Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Novartis is looking to advance its personalized medicine treatment programs by entering into a definitive agreement to acquire Genoptix, a laboratory offering personalized diagnostic services, for approximately $470 million or $25 per share. According to Novartis, the acquisition will support the development of companion diagnostic programs, particularly in oncology, and advance the company’s ability to define and monitor personalized treatment programs. 

Genoptix, based in California (USA), employs approximately 500 people and will become part of Novartis Molecular Diagnostics, a unit within the Novartis Pharmaceuticals Division. According to a 

, the Novartis tender offer represents a premium of approximately 27% over Genoptix’s January 21 share price. 

"The acquisition of the Genoptix medical laboratory will serve as a strong foundation for our individualized treatment programs," Joseph Jimenez, CEO of Novartis, said in the statement. “By integrating Genoptix within Novartis, we can greatly enhance the value we add to patients, clinicians, payers and society."

The Genoptix Board of Directors has unanimously approved the transaction and recommended that stockholders tender their shares and adopt the merger agreement. In a 

, CEO Tina S. Nova said: "We believe this transaction provides substantial value and liquidity to our stockholders. We are excited about becoming part of the Novartis Molecular Diagnostics unit and continuing to enhance the value that we bring to our core community oncologist customers.”

The transaction is conditional upon the tender of at least a majority of the shares of Genoptix in the tender offer, receipt of regulatory approvals and other customary closing conditions. The transaction is expected to close within the first half of 2011.

Articles

Novartis is looking to advance its personalized medicine treatment programs by entering into a definitive agreement to acquire Genoptix, a laboratory offering personalized diagnostic services, for approximately $470 million or $25 per share.

Novartis To Acquire Genoptix

The European Medicines Agency (EMA) has initiated a safety review of Sanofi’s anti-arrhythmic medicine Multaq following reports of serious liver injury in patients. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now assess all available data and their impact on the medicine’s benefit–risk profile. 

There have been several reports of severe liver complications that could possibly be linked to Multaq, including two cases of liver failure requiring transplant. The CHMP did note that the two patients were also taking other medications; however, a causal relationship with Multaq has not been excluded.

As a precaution, the CHMP has also recommended that warnings and precautions be added to the medicine’s prescribing information to help manage the possible risk of severe liver complications. The CHMP believes that patients’ liver function should be tested before initiation of treatment and closely monitored during treatment for signs of potential liver damage.

Sanofi-aventis will also be providing a letter to healthcare professionals explaining the recommendations for use. 

Multaq was authorized for use in the EU in November 2009 and is marketed in 16 member states, as well as Norway, for use in adults who have had atrial fibrillation in the past or who currently have non-permanent fibrillation. Multaq is used to prevent the fibrillation coming back or to lower the heart rate and contains the anti-arrhythmic active substance dronedarone. 

In the US, Multaq was approved in July 2009, but the FDA placed the drug on a list of medications raising potential safety concerns in 2010. Earlier this month, the agency issued a 

 about Multaq’s potential risk for severe liver injury. 

The European Medicines Agency (EMA) has initiated a safety review of Sanofi's anti-arrhythmic medicine Multaq following reports of serious liver injury in patients.

Sanofi's Multaq Under Safety Review

Johnson & Johnson’s run of quality issues, recalls and other bad news continues with yet another product recall. The company is voluntarily recalling, at the wholesaler level, certain lots of Tylenol, Benadryl, Sudafed PE and Sinutab products distributed in the US, the Caribbean and Brazil. All of the products were manufactured at the company’s McNeil division plant in Fort Washington, which was closed in April 2010 and has been 

“The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented,” explained a 

The company has also initiated a voluntary recall of certain lots of Rolaids Multi-Symptom Berry Tables in the US to update the labelling. The product labelling currently does not include the language “Does not meet USP”, which is required by regulations.

“McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its US manufacturing facilities to improve the quality systems at those sites,” said the company statement. 

The company submitted its Comprehensive Action Plan to the FDA in July 2010 and undertook a thorough assessment of company historical records. The assessment identified a number of areas for improvement, which are currently being addressed and have led to the latest recalls. McNeil has said that it will continue conducting assessments at other sites that manufacture its products, which may lead to further recalls if any other issues are identified. 

 providing an update on the plan, J&J Chairman and CEO Bill Weldon said: “Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world.”

J&J and its subsidiary McNeil Consumer Healthcare have been in industry headlines frequently since 2009 because of product recalls, phantom recalls and related congressional hearings. More information and background can be read in related 

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

J&J Recalls Yet More Medicines

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products. The amount is in addition the $2.36 billion legal charges previously announced in 

 for legal cases regarding Avandia, Paxil and the company’s former manufacturing site in Cidra (Puerto Rico).  

Since this time, GSK says it has continued to receive a “substantial” number of new product liability cases regarding Avandia in the US. The $3.4 billion estimate stems from the company’s assessment of the additional cases and an estimate of likely future claims. 

