Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

After its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again. This time, the Swiss pharma giant has its eyes on the DNA sequencing company Illumina, which is based in San Diego in the US. However, both companies are digging their trenches in preparation for a potentially lengthy battle.

		At the end of January, Roche made the first move by offering to acquire all the shares of Illumina for $44.50 per share. The offer represents a premium of 64% over Illumina’s closing stock price on 21 December 2011 (before rumours of the possible transaction began to emerge). According to a 

, Roche wants to combine its existing Applied Science business with Illumina and move the business area’s headquarters to San Diego, a move that Roche believes will be attractive to Illumina’s management and employees.

 the offer as “grossly inadequate”, “opportunistic” and “disadvantageous to Illumina’s stockholders”. In particular, Illumina believes that the offer has been timed to “capitalize on a recent share price dislocation”.

		Even before Illumina responded to the offer, Roche seemed to have anticipated the rejection. In its own press release about the tender offer, Roche explained that it has tried to negotiate with Illumina, but the company had been “unwilling to participate in substantive discussions”. However, Roche also has a backup plan. The company is already a shareholder of Illumina, which gives it the right to nominate candidates to Illumina’s Board of Directors. Four spots on the board are about to be up for grabs as current directors reach the end of their term. Roche has nominated four of its own candidates to fill the spaces. In addition, the company has also 

 that the board be expanded from nine members to eleven. Roche will be nominating its own candidates to fill these seats too, which means that the majority of the board will comprise Roche-nominated directors - a move that Illumina has 

		But Illumina is not without its defences. The company has 

 a shareholder Rights Agreement, which is more commonly known as a “poison pill”. The poison pill allows shareholders other than the bidder to purchase more shares at a discount, which can force a higher bid. Although such a strategy can prevent a hostile takeover, it can also act as a deterrent to other potential bidders because the deal becomes too expensive.

		The latest update in the situation has been for Roche to 

 its disappointment with Illumina’s decision to recommend that its shareholders do not tender their shares. However, the tender offer will be open until 24 February so whether shareholders will heed the recommendation remains to be seen.

		In a statement, Severin Schwan, CEO of the Roche Group, added that they would prefer to enter into a negotiated transaction with Illumina and that the company is ready to commence discussions at any time.

Articles

After its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again.

Roche and Illumina Ready the Trenches

The European Medicines Agency (EMA) has published an 

 for Europe’s new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation (Directive 2010/84/EU and Regulation (EU) No. 1235/2010) will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.

Four areas will be targeted in the legislation.

Collection of key medicines’ information:

 Activities in this area will include strengthening procedures for submitting risk-management plans to the EMA, as well as the need for marketing-authorization holders to provide periodic safety update reports (PSURs). Later this month, EMA plans to release a draft of the good pharmacovigilance practice module on PSURs for consultation. The agency will also be using a new approach to postauthorization safety and efficacy studies. A draft module on these safety studies will be released later this month

For patients, the legislation will give the right to report suspected side effects from a medicine directly to national regulatory authorities.

Better analysis and understanding of data and information:

 Throughout 2012, EMA will be investing in new information technology systems and signal-detection tools. In particular, the agency aims to strengthen its side-effects collection system, EudraVigilance, by adding increased functionality and improving data quality. The initial development of new IT systems, which will be needed to support certain provisions in the legislation, will start in 2012, but budget and resource restrictions will mean that full development will not begin until a later date.

EMA will be working with member states to establish a list of medicines that will require additional monitoring. According to the implementation plan, medicines on the list will be subject to changes in package leaflets that will increase transparency for patients about the extra monitoring and encourage the reporting of suspected side effects.

Regulatory action to safeguard public health:

 Starting in July 2012, a new pharmacovigilance risk assessment committee will begin meeting, stepping up to monthly meetings from September 2012. The committee will focus on the planning, assessment and monitoring of safety in issues of medicines, and its recommendations are likely to influence opinions adopted by EMA’s Committee for Medicinal Products for Human Use.

To rapidly assess emerging safety issues linked with EU medicines, EMA also intends to implement a new referral system that will be known as the Urgent Union Procedure.

 Transparency is explicit in the legislation and will lead to the online publishing of information, such as agendas from committee meetings, assessments, approvals, recommendations, and opinions, on EMA’s website. EMA hopes to take a more active role in supporting the coordination of safety announcements.

The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.

EMA to Implement Pharmacovigilance

The European Commission (EC) has closed an investigation into Servier that accused the company of providing “misleading” and “incorrect” information to the EC’s pharmaceutical sector inquiry. Another case examining Servier for breaking EU rules by using restrictive agreements and abusing its dominant marketing position, however, is still ongoing. 

At the end of last week, the EC released a 

 explaining that it had dropped the investigation, which was launched in 2010, after Servier put forward various arguments as to why the information it supplied in response to the EC’s inquiry was neither misleading nor incorrect. Investigating the arguments would use considerable resources, so the EC has instead decided to focus on the “substantive enforcement of competition rules in a number of pending cases, including one involving Servier”. 

 case began in July 2009, and involves several generic drug companies in addition to Servier. The proceedings concern “unilateral behaviour” by Servier and agreements that may have been made with the specific intention of hindering the European market entry of a generic form of Servier’s cardiovascular medicine perindopril.

 into the pharmaceutical sector, which included surprise inspections on companies and requests for information, such as documents relating to litigation and settlement agreements. One particular focus for the inquiry was identifying the cause behind the delayed market entry of generic products. The inquiry concluded that generics were being delayed due to four main factors:

patenting strategies such as patent clusters

disputes and litigation against potential generic competitors

patent settlements with generic companies

various interventions and the launch of follow-on products.

