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Roche tender offer for Illumina, Inc: $44.50 per share in cash

27-01-2012. Roche announced today that it has commenced a cash tender offer to acquire all outstanding shares of Illumina, Inc. (NASDAQ: ILMN). The offer and withdrawal rights are scheduled to expire at 12:00 midnight, New York City time, at the end of the day on February 24, 2012, unless the offer is extended. Under the terms of the offer, Roche is offering to acquire Illumina for $44.50 per share in cash, or an aggregate of approximately $5.7 billion on a fully diluted basis. This offer represents a premium of 64% over Illumina’s closing stock price on December 21, 2011 – the day before market rumors about a potential transaction between Roche and Illumina drove Illumina’s stock price significantly higher – a 61% premium over the one-month historical average and a 43% premium over the three-month historical average of Illumina’s share price, both as of December 21.


Roche’s offer is conditional upon, among other things, (i) the tender by Illumina’s stockholders prior to the expiration of the tender offer of a number of shares, which, together with the shares owned by Roche, represents at least a majority of the total number of shares outstanding on a fully diluted basis, (ii) the redemption of the preferred stock purchase rights associated with the shares or Roche’s satisfaction in its reasonable discretion that such rights have been invalidated or are otherwise inapplicable to the tender offer and the proposed merger, (iii) Roche’s satisfaction that the anti-takeover provisions of the Delaware General Corporation Law are inapplicable to the proposed merger and (iv) Illumina must not have entered into or effectuated any agreement or transaction with any person or entity having the effect of impairing Roche’s ability to acquire Illumina or otherwise diminishing the expected value to Roche of the acquisition of Illumina. If following the consummation of the offer Roche owns at least a majority of the outstanding

Source: Roche

 

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COSMO: Positive results of first parts of Phase II / Blu-colonscopy

20-06-2011. Cosmo Pharmaceuticals S.p.A. today announced that a live transmission of a colonoscopy on a patient that had taken a Methylene Blue MMX® tablet for the better diagnosis of polyps, dysplastic lesions and adenomas in the colon, took place in front of approximately 500 specialists from around the world present at the International Meeting for Advanced Gastroenterology Endoscopy at Humanitas Hospital in Milano/Italy. Separately Prof Repici of Humanitas Hospital, who is conducting the phase II dose ranging trial testing the colon staining efficacy of single increasing oral doses of Methylene Blue MMX modified release tablets, gave a preliminary analysis of the results from the first 40 patients that have been treated so far.  
 
Prof. Repici said, “The preliminary results of the phase II dose ranging study convincingly demonstrate Methylene blue-MMX®tablet’s ability to stain the entire colon and thus vastly increase the possibility of detecting small polyps, dysplastic lesions and adenomas. It is of utmost importance to detect these small polyps, lesions and adenomas as early as possible before they turn into cancer, also considering that every colon cancer patient costs between USD 35’000 and USD 85’000 per year. The results that have been achieved in my study point out that Methylene blue-MMX®could become the diagnostic of choice for every screening colonoscopy.”
 
The Methylene blue-MMX®tablet is an oral colon-release formulation in form of coated tablets, containing methylene blue. The tablets are formulated using Cosmo’s patented multimatrix technology (MMX®) that allows the delivery of the active ingredient directly inside the colon. With this technology, the maximum local bioavailability of the active ingredient is achieved and, consequently, the biological effect is optimized. Patents have been filed and are pending.
 
Provepharm SAS, France is the manufacturer of Proveblue™, the methylene blue powder used in Methylene blue-MMX® tablets. The active ingredient in the powder is manufactured in compliance with European Pharmacopoeia. Unlike other manufacturers the powder obtained at Provepharm reaches a purity grade of 99%. Cosmo and Provepharm have entered into an exclusive licensing agreement.
 
The phase II dose ranging study that is being conducted by Prof A. Repici at the Istituto Clinico Humanitas in Rozzano/Italy is designed to treat approximately 100 patients undergoing colonoscopy with single increasing oral doses of Methylene Blue MMX modified release tablets with the intention of testing the colon staining efficacy. It is scheduled to be completed in the second half of the year.

