopathic pulmonary fibrosis market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global idiopathic pulmonary fibrosis sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData’s team of industry experts.
The global Idiopathic Pulmonary Fibrosis (IPF) market was valued at $88m in 2009. It is expected to increase with a compound annual growth rate (CAGR) of 23% from $88m in 2009 to $462m by 2017. Earlier, the IPF market was underserved due to a lack of approved products. In October 2008, the Japanese manufacturer Shionogi received approval for Pirespa in Japan. It is under regulatory review for approval in the US and EU. The expected increase in sales is due to the expected approval of Pirespa in the US and the EU and also the expected launch of Tracleer and Letiaris. Growth in the IPF market is being driven by the sales of Pirespa, off-label drug use and the anticipated approval of Letiaris and Tracleer. Gilead’s Letiaris and Actelion’s Tracleer are the most anticipated molecules in the IPF market.
Scope
The report provides information on the key driver and challenges of the idiopathic pulmonary fibrosis market. Its Scope includes:
- Annualized global idiopathic pulmonary fibrosis market revenues data from 2001 to 2009, forecast forward for eight years to 2017.
- Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends. Key classes of mechanism of action include enzyme inhibitors, protein inhibitors, endothelin A antagonists, combination therapy, TNF alpha antagonists, platelet aggregation inhibitors, interferon alpha, interleukin inhibitors, immunosuppresants, growth hormone inhibitors, gene therapy, LPA1 receptor antagonists, tumor growth factor inhibitors and NK-1 antagonists.
- Analysis of the current and future market competition in the global idiopathic pulmonary fibrosis market. Key market players covered are Gilead Sciences, Actelion Ltd., Amgen Inc., InterMune Inc. and Amarillo Biosciences.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the future market associated with idiopathic pulmonary fibrosis therapeutics.
Reasons to buy
The report will enhance your decision making capability in a rapid and time sensitive manner. It will allow you to:
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global idiopathic pulmonary fibrosis market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments and companies likely to impact the global idiopathic pulmonary fibrosis market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain the competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- What’s the next big thing in the global idiopathic pulmonary fibrosis market landscape? – Identify, understand and capitalize. (rlk1-2011-02-15) olp
1 Table of contents 3
1.1 List of Tables 5
1.2 List of Figures 5
2 Global Idiopathic Pulmonary Fibrosis Market: Market Characterization 6
2.1 Overview 6
2.2 Idiopathic Pulmonary Fibrosis Market Size 6
2.3 Idiopathic Pulmonary Fibrosis Market Forecast and CAGR 6
2.4 Drivers and Barriers for Idiopathic Pulmonary Fibrosis Market 8
2.4.1 Drivers for Idiopathic Pulmonary Fibrosis Market 8
2.4.2 Barriers for Idiopathic Pulmonary Fibrosis Market 9
2.5 Opportunity and Unmet Need 10
2.6 Key Takeaway 11
3 Idiopathic Pulmonary Fibrosis Market: Competitive Assessment 13
3.1 Overview 13
3.2 Strategic Competitor Assessment 13
3.3 Profiles of the Major Therapeutic Class in Idiopathic Pulmonary Fibrosis 14
3.3.1 Overview 14
3.3.2 Immunosuppresants 14
3.3.3 Anti-inflammatory Drugs 15
3.3.4 Antifibrotics 16
3.4 Key Takeaway 18
4 Idiopathic Pulmonary Fibrosis Market: Pipeline Assessment 19
4.1 Overview 19
4.2 Strategic Pipeline Assessment 19
4.2.1 Technology Trends Analytic Framework 19
4.3 Idiopathic Pulmonary Fibrosis Therapeutics - Promising Drugs under Clinical Development 20
