NEWS Almac Clinical Services awarded for business excellence


Almac’s Clinical Services business unit has picked up three top accolades in the recent Northern Ireland Chamber of Commerce Awards and The Chartered Institute of Marketing (CIM), Ireland, Marketing Excellence Awards. The company also won the Business of the Year at the BMI / Belfast Telegraph Awards earlier in the year. Almac was recognised for its continued excellence in the field of contract drug


development and manufacturing within the biotechnology and pharmaceutical sectors. The company is now successfully delivering critical patient medication to more than 100 countries.


In the recent NI Chamber of Commerce Awards, Almac Clinical Services picked up two prizes – Business of the Year and the Award for Innovation through Technology for its Shipping Temperature Electronic Monitoring System (STEMS), which was designed to improve the efficiency of the monitoring process of temperature-sensitive


The Almac Clinical Services Team pictured with guest speaker, fashion designer Paul Costelloe, at the CIM Ireland Marketing Excellence Awards where they picked up the Award for Marketing Excellence within the Chemicals, Plastics and Pharmaceuticals sector. Pictured (l/r) are: Peter Sanford, Nicholas Griffin, Winnie McKeag, Laura Clarke, Maire Mullin, Jonathan Calderwood, Aileen Murphy, Paul Costelloe, Carolyn Timpany and Barry Cathcart.


clinical trial supplies during the distribution process. In the CIM Ireland Marketing Excellence Awards 2011, the business unit received an award for Marketing Excellence within the Chemicals, Plastics and Pharmaceuticals sector. The Almac Group provides a broad range of services from R&D, biomarker


discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology


(IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including leaders in the pharmaceutical and biotech sectors.


Pantarhei Bioscience discovers antigen treatment for ovarian cancer


Pantarhei Bioscience, a speciality pharmaceutical company focusing on the development of innovative, proprietary treatments in the fields of women’s health and endocrine cancer, has released results of research on an innovative treatment strategy for ovarian cancer. In


collaboration with Professor Nafis Rahman of the University of Turku and Professor Ilpo Huhtaniemi of Imperial College London, Pantarhei Bioscience is developing the Zona Pellucida


AMRI has announced that as part of a new collaboration agreement with Eli Lilly and Company, the company expects to hire more than 40 synthetic chemists by the third quarter of 2012 to support Lilly’s drug discovery


programmes. The chemists will


protein 3 (ZP3) antigen as an immunisation strategy against ZP3 positive ovarian cancer. Results in a transgenic mouse model for granulosa cell tumours show that early preventive immunisation with recombinant human (rh) ZP3 prevented ovarian tumorigenesis, and that delayed therapeutic immunisation reduced weights of existing tumours by 86 and 75 per cent, respectively, the researchers said. Liver metastases were found in controls, but none following


work on-site at Lilly’s headquarters in Indianapolis, Indiana, USA, where they will support the medicinal chemistry department. The collaboration aims to further accelerate Lilly’s drug discovery efforts by maximising real-time exchange of


active rhZP3 immunisation. Immunisation with rhZP3 was highly effective, as demonstrated by the induction of anti-ZP3 antibodies, as well as proliferative responses to the ZP3 antigen. The project is seen as a groundbreaking milestone by Pantarhei and development, upon further finance, into a Phase 1/2 clinical proof-of-concept study will start shortly with the hope of fast regulatory tracking to make the treatment available for patients as soon as possible.


AMRI to hire synthetic chemists to support Lilly chemistry services agreement


scientific information. AMRI expects to recruit the majority of the synthetic chemists who will be affiliated with this collaboration from Indiana and surrounding states. The collaboration is for six years, extendable by mutual agreement of both parties.


FDA News


FDA reports 35 new drugs approved in 2011


The FDA has reported that over the past 12 months, the agency has approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by the number of approvals in 2009 (37). Many of the drugs are important advances for patients, including two new treatments for hepatitis C, a drug for late-stage prostate cancer, the first new drug for Hodgkin’s lymphoma in 30 years, and the first new drug for lupus in 50 years.


Its report released early in November, FY 2011 Innovative Drug Approvals, shows faster approval times in the USA when compared to the FDA’s counterparts elsewhere. Twenty- four of the 35 approvals occurred in the USA before any other country.


Among the new drugs approved in FY 2011, two of the drugs, one for melanoma and one for lung cancer, are breakthroughs in personalised medicine. Seven of the new medicines provide major advances in cancer treatment. Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection. Ten of the drugs are for rare or ‘orphan’ diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema.


Almost half of the newly approved drugs (16) were approved under ‘priority review’, two-thirds of the new approvals were completed in a single review cycle, three were approved using ‘accelerated approval’, and 34 of the 35 drugs were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that the FDA approved in less than six months.


November/December 2011 sp2 7


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44