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	<title>Xconomy &#187; Antibiotic</title>
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		<title>Brain Cells’ Antidepressant Disappoints in Clinical Study, Otonomy Hears the Sound of Money, Cognionics Wins Startup Competition, &amp; More San Diego Life Sciences News</title>
		<link>http://www.xconomy.com/san-diego/2010/06/17/brain-cells-antidepressant-disappoints-in-clinical-study-otonomy-hears-the-sound-of-money-cognionics-wins-startup-competition-more-san-diego-life-sciences-news/</link>
		<pubDate>Thu, 17 Jun 2010 11:40:25 +0000</pubDate>
		<dc:creator>Denise Gellene</dc:creator>
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		<guid isPermaLink="false">http://www.xconomy.com/?p=88072</guid>
		<description><![CDATA[A spate of financings dominated the headlines in the past week. We’ve got it summarized for you here. —Brain Cells’ experimental antidepressant was no better than placebo in a mid-stage clinical trial, but the results hinted the drug might help people with a combination of depression and anxiety. Thecompany hasn’t decided what to do next, [...]]]></description>
			<content:encoded><![CDATA[ 
		 
		<strong>Denise Gellene</strong>
		<p>A spate of financings dominated the headlines in the past week. We’ve got it summarized for you here.</p>
<p>—<strong>Brain Cells’</strong> experimental antidepressant was <a href="http://www.xconomy.com/san-diego/2010/06/14/braincells-inc-with-novel-depression-drug-seeks-a-way-forward-after-mixed-result/">no better than placebo </a>in a mid-stage clinical trial, but the results hinted the drug might help people with a combination of depression and anxiety. Thecompany hasn’t decided what to do next, although it might pursue development of the drug for people with both depression and anxiety or post-traumatic stress.</p>
<p>—<strong>Cognionics</strong>, a startup formed by graduate students in engineering, science and business at UC San Diego, the Salk Institute, and The Scripps Research Institute, <a href="http://www.xconomy.com/san-diego/2010/06/14/cognionics-wireless-sensor-startup-wins-ucsd-entrepreneur-challenge/">won the top prize</a> of $25,000 in funding and $15,000 in legal services at the UCSD Entrepreneur Challenge. The company aims to develop a wireless sensor that can be used for remote monitoring of cardiac data and other health information.</p>
<p>—<strong>Otonomy</strong>, a company working on drugs for disorders of the ear, <a href="http://www.xconomy.com/san-diego/2010/06/10/otonomy-pockets-10m-for-hearing-loss/">converted $10.5 million in bridge loans </a>from Avalon Ventures into equity. The startup is working on drugs for Meniere’s disease, which causes dizziness and leads to hearing loss, and otitis media, an inflammation of the middle ear.</p>
<p>—<a href="http://www.xconomy.com/san-diego/2010/06/14/genetic-testing-companies-in-san-diego-boston-san-francisco-studying-fda-letters/">Illumina was among five companies to receive letters from the FDA </a>notifying them that the agency believes that genome-sequencing tests offered directly to consumers are medical devices requiring FDA approval. <strong>Illumina</strong> (NASDAQ: <a href="http://finance.yahoo.com/q?s=ILMN">ILMN</a>) got a letter because it knowingly provides two of the companies that sell genetic tests—23andMe<strong> </strong>and deCode Genetics—with gene-chip technology that has not been approved for clinical use. Besides Illumina, 23andMe and deCode, Navigenics and Knome<strong> </strong>received the FDA letters, which do not order the companies to stop selling the tests, but suggest it may not be legal to market certain genetic testing services. 23andMe and Navigenics are based in the San Francisco Bay area and Knome is based in Cambridge, MA.</p>
<p>—Bruce identified <a href="http://www.xconomy.com/san-diego/2010/06/16/we-got-deals-financings-breathe-new-life-into-local-life-sciences-companies/">a trio of life sciences companies </a>that raised fresh financing. <strong>Cylene Pharmaceuticals</strong>, a developer of cancer drugs, raised $6.1 million; Access Scientific, a medical device company, nabbed $2.6 million; and Ridge Diagnostics raised $577,000.</p>
<p><strong>—Trius Therapeutics</strong> and the FDA <a href="http://www.xconomy.com/san-diego/2010/06/16/trius-gets-fda-clarity/">agreed on a special protocol assessment </a>establishing the design of a pivotal clinical trial for Trius’ lead drug candidate, torezolid phosphate. The company postponed IPO plans in March after new FDA guidelines delayed the pivotal antibiotic study.</p>
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		<title>Sirtris Founders Resurface with New Fund, Icahn Continues to Make Biotech Waves, Sentillion Bought by Microsoft, &amp; More Boston-Area Life Sciences News</title>
