- Bird flu antidote
Indian
pharma companies are gearing up to produce anti-viral drugs and vaccines. Will
they then be able to meet intensified domestic and global demand? M
G Arun IF the current paranoia about avian flu presents
a business opportunity, the Indian drugs industry is certainly not willing to
miss the bus this time. India’s Cipla was the first such generic company
to say that it would come out with a generic version of Tamiflu by Dec-Jan 2006.
It is planning to introduce the drug in India, where the company expects
the government would invoke compulsory licensing in case of a bird flu pandemic.
This has pitted Cipla against Roche, which has said it will roll out its first
batch of Tamiflu drug in India by February 2006, with a prohibitive price tag
of Rs 1,800 for 10 tablets. Roche is also said to be planning to license out the
drug to generic players like Ranbaxy, Teva, Mylan and Barr for production. It
is expected that Cipla, which has previously challenged MNCs with low-price drugs
including its cheap cocktail of AIDS drugs, would place the drug at prices much
below than Roche’s, in case it is allowed to market the drug here. Dr Y K
Hamied, chairman, Cipla had said: ‘‘When there is an international emergency,
you cannot depend on one company (to supply the drugs needed).’’ Nicholas
Piramal India Ltd is working on an anti-viral drug that can treat the bird flu
virus, according to the company’s director Dr Swati Piramal. The company
is at present mining its plant library to identify herbal extracts which can be
converted into the anti-viral drug, and is expected to come out with the drug
in a year’s time. Virus
Attack According to medical experts, most avian influenza
viruses do not infect humans. However, in case an avian and a human influenza
virus co-infect a human or a pig, the possibility is that the virus strains can
join, mutate and create a completely new virus. This virus may be get transmitted
from animals to humans, and from humans to humans. Experts also say such a strain
of virus would have entirely new in composition, which makes vaccines available
today ineffective. Experts also believe the next influenza pandemic could result
from such a mutaion of virus strains. Ranbaxy too says its
fully prepared. Its CEO Brian Tempest said: ‘‘We had already developed
the systems and processes for producing Tamiflu a year back. Now, we are getting
in touch with various governments to gauge their interest in this product. We
can commercialise production in a couple of months.’’ The company will
begin talks with Roche soon. A spokesperson of Panacea Biotech, which has a tie-up
with Chiron for vaccine production, said the company would not like to make any
comments unless it has some concrete plans in place. Industry observers
believe that indifference shown by major pharmaceutical companies to manufacturing
vaccines in recent years has added to the impending crisis. Vaccine manufacturing
is no longer considered a profitable venture, with its markets getting shrunk
to underdeveloped and developing regions of the world. However, the recent outbreak
of bird flu in various parts of the world has brought the issue into sharp focus
as the requirement is now global. HSBC, however, has said the flu opportunity
may not bring in Cipla the big revenues that is expected. This is since Tamiflu,
patented on 26 February 1995, will be under patent protection in India, and the
procedures for compulsory licensing will be time consuming. Moreover, although
Cipla can bring small quantities to the market by 2006, it will take one to two
years to bring large commercial quantities to the market. The avian
flu that occurred among poultry in eight countries in Asia - Cambodia, China,
Indonesia, Japan, Laos, South Korea, Thailand, and Vietnam - during late 2003
and early 2004 is now threatening to grow in global proportions. Bird flu viruses
do not usually infect humans, but several cases of human infection with bird flu
viruses have occurred since 1997. Recent reports say that 60 people have died
of the disease in South East Asia, although only one report points at human to
human infection. Experts also opine that the need of the hour is to
generate enough vaccines to address the flu threat, for which big pharma companies
need to share or license their innovations out to smaller companies. Reports also
talk about certain alliances and enhancement of production already in the offing,
where large pharma companies including Merck and GlaxoSmithKline are eyeing acquisition
of smaller biotech companies for vaccine production. Currently no vaccine
is available to protect humans against the H5N1 virus that is being seen in Asia.
