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Roche 9-month Currency Neutral Sales Rise, Says FDA Approves Esbriet

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK,ROG.SW,RO.SW) Thursday said sales for the first nine months of the year edged down from the prior-year period, as several currencies remained weaker against the Swiss franc throughout the year, most notably the US dollar. Excluding the impact of currency, sales improved on the strength of oncology products.

The company also announced U.S regulatory approval for its idiopathic pulmonary fibrosis drug Esbriet, which it inherited as a result of the acquisition of InterMune last month.

Group sales were 34.757 billion Swiss francs ($36.9 billion), compared with 34.867 billion francs for the same period last year. At constant currency rates, sales improved 5 percent.

In the Pharmaceuticals Division, sales climbed 4 percent to 26.965 billion francs, driven by the oncology portfolio, in particular the medicines for HER2-positive breast cancer, Herceptin, Perjeta and Kadcyla. Comparisons are on a currency-neutral basis.

Within the division, US sales were 5 percent higher, Europe improved by 3 percent and Japan showed a 7 percent growth.

Diagnostics sales were up 6 percent at 7.792 billion francs, amid continued strong performance in Professional Diagnostics.

For full year 2014, Roche still projects low- to mid-single digit growth in Group sales at constant exchange rates. Core earnings per share are targeted to grow ahead of sales. Also, the company expects to further increase its dividend.

Further, Roche said it completed the acquisition of InterMune in September, adding a new medicine for idiopathic pulmonary fibrosis - Esbriet.

Separately, the company said the U.S. Food and Drug Administration has approved Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis or IPF.

IPF is a fatal disease caused by progressive scarring or fibrosis of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly.

The disease can advance quickly or slowly, but eventually the lungs will harden and stop working altogether.

The approval of Esbriet is based on data from a large, placebo-controlled Phase III study known as ASCEND. The study was supported by two other large Phase III trials known as CAPACITY 1 and 2.

In the ASCEND study, more patients who received Esbriet had a delay in the decline of lung function compared to those who received placebo.

Earlier this year, the FDA had granted Esbriet Breakthrough Therapy Designation based on the positive data from the ASCEND clinical trial and the serious and life-threatening nature of IPF. It has also been granted Orphan Drug designation in the U.S. Nearly 100,000 people in the U.S. have IPF.

Roche closed down 2.1 percent in Zurich on Wednesday at 258.90 francs.

For comments and feedback contact: editorial@rttnews.com

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