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		<title>Bard Acquires Lutonix, Inc.</title>
		<link>http://www.rivervest.com/bard-acquires-lutonix-inc/</link>
		<comments>http://www.rivervest.com/bard-acquires-lutonix-inc/#comments</comments>
		<pubDate>Tue, 20 Dec 2011 17:04:42 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Portfolio Company News]]></category>

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		<description><![CDATA[MURRAY HILL, N.J.&#8211;(BUSINESS WIRE)&#8211;C. R. Bard, Inc. (NYSE: BCR) today announced that it has acquired Lutonix, Inc. for a purchase price of approximately $225 million paid at closing, with an additional $100 million to be paid upon PMA approval of Lutonix’s drug-coated percutaneous transluminal angioplasty (PTA) balloon. The transaction is structured as a merger.
Lutonix, located [...]]]></description>
			<content:encoded><![CDATA[<p><strong>MURRAY HILL, N.J.</strong>&#8211;(BUSINESS WIRE)&#8211;C. R. Bard, Inc. (NYSE: BCR) today announced that it has acquired<a href="http://www.lutonix.com" target="_blank"> Lutonix, Inc.</a> for a purchase price of approximately $225 million paid at closing<span id="more-2708"></span>, with an additional $100 million to be paid upon PMA approval of Lutonix’s drug-coated percutaneous transluminal angioplasty (PTA) balloon. The transaction is structured as a merger.</p>
<p>Lutonix, located in Minneapolis, Minnesota, is conducting the first and only investigational device exemption (IDE) trial approved by the FDA using drug-coated balloons for the treatment of peripheral arterial disease. Drug-coated balloons have received growing attention in recent years as physicians look for effective ways to treat diseased arteries without having to leave a permanent implant behind. Independent forecasts suggest that the global peripheral vascular market for drug-coated balloons could approach $1 billion annually over the next decade. To date, no such device is approved for use in the United States.</p>
<p>The Lutonix LEVANT 2 study is a prospective, randomized, single-blinded, multi-center pivotal IDE trial comparing the Lutonix drug-coated balloon to standard balloon angioplasty. The trial will enroll 476 patients across 55 sites, including 40 in the United States and 15 in Europe. Lutonix began recruiting patients in the third quarter of 2011 and has enrolled over 160 patients to date. Eligible patients suffer from significant stenosis in previously unstented superficial femoral artery or popliteal artery lesions up to 150 mm in length. These patients will be followed for five years, with PMA submission after one year of follow-up. At this time, the company anticipates that submission could occur in 2014.</p>
<p>Lutonix received CE mark approval this year and Bard expects to start selling the device in Europe in the second half of 2012. The company plans to begin a larger registry study concurrent with the European launch to support broader marketing claims and obtain additional clinical data.</p>
<p>Timothy M. Ring, Bard’s chairman and CEO, commented, “In our evaluations, Lutonix has the only third-generation drug-coated balloon technology. They also have a significant lead with respect to U.S. launch, outstanding quality and depth of pre-clinical science, a strong clinical program, a very skilled and motivated team, and a coating technology we believe will demonstrate superior safety and efficacy. This position of leadership in a large potential market, combined with our current market leadership in PTA, makes this acquisition a compelling strategic fit for Bard.”</p>
<p>Bard expects this transaction to reduce 2012 earnings per share by approximately 25 cents, excluding items that affect comparability.</p>
<p>C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.</p>
<p>This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “forecast”, “plan”, “believe”, and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to the Cautionary Statement Regarding Forward-Looking Information in our September 30, 2011 Form 10-Q for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied.</p>
<p>Contacts</p>
<p>C. R. Bard, Inc.<br />
Investor Relations:<br />
Todd W. Garner, 908-277-8065<br />
Vice President, Investor Relations</p>
<p>or</p>
<p>Media Relations:<br />
Scott T. Lowry, 908-277-8365<br />
Vice President and Treasurer</p>
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		<title>Pfizer to Acquire Excaliard Pharmaceuticals</title>
		<link>http://www.rivervest.com/pfizer-to-acquire-excaliard-pharmaceuticals/</link>
		<comments>http://www.rivervest.com/pfizer-to-acquire-excaliard-pharmaceuticals/#comments</comments>
		<pubDate>Tue, 22 Nov 2011 13:50:24 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Portfolio Company News]]></category>

		<guid isPermaLink="false">http://www.rivervest.com/?p=2698</guid>
		<description><![CDATA[Lead Program Includes Novel Investigational Compound for Prevention/Treatment of Skin Scarring
NEW YORK &#38; SAN DIEGO&#8211;Pfizer Inc. (NYSE: PFE) and Excaliard Pharmaceuticals, Inc. announced today that they have entered into a definitive agreement under which Pfizer will acquire Excaliard, a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Lead Program Includes Novel Investigational Compound for Prevention/Treatment of Skin Scarring</strong></p>
