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Archive for November, 2009

BD Acquires HandyLab

Friday, November 20th, 2009

BD (Becton, Dickinson and Company) announced the completion of its acquisition of HandyLab Inc. (Ann Arbor, MI), a company that develops and manufactures molecular diagnostic assays and automation platforms.

In May 2009, BD and HandyLab announced an exclusive agreement for BD to develop and commercialize molecular assays on the HandyLab Jaguar platform, the first fully integrated molecular diagnostic system to provide hands-off operation, incorporating clinical sample preparation, nucleic acid extraction, and microfluidic real-time polymerase chain reaction (PCR) amplification and detection in a simple bench-top system. The self-contained workstation is designed to accommodate both batch workflows and on-demand testing for maximum lab efficiency and flexibility.

With this acquisition, BD will migrate its BD GeneOhm molecular assays for Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, and Vancomycin-resistant Enterococcus (VRE) onto the new platform and will market them as the new BD MAX system, an evolution of the current Jaguar system.

The healthcare-associated infections (HAI) opportunity is emerging worldwide and is potentially very large, and BD has a leading position with its BD GeneOhm molecular testing product line. As hospital screening and testing programs expand, they will require flexible, state-of-the-art automation systems to support their evolving needs. The flexibility of this novel platform will allow further expansion of the BD molecular diagnostic menu.

BD paid $275 million for HandyLab. The financial impact of the acquisition on fiscal year 2010 earnings has been incorporated into the guidance BD provided during its earnings call on November 4, 2009.

Tags: BD, Merger & Acquisition
Posted in Business News, Molecular Diagnostics | No Comments »

OraSure Settles Patent Suit with Inverness

Thursday, November 19th, 2009

OraSure Technologies Inc. announced the settlement of the patent infringement lawsuit filed against OraSure by Inverness Medical Innovations Inc., Inverness Medical Switzerland GmbH, and Church & Dwight Co..

Under the settlement, OraSure has agreed to pay Inverness a sum of $3,000,000 in cash, and Inverness has agreed to grant OraSure certain licenses to its lateral-flow patents. In addition, each party has received distribution rights to certain products supplied by the other party. Terms of the settlement include the following:

The grant to OraSure of worldwide, non-exclusive, royalty- bearing, lateral-flow patent licenses (subject to a royalty-free period) for the OraQuick HIV-1/2 test and other visually- read HIV lateral-flow products in the professional market, and for the OraQuick HCV test and other visually read HCV lateral flow products in the professional market;

The grant to OraSure of a worldwide, non-exclusive, royalty- bearing, license to Inverness lateral-flow patents for visually-read products for the detection of certain infectious diseases, metabolic disorders, cancer and autoimmune disorders;

The grant to OraSure of non-exclusive rights to distribute in the United States as private label products certain rapid, point-of-care, flu, strep, drugs of abuse, and pregnancy tests manufactured by Inverness;

A right of first negotiation during the 120-day period following the settlement effective date for OraSure to negotiate the terms for the marketing and distribution of the OraQuick HIV-1/2 test on an exclusive basis in the over-the- counter markets worldwide with the consumer diagnostics joint venture between Proctor & Gamble and Inverness; and

The grant to Inverness of exclusive distribution rights to the OraQuick HCV test in the employee health services and home healthcare markets and in acute care clinics located in pharmacies and other mass retail outlets in the United States.

Tags: Inverness, Litigation
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Qiagen Looking for More Acquisitions

Wednesday, November 18th, 2009

As reported on Bloomberg.com, Qiagen NV has spent about $2 billion on acquisitions since 2004 and is armed for yet more takeovers as it seeks additional gene-based tools to predict disease.

Qiagen has almost $1 billion in available funds and is in talks that may lead to another purchase this year, said chief financial officer Roland Sackers. The company may also spend $200-$500 million on deals next year, buying more companies than in 2009 as prices decline, he said.

“Now is a good time because we have seen that prices in areas we are looking for such as molecular diagnostics and applied testing have become more attractive than 12 -18 months ago,” Sackers said.

In September, Qiagen agreed to buy DxS Ltd. for as much as $130 million, a purchase it expects to add $30 million to 2010 sales. This month, it agreed to buy SABiosciences Corp. in a deal valued at $90 million. The $1.4 billion takeover of Digene Corp. in 2007, the company’s biggest acquisition, opened the door to the growing market for tests to detect the virus that causes cervical cancer.