However, vaccine development efforts are under way. The USFDA says there are four
manufacturers distriuting influenza vaccine this year: Sanofi Pasteur, Inc., MedImmune
Vaccines, Inc., GlaxoSmithKline Biologicals, and Chiron. Roche, whose Tamiflu
sales have soared since the flu threat, recently received the USFDA approval for
an additional capsule manufacturing site for Tamiflu. Not to be left
behind, the Indian government is said to be drafting a plan, which aims at establishing
a surveillance mechanism to identify any cases of the flu infection in birds or
humans. This will be followed by the manufacture of these drugs for the market.
Anbumani Ramadoss, the union minister for health, has said that the government
is trying to set up an infuenza drug manufacturing facility in the country, although
how fast such a unit can begin production is in doubt. Although there
has been no cases reported in India so far, the threat to the country cannot be
ruled out. Dr Piramal of Nicholas Piramal adds, ‘‘It is said that the
flu can hit Mumbai within 180 days after it hits Hong Kong, primarily due to the
frequent air travel between these two regions. From Mumbai, it is easy for the
virus to spread to other parts.’’ Given the potential damage that any
such outbreak in the country can cause, the Indian industry seems to be waking
up to the threat faster than the governmental authorities. The Confederation
of Indian Industry (CII) has already suggested to the government the need for
mandatory registration of poultry farms, the bifurcation of poultry and pigs in
farms and the need to have a national discussion on the topic, amongst others.
With more companies willing to enter anti-viral and vaccine production, can India
arm itself against the possible bird flu attack? Or even contribute to alleviating
the problems of other countries. —With inputs form Ravi Krishnan URL:
http://www.financialexpress.com/fe_full_story.php?content_id=106316
- Embryo of light brightens frontier research
Sankar Sridhar
Saturday,
October 22, 2005 20:34 IST
Visiting
your friendly neighbourhood cell bank and ordering a 'lab-fresh' liver may not
be the impossible dream it looked a while back, thanks to a South Korea-US partnership
and the breakthrough in stem-cell research. Stem cell research came under
a cloud after religious and rightwing groups branded it unethical, because the
cells are produced by creating embryos that get destroyed in the process. Even
the Pope, on his visit to the US in 2001, had told President Bush that it was
"as evil as infanticide". The Bush administration imposed a ban
on scientists using government funds for therapeutic cloning (the technique used
to create new embryonic stem cells to grow new tissues for repair). In 2005, the
US government even lent its support to an alliance that called on the United Nations
to draw up a treaty banning all cloning, including therapeutic cloning. Federal
funds for embryonic stem cell research permit US scientists to carry out experiments
on 64 stem cell cultures in research facilities and law allows private investors
to fund research using therapeutic cloning. Thanks to Robert Lanza, a scientist
at the Massachusetts-based stem cell company, Advanced Cell Technology, scientists
are once again hoping that the government will loosen its purse strings to allow
extensive research in this field. Lanza has shown that embryonic stem cells can
be created without therapeutic cloning. In tests carried out on mice, the
researchers let fertilised eggs divide for 2-3 days until they formed a ball of
eight cells. They then removed one of these cells, and cultured it in a dish,
where it multiplied into a mass of cells, of which some were embryonic stem cells. To
make them grow normally, the researchers then re-implanted the rest of the cells
into 48 surrogate mothers (mice). They succeeded in developing foetuses in 29
of them - a rate, the scientists, said, comparable to those of in vitro fertility
clinics. The progress in research and the prospect of free flow of funds
in the future also hold out fresh hope for scientists working on treatments for
motor-neuron diseases such as Parkinson's and Alzheimer's, and even diabetes.
The hope of this cutting-edge science saving millions is further bolstered by
South Korean scientists agreeing to partner their American counterparts in creating
new embryonic stem cells. But KV Subramaniam, executive vice-president for
Reliance Life Sciences, views this breakthrough with suspicion. "This work
(of Robert Lanza) is based on mouse models and may take time to translate
to human models," he says. In India, unhindered by the ethical and
societal hurdles that have stymied US scientists, examples abound of how progress
in research could grant a new lease of life to the likes of Abhishek Sharma. Sharma
had almost completely lost his vision because of a degenerative corneal disease,
when Virender Sangwan, a surgeon of LV Prasad Institute, Hyderabad, decided on
a stem-cell transplant. Stem cells taken from Sharma's parents - to lessen the
chance of rejection - were sutured on his damaged eyes. The operation, which had
been tried only on a handful of people here, was a success. There are bigger plans.
