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Food-medicine interface In brief: Lawyer Alice Hume looks at the amendments to the Therapeutic Goods Act 1989 which provide clarity and certainty for manufacturers, consumers and regulators at the food- medicine interface.
n The Amending Act n Importance of distinguishing therapeutic goods and food n Conclusion
The Therapeutic Goods Amendment Act 2003 (the Amending Act ) was implemented on 27 May 2003 to clarify the definition of therapeutic good, under the Therapeutic Goods Act 1989 (the Act), at the food-medicine interface. The Amending Act brings some foods which already have a prescribed standard under the Food Standards Code (the Code) within the administration of the Therapeutic Goods Administration (TGA). The amendment to the definition of therapeutic good in the Act (set out in Part 1 of Schedule 1) will provide greater clarity for industry, consumers and regulators at the food- medicine interface. Introduction
In some cases, it has been difficult in the past to ascertain whether goods were therapeutic goods under the Act or foods under the Code. Before the commencement of the Amending Act, where a food standard existed in the Code which applied to that goods or a class of goods, thoseat goods or class of goods wereas excluded from the definition of therapeutic good . Also, the Act did not allow for the Secretary to make a determination under section 7 of the Act that particular goods or classes of goods were therapeutic goods (section 7 allows the Secretary to declare particular goods or classes of goods to be or not to be therapeutic goods for the purpose of the Act).
Under the new amendments, whether a good is governed by the Code or the Act now depends on the presentation of the product in the general market place. For example, if a good makes a therapeutic claim or is sold in a therapeutic form (such as a tablet or capsule) or a dosage regime, that good will generally be found to bethe TGA may wish to designate the good as a therapeutic good. Previously, if a good was a food prescribed under the Code, it would not be classified as therapeutic good under the Act.
The Amending Act
The relevant provisions amended under the Act is section 3 as follows:
Formerly, therapeutic goods meant, generally, goods that are represented to be, or that are likely to be taken to be for therapeutic use - but did not include:
(e) goods for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991
The new definition repeals section 3(1)(e) and replaces it with:
(e) goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991
The definition of therapeutic good in the Act was amended to clarify the differentiation between therapeutic goods and food. The TGA is now able to designate food items as therapeutic goods. Now, where a food product prescribed under the Code is designated by Act as having therapeutic properties, the TGA may declare the product to be a therapeutic good, and therefore as subject to regulation under the Act. This may be used by the TGA to extend the operation of the Act to products like sports drinks, energy bars medicated lozenges and foods which may be regarded by consumers as possessing therapeutic properties, even where no therapeutic claim is made for the product.
Importance of distinguishing therapeutic goods and food
The distinction between therapeutic goods and food is important because some goods such as complementary medicine are regulated as food under the Code. This means that no pre--market assessment or post -market surveillance required for therapeutic goods under the Act was is not required for those types of products (which is required for therapeutic goods under the Act).
In addition, under the Code, food products are expressly prohibited from cannot carrying any medical or health claims, as that is expressly prohibited by the Code. As an example, a complementary medicine (non-prescription medicine) that may 'assist' sports performance with dosage instructions and indications for use may be regulated as a food.
The reason for the need for this timely amendment to the definition of therapeutic goods was to prevent further dissatisfaction and confusion with the regulation around the food-medicine interface. as tThe former definition represented a gap in the risk management of certain complementary medicines, which could have, in the future, posed public health and safety risks to consumers.
The amendment to the definition of therapeutic goods allows the Secretary to use of section 7 in the practical manner that the legislation and stakeholders always intended. Once a good has been or is declared to be, a therapeutic good, no matter when this occurs, it will be regarded as a therapeutic good and regulated under the Act, even if despite the fact that it is also a good for which there is also a prescribed food standard under the Code.
The new amendments to the Act means now that some products that are presented or sold as having therapeutic properties may be declared to be subject to the requirements of the Act as well as those of the Code. This is likely tomay be the case for goods like sports drinks or medicated
lozengesenergy bars where although the product does not make any health claims (as it is prohibited under the Code), the Secretary may declare the product to be a therapeutic good, and may therefore be subject to requirements of the Act, such as pre--market assessment and post -market surveillance as required under the Act.
Manufacturers should keep watch on any proposals by the TGA for their products to be designated as therapeutic goods. They may wish to lobby on the issue or prepare to meet the necessary standards.
IP law update
n Brazil GMO bill to go to Congress soon
n European Union's Court of Justice upholds Italian ban on GMO
n GMO treaty enters into force n New Zealand Parliament considers GMO framework
Brazil GMO bill to go to Congress soon
September 5 – Brazil's long-delayed bill on genetically modified organisms may go to Congress next week. Ten ministries recently sent a report on the bill to President Luiz Inacio Lula da Silva, providing impetus to push the bill along. The controversial bill has been stalled for months by strong disagreement between ministries about the safety of GM crops and opposition from environmental and consumer groups. The government's attention has been distracted from the wider issues of biotechnology by the illegal planting and sale of Monsanto's Roundup Ready soybeans in southern Brazil.
