The success of biopharmaceuticals has made generic firms keen to launch cheaper copies - but they have met with frustration as the major regulatory agencies have yet to finalise appropriate routes for their approval. Unlike small molecules, biological products can be affected by their production process-a factor the developers have used to lobby against biogenerics. The US FDA has been considering the matter and the EC has passed legislation for the approval of "similar biological medicinal products" that is due to take effect in late 2005. Biogeneric applications can already be made to the EMEA, and BioPartners submitted an MAA for an alpha-interferon product for the treatment of hepatitis C. Moreover the Australian Therapeutic Goods Administration approved Omnitrope, a biogeneric form of recombinant DNA human growth hormone from Novartis' generics unit Sandoz. Biogenerics are finally getting nearer the market. Worldwide sales of biological products could reach $50 billion in 2004, representing 10-15 per cent of the total pharmaceutical market. Biologics also represent approximately one-quarter of the total industry's pipeline. Moreover, the top 10 biotech companies have a market share of 84 per cent, versus 51 per cent for the top 10 pharma firms. At the moment the companies are focusing on genric versions of simpler proteins like hGH or GCSF (Neupogen), for which analytics are already available. Generic antibodies, however, could be in the pipeline in time for the first patent expiries of major products like Herceptin (trastuzumab) and Rituxan (rituximab).
Japan's pharma R&D
The Japanese pharmaceutical market is the third largest in the world after the US and Europe. The Japanese pharmaceutical market is at an interesting stage of development. Although its growth has slowed in recent years, there is potentially a great demand for new medicines, largely driven by the ageing of the population. From an industry perspective, the government has focused too heavily on cost containment measures to control healthcare expenditure and this has lessened the incentives for companies to carry out innovative R&D. Furthermore, it places the domestic industry in a weak position to challenge foreign rivals that are increasing their presence in the country. New medical products will be required by Japanese society in the future and the question is how much of a contribution Japanese companies will be able to make to meet this demand. As in Europe, the Japanese government will have to find a way to reward its domestic industry for their research efforts whilst it tries control the rising costs of healthcare Europe's health priorities for the world
WHO has recently released a crucial report, 'Priority Medicines for Europe and the World'. The report was commissioned by the Dutch government as the current president of the EU, with the aim of making its findings the primary focus of the seventh Framework programme for European Biomedical Research, driving the European research agenda from 2007 to 2010. One goal of the project was to identify public-health priorities, present and future, which coexist in developed and developing countries. The "Priority Medicines" project represents a refreshing and innovative approach. In emphasising a research driven approach and a constructive relationship between the pharmaceutical industry and public-health organisations it paves the way for a new era in Health Research. By identifying public-health priorities which will benefit both developed and developing countries the report also suggests one possible solution to the problem of driving innovation in otherwise neglected health areas.
First new drug approval for Indaflex (topical non-steroidal anti-inflammatory) from Mexico
AlphaRx announced that Mexico is the first country to grant approval for the sale and marketing of its lead pharmaceutical product, Indaflex. Industria Farmaceutica Andromaco will represent AlphaRx in Mexico. Andromaco is a well-established pharmaceutical company headquartered in Mexico City and will be responsible for the manufacturing, sales, marketing and distribution. It is anticipated that the production of Indaflex will begin in January 2005. Indaflex is a topical non-steroidal anti-inflammatory drug (NSAID) formulation. Topical Indaflex delivery, the company hopes may circumvent the significant GI side-effects found with orally-ingested NSAID's. Indaflex has not been approved by the US FDA so far.
'TouchSpray' electronic aerosol technology set for new uses
The Technology Partnership (TTP) is working with a number of international companies to commercialise its electronic aerosol technology, TouchSpray. This technology is the basis of Pari's new eFlow Electronic Nebulizer. TouchSpray enables liquid medication to be inhaled through the lungs with as much as 90 per cent efficiency and the technology is set to be expanded for use in a range of liquid and dense suspension drugs.
The technology enables a bioavailability as high as 90 per cent of the inhaled medication delivered to the lung. This compares with only 20 to 30 per cent typically delivered using conventional Metered Dose Inhaler technology. TTP has already licensed TouchSpray technology to Pari for electronic nebulisers. Pari has launched the eFlow nebuliser, a product which is now available in the US, and is involved in current clinical trials for asthma and CF medications exclusively delivered with eFlow.
Drug industry not tackling threats to public health, says WHO
Profit driven drug companies are not developing enough drugs and vaccines to address two major threats to public health influenza and resistance to antibacterial drugs that could kill millions of people across the globe, the World Health Organization said. In the report WHO has called for urgent action to address these two and 15 other diseases and conditions for which it says treatments do not exist, are inadequate, or are not reaching patients. "At present, pharmaceutical research and development are based on a market-driven incentive system relying primarily on patents and protected pricing as a prime financing mechanism," the report says. "As a result, a number of health needs are left unaddressed." The report showed that more research was needed to develop heat resistant drugs for people living in areas with little or no refrigeration in Africa, Asia, and Latin America. Heat resistant versions of insulin and oxytocin would be particularly useful. New, fixed dose combination drugs are also needed, particularly for HIV and AIDS, it says.
US Patent for solid dose delivery vehicle and methods for making
The US Govt has awarded to Quadrant Drug Delivery Ltd USA in November 2004 a patent which relate to an invention that encompasses a solid dose delivery vehicle suitable for therapeutic administration of a wide variety of substances, comprising a stabilizing polyol and a bioactive material. Preferred buffers, adjuvants and additional stabilizers are also provided. The delivery vehicle can be sized and shaped for a variety of modes of administration. It also encompasses methods of delivering a bioactive material by providing a solid dose delivery vehicle and administering the vehicle to the tissue. Administration can be by mucosal, oral, topical, subcutaneous, intradermal and by-inhalation. It further encompasses methods of making the solid dose delivery vehicle. The stabilizing polyol, bioactive material and any other components are mixed and processed by a wide variety of methods, including milling, spray drying, freeze drying, air drying, vacuum drying, fluidized-bed drying, co-precipitation and critical fluid extraction.
New drug approvals by US FDA
Click to view Table-1
New generic drugs approved for first time by US FDA
The US FDA has approved 18 formulations of 6 drugs as Generic Drugs (ANDAs) during October 2004. These drugs include Flumazenil, Carboplatin, Metformin, Levofloxacin, Gabapentin, Citalopram. The beneficiary companies include Aurobindo & Dr. Reddy's Laboratories from India. The details are given below:
Click to view Table-2
Compiled and presented as fair use from www by Dr.P. V.Appaji, Executive Director, PHARMEXCIL. appajipv@pharmexcil.com