The Indian American Chemical Society (TIACS), Please send an email to:
5109 Kali Era, Sarvajit
Vikramarka Era, Sarvajit
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
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
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.
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.
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
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.
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
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.
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
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, Bayarea.com, Chicago Tribune,
USA Today, Intellihealthnews, Deccan Chronicle
(DC), the Hindu, Hindustan Times,
Times of India, AP, Reuters, AFP,
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