Press Releases

  • Nycomed reports continued satisfactory performance

    12.11.2009

    Total net turnover increased 0.9% (3.2% in local currencies) to €820.0°million (Q3/08: €812.4°million)(1) Adjusted EBITDA decreased 3.1% (1.5% in local currencies) to €285.3°million (Q3/08: €294.4°million)(1) Pantoprazole sales resilient after loss of exclusivity. Newly-launched OTC variant performing strongly in Europe Roflumilast (Daxas®) submitted to FDA and agreement with Forest Laboratories on US commercialisation signed. Positive phase III trial results published in The Lancet Instanyl® approved in EU for breakthrough cancer pain with first launches in Denmark and Germany in September (1) Including one-time payments for US rights to roflumilast (Forest Laboratories,...
  • Nycomed sustains commitment to Russia-CIS and invests in new pharmaceutical production plant

    22.09.2009

    Modern, state-of-the-art production plant to be built in Yaroslavl region Investment up to €75 million Construction starts in 2010, plant opening in 2014 Nycomed today announced its decision to invest in a state-of-the-art pharmaceutical production plant near the city of Yaroslavl in Russia. The company plans to invest between €65 million to €75 million. The new facility will produce medicines for the local Russia-CIS market, which contributes 10% to Nycomed's turnover and plays an important role in the company's growth strategy. The plant, located in the Yaroslavl region, approximately 280 kilometres from Moscow, meets both the local and current Good Manufacturing Practice...
  • Largest asthma survey shows disease is not controlled in majority of children

    14.09.2009

    Asthma is not controlled in almost two thirds of affected children according to the largest ever international survey undertaken in paediatric asthma(1). This poor result is despite apparently straightforward clinical guidelines and widely available preventative treatments for children with asthma. The survey, “Room To Breathe”1 conducted by ICM Research, found that although only six per cent of parents had rated their child’s asthma as severe, nearly a quarter of their children (23 per cent) had been taken to an emergency department in the previous 12 months. In addition, the survey results highlighted some significant gaps between how physicians agree they should be treating children...
  • Roflumilast, a novel once-a-day tablet for COPD, reduces exacerbations and improves lung function

    13.09.2009

    Roflumilast an investigational drug Offers a new treatment principle that addresses the underlying inflammation of chronic obstructive pulmonary disease (COPD) Clinically meaningful benefit, also when given in addition to established bronchodilator therapy. Results of four placebo controlled phase III trials, presented today in Vienna at the European Respiratory Society Congress 2009, show that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, produces a statistically significant and clinically relevant reduction in exacerbations in patients with moderate to severe COPD. The studies also demonstrated that roflumilast works independently of current COPD treatments and provides...
  • Four studies published in The Lancet show roflumilast (Daxas®), a new oral approach to COPD, improves lung function and reduces exacerbations

    28.08.2009

    Once-a-day tablet Daxas® (roflumilast) is a first-in-class treatment under development targeting inflammation, the underlying cause of chronic obstructive pulmonary disease (COPD) Nycomed and Forest Laboratories today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD. COPD is an under-diagnosed progressive lung disease that may lead to death. Worldwide, COPD kills four people every minute and the World Health Organization (WHO) predicts that it will be...
  • Nycomed reports sustained momentum in second quarter 2009

    19.08.2009

    Total net turnover increased 0.5% to €786.9m (Q2/08: €783.3m)(1) Adjusted EBITDA increased 2.5% to €254.8m (Q2/08: €248.7m)(1) Turnover of Key Products excluding Pantoprazole grew by 6.9%(1) Pantoprazole OTC received marketing authorisation. Daxas® marketing authorisation applications filed in May for Europe and in July for the US. Forest Laboratories will commercialise Daxas® in the United States. Instanyl® approved in EU in July for breakthrough cancer pain. (1) Excluding a one-time execution payment of €100.9 million from Sepracor in H1 2008. The financial results reported in this press release are related to Nycomed S.C.A. SICAR and comprise all of the Nycomed...
  • Nycomed and Forest Laboratories to collaborate on US commercialisation of Daxas® in COPD

    10.08.2009

    Forest Laboratories acquires exclusive commercialisation rights to Daxas® in the United States in treatment of symptomatic COPD Nycomed to receive US$100 million upfront payment plus significant milestones and royalties Daxas filed for approval in US and Europe following encouraging results from four Phase III studies Access to Forest Laboratories' 2,700-strong US sales force completes global marketing strategy for Daxas Nycomed and Forest Laboratories, Inc. (NYSE: FRX) today announced that they have entered into an exclusive development, manufacturing and commercialisation agreement in the United States for Daxas® (roflumilast), a once-daily oral treatment for...
  • Nycomed to acquire local portfolio from Sanofi-Aventis and Zentiva

    03.08.2009

    Nycomed agreed with Sanofi-Aventis and Zentiva to purchase 20 branded generic products in several Central and Eastern European countries. The agreement will notably strengthen Nycomed's market position in particular in the Czech Republic and Slovakia. The transaction received approvals from the European Commission and the Czech Antimonopoly Office, and it is expected to be closed in September 2009. In an asset transfer transaction, Nycomed will purchase a portfolio of branded generic products in the Czech Republic, Slovakia, Romania, Hungary, Estonia, and Bulgaria, with a total annual turnover of approximately € 17 million. Nycomed will also assume production in the coming...
  • Nycomed’s Instanyl® is first intranasal fentanyl approved in Europe for managing breakthrough pain in cancer