“We recognise that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” P.D. Villarreal, SVP of Global Litigation at GSK, explained in a 

. “We have closed out a number of major cases over the last year and we remain determined to do all we can to reduce our litigation risk.”

Avandia — once GSK’s biggest grossing blockbuster — was recommended by the European Medicines Agency to be removed from the EU market in September 2010 (see a related 

) because of cardiovascular safety concerns. Around the same time, the US pinned stringent restrictions on the product’s use. 

The charges also relate to an investigation by the US Attorney’s Office for the District of Colorado into GSK’s US sales and promotional practices between 1997 and 2004.

, the charges may wipe out the company’s expected earnings for Q1. 

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.

Avandia Costs GSK $3.4 billion

The EU Commission is on the lookout for “potentially problematic patent settlements” and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies. 

This monitoring exercise is the second of its kind since the EC concluded its 

 in 2009, which was initiated to examine why fewer new medicines were being brought to market and why the entry of generic medicines appeared to be delayed. Among other factors, the inquiry found that patent settlements could be a problem, particularly if an originator company pays off a generic competitor in return for delayed market entry.

“Patent settlements are an area of particular concern because they may delay the market entry of generic medicines. The outcome of our first monitoring exercise showed that potentially problematic agreements had decreased significantly since the Commission’s sector inquiry,” Joaquín Almunia, EC Vice President in charge of competition policy, said in a 

. "The 2011 monitoring exercise is important to assess whether this positive trend is confirmed and to identify potentially problematic patent settlements."

The 2011 monitoring exercise will look at certain patent settlement agreements relevant for the EU/EEA markets concluded between 1 January 2010 and 31 December 2010. A number of companies have been asked for copies of their patent settlement agreements, together with annexes, related agreements and amendments. To limit the administrative burden on companies, the EC has asked for limited additional background information. A report providing a statistical overview will be published in the first half of 2011.

If a specific settlement raises additional questions, a more targeted request for information could follow. 

Although the EC did not name which companies it had approached, 

 believe that AstraZeneca, GlaxoSmithKline, Novartis, Roche and sanofi aventis have been contacted. 

 was conducted in 2010. According to the findings, only 10% of the total patent settlements between July 2008 and December 2009 were potentially problematic, compared with 22% in the period covered by the sector inquiry — January 2000 to June 2008. The amount of money involved in these settlements also decreased from more than €200 million recorded in the sector inquiry period to less than €1 million during the first monitoring exercise. 

“This suggested an increased awareness of the industry of which settlement agreements may attract competition law scrutiny,” said the EC statement. “It was also good news for consumers that cheaper generic drugs are not being unduly kept out or delayed into the market.”

Although the monitoring exercises are only taking place in Europe, the US is also examining so-called “pay-to-delay” patent agreements (see a related 

), with the possibility that such strategies may be considered illegal in the future. 

The EU Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies.

EU Examines Patent Settlements

The European Union Commission is on the lookout for “potentially problematic patent settlements” and has asked several pharmaceutical companies to submit copies of their patent-settlement agreements made between originator and generic-drug companies. 

This monitoring exercise is the second of its kind since the European Commission (EC) concluded its competition 

 in 2009, which was initiated to examine why fewer new medicines were being brought to market and why the entry of generic medicines appeared to be delayed. Among other factors, the inquiry found that patent settlements could be a problem, particularly if an originator company pays off a generic-drug competitor in return for delayed market entry.

“Patent settlements are an area of particular concern because they may delay the market entry of generic medicines. The outcome of our first monitoring exercise showed that potentially problematic agreements had decreased significantly since the Commission’s sector inquiry,” Joaquín Almunia, EC vice-president in charge of competition policy, said in a 

The 2011 monitoring exercise will look at certain patent settlement agreements relevant for the European Union/European Economic Area  markets concluded between  Jan. 1,  2010 and  Dec. 31, 2010. A number of companies have been asked for copies of their patent-settlement agreements, together with annexes, related agreements, and amendments. To limit the administrative burden on companies, the EC has asked for limited additional background information. A report providing a statistical overview will be published in the first half of 2011.

 reported that AstraZeneca, GlaxoSmithKline, Novartis, Roche, and sanofi aventis have been contacted. 

 was conducted in 2010. According to the findings, only 10% of the total patent settlements between July 2008 and December 2009 were potentially problematic, compared with 22% in the period covered by the sector inquiry—January 2000 to June 2008. The amount of money involved in these settlements also decreased from more than EUR 200 million recorded in the sector inquiry period to less than EUR 1 million during the first monitoring exercise. 

Although the monitoring exercises are only taking place in Europe, the United States is also examining so-called “pay-to-delay” patent agreements (see a related 

), with the possibility that such strategies may be considered illegal in the future.