Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The European Medicines Agency (EMA) has launched a pilot program for submitting centralized marketing authorization applications electronically. The pilot began on Mar. 12, 2012, and is expected to be active for four months. During this period, companies will be able to apply for initial marketing authorization applications for human medicines, and variation and renewal applications for human and veterinary medicines using an interactive PDF form.

, EMA explained that the pilot is a step towards using electronic applications as standard, using the Electronic Common Technical Document (eCTD) format. Electronic applications are expected to simplify and accelerate the application process by improving data quality and consistency during data entry, providing access to data in XML format, and integrating application data with controlled terminology.

Depending on the success of the pilot, the PDF forms may become an alternative, as well as the recommended format for submitting eCTD applications to EMA. The forms were developed in collaboration with the EMA, European Commission services, and medicines regulators in European Union member states, and their content is identical to that of the current application forms published by the European Commission in EudraLex, Volume 2.

Companies wishing to participate in the pilot are being encouraged to register their interest so that they will receive any urgent updates. Details on how companies can take part are described in the EMA’s 

Electronic Application Forms Pilot Guidance

Articles

The European Medicines Agency has launched a pilot program for submitting centralized marketing authorization applications electronically.

EMA Announces Electronic Applications Pilot Program

GlaxoSmithKline (GSK) is launching a new program that will create apprenticeships in several areas including manufacturing and R&D at the company’s United Kingdom sites. The scheme will commence in August and will offer 40 placements for young people (aged 16–24 years old) in the first intake.

Opportunities will be available in IT, R&D, manufacturing, supply chain management, and artwork design. The apprenticeships will be offered at nine sites: Barnard Castle, GSK House (London), Irvine, Maidenhead, Montrose, Slough, Ulverston, Ware, and Worthing. Depending on the discipline, the roles are expected to last between two and four years. Apprentices may be offered roles within the company at the end of the program.

 from GSK, the scheme will provide young people with hands-on experience in the life-sciences industry, as well as a base salary and a personalized training plan.

In the statement, John Hayes, the UK’s Skills Minister, said “The government has significantly increased investment in apprenticeships because we know they work for businesses and employees. The unique combination of high-quality training and meaningful work experience they offer helps to build a workforce with the skills our economy needs to grow. I am delighted that GSK are not only hiring new apprentices, but also expanding their program to cover a wide range of new disciplines.”

GSK has several programs in place to attract young talent. In 2011, the company revealed plans to reimburse 100% of uncapped university tuition fees for students recruited under its graduation scheme. This year, the company is also undertaking a ‘Scientists in Sport’ program in partnership with King’s College London (UK), which aims to showcase how science will be used during the upcoming 2012 London Olympic and Paralympic Games and inspire young people to choose scientific careers.

GSK currently employs approximately 15,000 people in the UK.

GlaxoSmithKline is launching a new program that will create apprenticeships in several areas including manufacturing and R&D at the company's United Kingdom sites.

GSK Launches UK Apprenticeship Program

GlaxoSmithKline (GSK) and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in Japan, as well as introduce new vaccines and create better and more convenient combination vaccines.

The joint venture will hold the development and commercial rights for the companies’ existing preventative vaccines. It will also supply globally recommended vaccines in Japan including those for Human Papillomavirus, Rotavirus, seasonal flu, mumps, Diphtheria Pertussis, and Measles Rubella. Both companies will sell their respective vaccines into the joint venture at agreed-upon prices and receive sales synergies in return. 

In Japan, many vaccines that contribute to disease prevention in other advanced countries are not used. In a 

, the companies explain that the joint venture will combine GSK’s pipeline and technology with Daiichi Sankyo’s knowledge and experience of the Japanese market and logistics to increase access to vaccines for all age groups.

The companies are investing a minimal cash investment of 100 million Yen (approximately $1.2 million) to cover the start-up capital requirements. Profits will be divided equally between the companies with a portion going toward funding ongoing capital needs of the joint venture. The new company will be called Japan Vaccine Co., Ltd., and will commence business on July 2, 2012. As new vaccines in the development pipeline are approved, the joint venture will be expanded.

According to Christophe Weber, president-designate of GSK Vaccine, the collaboration is part of the company’s strategy to increase its presence in key growth markets. In a 

, he said, “We are very pleased to be partnering with Daiichi Sankyo... Both companies have strong track records in commercialization and, in combination, will create further significant economies of scale in the development and distribution of vaccines in the Japanese market.”

