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Alnylam Pharmaceuticals, Takeda Pharmaceutical Company, Thermo Fisher, Kansas Bioscience Authority, US Food and Drug Administration, US Centers for Disease Control and Prevention, Collaborative Drug Discovery, Myelin Repair Foundation

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Alnylam, Takeda Ink First Japan Pharma-US Biotech RNAi Partnership
 
Alnylam Pharmaceuticals and Takeda Pharmaceutical Company this week announced that they have formed the first major RNAi therapeutics partnership between a Japanese pharmaceutical company and a US biotechnology company.
 
This collaboration provides Takeda with worldwide, non-exclusive access to  Alnylam's RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future.
 
The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets, subject to certain Alnylam third party obligations.
 
Takeda becomes Alnylam's strategic partner for RNAi therapeutics over a five-year period and the only Asian company to obtain a right of first negotiation to develop and commercialize Alnylam RNAi therapeutic development programs for the Asian market, excluding Alnylam's ALN-RSV01 program. In addition, Alnylam obtains options to co-develop and co-commercialize Takeda RNAi therapeutic programs in the US market on a 50-50 basis.
 
The partnership includes $100 million in upfront payments and $50 million in near-term technology transfer payments, and is valued at potentially over $1 billion in future research and development and commercial milestones, upon successful commercialization of multiple products. At Takeda's option, the scope of the partnership can be expanded to include additional therapeutic areas with a $50 million per field expansion payment.
 
Alnylam is also eligible to receive research and development funding related to the drug discovery collaboration. In addition, Alnylam is eligible to receive up to $171 million in development and commercial milestone payments and significant royalties per product. Alnylam plans to update financial guidance when it announces its second quarter 2008 financial results.
 


 
Thermo Fisher Expands Kansas Facilities
 
Thermo Fisher Scientific will complete a 30,000-square-feet expansion of its facilities in Lenexa, Kan., a company spokesperson confirmed this week.
 
The Kansas facilities, which include four buildings in Lenexa, manufacture the Remel brand of products sold by Thermo Fisher. Those products include microbiology lab products and diagnostics that are sold into the clinical, industrial, and research markets.
 
The spokesperson could not confirm the total cost of the expansion, which has been reported to be around $4 million.
 
The Kansas Bioscience Authority, a state-run initiative aimed at attracting and retaining bioscience research in Kansas, awarded $1.25 million to Thermo Fisher in September 2007 to help pay for the facility expansion. According to the KBA, the Remel business intends to add between 90 and 180 employees over the next five years to its operations.
 


 
Senate's Supplemental Appropriations Bill Seeks $26M for CDC, $72M for FDA
 
When the US Senate last week passed an amendment to the war funding bill that earmarked an additional $400 million for the National Institutes of Health’s 2008 budget, it also ushered along funding for two other agencies that have been seeking bigger budgets: the US Food and Drug Administration and the US Centers for Disease Control and Prevention.
 
The supplemental appropriations bill would add $26 million to the CDC’s budget, of which at least $5 million must go to responses to outbreaks of communicable diseases, including genetic sequencing of those who potentially have been exposed to such diseases.
 
The CDC’s budget for 2008 is around $6.1 billion, and President Bush has requested $5.7 billion for 2009.
 
The supplemental appropriations bill also would commit $48.5 million to the FDA’s Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs and $23.5 million to the Center for Biologics Evaluation and Research.
 
In 2008, the FDA was budgeted around $2.27 billion, and the White House requested $2.4 billion for the agency in 2009.
 
In January, an FDA subcommittee released a report stating that the agency lacks the resources to keep up with advances in biomedical sciences, particularly changes and advances that have come from pharmacogenomics and genomics research and development.
 
The report from the agency’s Subcommittee on Science and Technology, said that the FDA “cannot fulfill its mission” in part “because its scientific workforce does not have sufficient capacity and capability.”
 


 
Myelin Repair Foundation Taps Collaborative Drug Discovery’s Software to Link Researchers 
 
Collaborative Drug Discovery announced this week that its web-based software, which organizes preclinical research data to help scientists advance new drug candidates, has been selected by the Myelin Repair Foundation to enable the foundation's sponsored researchers to collaborate more effectively.
 
CDD’s database features the ability to share data with a spectrum of permissions — either selectively with just a few specific colleagues, openly with the entire scientific community, or not at all. This flexibility encourages data sharing where appropriate while protecting intellectual property, so promising approaches can be patented and commercialized.
 
MRF's Accelerated Research Collaboration, or ARC, model creates a partnership between academic researchers, scientific and drug discovery advisors, and a centralized management team to define and execute an integrated research plan that will reduce the time to market for patient treatments.
 
Focused exclusively at this time on identifying myelin repair drug targets that will lead to treatments for multiple sclerosis by 2009, MRF provides the business infrastructure for a team of some 30 scientists, working together virtually, from different university laboratories in the US.  
 
 

The Scan

Renewed Gain-of-Function Worries

The New York Times writes that the pandemic is renewing concerns about gain-of-function research.

Who's Getting the Patents?

A trio of researchers has analyzed gender trends in biomedical patents issued between 1976 and 2010 in the US, New Scientist reports.

Other Uses

CBS Sunday Morning looks at how mRNA vaccine technology could be applied beyond SARS-CoV-2.

PLOS Papers Present Analysis of Cervicovaginal Microbiome, Glycosylation in Model Archaea, More

In PLOS this week: functional potential of the cervicovaginal microbiome, glycosylation patterns in model archaea, and more.