		<link>http://www.xconomy.com/boston/2010/02/19/sirtris-founders-resurface-with-new-fund-icahn-continues-to-make-biotech-waves-sentillion-bought-by-microsoft-more-boston-area-life-sciences-news/</link>
		<pubDate>Fri, 19 Feb 2010 05:01:07 +0000</pubDate>
		<dc:creator>Erin Kutz</dc:creator>
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		<guid isPermaLink="false">http://www.xconomy.com/?p=64022</guid>
		<description><![CDATA[Despite the Presidents Day holiday, it’s been a big life sciences week for us. —A new venture fund is being assembled by the founders of Cambridge, MA-based Sirtris Pharmaceuticals, a developer of treatments for aging-related diseases that went to GlaxoSmithKline for more than $700 million in 2008. Christoph Westphal, Michelle Dipp, and Rich Aldrich have [...]]]></description>
			<content:encoded><![CDATA[ 
		 
		<strong>Erin Kutz</strong>
		<p>Despite the Presidents Day holiday, it’s been a big life sciences week for us.</p>
<p>—<a href="http://www.xconomy.com/boston/2010/02/12/sirtris-founders-build-new-venture-capital-fund-keep-mum/">A new venture fund is being assembled by the founders of Cambridge, MA-based Sirtris Pharmaceuticals</a>, a developer of treatments for aging-related diseases that went to GlaxoSmithKline for more than $700 million in 2008. Christoph Westphal, Michelle Dipp, and Rich Aldrich have pulled in $50.7 million from 24 undisclosed investors for their Longwood Founders Fund, according to an SEC filing.</p>
<p>—Helicos Biosciences (NASDAQ:<a href="http://finance.yahoo.com/q?s=HLCS">HLCS</a>) <a href="http://www.xconomy.com/boston/2010/02/12/helicos-president-resigns/">president Steve Lombardi has resigned</a>, the Cambridge-based company disclosed in a regulatory filing last Friday. Lombardi officially concluded his full-time work and his role on the Helicos board on February 11, but will continue to earn his salary through August. Helicos, which makes genetic analysis instruments, didn’t disclose the reasons for Lombardi’s departure, but said it wasn’t due to a conflict with company policies.</p>
<p>—Luke caught up with the <a href="http://www.xconomy.com/boston/2010/02/16/rib-x-maps-out-pivotal-antibiotic-trial-as-part-of-built-to-last-company-strategy/">CEO of Rib-X Pharmaceuticals, a New Haven, CT-based antibiotic developer that’s raised $35 million in the last year</a>. The company is hoping to get help from a Big Pharma company on a trial for its top drug candidate, which should lead to an application with the FDA to market the drug in 2012, if all goes well.</p>
<p>—Ryan looked at the bumpy ride experienced by <a href="http://www.xconomy.com/boston/2010/02/16/lantheus-medical-imaging-stakes-future-on-innovation-after-generic-hit-to-key-product/">Lantheus Medical Imaging, a North Billerica company once owned by Bristol-Myers Squibb</a>. The firm’s big focus is on new products like its contrast agent for diagnosing cardiovascular diseases, but it struggles to gain the name recognition that its previous owner had.</p>
<p>—Cambridge-based social networking site <a href="http://www.xconomy.com/boston/2010/02/16/patientslikeme-buys-reliefinsite-to-help-patients-track-their-pain-online/">PatientsLikeMe announced that it acquired ReliefInsite</a>, an online pain management firm that helps patients track their pain levels and share them with doctors. The move comes just after PatientsLikeMe’s West Coast rival, Keas, brokered a deal with Pfizer (NYSE:<a href="http://finance.yahoo.com/q?s=PFE">PFE</a>) to expand the use of its health-monitoring software.</p>
<p>—The Carl Icahn story continues. The big biotech investor known for gobbling up shares at companies such as Biogen Idec (NASDAQ:<a onclick="window.open(this.href); return false;" href="http://finance.yahoo.com/q?s=BIIB">BIIB</a>) and Amilyn Pharmaceuticals (NASDAQ:<a onclick="window.open(this.href); return false;" href="http://finance.yahoo.com/q?s=AMLN">AMLN</a>) has <a href="http://www.xconomy.com/boston/2010/02/16/icahn-boosts-genzyme-stake/   ">taken a bigger stake in Cambridge’s Genzyme</a> (NASDAQ:<a href="http://finance.yahoo.com/q?s=GENZ">GENZ</a>), increasing his holdings from 1.5 million shares in fourth quarter of 2009 to 4.6 million shares earlier this month.</p>
<p>—<a href="http://www.xconomy.com/boston/2010/02/17/eleven-biotherapeutics-raises-35m-seeks-to-crank-the-amplifer-up-on-protein-drugs/">Eleven Biotherapeutics roared out of stealth mode with a $35 million Series A round</a>, Luke reported. The Cambridge company, which looks to engineer protein treatments for blood clot disorders and autoimmune diseases, also has assembled a team of big names from the biotech and venture worlds.</p>
