Spanish Biotechnology Concentrates On Cancer
April 9, 2008
The Spanish Association of Bioenterprises (ASEBIO) has presented a poster with the portfolio of healthcare products that are being researched by Spanish biotech companies. This Spanish sector pipeline includes 28 companies contributing a total of 119 projects on drugs and diagnosis systems for use on humans and 12 products for animal health care.
Jorge Barrero, ASEBIO General Secretary has highlighted that “this presentation initiative from the Spanish biotechnology sector forms part of a more ambitious programme of activities that will culminate in Granada during the month of September with the BIOSPAIN 2008 International Convention.” The goal pursued by this event, which comprises a science congress, an investor forum and bilateral meetings to forge alliances, is “to give international projection to the capacities of Spanish biotechnology and attract the attention of the world pharmaceutical market regarding the opportunities that exist for collaboration with our country’s biotech companies.”
Among the 19 companies that are developing drugs, the most outstanding is Pharmamar, which in 2007 marketed the first innovative cancer drug developed in Spain. There are other products in the advanced clinical phase (phase III), including the Cellerix cell therapy for treatment of complex fistulas and Palau Pharma’s coronary stent in the cardiovascular field. Other Spanish biotech companies, such as Neuropharma, Advancell, Digna Biotech, Archivel, Thrombotargets or Fina biotech, have more recently entered into clinical phases. In total, ASEBIO has reports of 40 developments in clinical phases (3 in phase III, 24 in phase II and 13 in Phase I) and 50 projects in the preclinical phase.
Furthermore, the ASEBIO survey reports 26 new disease diagnosis and prognosis systems, some are which are soon to come out onto the market. Likewise, in the medical supplies field, the PRGF regeneration technology developed by BTI, a company from the Basque province of álava, also stands out.
Twelve animal health products round up the poster that ASEBIO will distribute internationally to raise awareness concerning Spanish biotechnology capacities and to thus foster its members’ search for allies.
This poster is available here.
About ASEBIO
The Spanish Association of Bioenterprises (ASEBIO) has over 130 members, in the main small enterprises created out of university research and national research centres.
ASEBIO has acted as a meeting and promotion platform for those organisations interested in the development of the national biotechnology scene since 1999. ASEBIO therefore works in close collaboration with regional, national and European governments together with all those social organisations interested in the use of biotechnology for improving the quality of life, the environment and the generation of skilled employment. http://www.asebio.com
About Biospain 2008
Granada will be hosting the fourth edition of the International Biotechnology Convention, BIOSPAIN 2008, from 17th to 19th September 2008, in its Congress and Exhibition Centre. The official inauguration of BIOSPAIN is scheduled to take place on 17th September at 12 o’clock, midday.
BIOSPAIN 2008 is the international presentation platform for the Spanish biotechnology sector and it is intended to satisfy the sector’s commercial and informative demands, providing the necessary tools to take informed decisions and thus be able to address the market’s every increasing requirements.
BIOSPAIN is directed at companies, academics, researchers, financiers and entities related to the Spanish and the international biotech sectors, and it comprises a broad programme spread over three days that aims to link up the main aspects of the biotech environment:
-SCIENCE through the BIOTEC 2008 congress, where renowned scientists and well-known personalities will share a pluri-disciplinary convention in BIOSPAIN. The objective is one of exchanging best practice, making contacts, creating synergies, attracting customers and investors and presenting innovations that pave the way to accessing a sector with excellent growth prospects, under its different working areas, whereby it will foster approaching positions between SCIENCE, TECHNOLOGY and ENTERPRISE.
-POLITICS and SOCIETY, thanks to a full Plenary Session programme, which will offer an opportunity to discover the most up-to-date viewpoints of scientists, the business community and politicians, to generate a debate that will foster support policies for the sector. It will be a meeting point for all professionals in the sector and will act as an observatory for all those social, business and political indicators that help to promote the development of biotechnology as an economic activity and its capacity to lever innovation into the various user sectors.
-BUSINESS DEVELOPMENT through the Partnering event, the international business development encounter, will enable one-to-one meetings between technology suppliers and potential clients, academics and businesspeople, investors and scientists who wish to find out the latest advances in the sector, entering a space with unlimited opportunities during the three days that the activity will last. Prior to visiting BIOSPAIN, all registered participants will be able to organise a personalised agenda of contacts, thanks to an individual work tool which will allow them to learn at all times who will be attending and the interest the event is producing. This will enable meetings to be set up in advance and people to prepare and focus their visit with a greater probability of success and make effective use of the time available.
