Having posted a mixed set of results for the third quarter, Teva Pharmaceutical Industries has lowered its full-year forecasts and revealed that it will not be filing for US approval of its multiple sclerosis drug laquinimod in the near future.
As reported yesterday by PharmaTimes World News, the Israeli drugmaker's net income fell 12.8% to $916 million, and while group sales increased 2.2% to $4.34 billion, turnover sank 48% in the USA to $845 million. The latter decline is due to the fact that there were no new significant launches of generic products.
Teva now says that it expects 2011 sales to be between $18.3-$18.6 billion, compared to a previous estimate of $18.5-$19 billion. Earnings per share, including a contribution of around $0.15 from the recent Cephalon acquisition, should be in the range of $4.92 to $5.02, down from $4.90- $5.20.
The company said that the forecast reflects "uncertainty about the timing of the regulatory approval and commercial launch in the USA of an important undisclosed generic product". If things do not go Teva's way, the firm expects to achieve "the low end" of the full year outlook.
The generic in question is probably Teva's copy of Sanofi's antithrombotic Lovenox (enoxaparin) according to Judson Clark, an analyst at Edward Jones. He told PharmaTimes World News that the guidance reduction "is modest and manageable". As for the $0.15 benefit from the Cephalon acquisition, this represents "yet another example of the quality acquisitions that this management team has made".
The lowered forecast concerned some investors but "we are looking through our long-term lens and care more about the company's positioning going forward", Mr Clark said. He believes Teva is "a compelling long-term investment" and his firm views "the near-term weakness as a buying opportunity".
Laquinimod filing would be 'premature'
Teva chief executive Shlomo Yanai also caused a bit of a stir by revealing that the company is holding off on filing laquinimod, developed with Sweden's Active Biotech, in the USA.
He noted that the company met with the US Food and Drug Administration last week to discuss the New Drug Application for the late-stage oral MS drug and following the meeting, he said "we now believe that it would be premature to file the NDA at this time". Mr Yanai added that "the FDA has offered to work with us to determine the best design for conducting an additional trial".
Mr Clark told PharmaTimes World News that the decision to put the submission on hold was "prudent". In August, initial results from the Phase III BRAVO study, the second of two late-stage trials on laquinimod, showed that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo.
However, at the time, Teva noted that the placebo and treatment study groups showed dissimilarity "in two baseline magnetic resonance imaging" characteristics and following a "pre-specified sensitivity analysis", when this imbalance was corrected, laquinimod demonstrated a significant reduction in the annualised relapse rate (21.3%) in the risk of disability progression and in brain volume loss (27.5%).
In the summer, the company still felt confident that an adjustment of the data would be enough to support a filing but Mr Clark said "this was not something upon which we expected the FDA would look favourably". That, "in conjunction with the lack of overwhelmingly positive data previously", led the analyst to "remove estimates for laquinimod from our model some time ago". Mr Clark concluded by praising Teva management's decision "to deploy their resources in the most sensible way possible and, for now, that means holding off on laquinimod".