Increased Investment in Stem Cell Technologies Drives Stem Cell Research Market

May 11, 2012 Stem cell research is a promising area of biotechnology, which holds tremendous potential in rendering a new approach to the treatment of various degenerative diseases. The area deals with employing regenerative stem cells for the replenishment of damaged cells of a particular organ or tissue with new cells. These repair blocks have created a new specialty in the area of medicine called the regenerative medicine. Stem cells hold potential to treat conditions such as Alzheimer's disease, Parkinson's disease, stroke, spinal cord injury, heart disease, diabetes, burns, rheumatoid arthritis and osteoarthritis. In addition to its therapeutic applications, stem cells are also finding use in drug discovery, promising new avenues in the area of drug development. Growth in the research space is attributed to the acceptance of stem cell technology by patients for treating chronic diseases. Moreover advancement in stem cell research can help reduce the escalating healthcare costs associated with conventional methods of treatment.   Stem cell technology is still in a nascent stage. The market still lacks substantial data that could establish its long-term efficacy as well as safety. Certain issues pertaining to its administration have also raised concerns. The regulatory and ethical barriers across the world, particularly in Western countries, are the major challenges ahead of stem cells research. The barriers are particularly more in embryonic stem cell research. On the other hand, countries such as India, with comparatively less opposition, are better positioned to conduct stem cell research. Lack of proper funding is also a matter of concern for stem cell research. Countries, such as Thailand, Taiwan, Malaysia, Singapore, China, and India, are engaged in commercial, clinical, and scientific advancements in stem cell research without proper funding.   Over the past few years, the stem cells market has witnessed several breakthroughs that bodes tremendous potential in reshaping the area of medicine. Potential therapeutic applications of stem cells cut across several debilitating and deadly disease areas, including cancer and AIDS. Stem cell research is entering new avenues of medicine, and promises to provide a solution to combat diseases that were hitherto believed to be incurable. There is a growing demand for such therapies, which in turn provokes continued investments in the area, and foretell a remarkable growth in the industry in the coming years. Presently, the field is focused upon the treatment of certain oncological ailments, which include non-Hodgkin's lymphoma, multiple myeloma, and leukaemia. Additionally, non-cancerous diseases, including lupus, immunodeficiency, and aplastic anaemia, are also being investigated for treatment using stem cell technology.   Mesenchymal stem cells and hematopoietic stem cells, extracted from adult bone marrow, are the leading types ofadult stem cells currently in demand in the area of medicine. Of these types, hematopoietic stem cells hold major share in disease management. The dominance of hematopoietic stem cells is in part due to the difficulty associated with the isolation of mesenchymal from the bone marrow owing to availability of cells in lower levels. The greatest strength of adult stem cells is the presence of genomic stability of a very high degree. Additionally, stem cell therapy does not necessitate pre-treatment or genetic modification that is required when dealing with embryonic stem cells.   The US represents the largest regional market worldwide, as stated by the new market research report on Stem Cell Research. Despite the 9-year ban, which ended in 2009, over federal funding for research in embryonic stem cells, North America is presently dominating the stem cell market. Key factors that have kept North American market on the top of the charts include advanced stem cell research infrastructure and facilities, and federal support for the research. Asia is emerging as the fastest growing regional market for stem cell research worldwide with countries such as Japan, China, Singapore, Korea, and Australia evolving as major hubs for stem cell research.   Major players profiled in the report include Advanced Cell Technology Inc., Athersys Inc., Cytori Therapeutics Inc., Genzyme Corporation, Geron Corporation, International Stem Cell Corporation, Mesoblast Ltd., Osiris Therapeutics Inc., StemCells Inc., ThermoGenesis Corp., among others.   The research report titled "Stem Cell Research: A Global Strategic Business Report" announced by Global Industry Analysts, Inc., provides comprehensive market overview, trends & issues, regulatory overview, overview on therapies under development, recent industry activity and profiles of market players worldwide. The report analyzes global adult stem cell research market in terms of annual investments in value for the years 2008 through 2017, for major geographic markets, including the US, Europe and Rest of World.

WuXi PharmaTech Announces First-Quarter 2012 Results

  By WuXi PharmaTech (Cayman) Inc.         Published: Thursday, May. 10, 2012  SHANGHAI, May 10, 2012 -- /PRNewswire-Asia/ -- WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for the first quarter of 2012. 