4.4 Molecule Profile for Promising Drugs for Idiopathic Pulmonary Fibrosis under Clinical Development 22
4.4.1 Letairis (ambrisentan) 22
4.4.2 Tracleer (bosentan) 23
4.4.3 Enbrel (etanercept) 24
4.4.4 Veldona (Oral interferon alfa) 25
4.5 Idiopathic Pulmonary Fibrosis Therapeutics Market - Clinical Pipeline by Mechanism of Action 26
4.6 Idiopathic Pulmonary Fibrosis Pipeline - Pipeline by Clinical Phases of Development 27
4.6.1 Idiopathic Pulmonary Fibrosis Therapeutics - Phase III Clinical Pipeline 28
4.6.2 Idiopathic Pulmonary Fibrosis Therapeutics - Phase II Clinical Pipeline 29
4.6.3 Idiopathic Pulmonary Fibrosis Therapeutics - Phase I Clinical Pipeline 29
4.6.4 Idiopathic Pulmonary Fibrosis Therapeutics - Preclinical Pipeline 30
4.7 Discontinued / Suspended Drug for Idiopathic Pulmonary Fibrosis 31
4.8 Key Takeaway 31
5 Idiopathic Pulmonary Fibrosis : Implications for Future Market Competition 32
6 Idiopathic Pulmonary Fibrosis Market: Future Players in the Idiopathic Pulmonary Fibrosis Market 34
6.1 Introduction 34
6.2 Gilead Sciences, Inc., California 34
6.2.1 Overview 34
6.2.2 Respiratory Disease Portfolio 36
6.2.3 Idiopathic Pulmonary Fibrosis Product Portfolio 36
6.3 Actelion Ltd. 37
6.3.1 Overview 37
6.3.2 Respiratory Disease Portfolio 38
6.3.3 Idiopathic Pulmonary Fibrosis Product Portfolio 38
6.4 Amgen Inc. 39
6.4.1 Overview 39
6.4.2 Respiratory Disease Portfolio 40
6.4.3 Idiopathic Pulmonary Fibrosis Product Portfolio 40
6.5 InterMune, Inc. 41
6.5.1 Overview 41
6.5.2 Respiratory Disease Portfolio 43
6.6 Amarillo Biosciences 44
6.6.1 Overview 44
6.6.2 Respiratory Disease Portfolio 45
6.6.3 Idiopathic Pulmonary Fibrosis Product Portfolio 46
7 Idiopathic Pulmonary Fibrosis Market: Appendix 47
7.1 Market Definitions 47
7.2 Abbreviations 47
7.3 Research Methodology 49
7.3.1 Coverage 49
7.3.2 Secondary Research 50
7.3.3 Forecasting 50
7.3.4 Primary Research 53
7.3.5 Expert Panel validation 53
7.4 Contact Us 53
7.5 Disclaimer 53
7.6 Sources 54
1.1 List of Tables
Table 1: Idiopathic Pulmonary Fibrosis Therapeutics, Global, Market Revenues ($m), 2001-2009 7
Table 2: Idiopathic Pulmonary Fibrosis Therapeutics, Global, Market Forecast ($m), 2009-2017 8
Table 3: Major Marketed Products Comparison in the Idiopathic Pulmonary Fibrosis Market, 2010 18
Table 4: Idiopathic Pulmonary Fibrosis Therapeutics - Most Promising Drugs Under Clinical Development, 2010 20
Table 5: Idiopathic Pulmonary Fibrosis Therapeutics - Phase III Clinical Pipeline, 2010 28
Table 6: Idiopathic Pulmonary Fibrosis Therapeutics - Phase II Clinical Pipeline, 2010 29
Table 7: Idiopathic Pulmonary Fibrosis Therapeutics - Phase I Clinical Pipeline, 2010 29
Table 8: Idiopathic Pulmonary Fibrosis Therapeutics - Preclinical Pipeline, 2010 30
Table 9: List of Discontinued Drugs for Idiopathic Pulmonary Fibrosis, 2010 31
Table 10: Gilead Sciences, Inc. -Respiratory Pipeline Products, 2010 36
Table 11: Actelion Ltd. -Respiratory Pipeline Products, 2010 38
Table 12: Amgen Inc. - Respiratory Disease Pipeline Products, 2010 40
Table 13: InterMune, Inc- Respiratory Disease Pipeline Products, 2010 43
Table 14: Amarillo Biosciences - Respiratory Disease Pipeline Products, 2010 45
1.2 List of Figures
Figure 1: Idiopathic Pulmonary Fibrosis Therapeutics, Global, Market Revenues ($m), 2001-2009 7
Figure 2: Idiopathic Pulmonary Fibrosis Therapeutics, Global, Market Forecast ($m), 2009-2017 8
Figure 3: Opportunity and Unmet Need in the Idiopathic Pulmonary Fibrosis Market, 2010 11
Figure 4: Strategic Competitor Assessment of the Major Marketed Products for Idiopathic Pulmonary Fibrosis, 2010 14
Figure 5: Technology Trends Analytic Framework of the Idiopathic Pulmonary Fibrosis Pipeline, 2010 19
Figure 6: Technology Trends Analytic Framework of the Idiopathic Pulmonary Fibrosis Pipeline - Description, 2010 20
