How many partners does GSK have?
Like many other pharmaceutical companies GSK does not reveal its exact number of partners. The company’s website, however, indicates GSK has hundreds of collaborations with others in industry, government, academia, and non-profit organisations worldwide. According to the company’s Annual Report for 2008 GSK entered into or expanded 21 new drug discovery alliances in 2007. Overall forty per cent of GSK’s pipeline is derived from licensing, acquisition, or other types of partnering. GSK’s product pipeline for 2008 shows that the largest number of licenses and alliance agreements is in the biopharmaceutical sector and the largest proportion (n=11) for all categories are currently in phase II of development.
Percentage of products in pipeline coming from licensing or alliance agreements 2008
|Total products||In-licensed or alliance||% in-licensed or alliance|
|Cardiovascular and metabolic||21||6||29%|
|Respiratory and inflammatory diseases||22||6||27%|
Income GSK generates from associates and joint ventures ($ million)
|Share of tax profits of Quest Diagnostics*||47||48||59||52||59|
|Share of losses of other associates||(3)||(3)||(2)||(1)||(1)|
|Share of after tax profits/(losses) of joint ventures||44||45||57||51||58|
|Share of turnover of joint ventures||13||13||21||32||31|
|Sales to joint ventures and associates||9||9||18||48||50|
Note the losses and profits are after tax.
*In 2008 GSK held an 18.7% interest in Quest Diagnostics Inc. Quest Diagnostics is the primary provider of clinical laboratory testing to GSK’s clinical trials testing requirements worldwide. During 2008 Quest Diagnostics provided services of £42 million to GSK.
GSK’s associates’ income ($ million). Losses indicated in brackets
In 2008 GSK’s investments in joint ventures comprised £36 million share of gross assets (2007 – £21 million) and £8 million share of gross liabilities (2007 – £6 million). These principally arose from 50% interests in two joint ventures, Shionogi-GlaxoSmithKline Holdings, L.P., which is developing specified chemical compounds, and GlaxoSmithKline Shire Canada, which primarily co-markets Combivir, Trizivir and Epivir in certain territories, together with a 29% interest in another joint venture, Pharmaceutical Insurance Limited, which is a mutual insurance company covering pharmaceutical property risk.
How does GSK source its partners?
GSK has a special unit called the Center for Excellence for External Drug Discovery (CEEDD) which is dedicated to building alliances for GSK. The goal is to bring the best science into the company from anywhere. The team at CEEDD is small comprising 19 experts, and its role is to source alliances. The CEEDD invites iotechnology companies to present their company and science to its leadership team. If successful the team then starts business negotiations for forming an alliance and the due diligence process. The CEEDD sponsors collaboration proposals through various committees within GSK.
GSK also has an Academic Discovery Performance Unit which acts as a specialist team to work specifically with academics on a portfolio of novel targets.
Another important source for alliances within GSK comes from GSK’s venture capital healthcare fund called SR One. The fund invests globally in emerging biotech companies focused on drug discovery, development or delivery. Since its founding in 1985 SR One has invested over $560 million in biotechnology. SR One teams are located in the US and Europe. SR One currently has a portfolio of approximately 25 private and public companies. Its current portfolio includes: Aileron Therapeutics, Alios BioPharma, Anaphore, CalciMedica, Concert Pharmaceuticals, CyDex, Genocea Biosciences, Locus Pharmaceuticals Inc, Novalar Pharmaceuticals Inc, Nupathe, Rib-X Pharmaceuticals, Scynexis Inc, Synovex, Trinity Biosystems, Zelos Therapeutics.
