Evotec has announced that it has licensed a portfolio of small molecules and biologics designed to trigger the regeneration of insulin-producing beta cells to Janssen Pharmaceuticals. Under the terms of this license and collaboration agreement, Janssen will receive exclusive access to a series of candidates designed to trigger the regeneration of insulin-producing beta cells. The small molecules and biologics were identified by scientists in the Harvard University, and further analyzed in collaboration with Evotec. The agreement between Evotec and Janssen triggers an upfront payment of $8 million. Janssen could make future milestone payments, of up to a total of $200 million to $300 million per product. Janssen will also pay royalties on future sales of any products that result from this collaboration. The upfront, milestone and royalty payments will be shared by Evotec and Harvard according to pre-agreed terms. Evotec will receive additional research support for discovery and early development work that will be conducted in collaboration with Janssen.
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Evotec has announced a second strategic alliance with Harvard University, this time including Brigham and Women’s Hospital. The alliance is aimed at discovering and developing new biomarkers and treatments in the field of kidney disease. The first collaboration was established in March 2011 to develop new diabetes therapies targeting beta cell regeneration. The new alliance will pursue the identification of kidney disease relevant mechanisms with particular interest in mechanisms with disease modifying potential.
Evotec has announced the signing of a research collaboration with Harvard University and the Howard Hughes Medical Institute aimed at discovering and developing new treatments in the field of diabetes. The initial goal of the collaboration is to identify and develop physiological mechanisms and targets that regulate beta cell replication. Harvard, HHMI, and Evotec bring together extensive expertise and know-how in beta cell biology and diabetes along with an unparalleled set of tools to exploit beta cell related mechanisms and targets.
Sanofi-aventis has announced a research collaboration with Harvard University. According to the company the aim of the alliance is to advance knowledge in the area of human health through basic and applied research and to promote scientific exchange between Harvard University and Sanofi-aventis. The focus of this collaboration is translational biomedical research in therapeutic areas such as cancer, diabetes and inflammation.
American universities are supposed to be becoming the nation’s scientific powerhouse, turning innovative research into the applied science that will drive new products and wealth creation. Well that’s the theory, anyway.
In reality an examination of New Drug Applications filed with the Federal Drug Agency reveals that just 5% of applications were supported by patents that originated in universities. The other 95% were backed by patents protecting the work of scientists employed by companies.
There are success stories to be sure and universities can hit the mother load when they happen to strike it lucky.
Emory is one such university. Emtricitabine is a compound used in the anti-HIV drugs, Emtriva and Truvada. Emtricitabine was discovered by scientists at Emory University. The compound was licensed in 1996 to Triangle Pharmaceuticals, an Emory University start-up company. In 2002, shortly after it had filed an NDA for emtricitabine to the FDA, Triangle Pharmaceuticals was acquired by Gilead Sciences. Emtricitabine received its first approval in the USA and Europe as an HIV drug in 2003. In 2005 Gilead Sciences and Royalty Pharma bought Emory’s interest in the compound for $525 million.
Overall between 1991 and 2006 Emory earned $720 million in revenue from its commercialised research. By 2006 Emory had 16 licensed therapeutic products already in the marketplace and 38 licensed products in various stages of drug discovery, clinical development or regulatory approval and had established 37 companies around the university’s technology, leading to seven publicly traded companies and seven companies marketing products.
Emory’s achievement in turning research into revenue streams is unusual to say the least. Stanford University and the University of California earned just over $200 million in royalties for Boyer and Cohen’s patent for DNA splicing by the time of its expiry in 1997. In 2002 the last year for which we have figures, Harvard University, received a total of just $20 million licensing revenue across all industrial, scientific and technological research areas. These licensing revenues accounted for less than 4% of Harvard’s total research spending of more than $520 billion in the same year. The licensing revenues came from over 550 outstanding licenses so each license generated just over $35,000 a year. In 2002 Harvard was involved in 59 patent applications, granted 89 licenses and options and was involved in 8 startups so it seems likely that a large chunk of the $20 million was swallowed up in legal and administrative costs. Other top universities do little better.
