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A Biotechnology Firm Making Its First Step Towards Profitability?

Posted: September 18, 2012 at 10:10 pm

By Declan Fallon - September 18, 2012 | Tickers: BIIB, ISIS | 0 Comments

Declan is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited.

As bullish markets expand, monies are channelled not just into established names, but to companies which offer the potential to become the next big names. In recent weeks, the number of stocks which have seen money flows above their typical average have markedly increased. Of these movers-and-shakers, one to make the grade was ISIS Pharmaceuticals (NASDAQ: ISIS).

ISIS Pharmaceuticals researches and develops antisense drugs, used for the treatment of cardiovascular, metabolic, severe and rare diseases, including cancer. The company focuses on Antisense RNA research. Antisense RNA operates like a blocker, preventing RNA (protein cooking instructions) from building proteins that may ultimately contribute or lead to disease. The company's business is to develop Antisense RNA-based drugs to a point where they can be licensed to a partner, who then commercialize it. The company has collaboration agreements with a number of companies, including Biogen Idec (NASDAQ: BIIB), Bristol-Myers Squibb, Eli Lilly,and GlaxoSmithKline.

Buyers regain momentum

ISIS Pharmaceuticals stock price has enjoyed a solid summer of 2012 after a few years of lackluster trading. The stock's nadir was 2009 when it ran into a $19 ceiling, and headed south to spend most of last year below $10 a share. But a couple of heavy trade days in early August following earnings, and more recently in September saw a shift from net selling to net buying. Largest was 3.3 million shares traded in a single day which was also so happened to come with a push above $14.

But income heavily tied to a single client

Like many biotechnology stocks, it has a variable but typically losing streak of earnings. Analyst expectations aren't a useful guide, although biotechnology stocks are probably less sensitive to earnings releases than perhaps other pharmaceutical companies which are less research focused. The company's revenues are heavily dependent on milestone payments from its research partners, Genzyme in particular. The Genzyme payments accounted for 90% and 84% of the $42.8 million and $59.1 million in reported revenue for the three and six months ended in June 30th 2012. ISIS almost squeaked a Q2 profit at a penny loss per share, although expectations for next quarter are for a $-0.28 loss.

Genzyme is working with ISIS Pharmaceuticals to develop its lead product, KYNAMRO, for the treatment of familial hypercholesterolemia. Commercialization can begin once it obtains the required regularly approval in Europe and the United States; the former application was made in June 2011, and latter to the FDA in May 2012. Submitting these applications generated a $25 payment from Genzyme. FDA approvals can take 6 to 10 months to complete, so it will be the latter part of the year until news of this is known. Should the FDA approve the commercial release of KYNAMRO then ISIS Pharmaceuticals will receive another $25 million payment from Genzyme. However, the larger picture is that ISIS Pharmaceuticals will have a new, more substantial, source of revenue in the form of license payments, not to mention a milestone payment of up to $825 million for commercialization of the drug.

However, it has more than one string to its bow

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A Biotechnology Firm Making Its First Step Towards Profitability?

Recommendation and review posted by G. Smith

BioSpain 2012 is Larger in Terms of Internationalisation and the Number of Exhibitors, Meetings and Visitors

Posted: September 18, 2012 at 10:10 pm

MADRID, September 18, 2012 /PRNewswire/ --

6th International Meeting on Biotechnology to be held atBilbao Exhibition Centre (BEC), in Barakaldo (Bilbao), from 19 to 21 September

The figures gathered to date by the BioSpain 2012 organisation show the event will be a major success and evidence the growing importance of biotechnology in Spain.

The 6th International Meeting on Biotechnology, BioSpain 2012 (http://www.biospain2012.org)-a biennial event, is organised by ASEBIO, the Spanish Association of Biotechnology Companies, in cooperation with Society for Competitive Transformation (SPRI), an agency of the Basque government, this year. BioSpain 2012 will run from 19 to 21 September in Bilbao Exhibition Centre (BEC), in Barakaldo.

International participants account for 30% of the total and twenty-five countries are represented at the event. The main countries, in terms of both participation and exhibition space, are the UK, the US, France, Germany, Mexico, Switzerland, Sweden, Belgium and the Netherlands.

The trade fair is fully booked with 216 exhibitors. The event will attract 1,450 professional visitors and 750 companies.

Also, the space for partnering/business development meetings provides room for up to 4,500 one-on-one meetings. That figure would place BioSpain in fourth place among the world's biotech business development events (from 7th place at present).

Regina Revilla, President of ASEBIO, considers that these figures evidence the importance of biotechnology in Spain. "We are very proud of the response on the part of our companies and institutions, and of the great interest that BioSpain 2012 has aroused, considering the large number of interesting biotech events in other countries. We are confident that BioSpain 2012 will fulfil participants' business expectations and help develop the industry in Spain".