 

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Provepharm: Synthetic Scheme for Methylene Blue

by B2Bioworld Editor* 

Source: US0291943, 26-11-09

 

 

* A non-sponsored service for free to readers of B2Bioworld - Get out more of PR

 


Neogen acquires VeroMara from GlycoMar Ltd.

20-06-2011. Neogen Corporation (NASDAQ: NEOG) announced today that it has acquired the assets of the VeroMara seafood testing laboratory from its parent company, GlycoMar Ltd. Based in Oban, Scotland, VeroMara offers testing services to the shellfish and salmon aquaculture industries. VeroMara’s services include testing for shellfish toxins, general foodborne pathogens, including E. coli, noroviruses, and salmon husbandry. VeroMara recorded revenues of approximately $800,000 (U.S.) in its most recently completed fiscal year. Terms of the acquisition were not disclosed.


“The acquisition of VeroMara deepens Neogen’s advancement into the aquatic sciences,” said James Herbert, Neogen’s CEO and chairman. “VeroMara’s services are complementary and a nice fit with our existing product lines for the seafood industry, including one of our biggest food safety diagnostic products — our histamine tests for the tuna industry. The VeroMara purchase also provides Neogen with key collaborative relationships with influential aquaculture partners, and increased access to important international markets. “Our new operation in Oban will work in close cooperation with our Neogen Europe headquarters in Ayr, Scotland, providing expanded products and services to a larger customer base,” Herbert continued. “Our sales and marketing operations in Ayr have the capability to expand VeroMara’s business to several other European countries.” “The sale of our VeroMara testing service allows GlycoMar to focus on our core business — marine natural product research and development,” said Dr. Charles Bavington, GlycoMar’s managing director. “We are pleased to have VeroMara join Neogen, a company we respect as being one of the world leaders in food safety. This transition will guarantee uninterrupted quality service to our customers.”


In addition to its comprehensive line of rapid foodborne pathogen, sanitation monitoring and histamine tests that it offers the seafood industry, Neogen recently released rapid tests to detect toxins in shellfish that cause amnesic shellfish poisoning (ASP) and diarrhetic shellfish poisoning (DSP). The detection of ASP and DSP toxins has been a key service VeroMara has offered its customers. Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division markets a complete line of diagnostics, veterinary instruments, veterinary pharmaceuticals, nutritional supplements, disinfectants, and rodenticides.

 

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Bayer AG: New Stakes in Stem Cells

Prof. Andreas Busch, Member of the Bayer HealthCare Executive Committee, responsible for Global Drug Discovery

Prof. Andreas BuschJanuary 2011. An unmasked account of decisions about investing into cancer stem cell research and the fate of regenerative medicine projects in Japan. Dr Busch summarises results and evaluates technology platforms like novel antibodies and wnt mechanisms. He voices his expectations from current key drug development partnerships, in particular with Oncomed and Micromet. Will these include companion diagnostics? To what extent does Bayer retain respective intellectual property rights? A comment on personalised medicine and cancer stem cells research pursued by Merck KGaA and others. What are prospects for classic oncology drugs?

 

 

 

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Elmar Schnee resigns from Merck KGaA's Board ... and Chemgenex?

Wolf G Kroner

 

Darmstadt, 13-12-2010. Merck Serono’s Chief Executive Officer and General Partner of Merck KGaA is resigning from his duties for ”personal reasons” end of year, his company told in a press release today. The leave of Mr. Schnee comes as surprise given his continued merits in profitably streamlining Merck’s pharma divisions and changing Serono’s culture of youthful impetuosity to a more sustainable one embodied by the Merck family. He is followed by Stefan J. Oschmann who has been lately President of Emerging Markets of Merck & Co, and will move from MSD’s headquarters at Whitehouse Station, New Jersey (US) to Darmstadt beginning January 2011.

