Archive for the ‘biopharmaceutical’ Category

Patenting Genes and Other Biotech Development Issues Monday, June 28th, 2010

Genes are “products of nature” which are not legally allowed to be patented. Additionally, giving monopoly to a company on a human gene is immoral. Thus go the arguments of those like American Civil Liberties Union (ACLU) and others who have filed suits against gene patenting.

A U.S. District Court ruled in favor of ACLU, and the company concerned, Myriad Pharmaceuticals, have gone in appeal.

The basic argument of gene patenting advocates is that developing biotech drugs is a highly expensive process, and that companies will have an incentive to do this and develop lifesaving diagnostics and therapies only if their discoveries are protected as intellectual property. The Patent Office has been granting patents on genes on the ground that once these are isolated from their natural environment in the body, they cease to be products of nature.

Other cases in courts include patentability of business methods, such as methods of analysis, data interpretation, and performing certain tasks including the administering of diagnostic tests and therapeutics.

Personalized medicine is a new development related to genes. A person’s genetic makeup can determine which treatments will be most effective for that person, as identified through genetic diagnostic tests. Companies have been developing such tests in the laboratory and these laboratory-developed tests (LDTs) are now being increasingly overseen by the Food and Drug Administration to assess the risks involved.

Read the article at TechJournal South.

Personalized Medicine Enhances the Effectiveness of Medical Treatment Monday, June 21st, 2010

The same medicine can work differently in different individuals depending on their genes. What this means is that you cannot always expect to get the same result that others have obtained from a medicine. Naturally, this reduces the effectiveness of medical treatment in general.

With the information gained from the Human Genome project, it has theoretically become possible to tailor medication to the individual’s genetic characteristics. This is known as personalized medicine and it has the potential to enhance the effectiveness of medical treatment.

However, putting the theory into practice faces many problems. New technologies are taking intensive efforts to achieve a breakthrough to make the potential a reality.

Gene diagnosis and personalized medicine will be the main focus area for the 9th INT’L BIO FORUM & BIO EXPO JAPAN to be held from June 30 – July 2, 2010. It is Asia’s largest bio-event and is being organized by Reed Exhibitions Japan.

According to their news release, the event will have 250 sessions covering “the hottest topics in biotechnology business development, research, marketing trends, best practice and more, with globally-recognized speakers…650 exhibitors from worldwide participate at the show venue for net-working and business meetings.”

The Expo will be “the best place for enhancing knowledge on life science.”

Read the news release at The Clinical Device Newsletter.

Clinical Research Group Acquires Chinese Contract Research Organization Thursday, May 6th, 2010

Charles River Group is a clinical research organization that provides contract research services to pharmaceutical companies. The group is offering $1.6 billion to buy WuXi PharmaTech that plays an important role in China’s drug development market. The acquisition involves paying a premium of 28 percent over the agreed-date share price of $16.57 to WuXi shareholders.

In addition to extending the reach of Charles River into Chinese markets, the purchase is expected to produce annual pre-tax savings of $20 million for the company through operating efficiencies. The deal will be closed in the fourth quarter of 2010 provided shareholders of both companies approve the deal.

According to the CEO of Charles River, James Foster, the “transaction revolutionizes the contract research landscape by creating the only global contract research organization, or CRO, to offer fully integrated research and drug development services from molecule creation to first-in-human testing.”

WuXi’s CEO, Ge Li, will become a corporate Executive Vice President, and president of global discovery and China services of Charles River. According to Li, the deal will allow WuXi to accelerate its good laboratory practice toxicology capabilities.

Charles River CEO emphasized the market proximity advantage that the deal will provide to the group. According to him, China is going to be an important and growing market for the life sciences industry.

Read the M&A story at The Burrill Report.

Biotechnology for World Health Monday, May 3rd, 2010

Pharmaceutical companies, like other businesses, are interested in returns for their shareholders and focus on profitable drugs and medicines. The improving health conditions in developed countries have made the profitability of many vaccines, for example, unattractive to these companies. Manufacture of these products for use in developing countries is just not profitable enough for the pharma companies.

Developing countries need effective drugs and vaccines at low costs, often for diseases that are unique to their particular regions. Affordable and rapid molecular diagnostic tests, recombinant and heat stable vaccines for tropical and other neglected diseases, new drug and vaccine delivery systems as well as a wider application of genomics are what biotechnology can offer to these countries.

As manufacturers in developed countries withdraw from the scene, it is public health intervention programs that try to fill the gap. However, a huge knowledge gap exists and developing countries by themselves may not be able to make a significant impact. Some hopeful signs are there in such countries as China, India and Brazil where biotechnology capacity and sophistication are increasing.