European Union's Court of Justice upholds Italian ban on GMO
September 9 – The EU Court of Justice has upheld an Italian ban on genetically modified foods made by Monsanto Co and Syngenta AG that are permitted in other EU countries. The ruling strengthens the right of EU nations to act alone in prohibiting freely traded products on safety grounds. The court held that Italy's ban was justified, at least until a decision is made on whether the measure is based on sound science. The EU is currently introducing food legislation abolishing a fast-track approval process that Italy challenged when imposing its ban in August 2000.
GMO treaty enters into force
September 11 – A UN treaty giving importers greater powers to reject genetically modified products, the Cartagena Protocol on Biosafety, was agreed in 2000 and entered into force on September 11 2003. The protocol regulates trade in GMOs and the UN is urging non-signatories, such as the US, to abide by it. Under the treaty exporters are obliged to provide greater information about GMO products, and nations have the power to reject GMO imports or donations if danger to traditional crops, local cultures or biodiversity is feared. It also establishes an internet based biosafety clearing house to help countries exchange information about GMOs. The treaty has been ratified by 57 nations, excluding Australia and the US. The US is currently challenging the EU in the WTO courts over GMO. The director general of the Ethiopian-headquartered Environmental Protection Authority believes this challenge presents a threat to the Cartagena Protocol.
New Zealand Parliament considers GMO framework
September 2 – The education and science parliamentary committee has recommended New Zealand's New Organisms and Other Matters Bill be passed with no major changes. The bill establishes regulations to allow the moratorium on the commercial release of genetically modified
organisms to expire on October 29. It includes fines for body corporates of up to NZ$10m or three times the value of any commercial gain, whichever is greater. The only party set to oppose the bill is the Greens, who are disappointed the bill contains no liability provisions in cases where GM organisms cause harm but the law is not breached. Concerns raised by other parties include the ministers' power to override the process and impose his or her own decisions or conditions, and the exposure of local councils to financial risk without the power to control release of GMOs in their area.
n BresaGen announces financial results and receives US patent n Cochlear CEO will retire once successor named n Compumedics reports increased revenues but overall loss
n CSL's new patent could lead to royalty revenue
n Eiffel signs insulin trial deal with US company n EpiTan in strong financial position despite posting loss n GTG acquires commercialisation rights from Sydney Uni
n GTG grants New Zealand license and releases financial results n Peplin reports loss due to R&D expenditure n Peptech benefits from Abbott's EU approval
n Starpharma raises A$6.9m in share placement
n Solbec seeking cancer success using plant extract n Unitract launches automatic retraction syringes n Xcell collaborators receive A$1m NIH grant
Biota implements share purchase plan
September 10 – Biota is offering shareholders an opportunity to buy up to A$5000 worth of shares at a 10% discount to the volume weighted average share price in the five trading days immediately prior to September 19. The share purchase plan aims to rebuild shareholder value, and could raise as much as A$13m. The offer has been capped at around 24 million shares. The funds raised will be used to bolster existing cash reserves and to fund ongoing R&D activities. About 4900 of Biota's 16 000 shareholders hold less than a marketable parcel of at least A$500 of shares. The share purchase plan will enable these small shareholders to increase their holding to a marketable parcel without incurring additional transaction costs. The offer closes on October 21.
BresaGen announces financial results and receives US patent
September 15 – BresaGen, an Adelaide biotechnology company, has announced a consolidated loss for 2002-2003 of A$13.95m, up from A$11.86m in 2002. Revenues were down from last year, at A$5.27m, compared to A$6.05m. The company announced a major restructure last month, including the spin off of its protein pharmaceutical and cell therapy divisions into separate companies. The results reflect the impact of the termination of trials for BresaGen's anti-cancer drug E21R at the start of the year, the subsequent focus on manufacturing opportunities in the emerging biogeneric market and reduced spending on R&D. The company recently announced that it has been awarded a US patent which covers a "cell delivery catheter and method", which has the potential to deliver BresaGen's stem cell derived products to target locations of the brains of Parkinson's patients with great accuracy. The device received FDA approval in August 2002 to be marketed for intracranial delivery of cells and drugs in patients with stroke and neurodegenerative diseases.
Cochlear CEO will retire once successor named
September 4 – CEO of Cochlear, Jack O'Mahony, is to retire once a successor has been named. The company said an international search has begun and the new appointment is expected to be announced within the next three to four months. Cochlear is the world's largest maker of hearing implants and has consistently reported profit growth of more than 20% over the past several years. The announcement is not a big surprise, given that O'Mahony had given a three year commitment when he took the job on in September 2000. The departing CEO believes Cochlear should be looking for someone who is more than just a business expert, someone with solid international experience and a good understanding of the interdependence the company has with audiologists, surgeons, and speech therapists.
[Source: Company Announcement and Reuters]
Compumedics reports increased revenues but overall loss
September 3 – Compumedics' revenues for the 2002-2003 financial year of A$32m reflect strong growth in the company's sleep diagnostics business. This figure represents a 62% increase on last year's result. Compumedics also reported an after-tax loss of A$18.7m due to a write-off of R&D costs and intellectual property acquired, as well as a revision of revenue recognition due to the change from a distribution model to direct sales. These changes were made in order to bring the growing company into alignment with nest practice. In its first full year of operation, the company's USA Neuroscience business increased its sales revenue by 300%. European sleep diagnostic sales also increased (45%), following the signing of a distribution deal with Drager Medical.
