Global Insight Perspective | |
Significance | Sanofi-Aventis’ attempt to win an injunction against Novo Nordisk for false advertising claims for its insulin Levemir has been rejected by a U.S. district court. |
Implications | The verdict leaves the way open for Levemir to compete directly with Sanofi-Aventis’ own insulin product, Lantus, in the key U.S. market. Novo Nordisk has already launched its own attack on Sanofi by demanding an ITC investigation over sales of the OptiClik insulin pen. |
Outlook | Sanofi-Aventis looks unlikely to appeal or renew its false-advertising case against Novo Nordisk, and with a string of U.S. regulatory difficulties pending, it would do better to focus its energies on boosting sales of Lantus as a combination therapy, following positive study results. |
U.S. Judge Mary Cooper has ruled that French pharmaceutical company Sanofi-Aventis had no "reasonable probability of success" in pursuing a preliminary injunction against Danish rival Novo Nordisk. The injunction was originally filed against the Danish firm in the U.S. District Court of New Jersey, over allegations of false advertising, with Sanofi-Aventis claiming that launch and pre-launch marketing materials for Novo’s long-acting basal insulin, Levemir (insulin detemir [rDNA origin] injection), contained several false statements. According to Novo Nordisk, these included Levemir’s capacity to work for up to 24 hours, its ability to be used once daily, its causing a lesser degree of weight gain than NPH insulin, and causing less injection-to-injection variability. Earlier this year, Sanofi-Aventis said that Levemir was only effective for 20 hours rather than 24.
Levemir and Levemir FlexPen were launched in the U.S. in late March, offering treatment for type 1 and 2 diabetes (see Denmark: 29 March 2006: Novo Nordisk Launches Levemir in U.S.). The drug is one of the main competitors to Sanofi-Aventis’s own insulin analogue, Lantus (insulin glargine), which has been on the market since 2001.
Outlook and Implications
Sanofi-Aventis has not had much luck in the U.S. regulatory arena of late, having recently been made to amend a settlement deal over a generic version of its blockbuster blood-thinner, Plavix (clopidogrel), after the original offer was rejected (see World: 26 June 2006: Sanofi-Aventis, BMS Agree to Shorten Patent Protection on Plavix by Three Months). The French market leader is also facing an investigation into clinical trials of its antibiotic drug, Ketek (telithromycin), after safety concerns from the FDA were prompted by several prominent U.S. senators. Finally, Sanofi is set for another face-off against Novo Nordisk within the next few months, after a complaint from the Danish company prompted an investigation by the International Trade Commission (ITC) over Sanofi-Aventis’ U.S. sales of the OptiClik insulin pen. According to Novo Nordisk, the U.S. imports of OptiClik from Sanofi-Aventis violated one of Novo Nordisk’s own patents (see France: 9 June 2006: Sanofi-Aventis Halts Paediatric Ketek Trials, as OptiClik Investigation Looms).
So far, there has been no word from Sanofi-Aventis on whether it is planning to appeal or renew its case against Levemir; however, as the French company has already withdrawn the part of its injunction specifically relating to launch materials on 11 April, its weakened case resting on pre-launch materials alone is not likely to make a comeback any time soon. A better strategy would be to focus on optimising the sales potential of Lantus, which was already Sanofi’s fastest-selling drug in 2005 and during the first quarter of 2006, with a 42% year-on-year (y/y) leap to 382 million euro (US$481.1 million) over the first three months of the year (see France: 5 May 2006: Sanofi-Aventis Posts Strong Q1 Earnings despite Generic Competition). Eager to promote this high level of growth, Sanofi has recently been exploiting ways of combining Lantus with other treatments in order to boost its effectiveness. Short-acting insulin Apidra, launched recently on the U.S. market (see France: 1 March 2006: Sanofi-Aventis Announces U.S. Availability of Apidra, as Plavix Litigation Delayed Again), is normally taken in conjunction with Lantus. The drug's apparent effectiveness, when taken with metformin, could contribute eventually to a wider expansion of Lantus sales. Meanwhile, at the recent American Diabetes Association conference in the U.S. capital, Washington D.C., Sanofi also touted study results demonstrating a greater level of efficacy for Lantus compared to short-acting mealtime insulin lispro, marketed as Humalog by U.S. pharma company Eli Lilly (see France: 15 June 2006: ADA 2006: Lantus Found More Effective than Lispro in Type 2 Diabetes Study from Sanofi-Aventis).