Global Insight Perspective | |
Significance | The European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) has recommended for approval some six new drugs and four biosimilars, while four already-marketed treatments have been recommended for approval in a new indication. |
Implications | Among the recommended drugs are GlaxoSmithKline (GSK)'s pandemic influenza vaccine Prepandrix, which, if approved, would be the first of its kind available in Europe. Other recommendations pose more of a threat to treatments already on sale, with Voltaris (GSK and Gilead Sciences) being a major challenge to Actelion's drug Tracleer. |
Outlook | Europe's market for biosimilars looks set to expand yet again, offering new lower-cost treatments for neutropaenia. Only one oncology drug is present among the CHMP's recommendations, but this new batch of drugs looks set to offer new options for a variety of chronic ailments. |
The latest meeting of the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) has resulted in a raft of new drugs being recommended for European marketing authorisation. The regulatory applications for some of the drugs date back to 2006, making this a long-awaited regulatory milestone for developers. Key among the recommendations for approval is Prepandrix, a pre-pandemic influenza ('flu) vaccine produced by U.K. pharma giant GlaxoSmithKline (GSK). Reportedly the first-ever pre-pandemic 'flu vaccine to be the subject of a potential European approval, Prepandrix has been developed from the split inactivated, adjuvanted H5N1 strain of avian 'flu, and is intended for use both prior to a pandemic being officially declared and during a pandemic. A mock-up pandemic 'flu vaccine known as Pandemrix, also produced by GSK, has been given the all-clear from the CHMP as well. This vaccine can also be used during a pandemic 'flu situation, but only once the relevant viral strain has been added to the serum.
Among the other 12 positive recommendations issued by the CHMP is the pulmonary arterial hypertension (PAH) treatment Volibris (ambrisentan), produced by GSK and U.S. drug-maker Gilead Sciences. Pending final approval from the European Commission, Volibris could pose a significant threat to rival PAH drug Tracleer (bosentan), made by Swiss biotech Actelion. Also recommended by the CHMP are four biosimilar neutropaenia treatments, while four further drugs are already available on the market but look set to be approved in new indications.
CHMP Recommendations for EU Marketing Authorisation | |||
Drug | Active Ingredient | Producer | Indication |
Approval Recommendations | |||
Adenuric | febuxostat | Ipsen | Chronic hyperuricaemia in conditions where urate/uric acid deposition has already occurred |
Mycamine | micafungin sodium | Astellas Pharma | Invasive candidiasis; |
Pandemrix | split inactivated, adjuvanted, H5N1 | GSK Biologicals | Pandemic influenza |
Prepandrix | split inactivated, adjuvanted, H5N1 | GSK Biologicals | Pandemic influenza |
Privigen | human normal immunoglobulin | ZLB Behring | Replacement therapy in immunodeficiency and for immunomodulation in immune-mediated diseases |
Volibris | ambrisentan | GSK, Gilead Sciences | Pulmonary arterial hypertension |
Biosimilars | |||
Biograstim | filgrastim | CT Arzneimittel | Neutropaenia |
Filgrastim Ratiopharm | filgrastim | Ratiopharm | Neutropaenia |
Ratiograstim | filgrastim | Ratiopharm | Neutropaenia |
Tevagrastim | filgrastim | Teva Generics | Neutropaenia |
Indication Extensions | |||
Abilify | aripiprazole | Otsuka Pharmaceutical | Moderate-to-severe manic episodes in bipolar-I disorder; |
Alimta | pemetrexed | Eli Lilly | First-line treatment in combination with cisplatin of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous-cell histology |
Azomyr, Aerius and Neoclarityn | desloratadine | SP Europe | Urticaria |
Forsteo | teriparatide | Eli Lilly | Osteoporosis associated with systemic glucocorticoid therapy in women and men at increased risk of fracture |
Source: EMEA. | |||
Outlook and Implications
With recommendations by the CHMP typically endorsed by the European Commission within two or three months, the producers behind today's endorsed medicines could easily target a European roll-out by the third or fourth quarter of 2008. The slew of biosimilar neutropaenia treatments recommended for approval will add to Europe's growing number of marketed biosimilars, posing a challenge to U.S. biotech Amgen, which produces Neupogen (filgrastim). Neupogen is the product on which all four biosimilars recommended by the CHMP are based, and the Committee has opined that the drugs are indeed "similar" to the Amgen brand. Neupogen was Amgen's fifth best-selling product in 2007, with U.S. sales of US$861 million and international turnover of 416 million. It is in this latter category that sales could be hit, with the effects potentially visible from early next year.
Meanwhile, GSK and Gilead's Voltaris presents a major challenge not only to Tracleer but to Actelion itself. While the Swiss biotech's sales have boomed in recent years, much of its success has been down to Tracleer, which accounted for over 90% of the group's turnover in 2007 (see Switzerland: 21 February 2008: One-Off Costs and Rise in Operating Costs Halve Actelion's 2007 Bottom Line). Voltaris was approved in the United States last June under the brand name Letairis, and is expected to perform well in the U.S. PAH market, given that it is viewed as having a more favourable side-effects profile than Tracleer (see United States: 18 June 2007: Gilead Breaks New Ground with U.S. PAH Drug Approval).
Finally, the potentially imminent arrival of Prepandrix in Europe will fill a major gap in demand, and could become the subject of government stockpiling contracts in several European Union member-states. To date, France's Sanofi Pasteur has secured approval for its bird 'flu vaccine in the United States for people at increased risk of contracting bird 'flu in the event of a pandemic (see France: 18 April 2007: World First for Sanofi Pasteur as U.S. FDA Approves Bird-'Flu Vaccine), but doubts over the product's safety and efficacy remain (see France: 27 February 2007: U.S. FDA Casts Doubts over Sanofi-Aventis' Bird 'Flu Vaccine Ahead of Panel Review). Should Prepandrix prove able to elude such doubts, its position in the pandemic 'flu market looks assured.