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Archive for May, 2009

DxS, Boehringer Ingelheim Collaborate on Companion Diagnostic

Friday, May 29th, 2009

DxS (Manchester, UK) and Boehringer Ingelheim (Ingelheim, Germany) entered into an agreement to provide a companion diagnostic test kit for Boehringer’s compound BIBW 2992 (Tovok) to identify mutations of the epidermal growth factor receptor (EGFR) in patients with non-small cell lung cancer. Financial terms of the agreement are not disclosed.

Clinical data published to date suggest that BIBW 2992 offers a marked increase in efficacy in comparison to standard treatments for lung cancer patients carrying mutations in the EGFR gene. Under the terms of the agreement, DxS and Boehringer will work jointly to make a suitable companion diagnostic test kit globally available.

BIBW 2992 is a novel tyrosine kinase inhibitor that acts by irreversibly blocking the EGFR /HER2 receptors. As with other tyrosine kinase inhibitor therapies, patients with mutations in the EGFR gene will be more likely to respond to a medication that targets these receptors, thereby allowing doctors to prescribe the most effective and individual treatment. Furthermore, BIBW 2992 has demonstrated preclinical activity against erlotinib and gefitinib resistant mutations.

The DxS EGFR companion diagnostic is a real-time PCR assay, designed to detect the most common mutations in the EGFR gene. The diagnostic has been developed and manufactured at DxS’ head office in Manchester, UK. and will be available later in the summer for Boehringer’s global, multicentre Phase III clinical trial for BIBW 2992.

Qiagen to Provide Blood Screening Technologies in Brazil

Thursday, May 28th, 2009

Qiagen (Venlo, The Netherlands) entered into an agreement to supply molecular sample and assay technologies for a new national, PCR-based blood screening program for HIV and Hepatitis C (HCV) in Brazil. Qiagen will provide Bio-Manguinhos, the main provider of vaccines and diagnostics to the Brazilian Ministry of Health, with a significant volume of molecular testing solutions, such as sample and assay technologies, related instrumentation, operational know-how and training. Following the approval by the Brazilian patent authorities, the agreement will run for five years and contains options for subsequent extensions.

For Qiagen, this contract marks another, significant step in its expansion into the emerging Latin and South American markets. This expansion reflects the company’s efforts to supply integrated molecular testing solutions for the improvement of health and living conditions in the region. In October 2008, Qiagen and the Mexican Public Health Agency SSA signed an agreement for the supply of sample and assay technologies to be used in a national screening program for human papillomavirus (HPV).

Under the terms of this agreement, Qiagen’s extraction and testing components will be included in the screening kits and sold in a format featuring Bio-Manguinhos’s name and branding. The kits will run on a high-throughput multiplex PCR platform that allows processing of large numbers of samples and detecting multiple pathogens in one single run. The highly automated platform, which includes an advanced control system based on biosafe viruses developed and patented by Bio-Manguinhos, has demonstrated excellent screening results in the field test. The partnership between Qiagen and Bio-Manguinhos also involves technical advice for implementation of the production of enzymes and buffers in Brazil, but excludes the delivery of primers and probes. These integral test components are developed and provided by Bio-Manguinhos.

Type 1 Diabetics Benefit from Continuous Glucose Monitoring, Study Finds

Wednesday, May 27th, 2009

People with type 1 diabetes who have already been successful in achieving recommended blood sugar goals can further benefit from using continuous glucose monitoring (CGM) devices, according to results of a major multicenter clinical trial by the Juvenile Diabetes Research Foundation (JDRF; New York City).

According to the JDRF study, using CGM devices enables people who have achieved excellent control (with HbA1c levels below 7%) to continue to tightly manage their diabetes while cutting down on the frequency of hypoglycemia.  The landmark Diabetes Control and Complications Trial showed that with intensive insulin therapy, excellent blood glucose control was obtained, but at the expense of a considerable increase in hypoglycemia.  Today, the JDRF study has shown that, with a CGM, hypoglycemia can be reduced while maintaining excellent blood sugar control.

In addition, the study found that for the people using CGM devices, the time the blood sugar level was below 70 mg/dL decreased by 37 minutes a day.  This compared with a decrease in the control group of only 5 minutes a day.  In other words, people in the CGM group spent almost two hours more time per day in the target blood sugar range of 71-180 mg/dL, compared with the control group, and about half an hour less time per day with glucose values in the potentially dangerous hypoglycemia range.

