VEPACHEDU EDUCATIONAL FOUNDATION
"Patent Protection and the Pharmaceutical Industry in the Indian Union,"
Intellectual Property Today, pp. 44-46, October 2004
Intellectual Property Rights, a presentation, October 2004
Orphan drug designation is granted to products that treat rare diseases or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug designation provides eligibility for a special seven-year period of market exclusivity at marketing approval, potential tax credits for research, grant funding for research and development, possibly reduced filing fees for marketing applications, and assistance with the review of clinical trial protocols. Medarex, Inc. announced that under the U.S. Orphan Drug Act, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Medarex's MDX-060 for the treatment of Hodgkin's disease. MDX-060 is a fully human antibody that targets CD30, a member of the tumor necrosis factor receptor superfamily and a molecule found on activated lymphocytes. CD30 has been found to be over-expressed in several lymphoproliferative disorders and is present on malignant cells of Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL), as well as other CD30- positive lymphomas. Currently, Medarex is conducting an expanded dose-ranging Phase II study with MDX-060 in patients with CD30-positive lymphomas.
Angina patients in the UK are being treated with vibrating trousers (pants) which work by increasing the blood flow to the heart - the treatment is called Enhanced External Counterpulsation (EECP). The Yorkshire Clinic in Bradford is offering EECP. This treatment is also available at the Nuffield Hospital, Leeds, the Alexandra Hospital, Manchester and the Cromwell Hospital, London.
How Not to Do A Clinical Trial
List of Best Selling Drugs in the US
The top selling drugs in the United States in 2003, their annual sales, what it treats and its manufacturer. The 2003 data is the most recent audited figures available.
1. Lipitor, $6.8 billion, cholesterol, Pfizer Inc.
2. Zocor, $4.4 billion, cholesterol, Merck & Co.
3. Prevacid, $4.0 billion, heartburn, TAP Pharmaceutical Products Inc.
4. Procrit, $3.3 billion, anemia, Johnson & Johnson
5. Zyprexa, $3.2 billion, mental illness, Eli Lilly & Co.
6. Epogen, $3.1 billion, anemia, Amgen Inc.
7. Nexium, $3.1 billion, heartburn, Merck & Co.
8. Zoloft, $2.9 billion, depression, Pfizer Inc.
9. Celebrex, $2.6 billion, arthritis, Pfizer Inc.
10. Neurontin, $2.4 billion, epilepsy, Pfizer Inc.
11. Advair Diskus, $2.3 billion, asthma, GlaxoSmithKline PLC
12. Plavix, $2.2 billion, blood clots, Bristol-Myers Squibb Co.
13. Norvasc, $2.2 billion, high blood pressure, Pfizer Inc.
14. Effexor XR, $2.1 billion, depression, Wyeth
15. Pravachol, $2.0 billion, cholesterol, Bristol-Myers Squibb Co.
16. Risperdal, $2.0 billion, mental illness, Johnson & Johnson
17. Oxycontin, $1.9 billion, pain, Perdue Pharma
18. Fosamax, $1.8 billion, osteoporosis, Merck & Co.
19. Protonix, $1.8 billion, gastrointestinal reflux disease, Wyeth
20. Vioxx, $1.8 billion, arthritis, Merck & Co.
UCSD 2004 Most Innovative New Product
TG100-115 is a small molecule, first in class, NCE discovered and developed by TargeGen scientists. Following a heart attack, the condition of hypoxia (oxygen deprivation) activates kinase signaling cascades which cause biochemical changes to blood vessels which permit vascular leakage. This leakage contributes to microcirculatory collapse, heart tissue damage and ultimate infarct size. TG100-115, when administered intravenously, has been designed to block vascular leakage following an ischemic event. By preventing vascular leakage, it is anticipated that heart muscle tissue will be preserved resulting in improved cardiovascular function. Acute Myocardial Infarction (AMI) is the number one disease related cause of death in the developed world with approximately 2.1 million new cases per year in the USA, Western Europe and Japan.
Scientists from the Institute of Biochemistry of Plants (Irkutsk), Institute of Chemical Biology and Scientific Centre of Virusology and Biotechnology ("Vector") (Novosibirsk) devised eatable transgenic tomatoes that can serve as vaccines against Hepatitis and AIDS. This vaccine has already been tested on animals and yielded positive results. According to Sergei Schelkunov, head of the department of molecular biology of genomes from the Scientific Centre of Virusology and Biotechnology, after being fed a portion of transgenic tomatoes three times a day, lab mice began showing positive signs of improvement of immune response towards hepatitis B and a less pronounced but also effective towards HIV, reports Pravda.
Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, as well as for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy. American Pharmaceutical Partners, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Carboplatin Injection (liquid form), the generic equivalent of Bristol-Myers Squibb Company's Paraplatin(R). APP will immediately launch this additional form of carboplatin, having recently launched the lyophilized form of the product. The combined sales of carboplatin (liquid and lyophilized) exceeded $775 million in 2003.
The topical prescription acne category is one of the largest segments in the U.S. dermatology market, and is estimated to exceed $1.2 billion annually. Approximately 17 million people in the U.S. have acne resulting in approximately 5.5 million office visits per year.
