Bayer Challenges Watson and Sandoz U.S. ANDA Filings on Yasmin®

Tuesday, 22 April 2008

Bayer confirmed that Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York (New York) against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Sandoz, Inc.

 

ViB’s Practical Market Share Forecasting in Pharma

Monday, 21 April 2008

Tuesday 24th and Wednesday 25th June 2008, Le Méridien Piccadilly London, UK Following the success of the Total Market Forecasting conferences, VIB events is now pleased to offer a practical hands-on market share forecasting workshop addressing the specific needs of European pharmaceutical affiliate companies. This practical workshop covers market share forecasting and assumption setting for both in-market and pipeline products.

 

FTY720, a novel oral therapy in development for multiple sclerosis

Monday, 21 April 2008

The investigational oral therapy FTY720 (fingolimod) continues to demonstrate sustained benefits in patients with multiple sclerosis (MS) after three years of treatment, according to new clinical data presented from an ongoing Phase II study extension[1].

 

GlaxoSmithKline and Regulus Therapeutics form strategic alliance

Monday, 21 April 2008

GlaxoSmithKline (GSK) and Regulus Therapeutics LLC (Regulus) announced a worldwide strategic alliance to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.

 

Bayer donates €250,000 for patients with hemophilia

Saturday, 19 April 2008

In celebration of World Hemophilia Day on April 17th, Bayer HealthCare donates €250,000 to the World Federation of Hemophilia (WFH) and more than 950,000 international units of Kogenate® FS (Antihemophilic Factor [Recombinant]).

 

Grindeks JSC is opening new representative office in Uzbekistan

Friday, 18 April 2008

Grindeks JSC is expanding its activities in the former soviet republics members of Commonwealth of Independent States by opening new representative office in Uzbekistan. The new representative office will have been cooperating with medicines administrating state authorities, Uzbekistan’s companies engaged in pharmaceutical and medicinal products wholesale and retail business, as well as providing drug registration processes and medicaments marketing.

 

Pfizer Reports First-Quarter 2008 Results

Friday, 18 April 2008

Pfizer Inc (NYSE: PFE) reported results for the first-quarter 2008. The Company recorded revenues of $11.8 billion, a decrease of 5% compared with $12.5 billion in the year-ago quarter, primarily due to the March 2007 loss of U.S. exclusivity of Norvasc as well as the January 2008 loss of U.S. exclusivity of Zyrtec, which Pfizer ceased selling in late January 2008. In the first-quarter 2008, Norvasc and Zyrtec revenues decreased by $556 million and $344 million, respectively, compared with the prior-year quarter.

 

New Drug Reference Application to Enable Access to Multilex DDF on the Move

Thursday, 17 April 2008

Healthcare professionals will soon be able to access the UK’s leading drug knowledge base, the Multilex Drug Data File (Multilex DDF), on the move, following the development of a new drug reference application for mobile devices. First DataBank Europe (FDBE), working in partnership with Swedish software company MedHand International AB, will be offering the ability to browse Multilex DDF via a mobile device.

 

Abbott Reports Double-Digit Sales and Earnings Growth in First Quarter

Thursday, 17 April 2008

Abbott (NYSE: ABT) announced financial results for the first quarter ended March 31, 2008.   Diluted earnings per share, excluding specified items, were $0.63, reflecting 14.5 percent growth, at the upper end of Abbott’s previously announced guidance range of $0.61 to $0.63. Diluted earnings per share under Generally Accepted Accounting Principles (GAAP) were $0.60, up 33.3 percent.