The expansion has helped boost Qiagen’s annual sales, which may pass $1 billion for the first time this year, according to some analyst estimates. Profit may increase 23% to $192.5 million, according to the average of 23 estimates.

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Tags: Merger & Acquisition, Qiagen
Posted in Business News, Molecular Diagnostics | No Comments »

deCODE Files for Bankruptcy

Tuesday, November 17th, 2009

deCODE genetics Inc. has filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code with the U.S. Bankruptcy Court for the District of Delaware to facilitate the sale of substantially all of its assets. deCODE is continuing to operate its business and manage its properties as a debtor-in-possession pursuant to Sections 1107 and 1108 of the Bankruptcy Code.

In recent months, deCODE and its advisors have explored multiple restructuring alternatives, including the sale of specific portions of deCODE’s operations, the restructuring of its outstanding convertible notes, and the obtaining of new equity financing. As a result of these efforts, deCODE has entered into and filed concurrently with its Chapter 11 petition an asset purchase agreement with Saga Investments LLC to sell its Iceland-based subsidiary Islensk Erfdagreining (IE), and its drug discovery and development programs. This agreement, pursuant to Section 363 of the Bankruptcy Code, is subject to a number of contingencies, including a competitive bidding procedure and court approval in accordance with bankruptcy law. IE conducts deCODE’s human genetics research, manages its population genetics resources, and provides its personal genome scans, DNA-based risk assessment tests, and genomics services for contract customers.

deCODE expects that if the asset sale is consummated, it would be liquidated pursuant to a plan of liquidation which would be subject to the approval of the bankruptcy court. In the event of a liquidation, any recovery for stockholders of deCODE would be highly unlikely.

deCODE has also entered into a secured loan agreement with Saga which, subject to bankruptcy court approval, will provide the company with interim financing to fund post-petition operating expenses. deCODE expects this debtor-in-possession financing, if consummated, to allow the delivery of services to deCODE’s customers and clients to continue without interruption during the bankruptcy process. Saga’s investors include Polaris Venture Partners and Arch Venture Partners.

deCODE has filed various “first day” motions with the bankruptcy court to ensure its ability to conduct normal business operations. This Chapter 11 filing is for deCODE genetics Inc. only, and does not include IE or deCODE’s former U.S.-based subsidiaries deCODE Biostructures Inc. and Emerald BioSystems Inc., recently sold to an unrelated third party.

Tags: Finance
Posted in Business News | No Comments »

Roche H1N1 Flu Assay Gains FDA Authorization

Monday, November 16th, 2009

Roche’s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from FDA. The Roche kit detects RNA from the 2009 H1N1 influenza A virus and allows rapid and accurate identification of patients infected with this virus. It is important to differentiate patients infected with 2009 H1N1 virus from others with similar symptoms so that appropriate patient management can be commenced as early as possible. The efficacy of the Roche assay was demonstrated by clinical evaluation at worldwide study sites.

The RealTime ready Influenza A/H1N1 Detection Set is used in conjunction with the RealTime ready RNA Virus Master kit also provided by Roche. The assay is carried out on the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler 2.0 system for real-time PCR. By providing detection reagents along with the master mix and necessary equipment, Roche is able to support all phases of the testing process for 2009 H1N1 virus.

Tags: FDA, Roche
Posted in Molecular Diagnostics, Regulatory Affairs | No Comments »

Agilent Posts 4Q Results

Friday, November 13th, 2009

Agilent Technologies Inc. reported revenues of $1.17 billion for the fourth fiscal quarter ended Oct. 31, 2009, 21% below one year ago. Fourth quarter GAAP net income was $25 million, or $0.07 per diluted share. Last year’s fourth quarter GAAP net income was $231 million, or $0.64 per share.

During the fourth quarter, Agilent had restructuring and asset impairment charges of $60 million and $10 million of non-cash amortization. Excluding these items and $16 million of other net charges, Agilent reported fourth quarter adjusted net income of $111 million, or $0.32 per share. On a comparable basis, the company earned $223 million, or $0.62 per share, one year ago.

