NEWS Cherwell expands clean room facilities for prepared media FDA News
FDA approves first drug for reducing risk of sexually acquired HIV
The FDA has approved Gilead Sciences Inc’s Truvada
(emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada is to be used for pre- exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk. The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older. Truvada’s safety and efficacy for PrEP were demonstrated in two large clinical trials. The iPrEx trial results showed Truvada was effective in reducing the risk of HIV infection by 42 per cent compared with placebo in the trial population. The Partners PrEP trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner in heterosexual couples where one partner was HIV-infected and the other was not.
Gilead is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters.
Cherwell Laboratories, a specialist in environmental monitoring and the validation of sterilisation processes for health care and pharmaceutical industry applications, has completed the first phase of its clean room expansion. Investment in the expanded facility, which follows the acquisition of additional space in adjacent premises, will enable Cherwell to support growing demand for its Redipor® Prepared Media, whilst maintaining the stringent quality requirements for its preparation, the company said.
The completed clean room will double the existing space from 440 sq m to more than 940 sq m and allows further improvements in product quality, as well as the automation of processes. Phase I covers 270 sq m with a new inspection and packing room, plus associated support rooms, including new gowning and office
Pictured at the opening of Cherwell Laboratories’ new clean room facilities are (at front, l/r) Andy Whittard, managing director; Daniel Sames, Mayor of Bicester; and Lawrence Whittard, founder and director, plus (far right) Henry Franklin, finance director.
space. The new inspection and packing room contains new flow wrap machinery to automate part of the packing process and offers increased space to allow Cherwell to continue to provide bespoke solutions. A new automatic labelling system has also been introduced to reduce handling and increase reliability.
Merck & Co licenses HIV drug candidates
Merck & Co has signed two licensing agreements for investigational HIV drug candidates and has also announced plans to initiate a Phase 2 study for a proprietary investigational next-generation non-nucleoside reverse transcriptase inhibitor, MK-1439. The company has formed an agreement with Chimerix Inc based in Research Triangle Park, North Carolina, USA for CMX157, an investigational oral nucleoside reverse transcriptase inhibitor currently in Phase 1 clinical development. Under the agreement, Merck will receive an exclusive worldwide licence and
will be responsible for development and
commercialisation of CMX157. In a separate development, Merck & Co has signed an agreement with Yamasa Corporation based in Choshi, Japan, to develop EFdA (4’- ethynyl-2-fluoro-2’- deoxyadenosine), a novel nucleoside reverse transcriptase inhibitor candidate that is in preclinical studies and has shown antiviral activity towards highly resistant HIV strains. As part of the agreement, Merck & Co will pay an upfront fee and future milestone payments in return for exclusive worldwide licence
The completion of Phase II of the clean room expansion project is scheduled for 2013. The company plans to increase production volumes to more than 6.5 million agar plates per year in order to serve the UK and export markets and it is estimated that 10-15 new employees will join the existing Cherwell team.
rights. The candidate was discovered in collaboration with a group led by the world renowned HIV research scientist Dr. Hiroaki Mitsuya of Kumamoto University’s Center for AIDS Research in Japan.
Merck & Co has also
announced plans to advance into a Phase 2b clinical trial an internally developed candidate, MK-1439, a next-generation non- nucleoside reverse transcriptase inhibitor. The company is initiating a dose-ranging clinical trial to evaluate the safety and tolerability and efficacy of MK-1439 in HIV- positive, treatment-naive patients compared to efavirenz, both in combination with Truvada. The trial will start in September.
Edmond de Rothschild Investment Partners launches BioDiscovery 4 fund
Edmond de Rothschild Investment Partners has completed the first closing of and launched the fourth fund in its BioDiscovery franchise dedicated to investing in life sciences in Europe. With the support of existing institutional investors and
8 sp2 Inter-Active July/August 2012
new investors EdRIP has reached its objective of €125 million for the first closing and confirms its final objective of about €200 million by the end of the year.
The company will deploy the same strategy for BioDiscovery 4 as for its previous funds with the
team leading investments in 15 to 20 life science companies across all stages of development. The investments will be made both in therapeutic drug development companies and a combination of medical technology and molecular diagnostic companies.
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