CSL's new patent could lead to royalty revenue
September 3 – A new US patent over human papillomavirus has been issued to CSL and the University of Queensland. If drug company Merck launches a vaccine for the virus in the US, the patent will lead to royalty revenue. The main claim granted to CSL was to the surface protein of the human papillomavirus 16 serotype necessary for the formation of virus-like particles. The virus is the agent of genital warts and cervical cancer. CSL and Merck have published details of the vaccine in a recent edition of the New England Journal of Medicine, which has already been more than a decade in development. In 1995 CSL gave Merck an exclusive licence to commercialise the technology in return for a royalty on all overseas sales and the right to market the vaccine itself in Australia and New Zealand.
Eiffel signs insulin trial deal with US company
September 5 – Eiffel Technologies, a Melbourne drug re-engineering company, has signed an agreement with an unnamed large US drug-delivery company to trial an inhalable form of insulin produced by Eiffel's proprietary supercritical fluid technology. The US collaborator will spend up to 12 months doing pre-clinical R&D on inhalable insulin in an animal model. Eiffel's proprietary technology employs supercritical fluids to dissolve compounds which are poorly absorbed by the body. This technique opens up new drug-delivery options. Eiffel claims that the potential global market for the delivery of all injectable, inhalable or transdermal drugs was US$40-50b. The global diabetes market is growing rapidly, currently worth about US$6b. Eiffel plans to bear the costs of early-stage pre-clinical and clinical development before licensing its technology to pharmaceutical companies.
EpiTan in strong financial position despite posting loss
September 8 – EpiTan has reported a loss of A$4m for the 2002-2003 financial year, significantly due to expenses associated with Phase II clinical trials on its lead drug candidate Melanotan. However the company is in a strong financial position, raising A$9m capital since the end of the financial year, increasing its cash position to more than A$10m. CEO Wayne Millen said EpiTan had made excellent progress on Melanotan throughout the year, and had also secured important collaborations to
develop more user-friendly formulations. The company expects to complete Phase IIb clinical trials on the use of Melanotan to increase skin melanin density and reduce sunburn injury before the end of the month. Preliminary results are expected to be announced in November. The next stage of development is to trial the treatment using a sustained release formulation delivered via human implants developed in collaboration with the Southern Research Institute in the US.
GTG acquires commercialisation rights from Sydney Uni
September 8 – Melbourne genetic testing company, Genetic Technologies, has acquired the exclusive worldwide rights to commercialise a test for a gene underlying athletic performance from the University of Sydney. The gene was identified by Professor Kathryn North of the university's Neurogenetics Research Unit in the Department of Medicine, and has been found to have two variants associated with sporting ability. One variation is associated with speed and power, and the other with endurance. The gene is likely to be used in training athletes to determine the best event for their muscle type. The potential market for a test for this gene is huge, according to GTG, and includes sports institutes as well as other organisations such as sports-oriented colleges in the US. The test may also have uses in developing treatments for muscle disorders. The agreement between GTG and Sydney Uni will allow the company to license the test out to other testing service providers, especially overseas, and will benefit the university through the payment of royalties. The organisations are already linked by the recent taking out by the university of a research licence for GTG's non-coding DNA analysis patents.
GTG grants New Zealand license and releases financial results
September 11 – Genetic Technologies has granted its first licence in New Zealand. Agreement has been reached with Vialactia Biosciences (NZ) Ltd of Auckland, New Zealand regarding the terms of a research and commercial license to the GTG non-coding patents. GTG has also recently released its financial results for the 2002-2003 financial year, including a net loss of A$4.16m, an improvement over last year's A$8.8m loss. Revenue dropped 29% to A$9.26m. The company is hoping for a neutral if not positive cash flow by the end of the 2003-2004 financial year. Over the course of the 2002-2003 year GTG made a number of licensing deals for its non-coding DNA analysis patents, bringing in A$5.5m. More licences are expected to be granted this coming year, and previously granted licences will start bringing in royalties and annual fees, boosting the company's cash flow. Revenue from genetic testing services, another growth area for GTG, rose from A$1.6m to almost A$3m, and is expected to continue rising over 2003-2004.
Peplin reports loss due to R&D expenditure
September 9 – Peplin Biotech, a Brisbane cancer drug developer, has reported a consolidated loss of A$3.7m for the 12 months to June 30. The loss is largely due to increases in research expenditure on its lead compound PEP005. This loss is within last November's predicted range of A$3.5m – A$4m. Revenue increased 140% to A$3.2m, which includes November's A$1m sign-on fee from US dermatology company Allergan for a licence to develop the lead compound for non-melanoma skin cancers and solar keratoses. The company currently has cash reserves of A$6.5m which should run to the end of 2004 at the current expenditure rate.