Figure 7: Idiopathic Pulmonary Fibrosis Therapeutics - Clinical Pipeline by Mechanism of Action, 2010 27
Figure 8: Idiopathic Pulmonary Fibrosis Pipeline by Phase of Clinical Development, 2010 27
Figure 9: Implications for Future Market Competition in the Idiopathic Pulmonary Fibrosis Market, 2010 32
Figure 10: Idiopathic Pulmonary Fibrosis Therapeutics Market - Clinical Pipeline by Company, 2010 34
Figure 11: GlobalData Methodology, 2010 49
Figure 12: GlobalData Market Forecasting Model, 2010 52
Companies mentionedGilead Sciences, Inc
Actelion Ltd
Amgen Inc
InterMune, Inc
Amarillo Biosciences
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GlobalData, the industry analysis specialist's new report, "Idiopathic Pulmonary Fibrosis - Pipeline Assessment and Market Forecasts to 2017" is an essential source of information and analysis on the global idiopathic pulmonary fibrosis market. The report identifies the key trends shaping and driving the global idiopathic pulmonary fibrosis market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global idiopathic pulmonary fibrosis sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData's team of industry experts. The global Idiopathic Pulmonary Fibrosis (IPF) market was valued at $88m in 2009. It is expected to increase with a compound annual growth rate (CAGR) of 23% from $88m in 2009 to $462m by 2017. Earlier, the IPF market was underserved due to a lack of approved products. In October 2008, the Japanese manufacturer Shionogi received approval for Pirespa in Japan. It is under regulatory review for approval in the US and EU. The expected increase in sales is due to the expected approval of Pirespa in the US and the EU and also the expected launch of Tracleer and Letiaris. Growth in the IPF market is being driven by the sales of Pirespa, off-label drug use and the anticipated approval of Letiaris and Tracleer. Gilead's Letiaris and Actelion's Tracleer are the most anticipated molecules in the IPF market.
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This report offers you:
* The report provides information on the key driver and challenges of the idiopathic pulmonary fibrosis market. Its scope includes:
* Annualized global idiopathic pulmonary fibrosis market revenues data from 2001 to 2009, forecast forward for eight years to 2017.
* Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends. Key classes of mechanism of action include enzyme inhibitors, protein inhibitors, endothelin A antagonists, combination therapy, TNF alpha antagonists, platelet aggregation inhibitors, interferon alpha, interleukin inhibitors, immunosuppresants, growth hormone inhibitors, gene therapy, LPA1 receptor antagonists, tumor growth factor inhibitors and NK-1 antagonists.
* Analysis of the current and future market competition in the global idiopathic pulmonary fibrosis market. Key market players covered are Gilead Sciences, Actelion Ltd., Amgen Inc., InterMune Inc. and Amarillo Biosciences.
* Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
* Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the future market associated with idiopathic pulmonary fibrosis therapeutics.
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The effects of high dose interferon-beta1a on plasma microparticles: Correlation with MRI parameters
Journal of Neuroinflammation, 05/10/2011
Lowery–Nordberg – This study’s data suggest that serial measurement of plasma microparticles [PMP], particularly in the initial stages of MS [when neuro–inflammatory cascades are more intense], may serve as reliable and reproducible surrogate markers of response to INF–beta1a therapy for MS. In addition, the progressive decline in plasma levels of PMPCD31+ and PMPCD54+ further supports the concept that IFN–beta1a exerts stabilizing effect on the cerebral endothelial cells during pathogenesis of MS.
