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GE Healthcare, Ambion, Sirna, Allergan, Amaxa, FDA, CytRx, ABI, Promega, Qiagen


GE Healthcare to Manufacture miRNA Arrays for Ambion on CodeLink Chips

GE Healthcare will manufacture microRNA microarrays on its CodeLink platform for Ambion, the companies said today.

These arrays, called mirVana miRNA microarrays, include a panel of known human, mouse, and rat miRNAs, as well as Ambion's "proprietary" and "non-published" microRNAs, called Ambi-miRs. Ambion will market the arrays, according to a company spokesperson.

Financial terms of the deal were not disclosed.

Sirna Stands to Gain $250M from Allergan in AMD Drug Pact …

Sirna Therapeutics stands to pocket $250 million in milestone and other payments as part of a deal with Allergan to develop an RNAi-based therapeutic for age-related macular degeneration and discover and develop other RNAi-based drugs against gene targets developed by Allergan for ophthalmic diseases, the companies said this week.

Terms of the alliance call for Sirna to receive an initial payment of $5 million and be eligible for development milestones of up to $245 million in addition to research funding and royalties on the worldwide sales of products resulting from the collaboration, the companies said in a statement. Sirna said it will also receive contract manufacturing revenues.

Allergan will assume all development and future commercialization responsibilities for the AMD drug, Sirna-027, which is currently in Phase I studies, and will bring to the alliance its ocular drug-delivery technologies, the firms said. Sirna will develop optimized lead compounds against Allergan's identified gene targets and Allergan will be responsible for all pre-clinical, clinical, and commercialization activities for those compounds.

The companies will form a Joint Steering Committee to oversee the research and move Sirna compounds through Allergan's discovery and development pipeline, the partners said.

… and Wins UK Patent Covering siRNA-Based Gene Expression Inhibition

Sirna Therapeutics said this week that it has been issued a UK patent covering RNAi-mediated inhibition of gene expression using siRNAs.

According to the company, the patent claims are not limited to a specific to an siRNA sequence or structure, and broadly cover any siRNA molecule which targets conserved sequences within a virus or a gene.

Sirna noted that the patent — No. GB 2396616 — covers the development of siRNA drugs in areas such as hepatitis C and HIV, as well as respiratory syncytial virus, influenza virus, bird flu virus, and severe acute respiratory syndrome — three indications that rival Alnylam Pharmaceuticals is pursuing.

The patent is entitled, "RNA Interference Mediated Inhibition of Gene Expression Using Short Interfering Nucleic Acid."

Amaxa to Optimize Nucleic Acid Technology Using ATCC Cell Lines

Amaxa said this week that it has signed a deal under which it will develop and optimize protocols for its nucleofector nucleic acid transfer technology using cell lines from the American Type Culture Collection.

"It is our goal to enable our customers to genetically manipulate the cell types they consider the best experimental model," Rainer Christine, CEO of Amaxa, said in a statement. "In looking for a partner, we needed a large collection of cell lines that came with reliable authentication. ATCC was the obvious choice."

Additional terms of the arrangement were not disclosed.

FDA Lifts Hold on CytRx ALS Drug, Grants Fast Track Status

CytRx said last week that US regulators have lifted a hold on a phase II clinical trial of the company's investigational small molecule amyotrophic lateral sclerosis arimoclomol.

As a result, CytRx said it has begun the phase II trial, and patient enrollment has commenced at several sites.

CytRx also announced this week that the US Food and Drug Administration has granted fast track status to arimoclomol. According to the company, the designation allows for scheduled meetings seeking FDA input into development plans, the option of submitting a new drug application in sections rather than submitting all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

ABI, Promega Settle Litigation Over PCR Technology

Applied Biosystems said this week that it has settled its litigation with Promega over PCR technology.

Promega originally sued Hoffman-La Roche and Applera in the US District Court for the Eastern District of Virginia on behalf of the US government but the court dismissed the company's amended complaint with prejudice a year ago. Both Promega and Applera filed appeals at the time, which they have now withdrawn.

Promega's suit was based on the False Claims Act, also known as the Informer's Act or the Qui Tam Statute, which allows a private person to sue a person or company that knowingly submits false bills to the federal government.

Following the settlement, Promega can now negotiate a license to Roche's PCR patents with ABI, the exclusive licensor of the patents for life science research and applied fields, according to ABI.

Earlier in the month, Promega settled its PCR-related litigation with Roche.

Qiagen to Acquire PCR-based Dx Maker Shenzhen PG Biotech

Qiagen said this week it plans to acquire Chinese molecular diagnostics company Shenzhen PG Biotech for $14.5 million in cash.

Under the terms of the agreement, which is pending Chinese government approval and subject to certain closing conditions, Qiagen will acquire all outstanding shares of Shenzhen-based PG Biotech. More than half of the company's shares are currently held by state-owned institutions. Depending on the date of the closing, Qiagen expects the acquisition to contribute $6millionn to $7 million in sales over 12 months.

PG Biotech, which has a staff of 120, with a "substantial number" in research and development, according to Qiagen, provides PCR-based molecular diagnostic assays in China. The company has more than ten assays approved by the Chinese State Food and Drug Administration, including assays for pathogens such as SARS, HBV, HPV, Mycobacterium tuberculosis, Neisseria, and Chlamydia. In addition, PG Biotech provides assays for import/export controls and quarantine testing, and is developing panels for disease profiles. Qiagen said PG Biotech's business profile is "comparable" to that of Artus, which the company acquired earlier this year.

This is not Qiagen's first foray in to the Chinese market: in June, the company acquired nucleic acid reagent provider Tianwei Times. Qiagen also opened an office in Shanghai this year and strengthened its distribution channels with Gene Company.

The Scan

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.