Hopes of achieving Millennium Development Goals (MDGs) through public interventions alone are dim. Biotechnology has a key role in achieving the goal of affordable healthcare. Local initiatives can help as when Cuba developed its own vaccine in response to an outbreak of meningitis B during the 1980s. The vaccine has been successful not only in curbing the epidemic but also in sustaining its impact till now.

For a real solution, however, closer collaboration between developed and developing countries, with adequate protection for intellectual property rights, is necessary. Read the report on this topic at Geneva Health Forum online news.

What should We Believe about Genetically Modified Crops? Friday, April 16th, 2010

Genetically Modified (GM) crops are targets for an often violent debate. Advocates of GM crops point to the higher yields and benefits like built-in pest resistance that modifying the genes of the crops can provide. Opponents say that the safety of GM crops has not been proven through long-term use and that they might cause unforeseen harm to environment and consumers.

Traditionally, the technique of cross-breeding between different species has been used to transfer desirable characteristics from one species to another. However, this procedure is time-consuming and cannot often produce the specific results that we want.

Genetic modification involves working with the genes of crop plants. Because it is genes that determine the characteristics of organisms, it is possible to change the characteristics by modifying the genes using molecular biotechnology. Scientists might, for example, locate a gene that provides drought resistance, and insert that gene into a plant used as food crop. Done successfully, this can provide drought resistance trait to the food crop.

Genetic modification has provided several advantages:

  • Crops with pest-resistance eliminate the need to use pesticides, with consequent lower costs and also elimination of the health hazards that pesticides cause
  • Crops resistant to herbicides can also provide a somewhat similar benefit. Herbicides are used to destroy weeds that reduce crop yields. Application of herbicides can affect the crop and also cause environmental damage. Both these results can be reduced by making the crops herbicide resistant
  • Genetic modification that can improve resistance against viruses, fungi and bacteria that cause damage to crops can increase crop yields
  • Tolerance for drought, cold and salinity can make it possible to grow crops in conditions formerly not possible, and thus meet the ever-increasing demand for food
  • People in poorer countries often depend on a single food, such as rice. These food items might not provide adequate nutrition. Genetic modification can make such food items more balanced in nutritive value
  • If food crops can be modified to provide medicinal and disease prevention benefits presently provided by medicines and vaccines, both availability and affordability of the medicines and vaccines can be improved
  • Non-food plants have been modified to clean up the environment, e.g. remove metal pollutants from contaminated soil

Opposition to GM crops have been also gaining strength, mainly because of:

  • Toxins designed to kill one type of organism, viz. pests, can also kill other, unintended, organisms. For example, pollen from B.t. corn is reported to have killed monarch butterfly caterpillars, a finding that is being contested by industry groups and others
  • Pests might become resistant to plants that have been modified for pest-resistance, just as mosquitoes become resistant to DDT
  • Genes can be transferred to other species through natural cross-breeding, causing not-so-beneficial results and other problems. For example, weeds might gain herbicide resistance from herbicide resistant crops, making them “super weeds.” GM characteristics might also be passed on to non-GM crops in neighboring fields, resulting in problems for farmers growing non-GM crops

Read more about the issues at ProQuest.

Fighting Allergies and other Inflammatory Diseases in a Strange way Monday, April 12th, 2010

Evidence points to the unappealing fact that infection with fecal-dwelling hookworms can protect against a number of inflammatory diseas. The diseases include asthma and allergy, multiple sclerosis, Crohn’s disease and type 1 diabetes.

Scientists are hoping to decipher how these organisms control the immune systems of their human hosts. Once the deciphering exercise progresses sufficiently, the scientists hope to replicate the parasite’s beneficial effect and develop effective therapies for the inflammatory diseases.

Swallowing pig whipworm eggs or deliberately infecting oneself with hookworms are effective. However, these are prospects that even severe allergy sufferers are not likely to accept. Hence the focus on finding out how the hookworms do it and trying to replicate the process through drugs. One scientist feels that the solution might lie in inducing the types of immune responses that chronic worm infections produce.

The rise in alergies and other ailments in rich countries is matched by a decrease in parasitic worm infection, which has been with us for a long time. Such long associations between two organisms, humans and parasitic worms in this case, tend to become mutually beneficial. By eliminating parasitic worm infections, we might be making ourselves vulnerableto immunologic diseases.

Research in animal models designed to mimic these diseases supports these conclusions. Infection with parasitic worms induces the type of allergic response triggered by allergens. This in turn raises levels of an antibody immunoglobulin which, when it binds with specific immune cells in the blood, causes the the cells to dump their contents into the bloodstream triggering allergic symptoms.

