Pharmaceutical Executive Europe - April 2008 - (Page 6)

6 News & Analysis April 2008 Pharmaceutical Executive Europe News & Analysis For more on these news stories and all the latest breaking pharma news, look at our website, which now features daily updates, interactive surveys and dedicated sections for your particular area of interest. NEWS Russia approves personalised cancer vaccine Russia became the first country in the world to approve a personalised therapeutic cancer vaccine, when regulatory authorities approved the marketing of Antigenics’ lead product Oncophage (vitespen) earlier this month. Vitespen is indicated for kidney cancer patients at medium risk of disease recurrence. The total patient population in Russia is estimated to be between 16000 and 17000, of whom 4000 to 5000 patients are eligible for treatment with this indication. A US small-cap biotechnology firm, Antigenics (NASDAQ:AGEN) filed with Russian authorities in August 2007, because of the potential of patients to receive state funding for treatment through the drug reimbursement programme (DLO), and a growing private payer community with the means to pay for premium-priced treatment costing tens of thousands of dollars per patient year. In addition, 28% of patients for Antigenic’s Phase III clinical trial were recruited from eight leading Russian centres. Speaking to Pharmaceutical Executive Europe, Dr Garo Armen, Antigenics’ CEO and chairman commented, “we had the most rapid enrolment in Russia and Poland, treatment compliance was best, and we had the fewest protocol exceptions.” In contrast to the EU or US regulatory authorities, the Russian regulatory process in notoriously opaque; however, Antigenics’ senior management found regulators fully engaged throughout the process. As recently as January this year, Dr Armen advised investors at the company’s quarterly earnings conference call that a regulatory decision by Russian authorities would be made in the middle of 2008. Received earlier than anticipated, this approval has been viewed propitiously by investors, sending the share price up 23% on the day of approval. For Antigenics, Oncophage launch preparation in Russia in 2008 is top of mind, but the company also has its sights on the wider European market, and is in discussions with EMEA. With Russian regulatory approval coming three months after Antigenics raised US$26 million in a private placement to fund further R&D and shape the market for launch, Dr Armen is justifiably bullish about the future: “We are at a transforming inflection point that will profoundly impact health care.” Gerhard Symons For more details about this story, visit Webcast to address the new pharma sales models sponsored by AZ and Ranbaxy settle over Nexium AstraZeneca (AZ) has settled its US patent dispute with India's Ranbaxy Laboratories over the blockbuster heartburn and ulcer pill, Nexium. Ranbaxy has conceded that all six patents asserted by AZ in the patent litigation are valid and enforceable, and also acknowledged that four of the patents would be breached by the unlicensed sale of Ranbaxy's proposed generic product. Ranbaxy had secured tentative approval from FDA in February 2008 to market a generic form of the drug. The two companies have agreed that Ranbaxy will be allowed to start selling a generic version of Nexium under licence from AZ from May 2014, when two of AZ's US patents for Nexium expire. AstraZeneca has other patents protecting Nexium that run through to 2019. Nexium had global sales of $5.2bn in 2007, making it the second most popularly prescribed medicine in the world. For more finance and M&A news, articles and comment, visit Regulatory can the sales model be evolved?’;and ‘What are the risks and critical success factors involved in change?’ In addition, two successful case studies will be presented. As places are limited CLICK HERE now to register for the webcast. Novartis and Alcon in $39 billion deal Novartis has entered into a twostep deal to acquire Nestlé's 77% stake in eye care company Alcon for up to $39 billion. Under the first step of the deal, Novartis will pay $143.18 per share to purchase a 25% stake of Alcon. This part of the transaction, which is valued at about $11 billion, is expected to close in the second half of this year. Under the second step of the agreement, Novartis has the option to acquire Nestlé's remaining 52% stake for $181 per share, or approximately $28 billion, between January 1, 2010 and July 31, 2011. “This acquisition furthers our strategy of accessing high-growth segments of the healthcare market while balancing inherent risks,” commented Novartis' CEO, Daniel Vasella. “We don't expect any anti-trust hurdles to the deal,” he added, “because the two businesses are very complementary.” Novartis currently markets wet, agerelated macular degeneration drug Lucentis in partnership with Genentech. For more finance and M&A news, articles and comment, visit Finance To share innovative approaches to evolving new pharma sales models, IMS is presenting an exclusive webcast on Thursday 24 April 10am GMT. The webcast will address critical issues around evolving sales models including ‘What defines and drives sales operating model thinking?’; ‘How

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - April 2008

Pharmaceutical Executive Europe - April 2008
From the Editor
News and Analysis
Brussels Report
Designing Tomorrow's Supply Chain
Look After Your eHealth
Why CIOs Need the X Factor
Doing It Right
Online and On-Message
Reward: Better Business
The Only True Advertising 'Reward'

Pharmaceutical Executive Europe - April 2008