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5110 Kali Era, Sarvadhari
Vikramarka Era, Sarvadhari
Pharma Giants to Collaborate
Three of the biggest pharma companies on the planet are joining forces to
back an unusual venture aimed at developing "breakthrough" discovery technology
that can reduce the frequency of trial failures and save them huge amounts
of money. Eli Lilly, Merck and Pfizer--which often compete on new therapies--are
joining forces with PureTech Ventures to provide $39 million to finance the
launch of Enlight Biosciences. Enlight in turn plans to spin off new companies
if the technology looks promising enough. Some of the new technologies the
collaboration will explore include finding ways to deliver drugs across the
blood-brain barrier and new biomarkers.
"Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical
companies are falling behind," Enlight co-founder Raju Kucherlapati, a genetics
professor at Harvard Medical School, told the Wall Street Journal. "The biopharmaceutical
industry has a great need for innovative enabling technologies that will
catalyze fundamental transformation of the drug discovery and development
process. A collaborative entrepreneurial initiative such as Enlight that
is dedicated to such technological innovation in R&D meets that need
in an ideal way. We are excited about our partnership with Enlight and its
team of world-renowned scientists," said Dr. Steven Paul, the executive vice
president, science and technology, at Eli Lilly.
Teva Gobbles up Barr
Teva Pharmaceutical Industries, the Israeli company and the world's largest
generic drug company, announced that it has agreed to acquire rival Barr
Pharmaceuticals Inc. for $7.46 billion, in a move that would give a significant
boost to its leadership in the U.S. market and strengthen its position in
Europe. The total deal value is $7.46 billion plus about $1.5 billion
of net debt, the two companies said in a statement. Under the terms of the
agreement, Teva will pay $39.90 in cash and 0.6272 of an American Depositary
Receipt for each Barr common share.
Teva's purchase means that a huge amount of shekels will have to be exchanged
to dollars, putting upward pressure on the rate. The result is the opposite
of the purchase of an Israeli firm for $4.4 billion by American investor
Warren Buffet more than two years ago. The exchange rate was as low as 3.20
shekels to the dollar a week ago.
FDA in India,
China, Europe and Latin America
Faced with the globalization of drug production, the United States is joining
with Europe and Australia to inspect factories in countries like China and
India that make an increasing share of the active ingredients in medications.
Bush administration officials said the agreement will allow regulators to
coordinate their inspections and share information, thereby covering a wider
territory and more foreign facilities.
The globalization of pharmaceuticals took on new focus last spring after
the blood thinner heparin — made with active ingredients from a Chinese facility
— was linked to dozens of deaths and hundreds of severe allergic reactions
in this country. The drug was recalled by Baxter International and the U.S.
blocked imports from the Chinese company.
The Food and Drug Administration found the heparin was contaminated with
a nutritional supplement that costs less, but mimics the real drug in routine
tests for potency, and thus was not detected. Investigators suspected deliberate
contamination. The FDA had not previously inspected the Chinese facility
because of a mix-up. And neither had Chinese drug safety regulators, because
the plant was registered as a chemical factory. The FDA expects to
soon open offices in three Chinese cities — Beijing, Shanghai and Guangzhou.
Thirteen employees would be assigned to work there.
The FDA wants to set up operations in India this year or in early 2009 to
improve oversight of food, medicines, medical devices and animal feed imported
into the U.S., Deputy Commissioner Murray Lumpkin announced. The agency is
preparing to open offices in China, India, Europe and Latin America by the
end of 2009. The agency also intends to set up offices in the Middle East.
The Senate Appropriations Committee unanimously passed an appropriations
markup measure, providing the FDA with a $2.04 billion fiscal 2009 budget.
Also, the FDA announced launching a two-year fellowship program aimed at
attracting scientists, engineers and health professionals to the agency.
The FDA Commissioner’s Fellowship Program will provide participants with
advanced training in the scientific analysis involved in the safety and regulatory
decisions unique to the agency’s mission.
Phase I Drugs From GMPs
More than two years after withdrawing a final rule that would have exempted
investigational drugs in Phase I testing from certain good manufacturing
practice (GMP) regulations, the FDA is issuing a final rule to do just that.
The new rule, which amends the GMP regulation with the exact same language
as the withdrawn rule, was published in Tuesday’s Federal Register. Slated
to take effect Sept. 15, it will apply to small-molecule drugs and biologics,
including vaccines and gene therapy products.
Roche on Buying Spree
Roche, a world-leading healthcare company, announced that it has proposed
to acquire the outstanding publicly held interest in Genentech, a leading
biotechnology company, for US$89.00 per share in cash, or a total payment
of approximately US$43.7 billion to equity holders of Genentech other than
Roche. Roche acquired a majority in Genentech in 1990 and currently owns
55.9% of all outstanding shares. The combined entity will be the seventh
largest U.S. pharmaceuticals company in terms of market share. It will generate
more than US$15 billion in annual revenues and will employ around 17,500
pharma employees in the U.S. alone, including a combined sales force of approximately
3,000 people. Including diagnostics, the Roche Group will employ around 25,000
people in the U.S. By reducing complexity and eliminating duplicative
functions in areas like development, manufacturing, corporate administration
and support functions, the combination will result in lean and efficient
Market and regulatory forces are driving biotech and Big Pharma closer together.
For 30 years the biotech industry has led a free and unobstructed life. Companies
that develop biologic remedies such as Genentech, Amgen, Gilead Sciences
and Genzyme have been free to flourish without many of the regulatory and
competitive pressures that giant pharmaceutical companies face. That relative
freedom allowed global biotech sales to grow 12.5 percent (to $75 billion
last year), compared to a 6.4 percent rate of sales growth for Big Pharma
Soon, there are going to be heavier burdens placed on biotech over the next
five or so. Biotechs are likely to experience greater competition in
disease areas like cancer from big drug companies that have bought smaller
biotechs or developed alliances with them. Meanwhile, the regulatory picture
for biotechs is radically changing. As drugs from the first wave of biotech
approvals two decades ago are approaching patent expiration, patients, doctors
and insurers are demanding inexpensive alternatives to biotech drugs. Congress
and the Food and Drug Administration are under pressure to fashion a new
regulatory pathway for federal review and approval of generic biotech drugs,
or "biosimilars." In June 2007, the Senate health committee passed
the "Biologics Price Competition and Innovation Act," a law that seeks to
allow biosimilars into the marketplace.
Also, Roche and Mirus Bio Corporation announced that they have entered into
a definitive agreement under which Roche will acquire Mirus Bio Corporation,
a privately-owned US company based in Madison, Wisconsin, that focuses on
the discovery and development of innovative nucleic acid based technologies,
including a proprietary RNAi (Ribonucleic Acid interference) delivery platform.
RNAi, a mechanism that the body uses to 'silence' certain genes, represents
a potential whole new class of therapeutics for difficult to treat diseases.
The major challenge of this promising technology has so far been the transport
of RNAi molecules into the target cell. Mirus' delivery platform provides
an innovative way of effectively getting RNAi therapeutics to specific disease
Roche and ARIUS Research Inc. announced that the two companies have signed
a definitive agreement for Roche to acquire ARIUS in an all-cash transaction
at a price of approximately C$191 million. ARIUS is the developer of a proprietary
antibody platform called FunctionFIRST(TM), which rapidly identifies and
selects antibodies based on their functional ability to affect disease before
progressing into clinical development. The FunctionFIRST(TM) platform will
allow Roche to further strengthen its developmental portfolio, initially
within the areas of oncology and inflammatory diseases where this new technique
offers potentially broad therapeutic applications.
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,
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