Since its inception SR One has invested in at least 99 companies including the following: Abiotic Pharmaceuticals*, Abiotic Systems*, Actimed Laboratories Inc, Adolor Corporation, Affinity Biotech Inc, Alatech Associates, Alere Medical, Algeta ASA, AlgoRx Pharmaceuticals Inc*, Amgen, AntiOx/Therox, Applied bio-Technology*, Applied Genetics Inc, Bactex Inc*, British Bio-technology Ltd*, Cabrellis Pharmaceuticals*, Cambridge Antibody Technology*, Cambridge Biotech Corporation*, Careside Inc, Caresoft Inc, Cephalon, ChekTec Inc, Cogent Neuroscience Inc, CombiChem Inc*, Conforma Therapeutics Corporation*, Corixa Corporation*, CPBD Inc*, Cruachem Holdings Ltd, CytoTech Inc, Descartes Therapeutics Inc*, Diagnostics Ultra Corporation, Electrosols Limited*, Embryogen Corporation*, Empirial Media Corporation*, Epitope Inc, Framingham Genomic Medicine*, Genset*, Gliatech Inc*, Global Thermionics Inc*, GMIS, IBAH Inc, IDEC Pharmaceuticals Corporation (now BiogenIdec), Improbio, Inhale (now Nektar Therapeutics), Institute for Clinical Applications Inc, International Canine Genetics Inc*, International Diagnostics Systems Corporation*, Kosan Biosciences Inc, KVM Biotechnologies Inc*, LaJolla Pharmaceuticals, LeukoSite Inc*, Lexicon Genetics Inc, Ligand Pharmaceuticals, MacroNex Inc*, Medi-Ject Corporation, Medical Foods Inc, Memory Pharmaceutical Corporation*, Message Pharmaceuticals Corporation*, Metastatix, Molecular Mining Corporation, Neurogenetics (now Torreypines Therapeutics Inc), Nihon Tectron*, NPS Pharmaceuticals Inc, Obtek Inc*, Ocean Genetics*, Oncogene Science Inc*, Oxford GlycoSystems*, Physician Service Verification*, PhysicianDispensing Systems, Physiome Science*, PKH Laboratories, Predix Pharmaceuticals Inc, Progenitor, Protein Forest Inc, Protez Pharmaceuticals, qmed Inc, Quidel Corporation, RedPoint Bio, Ribi ImmunoChem Research Inc*, Santarus Inc, Scion Pharmaceuticals*, Sepracor Inc, Sequenom Inc, Solution, Sosei R&D Forum, Sphinx Pharmaceuticals Corporation*, Strato Medical Corporation*, Symphony Pharmaceuticals*, Synaptic Pharmaceutical Corporation*, Synbiotics Corporation, Terragen*, Terrapin, Theratech, Third Wave Technologies Inc, Trigen, Triplex, Versicor*, Xenogen, Corporation, Xenova Ltd*.
* Company no longer exists.
GSK’s partners include the following: Amgen, Anacor, Archemix Corporation, Cellzome, ChemoCentryx, Chroma Therapeutics. Concert Pharmaceuticals, Cytokinetics Inc, Dynavax Technologies Corporation, Exelixis Inc, EPIX Pharmaceuticals, Galapagos, Harvard Stem Cell Institute, Ligand Pharmaceuticals, NeuroSearch, Oxford BioTherapeutics, OncoMed Pharmaceuticals, Pentraxin, Pharmacopeia, Ranbaxy Laboratories, Regulus Therapeutics Inc, Roche, Santaris Pharma, Sepraco Incr, Sirna Therapeutics Inc, Targacept Inc, Theravance.
What collaborations has GSK entered into over the past few years?
The following list indicates some of the alliances GSK has signed over the past few years:
- In October 2009 GSK and Jiangsu Walvax Biotech Company began a collaboration to to develop and manufacture paediatric vaccines for use in China. Together the companies will produce vaccines for measles, mumps, and rubella (MMR) (Priorix™) and potentially other paediatric vaccines. GSK is to transfer the technology to enable vaccine manufacture vacccines locally over time and a new manufacturing facility will be built for GSK’s paediatric vaccine Priorix to supply the vaccines to China’s public vaccine market. Overall a total of £41.2 million will be invested in the jkoint venture, with GSK initially investing £20.1m at incorporation and an additional £7.3 million in 2015. Walvax will invest a total of £13.8 million. Equity interest will be divided 65% and 35% between GSK and Walvax respectively with provisions enabling both parties to revise their equity share in the future.
- In July 2009 GSK and Amgen announced a commercialisation collaboration for Amgen’s monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen is to commercialise the drug for PMO and oncology in the United States and Canada and for all oncology indications in Europe and specified markets. GSK is to register and commercialise denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea. The structure of the collaboration allows Amgen the option of an expanded role in commercialisation in both Europe and certain emerging markets in the future. Financial terms of the partnership include an initial payment and near-term commercial milestones to Amgen totaling $120 million, and ongoing royalties. In Europe, Amgen and GSK will share profits after accounting for expenses associated with the partnership. In emerging markets, GlaxoSmithKline will be responsible for all commercialisation expenses and purchase denosumab from Amgen to meet demand. The companies’ combined commercialisation activities will expand access to denosumab, once approved, to patients worldwide who are afflicted by osteoporosis and other bone loss conditions.