<p><strong>NEW YORK &amp; SAN DIEGO</strong>&#8211;Pfizer Inc. (NYSE: PFE) and <a href="http://www.excaliard.com" target="_blank">Excaliard Pharmaceuticals, Inc.</a> announced today that they have entered into a definitive agreement under which Pfizer will acquire Excaliard, a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring.<span id="more-2698"></span> The acquisition is expected to close before the end of the year.</p>
<p>Excaliard’s lead product, EXC 001, an antisense oligonucleotide in phase 2, is designed to interrupt the process of fibrosis by inhibiting expression of connective tissue growth factor (CTGF). CTGF is a growth factor that can be over expressed in damaged skin or tissue following surgery or traumatic injury and lead to disfiguring skin scarring. The phase 2 program for EXC 001 has thus far produced positive clinical results in reducing scar severity. Upon completion of the acquisition, Pfizer plans to continue development of EXC 001 to address unmet medical needs in patient groups who suffer from excessive skin scarring. Currently, there are no FDA-approved products to reduce scar severity.</p>
<p>“The acquisition of Excaliard is part of our corporate research and development strategy to actively complement our robust internal project pipeline with innovative and differentiated drugs from biotech partners,” said Mikael Dolsten, president, Worldwide Research and Development, Pfizer.</p>
<p>Jose-Carlos Gutierrez-Ramos, senior vice president, Biotherapeutics, Worldwide Research and Development, Pfizer, added: “The science behind Excaliard’s lead compound aligns well with our R&amp;D focus on new treatments for fibrosis and tissue remodeling. We view EXC 001 as being well positioned to potentially become a novel, transformative therapy in a space with limited available treatment options.”</p>
<p>Gordon Foulkes, Excaliard’s CEO, said: “We are all excited about Pfizer becoming the company to move our drug forward. We began Excaliard just four years ago with closing the Series A financing. Since that time, using a virtual organization and maximum outsourcing, we were able to move from lead generation to the completion of three Phase 2 trials. The whole team has just done a fantastic job.”</p>
<p>While specific financial terms are confidential, Pfizer will provide to Excaliard an upfront payment and contingent payments if certain milestones are achieved. Isis Pharmaceuticals, Inc. is an equity owner of Excaliard and has granted Excaliard an exclusive worldwide license agreement for the development and commercialization of certain antisense drugs, including EXC 001. As such, Isis will receive a portion of the upfront and milestone payments paid by Pfizer to Excaliard.</p>
<p><strong>About Skin Scarring</strong></p>
<p>In the U.S. alone, there are over 35 million surgical procedures annually. Despite the best surgical technique and post-operative wound care, many procedures result in undesirable skin scarring. In addition to fine-line scarring, scars can be raised (hypertrophic) or even grow beyond the original site of injury (keloids). The prevalence of hypertrophic scarring has been reported to be as high as 70% in certain populations.</p>
<p>The American Society for Aesthetic Plastic Surgery reports that over 5 million reconstructive procedures were performed in the US in 2009 and well over 1.5 million cosmetic surgical procedures. In addition, opportunities exist in other non-cosmetic surgical scars such as Caesarian sections (1.3 million/yr in the US), as well as trauma and burn patients.</p>
<p><strong>Pfizer Inc.: Working together for a healthier world™</strong></p>
<p>At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.</p>
<p><strong>About Excaliard Pharmaceuticals</strong></p>
<p>Excaliard Pharmaceuticals, Inc. is a biotechnology company founded in 2007 focused on the development and commercialization of novel and innovative drugs for the amelioration of skin scarring and other fibrotic disorders. EXC 001 was co‐discovered by Excaliard Pharmaceuticals and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) and licensed to Excaliard. EXC 001 is a new chemical entity for potential treatment of skin scarring, an antisense oligonucleotide drug targeting expression of CTGF that is activated during skin scarring following the wound healing process.</p>
<p>PFIZER DISCLOSURE NOTICE: The information contained in this release is as of November 22, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.</p>
<p>This release contains forward-looking information about an agreement by Pfizer to acquire Excaliard Pharmaceuticals, Inc. (Excaliard); about Excaliard’s product candidate EXC 001 and its potential benefits; and about Pfizer’s plan to further develop EXC 001. Such information involves substantial risks and uncertainties including, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.</p>
<p>A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.</p>
<p>Contacts</p>
<p>Pfizer:<br />
Gwen Fisher (media), 484-865-5160<br />
Suzanne Harnett (investors), 212-733-8009</p>
<p>Excaliard:<br />
J. Gordon Foulkes (CEO), 760-431-1850</p>
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		<title>3,000+ Patient Meta-Analysis Reinforces Importance of Platelet Reactivity Testing to Aid in Risk Assessment</title>
