Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer’s and Parkinson’s diseases. The Cambridge–Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years. Its goal is to discover novel compounds that can alter the behavior of proteins associated with neurodegenerative disorders and be developed into new treatments.

“This agreement is a natural next step in the existing working relationship between our scientists in South San Francisco and scientists at the University of Cambridge,” said Dale Schenk, executive vice-president and chief scientific officer at Elan, in a 

. “This collaborative effort complements our portfolio of programs in neuroscience and supports the process of discovery, which we believe may lead to a class of therapeutics that no one has thought possible before.”

The center will combine Elan’s expertise in Alzheimer’s research and model systems with the University of Cambridge’s experience in biophysical approaches to study the molecular basis of protein misfolding and its link to disease. “Protein folding, misfolding, and turnover are central to neurological disease and will be the basis for further scientific and therapeutic advancements,” said Ted Yednock, executive vice-president and head of discovery and translation at Elan, in the press statement. “Our relationship with Cambridge will enable us to address the interconnecting biology and biophysics of protein misfolding in multiple disease areas simultaneously and in a timely way for the ultimate benefit of patients.”

The centre will gain global recognition, according to Christopher Dobson, the John Humphrey Plummer Professor of Chemical and Structural Biology at the University of Cambridge and master of St. John’s College. “Our collective expertise, proven ability to collaborate, and open innovation model provide an exciting basis for the future,” he said in the press statement. “The new center will bring together the skills of scientists working in an academic institution and in a biotechnology company to develop new and more effective therapies for some of the most devastating and increasingly common human diseases.”

Articles

Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer's and Parkinson's diseases. The Cambridge–Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years. Its goal is to discover novel compounds that can alter the behavior of proteins associated with neurodegenerative disorders and be developed into new treatments.

Elan, University of Cambridge Launch New Research Center

The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use. Avastin’s potential side effects include severe high blood pressure, bleeding and hemorrhaging, heart attack or heart failure, and the development of perforations in different parts of the body. In addition, and there is no evidence that the drug improves quality of life or helps patients to live longer.

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” said Hamburg in the FDA’s 

. “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Avastin will, however, remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer. In its own 

, Genetech also added that it will continue to pursue the potential benefits of Avastin with regards to breast cancer. Hal Barron, chief medical officer and head, Global Product Development, at Genetech said, “Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."

An FDA panel voted unanimously to withdraw approval for Avastin earlier this year in June. Hamburg’s final decision is based on extensive data from clinical trials, as well as a 2-day hearing that was requested by Genentech.

FDA Withdraws Approval for Roche's Avastin

FDA Revokes Breast Cancer Indication for Avastin

The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use.

FDA Removes Avastin Breast Cancer Indication

The European Commission (EC) has unveiled a comprehensive 

 against antimicrobial resistance that includes provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorizations. According to an EC press statement, approximately 25,000 patients die every year in the EU from infections caused by drug-resistant bacteria, with associated costs of more than EUR 1.5 billion ($2 billion) in healthcare expenses and productivity losses. 

 released to welcome the action plan, GlaxoSmithKline (GSK) explained the difficulties of developing new antibiotics. “The discovery of new antibiotics is an inherently difficult area of pharmaceutical R&D and can take many years and involve significant investment. In addition, once licensed new antibiotics are generally used only when patients have failed to respond to existing treatments. This significantly limits the commercial return that is needed to encourage continued investment in this area and fund future R&D.”

Among other areas, the EC has highlighted the development of new, effective antimicrobials or alternatives for treatment as a priority. In response, a funding program for R&D into this area will be initiated through the Innovative Medicines Initiative, and the EC will also establish an overarching framework agreement within the industry that defines the long-term objectives, commitments, priorities, principles, and modes of action for public–private collaborations. In addition, the action plan recognizes the importance of ensuring conditions for and implementing fast-track procedures for the marketing authorization of new antimicrobials.