Peptech benefits from Abbott's EU approval
September 11 – Abbott Laboratories has received approval to market Humira, its new rheumatoid arthritis drug, throughout all EU countries. Sydney biotech company Peptech will consequently earn a milestone payment under their licence agreement. The drug received FDA approval in December last year, and is expected to generate sales of more than A$380m. Humira targets the tumour necrosis factor protein linked to inflammation. Peptech's anti-tumour necrosis factor intellectual property is licensed non-exclusively to Abbott, and the licence agreement covers antibody sales in all countries
Starpharma raises A$6.9m in share placement
September 10 – Starpharma, a pooled investment firm and nanotech specialist, has raised A$6.9m in an oversubscribed placement to institutional and sophisticated investors. CEO John Raff said the placement had attracted a number of blue-chip institutional investors, some of who were making their first investments in the industry. The funds will be used to accelerate the development of the company's dendrimer-based microcidal VivaGel product for the prevention of HIV infection. The product was recently given FDA approval to begin clinical trials, as well as to continue the development of other products currently in the pipeline.
Solbec seeking cancer success using plant extract
September 8 – A research group at the University of Western Australia has shown that two glycoalkaloids extracted from the fruit of a thorny weed called devil's apple kill 160 different tumour cell lines in vitro. The experimental therapy has caused a range of benefits to seriously ill volunteers with advanced metastatic cancers, including the slowing, stabilising, shrinking or even disappearance of tumours. Western Australian Biotech company Solbec Pharmaceuticals is concentrating on the therapy's application to mesothelioma and malignant melanoma in order to qualify for fast -tracking under the FDA's orphan drug program. The treatment is believed to not only kill cancer cells but also to boost the response of the immune system to cancerous tumours.
Unitract launches automatic retraction syringes
September 11 – Unitract has launched the world's first syringe whose needle automatically retracts after use. The syringe is designed to protect health workers from accidental injury. Production of the device is expected to commence in the first quarter of 2004, and the syringe should be on the market by mid-year. Unitract CEO Alan Shortall said that using the safety syringe would cut insurance premiums paid by hospitals for workers compensation and lower costs for needle disposal. The company has estimated the total market in 2006 to be about A$230m in Australia and A$1.7b in the US. Unitract plans to initially produce 65 million units a year, with production eventually rising to 650 million units a year. The company will offer manufacturing and distribution licences in the US, Europe, South-East Asia, China and India.
Xcell collaborators receive A$1m NIH grant
September 5 – Collaborators of Xcell Diagnostics, a Perth devices company, have earned a US NIH grant worth over A$1m. The grant will be used to fund clinical studies on Xcell's Funhaler paediatric asthma spacer device, testing the device's performance to FDA standards. The grant was made to researchers at the University of Western Australia and the TVW Institute of Child Health. The clinical program is expected to commence shortly and will run for three years. However the trial results are not required for US FDA approval, so the company is expecting to submit a 510K application early next year. Xcell plans to file for European approval at the same time as the FDA filing. The Funhaler is already listed on the Australian Therapeutic Goods Register.
n Arthritis CRC gets A$5m funding from Federal government
n International Trade Show Assistance Program launched n Prime Minister announces science prizes n Queensland Government signs biodiscovery agreement
Arthritis CRC gets A$5m funding from Federal government
September 3 – The Cooperative Research Centre for Chronic Inflammatory Diseases will receive A$5m in funding from the Federal government to implement two new programs. The CRC applied for the supplementary funding to expand into the area of osteoarthritis, and to develop computational and structural biology techniques. In announcing the funding Australian Science Minister Peter McGauran said the research would reduce the need for osteoarthritis sufferers to undergo painful joint replacements. The treatments developed will range from medicines to manage inflammation, to helping repair bones affected by arthritis. Promoting and Maintaining Good Health was named as one of the four National Research Priorities for Australia, with one of the priority goals being preventative healthcare research.
International Trade Show Assistance Program launched
September 10 – Queensland Innovation Minister Paul Lucas recently launched the fifth round of the International Trade Show Assistance Program. The program is designed to assist biotechnology and information and communication technologies companies take part in international trade shows and overseas trade missions. Companies are encouraged to apply for a State Government grant to help them develop and expand their export opportunities. Grants of up to $5000 will be provided to small and medium sized organisations. The program has only this year been expanded to include biotechnology companies. Applications for the grants close on October 31.
Prime Minister announces science prizes
September 9 – The Prime Minister recently announced Emeritus Professor Jacques Miller AC, of the Walter and Eliza Hall Institute of Medical Research, as the winner of the A$300 000 Prime Minister's Prize for Science. Professor Miller's research into immunology has impacted greatly on international medical research and treatment, and his discoveries underpin much of modern medicine's understanding of how the immune system operates. Over his career Professor Miller has made two vital discoveries. He showed how the thymus was a crucial organ to the immune system, and discovered that mammals have two distinct types of white blood cells, those created by the thymus and those derived from bone marrow. His research has allowed the development of better vaccines and more targeted cancer treatments. Professor Miller has previously received recognition from international bodies, societies and associations based in the US, Canada, Europe and Israel.