]]> http://netevent.biz/wordpress/?feed=rss2&p=14 http://netevent.biz/wordpress/?p=13 http://netevent.biz/wordpress/?p=13#comments Tue, 22 Apr 2008 16:43:53 +0000 admin http://netevent.biz/wordpress/?p=13 Russia

Russia has the largest HIV epidemic in Europe, and accounts for around two-thirds of the cases in the Eastern Europe and Central Asia region. There were an estimated 940,000 people living with HIV at the end of 2005 in Russia - up from 760,000 in 2003 - and this figure looks set to increase even further.¹

The number of new HIV diagnoses being reported is falling however, with 88,577 new cases reported in 2001, 52,349 in 2002 and 39,699 in 2003. This reduction could be due to fewer people being tested, or it could be that HIV prevalence rates have reached saturation point amongst injecting drug users.

There are 12 regions in Russia, including the major cities of Saint Petersburg and Moscow, where HIV prevalence rates are said to be ‘above high’, and a further 11 with high prevalence rates.²

Scenes from Russia: the bleak landscape is a contrast to the famous image of St. Basil’s Cathedral in Moscow

Ukraine

In Ukraine ten years ago there were 183 registered cases of HIV; by mid-2004 there were more than 68,000. UNAIDS estimates that in addition there were probably many more unregistered cases over that period. Tuberculosis is the leading cause of death among people living with HIV in Ukraine.³

As in Russia there are many injecting drug users (IDUs) in Ukraine. A 2002 survey of 212 IDUs in the region found needle re-use was widespread and condom use was low. However the same study found that many of those IDUs who knew they were HIV positive were found to be abstaining from sex or using condoms.⁴

Central Asia

Central Asia contains Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan and Kazakhstan. Throughout this area HIV epidemics are growing fast. In 1995 there were almost no reported cases in the region.⁵However, from 2003 to 2005 the UNAIDS estimate of the number of people living with HIV infection more than doubled from around 24,000 to around 57,000.⁶

This region contains major drug trafficking routes between Russia and Europe, resulting in large amounts of injecting drug use. Indeed, in some parts of the region heroin is now said to be cheaper than alcohol.⁷

The Baltic States

The Baltic States consist of those countries in the north of Eastern Europe: Estonia, Latvia and Lithuania. Although overall numbers of infections remain low, HIV is spreading at an alarming rate in the Baltic States. Between 2000 and 2001 there was a large increase in the number of new reported HIV cases, from 921 to 2,353, the majority of which were reported in Estonia. Between 2001 and 2003 however the number of cases reported dropped considerably with Estonia and Latvia virtually halving their cases over the two-year period.⁸ This could be due to fewer infections, or to changes in reporting methods.

The Caucasus

The three countries between the Black and Caspian Seas - Georgia, Armenia and Azerbaijan - have much lower HIV prevalence rates than Russia. However the estimated number of people living with the virus in Azerbaijan grew from 1,400 in 2003 to 5,400 in 2005, and there is a high potential for explosive epidemic growth in all three countries. Some cities already have very high rates of HIV infection among injecting drug users.⁹

The impact of AIDS on countries

Countries such as Russia and Ukraine have a population that is getting older with declining birth rates. As HIV is mainly affecting the young in these parts the number of young people will be further reduced; this may result in many pensioners with few wage earners and a shrinking population as the elderly naturally die. It is estimated in Russia that GDP, investment and labour supply will all decline between now and 2020 unless there is an increase in effective HIV prevention.¹⁰ The deputy prime minister of Russia, Alexander Zhukov, has stated that ‘the growth of AIDS has gone beyond a medical problem, and has become an issue of strategic, social and economic security of the country’.¹¹

At the other end of the scale, in Central Asian countries, there is a high birth rate. An increase in AIDS related deaths here could result in many children being orphaned.

Children

A child in Russia made

this Stop AIDS poster during

a lesson attended by AVERT

director Annabel

The Romanian communist government in the 1980s believed that blood transfusions helped people to keep healthy and administered them unnecessarily to children in orphanages. Although these transfusions were thought to boost the immune system, ironically some of them were contaminated with HIV. In addition many of the nurses reused vaccination needles, further aiding the spread of the virus.