Methods- During the prospective 1–year study, this study used flow cytometry to measure changes in plasma microparticles [PMP] bearing CD31 [PMPCD31+], CD146 [PMPCD146+], and CD54/ICAM–1 [PMPCD54+] in 16 consecutive patients with relapsing–remitting MS [RRMS] before and after 3, 6, and 12 months of subcutaneous therapy with interferon–beta1a [44 micrograms, 3X weekly].
- At each visit, clinical exams and expanded disability status scale [EDSS] scores were recorded.
- Plasma levels of PMPCD31+, and PMPCD54+ were significantly reduced by treatment with IFN–beta1a.
- PMPCD146+ appeared to decrease only at 3 months, this protection did not persist and was lost at 6 and 12 months.
- In addition, the decrease in plasma levels of PMPCD31+ and PMPCD54+ levels were associated with a significant decrease in the number and volume of contrast enhancing T1–weighted lesions.
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Form 10-Q for AMARILLO BIOSCIENCES INC
19-May-2011
Quarterly Report
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our financial statements and the notes thereto which appear elsewhere in this report. The results shown herein are not necessarily indicative of the results to be expected in any future periods. This discussion contains forward-looking statements based on current expectations, which involve uncertainties. Actual results and the timing of events could differ materially from the forward-looking statements as a result of a number of factors. Readers should also carefully review factors set forth in other reports or documents that we file from time to time with the Securities and Exchange Commission.
Company Goal - FDA Approval and Commercialization of Oral Interferon. Amarillo Biosciences, Inc. (OTCBB: AMAR), is the world leader in the development of low-dose interferon for oral delivery and is conducting Phase 2 clinical studies testing oral interferon in animal and human diseases. We have changed our focus from Orphan Diseases (small markets) to treatment of diseases with large markets to attract large pharma partners. Our funding strategy is to seek private placement and partner funding to complete Phase 2 clinical studies for influenza, chronic cough in COPD patients, and hepatitis C; then seek large pharma partners to fund and help with the regulatory approval process in the US and Europe. We believe that our technology and the large, billion-dollar markets for these disease indications will attract global pharma partners sometime later this year or early next year.
Intellectual Property
Our portfolio consists of patents with claims that encompass method of use or treatment with interferon and composition of matter and manufacturing. We currently own or license five patents related to low-dose orally delivered interferon, and one issued patent on our dietary supplement. We have completed more than 100 pre-clinical (animal) and human studies of the safety and efficacy of low-dose orally delivered interferon.
Technology - Non-toxic Interferon
Injectable interferon is FDA-approved to treat some neoplastic, viral and autoimmune diseases. Many patients experience moderate to severe side effects that result in discontinuance of injectable interferon therapy. Our main product is a natural human interferon alpha delivered into the oral cavity as a lozenge in low (nanogram) doses. The lozenge dissolves in the mouth where interferon binds to surface (mucosal) cells in the mouth and throat resulting in stimulation of immune mechanisms. Orally delivered interferon has been shown to activate hundreds of immune system genes in the peripheral blood. Human studies have shown that oral interferon is safe and effective against viral and autoimmune diseases. Oral interferon is given in concentrations 10,000 times less than that usually given by injection. The Company's low dose formulation results in almost no side effects; high dose injectable interferon causes adverse effects in at least 50% of recipients.
Governmental or FDA approval is required for our principal products. Our progress toward approval is discussed under each specific indication, below.
Influenza
Influenza, commonly referred to as the flu, is an infectious disease caused by RNA viruses of the family Orthomyxoviridae that affects birds and mammals. The most common symptoms of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing, weakness/fatigue and general discomfort. Influenza spreads around the world in seasonal epidemics, resulting in the deaths of between 250,000 and 500,000 people every year, up to millions in some pandemic years. On average 41,400 people died each year in the United States between 1979 and 2001 from influenza. Two publications in the April 2009 issue of the Journal of Virology report that interferon placed in the nose of guinea pigs or ferrets significantly suppresses replication of influenza virus. These publications reinforce the Company's view that low-dose interferon is protective against influenza.