[Source: Prime Minister's Media Release]
Queensland Government signs biodiscovery agreement
September 13 – A Far North Queensland company, EcoBiotics, has signed a Benefit Sharing Agreement with Queensland's State Government to search for active compounds in plants and animals that could be used in commercial products. The agreement will allow EcoBiotics to conduct biodiscovery in tropical rainforest areas, searching for material such as leaves and fungi with potential as anti-cancer drugs, antibiotics, fungicides, anti-parasitics or drugs for inflammatory diseases. EcoBiotics is the third organisation to sign such an agreement with the Queensland Government, which gives the company rights to use the bioactive chemicals they source. The other organisations involved are the Australian Institute of Marine Science and BioProspect. Royalties are paid to the government for any discovery that results in commercialisation.
n Angioplasty proves more effective than clot-busting drugs for heart attack victims n Chimp genome may hold key to new anti -HIV treatments n Cholesterol drug may also be good for mental health
n Lizard spit drug found to control diabetes and cut weight n Malaria vaccine not far away n New cancer gene identified
n Sage a possible ally against Alzheimer's
Angioplasty proves more effective than clot-busting drugs for heart attack victims
August 20 – The New England Journal of Medicine has said that given the results of a new study, surgery to reopen clogged arteries should be the standard treatment for heart attack victims. The Danish study found that even if patients had to travel up to two hours to receive it, the surgical technique known as angioplasty was the best treatment, being far more effective than the available drugs. The current problem with the surgery is availability, because even in the United States most hospitals do not perform the operation, and those that do are not ready to perform it on an emergency basis. The study found that for every 18 patients who received angioplasty instead of drugs, one follow-up heart attack, disabling stroke or death would be avoided.
Chimp genome may hold key to new anti-HIV treatments
August 20 – The fact that chimpanzees can be infected with HIV but not develop full-blown AIDS was initially a research setback, making the search for animal models of the disease more complicated. However scientists at Evolutionary Genomics now hope to capitalise on this fact to develop new anti-HIV treatments. It is believed that chimps have adapted over the last two million years, and consequently have developed some mechanism for dealing with the virus. Researchers are studying blood samples from infected chimps in order to determine the proteins that enable the animals to beat HIV. The genes that play an important role in the progression of the disease can be culled using Evolutionary Genomic's Adapted Traits bioinformatics platform, which allows the institute to compare genes of closely related species and pick out particular genes. Given the similarity between the human genome and the chip genome, the fact that chimps do not progress to AIDS is one of the rare differences between the species.
Cholesterol drug may also be good for mental health
August 19 – Researchers in Boston have found that long-term treatment with cholesterol-lowering statins (such as Zocor or Lipitor) may decrease the risk of anxiety, depression and hostility. The finding is unexpected, given the link that was made more than a decade ago between vigorous cholesterol lowering and increased risk of depression and violent behaviour. The research involved comparing patients receiving statin treatment continuously, patients receiving the treatment intermittently, and people who had never been prescribed a cholesterol-lowering drug. A 30-40% reduction of risk was observed. Furthermore, the risk of mental illness decreased with each additional year of statin treatment.
Genome screening race heats up
August 20 – The sheer power of RNAi screening has prompted growing interest by both scientists
and pharmaceutical companies (such as Novaris and Bristol-Myers Squibb) to be the first to claim they understand how sets of genes contribute to the function of biological pathways. However, there are questions being raised as to how willing courts are going to be to uphold some of the broad claims to gene function that many companies are hoping to secure. There are many different ways in which to study the same system, which means RNAi is being used by different groups to study the same cell lines, each in unique way. Nevertheless, various approaches to comprehensively screening genomes to determine the functions of individual genes have been developed by several groups of researchers in the US and Europe.
Lizard spit drug found to control diabetes and cut weight
August 25 – Amylin Pharmaceuticals and Eli Lilly have released new study findings at the 18th Congress of the International Diabetes Federation in Paris. They announced that an experimental diabetes drug they are developing, which is derived from lizard saliva, not only control's patients' blood sugar levels but also cuts their weight. The drug is the first in a new class of therapies for type 2 diabetes, and is expected to be approved in 2004. The latest Phase III clinical trial results involved patients who had previously failed to reach target glucose levels on diabetes drugs metformin and sulfonylurea. The lizard whose saliva is used in the manufacture of the drug is the Gila monster, which lives in the Arizona desert and only eats four times a year. Its saliva helps it to prevent a sudden surge in blood sugar level in response to these infrequent but large meals.
Malaria vaccine not far away
August 22 – Australian scientists are at the forefront of the international effort to develop a malaria vaccine. At present the only anti-malarials available have to be taken regularly and are too costly for much of the third world. What is needed to protect against the disease is a vaccine which targets the many different strains of malaria. Walter and Eliza Hall Institute scientists have found that a toxin produced by the malaria parasite is what causes the most damage to the patient. Years have been spent identifying and purifying the toxin, and trying to understand its behaviour. More recently, synthetic chemists have developed an experimental vaccine directed against the toxin. Researchers expect a vaccine to be having an impact against malaria by 2015.
