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FDA, GVKBio, Curidium, Qiagen, Digene, Quest, Ventana, Affymetrix, Third Wave, CTI, TGen

FDA to Use GVKBio’s Biomarker DB in Voluntary Exploratory Data Program
GVK Biosciences said this week it has inked an agreement that will give the US Food and Drug Administration access to the company’s Clinical Biomarker Database.
Under the agreement, the FDA will use the database as part of its Voluntary Exploratory Data Submission Program and in internal research projects.
The database holds information from published literature relating to clinical and pre-clinical biomarkers, and may be used in biomarker design and validation research, the company said.
GVK Bio, which is headquartered in Hyderabad, India, has a US base in Columbia, Md.
Financial terms of the agreement were not released.

Curidium Lands $5M in Share Offering, Plans to Push Mental Health Dx
Curidium Medica said this week that it has grossed £2.5 million ($5.1 million) through the sale of 100 million shares at a price of 2.5 pence per share.
The London-based company said it plans to use the proceeds from the stock sale to fund product and business development programs. Part of the new capital will feed new R&D and business development programs for Curidium’s PsychINDx test, a blood-based diagnostic that categorizes patients with schizophrenia/bipolar disorder into four subgroups.
The company said the test is expected to support the development of new drug treatments targeted for the different subgroups.
The test runs on the company’s Homomatrix analysis tool, which uses pattern-recognition algorithms to analyze large sets of gene expression and other biological data from heterogenous populations, according to Curidium’s website.
The financing "will help accelerate the company's development in the personalized medicine space over the near term,” said company executive chairman Gosse Bruinsma in a statement.
The company said the lead investor in the offering will receive options to buy 5 million ordinary shares at 2.5 pence that may be exercised over the next five years.

Qiagen Closes $1.6B Digene Acquisition, Opens Hong Kong Subsidiary
Qiagen said this week it has closed its acquisition of Digene through a tender offer and merger valued at around $1.6 billion, under which Digene will become a wholly owned subsidiary of Qiagen North American Holdings.
Qiagen announced its intention to purchase the firm in early June.
Digene's central offering is a diagnostic test for human papillomavirus. One of its tests has been approved by the US Food and Drug Administration and has received CE-mark clearance by European regulators.
In June, Qiagen CEO Peer Schatz said the acquisition of Digene's molecular diagnostics assets would provide the firm "with many ways to drive top-line and bottom-line growth, such as access to new channels with existing and new products and combined technology, resources and infrastructure to provide greater operating strengths."
Under the terms of the deal, Qiagen shareholders agreed to pay $61.25 or 3.545 shares of Qiagen stock for each share of Digene stock. Qiagen said that 94 percent of Digene shares were tendered and that 90 percent of the shares tendered opted to receive Qiagen stock.
Advisors for the transaction were Goldman Sachs for Qiagen and JP Morgan for Digene.
In a separate announcement this week, Qiagen said that it has opened a new subsidiary in Hong Kong, which will serve as the hub for further expansion in the region.
Frauke Ehlert, general manager of Qiagen China and Hong Kong, said in a statement, "Hong Kong is a focal point for science, healthcare, and the fast-developing market for biomedical research."
Qiagen has 12 offices and approximately 300 employees throughout Asia. According to the firm, Asian sales contribute 15 percent to Qiagen's overall revenues.

Quest Extends HPV Marketing Deal With Digene for Four More Years
Digene last week said it has extended by four years a three-year marketing agreement with Quest Diagnostics under which Quest will market Digene’s test for human papillomavirus.
Digene will continue to supply Quest’s labs with the instrumentation and reagents for HPV testing, the company said.
Digene also said that Quest will “continue its efforts with Digene to educate and promote HPV screening along with the Pap test to its customer base of hospitals, physicians, and other healthcare providers.”

The test is used to detect HPV, which is “the recognized cause of cervical cancer,” and has been approved by the US Food and Drug Administration for use along with a Pap test in women aged 30 and older as a cervical cancer screen, Digene said.

Financial terms of the agreement were not released.

Ventana Brushes Aside Roche's Extended Takeover Bid
Roche last week extended its tender offer deadline to buy Ventana Medical Systems to the close of business on Aug. 23.
Roche's original deadline lapsed last night, and the federal anti-trust waiting period passed last week.
In response, Ventana reiterated that the offer remains “wholly inadequate” and that it is “significantly below our current market price.”
The offer “does not even come close to reflecting the intrinsic value of the company, its strong growth prospects in an accelerating market, and the synergy value of Ventana to Roche,” Ventana said.