Geographically, weakness was most pronounced in the United States and Europe, which were off 12% and 11%, respectively, from one year ago. Asia was generally flat, with Japan up 2% and other Asia off 1%. China revenues were flat versus last year but only because of an extraordinary surge in volumes last year related to food safety issues; fourth quarter orders in China were 30% above one year ago.

Tags: Financial Results
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CombiMatrix Posts 3Q Results, Explores Merger Options

Thursday, November 12th, 2009

CombiMatrix Corp. reported financial results for the three and nine months ended September 30, 2009. Revenues for the third quarter of 2009 were $970,000 versus $1.2 million for the second quarter of 2009 and $1.0 million in the third quarter of 2008. Third quarter 2009 revenues were comprised of $133,000 in government contact revenues, $234,000 in CustomArray product, equipment and service revenues, and $603,000 in diagnostic lab revenues. Third quarter 2008 revenues were comprised of $343,000 in government contract revenues, $205,000 in CustomArray product, equipment and service revenues and $463,000 in diagnostic lab revenues. Government contract revenues have decreased due to fewer active contracts with the U.S. Department of Defense in the current reporting period than in the comparable historical period. CustomArray product revenues have increased due to slightly higher instrument sales in the current reporting period than in the comparable historical period. Diagnostic laboratory revenues increased during the third quarter of 2009 versus the comparable period in 2008 by 30% due primarily to expanded sales and marketing efforts as well as a larger suite of diagnostic test offerings in the current reporting period than in the comparable 2008 period.

“Additionally, the strategic discussions we have initiated with RW Baird, our financial advisor, are progressing,” stated Dr. Amit Kumar, president and CEO of CombiMatrix. “Although I am not able to provide specific information about companies contacted or the content of related discussions, I would like to give a general update. We have been in contact with a number of companies and have made, and will continue to make, management presentations to those who express interest. Some potential suitors who have signed non-disclosure agreements have initiated due diligence. These companies do not fit a single mold — they include both large cap companies and companies in the middle market, as well as financial organizations that have expressed an interest in getting into this space and are seeking a platform. Some companies appear interested in acquiring our whole company, while others seem interested in components that are a strategic fit for them. In time, we expect to be able to evaluate offers, if any, from interested parties. As already noted, the content of our discussions and the identity of contacted parties are confidential, so I cannot provide additional information at this time; however, we intend to provide further updates when we conclude that circumstances are appropriate. I also note that at this time, there is no assurance that we will receive any firm offers from interested parties, or that our management would deem any offers acceptable.”

Tags: Financial Results
Posted in Business News, Molecular Diagnostics | No Comments »

Epigenomics Posts 3Q Results

Wednesday, November 11th, 2009

Epigenomics AG reported financial results for the third quarter and for the first nine months of 2009, which ended September 30, 2009. Epigenomics’ revenue for the first nine months of 2009 amounted to EUR 3.2 million, an increase of more than 77% compared to EUR 1.8 million during the same period in 2008. The revenue during the first nine months was generated from continued and newly signed collaborations and licensing agreements in the form of R&D payments, licensing fees, reimbursements as well as sales of research-use-only products.

R&D costs dropped from EUR 6.8 million during the first nine months of 2008 to EUR 5.1 million in the reporting period primarily resulting from increased resource allocation to commercial collaboration projects and a corresponding shift to cost of sales. Costs of sales increased to EUR 2.1 million compared to EUR 0.7 million during the first nine months of 2008, mainly as a result of increased product development expenses associated with collaboration agreements with Abbott and Philips and costs for the acquisition of clinical samples under the agreement with Abbott.

Net loss for the reporting period amounted to EUR – 7.1 million, a substantial reduction compared to EUR – 8.1 million during the first nine months of 2008. Basic loss per share improved from EUR – 0.32 during the first nine months of 2008 to EUR – 0.24 during the first nine months of 2009.

Tags: Financial Results
Posted in Business News, Molecular Diagnostics | No Comments »

Qiagen Announces 3Q Results, Acquisition

Tuesday, November 10th, 2009

Qiagen NV announced the results of operations for the third quarter and the nine-month period ended September 30, 2009. The reported net sales and the adjusted earnings per share for the third quarter 2009 exceeded the guidance provided by the company on August 11, 2009.