GlaxoSmithKline and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in the Asian nation as well as introduce new vaccines.

GSK and Daiichi Sankyo Launch Vaccine Venture in Japan

	Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now in the area of GMP inspections of API manufacturers, but now the partners are seeking to further expand the international effort by looking to include additional partners.

	The World Health Organization has also agreed to join the collaboration and will be taking part through its Prequalification of Medicines Programme. This is an initiative that aims to make quality priority medicines available to those who need them, and includes evaluation, inspection and quality monitoring activities, as well as building national capacity for sustainable manufacturing.

	The current participants in the project are the EMA, EU member states, the European Directorate of the Quality of Medicines and Healthcare, the FDA and the Australian Therapeutic Goods Administration. Collaboration has involved sharing inspections information about API manufacturers (particularly those outside of the participating countries) and conducting joint inspections.

	An initial pilot phase of the project involving the EMA, the FDA and the TGA ran from December 2008 to December 2011, during which nearly 100 inspection reports were shared and 9 joint inspections conducted. Last year, the agencies 

 that they would continue with collaborations in this area.

	“The project has contributed substantially to a better understanding of the regional approaches to inspection and the building of mutual confidence,” explained a document on the EMA’s website. “To further develop collaboration, all participants were supportive of continuing the API inspection collaboration, and extending the project to new contributors.”

	The current participants in the project have agreed that clear criteria needs to be established for any potential new participants to be accepted, as well as for maintaining ongoing participation. As such, the EMA has published a document titled Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers, which outlines the common principles and procedures that will be necessary for successful collaboration.

	However, if a potential new partner does not meet the criteria listed in the document, they may still be accepted as partners for the benefit of global health. In addition, authorities who may not yet be in a position to participate (or who may not want to collaborate) may still request access to the information sharing. In this cases, information sharing will be facilitated in a way that does not compromise any confidential information.

	The EMA document talking about the programme is not too long (6 pages) but there are too many points to list here. Below are a few key principles from the document to show what the programme aims to achieve. The whole piece is available to read on the 

		The reference GMP standard for inspections will be ICH Q7. For sterile products not covered by this guideline, regional guidelines will be followed.

		Participants agree to share inspection plans and outcomes.

		Participants are responsible for ensuring that appropriate confidentiality arrangements are in place.

		If an inspection results in regulatory action or license suspension, this decision will be shared with the other authorities.

	More about international efforts in the area of joint inspections can be read these related articles, which are available on our website 

	The above-mentioned programme is also not the only activity going on in the area of regulatory harmonisation in the pharmaceutical industry. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are other initiatives that aim to promote active and constructive co-operation in the field of GMP. Read more about this on the 

FDA–EMA Joint Manufacturing Inspections to Begin in 2012

FDA, EMA Say Future Joint API Inspections Likely

Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now in the area of GMP inspections of API manufacturers.

Expanding International GMP Collaboration

The pharma industry has reached the longdreaded patent cliff and profits for branded medicines are plummeting because of generic erosion. For copycat products, on the other hand, business is booming. Analyst firm Frost & Sullivan has recently released two reports examining the markets for generic drugs and biosimilars respectively, and has predicted huge growth for both in the lead up to 2017. 

Generic Pharmaceuticals Market — A Global Analysis

, pharmaceutical products worth $150 billion will go off patent between 2010 and 2017, which will propel the generic-drugs market from revenues of $123.85 billion in 2010 to an estimated $231 billion by 2017.  

However, as competition intensifies, genericdrug manufacturers will need to carefully consider their product segments and the appropriate time for market launch. Companies will also have to deal with increasingly harsher costcutting measures from governments and healthcare service providers. Although generic products are often favoured over branded medicines because of their lower cost, the profit margins of generic manufacturers are still likely to be squeezed. According to the report, many generic manufacturers, including Teva, Sandoz and Mylan, are opting to produce higher value products, such as difficult to produce generics, specialty products and biosimilars.  

In a press statement, Aiswariya Chidambaram, a research analyst at Frost & Sullivan, advised, "Large multinational generic firms need to adopt a differentiated approach by opting for products with technologically challenging formulations, products which require significant regulatory support and products with limited availability of active pharmaceutical ingredients." 