Highlights   ‧Net Revenues Increased 26.2% Year Over Year to $118.0 Million  ‧Manufacturing Services Net Revenues Grew 35.0% Year Over Year to $31.4 Million  ‧Laboratory Services Net Revenues Grew 23.2% Year Over Year to $86.6 Million  ‧China-Based Laboratory Services Net Revenues Increased 25.8% Year Over Year to $64.5 Million  ‧U.S.-Based Laboratory Services Net Revenues Increased 16.4% Year Over Year to $22.2 Million  ‧GAAP Diluted Earnings Per ADS Grew 15.8% Year Over Year to $0.28  ‧Non-GAAP Diluted Earnings Per ADS Increased 15.1% Year Over Year to $0.33  ‧Company Reconfirms 2012 Financial Guidance   

Management Comment  "WuXi began 2012 with a strong first quarter, achieving 26.2% revenue growth," said Dr. Ge Li, Chairman and Chief Executive Officer. "This strong revenue growth was broad-based across all of our businesses. We met or exceeded all of our financial targets for revenues and margins for the quarter. And we continue to invest to build capabilities and to expand capacities in both laboratory services and manufacturing services. For example, our new Wuhan chemistry site began operations in February.  "WuXi is building a comprehensive and integrated technology platform and service offerings that will enable anyone and any company to discover and develop new products efficiently and cost-effectively," Dr. Li concluded. "China is becoming an important hub for pharmaceutical R&D in part because of China's pharmaceutical market, already the third largest in the world and growing very rapidly. By building high-quality operations to better serve our customers, WuXi has become the leader in the Chinese pharmaceutical R&D services industry. We are well-positioned to take full advantage of the significant long-term trend for increasing outsourcing of pharmaceutical research and development."  Beginning with this financial report for the first quarter of 2012, WuXi PharmaTech presents its results of operations for Process Chemistry under the Manufacturing Services segment rather than the Laboratory Services segment. Process Chemistry develops processes for making active pharmaceutical ingredients (APIs) and advanced intermediates and thus is more closely related to operations of the Manufacturing Services segment. Prior-year results in this report also reflect this reclassification.  Also beginning with the first quarter of 2012, WuXi PharmaTech presents other comprehensive income and its components in its Statement of Comprehensive Income in accordance with Accounting Standards Update 2011-05. For the periods presented herein, other comprehensive income consists of foreign currency translation adjustments resulting from the translation of our financial statements into our reporting currency, the U.S. dollar. The functional currency of our China-based operations is the RMB. 

GAAP Results  First-quarter 2012 net revenues increased 26.2% year over year to $118.0 million due to strong growth in both Manufacturing Services and Laboratory Services. Manufacturing Services revenue growth was driven by robust demand for clinical-trial materials from our research manufacturing business and solid demand in our commercial manufacturing business. Revenue growth in Laboratory Services was driven by our comprehensive and integrated discovery and development services, with particularly strong growth in integrated medicinal chemistry, DMPK/ADME, formulation, toxicology, and bioanalytical services in China and by increased demand for testing services in the United States for both biologics and medical devices.  First-quarter 2012 GAAP gross profit increased 20.7% year over year to $41.9 million mainly due to 26.2% revenue growth. First-quarter 2012 GAAP gross margin decreased year over year to 35.5% from 37.1%. Gross margin in Laboratory Services decreased year over year to 37.1% from 39.3% mainly due to the effects of increasing labor costs in China and the negative impact from appreciation of the RMB relative to the U.S. dollar, partially offset by improved productivity. Gross margin in Manufacturing Services slightly improved year over year to 31.0% from 30.5%.  First-quarter 2012 GAAP operating income grew 4.0% year over year to $20.6 million due to the 20.7% increase in gross profit, offset by increased operating expenses relating to the hiring of new senior staff and sales and marketing personnel, RMB appreciation relative to the U.S. dollar, and R&D investment in developing capabilities in biology, biologics, genomics, and other areas. Operating margin decreased to 17.5% from 21.2% due to the increase in operating expenses.  First-quarter 2012 GAAP net income increased 15.2% year over year to $21.0 million due to a 4.0% increase in operating income, gains on foreign-exchange forward contracts of $1.8 million, higher interest income from short-term investments, and a small decrease in the effective tax rate.  First-quarter 2012 GAAP diluted earnings per ADS increased 15.8% to $0.28, mainly due to the 15.2% increase in net income and a lower share count caused by the repurchase of about 22.8 million ordinary shares, equivalent to about 2.8 million ADSs, which were previously converted from the convertible bonds by General Atlantic in February 2012.  First-quarter 2012 GAAP comprehensive income decreased 1.1% year over year to $21.4 million due to the decrease in currency translation adjustments, partially offset by the 15.2% increase in GAAP net income. 

Non-GAAP Results  Non-GAAP financial results exclude the impact of share-based compensation expenses and the amortization of acquired intangible assets and the associated deferred tax impact.  First-quarter 2012 non-GAAP gross profit increased 20.7% year over year to $43.5 million mainly due to broad-based revenue growth. Non-GAAP gross margin decreased to 36.8% from 38.5%. Non-GAAP gross margin in Laboratory Services decreased year over year due to increased labor costs and the negative impact from appreciation of the RMB relative to the U.S. dollar, partially offset by improved productivity. Non-GAAP gross margin in Manufacturing Services improved due to strong revenue growth and increased capacity utilization.             First-quarter 2012 non-GAAP operating income increased 5.1% year over year to $24.3 million, primarily due to the 20.7% increase in non-GAAP gross profit, partially offset by the increase in non-GAAP operating expenses driven by the hiring of new senior staff and sales and marketing personnel, RMB appreciation, and R&D investment in developing capabilities in biology, biologics, genomics, and other areas. Operating margin decreased to 20.6% from 24.7% due to the increase in operating expenses.  First-quarter 2012 non-GAAP net income grew 14.5% year over year to $24.5 million due to the 5.1% increase in non-GAAP operating income, gains on foreign-exchange forward contracts of $1.8 million, higher interest income from short-term investments, and a small decrease in the effective tax rate.  First-quarter 2012 non-GAAP diluted earnings per ADS grew 15.1% year over year to $0.33, mainly due to the 14.5% increase in non-GAAP net income and lower share count caused by the repurchase of about 22.8 million ordinary shares, equivalent to about 2.8 million ADSs, which were previously converted from the outstanding convertible bonds by General Atlantic in February 2012. 