New cancer gene identified
August 28 – US researchers have reported that nearly one in 10 people have a gene mutation that can raise their risk of cancer by at least a quarter. The gene, which raises the risk of breast and ovarian cancer by 50% and the risk of colon cancer by 38%, is thought to be the most common cancer-linked gene identified to date. People with two copies of the mutated gene have double the risk. The proliferation of the gene becomes clear when compared to other cancer-linked genes such as BRCA1 and BRCA2, which are linked to breast cancer, and are found in one in 500 people. The gene was identified by Dr Boris Pasche, director of Northwestern's Cancer Genetics Program, in 1998. The recent research is a result of the pooling of seven published studies. Researchers believe that the findings could eventually be used to screen people for cancer risk and perhaps to develop better therapies.
Sage a possible ally against Alzheimer's
September 1 – Scientists, inspired by the writings of herbalists working four centuries ago, have identified sage as a possible ally in the fight against Alzheimer's. The writings mention a marked improvement in the memory capabilities of people taking sage oil extract. These findings are consistent with research at the Newcastle and Northumbria Universities' Medicinal Plant Research Centre, which found that sage protects a key chemical destroyed in Alzheimer's. The research will be used to inform drug research and development, especially given that sage has no side-effects. Johnson & Johnson and Shire Pharmaceutical's Reminyl, made from daffodil bulbs, is already on the
n Aventis signs licensing deal with Dainippon n Bristol-Myers and Flamel combine to develop new insulin form n Bristol-Myers may pull antidepressant drug from Canada
n Exten subsidiary MultiCell signs exclusive distribution agreement with XenoTech n GSK and Bayer's Levitra wins US approval n GSK's Wellbutrin FDA approved
n Novartis launches generic version of Prilosec despite legal risks
n Pfizer and Merck scale back plans for R&D in Germany n Vical grants options to Merck for cancer targets
Aventis signs licensing deal with Dainippon
August 28 – A deal between drugmaker Aventis and Japanese Dainippon Pharmaceuticals gives Aventis exclusive worldwide development and marketing rights to Dainippon's novel anti-dementia agent AC -3933. The deal bolsters Aventis' portfolio of drugs to fight Alzheimer's disease. AC-3933 is expected to show better benefits than memory -improving treatments currently on the market. As a result both companies believe AC-3933 has the potential to become a key product in the global market. Phase IIa proof -of-concept clinical trials will focus on Alzheimer's related dementia and are planned to begin in Europe in the autumn.
Bristol-Myers and Flamel combine to develop new insulin form
August 28 – Bristol-Myers Squibb and France's Flamel Technologies have agreed to develop a controlled-release insulin for diabetics, which will be marketed under the name Basulin. The news caused Flamel's shares to rise to a record high. The company will receive an initial payment of US$20m, and US$145m in milestone payments, as well as royalties on sales. Basulin will be the first controlled-release insulin that uses recombinant human insulin, and is now entering Phase II clinical trials to test the safety and efficacy in humans. Under the agreement Bristol-Myers will lead and assume the cost of development and manufacture, and will hold worldwide exclusive rights. Dr Nathaniel Clark, national vice president for clinical affairs for the American Diabetes Association, said that usually both a slow-acting long-lived insulin, as well as a fast-acting insulin, are necessary for patients. He believes Basulin would only replace the slow-acting version, and an additional fast-acting insulin would still be necessary.
Bristol-Myers may pull antidepressant drug from Canada
August 29 – Bristol-Myers Squib is considering withdrawing its antidepressant drug, Serzone, from the Canadian market amid possible links to liver damage. The company is currently in talks with Canada's drug-safety overseer Health Canada about the "risk-benefit ratio" of Serzone. If the drug is withdrawn from Canda, it would leave the US and Australia as the only major markets available. In January, British regulators said that Bristol-Myers would stop selling the antidepressant after it had been linked to liver damage in European countries.
Exten subsidiary MultiCell signs exclusive distribution agreement with XenoTech
August 20 – Exten Industries' wholly-owned subsidiary, MultiCell Technologies, has executed a marketing and distribution agreement for its proprietary immortalised human liver cell lines with XenoTech. The agreement gives XenoTech a seven year exclusive right to distribute the proprietary liver cell lines globally, in return for an initial cash payment of US$1.5m plus a minimum of US$18m in royalties over the term of the agreement. Jerry Newmin, Exten's CEO, commented that "the XenoTech Agreement represents an avenue to rapidly maximise MultiCell's exposure to the pharmaceutical industry", given XenoTech's commercial relationships and expertise. The agreement will allow XenoTech's cell manufacturing facilities and sales organisation to expand the distribution of MultiCell's liver cells throughout the pharmaceutical industry.
GSK and Bayer's Levitra wins US approval
August 20 – Levitra, a new oral impotence treatment developed by GlaxoSmithKline Plc and Bayer AG has won approval in the US. Levitra's makers are planning a major marketing campaign to reach the estimated 30 million US men who experience some level of erectile dysfunction. The drug is expected to be available in September. Another competitor, Cialis, is also expected to hit the US market later this year. Pfizer, the maker of Viagra, the original impotence drug, believes it can handle the competition and plans no changes to marketing.
