Industry News

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Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-01-01-2006, Volume 18, Issue 1

Recent EU legislation change has opened the door for UK firm Accentus to use its novel predictive crystallization technology to discover and develop generic alternatives to patented drugs. Accentus will also licence its CrystalGEM predictive crystallization technology to generics manufacturers.

Protected products could face market challenge

Recent EU legislation change has opened the door for UK firm Accentus to use its novel predictive crystallization technology to discover and develop generic alternatives to patented drugs. Accentus will also licence its CrystalGEM predictive crystallization technology to generics manufacturers.

New crystallization technology threatens patents.

Under the new Bolar provision, a manufacturer may perform R&D of a generic drug while the branded version is still under patent. This change will enable companies to use Accentus' technology without infringing on the original patents.

The new solution reportedly reduces the time required to conduct crystallization screening, which will help speed up the discovery process. It can identify specific experimental conditions hence, decreasing the processing possibilities that are typically in the thousands.

CrystalGEM will be available to generics companies at half the price of traditional methods, indicating that there will be a rise in the amount of generic substitute drugs on the market.

Pharmaceutical packaging demand rising

World pharmaceutical packaging demand will increase by 6.3% each year, reaching $30 billion in 2009, according to The Freedonia Group. In its study titled World Pharmaceutical Packaging, it claims that expanding manufacturing capabilities in China will provide the strongest growth opportunities, but that the developed countries of Western Europe, the US and Japan will continue to account for 70% of the demand.

The report details how the US will remain the largest consumer of pharmaceutical packaging because specialized packaging will be needed for sophisticated therapies being introduced. Western Europe will benefit from upgraded government standards and in Japan favourable sales for pharmaceutical packaging will result from the reduction of government-imposed drug price controls.

Prefillable syringes and inhalers are likely to provide rapid growth opportunities because of drug delivery performance advantages. Solid and liquid oral medication packaging is expected to expand above average to incorporate the growing number of applications. Growth of approximately 5.1% in the world market for pharmaceutical closures and accessories is predicted and strong growth should occur in global demand for pharmaceutical blister packaging.


Gene therapy restricted by medico-ethical issues

It is expected that there will be considerable growth within the gene therapy market after significant effort has been made to deal with the toxicological complications and poor therapy efficacy. The US gene therapies market expects to see revenues reach $125 million in 2006 growing to approximately $6541 million in 2011.

Despite this the majority of biotech companies are a long way from getting a product approved and marketed. The China-based company Shenzhen SiBiono GeneTech is the only exception having the first gene therapy approved for marketing in the world in 2003. The treatment consists of an adenovirus, which inserts into a gene called p53. This gene codes for a protein that will cause cell suicide and when restoring the protein to cancers it should kill the tumour cells.

China's advances in gene therapy have not gone unnoticed, especially in the US although it is considered at Frost and Sullivan that the medico-ethical concerns will have more of an effect on the industry than health and safety issues. US legislation and ethical internal strife over stem cells, which are necessary in cell treatment, has slowed down progress.

Transdermal pain relief

A novel product that will allow hospital patients to administer pain relief without an intravenous line is waiting for FDA approval. Alza, the developer of the drug delivery system, has resubmitted a new drug application, which indicates that the product will be available within 6 months.

Could this be a thing of the past?

Ionsys is the first product from the company to incorporate its E-TRANS iontophoretic transdermal drug delivery system. It is an alternative to the usual patient-controlled analgesia systems that use a programmable machine, a pole and connective tubing attached to the patient via an intravenous line in their arm.

The innovative drug delivery system under consideration is a transdermal formulation of the opioid analgesic fentanyl hydrochloride, which is lightweight and about the size of a credit card. The system adheres to a patient's upper arm or chest and delivers the drug systematically by using low-level electrical energy to actively transport the drug through the skin without breaking it, and into the bloodstream. The patient can control the amount of painkiller administered by pushing a button, which instructs the system to deliver a small amount of short-acting analgesic fentanyl.

The company resubmitted the product after it received an FDA approvable letter in 2004. The original submission was in 2003.

Shift towards secondary care

Pharma manufacturers look to develop hospital products

Reportedly 90% of European pharmaceutical companies believe that they need to alter their business because of a shift in the industry towards secondary care. The report, An Era of Secondary Care, from Innovex revealed that less than half of the companies interviewed thought that this move into secondary care will not cause the downfall of the blockbuster drug.

GPs make more secondary care decisions.

The reallocation of the recent pipeline of drugs to secondary care appears to be a result of manufacturers developing more medium-sized hospital products, which offer a high margin of return. It was found that within seven European markets there is widespread uncertainty and disagreement over how the industry should react to the changes.

Out of the 233 interviews conducted it was discovered that the most anticipated changes were to occur within sales and marketing functions, which was also at the top of the list of changes that have already been implemented. Nearly one fifth of companies stated that the change in market conditions would require a complete restructuring of personnel.

Some surprising results were also found, such as 71% found that GPs make more decisions about secondary care than specialists and consultants. This is a result of the close contact between patients and GPs, which is an important consideration for sales and marketing.

The report also identifies the importance of investment returns and how accuracy is needed from marketing and sales.

Drug prices could be driven down

A group of US researchers has united to apply pressure regarding escalating drug prices. The National Institute for Pharmaceutical Technology and Education, which is a collaboration of 11 major US universities, will examine ways of reducing costs by focusing on improving development and manufacturing. It aims to learn more about the exact science that is used in the manufacture of pharmaceuticals.

The Tufts Center for the Study of Drug Development reported that between 1997 and 2003 the amount of drugs submitted to FDA for approval had dropped by almost 50%. This can be attributed to the increasing complexity of manufacturing processes, which makes the production of safe and effective drugs at a low cost to patients more difficult without performing fundamental research in product development and manufacture after a new molecule is discovered. In addition, there are difficulties in discovering new molecules and most companies only want to produce blockbuster drugs to avoid the high costs of R&D and manufacturing.

Current methods for product development on a new molecule are trial and error based processes, which result in high costs and manufacturing processes that are not vigorous. Another factor for rising drug costs is that as diseases and drug delivery mechanisms become more complex, the process of manufacturing and developing new drug therapies is becoming more complicated. Even after successful development of a compound, the variation in manufacturing processes can waste a large amount of product, which has been estimated to cost manufacturers $20–50 billion. It is believed that by improving development processes, drug costs could be greatly reduced.

The group aims to tackle these problems through research and by providing education to improve understanding and quality via 'learning before doing'. The collaboration is working in conjunction with FDA.

Results of this research are anticipated to be released to the public in 5–10 years.


SERS production facility

The first production facility devoted to the manufacture of surface enhanced Raman spectroscopy substrates is open in the UK. Mesophotonics has invested a £250 million in the Southampton facility, which aims to meet demand for its high-sensitive Klarite substrates launched earlier this year.

Omron's RFID aim

In a bid to tap into the industry, Omron plans to gain more ground in the radio frequency identification (RFID) market with a $20 million investment. RFID is used as a solution to problems in drug production and manufacturing. This market is expected to increase to $26.9 billion by 2015.

Merger speculation

After disappointing trial results, regulatory setbacks and faltering drug developments, Altana and Serono, are considering takeover talks. There is speculation of possible takeover bids with Pfizer, Novartis, Wyeth and Sanofi-Aventis named as potential buyers.

Pandemic preparation

With increasing avian flu cases, the production of antivirals and vaccines is vital in reducing the damage of pandemic influenza across Europe. European Vaccines Manufacturers, which produces 70% of the global vaccine production, has stated that accelerated prototype vaccine production and anticipation of the required demand is essential.