India plans to set up a stem cell priority fund to support stem cell research
for the treatment of diabetes, and heart/nerve diseases. D Balasubramanian,
the chairman of the task force on stem cell research of the Department of Biotechnology
(DBT) says they have a proposal ready for an "exclusive fund for stem cell
research and…the government is keen to set up the stem cell priority fund". The
funding, so long reserved only for the DBT, will now be shared with the Indian
Council of Medical Research, the Department of Science and Technology, and Defence
Research and Development Organisation. The DBT budget has also been increased
from Rs400 crore last year to Rs500 crore this fiscal. A leading private company
has also pledged Rs200 million for stem cell research.
- Avesthagen
and TNO Sign Letter of Intent to Collaborate in Nutrigenomics
http://www.primezone.com/newsroom/news.html?d=88373
LEIDEN,
Netherlands, Oct. 23, 2005 (PRIMEZONE) -- Avestha Gengraine Technologies Pvt.
Ltd. of Bangalore, India, and TNO of the Netherlands have agreed to develop a
collaboration to join forces in developing new strategies to combat the worldwide
growth of obesity and related disorders. In the joint effort, longstanding knowledge
from traditional Indian medicine and state-of-the-art genomic research will be
integrated into a strategic collaboration aimed at finding new plant-derived bioactives
that manage and counteract development of overweight and associated later-stage
disease development.
The Letter of Intent was signed today on the occasion
of the visit to Avesthagen of a high level Dutch Business Mission presently touring
India. The LOI was signed by Avesthagen's CEO and Founder Dr. Villoo Morawala-Patell
and Dr. Kees Ekkers, Director of TNO Quality of Life and counter-signed as witness
by the Dutch Minister of Economic Affairs and Deputy Prime Minister, Laurens Jan
Brinkhorst, who is heading the Dutch Business Delegation. In the envisaged collaboration,
both parties intend to combine the best of two worlds, harnessing a wealth of
knowledge from India's rich history in traditional plant-based medicine by using
modern genomics-based research to unravel complex molecular networks in the human
body. The collaboration therefore is expected to yield new insights in managing
metabolic syndrome, diabetes, obesity and cardio-vascular diseases, threatening
many societies, at an early stage by developing new dietary solutions. TNO
and Avesthagen are excited about the perspectives of the collaboration. Kees Ekkers
praises Avesthagen's strong technology and business model by combining a solid
foundation into India's traditional medicine, having access to bioactive plant
extracts, with expertise in modern plant genetic technologies and a highly entrepreneurial
corporate management. This strategy has led to establishing a global network of
partnerships with front-runners in different markets within its first five years.
Villoo Morawala-Patell acknowledges TNO's international reputation in nutritional
research. "TNO has developed several very important human disease models
in animals. They also have a unique dynamic model for kinetic studies in digestive
physiology and a strong expertise in nutrigenomics research which is also expressed
by TNO's coordinating role in the multimillion euro EU project on Human Nutrigenomics."
Avestha Gengraine Technologies Pvt Ltd is India's leading Healthcare Technology
Group focused on the convergence between food and pharmaceuticals and the development
of preventive and potentially personalised medicine. TNO is the largest
science and technology organisation in the Netherlands, carrying out contract
research for companies, government bodies and public organizations and employing
about 5,000 people. TNO develops knowledge for important national and international
market clusters such as 'Agriculture and Nutrition' and 'Chemistry' and 'Pharmaceutics'.
- India,
Dutch Sign Biotech Deal
http://www.redherring.com/Article.aspx?a=14145&hed=India%2C+Dutch+Sign+Biotech+Deal§or=Industries&subsector=Biosciences
Two
countries aim to address healthcare and food security issues.
