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A conference call for analysts, press and investors hosted by President &CEO Andrew Kay will be held today at 10:00 CET - dial in details are givenbelow.
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Under the terms of the agreement, Algeta has an option for up to 50%co-promotion with Bayer in the United States under a profit-sharearrangement. Bayer will commercialize Alpharadin globally and pay tiereddouble-digit royalties on net sales in markets where there is no co-promotion.
The Alpharadin deal with Bayer totals up to $800 million (EUR560m) toAlgeta. This is made up of an upfront payment of $61 million (EUR42.5m) plusfurther cash payments based upon the achievement of certain development,production and commercialization milestones. Algeta will be responsible formanufacturing and supply of the commercial product.
Bayer will also contribute a substantial majority of the costs of futuredevelopment of Alpharadin as a treatment for bone metastases resulting fromHRPC and from other cancer indications, and will fully fund any additionallate-stage trials.
Alpharadin is Algeta's lead cancer therapeutic. It is the first in a newclass of alpha-emitting pharmaceuticals ( 'alpha-pharmaceutical') and isbased on radium-223. Alpharadin is in a global phase III clinical trial(ALSYMPCA) designed to confirm its efficacy and safety as a targetedtreatment for bone metastases in patients with HRPC. Alpharadin isadministered as a simple injection and has a unique mode of action whereby ittargets bone metastases specifically and exerts a highly localized effect ontumor cells while minimizing damage to normal surrounding tissues. In phaseII studies, Alpharadin demonstrated strong evidence that it can prolongpatient survival, improve quality of life and offer a benign safety profile.
Andrew Kay, CEO of Algeta, said, "This agreement is the culmination of anextensive process to establish and deliver the best possiblecommercialization strategy for Alpharadin. In Bayer we have selected aworld-class oncology company with a proven global track record of launchingmajor cancer products. We are very excited about working with the Bayer teamto deliver this novel and potentially first choice treatment for cancerpatients with bone metastases."
Kemal Malik, Head of Global Development and member of the BayerHealthCare Executive Committee said, "We recognize the tremendous potentialof Algeta's Alpharadin as a possible treatment for bone metastases in cancerpatients - a serious, life-threatening condition. The data we have seensuggest that Alpharadin represents a highly targeted treatment option withconvenient handling and manageable side effects. Bayer is committed to itsglobal oncology franchise and has made significant progress in building acomprehensive pipeline of promising compounds that may provide innovativetherapies to cancer patients in need of treatment."
Conference call details
A conference call for analysts, investors and press will take place todayat 10:00 CET.
To participate in the conference call, please dial the appropriate numberbelow:
800-80-119 (from Norway)
+47-23-00-04-00 (from abroad)
The presentation will be made available on http://www.algeta.com in theInvestors section from 09:00 CET.
To access the replay, please dial +47-67-89-40-91. Enter account no. 1428followed by #, then press 1, conference no. 428 followed by #. Press 1 toplay. A replay version of the conference call will also be available athttp://www.algeta.com
Upfronts, milestones and royalty payments according to the agreementbetween Bayer and Algeta will be in EUR. USD amounts provided in this releasehave been translated at 1 Euro: USD1.43
About Algeta
Algeta ASA is a cancer therapeutics company built on world-leading,proprietary technology. Algeta is developing a new generation of targetedcancer therapeutics (alpha-pharmaceuticals) that harness the uniquecharacteristics of alpha particle emitters and are potent, well-tolerated andconvenient to use.
Algeta's lead alpha-pharmaceutical candidate, Alpharadin (based onradium-223), has blockbuster potential for treating bone metastases arisingfrom multiple major cancer types, owing to its bone-targeting nature, potentefficacy (therapeutic and palliative) and benign, placebo-like safetyprofile. Development of Alpharadin is most advanced targeting bone metastasesresulting from hormone-refractory prostate cancer (HRPC), and it entered aninternational phase III clinical trial (ALSYMPCA) in mid-2008 based oncompelling clinical results from a comprehensive phase II program. This trialis currently open for recruitment.
In September 2009, Algeta entered into an global agreement with BayerHealthcare AG for the development and commercialization of Alpharadin. Aspart of the agreement, Algeta retains an option to co-promote Alpharadin inthe United States and to share profits from future sales.
Algeta is also developing other technologies for deliveringalpha-pharmaceuticals. These include methods to enhance the potency oftherapeutic antibodies and other tumor-targeting molecules by linking them tothe alpha particle emitter thorium-227. The Company is headquartered in Oslo,Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange inMarch 2007 (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in thefields of health care, nutrition and high-tech materials. Bayer HealthCare, asubsidiary of Bayer AG, is one of the world's leading, innovative companiesin the healthcare and medical products industry and is based in Leverkusen,Germany. The company combines the global activities of the Animal Health,Bayer Schering Pharma, Consumer Care and Medical Care divisions. BayerHealthCare's aim is to discover and manufacture products that will improvehuman and animal health worldwide. Find more information athttp://www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceuticalcompany. Its research and business activities are focused on the followingareas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women'sHealthcare. With innovative products, Bayer Schering Pharma aims for leadingpositions in specialized markets worldwide. Using new ideas, Bayer ScheringPharma aims to make a contribution to medical progress and strives to improvethe quality of life. Find more information athttp://www.bayerscheringpharma.de.
Forward-looking Statement
This news release contains forward-looking statements and forecasts basedon uncertainty, since they relate to events and depend on circumstances thatwill occur in the future and which, by their nature, will have an impact onresults of operations and the financial condition of Algeta. There are anumber of factors that could cause actual results and developments to differmaterially from those expressed or implied by these forward-lookingstatements. Theses factors include, among other things, risks associated withtechnological development, the risk that research & development will notyield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable business deals, therisk of non-approval of patents not yet granted and difficulties of obtainingrelevant governmental approvals for new products.OSLO, September 3 /PRNewswire-FirstCall/ -- - Algeta Retains Option for Co-promotion and Profit Sharing in USA - Potential deal value of $800 million (EUR560m*) plus tiered double digit royalties - Algeta to receive $61 million (EUR42.5m) cash upfront, followed by development and sales milestones - Algeta retains option for co-promotion and profit-sharing in USA - Algeta and Bayer will jointly develop Alpharadin, with Bayer contributing a substantial majority of the costs of future development
SOURCE Algeta
