Lawsuit over delivery technology from Protiva.
Cheers,
Thomas
Protiva Biotherapeutics Files Suits Against Inex Pharmaceuticals and Sirna Therapeutics
3/28/2006 3:54:00 PM EST
Protiva, a Clear Leader in the Field of siRNA Delivery, Challenges Inex and Sirna to Stop Thwarting Progress in the Development of Novel Drugs
Protiva Biotherapeutics announced today it has filed two lawsuits to protect its right to continue advancing the research and development of delivery technologies that are crucial to a new class of drugs that could help prevent and treat a wide variety of diseases.
Protiva is a clear leader in the development of delivery technologies for small interfering RNA (siRNA) therapeutics. In fact, Protiva's robust delivery technology is the only technology to date that has been shown in pre-clinical studies published in peer-reviewed journals to be capable of delivering siRNAs efficiently and with profound potency to appropriate disease sites after being administered intravenously (i.e. systemic administration). This new class of drugs is being developed ultimately to attack a variety of human diseases and conditions, including Hepatitis, Ebola infection, Influenza, and high levels of cholesterol, among others.
"We've brought these lawsuits so we can continue our efforts to develop our new systemic delivery technology - which is currently the best approach to providing the essential missing component of siRNA drugs," said Mark J. Murray, Protiva's President and CEO. "And that, of course, is all about advancing public health. We have acted to prevent these two companies from further attempts to thwart our progress and to forestall further successes by us."
See the attached Fact Sheet for a description of siRNAs and Protiva's Stable Nucleic Acid Lipid Particle (SNALP) technology.
In one lawsuit, filed in the Supreme Court of British Columbia against Vancouver-based Inex Pharmaceuticals and four present or former Inex officers, Protiva is seeking, among other things, court orders stating that Inex lacks the rights it claims to have in Protiva's discoveries and preventing Inex from continuing to claim that Inex has such rights. Protiva also hopes to prevent Inex from transferring, in violation of its agreements, various Protiva agreements and patents licensed to Protiva to a new Inex subsidiary called Tekmira.
In the other lawsuit, which was brought against San-Francisco-based Sirna Therapeutics in California Superior Court, Protiva seeks, among other things, to stop Sirna from misappropriating trade secrets Protiva shared in confidence when they were working together in a strategic alliance. Last month, Sirna ended this relationship by filing suit against Protiva in violation of the parties' dispute resolution agreements and, in the process, making public important Protiva confidential information. Protiva believes that Sirna's filing was instigated in part by the false claims Inex has made about Protiva's rights.
"Our approach has been to collaborate with other companies as the best way to make further progress in getting the benefit of our promising technology into service to save lives. We've had considerable success, and that's been good for the field," said Murray. "However, we have now come to a point where we must challenge those who are trying to block us."
Murray continued: "In our view, Inex is trying to expand its business into an area they knew nothing about until Protiva validated it. They are trying to usurp Protiva's discoveries, created by our scientists and funded by our investors, with no help from Inex, other than the prior encouragement we got from the Inex representatives who used to sit on our Board."
Protiva's Solution to the Delivery Problem
Protiva's technology, known as SNALP, employs lipid (also known as fats or oils) nanospheres, or small particles, to carry a "payload" of siRNA molecules into the cells of the body. The SNALP particles are "programmed" to accumulate in the target disease areas. This enables siRNA drugs using Protiva's technology to be administered through the blood stream, rather than having to be placed directly at the disease sites, greatly expanding the sorts of siRNA drugs that can be developed.
Protiva's delivery technology has been crucial to published results in two seminal articles in the field, enabling the promising results reported in those studies.
The first appeared in the July 2005 issue of the preeminent scientific journal Nature Biotechnology, and reported a 95% knockdown of Hepatitis virus in a mouse model (i.e., greatly reducing the levels of the virus). This result was obtained with Sirna Therapeutics scientists using siRNA in SNALP formulations developed by Protiva.
