Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

 by  EMA relating to centralized procedure activities for human medicines appear to show a marked slowdown in the number of generic-drug applications filed and finalized this year to date (9 and 12, respectively). Although this number will undoubtedly increase by the end of the year, a marked difference is already evident in comparison to 2009, when 38 generic-drug product applications were filed.

Despite many in the industry believing that generic drugs are beginning to dominate with more products going off patent, the figures for 2010 show a different story. Generic drugs clearly dominated 2009, but for 2010 they appear to be lagging markedly behind with only nine generic-drug product applications filed versus 20 applications for new products. In terms of finalized applications, generic drugs and new products are roughly even so far with 12 for generic drugs and 11 for new products.

In general,  EMA has reported a reduction in overall positive opinions, with only 28 having been adopted as of July 2010. Companies have a lot of catching up to do if this number is to match the 117 mark reached in 2009, or even the 58 and 66 positive opinions that were adopted in 2007 and 2008, respectively. 

The number of negative opinions is also down from eight in 2009 to just one so far in 2010. Although this may seem like a positive development, it seems to be part of a larger and more disturbing trend for a lack of marketing authorization applications as a whole. So far for 2010, only 40 new marketing authorisation applications have been filed. Again, this figure will change as the year goes on but if the pace continues throughout the second half of 2010 then the number will lag behind previous years. For 2007, 2008, and 2009, the total number of product applications started was 90, 103, and 95, respectively. 

Looking solely at marketing authorization applications for new products, there is mixed news. The number of filed applications is already 20 for 2010, compared with 35 for the whole of 2009, which is a robust number considering the drying pipelines of many companies. For finalized applications, however, the difference between this and previous years is  greater-only 11 have been finalized thus far compared with 40 and 49 for 2008 and 2009, respectively.

Overall, the total number of finalized marketing authorisation applications for all products is much lower than 2009, in which  125 applications were finalised. So far, only 30 applications have been finalized in 2010. In comparison, in 2007 and 2008, 65 and 72 marketing authorization applications were finalized, respectively. The sharp increase in finalized applications in 2009 could mainly be attributed to a huge rise in the number of applications for generic-drug products seen in 2008 (30 applications filed) and 2009 (38 applications filed), with 51 applications finalized in 2009. 

There’s still five months of the year remaining before  a full picture of marketing authorization application trends for the year presents itself. However,  EMA has said it will be providing monthly updates on its website. 

Articles

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalized this year to date (9 and 12, respectively).

EU Generic Applications Down in 2010

Novartis has been told off by the FDA in a 

 about a social media Facebook widgit that appears on the company’s Tasigna website. The problem? “The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug,” said the FDA letter. As such, the FDA has said the company is in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.

When clicked on, the Facebook Share widget (which has now been removed from the Tasigna website) generated Novartis-created information for its oncology drug Tasigna that could be shared by being displayed on a Facebook user’s profile and, potentially, on the homepage stream of all of their friends. According to the FDA, each time a link is shared by one user, potentially hundreds of new people may see and click through.

Although users can add comments about the shared information, the information itself as provided by the original source (Novartis) cannot be modified. In the case of Tasigna, the shared information was too promotional and did not communicate the risks of using the drug, which has been associated with a number of serious risks including sudden death and liver function abnormalities. The FDA also added that the information “inadequately communicated the drug’s FDA approved indication” and implied “superiority over other products”.

Novartis was asked to submit a written response to the letter by 12 August 2010.

, this is the first known enforcement by FDA regarding Facebook.

Novartis has been told off by the FDA in a letter about a social media Facebook widgit that appears on the company?s Tasigna website.

Novartis Gets Warning Letter For Facebook Widgit

Merck has received letters from the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) seeking information about “activities in a number of countries” with reference to the 

. The Act makes it unlawful for US companies to bribe foreign government officials to obtain or retain business. Merck disclosed the information in a 

 and has said it is cooperating with the agencies and their requests. 

Although the company has released no further details of the probe, third-party reports including 

 claim that a spokesperson for Merck has said that it has not been charged for violating the Act and has a compliance programme in place to prevent such occurrences. On its 

, Merck explains that it operates under a federal Corporate Integrity Agreement, which requires it to retain an independent review organisation to “conduct a systems review of its promotional policies and procedures and to conduct, on a sample basis, transactional reviews of Merck's promotional programs and certain Medicaid pricing calculations”. The company is also required to provide regular reports and certifications to the US Department of Health and Human Services Office of Inspector General regarding its compliance with the integrity agreement. 

In the SEC filing, Merck also added that it believes the inquiry is “part of a broader review of pharmaceutical industry practices in foreign countries”. According to a report from 

, the DOJ and the SEC have investigated several pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act. 

Merck has received letters from the US Department of Justice and the US Securities and Exchange Commission seeking information about "activities in a number of countries" with reference to the Foreign Corrupt Practices Act.