台灣醫療提供 early aging (初老症) 協助!!

Taiwan aids early aging Vietnam woman  Saturday, May 12, 2012   Taiwan has emerged as one of the most desired destinations for a great variety of medical treatments and plays an important role in providing medical relief to disadvantaged people suffering from rear diseases. Perfectly illustrating this is a recent case of the "transformation" of an early aging Vietnamese woman, jointly announced yesterday in Taipei by the Taiwan External Trade Development Council (TAITRA) and the China Medical University Hospital (CMUH).   At 28 years of age, Nguyen Thi Ngoc Mai looked and walked like a saddened 70-year-old woman, with wrinkled and sagging skin due to premature aging resulting from the autosomal recessive disease encrypted on her eighth set of chromosomes, Werner Syndrome.   Upon evaluation, the CMUH medical team in charge of Nguyen's case - a group of some 40 medical professionals from 12 departments - identified the woman's main medical complications resulting from Werner Syndrome as having multiple endocrine neoplasia syndrome, pulmonary fibrosis, and vascular atrophy.   Over the past month, Nguyen underwent various treatments, a sophisticated cranial operation, and has received multiple plastic surgeries to restore her external youth. She is now free of vasculitis and her lung function has improved substantially; she can now walk decent distances without fearing that she might faint. Despite slight plumpness in the face from her last plastic surgery, Nguyen smiled and said, through tears, "Thank you, Taiwan."   According to Superintendent of CMUH's International Medicine Service Center Chen Hong-ji, Nguyen has said that she has two birthdays, "One is the day I was born, and the other is the day I came to Taiwan, where I was given new hope."   Nguyen's case is a perfect example of a successful, international humanitarian medical effort, Chao Yuen-chuan, president of TAITRA, said at the press conference, encouraging further humanitarian efforts be introduced into the country. 

護理人員的也需要人性化的環境!!

《地球證詞導讀》超級護士 (四) 

老年肺癌治療: AVAiL (AVAstin in Lung Cancer) trial 合併化療 效果..??

Questions about Benefit from Avastin in Older Patients

Published April 26, 2012 | By Dr West  A group of investigators at Dana Farber Cancer Institute in Boston, MA recently published a very newsworthy article in the Journal of the American Medical Association (JAMA) that argues that patients with advanced non-small cell lung cancer (NSCLC) who are over 65 don't appear to benefit from the addition of Avastin (bevacizumab) to standard chemotherapy with carboplatin/Taxol (paclitaxel).  Several years ago, Avastin was demonstrated in the ECOG 4599 trial to lead to a survival benefit when it was added to carbo/Taxol in Avastin-eligible patients, who are a pretty limited subgroup with a good performance status, no brain metastases (a requirement since relaxed with more experience), no significant hemoptysis, and non-squamous NSCLC histology.  However, there have always been elements of the story that have cast some doubt as to how much benefit it really offers, particularly in older patients.  A subset analysis of the ECOG 4599 trial showed that patients over 70 experience disproportionately greater side effects and complications from Avastin and no survival benefit.   Meanwhile, another large randomized phase III trial called AVAiL (AVAstin in Lung cancer) that was conducted in Europe showed a statistically significant but overall very unimpressive improvement in response rate and progression-free survival when Avastin was added to a different standard chemotherapy backbone of cisplatin and gemcitabine, and this study demonstrated no benefit at all in survival.  Since Avastin was approved by the US FDA in October of 2006, it has been considered a standard of care but not clearly the standard of care, and only about 20-25% of patients in real world clinics actually get it.  The reason it ends up being given to only a minority of patients is a somewhat open question, but in truth, I think that when you disqualify patients with many of the clearer contraindications and then also factor in some relative contraindications such as a cancer next to major blood vessels or a poorly differentiated cancer that is suspected may be of squamous histology, the actual proportion of patients who are really strong candidates for it is probably below 40%.  And then, there is also the question of how much stock clinicians place in the ECOG trial vs. the AVAiL trial that failed to show a benefit…and the fact that the median age of newly diagnosed lung cancer in the US is now around 71 meaning that a very significant fraction of patients with advanced NSCLC are in an age range where the value of Avastin is quite questionable.