The European Medicines Agency (EMEA) has recommended that the European Commission approves a cell-based therapy called ChondroCelect, developed by TiGenix.

The lowdown: In December 2008, a new regulation on advanced therapy medicinal products (ATMPs) came into effect in the European Union (EU) (regulation no. 1394/2007). The regulation

established the Committee for Advanced Therapies (CAT), which now assesses all marketing authorization applications for ATMPs developed in the EU and reports its findings to the Committee

for Medicinal Products for Human Use (CHMP). The first ATMP, which was authorized for marketing by the EMEA's CAT and CHMP on 26 June 2009, is ChondroCelect (consisting of characterized

outside the body and then surgically re-implanted with the aim of repairing cartilage defects by the formation of durable cartilage. The ultimate goal of the treatment is to reduce the risk

of developing knee osteoarthritis in the long term.

Also, the CAT has adopted its first scientific recommendation on the classification of an ATMP for a somatic-cell therapy medicinal product intended for the treatment of chronic venous leg

ulcers. It is composed of substantially modified human allogeneic fibroblasts and keratinocytes, administered in conjunction with fibrin as a structural component. All requests for

classification are assessed by the CAT (see http://www.emea.europa.eu/htms/human/advanced_therapies/atmp_classification.htm).

The International Union of Basic and Clinical Pharmacology (IUPHAR) has announced the publication of an ion channels database that includes both voltage-gated ion channels (VGICs) and

ligand-gated ion channels (LGICs).

The lowdown: The IUPHAR database (http://www.iuphar-db.org/) contains peer-reviewed information about pharmacological, chemical, genetic, functional and pathophysiological properties of

human, rat and mouse genes. The current release adds detailed information on 8 VGIC and 3 LGIC families (specifically, 141 VGIC and 71 LGIC subunits), to the information on the 354

non-sensory G protein-coupled receptors (GPCRs), including orphan receptors, that has been available since 2005. Curation of information about the five remaining ion channel gene families is

ongoing.

Alnylam Pharmaceuticals has donated over 1,500 patents (issued or pending) on its RNA interference technology to the patent pool for neglected tropical diseases (NTDs), which was established

by GlaxoSmithKline in March this year.

The lowdown: By donating these patents, the aim is provide the knowledge needed for the development of new medicines for the treatment of US FDA-defined NTDs (tuberculosis, malaria, blinding

trachoma, Buruli ulcer, cholera, dengue and dengue haemorrhagic fever, racunculiasis, fascioliasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis,

onchocerciasis, schistosomiasis, soil-transmitted helminthiasis and yaws). In addition to its intellectual property, Alnylam will also provide technical know-how on a royalty-free,

non-profit basis in the least developed countries through licensing agreements with qualified third parties.

Merck has also recently announced a collaboration with the not-for-profit Drugs for Neglected Diseases initiative (DNDi) to discover and develop improved treatments for NTDs. Through the

collaboration, Merck will contribute small-molecule assets and related intellectual property through a non-exclusive, royalty-free licence to DNDi to conduct early development programmes of

drug candidates. The Drug Discovery Unit at the University of Dundee has also recently announced a collaboration with the DNDi.

The Unit at Dundee will develop a dedicated leishmaniasis drug discovery group that will form consortia with academic centres such as the Structural Genomics Consortium in Oxford, UK, and

the London School of Hygiene and Tropical Medicine, UK.

Following a review by the US FDA of Oxford Biomedica's Phase III trial of TroVax in renal cancer, the company can continue to develop the product for various metastatic cancer indications.

The lowdown: TroVax is a gene-based tumour vaccine that uses a modified poxvirus vector to deliver the tumour antigen gene 5T4 and induce an immune response against the 5T4 antigen. Oxford

Biomedica started a Phase III clinical trial of TroVax in patients with advanced or metastatic renal cell carcinoma in November 2006 (called TRIST (TroVax Renal Immunotherapy Survival

Trial)). However, in July 2008, a preliminary analysis by an independent data safety monitoring board indicated that the trial would not meet its primary end point. The board recommended

that the trial continue, without further vaccinations, to allow patient follow-up. Oxford Biomedica have now announced that the TRIST trial did show a survival advantage in certain subsets

of patients with renal cancer and the FDA has invited them to submit adaptive Phase II–III trial designs in metastatic colorectal cancer.

The Japanese regulatory authorities have approved their first biosimilar product — Sandoz's version of recombinant human growth hormone somatropin (Omnitrope).

The lowdown: On 25 June 2009, Sandoz announced that their follow-on version of somatropin has been approved for use in Japan for the treatment of children with growth hormone deficiency, as

well as growth disturbance associated with Turner's syndrome or chronic renal insufficiency. Earlier this year, the Japanese Ministry of Health, Labour and Welfare (MHLW) published

guidelines for a national biosimilar regulatory pathway based on similar scientific principles to the approval pathway of the European Medicines Agency (EMEA).

The MHLW are not the only regulators that could benefit from the EMEA's experience in biosimilars. It was reported from the annual Drug Information Association meeting that the US FDA will

learn from the EMEA's experience in biosimilars when defining their own regulatory pathway, according to Steven Kozlowski, director of the FDA's Office of Biotechnology Products. This comes

at a time when the details of a regulatory pathway for such products are under considerable debate in the United States. The main point of contention is the length of data exclusivity before

another company can make a regulatory filing for a follow-on product that uses data generated by the innovator company for the original product. The Senate Health, Education, Labor and

Pensions Committee has voted 16–7 in support of an amendment to the health-care reform package that provides 12 years of data exclusivity for innovative biologics. This is in addition to

growing support in the House for H.R. 1548 (The Pathway to Biosimilars Act), which also recommends at least 12 years of exclusivity and has 133 co-sponsors (at the time of going to press). A

competing bill, H.R. 1427 (The Promoting Innovation and Access to Life-Saving Medicine Act), which recommends 5 years of data exclusivity, has 14 co-sponsors (at the time of going to

press).

An Alliance for Regenerative Medicine has been formed between universities, life sciences companies and health-care investors, to be based in Washington, DC, USA.

The lowdown: The Alliance for Regenerative Medicine aims to promote regulatory, research and reimbursement policies that will foster innovation in regenerative medicine (such as stem

cell-based therapies). Also, the Alliance will serve as a source of information about regenerative medicine for policymakers, the media and the general public. The advocacy organization has

a number of initial charter members: the universities that will participate include the Georgia Institute of Technology, Stanford University, the University of Washington and Wake Forest

Institute for Regenerative Medicine; the life science companies include Aldagen, Fate Therapeutics, Geron, iZumi, Johnson & Johnson and Maxcyte; the investor organizations include Caufield

and Byers, Kleiner, Perkins and Proteus Ventures. In addition, the Genetics Policy Institute is a charter member. It was formed in 2003 with the express purpose of promoting and defending

stem cell research and its application in medicine, by leading a global network of stakeholder groups representing patient advocates, scientists, physicians and health-care professionals,

industrialists, bioethicists, lawyers, educators and policymakers. At the time of going to press, the full list of charter members is expected to be published by the end of July 2009.

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