In people with parasitic infections, there are lots of immunoglobulins and lots of the cells that cause allergies, and yet they don’t suffer allergies. The mechanism for this phenomenon is not fully clear though one scientist has noticed that worms produce an enzyme that prevents the immunoglobulins from binding with immmune cells (and causing the latter to dump allergy-triggering substances into the bloodstream).

Read more details at TechnologyReview.com.

Generics and Branded Drugs: Are they the same? Tuesday, March 30th, 2010

New drugs require years of research and clinical trials to prove their efficacy, and compliance with a lot of formalities before they are approved for the market. Pharmaceutical companies cite these as reasons for prolonged patent and other kinds of brand protection.

Branded products are priced high and the ordinary consumer often finds them unaffordable. This is particularly true in developing countries where the income levels of most people are low.

Generics are drugs without a brand name that are made using the research and trial findings used for the branded version. Even generic drugs have to conform to the same safety standards as branded drugs.

Generic drugs are cheaper because the companies making them did not incur the heavy development and promotional expenses of the original brand name drug. Additionally, because several companies are making the generic version, competition drives down the price.

While the above is the scenario at the introduction of innovative new drugs, pharmaceutical companies have been accused of making minor changes to an existing, proven drug and claiming brand name protection for the modified version. In this case, they would not have incurred any heavy research and development expenses and the claim for continued protection is not justified.

Brand name protection prolongs the period of lifesaving drugs becoming available at affordable prices. As a result, there is a strong movement for restricting protection to as low a period as possible.

Read about generic drugs at the FDA Website.

New Biotech Antibiotic Kills Bacteria Directly Tuesday, March 23rd, 2010

Clinical trial data for PMX-30063, a defensin-mimetic antibiotic compound developed by PolyMedix, Inc. was presented at the 8th World Congress on Trauma, Shock, Inflammation and Sepsis (TSIS) in Munich, Germany.

A common problem with antibiotics is that bacteria develop resistance to the drug over a period of time. PMX-30063 has characteristics that prevent such resistance being developed, according to the presentation.

The data showed that the drug kills Staph bacteria in human serum blood samples at specific therapeutic dose levels. Phase 1B dose-escalation clinical study had demonstrated that the administration of multiple doses of PMX-30063 is safe and well-tolerated.

PMX-30063 is a small molecule mimetic of human host-defense proteins, which are highly effective antimicrobial defense systems found in virtually all living creatures. The drug disrupts bacterial membrane directly thus making development of bacterial drug resistance unlikely.

Unlike other antibiotics that act by stopping bacterial reprodcution, PMX-30063 kills bacteria directly, and is fast acting. The drug is said to be the first antibiotic with this mechanism of action.

Read the news release at Market Watch.

Leukemia Vaccine to Kill Remaining Cancer Cells Tuesday, March 23rd, 2010

Leukemia patients taking the drug Gleevec (imatinib mesylate) still had cancer cells present after one year. Human clinical studies of GVAX Leukemia vaccine developed by BioSante Pharmaceuticals, Inc. showed that it was possible to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking Gleevec.

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center investigators used a vaccine made from CML cells. The cancerous potential of the CML cells was halted by irradiating them. The cells were also genetically altered to produce an immune system stimulator called GM-CSF.

The treated cells also carried antigen molecules specific to CML cells that prime the immune system to recognize and kill circulating CML cells.

Cancer vaccines may be a good way to mop up the residual disease according to Dr Levitsky, Professor of oncology, medicine and urology at the Johns Hopkins Kimmel Cancer Center, in Baltimore, Maryland.

Read the news at BioMed Reports.

What Strategies do Successful Biotechnology Companies Use? Monday, March 1st, 2010

Aarkstore has announced the publication of a report titled “The Fastest Growing Biotechnology Companies: Growth strategies, comparative analyses and company profiles.”

Biotechnology is providing more and more solutions in healthcare field and the interest of pharmaceutical companies in these solutions are driving them to partnerships with biotech companies. Drug discovery is becoming more science-intensive and biotech scientists are in a position to help.

Biotech companies do R&D for the big pharmaceutical companies on a contract basis and receive their financial help to meet high R&D costs and commercial pressures. The pharma companies, in turn are coming to depend on the biotech companies ever more.

The Aarkstore report claims to be based on research into the strategies adopted by the fastest growing biotech companies. According to the publisher’s release, the report looks at the structure and organization of the biopharmaceutical industry and analyses  the growth strategies adopted by the biotech companies to meet cost pressures and competition from generics, complex pricing, government regulations and globalization.

Read more details of the report at: Aarkstore Market Research