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Samyang, Access Pharmaceuticals Ink RNAi-Delivery Research Deals

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By Doug Macron

While recent pullbacks in the RNAi drugs space by some major pharmaceutical firms have raised concerns among industry watchers, two drug-delivery research collaborations announced this week by Samyang and Access Pharmaceuticals suggest that big pharma remains interested in the gene-silencing technology.

Under the first deal, Japan's Takeda Pharmaceutical will work with Korea-based Samyang for at least three years to co-develop novel systems for RNAi drug delivery based on the latter company's biopolymer delivery technologies.

Takeda will give Samyang an undisclosed upfront payment, and will pay development milestones and royalties on marketed products. Additional terms were not provided.

Samyang said it has developed a variety of biodegradable polymers including polyethylene glycol-polylactic acid block copolymers that self-form into nanometer-sized micelle particles. These particles, which can be delivered locally or systemically, are designed to release a drug payload over a sustained period of time.

“Testing to date has demonstrated significant pharmaceutical and biological advantages for polymeric micelle formulations as compared to standard preparations,” according to Samyang. “The technology enables formulation without employing certain toxic excipients, enhances stability, and improves bio-availability of compounds.”

The companies will try to co-develop the systems for use within Takeda's RNAi drug programs, which started up in earnest in 2008 when the company obtained access to Alnylam Pharmaceuticals' RNAi intellectual property and technology for use in developing siRNA-based therapies for cancer and metabolic diseases (GSN 5/29/2008).

“We are delighted to strengthen our pipeline in RNAi therapeutics through this research collaboration with Samyang, [which] has a proven track record in cutting-edge biopolymer-based [drug delivery] technology,” Takeda CSO Shigenori Ohkawa said in a statement.

Notably, Takeda's interest in Samyang's biopolymer technologies comes at a time when partner Tekmira Pharmaceuticals is embroiled in a legal dispute over the ownership of its lipid nanoparticle delivery technology with Alnylam (GSN 3/17/2011 & 4/7/2011). Takeda had been evaluating Tekmira's technology for use in its own programs through its own arrangement with Alnylam.

Also this week, Access said it signed a deal giving an undisclosed “major global pharmaceutical company” access to its CobaCyte and CobOral delivery technologies. Under that deal, the pharma will evaluate the technologies for intravenous and oral siRNA drug administration.

The two delivery approaches are based on Access' so-called Cobalamin technology, which takes advantage of the body's natural vitamin B12-uptake mechanism. A polymer and an active pharmaceutical ingredient, in this case, an siRNA, are joined to make a nanoparticle, which is then coated with the vitamin.

"We basically trick the body into thinking its absorbing vitamin B12," Access President and CEO Jeff Davis explained to Gene Silencing News last year.

Access said it has successfully used the approach to deliver insulin and human growth hormone orally in animal models, and has been looking for partners interested in taking the technology forward in the RNAi space for at least a year and a half (GSN 2/11/2010).

“We have made great progress in our CobOral and CobaCyte siRNA-delivery programs over the past year, demonstrating the efficiency and safe delivery needed for a viable RNAi therapeutic,” David said in a statement this week. “The signing of this agreement serves as further validation of our previous work related to our CobaCyte technology’s unique ability to deliver inactivated siRNA particles to disease target sites.”

Specific terms of the deal were not disclosed, but Access said that it will co-own with the pharma any drug formulation developed through the arrangement, which would be subject to a formal licensing agreement.


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