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Sirna Granted U.S. Patent Broadly Covering Synthesis and Manufacturing of RNA Tuesday January 24, 8:23 am ET Patent Covers Large-Scale Synthesis of RNAi-Based Therapeutics
SAN FRANCISCO, Jan. 24 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (Nasdaq: RNAI - News), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has granted Sirna U.S. Patent No. 6,989,442 for the chemical synthesis and manufacturing of ribonucleic acids (RNA). The patent broadly covers a process for the synthesis, deprotection and purification of nucleic acids with one or more ribonucleotides. This process is critical for the efficient synthesis of RNA at high yields and high purity and is applicable to both small- and large-scale production of oligonucleotides such as siRNAs and aptamers. The patent further expands Sirna's leadership position in the area of synthesis and manufacturing of GMP quality RNA which is required for both chemically modified and unmodified siRNA-based therapeutics. ADVERTISEMENT
"The process detailed in this patent was invented and developed by the team here at Sirna," stated Chandra Vargeese, PhD, Sirna's Vice President of Chemistry. "One of the great challenges in developing siRNA-based therapeutics is efficient manufacturing of large quantities of GMP quality RNA at commercially viable costs. Sirna has made tremendous progress in overcoming this challenge through its pioneering research in the chemistry, process development and manufacturing of oligonucleotides. The manufacture of an siRNA requires a 150 step chemical synthesis. We have achieved chemical yields in excess of 60% while maintaining high purity. This chemical yield is unparalleled in the area of oligonucleotide synthesis and clearly establishes Sirna as the world leader in RNA chemistry and manufacturing."
Sirna is the only RNAi therapeutics company with its own cGMP manufacturing capacity and can produce approximately 25 kilograms per year of oligonucleotide-based compounds. Sirna has produced all material for human testing of Sirna-027, its siRNA-based clinical candidate for Age-related Macular Degeneration. Sirna-027 is partnered with Allergan and is expected to enter Phase II human trials in the second quarter of 2006. Sirna will also be producing clinical material for Sirna-AV34, its clinical candidate for the treatment of hepatitis C, which is expected to enter the clinic this year.
"This patent adds to our 48 issued and over 240 pending patent applications covering all aspects of siRNA technology," stated Bharat Chowrira, PhD, Sirna's Vice President, Legal Affairs and Chief Patent Counsel. "This new patent expands Sirna's broad coverage on the processes for the efficient synthesis and manufacturing of RNA and strengthens Sirna's leadership position in the development of RNAi-based therapeutics."
About Sirna Therapeutics
Sirna Therapeutics is a clinical-stage biotechnology company developing RNAi-based therapies for serious diseases and conditions, including age-related macular degeneration (AMD), hepatitis B and C, dermatology, asthma, Huntington's disease, diabetes and oncology. Sirna Therapeutics has presented interim Phase 1 clinical trial data for its most advanced compound, Sirna-027, a chemically optimized siRNA targeting the clinically validated vascular endothelial growth factor pathway to treat AMD. Sirna-027, which has been partnered with Allergan, Inc., continues to demonstrate that it is safe and well tolerated with 100% of patients showing visual acuity stabilization after eight weeks from a single injection. In addition, Sirna recently announced that it has selected Sirna-AV34, a systemically delivered, optimized siRNA compound, as its candidate for advancement to human clinical testing against Hepatitis C virus. Sirna has a leading intellectual property portfolio in RNAi with 49 issued patents and over 240 pending applications worldwide. More information on Sirna Therapeutics is available on the Company's web site at http://www.sirna.com.
Safe Harbor Statement
Statements in this press release which are not strictly historical are "forward-looking" statements which should be considered as subject to many risks and uncertainties. For example, there is a significant risk for any given patent application that it will not become an issued patent, or that for any issued patent, it could be subject to challenge or may not be enforceable. Moreover, Sirna's ability to develop products and operate as a going concern requires significant cash to fund its operating programs. Additional risks and uncertainties include Sirna's early stage of development and short operating history, Sirna's history and expectation of losses and need to raise capital, Sirna's need to obtain clinical validation and regulatory approval for products, Sirna's need to obtain and protect intellectual property, risk of third-party patent infringement claims, Sirna's need to attract and retain qualified personnel, Sirna's need to engage collaborators, availability of materials for product manufacturing, the highly competitive nature of the pharmaceutical market, the limited trading volume and history of volatility of Sirna's common stock, Sirna's concentration of stock ownership, and risks from relocating Sirna headquarters. These and additional risk factors are identified in Sirna's Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings. Sirna undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.
Contacts: J. Michael French Senior Vice President, Corporate Development Sirna Therapeutics, Inc., (303) 449-6500
Investors Francesca DeMartino The Ruth Group (646) 536-7024 fdemartino*theruthgroup.com
Media Jason Rando The Ruth Group (646) 536-7025 jrando*theruthgroup.com
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