(C) Wolf G Kroner 2010Mr. Schnee (51) is a marketing veteran in the pharmaceutical industry where we worked with Fisons Pharmaceutical, Sanofi-Synthélabo, and UCB Pharma before joining Merck in 2003. He started as Managing Director of Merck Santé SAS at Lyon (FR) with responsibilities to commercialise Merck’s prescription medicines and managing distribution alliances. Since 2006 he is General Partner of Merck KGaA. In the group he is responsible for the pharmaceutical business including consumer healthcare. Currently, one of Mr. Schnee’s very few external duties is with ChemGenex Pharmaceuticals (ASX: CXS; American Depository receipts: CXSPY). Since 2007 he is Director of Board of this company and the architect of acquiring shares for Merck. With 8.49% Merck Santé is CXS’ third largest shareholder. This has raised questions, how the resignation will affect ChemGenex.

Chemgenex is rapidly approaching the market stage and aims for a global reach. Its most advanced drug candidate is omacetaxine mepesuccinate (trade name: OMAPRO) for patients with chronic myeloid leukemia (CML). It is directed to Philadelphia chromosome positive chronic myeloid leukaemia in patients who have the T315I Bcr-Abl kinase domain mutation and who are resistant to prior therapy of Novartis’ imatinib (trade name: Glivec). In fall 2008 the company already established European operations at Lyon to pursue EU marketing authorisation of OMAPRO and has received an orphan drug designation meanwhile. With expectations of approval by EMEA ChemGenex has entered with Hospira into a marketing agreement for Europe, the Middle East and parts of Africa in December 2009. In the United States ChemGenex intends to commercialise itself the drug. However, in March it experienced a setback in the US as an FDA advisory committee recommended submission of ”a well characterized” diagnostic test instead of the ones used in previous trials in order to identify patients with the mutation prior to approval of the drug. In this situation CXS is to benefit more than ever from Elmar Schnee’s advice as he “will continue to support Chemgenex on the board of directors”, at least during the next 12 months Dr Greg Collier, the company’s CEO told B2Bioworld.
 
Given the abrupt departure in conjunction with the rapid nomination of Dr. Oschmann to Mr. Schnee’s post, observers say, that the present resignation might be more related to internal dynamics of Merck than to external companies, a view which Mr. Schnee is confirming. Asked about his plans, in particular with regard to Chemgenex Pharmaceuticals, he told B2Bioworld: ”I will have to take it apart, if I have a moment to spare. Up to now I have been fully occupied, and then, we’ll see.”

 

This article is offered to you for free reading by B2Bioworld - Quality News.

 

(C) B2Bioworld 2010. All Rights Reserved

Researchers Solve Mystery of Uner Tan Syndrome with Targeted Next-Generation Sequencing

Using Roche NimbleGen Sequence Capture and 454 Sequencing Systems

29-07-2010. A team of researchers from leading universities in Turkey and the United States have reported that they have identified the genetic mutation responsible for the Uner Tan Syndrome (UTS) using advanced genetic capture and sequencing technologies from Roche (SIX: RO, ROG; OTCQX: RHHBY). The combined genomic technologies enabled the team of scientists to identify the causative mutation of this debilitating disease after years of mystery. The study was presented by Suleyman Gulsuner, M.D. from Bilkent University, Turkey during the European Human Genetics Conference recently held in Gothenburg, Sweden at which he was awarded the prestigious Isabelle Oberlé Award for outstanding work in the field of genetics of mental retardation.

Uner Tan Syndrome is a debilitating condition that causes those affected to walk with a quadruped gait, using their feet and the palms of their hands while also suffering from severe mental retardation. This syndrome attracted worldwide attention and was featured in the 2006 BBC2 documentary The Family That Walks On All Fours. In addition to the initial family, other families with the same syndrome have been reported in Turkey as well as in Iraq, Iran and Brazil. Initial mapping studies indicated genetic heterogeneity. The scientific group, led by Prof. Tayfun Özçelik, M.D. at Bilkent University, identified the first gene in 2008 (Proc Natl Acad Sci U S A, 105:4232-6). However, the cause of this disorder in the original family featured in the BBC documentary remained unclear and theories regarding the contribution of genetic and environmental factors have been postulated. To identify the genetic basis, scientists have focused their search on a specific region on chr 17p13 in the genome. However, finding the disease causing mutation in the more than 7 million DNA bases within this region has presented an enormous challenge.

