Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Pfizer and GlaxoSmithKline have entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Each company has agreed to supply as many as 480 million doses of their pneumococcal vaccines 

In a deal worth almost €2 billion, Bristol-Myers Squibb has commenced a cash tender offer to purchase all outstanding shares of Inhibitex. The transaction will provide BMS with an oral nucleotide polymerase inhibitor that is currently in Phase II development for the treatment of hepatitis C.  

Sanofi is extending a helping hand to start-up biotech company Warp Drive Bio by providing funding, access to its strains library and expertise in natural products. Two US venture capitalist firms will also invest in the start up, with all three offering funding that could amount during $125 million in the next five years. 

Pledging to strengthen procedures and policies to ensure data integrity and comply with cGMP, Ranbaxy has signed a consent decree with the FDA. The company will also make a provision of $500 million to resolve liability in connection with an investigation by the US Department of Justice. 

How can pharma make use of social media opportunities without running afoul of regulators? Pharma companies worldwide have been waiting for an answer to this question for years, but progress has been slow. In the US, however, the FDA recently released a draft guidance entitled 

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

 that includes recommendations on responding through online channels such as forums and chat rooms. The guidance only deals with social media in the specific context of unsolicited information requests, but it demonstrates that regulators are considering how social media affects different aspects of pharma's business activities.  

In terms of off-label information, the internet and social media have a big role to play. Firms often encounter requests for such information about their products through websites, discussion boards, chat rooms or other electronic forums. Many companies, wary of invoking the wrath of regulators, may shy away from responding, but the guidance acknowledges that it can be in the best interest of public health for companies to step in as other participants in the discussion may not have the most uptodate information about their products. In the guidance, the FDA also states that it acknowledges that firms are capable of responding to information requests in a "truthful, non-misleading, and accurate manner". Despite this, however, the FDA is concerned about the public availability of responses. 

The FDA's main concern is that firms may post detailed public responses to questions about off-label uses of their products in a way that communicates unapproved information to those who have not asked for it, such as other participants browsing the discussion.  

The FDA recommends that firms only respond to public requests that pertain specifically to their own named products. Caution should also be taken when responding to more general questions. For example, for a question such as "What drug/device can be used for Condition X", the firm should not respond if its product has not been FDA-approved or cleared for the mentioned condition. A safer question to respond to is a specific request such as "Can Drug/Device Y be used for Condition Y", where Y is a named product of the company. To alleviate the concern mentioned above, however, the FDA states that the reply should be limited to providing contact information that allows people to follow up through a one-to-one phonecall or email. 

If a firm responds to unsolicited requests for off-label information in the manner described in the draft guidance, the FDA said that it will not use such responses as evidence of a firm's intent that the product be used for unapproved or cleared uses. 

In Europe, news on social media regulations has been quiet. Last year, however, the Association of the British Pharmaceutical Industry (ABPI) published a guidance that suggested best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools. Read more about this at 

Although the FDA and the EMA work differently, they tend to draw from one another's regulations and guidelines. The FDA's draft guidance could eventually impact how European regulators approach social media issues.  

The FDA is developing additional draft guidances that deal with social media, but the agency says that it is difficult to provide a timeline for their issuance because of extensive work and review processes. According to a note on the FDA website, the main priority areas the agency is striving to address are fulfilling regulatory requirements when using tools associated with space limitations, fulfilling postmarketing submission requirements, on-line communications for which manufacturers, packers, or distributors are accountable, use of links on the internet and correcting misinformation. 

If European regulators do decide to follow guidances from the FDA, however, it will take time for them to be transferred to Europe. In particular, the ban on direct-to-consumer advertising could make it more difficult for European companies to exploit social media. 

Articles

How can pharma make use of social media opportunities without running afoul of regulators?

News: FDA's Social Media Insight

Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost. Could personalized medicines and diagnostics offer a solution to both?

		In April 2011, the EMA’s Committee for Medicinal Products for Human Use 

 a label update for Biogen and Elan’s multiple sclerosis drug Tysabri (natalizumab). Late in January 2012, the FDA also approved the label change in the US.

		Although touted as an effective treatment, Tysabri has also been associated with the risk of developing a serious and, often fatal, brain infection called progressive multifocal leukoencephalopathy (PML). The new label identifies that a certain antibody status (presence of anti-JCV antibodies) is a risk factor for developing PML. A test to detect these antibodies can identify at-risk patients, which is a development that marks a step towards personalised medicine - matching the right treatments with the right patients to maximize therapeutic effect.

, Biogen and Elan added that Quest Diagnostics will be producing the STRATIFY JCV Antibody ELISA testing service in the US, which is the first blood test authorised by the FDA for the qualitative detection of JCV antibodies. When used with other clinical data from the patient, the test can help healthcare providers determine the risk for developing PML. Such testing has already been used in Europe since the label was updated last year.

