2Q Sanofi pipeline receives mixed response

By Wai Lang Chu

- Last updated on GMT

Related tags Sanofi-aventis Clinical trial Pharmaceutical industry

The creation of Sanofi-Aventis last year created a dent in its
second-quarter net profit as the French company looked to provide
good news to its investors. The drug maker managed to raise its
earnings target for the year and accelerated merger savings goals

The company, formed by Sanofi-Synthelabo takeover of Aventis said profit in the year-earlier quarter would have reached €1.23 billion - excluding the cost of the merger and income from units not included in the deal.

Europe's number one largest drug maker posted a 26 per cent rise in second-quarter net income and said 2005 adjusted earnings per share would grow by at least 20 per cent, up from 18 per cent predicted initially.

Net income was 26 per cent higher at €1,553 million, and represented 23.2 per cent of net sales. This is compared to 19.6 per cent achieved for the second quarter of 2004.

This caused the company to issue 2005 guidance, which stated, "Barring major adverse events, Sanofi-Aventis expects 2005 full-year adjusted EPS growth to be at least 20 per cent."

"This takes into account substantial expenditure in preparation for the launch of Rimonabant, the launch costs of Ambien CR, and the increased spending on clinical trials, all of which are expected to be incurred in the second half of the year,"​ the statement added.

The first in a new class of therapeutic agents called selective CB1 Blockers, Rimonabant was the subject of a recent Phase III study in which the drug was shown to significantly improve HbA1c (a measure of blood sugar control), dyslipidemia (abnormal levels of fat in the blood), and systolic blood pressure.

Sanofi confirmed it still expects to launch a new controlled release version of its existing Ambien sleeping pill before the end of the summer.

According to Sanofi, the company has one of the largest pipelines in the pharmaceutical industry, with 128 products in development of which 35 are in Phase IIb or Phase III.

Amongst some of its late stage compounds, which represent the first wave of clinical results expected in 2005, include three Central Nervous System (CNS) compounds, two compounds in Oncology and one in Internal Medicine.

The research and development update provided positive and negative news. Sanofi​ said that two programs in phase IIb, three in phase I and three in pre clinical stages were stopped due to various reasons. The phase IIb molecules involved were Pranalcasan (HMR 3480) and schizophrenia treatment Osanetant (SR142801).

One drug candidate, SSR 591813, developed for the treatment of an experimental drug to help people stop smoking, which underwent phase IIb testing, met its primary efficacy criteria of prolonged abstinence during the last four weeks of treatment. The overall safety profile of the product was acceptable.

Sanofi's SR 58611, a treatment for depression, met its primary objective of demonstrating the improvement of depressive symptoms over placebo after treatment of six weeks in a phase III European study.

In other financial results, current operating income rose by 24.4 per cent to €2.26 billion ($2.75 billion) up from €1.81 billion a year earlier.

Activity in the R&D pipeline meant that research and development costs would rise in 2006, as phase-three studies get under way for four experimental drugs.

Research and development expenses decreased to €979 million or 14.6 per cent of net sales in the second quarter, from €989 million, or 15.8 per cent of net sales, in 2004.

Related topics Preclinical Research

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