Improving Diagnosis of ‘New’ Chlamydia

Tuesday, May 26th, 2009

New sequencing and analysis of six strains of Chlamydia will result in improved diagnosis of the sexually transmitted infection. A study by the Wellcome Trust Sanger Institute and University of Southampton provides remarkable insights into a new strain of Chlamydia that was identified in Sweden in 2006 after spreading rapidly across the country by evading most established diagnostic tests.

The results also reveal more about the evolution of the Chlamydia trachomatis bacterium. As part of a long-standing collaboration between the Wellcome Trust Sanger Institute and University of Southampton, the team of researchers focused on six strains of Chlamydia. Of particular interest to the team was the new Swedish strain provided by collaborators at Malmo University Hospital, Sweden.

The genome of the Swedish strain features an evolutionary hiccup that allowed it to go undetected in Sweden for several months. Indeed, doctors thought that the numbers of cases of Chlamydia were falling, when the opposite was true. Through nondiagnosis, this version of Chlamydia spread silently. The reason was a deletion of the region of genetic information used to diagnose the presence of Chlamydia.

The deletion, 377 letters of genetic code, occurred on the plasmid of the bacterium. Chlamydial plasmids have been shown to vary little between different strains of Chlamydia, and are present in larger quantities than the chromosome. This makes them ideal candidate targets for diagnostic tools. Clinical tests have focused on one region of the bacterial plasmid, a gene of unknown function which is largely deleted in the new Swedish strain.

Axis-Shield Sells Plasmatec Unit

Thursday, May 21st, 2009

Lab21 (Cambridge, UK) has expanded its diagnostic product range and increased its distribution channels through the acquisition of Plasmatec Laboratory Products Ltd. Plasmatec is based in Bridport, Dorset, and sells a comprehensive range of diagnostic tests in regions including Europe, Central and South America, Africa, the Middle East, and Asia Pacific. Plasmatec was founded in 1990, and since 1996, it has been a wholly owned subsidiary of Axis-Shield plc (Dundee, Scotland). Plasmatec has been sold to enable Axis-Shield sold Plasmatec to increase its focus on its point-of-care and laboratory divisions.

Lab21 has been advised by Excalibur Capital throughout the acquisition process. Financial terms of the acquisition are not being disclosed.

Bio-Rad Sells Notes, BD Declares Dividend

Wednesday, May 20th, 2009

Bio-Rad Laboratories Inc. (Hercules, CA), announced that it intends to commence an offering, subject to market and other conditions, of $250 million aggregate principal amount of senior subordinated notes in a private offering. Bio-Rad intends to use the proceeds for working capital and general corporate purposes, which may include acquisitions.

In other financial news, the Board of Directors of Becton, Dickinson and Co. (BD; Franklin Lakes, NY) has declared a quarterly dividend of 33 cents per common share, payable on June 30, 2009 to holders of record on June 9, 2009. BD’s indicated annual dividend rate is $1.32 per share.

Beckman Coulter Seeks Financing

Tuesday, May 19th, 2009

Beckman Coulter Inc. (Fullerton, CA), has commenced a public offering of shares of its common stock to finance in part the previously announced acquisition of the diagnostic systems portion of Olympus Corp.’s Life Science business. Beckman Coulter expects to raise proceeds of approximately $235 million in the offering, or $250 million if the over-allotment option granted to the underwriters is exercised in full. Morgan Stanley & Co. Inc. and Goldman, Sachs & Co. are acting as joint book-running managers for the offering.

In addition, Beckman Coulter announced the following pricing of its senior notes offering: $250 million of Senior Notes that mature in 2015 and bear interest at a rate of 6%, and $250 million of Senior Notes that mature in 2019 and bear interest at a rate of 7%.

Beckman Coulter also expects to use the net proceeds from this offering of approximately $495 million to finance a portion of the acquisition price for the diagnostic systems portion of Olympus’ Life Science business and for general corporate purposes. Pending the application of the net proceeds, Beckman Coulter plans to invest the net proceeds in U.S. government obligations, bank deposits, or in other secure, short-term investments.

Clinical Data, Dana-Farber Collaborate on Breast Cancer Gene Study

Monday, May 18th, 2009

PGxHealth, a division of Clinical Data Inc. (Newton, MA) has established a research collaboration with the Dana-Farber Cancer Institute to validate the use of genetic variants in Fc gamma receptors (FCGRs), including FCGR3A, in predicting response to trastuzumab (Herceptin) therapy in patients with breast cancer. The research, directed by Karen S. Anderson, MD, PhD at Dana-Farber, complements other studies underway to further demonstrate the contribution of genetic variants in the FCGR family to monoclonal antibody (mAb) response in cancer treatment. Importantly, the collaboration includes a large-scale effort to discover new genetic variants influencing response to Herceptin that may also predict response to other mAbs of the IgG1 class. The collaboration expands PGxHealth’s FCGR program, which includes its PGxPredict:RITUXIMAB test for a gene variant used to determine response to rituximab monotherapy in follicular non-Hodgkin’s lymphoma. Fc gamma receptors are antibody receptors found on immune-regulatory white blood cells, such as T-cells.