		Biogen and Elan have also identified two other PML risk factors: over two years of treatment with Tysabri, and previous treatment with medicines known to weaken the immune system.

		Tysabri has had a rickety life. It was voluntarily withdrawn from the US market in 2005 because of concerns over PML, but relaunched in 2006 with a black box warning and a strict monitoring plan. In Europe, Tysabri was approved in 2006 but has been under close scrutiny by the EMA. The EMA has also kept a tight watch and finalised a review of the medicine in January 2010, concluding that the benefits of the medicine outweigh the risks.

		As well as improving the safety of patients, the new label could also help to boost Tysabri sales. According to an article by 

, financial analysts have forecast that Tysabri could see its global sales grow to as much as $3 billion by 2016. Without the label change, the drug may only have seen sales of $1.5 to 2 billion.

		The JCV diagnostic test is a good example of how pharma companies can improve their medicines. All drugs, unfortunately, have side effects but a lot can be gained by understanding how those effects occur-and in which patients. Biogen and Elan are not the only companies making efforts to personalise their medicines. As was well 

 last year, Sanofi’s Avastin had its breast cancer indication removed in the US. However, Sanofi is looking hard at the drug in order to evaluate a potential biomarker that could help identify which people might derive more substantial benefit from the drug. Interestingly, Avastin was in the headlines yesterday with 

 running a news piece about how Avastin studies have pointed to potential benefits when used in early-stage breast cancer.

		No doubt there is more to come in the world of biomarkers, diagnostics and personalized treatments.

Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost.

Personalizing for Better Products

As the European Union (EU) debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop 

 and computational techniques that can replace the use of animals in medical experiments.

, which combines funding from various programs, including the seven Framework Programs, with the aim of driving growth and jobs in Europe. The initiative will run from 2014 to 2020 and will have a total funding of EUR 80 billion ($104 billion). More than a quarter of this, (EUR 24.6 billion [$32 billion]) will be dedicated to scientific research while another EUR 17.9 billion ($23.3 billion) will be used to invest in key industrial technologies, including nanotechnology and biotechnology.

According to the Humane Society International/Europe, there are many limitations in medical research that can be attributed to animal experiments. A press release claims that 92% of new drug candidates that are safe and effective in animal studies fail when given to humans. 

“It is clear that in order to reverse the slow pace of progress in key areas such as cancer, asthma and degenerative neurological disorders, we need far greater investment in sophisticated tools and technologies that are more relevant to humans,” says the statement.

Troy Seidle, director of research and toxicology for Humane Society International/Europe added, “If Horizon 2020’s key objective of supporting science excellence is to be achieved, it is vital that substantial funding is focused on advanced, human-relevant research and testing methods. By investing in the development of emerging and future research technologies, we can harness the very latest human health and drug discovery advances that science has to offer and improve the quality of our medical research endeavours. Supporting industries today that are inventing the science techniques of tomorrow will also stimulate economic growth.”

As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments.

Call for Funding to End Animal Experiments

A new report from Frost & Sullivan has forecast that the utilization rates of pharmaceutical manufacturing plants will decrease by half in upcoming years, triggering an increase in outsourcing.

European Pharmaceutical and Biotech Contract Manufacturing Markets

, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011’s revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.

The trends towards reduced facility utilization and increased outsourcing are partly being driven by the expiration of blockbuster drugs. Another Frost & Sullivan report has forecast that drugs worth $150 billion will go off patent between 2010 and 2017. Currently, large pharmaceutical companies contribute to around 10–25% of the total revenues for contract manufacturing organizations in Europe, but this could rise to 40% by 2013 and to 50% by 2018.

“As pharmaceutical and biotech companies strive to enhance their internal core competencies, outsourcing is likely to become increasingly entrenched as a strategic manufacturing option,” said Frost & Sullivan research analyst Aiswariya Chidambaram in a statement. “The impact of the economic crisis, coupled with the poor performance of the venture capital industry in Europe, has underlined the popularity of contract manufacturing as it has become synonymous with cost-cutting and the timely entry of products into the market.”

Frost & Sullivan expects the market prospects for contract manufacturers to be “buoyant” with a compound annual growth rate of 10.9% from 2011–2018. Biotechnology will also experience high growth—12.1% over the same period. However, contract manufacturers will have to be careful not to end up with over capacity. Aiswariya said, “Although the demand for manufacturing capacity is rising, a careful weighing of benefits and risks is required by CMOs while planning capacity expansions lest they be hit by over capacity, which, in turn, could lead to the acquisition of smaller CMOs by larger ones.”

According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.