Using Roche NimbleGen’s Sequence Capture technology and the GS FLX System from 454 Life Sciences, a Roche company, the ~ 7 Mb targeted candidate region from two affected and two carrier individuals were quickly extracted from the genome and sequenced. Trimming of the candidate mutations found in the region led to a list of four final candidates based on gene function and Mendelian disease models.  Out of these four candidates, three were excluded by further screening 300 healthy controls. In the end, a single mutation was discovered from this study as the genetic basis for Uner Tan Syndrome in the affected family.

“Human genomics is enjoying a most productive period in the identification of genes associated with rare diseases thanks to next generation sequencing technologies. The gap between the identification of a disease locus and the actual documentation of causative mutations was a daunting task until recently; presenting a serious bottleneck in medical genetics studies” explained Prof. Tayfun Özçelik, “However, now as we celebrate the 10th anniversary of the completion of the human genome project, ‘omics technologies coupled with genome sequencing approaches are offering unparalleled opportunities to better understand human evolution, early human migration and genetic diversity. Undoubtedly, next generation sequencing will lead to scientific discoveries, which will enable genetic knowledge to be translated into medical knowledge and contribute substantially to the understanding of the genetic basis of human diseases worldwide”.

“NimbleGen and 454 Life Sciences’ technologies worked wonderfully in this study. Combining new targeted next generation sequencing technologies with the traditional genetic linkage analysis enabled the efficient capture and high quality sequencing of the region, and led to the discovery of the disease causing mutation at a speed which was unimaginable a few years ago. It is quite convincing that, these kinds of studies will be a primary scientific and medical tool in the near future.” added Dr. Gulsuner.

“We are excited to see the medical value that Roche products, such as NimbleGen Sequence Capture, provide in helping researchers unravel another unknown mystery in inherited diseases.” stated Dr. Frank Pitzer, CEO at Roche NimbleGen.  “We believe similar studies carried out by researchers like Prof. Tayfun Özçelik will help us better understand the causes of many genetic diseases, hopefully leading to future breakthroughs in diagnostic and therapeutic interventions.”

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FDA clears Roche’s LightCycler® MRSA Advanced Test for use in the U.S.

Easy-to-use molecular test offers faster results to help healthcare facilities control spread of methicillin-resistant Staphylococcus aureus (MRSA)


09-07-2010. Roche Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration (FDA) cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States. The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA, and it is designed to aid in the prevention and control of MRSA infections in healthcare settings. Roche’s new real-time polymerase chain reaction (PCR) test delivers rapid results (within two hours) and appears to have better sensitivity compared to direct culture-based methods.
"It is important that healthcare professionals have access to MRSA testing technology that provides rapid and reliable results, allowing faster implementation of appropriate infection control measures,” said Paul Brown, Ph.D., president and CEO, Roche Molecular Diagnostics. “Roche’s new LightCycler® MRSA Advanced Test is designed to offer a simple, flexible, and reliable method for MRSA screening to support hospitals in the prevention of MRSA infections.”
High rates of infection, mortality, and high costs of treatment due to healthcare-associated infections (HAIs) caused by MRSA are a critical issue for healthcare facilities worldwide. In addition, community-associated MRSA (CA-MRSA) infection has spread in the U.S., feeding the pipeline of infection in hospitals, and underscoring the need for comprehensive infection control programs along with more rapid and reliable MRSA screening methods. In response to this public health issue, an increasing number of states have passed legislation requiring mandatory reporting and/or screening for HAI’s.
“The introduction of this new advanced test will expand the options healthcare facilities have for MRSA screening using molecular diagnostic methods,” said Lance Peterson, M.D., FASCP, epidemiologist and a founder of the MRSA screening program at NorthShore University HealthSystem in Evanston, Illinois. “The test showed good sensitivity with minimal hands-on time. Technicians now have the ability to have flexible batch sizes which could make it the cost-effective choice for many hospital laboratories.”