So what is going on here? It may be that university scientists focus on the type of research that gets published in Nature and Science and generates citations rather than research that companies want to license. It could be that the huge spend by the American government in universities skews research away from research that can be turned into products. It may be that universities are not very good at identifying commercialisable research and selling that research to companies. It could be that companies are not very good at recognising promising research in the academic laboratory. Or it may just be that companies prefer to deal with other companies operating on the same profit and loss driven mind-set as themselves.
Churning out scientists who found companies, invent new products and make fortunes is one thing. Keeping a stake in that innovation-driven wealth creation is an altogether more difficult challenge.
Whatever is the case universities have some way to go before they become the nation’s scientific engine of growth.
On November 5th 2007 the pharmaceutical company GlaxoSmithKline (GSK) announced that it had formed a five year alliance with the Texan based non-profit research institution MD Anderson Cancer Center to discover and develop new therapeutic, diagnostic and imaging products for cancer. According to the company the objective of the partnership is to get scientists from both organisations working together early in the discovery and development process to reduce delays in drug approval process.
This strategy diverges from the more typical approach of pharmaceutical companies who typically start to work with clinical centers like the MD Anderson Center only once they have obtained approval of investigational new drugs (IND) from the U.S. Food and Drug Administration. GSK’s alliance with the MD Anderson Cancer Center involves getting each institution’s scientists working together early in the process to monitor progress in research and development and to select biomarkers and imaging techniques in advance of an IND approval so that clinical trials can be launched with immediate effect when given the go ahead by the FDA. Given the fact that time is often one of the most expensive factors in clinical trials, this could provide a useful means cutting down on the costs of clinical development and help flag problems early on.
The alliance with MD Anderson Cancer Center is part of a trend for GSK which has entered a number of public/private partnerships in recent years. In 2000 the company entered a partnership to develop a malaria vaccine for children with the Malaria Vaccine Initiative (MVI), an organisation started by the Bill & Melinda Gates Foundation in 1999. By 2004 clinical trials were showing promising results for a malaria vaccine candidate produced from the partnership. In 2003 GSK began marketing Lapdap, a drug directed towards the most life-threatening malaria parasite, which had been developed through a public/private partnership begun in 1993 between GSK, the Tropical Disease Research Programme of the World Health Organization, the UK Government’s Department for International Development, the University of Liverpool, the Liverpool School of Tropical Medicine.
In 2005 GSK entered another public/private partnership with the International AIDS Vaccine Initiative (IAVI) to develop an AIDS vaccine. The aim of the collaboration was to support early research and development of a new technology developed at the University of Pennsylvania exclusively licensed to GSK which uses non-infectious vaccine vectors to stimulate specific immune responses directed against HIV. Under the terms of the alliance GSK and IAVI researchers were to form a joint research and development team and IAVI was to contribute technical expertise and funding.
GSK’s partnerships with public organisations are not unique. In 2005 the pharmaceutical company Bayer Healthcare entered an alliance with the non-profit organisation Global Alliance for TB Drug Development to study the potential of Bayer’s antibiotic, moxifloxacin, to reduce the standard 6-month treatment of tuberculosis to 2-3 months. In 2004 the swiss based pharmaceutical company Novartis entered an alliance with the Broad Institute of MIT and Harvard and the Lund University to form the Diabetes Genetics Initiative with the aim of deciphering the genetic causes of type 2 diabetes. In February 2007 the partnership released on the web the data of the genome-wide analysis of genes associated with type 2 diabetes and other related metabolic disorders.
With patents expiring, product pipelines drying up, spiraling development and clinical costs and a hostile press, public/private partnerships offer an attractive strategy for pharmaceutical companies to improve their image and reduce costs. Public/private partnerships are unlikely to improve a company’s profit revenues in the short-term, however, because they are more likely to occur where the public has a vested interest in a specific disease which affects the poor. For public institutions they offer an important means of co-ownership and lowering the cost of medicines.