October 25, 2005
India
and the Netherlands signed an agreement on Tuesday for cooperation in biotechnology,
focusing on areas in healthcare and food security. Under the agreement,
signed between India’s Department of Biotechnology and the Netherlands’
Institutes of Higher Education, the two sides will invest $1.75 million and $2.5
million, respectively, as well as identify specific areas of cooperation in the
next three months. Specifying the interest areas, Indian Science and Technology
Minister Kapil Sibal said the Netherlands has technology to grow plants in saline
soil that could be useful for India. “We would also take up projects
to grow plants in conditions of biotic and abiotic stress,” said Mr. Sibal. Earlier,
TNO, the largest science and technology umbrella organization in the Netherlands,
which is part of the Dutch delegation to India, signed an agreement with a Bangalore-based
healthcare technology company, Avesthagen, to develop new products for obesity
and cardiac disorders.
TNO Quality of Life, one of the wings of TNO,
operates through a public/private partnership in its native country and spins
off firms as the research nears commercialization.
Both TNO and Avesthagen
propose to explore research models and genomics-based science to look at complex
molecular networks in the human body. They wish to identify new plant-derived
bio-actives related to obesity and later-stage disease progression. “After
initial exploratory work for six months, TNO plans to float a joint venture with
Avesthagen to commercialize and raise money abroad,” said Kees Ekkers, managing
director of TNO Quality of Life. TNO has developed several important human
disease models in animals. “They also have a unique dynamic model for studies
in digestive physiology and a strong expertise in nutrigenomics research, which
is also expressed by TNO’s coordinating role in the multimillion-euro EU
project on Human Nutrigenomics,” said Dr. Villoo Morawala Patell, chief executive
of Avesthagen. With this collaboration, said Dr. Patell, her company intends
to advance its food-for-medicine program through traditional Indian plant-based
medicines in tandem with Western validation methods. Posted on 25 Oct 2005
# ANI - India, Netherlands sign MoU for cooperation in biotechnology
New Delhi: India and
the Netherlands signed a Memorandum of Understanding (MOU) on Tuesday for cooperation
in the field of Biotechnology, an official release said.
The
MoU was signed by Minister for Science and Technology and Ocean
Development Kapil Sibal and Laurens Jan Brinkhorst, Deputy Prime Minister of the
Netherlands in the capital today.
The MoU aims at developing joint activities
between investigators of Institutes of Higher Education of Government
of Netherlands and Universities and Laboratories of India. It
also envisages setting up of 30-50 Ph.D. sandwich bursary projects for Indian
researchers working in the Indian research institution.
After signing
the MoU, Sibal said that both the countries had decided to identify key areas
of cooperation and would prepare a road map for the next one year in this regard.
While Brinkhorst emphasized on the need for biotechnological solutions for food
security and health care and said that this bilateral cooperation
would prove beneficial for public as well as private sector.
The joint
activities was aimed at developing tailor made biotechnology products, processes,
techniques and policy matters based on local consultation and local needs involving
joint research and development activities between the two countries, the release
said.
As per the memorandum, the specific areas of cooperation include
agriculture and food biotechnology and medical biotechnology besides cross cutting
biotechnology policy issues.
Projects would be developed in the areas
of molecular biology, plant breeding, and food processing technology, food nutrition,
bioorganic chemistry, microbiology, life-science developments, intellectual property
rights, bio-safety and others.
Investigators from both
countries would be invited to submit pre-proposals for initiating bilateral projects
in the coming months, while the first round of projects proposals selected based
on peer-review and the recommendations of a Joint Action Committee would be implemented
in the financial year 2005-06, it added.
