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2007 Patent
Harvest
Biotech Deals Wyeth Considers Job Cuts Blood Pressure Medication Etravirine New Medication for Diabetes ALVESCO(R) New Chemical Buffer Sublingual Vaccines India's Energy Reserves China Surges Past India Indo-French Nuclear Deal 2007 Patent Harvest IBM was the big winner with 3,148. The largest number was awarded to Bristol-Myers Squibb, with 82 (http://www.pharmalot.com/wp-content/uploads/2008/01/ifi-patent-chart-3.jpg). A caveat, however, for those unfamiliar with the patent world. This reflects only the number of patents granted by the USPTO last year, but that isn’t the same thing as saying these match the number of patents filed in 2007. There is always a backlog of patents pending. In other words, Bristol scientists and patent lawyers may well have been busier a couple of years earlier. Biotech Deals Continuing the hot trend of biopharma companies partnering with research institutions, Pfizer has signed a $25 million, five-year deal with St. Louis-based Washington University. The move extends a previous relationship between the two that stretches back to 1982. As part of the deal, Washington University and Pfizer researchers will identify, design and execute projects focused on immuno-inflammatory disorders such as arthritis, asthma and diabetes. In addition, a Wyeth Considers Job Cuts Wyeth is considering cost cuts that could eliminate 10 percent of its work force over a three-year period. The company's earnings prospects have been hurt by delays last year in approvals of new medicines including its Pristiq depression drug, and the recent launch of a generic form of its blockbuster Protonix ulcer medicine. Wyeth currently has 50,000 employees worldwide. Blood Pressure Medication Tablets containing a combination of the blood pressure medication aliskiren and water pill hydrochlorothiazide have been approved by the Food and Drug Administration, the product's manufacturer, Novartis AG. Sold under the name Tekturna in the United States, the hypertension compound aliskiren was approved last March. It acts by targeting renin, an enzyme responsible for high blood pressure. The newly approved version also includes hydrochlorothiazide, a compound that inhibits the kidney's ability to retain water. This water pill is commonly used to treat high blood pressure. Tekturna HCT tablets are intended for patients whose blood pressure has not been controlled by a single drug. They will be available in early February the company said. Side effects associated with the new combination tablets include dizziness, flu-like symptoms, diarrhea, cough, tiredness and skin rashes. Tysabri for Crohn's Disease The Food and Drug Administration approved the use of the multiple sclerosis (MS) drug Tysabri to treat Crohn's disease. Tysabri was approved for patients with moderate to severe Crohn's disease who have not responded to standard treatments. Crohn’s disease is an ongoing disorder that causes inflammation of the digestive tract, also referred to as the gastrointestinal (GI) tract. Crohn’s disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling extends deep into the lining of the affected organ. The swelling can cause pain and can make the intestines empty frequently, resulting in diarrhea. Like MS patients who take Tysabri, people using the drug for Crohn's disease will have to enroll in a special distribution program, including an educational program on Tysabri's risks, and will only be able to get injections of the drug from a list of registered doctors. The restrictions were a condition of Tysabri's return to the market in 2006. The drug had been pulled in 2005 because it was linked to a rare but serious side effect, a nervous system disorder called multifocal leukoencephalopathy, or PML. Etravirine The U.S. Food and Drug Administration approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals. Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA. Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains. Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., based in Bridgewater, N.J. New Medication for Diabetes Diabetes affects an estimated 21 million Americans and its incidence is increasing by approximately 1.5 million new cases each year in the United States alone. Approximately 90 percent to 95 percent of people with diabetes suffer from type 2 diabetes, the most common metabolic disease in the world and the fifth deadliest disease in the United States. Diabetes is the leading cause of blindness, end-stage renal disease, and non-traumatic loss of limb. It can also lead to heart disease, stroke, high blood pressure, kidney disease, and other serious conditions. In the United States, the public health cost of diabetes is more than $130 billion per year. Daiichi Sankyo, Inc., announced that the United States Food and Drug Administration (FDA) has approved Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C). The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 percent of these people having type 2 diabetes.(1) Forty percent of patients with type 2 diabetes also have high LDL-cholesterol.(2) Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes. Depomed, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the 1000 mg strength tablets of GlumetzaTM (metformin hydrochloride extended release tablets). Glumetza (metformin hydrochloride extended release tablets) is indicated alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in adult patients (18 years and older) with type 2 diabetes. Obesity surgery can cure type 2 diabetes, according to a new Australian study. The study, published in the Journal of the American Medical Association, found that obese people who had stomach band surgery to reduce the size of their stomachs were five times more likely to have their diabetes disappear over the next two years than people who got standard diabetes care. The study involved 55 obese patients, age 47 on average, who had been diagnosed with type 2 diabetes during the past two years. Half the patients underwent laparoscopic gastric banding surgery, while the others received standard care. Both groups were taught about low-fat, high-fiber diets and encouraged to exercise, and all the study participants could meet with a health professional every six weeks. Over the two-year study period, the surgery patients lost an average of 46 pounds and standard-care patients lost an average of 3 pounds. Blood tests showed diabetes remission in 22 of the 29 surgery patients, compared to only four of the 26 patients in the non-surgery group. Those who lost the most weight were most likely