-FINANCE by attracting capital in the Investors’ Forum. The international investors’ forum will promote the presentation of new projects, facilitating and motivating access to finance, offering continuity to research and business projects. Public and private researchers will present their lines of work before a national and international audience comprising public and private investors, venture capital entities and other related agents. This forum aims to encourage researchers and business seeking finance to undertake their projects, and
-TRADE PROMOTION reflected in a dual Trade Show (companies and institutions). The trade show will host companies and institutions that will share with the visiting public, Scientific community, universities and technology centres, (biotechnology, health sciences, environment, agricultural sciences, nutrition, etc.), university students, businesspeople (from all the areas of the biotech sector), Local, Regional and National Authorities which foster, develop or apply biotechnology, economic agents, finance and venture capital entities, legal firms and information and communications media) the presentation of technical and scientific innovations, in addition to the analysis and observation of the latest projects in the Spanish and international biotech sector.
In its third edition, held in Madrid in September 2007, BIOSPAIN attracted over 1,000 visitors of 20 different nationalities and over 40 exhibitors. In 2008, the Organising Committee expects to double these figures and to do so it has enrolled the support of academics and professionals, public and private institutions and the joint work of the national and international bodies representing all the spheres of biotechnology.
BIOSPAIN 2008 will open exclusively to professionals from this sector on 17th and 18th September, from 09.00 to 18.00 hours and on 19th September from 09.00 to 16.00 hours. The times of the BIOTEC 2008 Scientific Congress can be viewed at http://www.biospain2008.org.
Spanish Association of Bioenterprises
Fight Against Counterfeit Drugs Advanced By Faster Test Reported For Detecting Fake Tamiflu
April 8, 2008
Chemists in Georgia are reporting development of a fast new method to detect fake Tamiflu, the mainstay medication for preventing and treating bird flu. Tamiflu has become a target for counterfeiters as recent outbreaks of bird flu have increased public demand for supplies of just-in-case antiviral drugs to use in case of an epidemic of the deadly disease.
In a report at the 235th national meeting of the American Chemical Society, Facundo M. Fernandez, Ph.D., and colleagues describe use of a method called Desorption Electrospray Ionization Mass Spectrometry (DESI-MS) that can determine authenticity of large batches of Tamiflu samples up to 20 times faster than conventional methods.
“It’s a one-step process that doesn’t require any extensive sample preparation,” said Fernandez, of the Georgia Institute of Technology. Using DESI-MS, analysis of the Tamiflu powder yields results in less than one minute. The “gold standard” for gauging pharmaceutical quality control is a powerful but much slower method called high performance liquid chromatography (HPLC), he said. Analysis by HPLC could take up to an hour.
The researchers describe their study as the first successful demonstration of DESI-MS’s use for Tamiflu screening. “This method is really targeted at screening large amounts of products” that might be expected during a pandemic of influenza, Fernandez said. “In case of a crisis, you wouldn’t be able to wait an hour per sample. You’d want to screen hundreds of samples per day.”
When fears of a pandemic, a global epidemic, of avian influenza first emerged, worried consumers in the United States and other countries began to horde Tamiflu in 2007, seeking prescriptions from physicians and purchasing the medication from online pharmacies. In 2007, there were 86 confirmed human cases of bird flu in the world, according to the World Health Organization. The fatality rate was high, with 59 deaths.
Fernandez tested DESI-MS’s effectiveness by collecting different Tamiflu samples from online pharmacies and found all of them to contain the active ingredient. Customers who purchase from online pharmacies, he warns, should use extra caution when shopping. Although some online pharmacies are certified, he says people usually look for low prices instead. “What you get online can be pretty much anything,” he said. “It’s very easy for the counterfeiter to bypass the system that’s in place to protect the consumer. And it’s very easy for the consumer to get medications.”
At $6.50 per pill, Tamiflu’s high cost and demand have made it a preferred target for fakes, Fernandez noted. Counterfeits have already surfaced in Chicago, San Francisco and other areas.
