- Lundbeck is granted commercial rights to several Cephalon products in Canada and/or Latin America
- Treanda® (bendamustine hydrochloride) for Injection, Nuvigil® (armodafinil) Tablets [C-IV] and Provigil® (modafinil) Tablets [C-IV] represent attractive product opportunities adding significant sales in Canada and Latin America, respectively, from 2012
- The products are well known and already launched in the US and/or Europe.
H. Lundbeck A/S (Lundbeck) today announced that Lundbeck has been granted commercial rights to several Cephalon products in Canada and Latin America. As part of the agreement, Lundbeck will register and commercialise several key products which are currently available in the US and/or Europe on behalf of Cephalon. Key products in the agreement include Fentora® (fentanyl buccal tablet) [C-II], Provigil®, Treanda®, Trisenox® (arsenic trioxide) injection, Myocet® (liposomal- doxorubicin) and Nuvigil®.
"The Cephalon brands will significantly strengthen our position in these markets while leveraging on existing sales and marketing capabilities adding significant sales in Canada and Latin America from 2012," says Ulf Wiinberg, President & Chief Executive Officer at Lundbeck. "It is our belief that the clinical and regulatory risk is minimal as these products are already approved in the US and some of the products also in Europe."
The Cephalon products for improving wakefulness, Provigil® and Nuvigil®, as well as the pain product, Fentora®, have a strong fit to Lundbeck's already strong CNS franchise and will contribute to the continued growth in both Canada and Latin America. Lundbeck is currently successfully promoting modafinil in Mexico. Provigil® and Nuvigil® address a market with a substantial under-diagnosed and under-treated patient group. Nuvigil® is expected to be approved in Canada and Latin America in the 2012-2014 time period. In 2009, Cephalon realised revenue of USD 73 million in the US on Nuvigil® and in the first nine months of 2010 revenues were USD 127 million. Lundbeck expects to promote these products with the existing sales and marketing organisation.
Also included in the deal is the leading Cephalon oncology product Treanda® which is to be commercialised by Lundbeck in Canada. Treanda® will add significantly to revenue and earnings in Lundbeck's Canadian business. The new oncology franchise in Canada will be complemented by Trisenox® and the pain product, Fentora®. Treanda® has proven clinical activity in the treatment of haematological malignancies, including those refractory to conventional anti-cancer agents. In 2008, the American Society of Clinical Oncology (ASCO) recognized Treanda® as one of the major advances in cancer treatment. In 2009, Cephalon realised total revenue of USD 222 million on the product and in the first nine months of 2010 revenue reached USD 285 million in the U.S. Treanda® is expected to be filed during 2011 in Canada and Lundbeck will establish a dedicated oncology sales organisation in Latin America and Canada in order to achieve the full potential of the oncology portfolio.
The financial terms of the agreement have not been disclosed, but Lundbeck is to pay double-digit royalties on sales which will be the main overall revenue stream for Cephalon from these products in these territories.
Product Indication Territory
Nuvigil® (armodafinil): Improve wakefulness in adults who experience excessive sleepiness (ES) due to treated obstructive sleep apnoea (OSA), shift work disorder (SWD), or narcolepsy Canada (Nuvigil® only) and Latin America
(bendamustine HCI): Treatment of indolent B-cell non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) Canada
(fentanyl buccal tablet): Compound for breakthrough pain in opioid tolerant patients with cancer Canada and
Trisenox® (arsenic trioxide): Cytotoxin for acute promyelocytic leukaemia (APL) Canada
Myocet® (liposomal- doxorubicin)1): Cytotoxin for metastatic breast cancer Latin America
1) Myocet® will be included in the agreement at a later stage
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2010 which was provided on 4 March 2010 in connection with the release of the financial results for 2009 and further specified with the release of the third quarter report on 3 November 2010.
In the US, Fentora® is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Full US prescribing information for Fentora® can be found at www.fentora.com.
Nuvigil® is the longer-lasting isomer of modafinil. In the US it is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnoea (OSA), shift work disorder (SWD), or narcolepsy. Full US prescribing information for Nuvigil® is available at www.nuvigil.com.
In the US, Provigil® is indicated to improve wakefulness in patients with excessive sleepiness associated with treated OSA, SWD or narcolepsy. Full US prescribing information for Provigil® can be found at www.provigil.com.
In the US, Treanda® is indicated for the treatment of patients with chronic lymphocytic leukaemia. Treanda® is also indicated in the US for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Cephalon holds exclusive rights to market and develop Treanda® in the US. Treanda® is licensed from Astellas Deutschland GmbH. Bendamustine HCl, the active ingredient in Treanda®, is marketed in Europe by Astellas' licensee, the Mundipharma Group of Independent Associated Companies. SymBio Pharmaceuticals Ltd. holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries. Full US prescribing information for Treanda® can be found at www.treanda.com.
In the US, Trisenox® is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Full US prescribing information for Trisenox® can be found at www.trisenox.com.
In Europe, Myocet®, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in women. Full prescribing information can be found on the European Medicines Agency website, www.ema.europa.eu.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, Huntington's, epilepsies, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.
About Cephalon, Inc.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at www.cephalon.com.