About methicillin-resistant Staphylococcus aureus (MRSA)
Methicillin-resistant Staphylococcus aureus (MRSA) is a type of bacterium that is resistant to certain antibiotics, such as methicillin, oxacillin, penicillin and amoxicillin. Staphylococcus aureus is one of the most frequently isolated bacteria from patients with healthcare-associated infections (HAIs). Estimates suggest that 2 million HAIs and 90,000 deaths are attributable to these infections each year in the U.S., and that between 5% and 10% of inpatients in U.S. hospitals acquire an HAI. (1) 
Antimicrobial resistance and HAIs, either combined or separately, constitute a major infectious disease problem in the U.S. and show signs of becoming more prevalent in the future. MRSA infections are a tremendous burden for healthcare systems and hospitals and are associated with significant healthcare costs. In 2007, the Centers for Disease Control and Prevention (CDC) estimated that HAIs were responsible for $4.5 to $5.7 billion in added healthcare costs each year.(1)  Experts generally believe that at least 20-30% of such infections are preventable, and molecular-based diagnostic tests to detect HAIs offer faster, sensitive methods to detect infections and prevent their spread. In the U.S. it is estimated that the market for molecular-based MRSA screening is estimated to be worth approximately $125 million in 2010 and growing at 20% per annum.


References:
1 http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf. Public Health Reports, March-April 2007. Accessed July 2009.

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xCELLigence System for Cell Analysis

xCelligence RTCA DPThe extent to which protein targets are modulated by drugs or small molecule compounds depends on a number of factors, including the expression levels of the target, the effective concentration of the compound, and the time needed for the compound to perturb the target. One of the limitations of current multidimensional phenotypic profiling approaches is that typically a single time point is chosen to assess the effect of compounds. The conclusion, regarding the compounds´ mechanism of action, is based on the time point at which the samples are processed.

To address these restrictions, researchers Abassi et al. (1) have devised a live cell morphological profiling approach for dynamic monitoring of the effect of small molecule compounds that was based on impedance measurement of cells with the xCELLigence RTCA System of Roche Applied Science (SIX: RO, ROG; OTCQX: RHHBY). The approach was tested by screening a library containing FDA approved drugs, experimental compounds, and natural compounds. Compounds with similar activity produced similar impedance-based Time-dependent Cell Response Profiles (TCRPs). The compounds were clustered then based on TCRP similarity.

The researchers identified novel mechanisms for existing drugs, confirmed previously reported calcium modulating activity for COX-2 inhibitor celecoxib, and discovered an additional mechanism for the experimental compound monastrol. They also recognized and characterized a new antimitotic agent. This approach will also help to detect the off target effect of a given compound.

The TCRP technique described by Abassi et al. can overcome the limitations of current approaches, because the profile generated is time dependent. In combination with measurement of cell number, morphology, and adhesion, the TCR technique allows greater expansion of the ‘‘biological space’’ at which compounds are screened. It provides ample opportunity to detect and identify biological activity associated with small molecules.

In conclusion, these findings indicate that the time-dependant resolution, provided by the TCRP approach, can be used in conjunction with phenotypic profiling approaches to obtain additional data associated with small molecule compounds. TCRP approach provides predictive mechanistic information for small molecule compounds.

The non-invasive and label-free xCELLigence analysis method, originally invented by ACEA Biosciences in San Diego, USA is based on measuring the impedance of cells. The technique utilizes an electronic readout of impedance to non-invasively quantify cellular status in real-time. Cells are seeded in E-Plate microtiter plates, which are integrated with microelectronic sensor arrays. The interaction of cells with the microelectrode surface generates a cell-electrode impedance response, which not only indicates cell viability but also correlates with the number of the cells seeded in the well. In conjunction with its user-friendly data collection and analysis capabilities, the xCELLigence System makes a unique platform for continuous, real-time cell-based assays and provides a huge opportunity for cellular and molecular biology.

 

For more information on the technology, please visit www.roche-applied-science.com.

Literature:

(1) Abassi YA et al.: Kinetic cell-based morphological screening: prediction of mechanism of compound action and off-target effects. Chem Biol 2009; 16:712-723.

 

More information: www.xCELLigence.roche.com.

All trademarks used or mentioned in this release are protected by law.XCELLIGENCE is a trademark of Roche.E-PLATE and ACEA BIOSCIENCES are registered trademarks of ACEA Biosciences, Inc. in the US.

 

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