Further support of the efficacy of oral interferon against influenza was generated by The University of Western Australia in a Phase 2 clinical trial with 200 healthy volunteers during the 2009 winter cold/flu season in Australia. The study found that volunteers who took oral interferon had less severe cold/flu symptoms, compared to volunteers who received placebo. Publication of these results is pending.
In January 2011, CytoPharm, Inc., ABI's licensee for Taiwan and China, launched an influenza treatment study in Taiwan. Up to 60 patients being treated with Tamiflu for influenza A infection of less than 48 hours duration may be randomly assigned to co-treatment with oral IFN or placebo. The aim of the study is to examine whether the combination of oral IFN and Tamiflu is superior to Taimflu alone in the treatment of influenza illness.
Chronic Cough in COPD
COPD affects approximately 10% of the population over 40, is a growing problem, and is the 4th leading cause of death in the world. Chronic obstructive pulmonary disease (COPD) is a clinical condition with a progressive airflow limitation that is poorly reversible and characteristic of chronic bronchitis and emphysema. The causes of COPD include tobacco smoke, occupational dusts, chemicals, vapors and environmental pollutants. COPD is estimated to affect more that 600 million people worldwide. There are no effective therapies for emphysema, nor are there efficient clinical management strategies.
Data from a Phase 2 clinical study at Texas Tech University shows that treatment with oral interferon leads to a rapid and significant reduction in the cough associated with idiopathic pulmonary fibrosis (IPF), resulting in improved quality of life. Blinded, controlled studies in the US and Canada showed that oral interferon relieves chronic coughing in horses with COPD-like disease. A proof-of-concept study of low-dose oral interferon as treatment of chronic cough is ongoing at Texas Tech University. This clinical study is a Phase 2, randomized, double-blind, placebo-controlled, parallel trial in which 40 eligible volunteers with IPF- or COPD-associated chronic cough will be randomly assigned to one of two groups in equal numbers to receive either oral interferon or placebo lozenges. Treatment will be given three times daily for 4 weeks, and patients will be followed for 4 weeks post-treatment to assess durability of response. The study will evaluate the ability of oral interferon to reduce the frequency and severity of chronic cough, compared to placebo.
Hepatitis C
ABI's licensee CytoPharm, Inc. is funding an ongoing Phase 2 study of oral interferon treatment of hepatitis C virus-infected patients in Taiwan. The study is exploring the ability of oral interferon to reduce virologic relapse in patients who have completed standard therapy with pegylated interferon plus Ribavirin. Up to 50% of patients with certain genotypes of HCV relapse after receiving standard therapy, so reducing this relapse rate will represent a major breakthrough in the management of HCV. Completion of the study is expected by the end of 2011 with final results to be available in early 2012. Enrollment was completed in 2010 with 167 subjects.
Strategic Alliance with HBL
Hayashibara Biochemical Laboratories, Inc. ("HBL") was established in 1970 to engage in research and development. It is a subsidiary of Hayashibara Company, Ltd., a privately-owned Japanese holding corporation with diversified subsidiaries. For more than 130 years, the Hayashibara Company, Ltd. and its predecessors have been applying microbiological technology to the starch industry for the production of maltose and other sugars.
In 1981, HBL established the Fujisaki Institute to accelerate development of industrial methods for the production of biologics and to sponsor clinical trials for such products. In 1985, HBL built the Fujisaki Cell Center to support basic research. In 1987, HBL successfully accomplished the mass production of human cells in an animal host by producing human cells in hamsters. This made it possible to economically produce a natural form of human interferon alpha and other biologics. HBL also has developed and obtained patents for technology relating to the production of interferon alpha-containing lozenges by which the stability of the interferon alpha activity can be maintained for up to 24 months at room temperature and up to five years if the product is refrigerated. We believe that the use of such lozenges gives us advantages over competitive technologies in terms of cost, taste and ease of handling. On March 13, 1992, we entered into a Joint Development and Manufacturing/Supply Agreement with HBL (the "Development Agreement"). Such Development Agreement was subsequently amended on
January 17, 1996; May 10, 1996; and September 7, 2001. The current expiration date of the Development Agreement is March 12, 2014, at which time it will automatically renew for an additional three (3) years, unless the parties agree otherwise. Among other things, the Development Agreement provides us with a source of natural human interferon alpha for use in the Company's interferon alpha-containing products.