		<link>http://www.rivervest.com/3000-patient-meta-analysis-reinforces-importance-of-platelet-reactivity-testing-to-aid-in-risk-assessment/</link>
		<comments>http://www.rivervest.com/3000-patient-meta-analysis-reinforces-importance-of-platelet-reactivity-testing-to-aid-in-risk-assessment/#comments</comments>
		<pubDate>Wed, 26 Oct 2011 17:52:01 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Portfolio Company News]]></category>

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		<description><![CDATA[Stent Patients with High Platelet Reactivity Had Twice the Rate of Cardiovascular Events
SAN DIEGO, CA  – Accumetrics, Inc., developer of the VerifyNow® System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, today announced that results from a patient-level meta-analysis of more than 3,000 stent patients have been published [...]]]></description>
			<content:encoded><![CDATA[<p><em><strong>Stent Patients with High Platelet Reactivity Had Twice the Rate of Cardiovascular Events</strong></em></p>
<p>SAN DIEGO, CA  – <a href="http://www.accumetrics.com" target="_blank">Accumetrics, Inc.</a>, developer of the VerifyNow® System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, today announced that results from a patient-level meta-analysis of more than 3,000 stent patients have been published in the Journal of the American College of Cardiology1.<span id="more-2694"></span> Patients in the study with high platelet reactivity, as measured by the Accumetrics’ VerifyNow P2Y12 Test, exhibited more than twice the rate of cardiovascular death, heart attack and stent thrombosis over 2 years compared to patients without high platelet reactivity. The VerifyNow P2Y12 Test is used to measure a patient’s platelet reactivity and the antiplatelet effect of medications such as clopidogrel and prasugrel (Plavix® and Effient®).</p>
<p>&#8220;The results from this meta-analysis provide further insight into the established relationship between platelet reactivity and clinical outcomes, and give greater clarity to a target for identifying patients at risk,” said Somjot Brar, MD, of Kaiser Permanente in Los Angeles, CA, and lead author of the article. “The additional information provided by platelet reactivity testing, on top of our traditional clinical and procedural risk factors, can allow us to better classify patients that may be at greater risk of recurrent cardiovascular events after a stent procedure.”</p>
<p>2011 marks a banner year for advancing the understanding and progression of the role of platelet reactivity testing in clinical practice. With the inclusion of testing into 3 major guidelines (ACCF/AHA, STS/SCA and ESC) and numerous published reports, including the recent pharmacodynamic analysis of GRAVITAS2, platelet reactivity testing and personalized antiplatelet therapy continue to be in the forefront of cardiovascular medicine.</p>
<p>“The new publications and guideline recommendations have greatly increased clinical demand for the VerifyNow System as physicians move towards a more individualized approach to cardiovascular medicine,” said President and CEO of Accumetrics, Timothy I. Still. “As we progress towards the era of generic Plavix in the US along with a broader array of new and more expensive antiplatelet agents, there is greater need for more information to help physicians determine the most cost-effective treatment strategies and provide the highest quality patient care.”</p>
<p>The VerifyNow P2Y12 Test is the first clinically available, rapid and easy-to-use point-of-care system for measuring the level of P2Y12 receptor blockade. Additionally, it is indicated outside the US for evaluating the risk for recurrent events in cardiovascular patients. The VerifyNow System is used by physicians in over 700 facilities in the United States and over 70 countries worldwide where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke.</p>
<p>1 Brar, S et al. J Am Coll Cardiol 2011;58:1945–54<br />
2 Price, MJ. et al Circulation. 2011;124:1132-1137</p>
<p><strong>About Accumetrics</strong><br />
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.</p>
<p>Accumetrics’ VerifyNow System is the first rapid and easy-to-use platform to help physicians determine an individual’s response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient®) and clopidogrel (Plavix®)), and GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides valuable information to help physicians make informed treatment decisions. For more information about the Company and its products, visit www.accumetrics.com.</p>
<p>The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Eli Lilly and Company.</p>
<p># # #</p>
<p>CONTACTS:</p>
<p><a   rel="nofollow" id="sto_emailShroud2" href="http://www.somethinkodd.com/emailshroud/emailaddress.php?domainName=biosector2.com&amp;userName=jjakobsen&amp;ver=2.2.0"  target="_blank">Jakob Jakobsen</a><br />
310-309-1003</p>
<p><a   rel="nofollow" id="sto_emailShroud3" href="http://www.somethinkodd.com/emailshroud/emailaddress.php?domainName=accumetrics.com&amp;userName=press&amp;ver=2.2.0"  target="_blank">Timothy I. Still</a><br />
President and CEO<br />
Accumetrics<br />
858-404-8260</p>
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		<title>Otonomy Presents Positive New Findings from Phase 1b Study of OTO-104 in Ménière’s Disease at International Conference</title>
