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Snapshot: Partnership Goals, Track Records in the RNAi/miRNA Space

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Rosetta Genomics President and CEO Kenneth Berlin this week told investors that the microRNA diagnostics shop expects to form at least one strategic partnership before the end of the year.

In doing so, Berlin, who made his comments during the Lippert/Heilshorn & Associates Life Sciences & Med Tech online forum, provided guidance on what is undoubtedly one of the most important milestones for firms in the RNAi/miRNA space — industry alliances.

Below is an overview of partnership guidance provided by top players in the field, as well as a snapshot of key product development or technology licensing deals already struck.

On Deck

Alnylam Pharmaceuticals

Guidance: Alnylam executives have said publicly that the company expects to form additional alliances in 2010, but have not indicated the number of deals expected to be signed.

The company's caution comes after Alnylam failed to meet previous guidance of forming two or more partnerships during 2009, in addition to a deal for the US rights to its respiratory syncytial virus drug candidate.


MDRNA

Guidance: MDRNA expects to ink two "major" research and development deals before year end with big pharma/biotech partners, potentially ones with which the company is already has ongoing early-stage collaborations.


Rosetta Genomics

Guidance: Rosetta expects it will form at least one strategic partnership in 2010, although it is not clear whether it would be around its diagnostics, drug research biomarker, or therapeutics efforts.


RXi Pharmaceuticals

Guidance: RXi expects to consummate one or more industry partnerships before the end of 2010, which would be its first since it was founded in 2007.

Done Deal

Alnylam Pharmaceuticals

Partner: Merck

Overview: In 2003, the companies agreed to a five-year deal to develop RNAi drugs and technologies. Another deal focused on ocular diseases was inked the next year.

The relationship was scuttled in 2007, in part due to Merck's decision to acquire Alnylam rival Sirna Therapeutics.


Partner: Medtronic

Overview: In 2005, the companies partnered to develop therapies for neurodegenerative diseases, including Huntington's disease, with Alnylam contributing RNAi know-how and Medtronic developing drug-delivery devices. The collaboration is ongoing.


Partner: Novartis

Overview: In 2005, the companies inked a broad RNAi drug-discovery and -development deal worth up to $700 million to Alnylam.

Last year, Novartis agreed to extend the deal for a fifth and final year. Due to expire in October, the deal gives Novartis the option to buy non-exclusive access to Alnylam's RNAi platform for use in its internal programs.


Partner: Biogen Idec

Overview: In 2006, Alnylam signed on to help Biogen Idec develop an RNAi-based drug progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain that is a rare complication of Biogen's multiple sclerosis drug Tysabri. The collaboration is ongoing.


Partner: Roche

Overview: In 2007, Alnylam signed a deal giving Roche non-exclusive access to its intellectual property for use in developing siRNA therapeutics

As part of the arrangement, Roche also purchased Alnylam's German subsidiary and its 40 employees.


Partner: Takeda Pharmaceutical

Overview: In 2008, Alnylam granted Takeda a worldwide, non-exclusive license to its IP for use in developing drugs for cancer and metabolic disorders.


Partner: Kyowa Hakko Kogyo

Overview: In mid-2008, Kyowa Hakko Kogyo acquired the Asian market rights to Alnylam's investigational respiratory syncytial virus drug ALN-RSV01.


Partner: Cubist Pharmaceuticals

Overview: In early 2009, Cubist acquired the rights to ALN-RSV01 in all markets outside of Asia.

Later that year, Cubist opted to pass the rights to the drug back to Alnylam in favor of a second-generation version dubbed ALN-RSV02.


Dicerna Pharmaceuticals

Partner: Kyowa Hakko Kirin

Overview: Early this year, Dicerna announced that it had partnered with Kyowa to develop an RNAi-based cancer drug based on Dicerna's Dicer-substrate technology.


Partner: Ipsen

Overview: This year, Dicerna forged a deal to develop RNAi therapeutics in oncology and endocrinology with France's Ipsen.

The arrangement will combine Dicerna's Dicer-substrate molecules with Ipsen's peptide-based targeting vectors.


MDRNA

Partner: Roche

Overview: In 2009, MDRNA non-exclusively licensed a portion of its technology platform to Roche for use in developing RNAi therapeutics.

Although the terms of the deal were not disclosed, a Roche official confirmed that it includes access to Dicer-substrate molecules, which MDRNA had previously licensed but decided not to pursue.


Partner: Novartis

Overview: In 2009, MDRNA signed a deal giving Novartis non-exclusive access to its liposomal-based siRNA-delivery platform.

Novartis also signed a separate agreement through which it was given an undisclosed, exclusive timeframe to negotiate a research-and-development collaboration with MDRNA.


Regulus Therapeutics

Partner: GlaxoSmithKline

Overview: In 2008, GlaxoSmithKline partnered with Regulus to develop miRNA-targeting treatments for inflammatory diseases.

About two years later, the companies forged another deal to develop drugs targeting miR-122, with an initial focus on hepatitis C.


Partner: Sanofi-Aventis

Overview: This year, Regulus struck a deal giving Sanofi-Aventis the rights to develop and sell four therapeutics based on Regulus' miRNA technology.


Tacere Therapeutics

Partner: Pfizer

Overview: In 2008, Pfizer acquired the rights outside of Asia to Tacere's expressed RNAi-based treatment for hepatitis C, TT-033.


Tekmira Pharmaceuticals

Partner: Sirna Therapeutics (Merck)

Overview: In 2007, Tekmira (then known as Protiva Biotherapeutics) gave Sirna a non-exclusive license to its proprietary lipid-based siRNA-delivery technology in order to settle litigation between the companies.

Merck has yet to indicate that it plans to use the technology in any of its programs.


Partner: Roche

Overview: In 2009, Roche acquired the rights to use Tekmira's delivery technology with two RNAi therapeutics.


Quark Pharmaceuticals

Partner: Pfizer

Overview: In 2006, Quark licensed its proprietary gene target RTP-801 to Pfizer for certain diseases including wet age-related macular degeneration. Pfizer also acquired an RPT-801-targeting siRNA drug from Quark, which is currently under phase II development for AMD and diabetic macular edema.


Partner: Nitto Denko

Overview: This year, the companies agreed to develop RNAi-based treatments for fibrotic diseases. Quark will contribute its siRNA expertise and intellectual property, while Nitto will provide access to its drug-delivery technologies.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more