International trade in counterfeits is a lucrative enterprise - and an increasingly sophisticated one, Fernandez said. According to the International Chamber of Commerce, global trade in counterfeit goods costs the U.S. economy between $200 billion and $250 billion a year in lost sales and is responsible for the loss of more than 750,000 American jobs. “The penalties for counterfeiting pharmaceuticals are much lower than for trafficking illegal drugs like cocaine,” Fernandez said. “Many of the operations focused on making illegal drugs are shifting to counterfeiting drugs because of the low penalties and high profits.”
A few initiatives have surfaced to fight the presence of fakes, including ones by the U. S. Food and Drug Administration and the WHO, among others. Global awareness has increased, Fernandez said, but it’s not enough. “What’s the percentage of fake drugs in the marketplace? I don’t know. I don’t think anybody can give you a real number. That’s really a huge problem.”
Fernandez remains optimistic about solving the problem of fake Tamiflu, however. “I think it’s possible to shut down this traffic, but it will require new tools and new approaches,” he said. “We need to get very creative because the incentive for making fake drugs is huge. We always feel like we’re trying to catch up with the counterfeiters. Every time we get a new batch of fakes, they’re more sophisticated than the previous batch.”
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The American Chemical Society - the world’s largest scientific society - is a nonprofit organization chartered by the U.S. Congress and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.
- John Simpson
Source:
Charmayne Marsh
Michael Bernstein
American Chemical Society
Medicines Australia Welcomes Revitalisation Of Industry Working Group
April 8, 2008
Medicines Australia chief executive Ian Chalmers congratulated the Minister for Health and Ageing, Nicola Roxon MP, and the Minister for Innovation, Industry, Science and Research, Senator Kim Carr, on their joint announcement that the Pharmaceutical Industry Working Group (PIWG) would be reconvened.
The joint announcement was made in Canberra today at AusPharma08, the industry conference for Medicines Australia members.
“It gives us a strategic platform to discuss industry policy directly with the two Ministers of most importance in the pharmaceutical policy arena,” Mr Chalmers said.
“This direct dialogue is immensely important. There are key policy changes under consideration by the Government.
“The Pharmaceutical Industry Working Group provides industry with the opportunity to propose ideas, debate and collaborate constructively and directly with the Ministers.” PIWG has brought together industry expertise from Medicines Australia, the Generic Medicines Industry Association, AusBiotech and the National Health and Medical Research Council.
The group provides a platform for the industry to engage strategically with Government to ensure an environment that encourages investment in innovation in Australia.
Medicines Australia
Specialized Genasense(R) Clinical Trials Featured At AACR Meeting
April 8, 2008
Genta Incorporated (Nasdaq: GNTA) announced that presentations related to Genasense(R) (oblimersen sodium) Injection, the Company’s lead anticancer compound will be featured at the annual meeting of the American Association for Cancer Research (AACR). The meeting will be held in San Diego, CA from April 12-16, 2008. The subject matter of several abstracts, which are relevant to both the Company’s ongoing randomized Phase 3 trial of Genasense in patients with advanced melanoma, and also to any subsequent regulatory filings that may ensue from that trial, include the following:
Pharmacokinetics (PK) of oblimersen in subjects with mild and moderate renal impairment. Authors: Quereshi A, et al.
Summary: Describes the PK of Genasense in patients with impaired kidney function that may be relevant for prescribers.
Population pharmacokinetics (PK) of dacarbazine and Genasense in adult patients with advanced melanoma. Authors: Rezai K, et al.
Summary: Describes the PK of both Genasense and dacarbazine (the chemotherapy drug given to all patients in the Phase 3 melanoma study) and how these drugs interact when co-administered in human subjects.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company’s lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta’s Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi- synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Ganite and Genasense are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: http://www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:
— the Company’s ability to obtain necessary regulatory approval for Genasense(R) from the U.S. Food and Drug Administration (”FDA”) or European Medicines Agency (”EMEA”);
— the safety and efficacy of the Company’s products or product candidates;
— the Company’s assessment of its clinical trials;
— the commencement and completion of clinical trials;
— the Company’s ability to develop, manufacture, license and sell its products or product candidates;
— the Company’s ability to enter into and successfully execute license and collaborative agreements, if any;
— the adequacy of the Company’s capital resources and cash flow projections, and the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations;
— the adequacy of the Company’s patents and proprietary rights;
— the impact of litigation that has been brought against the Company and its officers and directors and any proposed settlement of such litigation;
— the Company’s ability to retain compliance with the NASDAQ’s listing qualifications; and
— the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company’s Annual Report on Form 10-K for 2007 and its most recent quarterly report on Form 10-Q.
