Press Releases

  • Nycomed is keeping the pace in third quarter 2010

    10.11.2010

    Nycomed’s strategy of focusing on emerging markets and specialty products is paying off. The third quarter results shows that the sales of Key Products and in emerging markets are continuing to help offset the impact from the loss of exclusivity of pantoprazole. Daxas® (roflumilast) has recently been launched in the first EU markets and further launches are underway over the coming months. To accelerate the expansion in China, one of the fastest growing pharma markets, Nycomed acquired the majority stake in Guangdong Techpool Bio-Pharma Co., Ltd.

  • Nycomed to acquire a majority stake in Guangdong Techpool Bio-Pharma

    01.11.2010

    Nycomed has acquired 51.34% of the shares of Guangdong Techpool Bio-Pharma Co., Ltd., a fast-growing Chinese pharmaceutical company based in Guangdong Acquisition demonstrates importance of China as a key part of Nycomed’s emerging markets strategy Nycomed gains access to a leading, high quality manufacturer of biologic and protein-based drugs with international potential Creates enhanced commercialization base for Nycomed products including Pantoloc®, Ebrantil® and Actovegin® in China Nycomed today announced that it is significantly expanding its presence in China through the acquisition of a majority stake in Guangdong Techpool Bio-Pharma Co., Ltd. (Techpool), a...
  • Zydus Nycomed commissions the newly expanded API manufactoring facility at Navi Mumbai

    29.09.2010

    Zydus Nycomed, the joint venture company of Zydus Cadila and Nycomed, has commissioned its newly expanded API manufacturing facility at Navi Mumbai. The company is expected to start commercial production of APIs by December 2010. To start with, the plant will be manufacturing Pantoprazole, Urapidil and Lornoxicam. By 2011, the company will produce eight additional APIs.

  • First European Filing for Marketing Approval of Osteoporosis Drug

    21.09.2010

    The Lausanne, Switzerland, based drug delivery company EffRx Pharmaceuticals SA (“EffRx”) and its partner, the global pharmaceutical company Nycomed, headquartered in Zurich, Switzerland, today announced that the first European filing for marketing approval of EX101, a once-a-week 70mg buffered effervescent alendronate, for the treatment of osteoporosis, has been submitted. The filing triggers a milestone payment to EffRx.

  • Daxas® (roflumilast) data analysis shows reduction in harmful lung attacks

    19.09.2010

    A global survey of clinicians and COPD patients released today shows that the long-term (12-month) impact of exacerbations (also known as lung attacks) is underestimated. This is despite evidence that the death rate one year after admission to hospital for a COPD exacerbation is worse than that for heart attacks.   The survey, ‘Hidden Depths of COPD’, also showed that exacerbations are a major issue for most COPD patients, with nearly 70% of respondents saying they had experienced an exacerbation in the previous 12 months.

  • Nycomed’s US partner Forest Laboratories responds to FDA complete response letter for Roflumilast (Daxas®)

    13.09.2010

    Nycomed today announced that its US partner Forest Laboratories, Inc. (NYSE: FRX) has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast (Daxas®). The FDA has acknowledged receipt of the resubmission and considers it a complete, class 2 response to their May 17, 2010 complete response letter, which requested certain additional information and analyses of existing data. No additional patient trials were requested.
     

  • From Oranienburg to the rest of the world: global market launch of Daxas® (Roflumilast) kicks off in Germany

    01.09.2010

    Stefan Brinkmann, Managing Director of Nycomed GmbH, kicked off the German market launch of Daxas® (Roflumilast) in Oranienburg today, making Germany the first country to market the medicine. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that was developed by Nycomed to treat the progressive, life-threatening lung disease COPD.

  • Nycomed achieved significant milestones in second quarter 2010

    17.08.2010

    Nycomed’s performance in the second quarter was satisfactory, with sales of Key Products and in emerging markets, especially Russia/CIS and Brazil, continuing to help offset the revenue impact from the loss of exclusivity of pantoprazole. Turnover for the rest of the portfolio increased at double-digit rates. These results support Nycomed’s strategy of focusing on emerging markets and specialty products. In early July, Daxas® (roflumilast) received marketing authorisation in the EU. Product launches in the first EU markets, starting with Germany and the UK, are underway.