Affymetrix Posts 10-Percent Rise in Q2 Revenue as Loss Swings to a Profit
Affymetrix last week said second-quarter revenue rose 10 percent, R&D costs dropped 10 percent, and a net loss swung to a small profit.
Total revenue for the three months ended June 30 rose to $88.3 million from $80.1 million year over year.
For the quarter, Affy said product revenue increased about 5 percent to $64 million; product-related revenue rose 21 percent to $17.2 million; royalties and other revenue rose 12.5 percent to $2.7 million; and revenue from Perlegen Sciences doubled to $4.4 million.  
The company said GeneChip consumable revenue was $67.2 million, consisting of array revenue of $41.0 million, reagent revenue of $14.2 million, and genotyping services revenue of $7.6 million. Instrument revenue was $8.8 million for the quarter.
“We are pleased with the sequential and year-over-year top-line revenue growth driven by the strong adoption of our new SNP 6.0 genotyping product," Kevin King, Affy’s Life Sciences’ president, said in a statement. "The successful launch of this product [in May] has resulted in a number of important new global commercial agreements.”
R&D spending slipped to $19.4 million from $21.6 million in the prior-year period.
The company posted a $1.2 million profit from a loss of $10 million year over year.
As of June 30, Affy had $232 million in cash, cash equivalents, and short-term investments.
The company said it expects total 2007 revenue in the range of $365 million to $385 million.

Third Wave's Q2 Clinical Dx Sales Up 24 Percent as R&D Costs Feed Loss
Third Wave Technologies last week reported that its second-quarter revenues grew 9 percent as R&D spending rose 73 percent and net loss widened 53 percent.  
Total receipts for the three months ended June 30 increased to $7.4 million from $6.8 million year over year.
Revenue from clinical products rose 26 percent to $6.3 million, while receipts from research products tumbled 37 percent to $1.1 million.
"Revenue growth from our current molecular diagnostic product menu forms a strong foundation for the significant value we anticipate creating for our shareholders with our HPV products," CEO Kevin Conroy said in a statement.
R&D expenses rose to $5.2 million from $3 million the previous year.
Net loss for the period swelled to $7.2 million from $4.7 million year over year. Third Wave attributed the widening loss to its investment in clinical trials for its HPV product.  
Third Wave had around $47.8 million in cash, cash equivalents, and short-term investments as of June 30.
“Third Wave continued to focus on advancing our HPV clinical trial, and growing our clinical revenue and customer base” over the quarter, Conroy said.
A judge in a US District Court in Wisconsin last week sided with the company’s definitions of its HPV patent an infringement lawsuit against Digene, which markets its own HPV test.
That development that could remove a large barrier from Third Wave’s path as it pushes its HPV test to market.
The company reaffirmed its full-year 2007 guidance of $26 million to $28 million in revenues for its clinical molecular diagnostics business and $31 million to $33 million in total revenue for the year.

CTI to Buy TGen-Affiliated PGx Drug Maker for At Least $20M
Oncology products maker Cell Therapeutics has struck a deal to buy Systems Medicine, a pharmacogenomics-focused cancer drug company co-founded by Translational Genomics Research Institute’s physician-in-chief, Daniel Von Hoff, CTI said last week.
In a stock merger valued at around $20 million, with the potential for an extra $15 million more in milestone payments going to SMi stockholders, CTI intends to use “SMi’s strategic affiliation with TGen” to guide “clinical trials toward patient populations where the highest likelihood of success should be observed, thereby potentially lowering risk and shortening time to market.”
Tucson, Ariz.-based SMi focuses on using pharmacogenomic profiling to develop oncology drugs that target what it calls “the tenderloin” of patients that may benefit from a drug through clinical trials.  
Under the terms of the agreement, SMi will operate as a wholly owned subsidiary of CTI where it will use its genomic-based platform to guide development of CTI's oncology products.
Von Hoff, who is also director of the Clinical Translational Research Division at TGen and chief scientific officer of U.S. Oncology, is expected to head CTI's “strategic product portfolio committee.”
Richard Love, a founder of SMi and former founder and CEO of ILEX Oncology, is expected to join CTI's board.

According to a statement, SMi “applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context-of-vulnerability.'”

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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.