The company reported that consolidated net sales for its third quarter 2009 increased 13% to $259.7 million from $230.8 million in the same quarter of 2008. Excluding the unfavorable impact from foreign currency exchange rates, net sales for the third quarter 2009 would have increased 16%. The reported operating income for the quarter increased 40% to $53.4 million from $38.2 million in the same quarter of 2008, and net income for the quarter increased 81% to $37.7 million from $20.8 million in the same quarter of 2008. Diluted earnings per share for the third quarter increased 80% to $0.18 in 2009 from $0.10 in 2008.

On an adjusted basis, third quarter operating income increased 22% to $81.8 million in 2009 from $66.8 million in 2008, and third quarter 2009 adjusted net income increased 26% to $53.5 million from $42.4 million in 2008. Adjusted diluted earnings per share increased 24% to $0.26 in the third quarter 2009 from $0.21 in 2008.

For the nine-month period ended September 30, 2009, net sales increased 10% to $720.7 million compared to $655.8 million in the same period of 2008. Operating income as reported for the nine months ended September 30, 2009 increased 30% to $137.3 million from $105.2 million for the same period in 2008. Net income increased 45% to $93.3 million from $64.4 million in 2008, and diluted earnings per share increased 45% to $0.45 in 2009 from $0.31 in 2008.

On an adjusted basis, operating income for the nine-month period ended September 30, 2009 increased 14% to $212.7 million in 2009 from $186.1 million in 2008, and adjusted net income increased 19% to $142.0 million from $119.6 million. Adjusted diluted earnings per share in the nine months ended September 30, 2009 increased 19% to $0.69 per share from $0.58 per share in the same period of 2008.

Qiagen also announced that it has signed a definite agreement to acquire SABiosciences Corporation, a privately-held developer and manufacturer of disease- and pathway-focused PCR assay panels. SABiosciences is based in Frederick, MD, and employs a staff of around 100. The transaction is valued at US$90 million in cash (subject to customary purchase price adjustments) and is expected to close in late December 2009, following approval of SABiosciences’ stockholders and the expiration of the statutory waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

SABiosciences holds a leading position in the design and commercialization of disease- and pathway-focused real-time PCR-based assay panel. The company’s primary product family includes more than 100 real-time PCR assay panels designed for high-performance analysis of DNA, RNA, epigenetic and microRNA targets in biological pathways associated both with specific diseases such as cancer, diabetes, immune and cardiovascular disorders, as well as with pathways such as apoptosis (programmed cell death), signal transduction and toxicology.

Tags: Financial Results, Merger & Acquisition, Qiagen
Posted in Business News | No Comments »

Caliper Reports 3Q Results, EPA Funding

Monday, November 9th, 2009

Caliper Life Sciences Inc. reported results for its third quarter ended September 30, 2009. GAAP revenues increased by 4% to $32.2 million, from non-GAAP revenues of $31.0 million in the same period of 2008, which represents GAAP revenue of $34.0 million in the third quarter of 2008 reduced by $3.0 million for the impact of divested product lines. The overall increase in revenues was led by strong performance of the company’s IVIS Imaging and LabChip product families. Foreign currency changes did not have a significant impact on total revenue in the quarter. The company achieved positive operating net cash flows of $2.8 million in the quarter as a result of effective inventory management coupled with year-to-date improved bottom-line performance.

Caliper also announced that its Caliper Discovery Alliances and Services (CDAS) unit has been awarded a new funding commitment for $1.8 million under its contract with the Environmental Protection Agency (EPA) for the EPA’s ToxCast screening program. This new task order increases the cumulative funding Caliper has been awarded under the ToxCast program to $5.6 million.

Caliper has been working with EPA on its ToxCast program since 2007. The initial goal of the ToxCast program is to create a database of in vitro (laboratory) assay data on a broad set of compounds for which in vivo (animal) safety data already exists. The long term goal of ToxCast is to identify in vitro assays that can predict toxicity in humans and animals and then employ those predictive tests to supplement or replace existing animal-based tests, thus reducing the cost and improving the speed of regulatory approval of new environmental chemicals.

Tags: Collaboration, Financial Results
Posted in Business News | No Comments »