A new feature of BioSpain 2012 is the biotechnology Career Fair, which will enable students and professionals to interface with companies and academic institutions in order to explore employment and training opportunities.

BioSpain 2012 also includes an Investment Forum. A total of 32 projects have been presented and will be assessed by a panel of Spanish and international experts. Other features include breakout sessions and Biotec 2012, the scientific conference of the Spanish Society of Biotechnology (SEBIOT).

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BioSpain 2012 is Larger in Terms of Internationalisation and the Number of Exhibitors, Meetings and Visitors

Recommendation and review posted by G. Smith

Wiley signs collaboration agreement with the Asian Federation of Biotechnology

Posted: September 18, 2012 at 10:10 pm

Public release date: 18-Sep-2012 [ | E-mail | Share ]

Contact: Ben Norman Sciencenewsroom@wiley.com 44-012-437-70375 Wiley

Weinheim, Germany. September 18, 2012. John Wiley & Sons, Inc., has announced the signing of a new collaboration agreement between Biotechnology Journal and the Asian Federation of Biotechnology (AFOB). From 2013 the Federation will contribute two special issues to the journal annually, while representatives from the AFOB will join the editorial board.

Since launching in 2006 Biotechnology Journal has become a truly international title. Edited by Professor Sang Yup Lee, from KAIST University in South Korea, and Professor Alois Jungbauer from BOKU University in Austria, the journal attracts international authors, a global readership and will be awarded an official Impact Factor in 2013.

As a partner journal of the AFOB, the Biotechnology Journal will work with the Federation to disseminate scientific knowledge from Asian research communities to a global audience by dedicating special issues to research and breakthroughs on topics that are relevant to all biotechnologists.

A new "AFOB Highlights" section will also be introduced to the journal as a forum for reporting Federation news, announcements, prizes and awards.

The AFOB will also contribute news and views to Wiley's BiotecVisions e-magazine, which will be circulated to all Federation members on a monthly basis.

Biotechnology Journal will continue to collaborate with the European Federation of Biotechnology section on Biochemical Engineering, placing it in a unique position to serve as a bridge between European and Asian biotechnologists.

"Wiley's mission is to bring the best of science to an international audience," said Carol Bacchus, Vice President and Publishing Director, Life Sciences, Wiley. "This AFOB collaboration is a new milestone, which will foster greater international co-operation between Asian and non-Asian scientists to enhance our knowledge in all areas and applications of biotechnology and engineering technologies."

"Working with Biotechnology Journal has always been a pleasurable and successful experience for the AFOB," said Professor Ho Nam Chang, AFOB's incoming president. "We are therefore delighted to have this official agreement, which will further promote research from Asia to an international audience."

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Wiley signs collaboration agreement with the Asian Federation of Biotechnology

Recommendation and review posted by G. Smith

DNA2.0 Taps VTU Technology as Research Partner for Industrial Scale Protein Expression

Posted: September 18, 2012 at 10:10 pm

MENLO PARK, Calif. & GRAMBACH/GRAZ, Austria--(BUSINESS WIRE)--

DNA2.0, the leading bioengineering solutions provider and VTU Technology, the leader in Pichia pastoris protein expression services, today announced a partnership to develop and refine a gene design algorithm to enable maximized protein production in the yeast P. pastoris. The collaboration will combine VTUs deep P. pastoris expertise and AOX1 promoter technology with DNA2.0s gene design technology for robust translation.

Pichia is ideally suited for high-level expression of recombinant proteins for therapeutic and industrial applications, said Dr. Thomas Purkarthofer, Head of Business Development of VTU Technology. We are excited to merge the unparalleled strength of our P. pastoris expression system with DNA2.0s industry-leading gene design and expression optimization technology.

VTUs P. pastoris protein expression platform is based on engineered versions of the AOX1 promoter, one of the strongest eukaryotic promoters known. VTUs approach delivers up to 20 g/L of secreted protein within a few weeks development time, and the company has a proven track record for expressing commercial levels of a wide range of proteins including serum proteins, cytokines, fusion proteins, Fabs, antibody derived fragments, scaffold proteins and enzymes.

The protein target for this collaboration is DNA2.0s IP-free CometGFP, which is part of a novel family of fluorescent and colorimetric proteins developed by DNA2.0. The corresponding IP-free genes are brought to market without expensive, constrained licensing.

We developed our initial Pichia gene design algorithm with the world-leading P. pastoris laboratory of Anton Glieder, and we are thrilled to expand the breadth and scope of our P. pastoris technology for industrial scale applications with the proven commercial leader in the field, VTU Technology, said Jeremy Minshull, Ph.D., cofounder and CEO of DNA2.0. Controllable, consistent and strong protein expression is the goal regardless of the type of research in which you are engaged, and our patented GeneGPS technology has been proven to produce orders of magnitude increases in protein expression.