Genta Incorporated
http://www.genta.com
Ardea To Present Data On HIV Non Nucleoside Reverse Transcriptase Inhibitor And Two MEK Inhibitors At Upcoming Medical Conferences
April 8, 2008
Ardea Biosciences, Inc. (Nasdaq: RDEA) announced that data will be presented on its second generation non-nucleoside reverse transcriptase inhibitors (NNRTIs), at the 21st International Conference on Antiviral Research (ICAR). Additionally, data on two of the Company’s mitogen-activated ERK kinase (MEK) inhibitors, RDEA119 and RDEA436, will be presented at the American Association for Cancer Research (AACR) annual meeting.
The presentation details are as follows:
— 21st ICAR in Montreal, Quebec, Canada
Date/Time: Monday, April 14, 2008 at 4:00 p.m. Eastern Time
Title: A Novel NNRTI Class with Potent Anti-HIV Activity against
NNRTI-Resistant Viruses
Location: Poster Session 1 (Poster #80)
- AACR Annual Meeting in San Diego, California
Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA119, a Potent and Highly Specific MEK Inhibitor is
Efficacious in Mouse Tumor Xenograft Studies
Location: Poster Session 32 (Poster #4878), Exhibit Hall B-F
Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA436, a Novel MEK Inhibitor with Favorable
Pharmacokinetic Properties
Location: Poster Session 32 (Poster #4895), Exhibit Hall B-F
About Ardea Biosciences, Inc.
Ardea Biosciences, of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout. We have three drug candidates in clinical trials and several others in preclinical development and discovery. Our most advanced drug candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We are also investigating RDEA806 for the treatment of gout. Our lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, is in a Phase 1 study in advanced cancer patients and is being investigated for the treatment of inflammatory diseases. RDEA436, our second generation MEK inhibitor for the treatment of cancer and inflammatory diseases, has been evaluated in a human micro-dose pharmacokinetic study and has been selected as a development candidate. In addition to the foregoing clinical programs, we are developing a second generation NNRTI for HIV, as well as other drug candidates in earlier stages of preclinical development and discovery.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: sufficiency of cash resources and our goals, including the expected properties and benefits of RDEA806, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Ardea Biosciences, Inc.
http://www.ardeabio.com
Taro Receives Tentative FDA Approval For Lamotrigine Tablets ANDA
April 7, 2008
Taro Pharmaceutical Industries Ltd. (”Taro,” the “Company,” Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration (”FDA”) for its Abbreviated New Drug Application (”ANDA”) for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg (”Lamotrigine Tablets”).
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline’s Lamictal® Tablets. According to industry sources, Lamictal® Tablets had annual U.S. sales of approximately $2.6 billion.
The tentative ANDA approval for Taro’s Lamotrigine Tablets is an FDA determination that Taro’s ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA’s attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at http://www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s lamotrigine product. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include failure to receive final approval for Taro’s ANDA submission for Lamotrigine Tablets; the granting of additional exclusivities or restrictions to Lamictal® Tablets; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro’s Lamotrigine Tablets; changes in the Company’s financial position; regulatory actions; and, other risks detailed from time to time in the Company’s SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.
Taro Pharmaceutical Industries Ltd.
BGMA Urges MPs To Promote Competition Through Biosimilars
April 7, 2008
In response to a House of Commons debate on Biosimilar Medicines this evening, BGMA Director, Warwick Smith, said:
“Medicinal products developed through biotechnology-biopharmaceuticals-constitute an essential part of medicines available to patients today.
When the patent expires on these products, other companies may manufacture them. These are known as biosimilar medicines or biosimilars. Biosimilars are assessed by the same regulatory agency as originator biopharmaceuticals, with the same scientific rigour, using the same regulatory systems, to ensure that they match the originator product in terms of quality, safety and efficacy.
Their development introduces competition in the market which enhances patient access to safe and effective-and more affordable-biopharmaceuticals. Without this competition, the prices of the originator products would remain artificially high. Similarly, this competition stimulates research into new originator medicines.