Merck Probed For Corrupt Foreign Practices

Merck & Co. (Whitehouse Station, NJ) has received letters from the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) seeking information about “activities in a number of countries” with reference to the 

 with the SEC and has said it is cooperating with the agencies and their requests.
 
Although the company has released no further details of the probe, third-party reports including 

 stated that a spokesperson for Merck has said that it has not been charged for violating the Act and has a compliance program in place to prevent such occurrences. On its 

, Merck explains that it operates under a federal Corporate Integrity Agreement, which requires it to retain an independent review organization to “conduct a systems review of its promotional policies and procedures and to conduct, on a sample basis, transactional reviews of Merck's promotional programs and certain Medicaid pricing calculations.” The company is also required to provide regular reports and certifications to the US Department of Health and Human Services Office of Inspector General regarding its compliance with the integrity agreement.
 
In the SEC filing, Merck also added that it believes the inquiry is “part of a broader review of pharmaceutical industry practices in foreign countries.” According to a 

, the DOJ and the SEC have investigated several pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act.
 

Merck & Co. (Whitehouse Station, NJ) has received letters from the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) seeking information about "activities in a number of countries" with reference to the Foreign Corrupt Practices Act.

Merck Probed for Corrupt Foreign Practices

French pharma giant Les Laboratoires Servier SA has been accused of providing “misleading” and “incorrect” information during the EC’s antitrust investigation. If Servier did indeed intentionally or negligently provide such information, the company could face a fine worth 1% of its total turnover for the preceding business year.

 into the pharmaceutical sector was concluded in July 2009. During this time, several questionnaires were sent out to industry stakeholders and pharma companies, including Servier. After further investigating the company’s reply, the EC “takes the preliminary view that this reply included information which appears to be misleading and incorrect”, according to a 

The EC has sent a Statement of Objections to the company, although it also added that this will “not prejudge the final outcome of the investigation”.

As well as this new development, Servier is already 

 for suspected breaches of restrictive business practices and abuse of a dominant market position. In particular, the company is accused of forming agreements with generic companies that may have delayed the market entry of cheaper versions of its heart disease drug, perindopril.

Earlier this month, the EC explained that the number of “potentially problematic” patent settlements in the pharma sector fell to just 10% during July 2008 to December 2009, compared with more than 20% in the period covered in the competition inquiry (January 2000–June 2008).

"Patent settlements are an effective means to end patent-related disputes and litigation. Nobody disputes this. However, some of them may be anticompetitive,” Joaquín Almunia, the Commission Vice President in charge of Competition Policy, said in a 

. “Our report appears to show the sector's increased awareness of the potential competition concerns, but the Commission will remain attentive to ensure that the sale of safe, affordable medicines is not delayed by unfair practices.” 

French pharma giant Les Laboratoires Servier SA has been accused of providing "misleading" and "incorrect" information during the EC?s antitrust investigation.

Servier under EC scrutiny for anticompetitive behavior

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis’s displeasure. Sanofi has expressed concerns about the generic’s safety and, according to a report from 

, has even asked a court to block the approval, claiming that the FDA’s decision was “arbitrary and capricious”.

“Sanofi-aventis is concerned by potential implications for patient safety, since the product approved has not been subjected to extensive clinical trials to demonstrate its efficacy and safety,” said Sanofi, in a 

Sanofi’s main reservation relates to the complexity of Lovenox, which is a mix of sugar molecules derived from pig intestines. According to Sanofi, the product’s efficacy and safety profile relies on “strict adherence” to specific manufacturing processes, as well as traceability from the animal mucosa to the finished product.

No doubt Sanofi will also be concerned about the financial implications of the approval. Lovenox was Sanofi’s second biggest selling product in 2009, with US sales of approximately $2.7 billion. The product, which can help prevent deep vein thrombosis, is also claimed to be the best-selling hospital medicine in the US. Sanofi had initially believed that Lovenox was under patent protection until 2012; however, in 2007 a US court found that the patents were 

 when challenged by generic companies Teva and Amphastor.

On the other side of the fence, Sandoz and Momenta, who collaborated on the development of the newly FDA-approved generic, are both celebrating, despite Sanofi’s threat in its company press statement of utilising all appropriate analytical and clinical avenues to assess the quality and safety of the generic.

"Sandoz is the first company to launch generic enoxaparin sodium in the US, delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products," Jeff George, Global Head of Sandoz, said in a 

Meanwhile, Teva is hoping that Sandoz and Momenta’s success will also lead to the approval of its pending generic version of Lovenox. However, the generic manufacturer also has reason to be concerned by the FDA’s approval of such a complex generic product. Its proprietary multiple sclerosis medicine, Copaxone, which also requires complex manufacturing procedures, is due to go off patent in the coming years. In a 

 commenting on the FDA’s approval of generic Lovenox, Teva adds that: “any potential generic version of Copaxone should be evaluated via preclinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in a real patient population.”

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis's displeasure.