- In June 2009 GSK and Chroma Therapeutics started a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process. Chroma will undertake four discovery and development programmes with GSK’s CEEDD to identify small molecule therapeutics, including Chroma’s macrophage-targeted HDAC inhibitor programme for inflammatory disorders such as rheumatoid arthritis. Under the agreement Chroma received a significant up-front cash payment and an investment from GSK invest its Chroma’s Series D equity financing. Chroma is also eligible to receive milestones, option fees and tiered royalties based on compounds arising from the collaboration. Overall, Chroma has the potential to receive in excess of $1 billion in total milestone and option payments in the event that all four programmes are successful. Chroma has responsibility for research and development activities through completion of clinical proof of concept studies for all the programmes. After the completion of such studies for each programme, or earlier if it so chooses, GSK may elect to obtain an exclusive, worldwide license to product candidates within the programme. At such time GSK will assume full responsibility for development and commercialisation. Chroma will retain full rights to further develop and commercialise its product candidates in any programme GSK chooses not to license.
- In June 2009 GSK began an alliance with Concert Pharmaceuticals to develop and commercialise deuterium-containing medicines. The deal includes three of Concert’s research and development programmes: 1) CTP-518, a protease inhibitor for the treatment of HIV expected to enter Phase I clinical trials in the second half of 2009; 2) a preclinical compound for chronic renal disease; and 3) a third research product in Concert’s pipeline. Concert is to also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop. Under the terms of the agreement, Concert received $35 million in upfront payments, including a $16.7 million equity investment by GSK. Concert is eligible to receive milestones and tiered, double-digit royalties based on deuterium-containing products arising from the Concert pipeline programmes. In addition, Concert is eligible to receive milestones as well as royalties on the sales of deuterium-containing products arising from the GSK pipeline compounds. Overall, Concert has the potential to receive in excess of $1 billion in total milestone and upfront payments from GSK spread across all programmes. For each Concert pipeline programme, Concert has responsibility for research and development activities through completion of pre-agreed clinical trials. After the completion of such clinical trials for each programme, or earlier if it chooses, GSK can elect to obtain an exclusive, worldwide license to product candidates within the programme. At such time, GSK will assume responsibility for development and commercialisation. Concert will retain full rights to further develop and commercialise its product candidates in any programme GSK chooses not to license.
- In May 2009 Oxford BioTherapeutics began a strategic alliance with GSK to discover, develop and commercialise novel, therapeutic antibodies for the treatment of primary, metastatic and recurring forms of cancer. Under the alliance, GSK will develop novel antibody therapies against selected OBT targets. In parallel OBT will develop one of its own monoclonal antibodies through to clinical proof of concept, at which point GSK will have an exclusive option to in-license this monoclonal antibody and will thereafter assume responsibility for further clinical development and commercialisation on a worldwide basis. OBT received an undisclosed upfront payment and is eligible for up to a total of $370 million (GB £244 million) upon the achievement of specified discovery, development, regulatory and commercialisation milestones. In addition to the upfront and milestone payments, OBT will receive double-digit royalties on sales of any product that it develops to clinical proof of concept and single-digit royalties on worldwide sales of marketed GSK antibody products aimed at OBT targets. Furthermore, OBT may opt to carry forward the OBT or GSK collaboration programmes that GSK chooses not to develop further.
- In September 2008 GSK and Cellzome Inc signed a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases. The alliance gives GSK access to Cellzome’s expertise in identifying and developing selective kinase inhibitors and its proprietary Kinobeads™ technology which, by screening compounds in a physiological setting, is designed to improve the predictability of these drug candidates’ performance in clinical testing. Under the agreement GSK has exclusive options to license drug candidates from Cellzome’s kinase programmes directed against four identified targets, and three additional targets to be jointly identified by both parties. In the alliance, Cellzome is to utilise its technology to discover novel small molecule inhibitors of these targets, and develop the most promising product candidates through to completion of a clinical proof of concept trial, unless GSK elects to exercise its option earlier. Cellzome is eligible to receive success-based milestones from GSK as product candidates are advanced. Upon Cellzome’s achievement of clinical proof of concept for a product candidate for a particular kinase target, GSK would have an exclusive option to license all product candidates from that programme. GSK would then assume full responsibility for further clinical development and commercialisation on a worldwide basis. Cellzome retains the right to continue the development and commercialisation of drug candidates if GSK chooses not to exercise its option to that programme. Under the terms of the agreement, Cellzome will receive upfront payments of £14.4 million comprised of both cash and equity. Cellzome is eligible for up to £118 million per programme in potential development, regulatory and commercial milestones and up to double digit royalties on net sales of products resulting from the programme.