We cannot afford not to have competition from biosimilar products. The 60+ age group will grow by at least 25% by 2015 and will cost on average three to four times more on medicines than when they were 30.
I urge MPs to protect taxpayers and patients in tonight’s debate by supporting the development of high quality lower cost biosimilar medicines.”
The BGMA represents the interests of United Kingdom-based manufacturers and suppliers of generic medicines and promotes the development of the generic medicines industry in the United Kingdom.
The BGMA is made up of 18 members of the generic manufacturing industry, who between them account for around 85% of the UK market by volume.
Dr Brian Iddon MP recently produced a report on Biosimilar Medicines sponsored by Amgen. Dr Iddon will speak on Biosimilar Medicines in an adjournment debate in the House of Commons this evening.
BGMA
Latest Trends And News In Health Care At 5th Annual World Health Care Congress April 21-23, Washington, D.C.
April 5, 2008
The World Health Care Congress is the premier forum for health care executives to explore a myriad of emerging issues and to network with key leaders. The 2008 Congress will include senior executives and government officials from the nation’s largest employers, hospitals, health systems, health plans, pharmaceutical and biotech companies, and government.
Health and Human Services Secretary Michael Leavitt will deliver the keynote address on “Building a Health Care System Based on Value” “Building a Health Care System Based on Value on Wednesday, April 23 at 11:30 a.m. Secretary Leavitt will immediately follow his address with a news conference. One of the program’s many highlights, the “Presidential Health Care Agenda,” will feature key health care advisors to Presidential hopefuls Sen. Barack Obama and Sen. John McCain, followed by an in-depth critique by panelists, including former U.S. Secretary of state George Shultz, co-author of a recently published health care reform book.
TOPICS INCLUDE:
Practices for Payers and Providers
Chronic Care
Consumer Empowerment
Medicare and Medicaid
International Health
Personalized Medicine
Convergence of Healthcare and Banking
Employee health care benefits
Hospitals and health systems
Group practice summit
FEATURED WHCC 2008 SPEAKERS INCLUDE:
U.S. Health and Human Services Secretary Mike Leavitt
Steve Burd, Chairman and CEO, Safeway Foods
James Hagedorn, CEO, Scotts Miracle-Gro Company
Delos (Toby) Cosgrove, MD CEO, Cleveland Clinic
Denis Cortese, MD, CEO, Mayo Clinic
Herbert Pardes, MD, Chairman CEO, New York Presbyterian Hospital
Reed Tuckson, MD, EVP and Chief of Medical Affairs, UnitedHealth Group
George Halvorson, Chairman and CEO, Kaiser Foundation
Mack Banner, CEO, Bumrungrad International (Thailand)
Sam Nussbaum, MD, EVP and Chief Medical Officer, Wellpoint
David Cordani, President, CIGNA HealthCare
Uwe Reinhardt, PhD, Professor of Economics and Public Affairs, Princeton University
U.S. Rep. Jim Cooper (D-Tenn.) health care policy advisor to Sen. Barack Obama
Thomas Miller, health care policy advisor to Sen. John McCain
Cal Ludeman, Commissioner, Minnesota Department of Health and Human Services
Prof. Hans Rosling, PhD Professor of International Health, Karolinska Institutet (Sweden)
Michael Howe, CEO, MinuteClinic
James Roosevelt, President and CEO, Tufts Health Plan
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Source: Patrick Golden
World Health Care Congress
GlaxoSmithKline Statement Lancet Publication Of D:A:D Data
April 5, 2008
Data published in the Lancet from the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) suggest a possible association between anti-retroviral therapy (ART) regimens that contain abacavir and an increased risk of myocardial infarction. Conversely, analyses of GlaxoSmithKline data show no increased risk of myocardial infarction associated with abacavir.
“The D:A:D findings are unexpected, since we have not seen similar findings in our studies, and we are unaware of any potential biological mechanism that would explain them. In our own analysis of trials involving more than 9,600 patients, no increased risk of heart attack associated with abacavir was found. It is important to note that although the relative risk of heart attack risk seen in the D:A:D study was increased in patients who had recently taken abacavir, the likelihood of an individual patient having a heart attack remains low in absolute terms. Abacavir remains an important treatment option for patients with HIV and patients should not discontinue treatment on their own,” said Didier Lapierre, Vice President of Clinical Development for Infectious Diseases at GlaxoSmithKline.