GSK's Wellbutrin FDA approved
August 28 – FDA has approved GlaxoSmithKline's Wellbutrin for the treatment of major depressive disorder in patients 18 years and older. The new treatment is taken once-daily and carries low risk of sexual side effects and weight gain. These side-effects are important considerations in choosing antidepressant therapy, as they may be caused by either the medication or by the depression itself. GSK expects Wellbutrin to be available by mid-September. The company licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001. The drug will be available in two strengths to allow for dosing flexibility. GSK believes the current twice-daily dosing requirement is a major prescribing barrier, and thus this new once-daily formulation will be a welcome improvement for both physicians and patients.
Novartis launches generic version of Prilosec despite legal risks
August 20 – Novartis stands out from other big pharmaceutical companies by having a strong and expanding generics unit, recently rebranded Sandoz. The company has recently decided to launch a generic version of AstraZeneca's multi-billion-dollar ulcer pill Prilosec in the US. This decision comes despite legal risks, and displays Sandoz's willingness to take calculated risks in order to capitalise on the growing demand for generics among cost-conscious governments and health insurers. However, according to Steve Waterman of Commerzbank in London, "revenues from generics are a lot lower quality and profitability is a lot lower". Additionally, Novartis is looked at tapping into the potential market opportunity in generic biotechnology medicines, which so far are still mostly patent-protected.
Pfizer and Merck scale back plans for R&D in Germany
August 25 – Germany's proposed health care reforms have caused Pfizer and Merck to cut back plans to carry out research in the country, because of fears the reforms would hit profits. Merck has abandoned plans to build a research centre in Germany, and Pfizer has decided to move its research activity to the United Kingdom. Eli Lilly, which has been planning to add 100 employees to its research centre in Hamburg, also reported that the planned health care reforms added to uncertainty and that no final decision had yet been made on the expansion. The drugmakers are particularly annoyed by a provision in the reforms which would increase the rebate companies have to pay insurers on sales of their products in Germany from six to 16%. The move is intended to cut German health care costs, but reduces the incentive for the companies to spend money on research.
Vical grants options to Merck for cancer targets
August 21 – Vical Inc and Merck & Co have amended their existing license agreement. Vical has granted Merck an option to use its patented non-viral gene delivery technology for three cancer targets. The exercise of each license will result in a license fee payment, plus milestone and royalty payments following any further developments. Vical has expanded its infectious disease portfolio by reacquiring rights to apply its core vaccine technology for flu, herpes simplex and human papilloma virus, which were previously licensed to Merck. Merck will retain rights to use the technology for HIV and hepatitis B and C.
Medicine for the Public Tuesday 16 September – Tuesday 28 October 2003 Bethesda, Maryland http://www.cc.nih.gov/ccc/mfp/current/index.html Third Virtual Conference on Genomics and Bioinformatics Tuesday 16 – Friday 19 September 2003 Virtual Locations, Worldwide http://www.ndsu.edu/virtual-genomics/conference_2003.htm FBIG Oxoid Young Speakers Evening: "Veggietones - vegetable peptones" Thursday 18 September 2003 Victoria http://www.ausbiotech.org/fbigevents.php Networking Forum and Presentations: "Bioscience Tools in the 21st Century: Launch of the Adelaide Integrated Biosciences Laboratories" Thursday 18 September 2003 Bonython Hall, University of Adelaide, SA Email: firstname.lastname@example.org NEW Networking Forum and Presentations: "Changing the Landscape: Launch of the AIB Labs" Thursday 18 September 2003 Bonython Hall, University of Adelaide, SA Email: email@example.com International Association of Biomedical Gerontology, 10th Congress Friday 19 – Tuesday 23 Sepember 2003 University of Cambridge, England http://www.biospace.com/calendar/detail.cfm?CID=506220 NEW Strategic Research Institute: Outsourcing of Clinical Drug Development Monday 22 – Wednesday 24 September 2003 Scottsdale, Arizona http://www.biospace.com/linkto.cfm?link=www.srinstitute.com/clinical BIOPHEX / INTERPHEX: bridging the gap between post-discovery and commercialization Tuesday 23 – Thursday 25 September 2003 San Jose, California http://www.biospace.com/calendar/detail.cfm?CID=503420 PharmaSec: The Conference on Pharmaceutical and Biotech Information Security
Tuesday 23 – Thursday 25 September 2003 Chicago http://www.misti.com/northamerica.asp