http://www.newkerala.com/news.php?action=fullnews&id=41710
- Exclusive pharma park coming up near Vishakapatnam
Posted
online: Monday, October 24, 2005 at 0040 hours IST
MUMBAI, OCT 23: In order to provide an expansion base for the Indian pharmaceutical
companies, the Andhra Pradesh government is setting up an exclusive pharma park
near Vishakapatnam at an estimated cost of Rs 313 crore. The project is
being established at Parwada near Vishakapatnam in an extent of 2,200 acres under
‘public-private partnership’ involving Andhra Pradesh Industrial Infrastructure
Corporation Ltd (APIIC) and Ramky Pharma City India (RPC). “The pharma
city, called as Jawaharlal Nehru Pharma City (JNPC), is being set up to meet the
increasing demands of bulk drug manufacturers. Majority of them located in Hyderabad,
they were unable to expand due to environment issues. Hence this was envisaged
three years ago,” APIIC vice chairman and managing director Dr B P Acharya
said. —PTI - Drug companies in India keen on developing
bird flu drug
http://www.medindia.net/News/View_news_main.asp?t=ph&x=5402;
24 October 2005
The
government is likely to invoke the compulsory licensing (CL) provision in the
Patents Act that would enable domestic drug firms to produce and stockpile Swiss
drug maker Roche’s patented drug Tamiflu, useful in combating the global
threat against the most dreaded avian flu virus. Section 92 empowers the government
to issue CL without receipt of an application from the industry. Furthermore,
the issue of such license is independent of third party consent. The following
proposal is expected to help cope up with a public health emergency that might
arise in case the pandemic hits India. Once compulsory licensing has been issued,
manufacture of the drug can be initiated, to ensure both domestic and international
supply. The drug companies in India are more than willing to participate
in the initiative. Ranbaxy Laboratories has already initiated talks with the Swiss
pharma company regarding the issue. The company is also getting in touch with
governments across the world, interested in sourcing the drug from it. The
situation would however require a critical analysis of patents issue across the
world. It would be six months before the drug can actually be manufactured following
regulatory approvals. In response to the above situation, Roche has announced
it would not welcome interventions by generic drug makers in Tamiflu market, the
demand for which has increased manifold following reports that the pandemic has
reached Europe and SE Asia. Medindia on Bird Flu: Avian
influenza (AI) or Bird Flu is a disease of viral etiology that ranges from a mild
or even asymptomatic infection to an acute, fatal disease of chickens, turkeys,
guinea fowls, and other avian species, especially migratory waterfowl.
Indian
Government Sets Up Task Force For Avian flu The government of
India is closely watching the ‘Avian Flu’ that is spreading through
migratory birds from China. It has now formed a task force to tackle this emergency. The
task force is headed by Cabinet Secretary B.K.Chaturvedi and includes secretaries
of health, environment, animal husbandry and agriculture ministries. The inter-ministerial
task force is to formulate guidelines on how to tackle the problem if it does
occur in India and also ensure stockpiling of sufficient drugs. The group will
network with international agencies like the WHO and exchange information regularly.
Health Secretary P.K.Hota said: 'While the inter-group consultations would
take place everyday, the Cabinet Secretary would review the situation every fortnight.’
There have so far been almost 60 deaths due to the Bird Flu in the world and WHO
is predicting that it could get worse with time. The nodal agency that
would be in charge would be ‘National Institute of Communicable Diseases
(NICD)’ and it will network with National Institute of Immunology (Pune),
AIIMS (Delhi) and Antiviral Laboratory in Mumbai to screen people for the virus.
Stockpiling of Vaccines and drug like Tamiflu is another priority and The
Health Ministry has invited many Pharmaceuticals to help out. ‘We have spoken
to Roche, Cipla and Ranbaxy, and are looking into the licensing and patent issues,’
said an official from the Health Ministry. The government is following
the WHO Action Plan that classifies the disease in six phases. India is a Phase
I country as no cases have been reported so far. ‘While we have got the reagent
from CDC Atlanta, we have also formed our own testing kit,’ said Dr Shiv
Lal, the director of the NICD. New Generation Drug Discovery Software
Enters Market
Quantum Pharmaceuticals is issuing its first
commercial release of research software that is expected to speed up pharma R&D
radically and irrevocably change the drug discovery software market.
[ClickPress,
Tue Oct 25 2005] Quantum 3.1 is a suite of drug discovery software for
Linux and Windows designed to enhance stages of drug discovery workflows, such
as target identification, drug hit identification, lead identification and lead
optimization.
The Quantum software was developed using a new paradigm
in molecular modeling – applying quantum and molecular physics
instead of statistical scoring-function-like and QSAR-like methods.
The
key benefit of Quantum is the outstanding precision of molecular modeling and
calculations. Using Quantum 3.1, researchers can calculate the IC50 of protein-ligand
and protein-protein complexes, perform ligand docking, perform virtual screening
of small-molecule libraries, analyze large-scale protein movements, perform de
novo drug design and calculate the solvation energy and solubility.