HBL is part of the Hayashibara Group of companies, which announced on February 2, 2011 on its website in Japan that it had filed a petition for corporate reorganization with the Tokyo District Court. In a letter to customers dated February 2, 2011, Mr. Hideki Matsushima, who has been appointed by the Tokyo District Court to be the provisional administrator of HBL, made the following statement, "We believe that we will be able to ensure a stable supply of our products, since we have been permitted by the Tokyo District Court to pay our debts to our suppliers related to the purchase of raw materials for our products, on the condition that our suppliers will continue to do business with us under the pre-existing payment terms and conditions." Based on this statement from Mr. Matsushima, ABI does not expect any disruption in the supply of interferon or ACM from HBL.
Strategic Alliance with Nobel.
A licensing and supply agreement was executed in September 2004 with a Turkish pharmaceutical company, NOBEL ILAC SANAYII VE TICARET A.S., providing the rights to oral low-dose interferon-alpha for the treatment of Behcet's disease in Turkey and in Azerbaijan, Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrghyzstan, Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkmenistan, Uzbekistan, and Federal Republic of Yugoslavia.
Strategic Alliance with Bumimedic.
In January 2006, a license and distribution agreement was executed with Bumimedic (Malaysia) Sdn. Bhd, a Malaysian pharmaceutical company that is a part of the Antah HealthCare Group, to market our low-dose interferon (natural human IFN) in Malaysia. Bumimedic will seek registration for our natural human IFN and commence marketing the product after approval. The terms of the agreement call for Bumimedic to manufacture lozenges from bulk natural human IFN (supplied by Hayashibara Biochemical Laboratories); package the lozenges and distribute them to local hospitals, pharmacies and clinics in Malaysia. Pursuant to the agreement, the Company will receive a series of payments, in three stages: upon formal execution of the distribution agreement, upon regulatory approval, and upon production. The Company will also receive a royalty on the sale of the natural human IFN.
Strategic Alliance with CytoPharm.
In November 2006, the Company entered into a License and Supply Agreement with CytoPharm, Inc., a Taipei, Taiwan-based biopharmaceutical company whose parent company is Vita Genomics, Inc., the largest biotech company in Taiwan, specializing in pharmacogenomics and is a specialty Clinical Research Organization. Under the terms of the Agreement, CytoPharm and its subsidiary will conduct all clinical trials, and seek to obtain regulatory approvals in both China and Taiwan (the "Territory") to launch our low dose oral interferon in the Territory for influenza and hepatitis B ("HBV") and hepatitis C ("HCV") indications. According to the Agreement, CytoPharm will make payments to the Company upon reaching certain milestones and will also pay royalties on low dose oral interferon sales in the Territory.
In March 2008, the Company entered into a Supply Agreement for Animal Health with CytoPharm, Inc. Under the terms of the Agreement, CytoPharm will conduct all clinical trials, and seek to obtain regulatory regulatory approvals in China and Taiwan (the "Territory") to launch
our low dose oral interferon in the Territory for treatment of diseases and other healthcare applications of swine, cattle and poultry. CytoPharm will make payments to us upon reaching certain milestones and will also pay royalties on low dose oral interferon sales in the Territory.
Strategic Alliance with Intas Pharmaceuticals.
On January 7, 2010, the Company entered into a License and Supply Agreement with Intas Pharmaceuticals Ltd., an India-based pharmaceutical company with three decades of experience in the healthcare industry and a global presence in 42 countries worldwide. Under the terms of the agreement, Intas will pay the Company a royalty on net sales in India and Nepal after marketing approval is obtained.