European Outsourcing Revenue to Grow by 50%

Takeda has announced “strategic measures to achieve efficiencies for long-term growth”, which includes cutting close to 3000 jobs, 2100 of which will come from Europe. According to Takeda, the measures will better align the global workforce, consolidate operations and help to integrate Nycomed, which the company acquired in September 2011.

A number of sites and functions will be consolidated, including the potential merger or liquidation of subsidiaries (mainly in Europe) and a reduction of the company’s US workforce. Overall, 2800 positions are expected to be axed by the end of 2015. The majority (2100) will be in Europe with the remaining 700 coming from the US. Job losses will mainly occur in R&D, commercial operations and general and administrative functions.

“The combination of Takeda and Nycomed... brought together Takeda’s strong presence in the Japanese and US markets with the legacy Nycomed business infrastructure in Europe and high-growth emerging markets,” Yasuchika Hasegawa, President and CEO of Takeda Pharmaceutical Company, said in a 

. “While our combined operations in more than 70 countries are more complementary than overlapping, there are a number of areas where we will need to make changes to ensure efficient and flexible operations moving forward.”

Takeda estimates the cost of the measures to be 70 billion JPY ($912 million) during 2011–2015, but the same period will also result in cost synergies of approximately 200 billion JPY ($2.6 billion). 

The company is also planning changes to its product portfolio, which will move to centre more on new, diverse products. The combined company of Takeda and Nycomed will have a commercial presence in metabolic disease, gastroenterology, oncology, cardiovascular health, central nervous system diseases, inflammatory and immune disorders, respiratory diseases and pain management. Although R&D sites will be consolidated, support will be ensures for marketed products and the company will invest strongly in R&D focused on core therapeutic areas. 

The financial impact of this plan within fiscal 2011 ending March 2012 is estimated at 35 billion JPY ($456 million) downward in income. Takeda is expected to release a revised forecast of its consolidated financial statements in February 2012 when the company reveals its fiscal 2011 Q3 earnings. 

Takeda has announced "strategic measures to achieve efficiencies for long-term growth", which includes cutting close to 3000 jobs, 2100 of which will come from Europe.

Takeda to Axe 2100 Jobs in Europe

Earlier this week, Novo Nordisk launched a diabetes initiative in the US that stars the celebrity chef Paula Deen. Usually, it’s the pharma company that gets the sharp end of the stick when it comes to criticism but this time the negative attention has fallen on Deen, with Norvo Nordisk barely getting a mention in many news sources.

		They’ve also overlooked a lot of the positive aspects of the project. Deen will be offering diabetes-friendly recipes that do not comprise taste and appearing at diabetes cooking events across the US. The initiative is called 

		But if you’re familiar with Deen’s cooking, you’ll be aware that a lot of her dishes are not exactly promotional of a healthy diet (examples include bacon cheeseburger meatloaf and southern fried chicken – you can take a look at the recipes on her 

), which is where media criticism has been directed. Deen herself was also diagnosed with Type II diabetes three years ago, but only revealed this to the public this week, another aspect that has attracted criticism since she’s maintained her cooking style, despite the fact that diet is an important part of managing diabetes.

		However, Deen makes a good point of saying in a 

 that “diabetes does not have to stop you from enjoying the things you love”.

		At a time when obesity is rising, it’s important for us to be aware of healthy food, and chefs need to take some responsibility. Let’s be honest though, most of us don’t want to be healthy all the time, so we want to know how to make the best of our butter!

		In their criticism, a lot of news sources have overlooked the contributions Deen is making to the diabetes battle. She claims to have made small dietary changes and to have worked more exercise into her day. Being a celebrity spokesperson for diabetes will also be a good influence – some sources have made snide comments about the connection between Deen’s weight, her recipes and diabetes, which will no doubt influence some people into avoiding unhealthy foods.

		And with all the attention being focused on the responsibility of celebrities and chefs to promote healthy eating, Novo Nordisk and the pharmaceutical industry has gotten a bit lost. The pharma industry also has a responsibility to promote good health; indeed, this focus is becoming increasingly important in pharmaceutical business strategies as non-traditional companies, such as food and IT companies, muscle into the healthcare sector. Ernst and Young has a really good report about this trend available on their 

		Even though the diabetes campaign is partly to promote Novo Nordisk’s diabetes drug, Victoza, it’s also a step towards health education. According to one 

, many diabetes patients have trouble managing their diet. Havilah Clarke, senior manager, product communications at Novo Nordisk is quoted in the report as saying, “Based on what were hearing from some primary research we were doing, people living with diabetes thought that food was one of the most difficult challenges to address in their social lives. They thought they had to deprive themselves.”

		Whatever Novo Nordisk’s intentions, it remains to be seen whether using Paula Deen will be a successful strategy given the amount of criticism the partnership has received. But there’s no such thing as bad publicity, right?