About VTU Technology:

VTU Technology is a leading provider of comprehensive services based on exclusive and innovative Pichia pastoris protein production technologies. With exclusive know-how and extensive experience, VTUs skilled team delivers fast-track development of high-performance industrial protein production strains enabling high expression yields and economically attractive production processes.

Headquartered in Grambach/Graz, Austria, VTU Technology is a private company and a subsidiary ofVTU Holding, an Austrian enterprise that combines several technology and engineering companies in chemistry, pharma & life science as well as power and fuel industries. For more information, please visit http://www.vtu-technology.com

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DNA2.0 Taps VTU Technology as Research Partner for Industrial Scale Protein Expression

Recommendation and review posted by G. Smith

Leading stem cell scientists to focus on diabetes, eye diseases at Cedars-Sinai symposium

Posted: September 18, 2012 at 2:11 am

Public release date: 17-Sep-2012 [ | E-mail | Share ]

Contact: Nicole White nicole.white@cshs.org 310-423-5215 Cedars-Sinai Medical Center

LOS ANGELES Sept. 17, 2012 Leading scientists and clinicians from across the nation will discuss the latest findings on potential stem cell treatments for diabetes and eye diseases at the second Cedars-Sinai Regenerative Medicine Scientific Symposium.

WHO: Stem cell scientists, clinicians and industry leaders.

The symposium is being hosted by the Cedars-Sinai Regenerative Medicine Institute, led by Clive Svendsen, PhD. The institute brings together basic scientists with specialist clinicians, physician scientists and translational scientists across multiple medical specialties to convert fundamental stem cell studies to therapeutic regenerative medicine.

FEATURED RESEARCH: The symposium's morning session will feature an overview of the current state of stem cells and diabetes, including efforts to start the first clinical trials with stem cells for the treatment of diabetes. Other research to be presented includes an update on regenerative medicine approaches to treating macular degeneration, a progressive deterioration of the eye that causes gradual loss of vision. This will include an update from Gad Heilweil , MD, on a key, stem-cell clinical trial on macular degeneration at the University of California Los Angeles.

WHEN: Sept. 21, 2012 8:30 a.m. to 6 p.m. Thomson's lecture begins at 8:40 a.m.

WHERE: Harvey Morse Auditorium Cedars-Sinai Medical Center 8700 Beverly Boulevard Los Angeles, CA 90048

How to register: http://www.cedars-sinai.edu/RMI

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Leading stem cell scientists to focus on diabetes, eye diseases at Cedars-Sinai symposium

Recommendation and review posted by G. Smith

Cytomedix Shares Now Trading on OTCQX

Posted: September 18, 2012 at 2:11 am

GAITHERSBURG, Md., Sept. 17, 2012 /PRNewswire/ -- Cytomedix, Inc. (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that its common shares are now trading on the highest OTC marketplace, OTCQX, under the ticker symbol "CMXI."

Cytomedix upgraded from OTCQB today to trade on the OTC market's prestigious marketplace, OTCQX. Investors can find current financial disclosure and real-time Level 2 quotes for the Company's common shares at http://www.otcmarkets.com.

"We believe investors will appreciate the quality-controlled admission process, the transparent trading and easy access to company information that are hallmarks of the OTCQX," said Martin P. Rosendale, Chief Executive Officer of Cytomedix.

C. K. Cooper & Company will serve as Cytomedix's Designated Advisor for Disclosure ("DAD") on OTCQX, and will be responsible for providing guidance on OTCQX requirements.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. The Company's commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using the proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

About OTC Markets Group Inc. OTC Markets Group Inc. (OTCM) operates Open, Transparent and Connected financial marketplaces for investors to easily trade almost 10,000 equity and debt securities through the broker of their choice. Our OTC Link ATS directly links a diverse network of broker-dealers that provide liquidity and execution services for a wide spectrum of securities. We organize these securities into tiered marketplaces to inform investors of opportunities and risks including OTCQX - The Intelligent Marketplace for the Best OTC Companies; OTCQB - The Venture Marketplace; and OTC Pink - The Open Marketplace. Our data-driven platform enables efficient trading through any broker at the best possible price and empowers a broad range of companies to improve the quality and availability of information for their investors. To learn more about how we create smarter financial marketplaces, visit http://www.otcmarkets.com.

OTC Link ATS is operated by OTC Link LLC, member FINRA/SIPC and SEC registered ATS.

About Cytomedix, Inc.Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix Shares Now Trading on OTCQX

Recommendation and review posted by G. Smith


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