Strategic Alliance with Cadila Healthcare On October 18, 2010, the Company entered into a License and Supply Agreement with Cadila Healthcare of Amedabad, India. The Company will supply anhydrous crystalline maltose (ACM) to Cadila for sale as an active ingredient in nutraceutical and healthcare products for human consumption to relieve dry mouth in India and Nepal.
Strategic Alliance with Oasis Diagnostics On January 12, 2011, the Company entered into a License and Supply Agreement with Oasis Diagnostics of Vancouver, WA. The Company will supply ACM to Oasis for sale as an active ingredient in nutraceutical and healthcare products for human consumption to relieve dry mouth in China, Taiwan and the Americas.
Equity Funding. In the first quarter of 2011, the Company sold 200 unregistered shares of preferred stock for $100 per share, convertible to common stock with a $0.10 conversion price. Net proceeds from the stock sale were $18,000 after payment of $2,000 in commissions.
Results of Operations for Quarters Ended March 31, 2011 and 2010:
Revenues. During the quarter ended March 31, 2011, $1,320 from dietary supplement sales was generated compared to $96 for the quarter ended March 31, 2010, an increase of $1,224 (1275%). During the quarter ended March 31, 2011, $1,400 of ACM sales was generated compared to no ACM sales for the quarter ended March 31, 2010, an increase of $1,400 (100%).
Research and Development Expenses. Research and development expenses of $86,945 were incurred for the quarter ended March 31, 2011, compared to $101,288 for the quarter ended March 31, 2010, a decrease of $14,343 (14%). The decrease was mostly because oral warts, influenza and hepatitis C costs and personnel costs were lower in the first quarter of 2011. The oral warts in HIV+ patients and influenza studies were mostly completed in 2009.
Selling, General and Administrative Expenses. Selling, general and administrative expenses of $111,224 were incurred for the first quarter in 2011, compared to $175,162 for the first quarter of 2010, a decrease of $63,938 (37%). Most of this decrease was due to lower salaries, Black-Scholes option expense, PR/IR, insurance and stock grants than in the first quarter of 2011.
Change in Fair Value of Derivative Instruments. Change in fair value of derivative instruments was realized as a $610 loss in the first quarter of 2011 compared to $63,733 gain in the first quarter of 2010. Derivative liabilities increased $610 from December 31, 2010 to March 31, 2011.
Other Income. During the three-month period ended March 31, 2011, $300 interest and other income was generated compared to no interest and other income for the three-month period ended March 31, 2010.
Net Operating Loss. In the three-month period ended March 31, 2011, the Company's net operating loss was $196,880 compared to a net operating loss for the three-month period ended March 31, 2010 of $276,411, a $79,531 (29%) reduction. The operating loss was lower mostly because the $63,938 (37%) reduction in Selling, General and Administrative expenses.
Net Loss. In the three-month period ended March 31, 2011, the Company's net loss was $220,253 compared to a net loss for the three-month period ended March 31, 2010 of $235,447 a $15,194 (6%) reduction. The operating loss was lower mostly because of the derivative liabilities decrease, due to a return of 12,000,000 warrants to the Company in December 2010.
Liquidity Needs: On March 31, 2011, the Company had available $1,539 cash and had a working capital deficit (current assets less current liabilities) of $3,685,197. Current liabilities include two $1 million notes, $773,486 of accrued interest and $78,360 of accrued expenses owed to Hayashibara Biochemical Laboratories, Inc. (HBL), and $220,000 of notes, and $426 of accrued interest owed to Paul Tibbits. Accrued payroll and vacation expenses owed mostly to officers is $385,021. Derivative liabilities from warrants with embedded variable features valued at $60,394 are also included in the working capital deficit. That leaves approximately $307,657 of accounts payables and accrued expenses in the working capital deficit.
Assuming there is no decrease in current accounts payable, and accounting for various one-time expenses, the Company's negative cash flow for operating activities plus patent filings, the Company's cash burn rate is approximately $66,000 per month. The Company's continued losses and lack of liquidity raise substantial doubt about whether the Company is able to continue as a going concern for a reasonable period of time. The Company's ability to continue as a going concern is dependent upon several factors including, but not limited to, the Company's ability to generate sufficient cash flows to meet its obligations on a timely basis, obtain license and milestone fees, obtain additional financing and continue to obtain supplies and services from its vendors. The Company will need to raise additional funds in order to fully execute its 2011 Plan. The Company is currently pursuing potential investors for funding. In addition, the Company is also pursuing potential pharmaceutical partners to provide upfront license fee payments and funding for clinical studies. There can be no assurance that private placement funding or pharmaceutical partner funding will become available.