Clindamycin is the most popular topical antibiotic used for treating acne patients and represents approximately one-third of the topical acne market. The U.S. Food and Drug Administration (FDA) has approved Evoclin (clindamycin) Foam, 1% for the treatment of acne vulgaris. Evoclin (formerly referred to as Actiza(TM)) is the first product approval for Connetics Corporation, a specialty pharmaceutical company that develops and commercializes dermatology products.
Abbott Acquired Spine Next
Abbott acquired Spine Next, S.A., of Bordeaux, France. Spine Next is a privately owned manufacturer of orthopedic spinal implant devices including a dynamic stabilization device that treats early degenerative disc disease without fusion of the vertebrae, helping patients preserve motion.
Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), one of eight subtypes of acute myeloid leukemia (AML), is a malignant disorder of white blood cells that can affect patients of any age. APL is characterized by a specific chromosomal abnormality -- a switch, or translocation, of genetic material from chromosome 17 to chromosome 15. This genetic alteration results in an abnormal protein that inhibits normal cell growth and prevents maturation of white blood cell precursors in the bone marrow, ultimately resulting in cancer. The standard treatment for newly diagnosed APL has been a combination of chemotherapy and all-trans-retinoic acid (ATRA), which results in a complete response in 70 to 90 percent of newly diagnosed patients. However, approximately 20 to 30 percent of patients who receive this treatment regimen relapse. This poor response to drug therapy has led to the use of allogenic stem cell transplantation (the transfer of healthy, young cells from the bone marrow or bloodstream of a donor) to prolong survival. TRISENOX provides another treatment option for this patient population. Cell Therapeutics, Inc. (CTI) announced that Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) received approval from the Japanese Ministry of Health to market TRISENOX(R) (arsenic trioxide) for patients with relapsed or refractory acute promyelocytic leukemia (APL) in Japan.
Eurand announced that it has received final approval from the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom (UK) for its Application for Sodium Diclofenac 75mg and 100mg modified release capsules. Sodium Diclofenac modified release is the generic version of Voltarol(R), a Novartis product. Sodium Diclofenac is used to treat all levels of pain and inflammation in a wide variety of conditions. The market for sodium Diclofenac in the UK is approximately $130M.
Globally, over one million people, many of them children under the age of five, die from malaria each year. A team, led by Spanish experts from the University of Barcelona, working with drug company GlaxoSmithKline, developed an effective vaccine against malaria that could be licensed by 2010. The research was funded by GSK Biologicals and a global project, created through a grant from the Bill & Melinda Gates Foundation, to overcome barriers to malaria vaccine development - the PATH Malaria Vaccine Initiative. The findings appear in the Oct. 16 issue of The Lancet.
Chip on the Shoulder
A computer chip that is implanted under the skin won U.S. approval on Wednesday for use in helping doctors quickly access a patient's medical history. The VeriChip, sold by Applied Digital Solutions Inc., is placed in the upper arm in a painless procedure that takes minutes.
Decaffeinated coffee accounts for about 10 per cent of the world coffee market but industrial methods in operation today to decaffeinated coffee use organic solvents and carbon dioxide to remove the caffeine from the beans, a process that can strip necessary flavor compounds out of the finished drink. US chemists are working to develop bacteria that could ultimately lead to improved production of naturally derived decaffeinated coffee. Scientists at the Emory University Health Sciences Centre are hoping to widen the understanding of an enzyme that breaks caffeine down into theophylline, using bacteria that need the breakdown product of the enzyme for survival. This latest research joins reports earlier this year that scientists in Brazil had identified naturally growing caffeine-free coffee plants, paving the way for cheaper processing methods for makers of decaffeinated coffee.
A portable heart monitor that would use sensors woven into underwear to warn patients before they suffer a stroke is in the making. The system keeps track of important risk factors for heart disease, such as inactivity, poor sleep and stress. MyHeart, a European Union supported research project, involves healthcare, electronics and communications companies - a group of 33 firms, including Nokia and Philips.
As many as 30 million American women will have gone through natural menopause by 2005 and another 10 million will be menopausal because of having their ovaries removed, Procter & Gamble estimates. Menopausal women on the testosterone patch had sex about four times more than they usually did in two months compared to only one additional session for women given a fake patch containing no hormone, a study found. Those who got real patches also reported more arousal, pleasure and orgasms, and had better self-images.
Back to the top
Internet in India
About 10 percent of the world's population has access to the Internet. However, in India, Internet penetration is pegged at just 0.4 percent, and high-speed penetration at 0.02 percent, in a country of more than a billion people. High costs, archaic telecommunications infrastructure, the archaiic laws and regulations, and the government hamper usage. Users now pay about 750 rupees for a 100-hour connection running at 50 kilobits per second, similar to dialup connections. Aiming very low, India said earlier this month it aims to have 20 million high-speed (just under 2%) and 40 million (just under 4%) dial-up users by 2010, and much of that growth is expected to come from wireless technologies.
U.S. chip maker Advanced Micro Devices Inc. has introduced a low-cost Internet access device that could cost just a few hundred dollars, aimed at first-time technology users in the developing world. Launching the Personal Internet Communicator (PIC) in India first, AMD will sell it with Videsh Sanchar Nigam Ltd., an international phone service and Internet access provider. AMD said the suggested price for the PIC itself was $185 with a keyboard, mouse and pre-installed software, or $249 including a monitor, but local providers would ultimately set the price.
Back to the top
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
One World One Family