The second article appeared just last weekend in Nature, and reported an 80% reduction in "bad" cholesterol levels in primates, resulting from the reduction of a protein linked to harmful levels of cholesterol. This result was obtained with Cambridge-based Alnylam Pharmaceuticals, working under a now-expired collaboration agreement with Protiva and, again, using SNALP formulations developed by Protiva.
In addition, strikingly successful results are soon to be published with respect to the prevention of Ebola virus-caused deaths in an animal study conducted by the U.S. Army Medical Research Institute of Infectious Diseases, again using SNALP formulations developed by Protiva.
Inex's False Claims to Protiva Technology
Spun out of Inex in 2001, Protiva has since been working independently in its research and development activities.
"Inex's claims to exclusive rights over Protiva's siRNA work are completely unfounded. In fact, Inex's representatives formerly on Protiva's Board of Directors actively encouraged Protiva to devote its efforts to developing the key technologies required for the systemic delivery of siRNA drugs. It was always clear to Protiva that it, and not Inex, would be the beneficiary of those efforts," Murray said.
Inex's current CEO is also named in the lawsuit as Inex continues to assert these false claims over Protiva's rights, to Sirna, among others.
After Inex's other drug development efforts foundered (when an FDA advisory committee did not recommend approval of its lead product, resulting in substantial layoffs of Inex employees), Inex attempted to claim that Inex owned or had other exclusive rights in Protiva's work in the siRNA field, in a desperate attempt to inject some value back into Inex.
Sirna Misappropriated Protiva's Trade Secrets and Breached Its Agreement With Protiva
Sirna entered a strategic alliance agreement with Protiva in early 2005, but is now attempting to retain and misappropriate trade secrets gained in confidence.
In the course of their collaboration, Protiva provided to Sirna trade secrets and other valuable know-how about Protiva's technology. In late 2005, Sirna abruptly and publicly claimed it had invented its own delivery technology.
"We are persuaded that Sirna took Protiva's confidential information - which we provided in good faith to enable a partner to make further advances in the siRNA field - and that they then violated that confidence," Murray said. "Sirna added insult to injury when they filed suit against Protiva last month and made public the terms of our confidential agreement with them. If not countered, the net effect of Sirna's actions threatens to impede Protiva's work in this promising field."
Fact Sheet on Protiva's siRNA and SNALP Technology
"Protiva's success in developing siRNA delivery technology represents a major breakthrough in the field. While the potential benefits of siRNA are clear, a key challenge has been to provide a 'smart,' robust delivery system that can target infectious agents and proteins that cause disease in the body. Protiva has funded and developed this technology on its own and has now validated it."
- Mark J. Murray, President and CEO of Protiva
"siRNAs," or 'small interfering RNAs' are short, double-stranded RNA molecules that selectively prevent the production of disease-associated proteins or infectious agents. Cellular proteins or infectious agents are produced in cells by the formation of a messenger molecule (mRNA), which translates genetic information in the cell into proteins that carry out biological functions. Each siRNA is designed to bind specifically to the messenger molecule producing the target protein and no other, leading to the selective removal, 'knockdown' or 'silencing' of the target protein. The knockdown of the protein or infectious agent results in a reversal or reduction of the symptoms or disease it caused.
"SNALP" (for stable nucleic acid lipid particle). SNALP particles are microscopic lipid spheres that contain fully encapsulated nucleic acid (i.e. siRNA) payloads. Lipids are also known as fats or oils. SNALP technology has been designed to protect siRNA payloads, stabilizing them in the blood stream and enabling their systemic (intravenous) delivery. SNALP technology also permits efficient uptake by cells and release of the siRNA into the target cells. SNALP particles can be 'programmed,' leading to preferential siRNA delivery to different tissue targets, e.g. to the liver or directed at tumors, etc. SNALP technology is robust enough to meet FDA regulatory standards and is currently being evaluated in human subjects (with a non-siRNA payload) under an Investigational New Drug application filed by Protiva with the U.S. Food and Drug Administration.
CONTACT:
Protiva Biotherapeutics Josh Galper, 202-339-8468 |