Today, whilst Romania has relatively low rates of HIV, it still has the highest rate of HIV/AIDS among children in Europe. There were reported to be 6,500 people living with HIV in Romania at the end of 2003 and the majority of these were said to be children.¹²

The AIDS orphans are often stigmatized. Families are not always happy about AIDS orphans being integrated into the community and do not want them playing with their own children.¹³ Fortunately, almost all children are receiving treatment and Romania now holds the world’s largest paediatric AIDS clinic treating 600 patients with antiretroviral drugs.¹⁴

Discrimination against children affected by HIV is widespread elsewhere in the region as well. Each day on average two babies born to HIV-postive women in Russia are abandoned by their mothers. Although orphanages are legally obliged to accept these infants, fear and prejudice result in many of them being isolated in hospital wards for months or even years.¹⁵

Drugs, sex and HIV

There are a number of issues occurring today in this region which contribute to the spread of HIV.

Drug use

A large number of people throughout this region use drugs, especially injecting drugs. For example, in Russia roughly 2% of the population - 2 million people - are IDUs.¹⁶ Since unauthorised possession of needles and syringes is illegal in much of this region, many drug users are compelled to share needles. In addition, reports suggest that it is sometimes actually considered rude in Russia not to share needles when taking drugs.¹⁷ An estimated 30-40% of injecting drug users in Russia use non-sterile needles or syringes.¹⁸

Non-sterile needles combined with poor health care, fear amongst drug users of using available health care, and sharing of needles, have all led to the spread of HIV amongst this group. In the capital of Azerbaijan, Baku, one in four street drug users was found to be HIV positive.¹⁹ Many of those using drugs are young, and consequently HIV affects many young people in this region, with more than 80% of those infected aged under 30.²⁰

Sex workers

There are many sex workers operating throughout this region. A large number of these are working in exchange for drugs or in order to get money for drugs. One study in Moscow found that many sex workers also injected drugs using non-sterile injecting equipment and of this group 45% were HIV positive.²¹

Sex workers are also engaging in sexual relations on a regular basis and may or may not use protection. Even if they do use condoms with clients, they may not with their regular partners, and this factor, combined with the potential for contracting HIV from sharing needles, makes them a high risk group who can easily contribute to the spread of HIV.

Prison conditions

Prisons in this area are often very overcrowded and unsanitary, with some Romanian prisons having up to a 700% occupation rate.²² Many of those imprisoned are IDUs, put in prison simply because they use illegal drugs. Of these people a majority continue to use drugs in prison and to share needles, and there is also unprotected sex between men. This leads to the spread of HIV amongst the prisoners.

The spread of HIV

The diagram below shows some of the main ways the groups described interact, increasing the spread of HIV. It shows the following scenarios:

• Prisoners contracting HIV in prison can infect partners, drug users they share needles with, and sex workers with whom they have unprotected sex.
• Sex workers are vulnerable to HIV from having unprotected sex with clients, partners and from sharing needles.
• Partners of people who have become infected with HIV from sharing needles or unprotected sex with sex workers can go on to infect other partners, who may fall into none of the assumed “high risk” categories.

Some of the main ways in which HIV can be spread

In actual fact the situation is much more complex than this; there are many more scenarios, and many people fall into more than one group. This existing combination of a thriving sex trade, high levels of drug use and unprotected sex means it may be easy for HIV to continue to spread in certain regions throughout Eastern Europe and Central Asia unless appropriate prevention methods are in place and being acted on.

Women

Sexual transmission of HIV is increasing in the most affected areas of Russia. Heterosexual infection has grown from 5.3% of all infections in 2001 to 20% in 2003. In Ukraine 40% of those infected with HIV are women. When more women are infected, more babies are born with HIV as well.