PGxHealth scientists will collaborate with Anderson and her colleagues to analyze certain genetic variants in breast cancer patients enrolled in two independent studies and receiving Herceptin along with other drugs in the neoadjuvant setting (before primary treatment), or in the setting of metastatic disease. Researchers will evaluate FCGR genotypes and their association with pathological and clinical response to Herceptin therapy. Preliminary data from the studies is anticipated by the end of 2009.

Growth in IVD Industry to Remain Steady in 2009

Friday, May 15th, 2009

According to a recent report by Kalorama Information (New York City), hospital industry woes may be a concern for the $47 billion IVD industry. With the key purchasers of IVD equipment and reagents facing cash crunches, reduced patient admissions and unpaid bills, growth for diagnostic companies will be more challenging over the next few years, as reported in Kalorama’s study, “In Vitro Diagnostics in a Recessionary Economy (IVD Market Forecasts, Analysis and Success Strategies).” 

Recent economic conditions have been rough for the hospital industry. Many hospitals and health systems have seen stock portfolios shrink and have had a difficult time obtaining credit to finance operations. A new survey from the American Hospital Association indicated that the majority of hospitals are seeing a moderate or significant decline in their financial health in 2009 versus the same period in 2008. 40% of hospitals expected losses in the first quarter of 2009. Recent employment information from the Bureau of Labor Statistics confirms that hospital employment is no longer growing and that the number of mass layoffs for hospitals reported in February was more than double what it was a year ago. Six out of ten hospitals nationally are seeing a greater proportion of patients without insurance coming through their emergency departments.

According to the report, consolidation is also possible since weaker hospitals may not survive and will be acquired, while larger hospitals will seek to acquire smaller entities instead of paying to expand existing facilities. Such consolidation will further erode the customer base for IVD products.

However, while the rough patch for hospitals may thwart grandiose expansion plans and intimidate new entrants, the report predicts steady but modest growth in the IVD industry, and notes that the industry still has a lot going for it. There has already been downsizing and cost cutting in the industry, and government programs and emerging markets will balance out downward sales to some extent.  

For more information on this report, click here.

Nanogen Files for Chapter 11

Thursday, May 14th, 2009

Nanogen Inc. (San Diego) has executed an asset purchase agreement with the Elitech Group to acquire substantially all of its assets.  As part of the sale, Nanogen filed a voluntary petition under chapter 11 of title 11 of the U.S. Code in the Bankruptcy Court for the District of Delaware, including a motion seeking bankruptcy court approval of the sale, subject to a court-supervised auction pursuant to Section 363 of the Bankruptcy Code and designating Elitech as the stalking horse bidder.  The auction bidding procedures, if approved, would require interested parties to submit higher and better binding offers to acquire all of Nanogen’s assets within approximately 30 days, and, assuming any qualified overbids are submitted, an auction would be held within approximately one week of the bid deadline.

Nanogen has agreed to sell substantially all of its assets to Elitech for a purchase price of $25.7 million. The sale is subject to customary closing conditions, approval of the Bankruptcy Court, and the auction process in which Nanogen will seek competing bids to achieve the highest price possible for the assets.  Nanogen will continue to manage and operate its businesses and assets during the pendency of the sales process, subject to the supervision of the Bankruptcy Court. 
 
In conjunction with the filing, Nanogen is seeking customary authority from the Bankruptcy Court that will enable it to continue operations and deliver products to customers in the ordinary course of business and without interruption.  The requested approvals include requests for the authority to make wage and salary payments, continue various benefits for employees, and honor basic terms of business for its customers.  In addition, Nanogen expects to honor its obligations to its vendors and other business partners for goods and services received after the bankruptcy filing. 

Last January, Nanogen sought alternatives to the previously announced share exchange agreement with Elitech.  Despite extensive and thorough efforts by Nanogen and its advisors, it was unable to secure sufficient working capital or alternative corporate transactions to enable it to service its debt obligations and fund its operations.  Nanogen’s management believes that filing for relief under Chapter 11 and the proposed sale of its businesses are in its best interests, as well as its partners, vendors, customers, and creditors.

Nanogen will not have sufficient proceeds to permit distributions of cash or other property to its holders of common stock unless it succeeds in selling its assets for an amount significantly in excess of the amount contemplated by the asset purchase agreement with Elitech.