Quantum
3.1 also helps detect potential moderate-to-serious adverse activity, additional
unexpected activity and broad relative selectivity for a library of compounds
by screening them against several hundred ADME/TOX-associated proteins.
The
Mutagenesis module of Quantum 3.1 provides an interface for changing the protein
sequence at specific sites through alterations to its amino acids and predicts
changes in the bioactivity after mutations.
The Quantum software was
successfully applied in different in-house and collaborative drug discovery projects
of Quantum Pharmaceuticals. As a result of applying Quantum software, the range
of the novel chemical inhibitor classes were discovered for disease targets, including
HIV-I integrase (AIDS), Beta-Secretase (Alzheimer’s disease),
Human Neutrophil Elastase (CF, COPD), FtsZ (TB) and some others. Quantum technology
has demonstrated itself to be very effective in creating revolutionary new medicine,
and it has demonstrated its ability to discover new classes of inhibitors.
The
free demo version of Quantum 3.1 can be downloaded from Quantum's web site. - Turmeric:
a hot topic in fighting disease
KNIGHT RIDDER NEWSPAPERS
October
25, 2005
WASHINGTON
- Turmeric, the Asian spice that makes curry yellow, not to mention French's mustard
and Hindu priests' robes, has yet another life: It's a promising potential weapon
against several cancers, Alzheimer's disease, cystic fibrosis, psoriasis and other
diseases.
"We know that it's an effective preventive at low doses,"
said Dr. Bharat Aggarwal of the experimental therapeutics department at the M.D.
Anderson Cancer Center in Houston. "The question is whether larger doses
can be therapeutic" for disease sufferers.
At least a dozen clinical
trials on humans are under way in the United States, Israel and England to test
the safety and dosages of turmeric's main ingredient, curcumin. It's a hot topic
in health journals, too, cited 967 times since 2000 in articles reported on PubMed,
the National Library of Medicine's research service.
Used for
centuries
The spice, which is a relative of ginger, comes from
the stems of the root of a large-leafed plant widely grown in Asia, especially
in the province of Maharashtra in southwest India. The stems are boiled, dried
and crushed to a powder with a bitter woody taste that's widely used as a spice
and in folk medicines to cure stomach ailments and skin lesions. Turmeric was
in use when the first Westerner, Marco Polo, visited the region in the 13th century.
Low
rates among Indians for colorectal, prostate and lung cancers as well as coronary
heart disease and Alzheimer's first drew Western researchers to curcumin. While
genetics might have explained the low incidences, the rise in rates among Indians
whose parents had moved to Western countries suggested a dietary cause. Subsequent
lab tests on diseased cells and in mice strengthened claims for curcumin.
It's
been demonstrated in animals to protect the liver, inhibit tumors, reduce inflammation
and fight some infections. Curcumin has both antioxidant and anti-inflammatory
properties, according to researchers, and may help lower cholesterol.
Cystic
fibrosis trials
Unlike newly invented pharmaceuticals, curcumin
has been widely used for many years, so a lot is known about it, according to
Dr. Christopher Goss of the University of Washington Medical Center in Seattle.
He's recruiting cystic fibrosis patients for a Phase I study of curcumin's safety
and efficacy. The patients will take up to 3 grams daily - six of the biggest
pills that U.S. pharmacies sell. That's more than 50 times the amount of curcumin
in a portion of curry.
Goss also will be seeking insight into findings
reported last year in the journal Science that curcumin corrects the cystic fibrosis
defect in mice. The defect, which suppresses a mutant protein essential to cell
health, results in thick mucous that fatally clogs the lungs and pancreas. Researchers
from Yale University and the University of Toronto found that curcumin treatment
released the protein and enabled cells and membranes to function normally, at
least in mice.
Cystic Fibrosis Foundation Therapeutics Inc., a nonprofit
drug-research arm, sponsored this study and Goss'. Among Indians and Pakistanis
living in England, the cystic fibrosis rate is 1 in 10,000, according to an epidemiological
study. That compares with 1 in 2,500 among Caucasians. Rates in India and Pakistan
are unknown.