Another strategy being adopted by genericdrug companies is to forge alliances with branded pharma for marketing and exclusivity rights to certain generic blockbusters, such as Lipitor and Crestor, among others.  

The global biosimilars market earned revenues of around $172 million in 2010, but this is estimated to jump to $3987 million in 2017, with the industry growing at a compound annual growth rate of approximately 56.7%. According to Frost & Sullivan's 

 report, impending patent expiries are expected to provide impetus to the market development of several new biosimilars. 

But strong growth doesn't necessarily mean that there will be a sudden boom of new developers seeking to enter the market. Although biosimilars offer "lucrative growth prospects," high investment is also required because of the complex production processes, expensive biological and chemical materials, rigorous clinical trials and stringent quality and safety tests, which are all needed for development. High manufacturing costs can also act as a barrier to market entry, but this can be overcome by using license agreements between companies.  

"The need for considerable financial outlays will hinder the entry of small biotech firms in particular," Frost & Sullivan analyst Srinivas Sashidhar said in a press statement."On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market." 

As with generic smallmolecule drugs, biosimilars are likely to be used in healthcare programmes in place of branded biopharmaceutical products for cost reasons. However, developing a biosimilar is much riskier than a traditional pharmaceutical. Biosimilars are highly complex and there is no guarantee that regulators will accept the product's similarity to its biological counterpart. In the US, in particular, the regulatory pathway for biosimilars is still very new. Uncertainty also remains about how successful a biosimilar will be in the market. According to Frost & Sullivan, one important factor to help achieve success will be effective communication with the scientific community, including close interaction with doctors and pharmacists to promote the benefits of biosimilars and increase uptake. 

The EMA has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July. The legislation will improve the safety and risk–benefit monitoring of drugs and represents the biggest change in the EMA's legal framework. 

Pfizer, Sanofi, GlaxoSmithKline and other major companies and global healthcare organisations have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The companies will donate an average of 1.4 billion treatments each year, while new collaborative R&D is expected to lead to new treatment options. 

AstraZeneca has announced restructuring initiatives that could lead to 7300 job losses. Positions affected include those in selling, general and administrative areas, as well as operations and neuroscience R&D. The restructuring is expected to deliver around $1.6 billion in annual benefits by the end of 2014. 

The FDA has released a draft guidance for API manufacturers that provides recommendations for procedures to ensure that crude heparin does not contain oversulfated chondroitin sulphates or nonporcine origin material. The guidance is titled 

Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

The pharma industry has reached the long-dreaded patent cliff, but for copycat products, business is booming.

News: Market Boom for Generics

Eli Lilly plans to invest EUR 330 million ($443.2 million) at its Kinsale location in Ireland to create a new biopharmaceutical commercialization and manufacturing facility. The investment will lead to 200 new jobs, as well as an additional 300 construction roles during the building process.

The facility is planned to be approximately 24,000 ft

 and will produce treatments for illnesses such as cancer and diabetes. In a 

, Lilly’s senior vice-president of global API and dry product manufacturing, Paul Ahern said, “This investment is part of Lilly’s planned growth strategy and proof of our confidence in Lilly’s pipeline of new products, many of which are derived from biotechnology.”

Eli Lilly first established its presence in Kinsale in 1981 and the facility makes APIs for several of the company’s products. The latest announcement marks the second significant investment that the company has made at the site in recent years. In 2006, the company committed to invest EUR 300 million in a biopharmaceutical and new-product commercialization facility. The new facility came on line in 2010, but is still undergoing start-up activities. It is expected to manufacture commercial products in late 2013.

Ireland’s investment agency, IDA Ireland, worked closely with Lilly to attract the investment. According to Ireland’s Minister for Jobs, Enterprise, and Innovation, Richard Bruton, the government has recently outlined a range of measures that will be taken in 2012 to target high-end manufacturing and the health and life science sectors for growth and job creation.

Several other pharmaceutical companies have invested in Ireland recently. Most recently, Abbott Laboratories 

 an EUR 85-million ($114.2 million) investment at its manufacturing facility in Sligo at the beginning of February 2012. In September 2011, Pfizer and Merck & Co. invested EUR 145 million ($194.8 million) and EUR 100 million ($134.3 million) in Irish pharmaceutical operations, respectively.

Eli Lilly plans to invest EUR 330 million ($443.2 million) at its Kinsale location in Ireland to create a new biopharmaceutical commercialization and manufacturing facility.