<p>—<a href="http://www.xconomy.com/boston/2010/02/17/technology-icon-ray-stata-gives-nabsys-a-big-boost-in-7m-series-b/">Providence, RI-based NABsys nabbed $7 million in Series B funding led by Stata Venture Partners</a>, run by Analog Devices co-founder and chairman Ray Stata.  NABsys, whose DNA sequencing technology hinges on semiconductor innovations, will use the funding from Stata to develop a platform intended to streamline the reading of DNA chains.</p>
<p>—Ryan wrote about <a href="http://www.xconomy.com/boston/2010/02/18/sentillion-sees-brighter-future-in-healthcare-software-under-microsofts-ownership/">healthcare software provider Sentillion’s entry into the big leagues with its acquisition by Microsoft</a> (NASDAQ: <a href="http://finance.yahoo.com/q?s=MSFT">MSFT</a>). Few aspects of Andover, MA-based Sentillion’s business have changed since the access management software company became part of Microsoft’s health and life sciences unit, says CEO Robert Seliger, who will stay on as a general manager.</p>
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		<title>Teva Takes Aim at Cubist Pharma’s Key Antibiotic Business</title>
		<link>http://www.xconomy.com/boston/2009/02/10/teva-takes-aim-at-cubist-pharma%e2%80%99s-key-antibiotic-business/</link>
		<pubDate>Tue, 10 Feb 2009 15:00:06 +0000</pubDate>
		<dc:creator>Ryan McBride</dc:creator>
				<category><![CDATA[Boston]]></category>
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		<category><![CDATA[Teva Parenteral Medicines]]></category>
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		<guid isPermaLink="false">http://www.xconomy.com/?p=12178</guid>
		<description><![CDATA[Cubist Pharmaceuticals (NASDAQ:CBST) plans to mount a lawsuit against Teva Parenteral Medicines after Teva made known that it plans to seek U.S. approval of a generic version of Cubist’s top-selling antibiotic daptomycin (Cubicin), Cubist announced this morning. Lexington, MA-based Cubist says that Teva informed the company in a letter that it planned to gain approval [...]]]></description>
			<content:encoded><![CDATA[ 
		<a rel="attachment wp-att-12180" href="http://www.xconomy.com/?attachment_id=12180"><img style="float:right;margin: 0px 0 5px 15px;" class="alignnone size-full wp-image-12180" title="Cubist logo" src="http://www.xconomy.com/wordpress/wp-content/images/2009/02/logo2.gif" alt="Cubist logo" width="104" height="102" /></a> 
		<strong>Ryan McBride</strong>
		<p>Cubist Pharmaceuticals (NASDAQ:<a href="http://finance.yahoo.com/q?s=CBST">CBST</a>) plans to mount a lawsuit against Teva Parenteral Medicines after Teva made known that it plans to seek U.S. approval of a generic version of Cubist’s top-selling antibiotic daptomycin (Cubicin), Cubist <a href="http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&amp;newsId=20090210005757&amp;newsLang=en">announced</a> this morning.</p>
<p>Lexington, MA-based Cubist says that Teva informed the company in a letter that it planned to gain approval of its daptomycin copy before two of Cubist’s patents on the drug expire in September 2019 and June 2016, telling Cubist that the patents are either invalid or not infringed. Cubist now has 45 days from receiving the letter to file a patent infringement lawsuit, which would block the FDA from approving Teva’s version of the drug for 30 months or until a district court rules that Cubist’s patents are invalid or not infringed upon by the Teva drug.</p>
<p>Daptomycin is key to Cubist’s current business. The injectable antibiotic, which is used to treat skin and blood stream infections caused by resistant bugs such as MRSA, brought the company $414.7 million of its $433.6 million in total revenue last year, according to the firm.</p>
<p>News of Teva’s bid to muscle in on Cubist’s daptomycin franchise had a chilling effect on Cubist’s stock price, which fell about 15 percent in pre-market trading from its close of $22.25 per share on Monday.</p>
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		<title>Targanta Faces New Challenges to Raise Cash After FDA Shoots Down the Firm’s Antibiotic</title>
		<link>http://www.xconomy.com/boston/2008/12/10/targanta-faces-new-challenges-to-raise-cash-after-fda-shoots-down-the-firm%e2%80%99s-antibiotic/</link>
		<pubDate>Wed, 10 Dec 2008 13:00:48 +0000</pubDate>
		<dc:creator>Ryan McBride</dc:creator>
				<category><![CDATA[Boston]]></category>
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		<category><![CDATA[Mark Leuchtenberger]]></category>
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		<category><![CDATA[Oritavancin]]></category>

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		<description><![CDATA[Targanta Therapeutics (NASDAQ:TARG) faces an uphill journey now that the FDA has decided to not to approve the Cambridge, MA-based biotech firm’s antibiotic oritavancin. The FDA, in summary, told Targanta to conduct an additional clinical trial to show the safety and effectiveness of oritavancin before it seeks approval again. The drug is intended to treat [...]]]></description>
