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5111 Kali Era, Virodhi
Vikramarka Era, Virodhi
Year, Ashada month
A U.S. Senate committee decided to give the biologic drugs 12 years of market
exclusivity, despite populist and short-sighted efforts by opponents to limit
the exclusivity at 5 or 7 years. This is a limitation that didn’t
exist before and there was no path for biosimilars’ approval thus far.
The sale of generic versions of most brand-name medicines is permitted after
patent/market exclusivity expires, but not complex biotech drugs. This measure,
which passed 16-7, calls for the sale of lower-cost generic versions of the
complex drugs, 12 years after the FDA approves the brand-name version.
The 12-year limit still needs approvals from the full Senate and the House.
Exclusivity refers to years of sales that a brand-name product gets before
a lower-cost generic or an improved product that relies on the brand-name
data can be approved by the Food and Drug Administration. It is separate from
patent protection, but runs concurrently. Generic-drug makers would have
to wait for both to run out before marketing their products.
Current US laws, which provide for generic competition on chemical pills,
don’t allow for cheaper copies of complex drugs made from living cells, because
they are very difficult to replicate and dangerous, unlike small-molecule
chemical pills. So, at present there is path for generic approval for vaccines
Large molecule biologics, such as vaccines and antibodies, are grown in
living organisms, such as cells or animals. Almost any difference in the
cell line or growth conditions can alter the resulting protein product, particularly
since its biological effects depend on glycosylation and other post-translational
modifications, as well as on the protein's amino acid sequence. Different
placement of a single carbohydrate can cause the biologic to react completely
differently in the body. Aside from allowing more time for competitors to
test their follow-on products for safety and efficacy, the longer period
gives the original maker a longer time to earn profits after spending hundreds
of millions of dollars on research and development. The expected average
cost of an approved biologic is about $1.2 billion.
In general, most countries outside the US and Europe allow copies after
five to seven years of exclusivity and do not develop any new drugs.
India doesn’t allow any market exclusivity and, no new branded products have
been marketed in India or outside of India, by the indian indigenous industry
so far. In the US, where there is a strong patent regime, patents will
give biotech companies more protection than any of the bills now in circulation.
However, patent protection is 20 years from filing date of a patent application,
and most of it is wasted during the development of the drug, clinical trials
and FDA approval process.
In Canada, under the regulations, an "innovative drug" that contains a medicinal
ingredient not previously approved in a drug by Health Canada is entitled
to an eight-year term of data protection. This term can be extended for an
additional six months for pediatric population submissions. If a subsequent
manufacturer seeks approval of its product on the basis of a direct or indirect
comparison with an innovative drug marketed in Canada, the manufacturer 1)
may not file its drug submission for six years; and 2) will not receive marketing
authorization for eight years (or eight years and six months) from the date
that the innovative drug was approved for sale.
The Canadian Guidance on Data Protection indicates that this prohibition
(data exclusivity for 8.5 years) will apply to a new drug submission for
Subsequent Entry Biologics (SEBs) or so called biosimilars where approval
is sought on the basis of a comparison to an innovative drug. The two key
features in an SEB submission are 1) a comparison to a reference product,
and 2) a reduced data requirement due to reliance on data previously generated
for the reference product by the innovator at high cost. Furthermore,
Health Canada intends to amend the Guidance on Data Protection to confirm
that data protection extends to an innovative drug when it is indirectly compared
to an SEB by virtue of a foreign reference product. As for patent protection,
when a non-Canadian reference biologic is substituted for the Canadian product
and a link is established to a drug marketed in Canada, this would be considered
a comparison that would trigger the data protection regime.
Several Canadian patents covering biologics have either recently expired
or will expire shortly; numerous SEB approvals are thus expected in the coming
years. Health Canada has indicated that a number of SEB submissions are pending
and so the industry is bracing for the arrival of additional SEBs into the
Drug Discovery: How it Happens - A Discussion: http://pipeline.corante.com/archives/2009/07/31/where_drugs_come_from_and_how_once_more_with_a_roll_of_the_eyes.php
Drug Approval Statistics: http://pipeline.corante.com/archives/2009/07/17/drug_approvals_natural_and_unnatural.php
Johnson & Johnson Buys Elan
Johnson & Johnson agreed to pay $1 billion for a stake in Elan Corp.
and will develop the Irish drugmaker’s medicines against Alzheimer’s disease.
J&J has one Alzheimer’s drug, Razadyne, which generated $541 million in
sales last year. Eli Lilly & Co. has two drugs in late stage testing,
an antibody treatment that would compete with bapineuzumab, and a type of
compound called gamma secretase inhibitor. Bristol-Myers Squibb Co. is also
working on a gamma secretase inhibitor in early human testing. The deal
with Elan gives J&J “access to a late-stage, first-in-class drug that
has the potential to delay disease progression for Alzheimer’s patients.
The Alzheimer's Immunotherapy Program (AIP) is a collaboration between Elan
and Wyeth to research, develop, and commercialize immunotherapeutic approaches
that may be used to treat and possibly prevent the onset of Alzheimer's disease.
The AIP is committed to researching the burden of care and cost of AD as well
as developing tools that help advance these efforts. The AIP is also currently
conducting clinical trial enrollment throughout Europe and the United States
for its lead investigative compound bapineuzumab.
