Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Emerging markets continue to attract the attention of pharmaceutical companies thanks to their high growth and large patient populations. Back in 2011, the locations of focus were the so-called ‘BRIC’ countries (Brazil, Russia, India and China). But with more markets emerging and drawing the eyes of the pharmaceutical industry have the original BRIC countries lost some of pharma’s favour?

		Not at all, judging by several developments this year.

		The latest poll on PharmTech.com asked which countries, aside from China and India, pharmaceutical companies were most interested in expanding business operations into. The clear favourite, chosen by 36% of respondents, was Brazil, followed by Other (19%) and Russia (14%).

		Other announcements also suggest that Brazil continues to be an important pharmaceutical market.

		In July, Quintiles, a US-based contract services provider, opened its Global Commercial Solutions business in Brazil. The business offers customised sales forces, market penetration strategies and product solutions. In addition, the company has also recently announced expansions in Russia, and the Middle East and North Africa region.

		Valeant Pharmaceuticals International has also invested in Brazil this year. In March, the company acquired a 19.9% minority equity investment in the research company Pele Nova Biotecnologia, which focuses on tissue regeneration.

		You can read more about Brazil’s pharmaceutical market 

		Abbott Laboratories signed an agreement in July for several R&D projects in Russia with the country’s ChemDiv Research Institute (CDRI). The two parties will be principally be concentrating on improving formulations of Abbott’s existing drugs.

		Pfizer has also been looking to Russia for R&D projects. In July, the company granted exclusive development and marketing rights to SatRx for their DPP(1)-IVi compound, which is being investigated as a potential treatment for type 2 diabetes.

		Novo Nordisk announced in April that it had started work on its new $100-million plant in Russia. The facility, located in Grabtsevo Technopark will formulate and fill insulin into the company’s Penfill and FlexPen systems for the Rusian market. The company announced its intentions to build the new plant in 2010 and manufacturing is expected to commence in 2014.

		You can read more abour Russia’s pharmaceutical market 

		Today, Mylan announced that its subsidiary Mylan Pharmaceuticals Private has commenced commercial operations in India, beginning with the launch of a portfolio of 18 antiretroviral products for the treatment of HIV/AIDS. The company added that it sees “significant growth potential in India” and will be looking to expand operations into the country with additional therapeutic categories.

		Also this week, the Indian pharmaceutical company Cipla announced that it would be investing in India by building facilities dedicated to active pharmaceutical ingredients in Patalganga, Bengaluru and Kurkumbh. The facilities are expected to be completed in 2012–2013.

		You can read more about India’s pharmaceutical market 

		Last week saw an announcement from Covidein about the opening of the company’s China Technology Center Research and Development facility in Shanghai. Covidien plans to invest up to $45 million over a three-year period into the center, which is expected to employ around 300 people. The facility includes laboratories, as well as a simulation suite that enables healthcare professionals to be involved in the medical device design and development process.

		In June, Eli Lilly said it would increase its equity in the Chinese drug-manufacturing company, Novast, by $20 million. Novast will use the investment to establish a platform that will support Eli Lilly’s branded generic products and increase the manufacturing capacity at its Nantong site over the next several years.

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Emerging markets continue to attract the attention of pharmaceutical companies thanks to their high growth and large patient populations.

BRIC Retains Pharma Investments

Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop and commercialize targeted cancer therapies. In particular, the two parties will focus on targeted chimeric antigen receptor (CAR) immunotherapies.

As part of the agreement, Novartis will acquire exclusive rights to the university’s investigational CAR therapy, which targets a protein associated with several B-cell malignancies, including chronic lymphocytic leukemia, B-cell acute lymphocytic leukemia and diffuse large B-cell lymphoma. The therapy is currently being studied in a clinical trial. Novartis will also gain an exclusive worldwide license for any other CARs developed through the collaboration.

As part of the collaboration, Novartis and the university intend to jointly establish a new R&D facility, which will be located on the university’s Penn campus, called the Center for Advanced Cellular Therapies. A specific focus of the center will be to develop and manufacture adoptive T-cell immunotherapies.

In addition, as part of the agreement, Novartis will provide an up-front payment, research funding, funding for the establishment of the R&D center and milestone payments for the achievement of certain milestones.

Mark Fishman, president of the Novartis Institutes for BioMedical Research, said in a 

, “Immunotherapy is one of the exciting frontiers in cancer research and the CAR technology developed by the team at Penn has shown early promise as a new way for treating cancer."

Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop and commercialise targeted cancer therapies.

Novartis in Cancer Collaboration with University of Pennsylvania

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011. Customs seized almost 115 million products suspected of being counterfeit, up from 103 million in 2010. Approximately 24% (around 27 million) of these products were medicines, compared with just over 3 million in 2010.

In 2011, there was an increase in the number of counterfeit items that could be potentially dangerous to health and safety (i.e., food and beverages, body care articles, medicines, electrical household goods, and toys). Such products accounted for 28.6% of seizures, compared with just 14.5% in 2010. The EC report attributes the increase to the large rise in medicines.

In general, the increase in the number of detained articles has been attributed to rises in postal traffic, of which medicines formed a large percentage. Approximately 36% of detained items in postal traffic were medicines.

