Friday, 31 August 2007
Selected Joint Ventures, Partnerships, and Alliances with Big Pharma
GlaxoSmithKline and Roche – Xenical – In April 2005 GSK and Roche signed a promotion agreement for a weight-loss drug called Xenical (orlistat). Shortly after the entry into force of the agreement, GSK representatives began meeting with doctors to sell Xenical. According to a Roche press release, "Under the terms of the agreement GSK obtains the exclusive right to detail and promote Xenical Rx in the US. The terms of the agreement remain confidential. This agreement is only valid in the US and does not affect any other market. Roche will continue to manufacture and invoice Xenical." http://www.roche.com/med-cor-2005-04-12
In February 2007, GlaxoSmithKline acquired exclusive rights to over-the-counter orlistat for markets outside the US, excluding Japan. Reported in Medical News Today – http://www.medicalnewstoday.com/articles/63819.php accessed August 31, 2007.
GlaxoSmithKline and Millennium – Intergrilin™ – In June 2004, GSK and Millennium signed a marketing agreement whereby GSK will exclusively market a blood clot inhibitor called Intergrilin in Europe. According to a GSK press release, "Under the terms of the agreement, Millennium is entitled to license fees, milestone payments and royalties from GSK on INTEGRILIN sales in Europe upon the achievement of certain objectives." The specific terms of the deal were not released. http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=282
GlaxoSmithKline and Exelixis – In October 2002, these two companies entered into an alliance to produce and commercialize an unspecified number of Exelixis' compounds in the areas of vascular biology, inflammatory disease and oncology. Exelixis agreed to deliver a number of compounds in Phase II testing, from which GSK would select a subset for further development and sale. Under the terms of this agreement, "GSK will make an upfront payment of $30 million to Exelixis. GSK will also initially acquire two million newly issued shares of Exelixis common stock at $7 per share, which represents a premium of approximately 100% to the current stock price. Exelixis has the option to sell GSK additional shares at a specified time in the future." In addition, "Over the initial six years of the agreement, GSK will provide Exelixis with a minimum of $90 million in development funding. Exelixis will receive clinical and regulatory milestone payments based on the number and timing of compounds reaching specified points of progression. Based on the continued successful development of these compounds, these payments could range from $220 million to $350 million up to and including first commercialization. In addition, GSK will make available a loan facility to Exelixis of up to $85 million. Exelixis will also receive sales-based milestone payments and royalties on product sales." http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=350183&highlight=
The agreement was amended in 2005, under the terms of which "GSK may pay selection milestones up to approximately $275 million for three compounds, additional development-related milestones and substantial royalties on product sales. Exelixis has retained certain co-promotion rights for these compounds in North America. Under the amended agreement, GSK will also provide research funding of $47.5 million over the remaining term of the collaboration." http://www.exelixis.com/about_alliances.shtml
Selected Joint Ventures, Partnerships, and Alliances with Small Pharma
GlaxoSmithKline and Targacept – In July 2007, GSK and Targacept entered into a strategic alliance to discover, develop and market Targacept’s painkillers. According to Targacept, "In connection with the alliance, GlaxoSmithKline made an initial payment of $35.0 million to Targacept, which includes a non-refundable payment of $20.0 million and the purchase of 1,275,502 shares of Targacept’s common stock for an aggregate purchase price of $15.0 million." – http://www.targacept.com/wt/page/pr_1185489662
GlaxoSmithKline and Genmab – ofatumumab – GlaxoSmithKline and Genmab are engaged in a development alliance for a treatment for rheumatoid arthritis. According to Life Sciences World, the drug is showing positive Phase II results – June 2007. http://www.lifesciencesworld.com/news/view/36700
GlaxoSmithKline and Fabre-Kramer Pharmaceuticals – In February 2007, GSK and Fabre-Kramer entered into a development and commercialization agreement for a drug to treat major depressive disorder. According to the GSK press release, "Under the terms of the agreement, which are confidential between the companies, FKP will receive an upfront cash payment followed by additional milestone payments based on NDA approval and launch of the product. In addition, FKP will be entitled to receive commercial milestone payments and double-digit royalty payments on global sales of gepirone ER. In return, GSK will be granted an exclusive, worldwide license to develop, manufacture and commercialise gepirone ER and follow-on products." http://us.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=1016
GlaxoSmithKline and XenoPort – In February 2007, GSK and XenoPort entered into a development and commercialization alliance for a drug to treat Restless Leg Syndrome and neuropathic pain. According to GSK, "Under the terms of the agreement, XenoPort is entitled to receive an up-front cash payment of £40 million. XenoPort is also eligible to receive aggregate milestone payments of up to £34 million for development activities leading up to the NDA filing for RLS, up to £111million in other potential development and regulatory milestone payments and up to £153million in potential sales milestone payments based on successful commercialization of XP13512 for RLS and neuropathic pain." http://www.medicalnewstoday.com/articles/62806.php