  • Nycomed’s U.S. patent for Protonix® (pantoprazole) valid

    19.07.2010

    Nycomed announced today that Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc. The decision upholds the jury verdict issued on April°23, 2010, confirming that the patent is valid and rejecting allegations by the defendants that the patent was invalid as obvious and invalid for double patenting. Against KUDCo, the US generic drug business of the Schwarz Pharma Group, which did not at-risk launch, final Judgment was entered as a result of Judge Jose L. Linares' rulings.

  • Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) receives marketing authorisation in the European Union for patients with COPD

    06.07.2010

    Nycomed today announced that the European Commission has granted marketing authorisation for Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD, a progressive, life-threatening lung disease.

  • Nycomed and Forest Laboratories receive complete FDA response letter for Roflumilast – no additional patient trials were requested

    17.05.2010

    Nycomed and Forest Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast (Daxas®). Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

  • Nycomed’s first quarter 2010 results confirm the direction

    11.05.2010

    Nycomed’s performance was driven by strong growth of Key Products and in most emerging markets. This overall positive performance could not fully offset the expected negative impact of pantoprazole’s patent expiry in Europe. Daxas® (roflumilast) is advancing well: Nycomed received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas® in the European Union. With Merck & Co., Inc. (MSD) a co-promotion agreement for five European countries and Canada has been signed.

  • GE Healthcare and Nycomed to form joint venture to sell, market and distribute medical diagnostic contrast agents in Russia and CIS

    27.04.2010

    GE Healthcare, a unit of General Electric Company (NYSE: GE), and Nycomed today announced the signing of an agreement to form a joint venture for the local sales, marketing and distribution of GE Healthcare’s medical diagnostic contrast agents in Russia and the Commonwealth of Independent States (CIS). The joint venture is expected to become operational during the second half of 2010, following the satisfaction of customary conditions.

  • Nycomed and Merck & Co., Inc., announce commercialization agreements for Daxas® in Europe and Canada

    26.04.2010

    Nycomed and Merck & Co., Inc. (based in Whitehouse Station, New Jersey and known as MSD outside the USA and Canada) today announced that they have entered into a co-promotion agreement for Canada and certain European countries for the commercialization of Daxas® (roflumilast), an investigational once-daily tablet for patients with chronic obstructive pulmonary disease (COPD).  In addition, the two companies have signed an exclusive distribution agreement for the commercialization of Daxas® in the United Kingdom.

  • Jury renders positive findings on US pantoprazole (Protonix®) patent

    23.04.2010

    Nycomed and Pfizer Inc. confirmed today that a jury in the U.S. District Court for the District of New Jersey has rendered positive findings in a trial involving the main U.S. patent covering pantoprazole (Protonix®).

  • Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) recommended for approval in the European Union for patients with COPD

    23.04.2010

    Nycomed today announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD.

  • Nycomed and Baxter receive FDA approval for TachoSil®, an adjunct to haemostasis in cardiovascular surgery

    06.04.2010

    Today Nycomed and its partner Baxter International Inc. (NYSE: BAX) received the approval for TachoSil®, a surgical patch, from the US Food and Drug Administration (FDA). TachoSil has been approved as an adjunct to haemostasis (control of bleeding) in cardiovascular surgery.

  • Nycomed on track in 2009

    01.03.2010

    Nycomed was on track in 2009, with strong growth in Key Products and most emerging markets. Pantoprazole sales were resilient after the loss of exclusivity in May in 12 European countries, as a result of a tailored approach to each region. The pipeline portfolio progressed strongly. Daxas® was submitted to EMEA and the FDA for approval, and positive Phase III trial data were presented in September and published in the medical journal The Lancet. Nycomed is working closely with Forest Laboratories on the US commercialisation of this key product. The launch of Instanyl® in Europe for the treatment of breakthrough pain in cancer patients is progressing well.

 

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