In 1998, 125 cases of pregnant women in Russia with HIV were reported, whereas in 2003 there were 3,531 cases. In total there have been 9,000 reported cases of babies being born with HIV in Russia up to and including 2003. In Ukraine however there are many programmes in place to prevent mother-to-child transmission and the percentage of babies born with HIV fell from 27% in 2001 to 12% in 2003.²³

Prevention and education

European countries pledged to ensure universal access to treatment and care by 2005 across the whole of Europe and Central Asia and aimed to make sure 80% of ‘high-risk’ people have access to prevention services by 2010. At the end of 2004 however, only a small percentage of ‘high-risk’ people were being reached by prevention programmes²⁴ and in Russia in April 2005, Cesar Chelala, an international public health consultant, stated that prevention efforts were almost nonexistent. On a positive note, in Central Asia a prevention project has been launched which will train medical workers and other people, and it is thought this and other treatment and prevention programmes could make a real difference in the area.²⁵

In 2004 a survey was conducted in Moscow which found that 70% of people interviewed felt ‘fear, anger or disgust towards those living with the virus’.²⁶ Similarly, a survey in Samara Oblast found that ignorance and discrimination were widespread, even among health workers and family members. Many people were afraid that they could acquire HIV through casual contact; some suggested isolating all infected people from the rest of the population.²⁷

In order to help change these types of negative attitudes a poster campaign was launched by UNAIDS and a Russian community group in 2004 featuring famous paintings alongside slogans such as ‘HIV is NOT transmitted through sport’.²⁸ Ukraine launched its own public information campaign in September 2005 with a World Bank backed television advert being shown daily for three months highlighting the fact that 8 Ukrainians die of AIDS every day.²⁹

Harm reduction

Harm reduction programmes seek to help protect drug users from drug-related harm such as becoming infected with HIV. Whilst these programmes do not deny the benefits of giving up the drugs altogether, they recognise that total abstinence is very difficult for addicts, and in some cases impossible.

One aspect of a harm reduction programme is the introduction of needle exchanges where injecting drug users can exchange dirty needles for clean ones. If a clean supply of needles is available to injecting drug users then they will be less likely to share needles, therefore reducing the risk of contracting HIV. For example, in a major study of 81 cities around the world on HIV infection rates amongst IDUs, it was found that in 52 cities without needle exchanges HIV infection increased year on year, whilst in those cities with needle exchanges HIV infections decreased year on year.³⁰

In addition to needle exchanges, harm reduction programmes also look at ways of encouraging IDUs to stop using drugs. One key way of doing this is by providing them with alternatives such as methadone. These alternatives are administered at clinics, and once inside, visitors can be offered further tests and treatment. Psychological assistance can be provided also, making the visitor feel valued and enriching their life.

Unfortunately, harm reduction services in Russia, Eastern Europe and Central Asia are not nearly adequate to meet demand. In general authorities prefer to criminalise drug users rather than help them to give up drugs or avoid infection. In some countries - including Russia - substitution treatment with methadone is illegal.³¹

Where they do exist, some harm reduction clinics have met with resistance from potential users due to wariness of government agencies. There are a number of ways the clinics deal with this, one example being that of Darko Kostovski, a Macedonian physician who has taken to wearing a Star Trek uniform to put the visitors at ease.³²

Treatment

AIDS prevention poster reading

‘HIV is NOT transmitted through sport’

Reproduced courtesy of UNAIDS

At the end of 2006 only 15% of those requiring antiretroviral treatment for HIV infection in this region were receiving it. Only Moldova and Romania are providing treatment to most of those in need. Although Russian law guarantees people treatment, only around 16,000 (11%) of the 140,000 needing treatment were receiving it at the end of 2006. Coverage is much lower than in many poor African countries such as Zambia (35%), Malawi (43%) and Uganda (41%), which have much more severe epidemics.³³

One reason for the low treatment figures is that medicines are very expensive. This is however becoming less of a problem, particularly in Russia.