GlaxoSmithKline and Sirna – in April 2006, the two companies "formed an exclusive multiyear strategic alliance for discovery, development, and commercialization of RNAi-based treatments for respiratory diseases. Sirna will receive $12M upfront (cash and equity) and milestone payments up to more than $700M. Sirna is also entitled to receive contract manufacturing revenues and royalties on worldwide product sales." source: Genetic Engineering and Biotechnology News. http://www.genengnews.com/articles/chitem.aspx?aid=1879&chid=0
GlaxoSmithKline and MedImmune are collaborating on research and development for drugs against human papillomavirus (“HPV”). According to MedImmune investor information on strategic alliances, "MedImmune conducted Phase 1 and Phase 2 clinical trials and manufactures clinical material for the studies. GSK is responsible for the final development of the product, as well as regulatory, manufacturing, and marketing activities. In exchange for exclusive worldwide rights to MedImmune’s HPV technology, GSK agreed to provide MedImmune with an up front payment, equity investment and research funding, as well as potential developmental and sales milestones and royalties on any product sales." In addition, "Under the amended agreement (2005), MedImmune may also receive certain milestone payments and royalties on future development and sales of an investigational HPV vaccine now in Phase 3 development by Merck & Co., Inc." http://www.medimmune.com/investors/alliances.asp
In addition, the collaborations page states that, "MedImmune has rights to a vaccine against certain subunits of Epstein-Barr virus (“EBV”), a herpes virus that is the leading cause of infectious mononucleosis. The vaccine is being developed by GSK under a worldwide collaborative agreement, excluding North Korea and South Korea. Under the agreement, MedImmune could receive future milestone payments, and royalties from GSK based on any net product sales." http://www.medimmune.com/investors/alliances.asp
GlaxoSmithKline and Vertex – In December 2005, these two companies entered into a development and marketing agreement for pain treatments. The Vertex collaborations website states that "Vertex received a $20 million up-front payment in 2005 and could receive up to an additional $385 million in development and sales threshold milestone payments based on the development of multiple compounds in major pharmaceutical markets across a range of indications. GSK will also pay Vertex royalties on annual net sales." http://www.vrtx.com/collaborations.html
According to Vertex's December 2005 8-K SEC filing, these two companies are also party to a development and commercialization collaboration for the HIV protease inhibitors Lexiva and brecanavir. http://www.secinfo.com/d11MXs.z1RSk.htm. The collaborations website states that, "Under the agreement, GlaxoSmithKline has paid Vertex $47 million in research, development and commercialization payments for Lexiva and Agenerase and now pays Vertex royalties for sales of both drugs. GlaxoSmithKline has exclusive rights to develop and commercialize Lexiva worldwide."
GlaxoSmithKline and EPIX entered into a worldwide research, development, and marketing agreement for the treatment of a variety of diseases, including for the treatment of Alzheimer's disease. The Wall Street Journal reports that, "As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock at a premium, and may be eligible to earn up to $1.2 billion in milestones across the four GPCR programs. Under the collaboration, EPIX is also entitled to receive tiered double-digit royalties of sales by GSK on all collaboration-developed product sales. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD)." http://online.wsj.com/public/article/PR-CO-20070814-901470-Na6rjQyqkBhhlG5Gwd_JOoLWP_g_20070814.html?mod=wsjcrmain
Alliances and Partnerships with Other Institutions
GlaxoSmithKline, Imperial College London, and the Medical Research Council in June 2007 opened the UK’s Clinical Imaging Centre (CIC). The venture represented a 50 million pound investment and, according to a GSK press release, "Backed by a 10 year commitment by GSK to invest an additional £11 million a year in this centre, the CIC will use and advance the latest technologies in magnetic resonance imaging (MRI) and positron emission tomography (PET). Its facilities include an advanced radiochemistry development facility, two MRI machines and two PET scanners which give the unit the capacity to conduct up to 2500 scans annually. Built over three floors it will be staffed by almost 80 clinical, scientific and support staff, plus an additional eight Research Fellows from Imperial College." The CIC will eventually employ 400 people. http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=1080
GlaxoSmithKline and Wellcome Trust in April 2007 entered into a partnership to target drug-resistant hospital infections, including those leading to pneumonia. According to the Wellcome Trust, "GSK has received a £4 million award from the Trust to accelerate development of compounds for the treatment of Gram-negative bacteria, which are becoming increasingly resistant to multiple antibacterials. GSK will make a matching contribution in staff, equipment and other programme costs. The Trust will receive a financial consideration on any commercial product resulting from the collaboration." http://www.wellcome.ac.uk/doc_WTX037132.html