Georgia Life Sciences Summit 2003: The Power Of Collaboration Wednesday 24 September 2003 Atlanta, Georgia http://www.biospace.com/calendar/detail.cfm?CID=510620 9th Bioscience Economy Conference Wednesday 24 – Thursday 25 September 2003 Geneva, Switzerland Milan, Italy http://www.capitalife.com/conferences.html Australian Venture Capital Association Ltd – Tenth Annual Conference Thursday 25 – Friday 26 September 2003 Gold Coast, Qld http://www.avcal.com.au 2003 Pharmaceutical Marketing Congress Monday 29 September – Thursday 2 October 2003 Philadelphia http://www.iirusa.com/pharmaevent/ Production and Economics of Biopharmaceuticals Monday 29 September – Thursday 2 October 2003 San Diego http://www.lifesciencesinfo.com/BPW NEW The 2003 Pharmaceutical Marketing Congress Monday 29 September – Thursday 2 October 2003 Philadelphia, Pennsylvania http://www.biospace.com/linkto.cfm?link=www.pharmaevent.com/ Strategic Business Planning for Technology Commercialisation Monday 29 September – Friday 3 October 2003 Melbourne http://www.muprivate.edu.au/commercialise FDA Auditing of Computerised Systems Tuesday 30 September – Thursday 2 October 2003 San Diego Email: firstname.lastname@example.org NEW Pharma License Exchange Wednesday 1 – Thursday 2 October 2003 Atlanta, Georgia, US http://www.biospace.com/calendar/detail.cfm?CID=508220 NEW MDN Program presents - "Develop Your Medical Device - Fast" Thursday 2 October 2003 Victoria http://www.ausbiotech.org/mdn.php Bio-Partnering Europe Mission Monday 6 – Tuesday 14 October 2003 SA http://www.bioinnovationsa.com.au/events/event_detail.php?event_id=49 NEW NEW InnoCentive, an e-Business Model for Drug Discovery: Implications for Intellectual Property
Tuesday 7 October 2003 Clayton Utz, Level 18, 333 Collins St, Melbourne http://www.ausbiotech.org/vic.php
"Are You Getting Enough?" Tips to Maximise the R&D Tax Break Wednesday 8 October 2003 Victoria http://www.ausbiotech.org/mdn.php Seminar: "Biotechnologies and their potential for Australian industry and society" Thursday 9 October 2003 Hilton International, Adelaide http://www.bioinnovationsa.com.au/events/event_detail.php?event_id=50 BioPartnering Europe Sunday 12 – Tuesday 14 October 2003 London http://www.techvision.com/bpe Branding in the Pharmaceutical Industry Monday 13 – Wednesday 15 October 2003 Brussels http://www.mce.be/events/1212.htmhttp://www.mce.be/events/1212.htm Australian Research Management Society Annual Conference: Lifting R&D Performance – Australian Best Practice Monday 13 – Thursday 16 October 2003 Auckland, New Zealand http://www.cmsl.co.nz/arms03/ Japanese Global Venture Forum Monday 20 – Tuesday 21 October 2003 Osaka, Japan http://www.gvf.ne.jp NEW The International Life Science Summit Monday 20 – Tuesday 21 October 2003 Georgetown University, Washington, D.C. http://www.biospace.com/linkto.cfm?link=www.connectionscorp.com/ NEW Techvest's 5th Annual Healthcare Conference & Expo Tuesday 21 – Thursday 23 October 2003 Marriott Long Wharf Hotel, Boston, Massachusetts http://www.biospace.com/linkto.cfm?link=www.techvestllc.com/usconference 3rd Annual Sachs-Bloomberg Biotech in Europe Investor Forum Wednesday 5 – Thursday 6 November 2003 Munich http://www.sachsforum.com ClubBio 2003/MLA Satellite Workshop Thursday 6 – Saturday 8 November 2003 Gold Coast, Queensland http://www.ausbiotech.org/qld.php Rendering Biological Knowledge from Proteomics & Genomics Sunday 9 – Wednesday 12 November 2003 Leesburg, VA http://www.chemistry.org/portal/a/c/s/1/general.html?DOC=acsprospectives%5Cproteomics2003% 5Cindex.html bioLOGIC Asia 2003
Wednesday 19 – Friday 20 November 2003 Singapore http://www.pharma-rd.net/2003/bioa_SG/
MEDICA 2003 35th International Trade Fair with Congress World Forum for Medicine Wednesday 19 – Saturday 22 November 2003 Düsseldorf Trade Fair Centre, Germany http://www12.medica.de/cipp/md_medica/custom/pub/content,lang,2/ticket,g_a_s_t/oid,155 Email: email@example.com Australasian Pharmaceutical Science Association - Annual Conference 2003 Wednesday 3 – Friday 5 December 2003 Bondi Beach, Sydney http://www.apsa-online.org NEW 7th World Biomaterials Congress 17 – 21 May 2004 Sydney Email: firstname.lastname@example.org
bebe stores, Inc. EPO 90/0 Plan Welcome to WellNet! The information below is a general description of your plan benefits and is not meant to be a complete list or complete description of available services. Please contact WellNet at 800-442-1101 with specific questions about your program. PRESCRIPTION DRUG COPAYS RETAIL (up to 30 day supply) MAIL SERVICE (up to 90 da
El Carvedilol reduce la morbilidad y la mortalidad en pacientes con insuficiencia cardíaca severa. Packer M, Coats AJS, Fowler MB, Katus HA, Krum H, Mohacsi P et al for the Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure N Engl J Med 2001; 344: 1651-1658. Objetivo: Valorar el efecto sobre la mortalid