- In July 2008 GSK and the Harvard Stem Cell Institute (HSCI) entered into a five-year, $25 million-plus collaborative agreement to build a unique alliance in stem cell science to hasten the development of treatments and cures for a range of diseases. GSK’s investment will support innovative research at Harvard and in at least four Harvard-affiliated hospitals in six disease areas – neurological, cardiac, cancer, diabetes, musculoskeletal, and obesity. In addition, GSK is providing an annual grant to HSCI’s “seed grant” programme, which supports early stage innovative research. The alliance set up an exchange programme whereby HSCI and GSK researchers spend up to several months in each other’s laboratories. The collaboration is overseen by a joint steering committee made up of HSCI and GSK scientists and managers.
- In April 2008 Regulus Pharmaceuticals and GSK entered an alliance, with a potential value of nearly $600 million, to develop drugs for inflammatory diseases. Under the agreement Regulus is responsible for the development of antagonists to four microRNA targets from discovery through completion of clinical proof of concept. GSK has an exclusive license for worldwide development and commercialisation of drugs developed by Regulus under each programme for the relevant microRNA. The alliance combines Regulus` unique expertise and comprehensive intellectual property estate in the microRNA therapeutics field with GSK`s extensive inflammatory disease expertise.
- In February 2009 GSK and University College London’s Institute of Ophthalmology started a three year strategic collaboration to investigate new compounds to treat potentially sight-threatening disorders. The alliance will apply the expertise and research facilities at UCL’s Institute of Ophthalmology to investigate the potential of compounds provided by GSK’s ophthalmic drug development unit Ophthiris. The collaboration provides IoO with dedicated staff and funding as well as a range of pharmaceutical compounds, biopharmaceuticals and reagents with which to probe ophthalmic disease mechanisms, while GSK gains access to world class ophthalmic experience, facilities and investigators. In addition the arrangement provided for undisclosed royalty payments to UCL Business should the research be successful in identifying a future medicine.
- In December 2008 GSK and Dynavax Technologies Corporationstarted a worldwide strategic alliance to discover, develop and commercialise novel inhibitors of endosomal Toll-like Receptors for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses. Under the terms of the alliance, Dynavax received an initial payment of $10 million for which GSK received an exclusive option over four programmes targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. Dynavax is to conduct research and early clinical development in up to four programmes and is eligible to receive future potential development and commercialisation milestones totaling approximately $200 million per programme. GSK can exercise its exclusive option to license each programme upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialisation of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product.
- In December 2008 Archemix Corporation and GSK started a worldwide strategic alliance to discover, develop and commercialise aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthesized oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity. The alliance leverages Archemix’s unique expertise and intellectual property position in the discovery and development of aptamer therapeutics and provides GSK with an option to license product candidates directed at seven different aptamer targets with relevance in inflammatory disease. Under the terms of the agreement, Archemix received $27.5 million in upfront payments from GSK, including a $6.5 million equity investment by GSK in the company. Archemix is also eligible for up to $200 million in development, regulatory and sales milestone payments for each of the seven aptamer therapeutics which may be discovered and developed as part of the alliance. Archemix would also receive tiered royalties up to lower double digits on worldwide sales of products that may result from the alliance.
- In December 2007 GSK and OncoMed Pharmaceuticals formed a strategic alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells. The alliance is conducted through GSK’s Center of Excellence for External Drug Discovery and leverages OncoMed’s expertise in the discovery and development of cancer stem cell antibody therapeutic. GSK has an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed’s broad library of monoclonal antibodies. OncoMed received an undisclosed initial payment that includes cash and an equity investment. In addition, OncoMed is eligible to earn milestone payments of as much as $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. GSK has an option to invest in a future initial public offering by OncoMed. OncoMed has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells. The alliance with GSK includes OncoMed’s lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008. In the alliance, OncoMed will utilize its proprietary in vivo xenograft cancer stem cell models to identify MAbs in a specific, undisclosed cancer stem cell pathway. OncoMed will develop the most promising of these monoclonal antibodies, including OMP-21M18, through clinical proof of concept across multiple indications. Upon achievement of clinical proof of concept in an agreed indication, GSK will have an exclusive option to license that MAb. GSK would then assume responsibility for funding of further clinical development and commercialisation on a worldwide basis. OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.
