Big Pharma made this a big year for Indian drugmakers. As multinational companies sought ways to cut costs and grow revenues, they ramped up their outsourcing programs and partnerships–and that has helped push sales growth past 20 percent for India’s leading drugmakers, such as Ranbaxy Laboratories, Cipla, Dr Reddy’s Laboratories, and Aurobindo Pharma, the Business Standard reports.

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That’s quite a leap; these big Indian pharmas been growing at an annual clip of about 12 percent over the past five years. And it’s quite a boost to particular companies’ ambitious goals.

Let’s take a look at the GlaxoSmithKline-Dr Reddy’s partnership. In June, the two companies announced a deal to develop and market certain products in emerging markets outside India. Dr Reddys is charged with manufacturing the products; GSK covers regulatory expenses, logistics, marketing and sales. A Nomura analyst told the Standard that this deal could help Dr Reddys deliver $1 billion in sales from emerging markets–one-third of the $3 billion in annual revenues that company is aiming for by 2013.

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The GSK-Reddys arrangement is just one of several Big Pharma forays into India of late, and more deals are coming down the pike–or so says the rumor mill, which has pegged Cipla as a potential long-term supplier for Pfizer. With pharma in need of emerging markets business and low-cost manufacturing, and Indian pharma looking for big growth, there’s sure to be plenty of action.

Source: FiercePharma

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Roche reported that Herceptin (trastuzumab) decreased the risk of death in patients with HER2-positive advanced stomach cancer by 26 percent, compared to chemotherapy alone, according to findings from a Phase III study. The additional details, presented at ASCO, follow the company’s announcement earlier this year that the trial had met its primary endpoint of improving overall survival. ASCO’s president, Richard Schilsky, remarked that the data will change medical practice and “will force us to test patients for HER2, treat patients who are HER2-positive, and conduct research on gastric cancer that is HER2-positive.”

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The randomised ToGA study enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer, who received first-line treatment with either Herceptin plus chemotherapy, or chemotherapy alone. Data showed that patients in the Herceptin arm had a median overall survival time of 13.8 months, compared to 11.1 months for those in the chemotherapy-only group. Furthermore, Roche stated that patients with tumours exhibiting high levels of HER2 lived 16 months on average when Herceptin was added to treatment with chemotherapy.

Principal investigator Eric Van Cutsem commented that “this is the first Phase III study to report improved overall survival with a personalised, targeted treatment for gastric cancer” and “the first time a biological [drug] has improved survival in gastrointestinal cancer.” He also noted that Herceptin reduced the size of tumours and increased survival significantly beyond the one-year mark that has been a hurdle for patients with advanced gastrointestinal tumours.

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Corinne Wolter remarked that the drugmaker will file Herceptin, which is currently approved for the treatment of breast cancer, for regulatory approval in the stomach cancer indication in countries outside the US. Spokesperson Kristina Becker of Genentech said a decision to file for expanded approval with the FDA is under review. Nomura analyst Amit Roy estimated that approval of Herceptin in patients with HER2-positive stomach cancer could add $450 million to the product’s annual worldwide sales, which exceeded $4.7 billion last year.

Source: FirstWord

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