to see remission. ALVESCO(R) (ciclesonide) Inhalation Aerosol Nycomed announced that the Food and Drug Administration (FDA) approved ALVESCO(R) (ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO(R) is an inhaled corticosteroid with novel release and distribution properties. Commercialisation and marketing of ALVESCO(R) will be achieved through a U.S. commercial partner. The decision of the FDA allows the product to be sold in the largest pharmaceutical market in the world, where it is patent protected until 2017. Nycomed is in active negotiations with possible marketing partners for the commercialisation of ALVESCO(R) in the United States. The outlicensing strategy in the U.S. is consistent with Nycomed's direction to seek marketing and commercialisation partnerships for the Nycomed's assets in the U.S. market. ALVESCO(R) is a new generation of inhaled corticosteroid that reduces inflammatory processes and is indicated for the use in patients with asthma. ALVESCO(R) has been approved in 45 countries including the U.S. and introduced in 30, with more launches expected in 2008. ALVESCO(R) is based on the active ingredient ciclesonide which is Nycomed's patented corticosteroid with a novel principle of action. Ciclesonide is a prodrug that is activated by intracellular esterases following oral inhalation. ALVESCO(R) has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response. New Chemical Buffer Researchers at the University of Illinois have found a simple solution to a problem that has plagued scientists for decades: the tendency of chemical buffers used to maintain the pH of laboratory samples to lose their efficacy as the samples are cooled. The research team, headed by chemistry professor Yi Lu, developed a temperature-independent pH (TIP) buffer that maintains a desired pH at a range of low temperatures. The study appears this month in Chemical Communications. Sublingual Vaccines Administering flu vaccines under the tongue may be more effective and offer more protection than injecting or inhaling the drug, a study with mice in South Korea has found in an article published in the Proceedings of the National Academy of Sciences. India's Energy Reserves India’s oil reserves will last just another 19.3 years at the current rate of production, according to the BP Statistical Review of World energy 2007, which was released by the British multinational company. India is in the company of Australia, Italy and Brazil, whose reserves are also projected to last for 20 to 21 years from now. Iraq and Kuwait’s reserves are expected to last for more than 100 years at their current rate of production, while that of Saudi Arabia is projected to last for another 66 years. At the present level of exploitation of coal reserves, the coal deposits in India may not last long either. Based on the speculation about the reserves of crude oil and coal, India would become a net importer of crude oil and coal after two to three decades which are not far away. China Surges Past India China's willingness to get aggressive in protecting biopharma's intellectual property is being credited with its surge past India in the total number of completed and ongoing clinical trials. High Court of Tamilnadu in Chennai ruled against Novartis on Gleevec, which is helping accelerate a trend away from the Indian continent. Meanwhile, China's generics industry is gearing up for an onslaught on the U.S. market. A drug maker this summer won the first FDA approval for a Chinese-made pill, in this case, an HIV remedy; others aren't far behind. And when you consider that India's drug exports were few and far between just 10 years ago--and how that country's drug industry has affected pharma since--it's clear that a Chinese push could send enormous ripples through the market. The country already has a big presence in active-ingredient manufacturing. That's a base generics-makers can build upon fairly quickly. Indo-French Nuclear Deal Nuclear scientists in India and France will be working more closely together after several agreements were signed on 25 January during French President Nicolas Sarkozy's visit to New Delhi. Indian researchers will participate in the construction of the Jules Horowitz research reactor, being built in Cadarache, France. They will also work with scientists at the GANIL heavy-ion accelerator in Caen. Under another agreement, a neuroscience laboratory will be set up in India by India's National Brain Research Centre, the University of Paris and French medical research centre INSERM. Delhi University and Grenoble University will set up two new joint master's programmes, in nanosciences and nuclear engineering. And additionally, India's Council of Scientific and Industrial Research and its French counterpart the CNRS will partner in green-chemistry approaches to find therapeutic agents for cancer and neurological disorders. Roughly half of India's 1.1 billion citizens have no electricity — instead millions of villagers use biomass and cattle-dung cakes to provide the energy for heating and cooking. Cities are polluted with particulate matter from diesel engines and coal-fired plants. Development threatens ecosystems and animal species such as the iconic tiger. Meanwhile, India's economy craves energy to feed its impressive nearly double-digit growth in gross domestic product — leaving some worried about its growing carbon footprint. Use of alternative energy sources such as wind, biofuels and solar power is being expanded, but their contributions are dwarfed by demand. Even as the country churns out thousands of scientists and engineers, energy and environmental policies lie fallow — there is sometimes insufficient political will for them to become engines for change. To compound matters, the country's ministries often fight among themselves for power and leverage. Good science and science policies need a government that helps rather than hinders — they also need good scientists. Science, Technology and environment budget for 2005-06 was a pitiful 3% equivalent of USD 3 billion. In the US, the NIH alone invests over $28 billion annually in medical research. More than 80% of the NIH’s funding is awarded through almost 50,000 competitive grants to more than 325,000 researchers at over 3,000 universities, medical schools, and other research institutions in every state and around the world. About 10% of the NIH’s budget supports projects conducted by nearly 6,000 scientists in its own laboratories, most of which are on the NIH campus in Bethesda, Maryland. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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