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Roche, Merck, Ventana, Gene Logic, NCI, Quest Diagnostics, Pathway Diagnostics, Med BioGene, JRG Ventures, Clinical Data, ELITech Group, XDx

Roche Dx’s HIV Viral Load Test Used in Studies for Merck’s New HIV Drug Isentress
Roche Diagnostics announced this week following the approval of Merck's new integrase inhibitor, Isentress, by the US Food and Drug Administration, that Merck used its COBAS HIV-1 AMPLICOR viral load test in clinical trials for the drug.
Merck’s HIV drug, more commonly called raltegravir, prevents virus replication by blocking insertion of HIV genetic material into DNA. In clinical trials, researchers gauged patient progress on Isentress by testing their viral loads with Roche's viral load test.
According to Roche Diagnostics, the test targets “the gag region of the HIV virus genome, a different area from the integrase region where many new drugs in the HIV pipeline are being developed.”

Roche's Fourth Bid to Buy Ventana Falls Flat … Again
Roche has again extended its unsolicited bid to buy Ventana Medical Systems for $75 per share, and Ventana again has said that the number is too low.
Roche said this week it has extended for a fourth time the offer it made in June to buy the company for around $3 billion, which amounts to a 44-percent premium over Ventana’s closing share price of $51.95 on the eve of the first offer. Ventana's shares closed at $86.98 Tuesday.
The new extension runs out Jan. 17, 2008. Roche said other terms of the proposed deal are unchanged, as was Ventana’s response.
Ventana CEO Christopher Gleeson swatted the renewed offer. “More than 99.5 percent of our investors have now essentially turned down Roche’s inadequate offer four times, and yet Roche persists with its futile and costly tactics,” Gleeson said in a statement.
"Virtually all of our investors agree with us that $75 [per share] is a non-starter and they recognize that we are gaining real momentum in our marketplace.”
As of the close of business Oct. 29, Roche said that around 64,000 Ventana shares had been tendered in the offer, a number that Ventana said amounts to around 0.2 percent of the company’s roughly 35 million outstanding shares.
Ventana has consistently urged its shareholders to disregard the “potential for distraction” that the Roche offer may stir.
Roche Diagnostics CEO Severin Schwan has previously said that Ventana would be an “ideal partner” and that a union would offer “an exceptional opportunity to create further value for patients, customers, employees, and shareholders through an expanded, global diagnostics platform for tissue analysis.”
Roche has stated that if it acquired Ventana, it would retain the company’s management team, employees, and Tucson, Ariz., headquarters.
Roche also has challenged an Arizona law that would prevent the Swiss drug and diagnostic giant from taking control of Ventana even if it could obtain enough shares.
In August, a US district court in the state sided with Roche in “ruling that Ventana may not take ‘any action to invoke, apply, or enforce the provisions’ of the Arizona Control Share Act and the Arizona Business Combination Act.”
Roche has also filed a suit in Delaware that would strip Ventana of take-over protection through a so-called “poison pill” defense that which would dilute Roche’s ownership of Ventana if it attempts to buy more than 20 percent of the company.

In Shift to Drugs after Ocimum Deal, Gene Logic Plans Name Change
Gene Logic said this week it plans to change its name to Ore Pharmaceuticals in order to better express its drug repositioning identity now that it has agreed to sell its genomics business to Ocimum Biosolutions.
The company said two weeks ago it plans to sell its genomics assets to Ocimum for $10 million as it completes its restructuring into the pharmaceuticals field.
Gene Logic said the new name has been approved by the board of directors and now awaits shareholder approval. The company also is waiting for the shareholders' nod to proceed with its proposed sale to Ocimum.
Gene Logic said it will shift ownership of its name to Ocimum when the deal closes.
“We believe that the Gene Logic name is a valuable brand that appropriately should remain with the genomics business of Ocimum Biosolutions," Gene Logic CEO Charles Dimmler said in a statement.
The company said it is currently collaborating with eight pharmaceutical companies to reposition some of their compounds. The pharma partners include Abbott, H. Lundbeck, Merck Serono, Organon, Pfizer, Roche, and Solvay.
Gene Logic also said its technology program includes the use of its own genomic and toxicogenomic databases, for which it will hold full and exclusive rights to use in its repositioning business.