Forward-Looking Statements: Certain statements made in this Plan of Operations and elsewhere in this report are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance, achievements, costs or expenses and may contain words such as "believe," "anticipate," "expect," "estimate," "project," "budget," or words or phrases of similar meaning. Forward-looking statements involve risks and uncertainties which may cause actual results to differ materially from those projected in the forward-looking statements.
Such risks and uncertainties are detailed from time to time in reports filed by the Company with the Securities and Exchange Commission, including Forms 8-K, 10-Q and 10-K and include among others the following: promulgation and implementation of regulations by the U.S. Food and Drug Administration ("FDA"); promulgation and implementation of regulations by foreign governmental instru�mentalities with functions similar to those of the FDA; costs of research and development and clinical trials, including without limitation, costs of clinical supplies, packaging and inserts, patient recruitment, trial monitoring, trial evaluation and publication; and possible difficulties in enrolling a sufficient number of qualified patients for certain clinical trials. The Company is also dependent upon a broad range of general economic and financial risks, such as possible increases in the costs of employing and/or retaining qualified personnel and consultants and possible inflation which might affect the Company's ability to remain within its budget forecasts. The principal uncertainties to which the Company is presently subject are its inability to ensure that the results of trials performed by the Company will be sufficiently favorable to ensure eventual regulatory approval for commercial sales, its inability to accurately budget at this time the possible costs associated with hiring and retaining of additional personnel, uncertainties regarding the terms and timing of one or more commercial partner agreements and its ability to continue as a going concern.
The risks cited here are not exhaustive. Other sections of this report may include additional factors which could adversely impact the Company's business and future prospects. Moreover, the Company is engaged in a very competitive and rapidly changing industry.
New risk factors emerge from time to time and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such risk factors on the Company's business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those projected in any forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual future events.
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Amarillo Biosciences Teams With Bio-Stasis International to Launch Dietary Supplement Virapress
AMARILLO, TX--(Marketwire - 07/19/11) - Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR - News) today announced that it has formed an alliance with Bio-Stasis International, Inc., a dietary supplement internet marketer, to launch Bio-Stasis International's Virapress. Bio-Stasis plans to embark on an extensive internet marketing program for Virapress on August 1, 2011, targeting alternative and complimentary medical practitioners.
Virapress is a dietary supplement derived from a bovine protein extract produced by ABI and will be marketed with claims to improve health and enhance immunity. In parallel with Bio-Stasis International's internet marketing campaign, ABI will market its bovine extract to health food stores and internationally under ABI's brand name. ABI has already received serious inquiries about distribution rights from marketers in 9 different countries in the Middle East and Africa and has commenced negotiations on international distribution rights.
"We expect our internet marketing campaign to significantly increase the market for Virapress and, also, its primary ingredient, bovine extract," said Lawrence H. Griffin, president, Bio-Stasis International.
Virapress has not been evaluated by the Food and Drug Administration, and should not take the place of a regular medical evaluation by a licensed health practitioner.
About Bio-Stasis International, Inc.
Bio-Stasis is committed to the promotion of natural products which have been shown to promote health and healing. Each Bio-Stasis product must have scientific evidence to support effectiveness, without side effects. For additional information, please visit the Bio-Stasis International Inc.'s website www.virapress.com
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 6% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2010.
Contact:
Investor Relations:
Philippe Niemetz
PAN Consultants, Ltd.
e-mail: p.niemetz@panconsultants.com
Tel: 800-477-7570; 212-344-6464
Fax: 212-618-1276
Investor Inquiries:
Josh Tyrell
Interactive Business Alliance, LLC
e-mail: jtyrell@ibaconsultingllc.com
Tel: 866-525-4714
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