Also, Johnson & Johnson has bought Cougar Biotechnology, which has a
pipeline focused on oncology, for almost US$1 billion. The company's lead
compound is abiraterone, an inhibitor of cytochrome P450 17 (CYP17), an enzyme
involved in androgen and oestrogen biosynthesis, which has recently shown
positive Phase II results in castration-resistant prostate cancer (CRPC).
Sanofi Buys Shantha
Sanofi-Aventis SA, France’s biggest drugmaker, agreed to take control of
Shantha Biotechnics in an acquisition valuing the Indian vaccine maker at
550 million euros ($784 million). Under terms of the agreement, Sanofi’s
vaccine unit will buy ShanH, which owns 80 percent of Shantha Biotechnics,
from the Merieux Alliance, Paris-based Sanofi said in a statement. The French
drugmaker is paying about 440 million euros for the purchase. The transaction
is set to close before the end of the third quarter, Sanofi said. The
purchase gives Sanofi a platform in India as well as access to Shantha’s pipeline
of new products, including an experimental typhoid vaccine. Prior to this
acquisition, Sanofi’s Indian operations had a total of 2,870 employees, mostly
based in Mumbai. Shantha brings in the low-cost production facilities that
ease access to emerging markets. Sanofi Pasteur, the French drugmaker’s
vaccine unit, will support Shantha’s development. Varaprasad Reddy, who founded
the Indian vaccine maker in 1993, will continue leading Shantha as managing
Hyderabad-based Shantha is expected to have sales of about $90 million for
the current fiscal year, Sanofi said. Shantha was the maker of the first recombinant
Hepatitis B vaccine produced in India in 1997 and the maker of numerous combination
vaccines. Shantha’s drugs under development were of particular interest
to Sanofi-Aventis. These include: rotavirus vaccine, conjugated typhoid vaccine,
and human papilloma virus vaccine. The deal is a sign of increased
international interest in the India biotech sector. Sanofi-Aventis
has in the past few months completed the purchase of smaller generic drugmakers
in Czech Republic, Mexico and Brazil, as well as Zentiva, which has operations
concentrated in eastern Europe and Turkey. Most recently, Sanofi-Aventis
agreed to pay $500 million for Brisbane, California-based BiPar Sciences,
which is working on a new cancer treatment. According to a report Sanofi-Aventis
will set aside 30 billion euros over three years for acquisitions.
GlaxoSmithKline, the UK-based pharmaceutical group, recently agreed a series
of licensing deals with generics drugs producers in India and South Africa.
Pfizer, the world's largest pharmaceuticals group, has also agreed partnerships
with two Indian generic groups currently involving no equity stake.
Bristol-Myers Squibb Company and Medarex, Inc Merge
Bristol-Myers Squibb Company and Medarex, Inc. announced in July that the
companies have signed a definitive merger agreement providing for the acquisition
of Medarex by Bristol-Myers Squibb, for $16.00 per share in cash. The transaction,
with an aggregate purchase price of approximately $2.4 billion, has been unanimously
approved by the boards of directors of both companies. Medarex’s projected
$300 million in net cash and marketable securities at closing would be an
asset acquired by Bristol-Myers Squibb resulting in an implied purchase price
of approximately $2.1 billion. Acquires Proven Antibody Discovery Technology.
Gains Full Rights to Promising Phase III Compound, Ipilimumab. Significantly
Expands Oncology and Immunology Pipeline. Medarex’s UltiMAb Human Antibody
Development System®, which produces high affinity, fully human antibodies
for use in a broad range of therapeutic areas, including immunology and oncology.
This validated technology platform has produced compounds which are now currently
marketed therapies (SIMPONI™, STELARA™ and ILARIS®). Medarex’s next-generation
Antibody-Drug Conjugate (ADC) technology, which is a novel and proprietary
platform that could open new fields in oncology drug development. Rights
to seven antibodies in clinical trials under Medarex’s sole sponsorship and
three other antibodies being co-developed with other partners. Rights to
pre-clinical assets in various stages of development by Medarex -- in particular,
monoclonal antibodies focused in oncology and immunology.
Genentech/Roche has taken 156,000 square feet of space at 500 Forbes Blvd.,
formerly occupied by Cell Genesys in South San Francisco, and is reportedly
on the hunt for more. Roche is closing manufacturing and cutting back-office
jobs in Nutley, N.J., letting loose more than 1,300 people in the process.
Roche is well on its way to shuttering its research facility in Palo Alto,
shifting hundreds of positions to South San Francisco and New Jersey, while
another 500 or so flat-out lose their jobs. Many biotech firms are
tightening the belt these days - Amgen, Affymetrix, Celera, Nanogen, Life
Technologies, Elan etc are all laying off.
Thousand Oaks-based Amgen laid off about 100 employees on July 22.
The most recent round of cuts was among the company’s clinical manufacturing
and quality-control workers. Previously, on May 1, Amgen laid off about 100
workers as part of an outsourcing of the company’s facilities services group.
Amgen has steadily reduced its workforce since hundreds of layoffs were announced
in the summer of 2007. The most recent cuts are part of the company’s ongoing
evaluation of staffing levels.
Celera also nnnounced cost-saving measures, which include a restructuring
program to reduce headcount by approximately 13%.
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Chicago Tribune, CNN, USA Today,
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