			<content:encoded><![CDATA[ 
		<img style="float:right;margin: 0px 0 5px 15px;" class="alignnone size-thumbnail wp-image-6316" title="Targanta logo" src="http://www.xconomy.com/wordpress/wp-content/images/2008/11/picture-31-180x38.png" alt="Targanta logo" width="180" height="38" /> 
		<strong>Ryan McBride</strong>
		<p>Targanta Therapeutics (NASDAQ:<a href="http://finance.yahoo.com/q?s=TARG">TARG</a>) faces an uphill journey now that the FDA has decided to not to approve the Cambridge, MA-based biotech firm’s antibiotic oritavancin. The FDA, in summary, told Targanta to conduct an additional clinical trial to show the safety and effectiveness of oritavancin before it seeks approval again. The drug is intended to treat antibiotic-resistant bugs, like the notorious MRSA.</p>
<p>After writing a <a href="http://www.xconomy.com/boston/2008/12/09/fda-declines-approval-of-targanta-antibiotic/">brief post</a> on the <a href="http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&amp;newsId=20081208006571&amp;newsLang=en">FDA’s decision</a> yesterday, I caught up with Targanta CEO Mark Leuchtenberger a few hours later. He was his normal upbeat self, yet he did acknowledge that his company has quickly gone from one with a projected marketing launch date for oritavancin in 2009 to one that will instead have to focus resources on another late-stage clinical trial for the next one or two years before it can ask the FDA for approval a second time. The drug’s development timeline is critical to the company, because it is vying to become Targanta’s first moneymaking product on the market.</p>
<p>What’s more, the company needs to raise money to support further development of oritavancin in a harsh financial climate to fund the clinical trial. How much? Leuchtenberger says he won’t know until the FDA provides guidance on the size and scope of the trial. The company <a href="http://www.xconomy.com/boston/2008/11/25/biotech-survival-index-boston-life-sciences-companies-brace-for-long-hard-winter/5/">finished September with  $42.6 million in the bank</a>, and Leuchtenberger tells me that money will fund the company in its current form into the third quarter of 2009.</p>
<p>“We knew [before the FDA's recent decision on oritavancin] we had a hefty challenge in front of us in what is a difficult fundraising market,” Leuchtenberger says. “We actually think that there will be interest and there has been interest in investing [in Targanta].”</p>
<p>Leerink Swann analyst Howard Liang wrote in a note to investors yesterday that there were already uncertainties in the market for antibiotics to combat MRSA due to a likely generic drug challenge for for a big brand-name antibiotic, daptomycin (Cubicin)—made by Lexington, MA-based Cubist Pharmaceuticals (NASDAQ:<a href="http://finance.yahoo.com/q?s=CBST">CBST</a>). “In an already difficult capital market environment,” Liang writes, “this uncertainty makes it more difficult for financing the additional Phase 3 trial [for oritavancin].”</p>
<p>Leuchtenberger says his firm will also need to “take the appropriate steps” to ensure that it is using  existing funds most appropriately, yet he declined to say which specific steps the company would take. (I think it’s safe to expect Targanta to cut at least some of the commercial workers it had hired in anticipation of the oritavancin launch in 2009, given that the company now has to focus its resources in the coming years on the next late-stage trial for oritavancin.)</p>
<p>Targanta had already expected to raise money for a late-stage trial next year of oritavancin in a single dose or less frequent doses than were given to patients in studies it used to apply for FDA approval. (In September Luke spoke to Leuchtenberger <a href="http://www.xconomy.com/boston/2008/09/22/targanta-aims-to-simplifi-treatment-of-deadly-bugs-with-single-shot-antibiotic/">about the potential to treat patients with antibiotic-resistant germs with a single shot</a>.) That study was supposed to take place as marketing began for oritavancin in more frequent doses. Leuchtenberger mentioned this study, but we didn’t discuss how the FDA response his firm got on Monday would impact plans for the single- or less frequent-dose trial of oritavancin.</p>
<p>After Targanta released the details of the FDA response late Monday night, the company’s stock predictably slid 40 percent yesterday, falling from $2.25 to $1.34 per share.</p>
<p>The FDA response followed an agency advisory <a href="http://www.xconomy.com/boston/2008/11/19/targanta-antibiotic-shot-down-by-fda-panel/">committee’s 10-8 vote last month to  recommend against approval of oritavancin. </a></p>
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