As well as being welcomed by pharmaceutical companies, such as GSK, the action plan has also received a positive reaction from other industry stakeholders, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). In particular, EFPIA welcomed the news that the Innovative Medicines Initiative is considering a large-scale program to boost the discovery and development of novel antibiotic drugs. In a 

, however, EFPIA Director-General Richard Bergström added, “In the short-term we emphasize the need to identify improved regulatory pathways that will enhance the feasibility of clinical trials in this area. Currently, there are too many situations in which it is no longer feasible to conduct trials.”

In the GSK statement, CEO Andrew Witty said, “Antibiotic resistance is a global problem and we face the continued threat of one day coming up against an infection to which we don’t have an effective antibiotic.” “Unfortunately, the current commercial model doesn’t stimulate the innovation needed in this area. We need a fundamentally different approach and public–private collaboration, with the sharing of information and funding, [that] provides us with a significant opportunity to reduce the hurdles in our way.”

The action plan covers seven areas where the EC believes that measures are most necessary: 

making sure antimicrobials are used appropriately in both humans and animals

preventing microbial infections and their spread

developing new effective antimicrobials or alternatives for treatment

cooperating with international partners to contain the risks of antimicrobial resistance

improving monitoring and surveillance in human and animal medicine research and innovation, communication, education, and training.

The plan also sets out 12 “concrete” actions:

improve awareness raising on the appropriate use of antimicrobials

strengthen EU law on veterinary medicines and on medicated feed

introduce recommendations for prudent use of antimicrobials in veterinary medicine, including follow-up reports

strengthen infection prevention and control in hospitals, and clinics

introduce legal tools to tighten prevention and control of infections in animals in the new EU Animal Health Law

promote unprecedented collaboration to bring new antimicrobials to patients

promote efforts to analyse the need for new antibiotics in veterinary medicine

develop and/or strengthen multilateral and bilateral commitments for the prevention and control of Antimicrobial Resistance (AMR)

strengthen surveillance systems on AMR and antimicrobial consumption in human medicines

strengthen surveillance systems on AMR and antimicrobial consumption in animal medicines

improve communication on AMR to the public.

The European Commission has unveiled a comprehensive action plan against antimicrobial resistance that includes provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorizations.

European Action Against Antimicrobial Resistance

GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto last week. The $50-million national fund will identify strategic investment opportunities in Canada’s life-sciences industry, including academic and health institutions, translational research centers, and start-up companies.

“The GSK Canada Life Sciences Innovation Fund will provide a competitive advantage to Canada’s life sciences industry and help advance the commercialization of research,” said Paul Lucas, President and CEO of GSK, according to a

. “This is an important step in addressing Canada’s innovation gap and we’re excited by the prospect of developing even closer ties with leading research organizations across Canada to enhance opportunities for innovation and create new high-value jobs.”

The fund will be managed by GSK in Canada and the company’s global corporate venture-capital arm, SR One. In the statement, GSK explains that the investment will enable Canadian researchers, academics, and organizations to benefit from the company’s significant R&D experience.

“Canada’s life sciences industry is respected around the world with many innovative companies and organizations engaged in high-potential research,” said Moncef Slaoui, global chairman of R&D at GSK, in the statement. “The establishment of this fund demonstrates GSK’s confidence in Canada to continue to be an important source of development for medicines of value for patients.”

A further innovation boost was also announced for Canada this week via a joint 

 issued by the Canadian Institutes of Health Research and the UK’s Medical Research Council. According to the statement, the entities have awarded funding via the Canada/UK Partnership on Antibiotic Resistance to two Canada–UK research teams to address the challenges of antibiotic resistance. 

Professor Gary Dmitrienko of the University of Waterloo and Professor Tim Walsh of the University of Cardiff will lead a team to focus on hospital-acquired infections, with the aim of developing a new treatment for infections caused by bacteria resistant to beta-lactam antibiotics such as penicillin. Meanwhile, Professor Anthony Clarke of the University of Guelph and Professor Chris Dowson of the University of Warwick will seek to increase understanding of bacterial cell wall growth and production, which may lead to targets for the development of new antibiotics.

GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto last week. The $50-million national fund will identify strategic investment opportunities in Canada's life-sciences industry, including academic and health institutions, translational research centers and start-up companies.

GSK Announces $50-Million Innovation Fund in Canada

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA for the first time brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. According to a 

, the workshop was designed to enable EMA and attendees to review regulatory and scientific challenges in developing medicines for eye disorders.

Attendees, which included European regulators, the pharmaceutical industry, doctors, and patient representatives, identified the fact that new developments and treatments are advancing the field of opthalmology rapidly. For example, the industry has recently witnessed breakthroughs in new medicines for wet age-related macular degeneration, as well as ongoing research in disease such as retinitis pigmentosa and dry age-related macular degeneration, which currently have no treatments.

Also discussed at the workshop were methods for measuring visual function in clinical trials, developing stem cells and gene therapy for retinal diseases, treatment for macular diseases and inflammation in the eye, repairing the corneal surface with stem cells, and treatment for dry eyes. Childhood eye disorders and their associated treatments were also discussed, with workshop participants identifying challenges relating to measuring outcomes in children, the absence of good-quality information on existing treatments used in areas such as eye inflammation, and the need for long-term safety data.

“The workshop was successful in developing interactions between European regulators, doctors, and patient representatives and pharmaceutical industry,” Spiros Vamvakas, head of scientific advice at EMA, said in the statement. “We will now move forward with regulatory guidance in areas such as dry eyes and macular oedema—swelling in the back of the eye—which will require further stakeholder input.”

However, Vamvakes also added that further research and discussion will be required before guidance in other areas, such as trial designs and endpoints in eye inflammation, and advanced therapies in corneal and retinal disease, can be provided.

“The workshop identified the need for future submissions for endpoints and biomarker qualifications from companies, academia, or consortia, and we are looking forward to receiving these,” said Vamvakes. “We also encourage companies developing eye products to come and discuss their development plans with us at an early stage.”

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, the European Medicines Agency has recently, and for the first time, brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop.

EMA Eyes Ophthalmic Medicines

Eli Lilly and Amylin Pharmaceuticals have mutually agreed to end a 10-year alliance relating to the diabetes medication exenatide.

Under the terms of the agreement, full responsibility of the global development and commercialisation of exenatide will be transferred to Amylin. Exenatide is currently marketed as Byetta, but the companies have also developed a long-acting form of the drug called Bydureon. Bydureon received approval in Europe in June 2011, but has yet to be approved by the FDA in the US after receiving a complete response letter.

Meanwhile, Eli Lilly will receive an upfront payment of $250 million and a secured note from Amylin for $1.2 billion plus accrued interest. Amylin will make future revenue sharing payments to Lilly in an amount equal to 15% of global net sales of exenatide products, which Eli Lilly will subtract from the note until the full amount has been paid. 

If, however, Bydureon has not received FDA approval by June 30, 2014, Amylin’s revenue sharing obligations will terminate and the company will instead pay Eli Lilly 8% of global net sales of exenatide products. In addition, Amylin will also pay Eli Lilly a $150-million milestone contingent upon the FDA approval of a once-monthly suspension version of exenatide, which is in Phase II trials.

The transfer of commercial operations for exenatide to Amylin will be completed by November 30, 2011 in the US. In other territories, Eli Lilly will transfer responsibility and commercialisation on a market-by-market basis in 2012 and 2013. 

"This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide," Enrique Conterno, president of Lilly Diabetes, said in a 

. "Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance's long-held goal of making Bydureon available to patients in the US."

The agreement also resolves the outstanding litigation between the two companies. In 

, Amylin filed a lawsuit against Eli Lilly for anticompetitive activity after Eli Lilly embarked on a partnership with Boehringer Ingelheim to develop and commercialise a product, which Amylin believes will compete with exenatide. 