    24.07.2009

    Nycomed today announced that the European Commission has granted marketing authorisation for Instanyl®, its first-in-class intranasal fentanyl spray. Instanyl is aimed at managing breakthrough pain in adult cancer patients already receiving maintenance opioid therapy for chronic pain. It is designed to closely match the typical episodes of breakthrough cancer pain. Nycomed plans to launch the product in 2009. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Up to 95% of patients with cancer pain experience breakthrough pain of which two-thirds experience inadequate pain control. Untreated breakthrough...
  • Nycomed announces FDA filing for Daxas® in COPD

    20.07.2009

    New drug application filed for United States Treatment aimed at patients with symptomatic Chronic Obstructive Pulmonary Disease (COPD) Data show reductions in moderate and severe exacerbations requiring medical intervention Partnering process underway for US commercialisation Nycomed today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas® as a once-daily oral treatment for patients with symptomatic COPD. The NDA submission is based on encouraging results from four Phase III trials of Daxas® (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation...
  • Nycomed receives Marketing Authorization for Pantoprazole 20mg OTC from European Commission following unanimous vote of 27 EU member states

    17.06.2009

    Nycomed received marketing authorisation from the European Commission for five applications: PANTOZOL Control®, PANTOLOC Control®, PANTECTA Control®, SOMAC Control® and CONTROLOC Control®.This new OTC medication is intended for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults as a medicinal product not subject to medical prescription. Pantoprazole, the active ingredient of PANTOZOL Control®, is a well-established therapy for acid-related gastrointestinal diseases that has been used by over 750 million patients. Pantoprazole belongs to the class of proton-pump-inhibitors (PPI), which are considered today as first line treatment for repeated...
  • Nycomed Reports a Solid Start to 2009

    27.05.2009

    Adjusted EBITDA increased 1.0% to €307.0m (Q1/08: €304.0m) Total net turnover increased 1.2% to €839.9m (Q1/08: €830.2m) Key products grew by 2.0% to €510.7m worldwide Daxas® filed for approval in Europe; outlicensing discussions in the US progressing well Positive CHMP opinion received for Pantoprazole OTC Positive CHMP opinion received for Instanyl®The financial results reported in this press release are related to Nycomed S.C.A. SICAR and comprise all of the Nycomed Group's operations. The full interim report is available at http://www.nycomed.com/en/Menu/Investors/Financials/ Nycomed reports a solid start to 2009, with total net turnover increasing by 1.2% to €839.9...
  • Nycomed files European marketing authorisation application for Daxas® in COPD

    08.05.2009

    Marketing authorisation application filed for EU Treatment aimed at patients with Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis Data show reductions in moderate and severe exacerbations requiring medical intervention Partnering process underway for commercialisation in the US Nycomed has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas® as a once-daily oral treatment for patients with COPD associated with chronic bronchitis. The MAA submission is based on encouraging results from four Phase III trials of Daxas (roflumilast) in the treatment of symptomatic COPD. Two pivotal...
  • Nycomed's Instanyl® receives positive CHMP opinion, bringing forward a new treatment for breakthrough cancer pain

    24.04.2009

    Nycomed's Instanyl (intranasal fentanyl spray) received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), recommending the granting of a marketing authorisation. Instanyl is aimed at managing breakthrough pain in adult cancer patients already receiving maintenance opioid therapy for chronic pain. If approved, Nycomed intends to launch the product in 2009. Nearly half of all early-stage cancer patients with chronic pain and up to 90 percent in later stages suffer the sudden onset of brief but acute 'breakthrough' pain. This refers to intermittent flare-ups that overcome the patient's regular pain medication. The...
  • A satisfactory 2008 for Nycomed

    24.02.2009

    Daxas® preparation for regulatory filing moving ahead Core products with continuous above-average growth Strong sales in most home markets Nycomed is well positioned for 2009 The financial results reported in this press release are related to Nycomed S.C.A. SICAR and comprise all of the Nycomed Group's operations. A full interim report is available at www.nycomed.com/en/menu/investors/financials. For Nycomed the twelve months of 2008 have been satisfactory and most of the markets performed well and met expectations. Key products developed strongly, with the exception of Pantoprazole sales in the United States and Canada, which is due to "at-risk" launch and generic competition,...
  • Positive CHMP opinion for Pantoprazole 20mg OTC will give pharmacists first line treatment for heartburn symptoms

    19.02.2009

    Nycomed's PANTOZOL Control® (Pantoprazole 20mg) received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), recommending the granting of a marketing authorisation for PANTOZOL Control®. PANTOZOL Control® is intended for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults as a medicinal product not subject to medical prescription. Pantoprazole, the active ingredient of PANTOZOL Control®, is a well-established therapy for acid-related gastrointestinal diseases that has been used by over 750 million patients. Pantoprazole belongs to the class of proton-pump-inhibitors (PPI), which are...
  • Expanded indication for Nycomed's TachoSil®

    17.02.2009

    European Medicines Agency (EMEA) has granted expanded indication Surgical patch TachoSil® - first and only dual action patch for general tissue sealing Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery. TachoSil is the key product in Nycomed's tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch,...
  • Nycomed strengthens its osteoporosis portfolio

    14.01.2009

    Licensing agreement for EX101 (effervescent alendronate) with EffRx,Inc. First effervescent formulation of alendronate - easy to administer Significant enhancement to Nycomed's osteoporosis portfolio Nycomed and EffRx today announced a licensing agreement on EffRx' drug EX101 (effervescent alendronate) for the treatment of osteoporosis. Under the agreement, Nycomed will receive the exclusive rights to develop, manufacture and commercialise the effervescent formulation of alendronate for the treatment of osteoporosis in a large number of countries worldwide. EX101 presents a significant enhancement to Nycomed's osteoporosis portfolio. EX101 is a once weekly administration of an...
 

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