Monthly Archives: July 2013

July 30 2013 | By Márcio Barra

Pfizer reported today their second-quarter profits, beating analysts’ estimates as it prepares to rearrange its business operations. Earnings excluding one-time items were 56 cents a share, compared with the 55 cents average estimated by Bloomberg and Thomson Reuters I/B/E/S. Net income rose more than fourfold to $14.1 billion, or $1.98 a share, from $3.25 billion, or 43 cents last year. Revenue however, fell 7% to $12.97 billion, compared with the $13.03 billion analysts estimated.

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July 30 2013 | By Márcio Barra

Pfizer announced yesterday that it will reorganize its commercial operations into three units, two focused on innovative drugs and a third comprising what Pfizer’s CEO Ian Read calls Pfizer’s “value” business, in a move that the company says it will help improve their ability to answer to different market’s dynamics.

The units are: Innovative Products Group, which will include therapeutics that are expected to have market exclusivity beyond 2015; Vaccines, Oncology and Consumer Healthcare, all three of which will operate as separate businesses; and Value, which comprises generic products and drugs that will soon lose their patent protection.

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July 29 2013 | By Márcio Barra

Paulo Lilaia, president of APOGEN

Portuguese generic drug makers will now be able to introduce new generic drugs into the market every month and not just quarterly, in another move by the Portuguese Ministry of Health to increase the market share of generics and reduce state drug expenditure.

Ordinance n.º 103/2013 from 26 July 2013 , changes “the mechanisms of creation of homogeneous groups and respective reference prices, aiming to maximize savings resulting from a greater incentive for generics use and promote an increase of market share in line with the international commitments of the Portuguese State, “reads the preamble of the statute. This ordinance updates Decree-Law n. -A/2010 48, already amended by Decree-Law n.º 106 -A/2010 and Law n. º 62/2011.

According to the Ordinance, the calculation and publication of the reference price of new homogeneous groups created as a result of the market introduction of new generic drugs has to be published by the twentieth day of each month. Until now, these approvals only occurred once every three months.

Paulo Lilaia, president of the Portuguese Association of Generic (Apogen), applauds the measure , requested for a long time by Apogen. “With these changes, entry of generic drugs in the market can happen faster and in a greater number. It’s good for the industry, for the National Health system and for users, “he concluded in declarations to the Jornal de Negócios (in Portuguese)

For more on Drug pricing in Portugal, please check this article. 

July 29 2013 | By Márcio Barra

EMA’s CHMP 22-25 July 2013 saw 8 new drugs obtaining a positive opinion for a marketing authorization (MA). Here is the rundown of approvals:

Approved marketing authorizations for new drugs:

Giotrif (afatinib), Boehringer Ingelheim International GmbH  –  Giotrif is an antineoplastic drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The drug is the first irreversible ErbB family blocker, a group of receptor tyrosine kinases overexpress in many cancers. This is the third drug to target EGFR mutations in NSCLC, joining erlotinib (Tarceva) and gefitinib (Iressa).

The CHMP’s positive opinion for Giotrif is based on data from the pivotal trial LUX-Lung,comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results from the study showed that patients taking afatinib lived for almost one year without their tumour growing again versus just over half a year for those treated with pemetrexed/cisplatin.

Afatinib was recently approved for this indication in the United States, under the name Gilotrif.

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July 26 2013 | By Márcio Barra

Pfizer received a second negative evaluation from the EMA’s CHMP regarding their rheumatoid arthritis treatment Xeljanz (tofacitinib citrate), confirming its April 25, 2013 opinion to recommend against the approval of Xeljanz. This is the second time that the CHMP says no to Pfizer’s drug.

After a re-examination of the application as requested by Pfizer, the CHMP remained on the opinion that Xeljanz does not demonstrate a favorable benefit – risk profile, and thus a Market Authorization was recommended against again.

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 July 25 2013 | By Márcio Barra

Following news of the leaked memo from the European Federation of Pharmaceutical Industries and Associations (EFPIA) earlier this week that sparked a wave of controversy, the EFPIA and the U.S.’ Pharmaceutical Research and Manufacturers of America (PhRMA) released their joint set of principles detailing their strategy to allow a more open access to clinical trial data.

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July 24 2013 | By Márcio Barra

Abbvie’s Humira

Evaluate Pharma has released today their sixth edition of their series EvaluatePharma’s World Preview. Like always, it is filled with high-quality data on the (mostly) post-patent cliff world that we live in, worthy of a careful read. Some highlights of the report follow:

  • Worldwide prescription drug sales forecast to grow by 3.8% to a total of $895 billion in 2018.
  • Worldwide prescription drugs sales experienced an unprecedented fall of 1.6% in 2012 due to a large number of blockbuster patent expiries, including Seroquel, Diovan, Plavix, Singulair, Lexapro and Geodon.
  • 2012 was the best year for new drug approvals since 1997, with the FDA approving 43 new drugs in 2012, a 23% increase from the 35 new entities approved in 2011. The 2012 approvals included 33 new molecular entities (nine more than 2011) and ten biologicals (one more than 2011).
  • Between 2013 and 2018, there are $230 billion of sales at risk from patent expiration. However, the market expects around only half of this value to be lost as a result of generic competition, due to growing sales of biotechnology products, who suffer less sales erosions from biosimilars.
  • Humira (Adalimumab), Abbvie’s TNF inhibitor for rheumatoid arthritis, is projected to be world’s largest selling product in 2018, with $12.3 billion. Number two goes for Merck’s diabetes franchise Januvia/ Janumet, third to Amgen’s/Pfizer’s Enbrel, and Sanofi takes fourth place with Lantus.
  • Pfizer remains top company by worldwide Rx sales in 2012; Novartis number two. In the U.S. Pfizer remained in the top position in terms of USA prescription drug sales in 2012 even after a 19% decline in sales primarily due to loss of exclusivity on Lipitor. As for Europe, Novartis was number one in prescription drug sales in 2012. In Japan, Takeda took the top spot.
  • By 2018, Novartis is expected to be number one in terms of worldwide Rx sales, with expected sales of $52.3 billion in 2018, $3.3 billion more than second-place Sanofi and $5.5 billion more than third-place Pfizer.
  • Novartis will also remain the top spender in R&D by 2018, spending approximately $10.3 billion.
  • Worldwide pharmaceutical R&D spend forecast to be $149 billion in 2018.
  • Gilead’s hepatitis C polymerase inhibitor, Sofosbuvir (acquired for $11.2 billion via Pharmasset in January 2012) will become the most valuable R&D product, with a current valuation of $28.6 billion. Sofosbuvir received recently a priority review status from the FDA, which cuts the evaluation period from 12 months down to 8 months.
  • Anti-coagulants are set to record the highest worldwide sales growth of major therapy categories to 2018, with an annual growth rate of 11.5%. Oncology is expected to remain number one in 2018, with Roche remaining its biggest stakeholder.
  • Within the top 100 prescription products in 2018, biological products are expected to account for more than 50% of sales
  • Sanofi to be the top vaccine company in 2018, with GlaxoSmithKline sliding to number three. Pfizer’s Prevenar 13 vaccine is predicted to have an annual growth rate of 8%, accounting for 15.6% of the entire vaccine market in 2018.
  • Teva Pharmaceutical remains leading generic drug maker in 2012  
  • Germany was the European Member state with the highest government expenditures on pharmaceuticals in 2011, followed by France, Italy, UK and Spain.

For the full report, please go here for Evaluate Pharma’s website, and download the report for free (requires registration)