- In December 2007 GSK and Santaris Pharma entered into a worldwide strategic alliance for the discovery, development and commercialisation of novel medicines against viral diseases. The collaboration provides GSK access to patented RNA antagonist compounds, based on Santaris Pharma’s unique Locked Nucleic Acid technology, for development as potential new therapies for selected viral diseases.Under the terms of the agreement, Santaris Pharma grants GSK options to drug candidates discovered and developed under the collaboration in up to four different viral disease programmes. In each of these R&D programmes, Santaris Pharma is responsible for the discovery and development of RNA antagonist drug candidates through to completion of Phase IIa, at which point GSK has an exclusive option to license each compound for further development and commercialisation on a worldwide basis. GSK also has an option to include as an additional programme in the collaboration, SPC3649, Santaris Pharma’s preclinical LNA-antimiR against microRNA-122, which is being developed by Santaris Pharma as a potential new therapy for Hepatitis C infection. Santaris Pharma received an upfront fee for the first antiviral programme of $3 million (£1.5 million) and GSK made an equity investment of $5m (£2.5 million) in Santaris Pharma. If candidate drugs from the first viral target programme are successful and reach the market, GSK could make additional milestone payments to Santaris Pharma of up to $140 million (£69.5 million) for this first programme. Similar upfront payments and milestones are payable by GSK to Santaris Pharma in respect of each of the further 3 antiviral programmes if GSK elects to initiate these additional programmes in the collaboration. In addition, if GSK exercises its option to further develop and commercialise SPC3649, it will make a further up front payment of $5 million (£2.5 million) and additional milestones of up to $122 million (£60.5 million) if the drug obtains regulatory approvals in Europe and the USA. Overall, under the collaboration Santaris Pharma could be eligible to receive in excess of $700 million (£347 million) in upfront fees and development and regulatory milestones payments. If a product is successfully commercialised, Santaris Pharma will receive high single to double-digit royalties on worldwide sales of alliance products.
- In October 2007 Anacor Pharmaceuticals and GSK signed a worldwide strategic alliance for the discovery, development and commercialisation of novel medicines for viral and bacterial diseases. The collaboration provides GSK access to Anacor’s proprietary boron-based chemistry for use against selected targets. GSK is participating in the alliance through its Infectious Diseases Centre of Excellence for Drug Discovery. Under the agreement, GSK has options to select product candidates developed under the collaboration that are directed to up to four discovery targets and with the potential for at least eight product options. Anacor will primarily be responsible for the discovery and development of boron-containing small molecule drug candidates through clinical proof of concept, at which point GSK has an exclusive option to license each compound for further development and commercialisation on a worldwide basis. Anacor has the right to further develop and commercialise compounds for which GSK does not exercise its option. Anacor received a $12 million upfront payment and a $10 million equity investment from GSK. Contingent on achieving certain milestones, Anacor is eligible to receive discovery, development, regulatory and commercial milestones ranging up to $252 million and $331 million for each product candidate. If GSK exercises its option at the proof of concept stage, Anacor will receive tiered double digit royalties, which are dependent on sales achieved.
- In July 2007 GSK and Targacept Inc signed a strategic alliance to discover, develop and market novel therapeutics that selectively target specified neuronal nicotinic receptors. The alliance includes Targacept’s lead product candidates for pain: TC-2696, then in a Phase 2 trial for acute post-operative pain, and TC-6499, a preclinical product candidate then planned for development for neuropathic pain. Targacept retained an option to co-promote TC-2696 and TC-6499 for pain to specialists and hospital-based physicians in the United States. The alliance also provides GSK with access to other discovery programmes across five therapeutic focus areas. In addition to pain, the other therapeutic focus areas of the alliance are smoking cessation, obesity, addiction, and Parkinson’s disease. Under the terms of the agreement, GSK made an initial upfront payment of $35 million to Targacept, which included an investment of $15 million for the purchase of 1,275,502 shares of Targacept common stock. In addition, Targacept is eligible to up to $1.5 billion in payments from GSK, contingent on the achievement of specified discovery, development, regulatory and commercial milestones across five therapeutic focus areas, as well as tiered double-digit royalties dependent on sales achieved. Upon Targacept’s achievement of clinical proof of concept for a lead product candidate for a particular therapeutic focus area, GSK has an exclusive option to license product candidates in development in the alliance from that programme. GSK would then assume full responsibility for funding of further clinical development and commercialisation on a worldwide basis.