India’s Sun Pharmaceutical is set to launch generic doceferez in European markets soon.
Sun Pharma has received recommendations from the European Medicines Agency for granting it marketing authorisation in the continent for cancer drug doceferez, the Mumbai-based company announced in a pres release.
Sun’s doceferez is a generic version of Sanofi-Aventis’ Taxotere.
“The Committee for Medicinal Plants for Human Use (CMPH) adopted a positive opinion, recommending the grant of marketing authorisation for the medicinal product Doceferez, 20 mg and 80 mg powder and solvent concentration…,” European Medicines Agency (EMA) said in a statement on its website.
The application was made by the European subsidiary of Sun Pharma, it added.
Dociferez has broad clinical anti-tumour activity against various types of cancer, such as lung, prostrate, gastric, head and neck, EMA said.
Sanofi has been trying to protect Taxotere that generated sales of around $2.9 billion for the company in 2008 from generic competition.
In August last year, Sanofi-Aventis SA, France’s largest drug maker, sued Sun Pharmaceutical Industries Ltd alleging patent violations on Taxotere.
Sun was seeking approval from the US Food and Drug Administration (FDA) to market two dosage forms of the drug before the patents expire in 2012, according to the complaint filed on 21 August in the federal court in Delaware.
Headquartered in Mumbai, India, Sun Pharma manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
In India, Sun Pharma leads in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics.
Sun Pharma has skills in product development, process chemistry,and manufacturing of complex API, as well as dosage forms.
Sun Pharmaceutical and Industries, currently the sixth largest generic maker India, has posted a 17% drop in the consolidated profits in the third quarter for the financial year 2010 compared to the similar period a year ago, owing to lower sales volumed in US market.
Sun Pharma’ consolidated revenues went down by 17.1 per cent to Rs 338.95 crore from Rs 408.64 crore last year even though the company’s consolidated net sales increased by 11.2 per cent during third quarter to Rs 1,020 crore from Rs 918.27 crore in the corresponding period of last year.
Sun’s earnings per share dipped to Rs 16.4 from Rs 19.7 period in the last period.
For the nine months period ended December 2009, Sun Pharma’s consolidated net profit declined sharply by 32.8 per cent to Rs 956.60 crore from Rs 1422.85 crore in the similar period of last year. Its EBDITA also moved down to Rs 1047 crore from Rs 1547 crore, a de-growth of 32.4 per cent. Its consolidated net sales declined by 4.6 per cent to Rs 2,994 crore from Rs 3,138 crore as its India branded generic sales remained flat at Rs 1,317 crore and Caraco’s sales declined by 38 per cent to US$ 178 million.
However, its APIs sales improved by 30 per cent during the period under review. Operating margin went down to 28 per cent from Rs 45 per cent Caraco achieved sales of US$ 178 million and net loss of US$ 6 million.
Sales of branded prescription formulations market in India wherein Sun Pharma holds 3.6 per cent market share, as per latest IMS ORG report, improved by 24 per cent to Rs 533 crore, contributing to over half of total sales.
Sun Pharma launched 17 key products, taking the total to 38 during this year.