In early 2005 the Russian minister of health, Mikhail Zurabov, announced that agreements had been made with pharmaceutical companies which would reduce the amount an AIDS patient had to spend on medicines from US$10,000 a year to around US$3,000.³⁴ The Russian government then announced in late 2005 that it would make AIDS a priority and pledged to spend at least 20 times more on treatment and prevention in 2006 than it spent in 2005.³⁵ A year later it was announced that spending would be doubled to US$289 million in 2007.³⁶ This increase has been aided by the Global Fund to Fight AIDS, TB and Malaria, which has pledged US$209 million over five years for treatment programmes.³⁷

Yet although it is hoped that the extra money will enable a rapid expansion of treatment access in Russia, there are other issues to address besides funding, including pervasive discrimination and segregation. People living with HIV in Russia must attend special clinics for all of their medical needs. These clinics are isolated from the rest of the health care system and anyone who visits them risks being stigmatised. Moreover, the lack of integration means that doctors and nurses in non-specialist clinics have very little knowledge of HIV.³⁸

Even specialist doctors are often unwilling to treat injecting drug users because they doubt they will be able to adhere to the medication.^39 40

Conclusion

In Russia and Ukraine the number of people with HIV looks set to increase, but there is still time to reverse this trend with the introduction of harm reduction programmes, other prevention programmes and improved testing and treatment. The countries in Central Asia are still in the early stages of the spread of the disease and, by following the example of countries such as Romania that have achieved treatment for all and minimal spread, could stop the disease from reaching the levels it has in Russia.

For further information, see our web page on HIV and drug use. For more Eastern European HIV & AIDS statistics, see our European summary.

© UNICEF/ HQ05-0710/Nesbitt

Children residing at Consol Homes Orphan Care in the village of Namitete near Lilongwe, Malawi. Many of the children have been orphaned by HIV/AIDS.

By Dan Thomas

TORONTO, Canada, 15 August 2006 – African children orphaned as a result of AIDS, especially adolescent girls and young women in the 15-24 age group, are at higher risk of HIV infection than other children, according to a report issued yesterday by UNICEF, UNAIDS and the US President’s Emergency Plan for AIDS Relief.

“We must do more to help. Millions of children affected by AIDS are out of school, growing up alone, vulnerable to poverty, marginalization and discrimination,” UNICEF Deputy Executive Director Rima Salah told journalists at the XVI International AIDS Conference in Toronto.

“Children who have lost parents and care-givers are left without their first line of defence,” she added. “One of the most effective ways to keep these children safe is to invest in education, especially for girls. In keeping with the theme of the Toronto International AIDS conference, ‘Time to Deliver’, we have a moral obligation to act with no delay.”

The missing face of AIDS

According to the new report, entitled ‘Africa’s Orphaned and Vulnerable Generations: Children Affected by AIDS’, 12 million of the 48 million orphans in sub-Saharan Africa have lost one or both parents to AIDS. In the most affected countries, it is proving increasingly difficult for surviving parents or their extended families to protect and care for the expanding number of orphans and vulnerable children.

“President Bush’s Emergency Plan for AIDS Relief has brought increased attention to families and to children living with and affected by HIV/AIDS,” said Assistant Administrator Kent Hill of the Bureau for Global Health at USAID. “To date, the Emergency Plan has supported care for 3 million people, including 1.2 million orphans and vulnerable children. With the number of AIDS orphans still growing, we must accelerate this progress.”

The situation of children affected by AIDS varies significantly across families, communities and countries. The report shows that, compared to other children, they are at higher risk of missing out on school, living in homes with insufficient food and suffering from anxiety.

© UNICEF/2006/Thomas

UNICEF Deputy Executive Director Rima Salah and HIV/AIDS Chief Peter McDermott meet former US President Bill Clinton at AIDS 2006, the XVI International AIDS Conference in Toronto, Canada.

“Responding to the needs of children affected by AIDS is complex. The data presented in this report will lead to better responses, reflecting local realities and meeting local needs,” said the Director of the UNAIDS Country and Regional Support Department, Michel Sidibe.