Since this time, the EC has opened investigations into several companies, including pharma giants Novartis and J&J in 2011. In addition, however, the EC 

 in 2011 that it had seen a decrease in “problematic” pharmaceutical patent settlements.

2012: A Good, Bad or Ugly Year for Servier?

Servier under EC scrutiny for anticompetitive behaviour

EC final report condemns industry malpractice

The European Commission (EC) has closed an investigation into Servier that accused the company of providing "misleading" and "incorrect" information to the EC?s pharmaceutical sector inquiry.

EC Closes Servier Investigation

Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its  restructuring initiatives “to drive productivity and support innovation”. It all sounds very high and important but basically it boils down to job cuts. And lots of them.
		Although the 

 doesn’t explicitly state the number of jobs that may go, it says that restructuring will “affect approximately 7300 positions”. If you’re an optimist, you may want to believe that a handful or so positions will be shuffled around, but, judging from past experience with Big Pharma companies we all know that the majority are likely to be let go.

		Most of the “affected” positions (3750) will be in selling, general, and administrative areas. One change already underway at the company is the simplification of its global commercial organisation structure by reducing the number of its sales and marketing regions from five to three. Small countries have also been clumped together in a move that AstraZeneca hopes will optimise its resources by increasing shared services and reducing cost bases.

		Another 2200 positions will come from R&D. The statement says, “The R&D function will accelerate its transformation, which the company unveiled in January 2010. Under the new programme announced today, further changes will create a simpler and more innovative R&D organization with a lower and more flexible cost base. Excess capacity in certain R&D functions will be reduced, matching resources to AstraZeneca’s more focused R&D portfolio.”

		One of the main focuses for R&D restructuring will be in the company’s neuroscience area. Although AstraZeneca recognises that there is much need in this area for better medicines, it adds that advances have been “elusive”. In response, the company will close one R&D site in Montreal (Canada) and wind down R&D activity at its Södertälje (Sweden) site.

		In a more positive note for neuroscience, however, the company added that it will continue to pursue innovation in this area by combining internal expertise with “innovative external science” using a virtual neuroscience Innovative Medicines (iMed) unit. The unit will be made up of around 40–50 AstraZeneca scientists, who will conduct discovery and development externally using a global network of academia and industry.

		Martin Mackay, president of Research and Development, AstraZeneca, said: “We’ve made an active choice to stay in neuroscience though we will work very differently to share cost, risk and reward with partners in this especially challenging but important field of medical research,” Martin Mackay, AstraZeneca’s president of research and development, said in the statement. “The creation of a virtual neuroscience iMed will make us more agile scientifically and financially – we will be able to collaborate flexibly with the best scientific expertise, wherever it exists in the world.”

		The remaining job cuts will be in operations as AstraZeneca seeks to make its supply chain more efficient. In particular, the company says it will be looking at its support functions.

		The restructuring is expected to deliver around $1.6 billion in annual benefits by the end of 2014, but that will be little consolation for those losing their jobs. An article in the 

 estimates that around 30000 jobs have been lost at AstraZeneca over the past five years.

Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its restructuring initiatives “to drive productivity and support innovation”.

AstraZeneca Axe Hovers Above 7300 Workers

Dedicated social media recommendations from FDA may not yet have materialized, but the agency is beginning to address some of the industry's questions in this area. At the end of 2011, FDA released a draft guidance titled 

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

, which includes recommendations on responding through online channels such as forums and chat rooms. 

According to the guidance, many firms encounter requests for off-label information about their products through websites, discussion boards, and other electronic forums, and FDA recognizes that firms are capable of responding to such requests in a "truthful, non-misleading, and accurate manner." Indeed, FDA acknowledges that it can be in the best interest of public health for companies to reply to these requests because other participants in the discussion may not be able to provide accurate information. 

The guidance discusses responses to both non-public information requests, such as a one-on-one email or telephone call, and public requests, such as a request on an online forum. The latter type is more complicated because firms must ensure that their response does not communicate unapproved information to those who have not asked for it.  

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

Guidance offered on how to deal with off-label information requests.

FDA's Social Media Insight

Pfizer, Sanofi, GlaxoSmithKline and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases (NTDs) by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization (WHO), and several other global health entities.

The group will aim to eliminate lymphatic filariasis (elephantiasis), guinea worm, blinding trachoma, sleeping sickness and leprosy, and control a further five diseases-soil transmitted helminthes (intestinal worms), schistosomiasis, river blindness, Chagas, and visceral leishmaniasis.

“The efforts of WHO, researchers, partners, and the contributions of industry have changed the face of NTDs. These ancient diseases are now being brought to their knees with stunning speed,” said Dr. Margaret Chan, director–general of WHO, in a 

. “With the boost to this momentum being made today, I am confident almost all of these diseases can be eliminated or controlled by the end of this decade.”

The pharma companies taking part in the consortium are Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck KGaA, Merck & Co., Novartis, Pfizer, and Sanofi. According to a statement, companies will donate an average of 1.4 billion treatments each year, while new collaborative R&D and access agreements will provide access to compound libraries that is expected to lead to new treatment options. 

“We have joined together to increase the impact of our investments and build on the tremendous progress made to date,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation, which will provide $363-million to support the development of products for tropical diseases, in a statement. “This innovative approach must serve as a model for solving other global development challenges and will help millions of people build self-sufficiency and overcome the need for aid.” 

NTDs are thought to affect more than one billion people in developing countries.

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.