The U.S. National Institute on Aging has launched a clinical
trial to assess the safety and efficacy of curcumin for individuals with mild
to moderate Alzheimer's disease. A report in the Journal of Biological Chemistry
in December found that in mice injected with a chemical that mimics Alzheimer's,
curcumin reduced by half the buildup of knots in the brain called amyloid plaques,
which have been linked to Alzheimer's.
M.D. Anderson, the Houston cancer
center, has small trials under way testing curcumin on pancreatic and bone marrow
tumors. Colon cancer studies using curcumin are under way elsewhere.
All
trials are in the earliest and easiest of four stages, preceding any Food and
Drug Administration approval of a curcumin-based pharmaceutical by many years.
Many drugs that look promising in mice fail to deliver in humans or prove to have
dangerous side effects.
Popularity growing
In
the less-regulated dietary supplement industry, curcumin's popularity is surging.
Grant Ferrier, the editor of Nutrition Business Journal, projects sales of $20
million in 2005 compared with $15 million last year.
Curry Pharmaceuticals
of Research Triangle Park, N.C., which hopes to sell a purified chemical analog
of curcumin, is working on a curcumin salve for skin diseases such as psoriasis.
Curcumin salves are popular in India and Pakistan.
Curcumin's side effects
are less of a concern, because it's been so widely used for so long. But there's
an issue with it: Curcumin consumed in small amounts from an early age may ward
off some Western ailments, Aggarwal said. But once someone's contracted these
diseases, curcumin's ability to counteract them is largely unproved.
AFX
News Limited
- J&J to take on over 50 pct of global
R&D costs for Bayer's new blood clot drug
10.26.2005, 11:10 AM
LEVERKUSEN,
Germany (AFX) - Johnson & Johnson will pay more than 50 pct of of the global
research & development costs of Bayer AG's blood clot drug BAY 59-7939 under
the licensing agreement announced today, head of Bayer HealthCare Arthur Higgins
said during a conference call this afternoon.
However, 'J&J will
only receive rights to the drug in the US, and will receive no royalties on worldwide
sales', Higgins said.
Prior to the signing of today's agreement, Bayer
bore all the R&D costs for the drug. However, under the terms of today's deal,
J&J will have to help fund several ongoing and future phase III trials for
the drug, before it can reap benefits.
Typically it costs 8-12 bln eur,
the lion's share of which is spent in late stage clinical trials, to develop one
drug and bring it to the market.
Higgins said even though J&J will
fund such a significant part of the blood clot drug's trials, Bayer still expects
to spend 18-20 pct of its total group sales on research & development.
Another
part of the deal is that J&J's unit Ortho-McNeil Pharmaceuticals will have
to make an up-front payment as well as milestone payments to Bayer in the range
of 290 mln usd.
Additionally it will pay royalties of up to 30 pct of
sales to Bayer following the drug's US launch.
Higgins did say which
sales figures would trigger which royalty percentages, but indicated that sales
between 1-2 bln usd would mean royalties of around 20 pct, while sales between
2-3 bln usd would suggest royalties of around 25 pct.
Under the deal,
Bayer also receives the right to all prescription sales in the hospital specialty
markets of Ortho-McNeil's drug Elmiron for relief of pain associated with inflammation
of the urinary bladder, known as cystitis.
Last year, Elmiron sales
amounted to 90 mln usd, and in 2006, projected total sales are seen at around
108 mln usd.
A spokeswoman would not disclose what share of that would
be Bayer's, but confirmed that Elmiron sales will be booked into Bayer sales with
immediate effect.
Higgins noted during the conference call that 'our
agreement with J&J on Elmiron is not co-dependant on the development or performance
of the Factor Xa inhibitor (BAY 59-7939)' and that even if trial and development
of the blood clot drug is terminated, 'this would not affect the Elmiron agreement'.
Bayer hopes to market BAY 59-7939 to treat blood clots after orthopaedic surgery
from 2008, and is also planning to submit an application in 2009 to treat blood
clots and prevent stroke in patients with atrial fibrillation - a disorder where
the heart's two small upper chambers quiver instead of beating effectively.
For
all indications, Bayer considers that BAY 59-7939 has a peak sales potential of
1 bln usd, or blockbuster status.
ragnhild.kjetland@afxnews.com
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