GSK data
GSK has analysed the company’s internal databases, which include information from external post marketing surveillance reports and data from 54 clinical trials with more than 14,000 patients, over 9,600 of whom were on abacavir. The analysis of GSK data shows no increased risk of myocardial infarction associated with abacavir. In addition, GSK is not aware of any confirmed increased risk of myocardial infarction with abacavir in the published literature.
No biological mechanism linking abacavir treatment with myocardial infarction has so far been identified. GSK believes that in totality, the data on the association of myocardial infarction with abacavir treatment are inconclusive at this time.
In recent years, GSK has increased the focus of our HIV research efforts, including initiating studies that identify and analyse risk factors and potential drug toxicities. GSK regards this as a critical part of establishing and maintaining drug safety and several studies have been performed and others are ongoing focusing on the long term safety impact of abacavir.
D:A:D database findings
Accumulated observational data were sufficient for the D:A:D to analyse five commonly used nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, didanosine, stavudine, lamivudine and abacavir. No analyses were conducted evaluating the risk of myocardial infarction among patients taking tenofovir or emtricitabine, two other drugs in the class of NRTIs
Overall, the data cited by the D:A:D are uncommon events: 6.1 events/1000 patient years among patients who had taken abacavir in the last 6 months versus 2.6 events/1000 patient years for those who had not (a difference of 3.5 events per 1000 patient years). By comparison to this doubling of relative risk, smoking can increase a person’s risk of heart attack by two or three times, while high cholesterol can increase the risk of heart attack further. As the D:A:D position paper states, for patients who smoke: “…stopping smoking would do more to reduce the risk of having a heart attack and other serious diseases more than by stopping abacavir:”
Observational studies can provide important information given their size and scope, but because they analyse patient experience in a real-life setting, they are subject to more variables than scientifically controlled clinical trials. It is important that findings of observational studies are confirmed with other data, and that reasons for any potential link between drug and effect be identified.
Regulatory Status
Importantly, on March 27, 2008, the US Federal Drugs Administration (FDA) stated that they currently believe the analyses conducted by the D:A:D are incomplete. They also indicate that the results of the GSK analysis are inconclusive, but did not show an increased risk. They are considering, but have not concluded, whether any regulatory action is warranted. In addition, the FDA stressed the risks of switching patients’ treatment without proper individual assessment, urging caution. The EMEA is also reviewing the D:A:D data and will post their findings in the near future.
Implications for managing HIV
HIV is a serious, life-threatening disease, and a number of factors go into choosing the right therapy. Therefore, GSK believes that:
- Patients should NOT discontinue treatment on their own.
- Although the D:A:D study data suggest a relative risk increase in heart attack risk associated with abacavir, that risk remains low in absolute terms, and therefore abacavir remains an important treatment option for those patients.
- The total patient profile including comorbidities, concomitant medications, previous retroviral experience, as well as the underlying risk of coronary heart disease should be considered when prescribing HIV antiretroviral therapy, including abacavir. Action should be taken to minimize modifiable cardiovascular risk factors in all patients (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) in line with current guidelines.
About HAART theory
Highly Active Anti-Retroviral Therapy (HAART) has revolutionized HIV treatment and dramatically extended the lifespan of HIV patients. The NRTI class, including abacavir, remains a cornerstone of HIV therapy; approximately 25% of HIV patients on HAART take abacavir as a proven medicine effective in treating HIV. For patients who have failed previous therapy, abacavir may be an essential part of treatment.
As with all medicines, doctors and patients must weigh the risks of the disease against the risks and benefits of the medicines available to treat it. Certain risks may be able to be managed as part of standard HIV patient care.
About GlaxoSmithKline
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://www.gsk.com.
Nature Publishing Group To Co-Publish Two Top-Quality International Journals Based In China
April 3, 2008
Nature Publishing Group (NPG) announces newly signed co-publishing agreements for two Shanghai-based journals. The Asian Journal of Andrology (AJA) and Acta Pharmacologica Sinica (APS) are both sponsored by the Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences; AJA is also sponsored by Shanghai Jiao Tong University (SJTU).
