The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
(dedicated to Andhra, My Mother's Homeland)

Chief Editor: Prof. Sreenivasarao Vepachedu
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Issue 44

5109 Kali Era, Sarvajit Year, Kartika/Margasira month
2065 Vikramarka Era, Sarvajit Year, Kartika/Margasira month
1929 Salivahana Era
Sarvajit Year, Kartika/Margasira month
 2007 AD, November





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Phase Forward in Hyderabad
Phase Forward, a provider of data management solutions for clinical trials and drug safety, announced the establishment of a wholly owned subsidiary, Phase Forward Software Services India Private Limited, based in Hyderabad, India. In building this subsidiary, Phase Forward will be working with current partner Virtusa Corporation, a leading global information technology (IT) services company. Virtusa ranked 80 on the list of financial technology companies that were judged according to their global revenues. Phase Forward’s Hyderabad center will be situated within Virtusa’s facilities.

Schering-Plough Corporation announced that it has completed the acquisition of Organon BioSciences N.V., creating a stronger combined company with broader human and animal health portfolios, an enhanced pipeline and increased R&D capabilities. Schering-Plough's agreement to acquire Organon BioSciences was announced on March 12, 2007. Organon BioSciences is comprised primarily of Organon, a human health business, and Intervet, an animal health business. It also includes Nobilon, a human vaccine development unit, and Diosynth, a third-party manufacturing unit of Organon. Schering-Plough acquired Organon BioSciences from Akzo Nobel N.V. for approximately euro 11 billion in cash.

Pfizer Inc announced it has entered into an agreement to acquire Coley Pharmaceutical Group, Inc., a publicly-held biopharmaceutical company specializing in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, allergy and asthma disorders, and autoimmune diseases.

Genzyme Corp. said it will acquire the diagnostics division of Diagnostic Chemicals Limited, a Canadian-headquartered manufacturer of medical diagnostic products. With this agreement, Genzyme is acquiring DCL's line of more than 50 formulated clinical chemistry reagents, which generated approximately $21 million in revenue during the company's 2007 fiscal year, according to Genzyme.

FDA Approvals
ABILIFY: Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY(R) (aripiprazole) as adjunctive, or add-on, treatment to antidepressant therapy (ADT) in adults with major depressive disorder (MDD). ABILIFY is the first medication approved by the FDA as add-on treatment for MDD that affects millions of U.S. adults at some point in their lives. Depression is one of the leading causes of disability in the U.S. In 2000, the total economic burden of treating depression in the U.S. was $83.1 billion, with workplace costs, including missed days and lack of productivity due to illness, accounting for the majority of the total economic burden (62 percent). Other economic burdens in 2000 included $26.1 billion (31 percent) for treatment costs and $5.4 billion (7 percent) for suicide- related costs. Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the development and commercialization of ABILIFY in the United States and major European countries.

NEXAVAR: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (about 19,000 in the United States, 54,000 in Europe, and 390,000 in China, Korea and Japan) and incidence is increasing. In 2002 approximately 600,000 people died of liver cancer including 13,000 in the United States, 57,000 in Europe and approximately 360,000 in China, Korea and Japan. Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent.

SEROQUEL: AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients. On May 17, 2007, the FDA approved SEROQUEL XR for the acute treatment of schizophrenia in adult patients. Launched in 1997, SEROQUEL has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the US in 2007, and clinical development programs and regulatory filings are planned for a number of other indications.  Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for long-term treatment options for schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes. Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions, affecting over 2 million American adults -- about 1% of the population 18 years and older.

MIRCERA: Roche announced that the U.S. Food and Drug Administration (FDA) has approved MIRCERA (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis. CRF is commonly known as chronic kidney disease (CKD). MIRCERA is the only FDA-approved erythropoiesis-stimulating agent (ESA) to provide correction of anemia with once-every-two-week dosing. MIRCERA is also the only FDA-approved ESA to maintain stable hemoglobin levels with once-monthly or once-every-two-week dosing in CKD patients. MIRCERA offers the added convenience of storage at room temperature for extended time periods when necessary. The outcome of an ongoing patent case will determine when patients can gain access to MIRCERA in the United States. Following approval by the European Agency for the Evaluation of Medicinal Products (EMEA), MIRCERA has already been launched in Austria, Sweden, Germany, the United Kingdom and Norway, and will continue its international rollout.

KALETRA (R): Abbott today announced that it has received U.S. Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra(R) (lopinavir/ritonavir), which is also marketed as Aluvia(R) (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the U.S. this month.

Abbott is awaiting EMEA marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. The soft gel capsule formulation of LPV/r is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in additional 45 countries for this formulation.

Indian Pharmaceutical Industry
India's pharma industry is finally coming of age. R&D investments now account for as much as 7-9% of sales.  Leading companies who are developing new molecules include Ranbaxy, Glenmark and Dr Reddy's. Over last couple of years, Indian pharmaceutical companies have stepped up their R&D spends, following a patent product regime. At present, nearly 10-12 companies have molecules under various stages of development.

