NEWS MedImmune and WuXi AppTec form jv for Chinese market biologic SOCMA News
Poor CFATS implementation creating burdens for small companies
SOCMA has testified to Congress that poor implementation of the USA’s chemical security regulations has created burdens on small chemical companies. Testifying on behalf of SOCMA before the House Subcommittee on Environment and the Economy, Matthew Leary, Corporate EHS&S Manager for Pilot Chemical Company, discussed several issues impeding compliance with the Chemical Facility Anti-Terrorism Standards (CFATS), which is administered by the Department of Homeland Security (DHS). Specifically, Leary highlighted communications issues with DHS and difficulties budgeting for compliance given the agency’s shortcomings with
implementation. Leary said small companies cannot afford to spend dollars on security in advance unless the company is certain it will lead to compliance. He also told lawmakers that smaller companies like his are looking to DHS for clear compliance guidance, a request the agency routinely declines. Instead, Leary said DHS provides non-specific feedback on Site Security Plans (SSPs) that security professionals cannot translate into action. He also called on the agency to focus on expediting the review and approval of SSPs and inspections of facilities. He said industry can provide DHS assistance in minimising the future cost and complexity of CFATS, but that the public-private partnership needs to improve. Leary said Congress should encourage DHS to work collaboratively with the regulated community to solve the issues hindering implementation.
AstraZeneca’s biologics business, MedImmune, and Chinese company WuXi AppTec have formed a joint venture to develop and commercialise MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China. MedImmune will provide technical and development expertise, while WuXi AppTec will provide local regulatory, manufacturing, preclinical and clinical trial support. When undertaking clinical trial development in China, the government requires local manufacture of medicines that have not been approved in other markets.
The joint venture will control the development of MEDI5117 for autoimmune and inflammatory diseases in China, and the two companies will have equal ownership in the business.
AstraZeneca/MedImmune will have the option to acquire the full rights to commercialise MEDI5117, otherwise the joint venture will have the right to commercialise the product. WuXi AppTec will earn revenue based on services provided to the joint venture. MedImmune will receive various milestone payments as the programme progresses. The Chinese government’s focus on health care reform, along with its investment in improving health care infrastructure and expanding medical insurance coverage, are expected to continue to drive growth and demand for quality medicines over the long term. China also continues to increase its biomedical R&D investment, fuelled by sustained GDP growth. The Chinese pharmaceutical market grew from $10 billion in
2004 to $41 billion in 2010 and, according to IMS Health, is projected to grow to more than $100 billion by 2014.
MEDI5117 is currently being studied in autoimmune and inflammatory diseases such as rheumatoid arthritis. MEDI5117, a novel investigational biologic, is a fully human monoclonal antibody that depletes IL-6 and bears MedImmune’s proprietary half-life extending mutation (known as the YTE technology) designed to give a long duration of action. IL-6 is known to be an important mediator in the production of inflammation and pain in a variety of disease states. The biologic is currently in Phase 1 development in the USA and Europe, and a local IND application will be filed in China for the drug, followed by the initiation of Phase 1 trials.
Pro Bono Bio licenses PolyTherics technology for haemophilia A treatment
International health care company Pro Bono Bio Group plc (PBB) and PolyTherics Limited have further progressed their haematology alliance to produce longer-acting versions of blood factor proteins. Following an agreement established between the companies in May of this year, PBB and PolyTherics undertook a feasibility programme to evaluate the use of PolyTherics’ TheraPEG™ technology to develop a long-acting PEGylated form of Factor VIII (TheraPEG FVIII) for the treatment of haemophilia A. The successful conclusion of this programme has led PBB to exercise an
option to take an exclusive, global licence to use TheraPEG technology to develop and commercialise a TheraPEG FVIII product that will be longer-acting than the FVIII products currently in use. Haemophilia patients treated with FVIII prophylactically require treatment on average three times a week. A longer-acting FVIII will therefore enable less frequent dosing of the product and thus greater convenience for patients, especially those using FVIII for regular prophylaxis against bleeding episodes.
The exercise of the option and signing of the licence has triggered an undisclosed milestone payment to PolyTherics.
The FDA accepted the NDA for
PolyTherics is also due to receive further development and regulatory milestones as well as royalties on future worldwide product sales.
PBB already has exclusive, global licences to use TheraPEG technology to develop and commercialise long-acting forms of Factor IX for the treatment of haemophilia B and Factor VIIa for the treatment of HA or HB in patients with an immune response to FVIII or FIX respectively, and also for use in trauma situations. The new licence to develop and commercialise TheraPEG FVIII completes this range of therapeutic blood factors.
FDA approves Medivation and Astellas prostate cancer drug The FDA has approved XTANDI (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor developed jointly by Medivation, Inc and Astellas Pharma Inc.
XTANDI in July 2012, and granted the filing Priority Review Designation. Medivation and Astellas expect to make the treatment available to patients in the USA in mid-September 2012. Separately, a Marketing Authorisation Application for XTANDI has been accepted for
10 sp2 Inter-Active September/October 2012
review by the European Medicines Agency (EMA). Medivation and Astellas have agreed with the FDA to conduct a safety study of XTANDI (160 mg/day) in patients who are at high risk for seizure. The companies have agreed to provide the data from this study in 2019.
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