The report on orphaned and vulnerable children was launched as part of the UNITE FOR CHILDREN, UNITE AGAINST AIDS campaign, which aims to put the missing face of children at the centre of the HIV/AIDS agenda. The global campaign serves as a platform for united efforts to stop the spread of the AIDS epidemic and its impact on children.

Before launching the report yesterday, Ms. Salah and HIV/AIDS Chief Peter McDermott met former US President Bill Clinton to discuss joint efforts to stop children being born with AIDS and to provide drugs to children who are HIV-positive.

Project Officer honoured

The second day of the biennial International AIDS Conference, also knows as AIDS 2006, started with an awards ceremony at which UNICEF’s Penelope Campbell was recognized as the winner of a prestigious international award for young women working to prevent HIV and AIDS.

Ms. Campbell, 35, collected the 2006 Young Investigator Prize: Women, Girls and HIV/AIDS Award for her pioneering work on the ‘Bashy Bus’ initiative with young people in Jamaica, where she works as a UNICEF Project Officer. The Bashy Bus is a mobile HIV-testing clinic and counselling service for young Jamaicans.

The award was conferred by the International AIDS Society and the International Centre for Research on Women, with the support of the International Community of Women Living with HIV/AIDS.

Aids drugs are in short supply in Africa

Taking multivitamins may help stop HIV infection developing into full-blown Aids, researchers from the Harvard School of Public Health in the US say.In a six-year study, 538 African women with HIV were given a daily supplement of a multivitamin or a dummy pill.

Of the 267 taking dummy pills, 12% developed Aids compared with 7% of the 271 on a multivitamin pill.

The 271 also suffered fewer late-stage complications, the researchers told the New England Journal of Medicine.

They said their findings suggested vitamin supplements could be given to people with HIV in the developing world to delay the need to start treating them with Aids drugs.

It’s a low-cost intervention that could result in major savings and be helpful to many individuals in terms of better quality of life.  Dr Wafaie Fawzi

Although Aids drugs have been shown to be effective, they are powerful, and do have side effects. 

Researcher Dr Wafaie Fawzi said: “It’s a low-cost intervention that could result in major savings and be helpful to many individuals in terms of better quality of life.”

The research was conducted in Tanzania, where until recently Aids drugs were not available to most people

A total of 1,078 women received either a multivitamin, a multivitamin with vitamin A, vitamin A alone or a dummy pill.

Fewer complications

Eighteen of the 271 women (7%) who took multivitamins developed Aids.

In contrast, 31 of the 267 women (12%) who took a dummy pill went on to develop full-blown symptoms.

The women on multivitamins also had fewer late-stage complications such as fatigue, diarrhoea and mouth ulcers and lower levels of the virus in their blood.

The researchers suspect that multivitamins not only boost the immune system, but also hinder the virus’ ability to reproduce itself.

They found no significant benefit to vitamin A alone, and adding vitamin A to multivitamins somewhat reduced their benefits.

Dr Fawzi said that although men were not studied, multivitamins are likely to benefit them as well.

The high-dose multivitamins with vitamins B, C, and E used for the study cost about $15 for a year’s supply. Aids drugs in Tanzania cost about $300 a year.

Dr Fawzi said further research was needed to find out whether lower-dose vitamins would have the same effect and whether vitamins would help people who were already taking Aids drugs.

‘Very positive’

Dr Cate Hankins, chief scientific advisor to UNAIDS, welcomed the study.

She told BBC News Online: “These findings are very encouraging and very positive.

“This is a relatively low-cost intervention that could be started immediately someone was found to be HIV positive.”

Dr Hankins said the fact that multivitamins reduced HIV-linked symptoms such as oral thrush, mouth ulcers and painful swallowing was also important.

These problems made it difficult for people with the virus to eat properly, at a time when taking on board sufficient calories was more important than ever.

Dr Hankins said ensuring people with HIV were properly nourished was key, as it helped to maximise the effect of anti-retroviral drugs.

2009 (Istanbul, Turkey)

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