Akzo Nobel Pharma preparing for the future

Arnhem, the Netherlands, March 27, 2006 — Akzo Nobel’s Pharma group is aiming to deliver at least one major filing per year from its pipeline as it positions itself for solid growth.

Speaking at today’s Akzo Nobel Pharma Analyst Meeting held in London, Toon Wilderbeek—the company’s Board of Management member responsible for Pharmaceuticals—updated analysts on the status of the early and late stage pipeline of its human healthcare business and also provided an overview of its animal health business. “The company has put considerable effort into successfully revitalizing its Pharma group to kickstart a return to solid growth,” said Wilderbeek, who is also President of Akzo Nobel’s human healthcare business, Organon. “With four products in our core therapeutic areas currently in phase III clinical trials, two files submitted and a further eight compounds in phase II, we are working towards at least one planned major filing per year to unlock the value in our strong and promising pipeline.” Wilderbeek added that as well as awaiting FDA approval in the United States for Implanon® (contraception) and Livial® (hormone therapy), targeted filing dates have been set for its four products currently in phase III, two of which—asenapine (mental health) and sugammadex (anesthesia)—are expected to be submitted next year. “Asenapine, a drug for the treatment of schizophrenia and acute mania in bipolar disorder which we are developing with Pfizer, is progressing according to plan,” he said. “The clinical program is due to be completed by the end of the year, while filing with the FDA in the United States is expected early in 2007. We also expect to submit the file for sugammadex—a reversal agent used during general anesthesia—during the first half of next year.” Herm Cukier, Organon’s Executive Vice President of Global Marketing, went on to inform analysts that the company’s new fertility product (Org 36286), is planned for submission in 2008, with a new contraceptive (NOMAC/E2) expected to be filed in 2009 and an insomnia treatment (Org 50081) expected to be submitted in 2010. Building on biotechnology and neuroscience Looking in more detail at human healthcare, analysts heard that the business will not only work to sustain leadership status in its traditional areas of gynecology (eg NuvaRing® and Livial®); fertility (Puregon Pen®/Follistim Pen®); and anesthesia (Esmeron®/Zemuron®); but will also focus on rebuilding its position in neuroscience. “Our core indication areas provide a solid base with selected opportunities for growth, while in the medium and long-term, neuroscience provides us with interesting growth opportunities,” explained Organon’s Executive Vice President of Research and Development, David Nicholson. “We are also building a biotechnology franchise as an additional long-term growth driver with a focus on immunology and oncology." He added that the company will work to build a biopharmaceutical pipeline by expanding research into new biological entities (NBEs), primarily at Organon’s U.S. Research Center in Cambridge, MA, both by seeking partnerships and through strategic acquisitions. Maintain and strengthen position as a world leader in animal health The status of Intervet’s pipeline was also highlighted, with General Manager Ruurd Stolp giving details about planned product introductions during the next few years, including new Cobactan® anti-infectives for cattle and horses and a new improved (live) horse vaccine for West Nile Disease. As one of the top three animal healthcare companies in the world and number one in Europe, Intervet will continue to pursue growth through innovative product development, as well as through bolt-on merger and acquisition activities and selective geographical expansion. Already the world leader in animal vaccine production and strong core molecules in various therapeutic areas, the company is working towards a stable flow of new product introductions for vaccines and pharmaceuticals to further strengthen its position as a world leader. Based on its strong IP portfolio, its state-of-the-art, in-house biotech expertise and its unique veterinary Drug Discovery program, Intervet can rely on a strong R&D pipeline. Highlights within the livestock sector include further additions to the successful Cobactan® range, based on a veterinary-specific anti-infective compound with a broad set of claims in a variety of species. In Companion Animal segments, the company will further expand its vaccine ranges with an extended duration-of-immunity claim, as well as with various pharmaceutical specialties to treat metabolic diseases. Nobilon: bridging expertise By bridging the fields of expertise at both animal and human healthcare, analysts heard that Nobilon will be able to effectively transfer Intervet’s vaccine technology and experience to human healthcare. The cost efficient production of vaccines through cell culture, plus the clinical and regulatory expertise of Organon, will give Nobilon a strong position in the areas of influenza and other respiratory vaccine development. After completing in vitro and toxicological testing, Nobilon is now preparing the next phase of development to determine the safety and efficacy of its first flu vaccine in humans. With regard to its capability to upscale production, Nobilon—which received European approval last year to manufacture both animal and human vaccines—recently produced 30 million poultry flu doses per 2,000 liter fermentor in one week using cell tissue growth technology, during a test on upscaling. Wilderbeek concluded: “After several years of reshaping the businesses of Akzo Nobel Pharma, we are standing on the threshold of an exciting new era and have a clear ambition to increase profitability and move forward through solid growth.” ---