According to the report, China is the main source of the counterfeit products, accounting for 73% of all intellectual-property infringing items. The majority of the counterfeit medicines detained by EU customs in 2011 originated from China (68%) and India (28%). In 2010, almost all of the medicinal products identified by customs came from India (93%). In 2011, most articles were intercepted in Bulgaria, Italy, Greece, Belgium, and the Netherlands, compared with Greece, Italy, Spain, the Netherlands, and Portugal in 2010.

Apart from medicines, other top categories for counterfeit products were packaging materials and cigarettes.

, Algirdas Šemeta, Commissioner for Taxation, Customs, Anti-fraud and Audit said, “Customs is the EU's first line of defence against fake products which threaten the safety of our citizens and undermine legal businesses. Today's report shows the intensity and importance of the work being done by Customs in this field. I will continue to push for even greater protection of intellectual property rights in Europe, through our work with international partners, the industry and Member States."

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011.

Medicines Top EU's Counterfeit List

The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram. Lundbeck has vigorously 

 from the EC, the market entry of generic citalopram may have been delayed for up to two years. After patents on citalopram expired, Lundbeck entered into agreements with several generic-drug companies, which involved “substantial value transfers” from Lundbeck to generic competitors, who subsequently chose not to market any generic versions of citalopram. “The value transfers included direct payments from Lundbeck to the generic competitors and also occurred in other forms, such as the purchase of generic citalopram stock for destruction or guaranteed profits in a distribution agreement,” said the EC statement. 

Other companies named in the Statement of Objections include Merck KGaA, Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy.

The sending of the Statement of Objections does not prejudge the final outcome of the investigation. 

The investigation against Lundbeck is part the EC’s focus on 

 in the European pharmaceutical industry after an inquiry concluded in 2009 indicated several structural issues and problems with company practices that could be delaying the market entry of generic drugs. The EC opened formal proceedings against Lundbeck in 2010, but is also investigating other companies including Les Laboratoires Servier, Cephalon, Teva, Johnson & Johnson, Novartis and Novartis’ generic branch Sandoz for possible violations of EU competition rules. 

The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram.

EC Investigates Lundbeck for Potential Pay-to-Delay Agreements

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials. Similar initiatives, mainly through extensions of clinical trials or managed-access programmes, are already in place in certain parts of the UK, as well as in the US and other countries, but these are often ad-hoc in nature and locally based. The proposed scheme would provide a national approach to providing early access to certain medicines in the UK.

		The need for new medicines to treat life-threatening illnesses, such as cancer, Alzheimer’s and heart failure, is well understood and both FDA and EMA offer fast-track approval processes for medicines that treat serious diseases and fill an unmet medical need. In the US, the fast-track process provides, among other things, more frequent FDA meetings concerning the drug’s development plan and eligibility for Accelerated Approval, which provides approval based on the effect on a surrogate or substitute endpoint that is likely to predict clinical benefit. These processes significantly shorten the time it takes for a medicine to be approved for the marketplace, although further tests are still required.

		However, the scheme the MHRA is proposing would not provide accelerated approval, but would instead give clinicians the option to offer patients treatments that are not yet approved and which are still progressing through clinical trials. Patients, however, would have to accept a certain amount of risks in taking such unlicensed medicines. According to the MHRA, there is broad-based support for such a scheme, particularly for patients with life-threatening illnesses.

		The Early Access to Medicines Scheme would only be open to patients with life-threatening, chronic or debilitating conditions, such as late-stage cancer. Under the scheme, the MHRA would give a scientific opinion on the benefits and risks of certain medicines before they are licensed. The opinion would then be available on the MHRA’s website to help clinicians and patients in making decisions about their treatments. The opinion would be based on scientific data submitted by the pharmaceutical company.

		Unlike medicines using accelerated approval processes, pharmaceuticals using the MHRA’s scheme would remain unlicensed until fully assessed and authorised. In addition, it would be up to the UK’s National Health Service (NHS) as to whether the treatment should be funded.

		The MHRA has conducted a lot of research on the subject of early access to medicines. I’ll look at some of their findings in my blog next week.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials

UK Mulls Access to Unlicensed Medicines

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials. The consultation will be open until Oct. 5, 2012.

The scheme is expected to apply to medicines for life-threatening, debilitating, or chronic conditions that are at the end of Phase III trials or, in certain cases, at the end of Phase II. Research conducted by MHRA has shown broad support for such a scheme, particularly for patients suffering from life-threatening illnesses.

If implemented, MHRA would review medicines that companies want to make available under the scheme and provide a scientific opinion on the risks and benefits. This information would help the country’s National Health Service in deciding whether the medicine should be available early.

“We have launched this consultation because we are committed to ensuring that where pharmaceutical companies want to make their new medicines available under this scheme, clinicians treating patients have access to robust scientific information to help them make appropriate treatment decisions,” explained Kent Woods, chief executive of MHRA, in a 

In its research, MHRA emphasises that patients will need to be fully aware of the risks of taking unlicensed medicines. There were also mixed views on whether early access to medicines should be given to patients with debilitating or chronic conditions, such as rheumatoid arthritis or diseases that may cause blindness.

After receiving all feedback, MHRA will aim to make a decision on implementing the scheme by the end of 2012.

The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.