AJA focuses on the increasingly important branch of medicine that deals with the male reproductive physiology and pathology and is the official journal of the Asian Society of Andrology. APS, the official journal of the Chinese Pharmacological Society, covers the entire breadth of pharmacology.
David Swinbanks, Publishing Director of NPG, said “We are excited to be co-publishing these journals with such distinguished partners. These new agreements, together with our existing partnership to publish the journal Cell Research, also based in Shanghai, mean that from 2009 we will publish the top three ranked journals in life science or chemistry based in mainland China. These are excellent additions to our program of partnerships with key scientific and clinical organizations across the Asia-Pacific region.”
“We are delighted that Nature Publishing Group, which is renowned as one of the world’s premier science publishers, will now be co-publishing these two high-quality journals with us,” said Professor Jian Ding, Director of SIMM. “We expect that this new partnership will help the journals to go from strength-to-strength in the future.”
Vice President of SJTU Zheng-Gang Zhu said “Our University is pleased to be a sponsor of the top andrology journal in Asia-Pacific, especially now that it will be co-published by Nature Publishing Group. This cooperation with NPG will build on the international reputation of AJA, furthering communication between Chinese researchers and their international peers.”
“This is an exciting partnership between AJA and NPG, improving both AJA’s global reach and NPG’s standing in Asia and China,” said Professor Yi-Fei Wang, Editor-in-Chief of AJA.
These partnerships are the latest in a series of partnerships that NPG Nature Asia-Pacific is undertaking with scientific and clinical societies in this region (see link below for more information).
AJA and APS will be able to take advantage of NPG’s strengths including editorial expertise, pioneering web technologies, innovative formats and high-quality production to provide premium information for scientific researchers in the public and private sectors, government agencies and educators. Papers published in the journals will receive high exposure through nature.com, which has over 35 million page downloads per month, and can also benefit from press coverage and quick publication, including publication ahead of print.
These landmark agreements, alongside the recent launch of the website Nature China, mark the next steps in NPG’s broader strategy to publish the best of Chinese science.
About Shanghai Institute of Materia Medica
The Shanghai Institute of Materia Medica, Chinese Academy of Sciences, was founded in 1932. It was established as the institute for drug research within the Chinese Academy of Sciences. The principal aim of the Institute is to promote drug discovery and development through research on the structure, targets and mechanisms of activity of bioactive substances. More information is available at http://www.simm.ac.cn/English/English.htm.
About Shanghai Jiao Tong University
Shanghai Jiao Tong University, formerly known as the Nang Yang Public School, was founded in 1896. It is one of the oldest universities in China. The University, with its 21 academic schools, places emphasis on the development of science and technology and has produced many prestigious alumni. For further information, please visit http://www.sjtu.edu.cn/english/index/index.htm.
About NPG and NPG Nature Asia-Pacific
Nature Publishing Group (NPG) is a division of Macmillan Publishers Ltd, dedicated to serving the academic, professional scientific and medical communities. NPG’s flagship title, Nature, was first published in 1869. Other publications include Nature research journals, Nature Reviews, Nature Clinical Practice and a range of prestigious academic journals including society-owned publications. NPG also provides news content through Nature News.? Scientific career information and free job postings are offered on Naturejobs.
NPG Nature Asia-Pacific is the Asia-Pacific wing of NPG, set up to serve the growing needs of the scientific and medical communities in the region, and has offices in Tokyo, Hong Kong, Delhi and Melbourne. For more information, please visit http://www.natureasia.com.
NPG is a global company with headquarters in London and offices in New York, San Francisco, Washington DC, Boston, Tokyo, Paris, Madrid, Munich, Hong Kong, Melbourne, Delhi, Mexico City and Basingstoke. For more information, please go to http://www.nature.com.
— Asian Journal of Andrology: http://www.asiaandro.com
– Acta Pharmacologica Sinica: http://www.chinaphar.com
– Chinese Pharmacological Society: http://www.cnphars.org
– Shanghai Institute of Materia Medica: http://www.simm.ac.cn/English/English.htm
– Shanghai Jiao Tong University: http://www.sjtu.edu.cn/english/index/index.htm
– Nature Publishing Group: http://www.nature.com
– NPG Nature Asia-Pacific: http://www.natureasia.com
– Nature China: http://www.nature.com/nchina
http://www.nature.com