NCI Seeks Collaborators, Licensees for 'First' miRNA Gene Used as Rx
The National Cancer Institute is looking to license or co-develop a microRNA sequence that it said can enhance the capacity of T-lymphocytes to recognize tumors in several kinds of cancer, according to the National Institutes of Health.
NIH said the technology, listed under patent application No. 60/940,172, is the “first reported use” of an miRNA gene to treat disease.
According to the agency, NCI discovered that genetically engineering T-lymphocytes with the gene, called miR-181a, “dramatically augmented the function of poorly responsive human tumor-infiltrating lymphocytes and TCR-engineered peripheral blood lymphocytes, resulting in potent anti-tumor reactivity.”
It also said that in a mouse model, miR-181a, “increased the function of self/tumor-specific CD8+ T cells enabling effective tumor destruction in the absence of vaccination or exogenous cytokines that were otherwise essential requirements.”
Pre-clinical work on miR-181a has been completed and clinical studies are being planned, the NIH said.
The IP is up for exclusive or non-exclusive license, NCI said. Additional information can be found here.
NCI also said that its Surgery Branch seeks statements of interest from parties that want to “develop, evaluate, or commercialize the therapeutic use of microRNA-181a in the adoptive immunotherapy of cancer.”

Quest Licenses HIV Tropism Assay from Pathway Diagnostics
Quest Diagnostics has licensed from Pathway Diagnostics the underlying technology used in its co-receptor tropism HIV assay, Quest said last week.
The non-exclusive license covers the heteroduplex tracking technology used in Pathway’s SensiTrop test. Quest said that a molecular-based assay for co-receptor tropism will help physicians personalize HIV therapy.
Quest, which is the first full-service national clinical laboratory in the US to license the technology, expects to develop a validated assay using the technology in the first quarter of 2008. Until then, the SensiTrop test may be ordered through Quest, which will refer the test to Pathway Diagnostics.
"HIV co-receptor tropism tests can help physicians identify which patients, of the estimated 500,000 people in the US being treated for HIV infection, will benefit from entry inhibitor drugs, the latest development in life-enhancing anti-retroviral therapies,” Joyce Schwartz, Quest’s vice president and chief laboratory officer, said in a statement.
Financial terms of the agreement were not released.

Med BioGene Taps JRG for Strategic Advice to Help Launch Cancer Dx
Med BioGene said last week that it has hired JRG Ventures for strategic business advice as it moves to commercialize a new genomic-based diagnostic test for lymphoma.
JRG will help the company define its partnering and commercialization strategy as it prepares to roll out its clinical laboratory LymphExpress Dx test.
JRG advises companies involved in life sciences, healthcare, and information technology, partnering, licensing, corporate and regulatory strategies, and operations and logistics.
Financial terms of the agreement were not released.

Clinical Data Sells IVD Business for $20M as Part of Plan to Focus on PGx Rx and Dx Plays
Clinical Data last week said it has sold its Netherlands-based in vitro diagnostics business Vital Scientific to French company ELITech Group for $19.5 million in cash.
The actual sale price was $15 million, but Clinical Data said it retained $4.5 million in cash from Vital Scientific immediately before the sale.
CEO Drew Fromkin said the divestiture is “the latest and most significant step” in Clinical Data’s plan to “devote all of our resources to our IP-driven pharmacogenomics tests and targeted therapeutics, as well as our genomics services division.”
ELITech President Pierre Debiais said the acquisition is important to his firm because “it complements the company's current portfolio of IVD products and, in particular, its clinical reagents business.”
Clinical Data said this is the third move it has made to let go of its IVD enterprises. The company last November sold its Australia-based Vital Diagnostics business for $1 million, and in June this year it sold its US-based Clinical Data Sales and Service arm for around $7 million.

Molecular Dx Company XDx Files IPO Papers; Funds May Pay for Acquisitions
Molecular diagnostics company XDx has filed an initial public offering prospectus with the US Securities and Exchange Commission.
XDx, which develops diagnostics for immune-mediated disorders in patients who require long-term monitoring, said it plans to use the funds generated by the offering to expand infrastructure, propel R&D to support current and future tests, increase sales, marketing, and research staff, and expand its facilities.
The Brisbane, Calif.-based company may also use the proceeds to expand other businesses or technologies, either through acquisitions or investments.
The company launched its first test, the AlloMap HTx molecular expression test, in January 2005. The test, which costs $2,950, is designed to monitor heart transplant recipients for acute cellular rejection.
The company said it is also in the process of developing a second gene expression-based test, the AlloMap LTx molecular expression test, which would monitor lung transplant recipients for acute cellular rejection.
XDx is also designing a clinical study to create a gene-expression test to monitor for disease flares in patients with systemic lupus erythematosus, and “intend[s] to pursue tests to monitor other immune-mediated conditions with significant unmet medical needs with the goal of making our genomic-based tests standard diagnostic procedures,” the company said in the SEC filing.
XDx said in the filing that it has not yet determined the number of shares it will make available or the price at which they will be offered. Also, it said that its filing has not yet become effective with the SEC.
The offering is being underwritten by JP Morgan, Morgan Stanley, Piper Jaffray, and JMP Securities, according to the SEC filing.
XDx was formed in 1998 as Hippocratic Engineering. It was renamed Expression Diagnostics in 2002, and renamed again as XDx in July of this year.

Filed under

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.