Dr Reddy's is the first Indian company to take a molecule - DRF2593 (Balaglitazone) to Phase III clinical trials. Balaglitazone is an oral anti-diabetic drug, are progressing well. Glenmark has six NCEs in the pipeline and expects its lead candidate for Asthma/COPD, Oglemilast, to be the first one to be launched commercially. This molecule has been out-licensed to Forest for development and marketing in North America (2004) and to Teijin Pharma (2004) for Japan.,prtpage-1.cms

Merck, Lilly and Mumbai-based NPIL

Mumbai-based NPIL signed drug discovery deals with Merck and Lilly this year.
NPIL will undertake a wide range of drug discovery activities, including identifying leads, performing preclinical work, and supervising trials on humans. NPIL has agreed to develop new cancer drugs for two targets provided by Merck & Co. Merck will have the option to buy the rights to compounds developed by NPIL after the drug candidates successfully get through Phase IIa of clinical trials. The Indian firm will earn as much as $175 million in milestone payments for each target, as well as royalties on pharmaceuticals that Merck commercially launches. NPIL researchers identify promising lead compounds mostly by drawing on the company's library of 40,000 natural product extracts. At present, an NPIL drug candidate that aims to treat multiple myeloma, a blood cancer, is undergoing human trials in the U.S. at Dana-Farber Cancer Institute. Earlier this year, NPIL signed a research agreement with Eli Lilly & Co. under which NPIL agreed to license a preclinical drug candidate. Under that deal, Lilly has the option to re-license the compound for as much as $100 million after NPIL completes clinical studies up to Phase III

Shopping The World
Chinese and Indian firms got their feet in the contract-research door in the mid-1990s by performing relatively simple tasks, such as high-throughput screening, that did not involve the sharing of much sensitive intellectual property (IP). This coincided with big pharmaceutical companies' belief that large-scale screening of compound libraries was a magic tool for generating great drug candidates. The rush for generic libraries is over. And firms in China and India can no longer solely rely on their cost advantage, because salaries have been rising rapidly in both countries. Meanwhile, buyers are increasingly interested in working with contractors that offer specific technologies or, more important, an integrated range of services in biology and chemistry….  No country has a monopoly on good chemists….  Ukrainian and Russian CROs began offering services that required more sophisticated synthetic and medicinal chemistry know-how.

Foreign Drugs Get Little Scrutiny by FDA
While nearly all U.S. drug makers are inspected at least once every two years, foreign manufacturers can go eight or more years between inspections, according to congressional investigators. While the domestic inspections are mandated by a law drawn up long before imports seized a sizable chunk of the drug market, there is no such requirement that the FDA conduct foreign inspections with any regularity.

Prescription drugs and drug ingredients pour into the United States from an estimated 3,000 foreign companies, though the real number is unknown and could be as high as 6,700, congressional inspectors said in a memo to members of the subcommittee.  The FDA plans to inspect just 300 foreign drug firms this year, announcing in advance its intent to do so each time. Of those inspections, most are of plants that make drugs awaiting FDA approval. Just 15 are of the type of periodic assessment meant to ensure a company's products remain safe in the years following FDA approval, though some pre-approval inspections also include some post-approval surveillance.

In contrast, the FDA comes close to inspecting the roughly 3,300 domestic drug manufacturers once every two years as required.  An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad.

Patent Reform Is About Wealth, Who Should Have It?
Attempts to alter the processes associated with creating, licensing and killing patents have waxed and waned. For the past 20 years, they have been failures. But this time reform will happen, and the reason is the growing sensitivity to a form of redistributing wealth, says Charles R. Neuenschwander of the International Patent Licensing Co.

Cough Medicine for Dyskinesias in Parkinson's
A cough suppressant and a drug tested as a schizophrenia therapy curb the involuntary movements that are disabling side effects of taking the Parkinson's disease medication levodopa, Portland scientists have found. Dextromethorphan, used in such cold and flu medications as Robitussin, Sucrets, Triaminic and Vicks, suppresses dyskinesias in rats, researchers at Oregon Health & Science University and the Portland Veterans Affairs Medical Center found. Dyskinesias are the spastic or repetitive motions that result from taking levodopa, or L-dopa, over long periods.

UN Report on Global Warming
The United Nations' Intergovernmental Panel on Climate Change (IPCC) has delivered its strongest warning on the coming impact of global climate change in November. UN Secretary-General Ban Ki-Moon stressed that the current IPCC report holds out the hope that "concerted and sustained action now can still avoid some of the most catastrophic scenarios" that are described in the IPCC analysis. Such scenarios include increases in sea level due to thermal expansion of the oceans; increases in the frequency of temperature extremes, heat waves, and heavy precipitation in parts of the world; and widespread impacts on human health. "I can tell you with assurance that global, sweeping, concerted action is needed now," Ki-Moon said during the press conference, "There is no time to waste."

"We have brought out an extremely policy-relevant document," said IPCC Chairman Rajendra K. Pachauri at the UN press conference in Valencia, Spain, announcing the report. "If this does not provide a strong scientific basis for those who are responsible for forming climate-change policies all over the world, then I'm afraid there is nothing else we can do….We really need a new ethic where every human being faces the challenge and starts to take action through changes in their lifestyle, attitude, and behavior," he said.

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, 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.

Copyright ©1998-2007
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2007.  All rights reserved.  All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for special medical conditions or any specific health issues or starting a new fitness regimen. Please read disclaimer.

Om! Asatoma Sadgamaya, Tamasoma Jyotirgamaya, Mrityorma Amritamgamaya, Om Shantih, Shantih, Shantih!
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
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