Alnylam, Biogen Idec to Collaborate on RNAi Drug for Rare Infection
Biogen Idec and Alnylam Pharmaceuticals announced this week that they have agreed to collaborate on the development of RNAi-based therapeutics for progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain.
“PML is a nearly always fatal neurological disease that can occur in immune-suppressed patients, and is a potential — albeit rare — complication of treatment with [the multiple sclerosis drug] Tysabri,” John Maraganore, president and CEO of Alnylam, noted in a conference call this week.
Biogen Idec’s Tysabri, which is co-marketed with Elan, was first approved in 2004 and was expected to be a major revenue-generator for the companies. However, the drug was pulled from the market after being associated with a limited number of cases of PML, two of which were fatal.
The drug has since returned to the market, but is only available to patients who enroll in a risk management program that includes MRI scans to assess their potential for side effects.
Under the deal, Biogen Idec will fund all research and development activities. Additionally, Alnylam will be paid $5 million upfront and stands to receive more than $51 million in potential milestones. Alnylam could also receive royalties and RNAi drug utilization fees.
“Selection and optimization of siRNAs for antiviral activity towards the JC virus [that causes PML] will be the first steps in this project,” Akshay Vaishnaw, Alnylam’s vice president of clinical research, said during the conference call. “We then plan to optimize the delivery of these siRNAs to the CNS in rodent and primate models. … Demonstration of safe and effective delivery to certain cell types of the CNS known to be susceptible to JC virus infection will constitute the basis for advancing the program towards an” investigational new drug application filing.
In response to an analyst’s question about how Alnylam planned to advance a PML drug through clinical trials when the infection is so rare, Maraganore said that “we’ve identified a path forward with Biogen Idec [and] we plan on meeting early with the [US Food and Drug Administration] to discuss that path. … Clearly, the path forward to approval may also recognize the existence of PML in … [immunosuppressed] patient populations [other than those receiving Tysabri],” he added.
Though this is the first collaboration between Alnylam and Biogen Idec, the companies have a long history. Alnylam co-founder Phillip Sharp also founded Biogen, while two of Alnylam’s board members held executive positions with the biotech firm before its merger with Idec.
Both Maraganore and Vaishnaw also previously worked at Biogen.
Protiva, USAMRIID to Receive $3.6M Grant for Viral Infection Work
Protiva Biotherapeutics announced this week that it and the United States Army Medical Research Institute of Infectious Diseases expect to receive a $3.6 million grant from the US Defense Threat Reduction Agency to support the development of siRNA-based therapies for hemorrhagic fever viral infection, including the Ebola and Marburg viruses.
According to Protiva, it will receive about $1.4 million of the total grant money.
Protiva and USAMRIID recently published in the Journal of Infectious Diseases in vivo data on the use of the company’s SNALP delivery technology with siRNAs to treat Ebola infection (see RNAi News, 5/18/2006).
Protiva also said that USAMRIID researcher Thomas Geisbert this week discussed the institute’s work with Protiva at this year’s International Centre for Infectious Diseases global symposium.
IDT Acquires RNA Manufacturer RNA-TEC
Integrated DNA Technologies said this week that it has acquired Belgian RNA manufacturer RNA-TEC.
Financial terms of the deal were not disclosed.
According to IDT, the acquisition expands its specialized large-scale RNA synthesis and purification capabilities. It also provides the company with a presence in Europe, where it will update and expand RNA-TEC’s existing facilities.
Sigma-Aldrich Adds Institutes to RNAi Partnership Program
Sigma-Aldrich said last week that researchers from six academic institutions have joined its RNAi Partnership Program.
The researchers are from the Wistar Institute, Mayo Clinic, Tufts University, Princeton University, the Moores Cancer Center at the University of California, San Diego, and Washington University in St. Louis.
Sigma-Aldrich established its RNAi Partnership Program in April to provide researchers with RNAi tools, including its Mission TRC shRNA libraries, while boosting its presence in the RNAi space (see RNAi News, 4/27/2006). The first to join the program was Rutgers University.
Genomatix Receives $1.6M Grant to Support RNAi Efforts
Germany’s Genomatix Software said last week that it has won a two-year “BioChance” research contract worth $1.6 million from the German Federal Ministry of Education and Research to investigate RNAi-mediated regulatory networks.
The funding will also support the company’s efforts to expand its product line in the RNAi field.
As part of its research, Genomatix said it will be “complemented” by “at least” two academic research partners, including the LMU Munich and the DKFZ Heidelberg, which will carry out the wet lab experimental part of the research.
Inex Shareholders Approve Spin Out of Company Assets
Inex Pharmaceuticals said this week that its shareholders have approved the company’s planned spin out of all its technology, products, cash, and partnerships into a new company, Tekmira Pharmaceuticals.
"Tekmira will take advantage of the recent successes at Inex including the signing of two significant partnerships and the development of a promising oligonucleotide drug candidate,” Timothy Ruane, president and CEO of Inex, said in a statement.
The spin out is subject to a number of conditions, including the transfer of litigation between Inex and former subsidiary Protiva Biotherapeutics to Tekmira. Protiva has sued Inex to prevent the spin out (see RNAi News, 9/14/2006).
Genta to Sell $16M of Common Stock to Institutional Investors
Antisense drug developer Genta said this week that it has signed definitive agreements to sell 20 million of its shares to institutional investors, for gross proceeds of $16 million.
Closing of the transaction is expected to take place by the end of the week.