		<link>http://www.rivervest.com/otonomy-presents-positive-new-findings-from-phase-1b-study-of-oto-104-in-meniere%e2%80%99s-disease-at-international-conference/</link>
		<comments>http://www.rivervest.com/otonomy-presents-positive-new-findings-from-phase-1b-study-of-oto-104-in-meniere%e2%80%99s-disease-at-international-conference/#comments</comments>
		<pubDate>Thu, 29 Sep 2011 16:51:16 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Portfolio Company News]]></category>

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		<description><![CDATA[Observed Clinical Activity Suggests OTO-104 Provides Clinically Meaningful Reduction in Vertigo Frequency and Improvement in Tinnitus
San Diego, CA &#8211; Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company’s [...]]]></description>
			<content:encoded><![CDATA[<p><em>Observed Clinical Activity Suggests OTO-104 Provides Clinically Meaningful Reduction in Vertigo Frequency and Improvement in Tinnitus</em></p>
<p><strong>San Diego, CA</strong> &#8211; <a href="http://www.otonomy.com" target="_blank">Otonomy, Inc.</a>, a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company’s lead product candidate, OTO-104, in patients with Ménière’s disease. <span id="more-2675"></span>The presented data showed that patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus as compared to placebo. These results were presented today in an oral presentation at the 28th Politzer Society Meeting in Athens, Greece.</p>
<p>Researchers presented findings showing clinically meaningful reductions in vertigo frequency at three months with the 12 mg OTO-104 dose as compared to placebo. Prior to treatment, patients in both the 12 mg OTO-104 and placebo groups experienced an average of eight days with definitive vertigo episodes during a baseline period of one month. Following a single intratympanic (IT) injection, patients in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, at three months following treatment, the 12 mg study group experienced a 70 percent greater reduction from baseline in the number of days with definitive vertigo episodes. There was no clinically meaningful difference in vertigo frequency between the 3 mg OTO-104 and placebo groups at three months following treatment.</p>
<p>Additionally, the presented study data demonstrated that both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus as measured by the Tinnitus Handicap Inventory (THI-25). THI is a clinically validated patient-reported measure that can be used to quantify the impact of tinnitus on activities of daily living. Both OTO-104 doses resulted in reductions in THI Total Score from baseline as early as one month following treatment. Furthermore, these THI Total Scores continued to decrease throughout the entire three month follow-up period, suggesting continued improvement in tinnitus symptoms experienced by patients treated with OTO-104. By contrast, the study’s placebo group demonstrated little change in THI Total Score from baseline during the three month follow-up period.</p>
<p>As previously reported, results from this study showed OTO-104 to be safe and well-tolerated at both doses tested when delivered via a single IT injection. It is important to note that despite demonstrating meaningful clinical activity in the areas of vertigo and tinnitus, this study was not powered to demonstrate statistical significance. Based on these study results, Otonomy will initiate a Phase 2 clinical trial of OTO-104 in Ménière’s disease during the fourth quarter of 2011.</p>
<p>“These new results provide the first demonstration of OTO-104’s clinical activity in a cohort of Ménière’s disease patients experiencing frequent vertigo episodes,” stated Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery, Medical University of South Carolina, and the study’s lead investigator. “Furthermore, the continued reduction in vertigo frequency and improvement in tinnitus symptoms for the 12 mg OTO-104 group observed through three months of follow-up provides a strong rationale for initiating broader clinical evaluations of this sustained release product.”</p>
<p>A total of 44 patients with unilateral Ménière’s disease were enrolled in this prospective, randomized, double-blind, placebo-controlled multicenter study. Patients participated in a one month baseline period to characterize disease status, followed by randomization to receive a single IT injection of OTO-104 (3 mg or 12 mg) or placebo. Patients were monitored over a three-month observation period following injection. The study’s primary objective was the evaluation of the safety and tolerability of OTO-104. Additionally, the study evaluated various indicators of OTO-104 clinical activity including changes in vertigo, tinnitus, hearing function and patient quality of life.</p>
<p>“Following a meeting with the United States Food and Drug Administration regarding these Phase 1b results and our proposed plans for continued clinical development of OTO-104, we are now in a strong position to move this program forward,” said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “Importantly, our upcoming Phase 2 study will include a much greater number of patients and be powered to deliver statistically significant findings with regard to clinical efficacy. As such, we look forward to the initiation of this study as we seek to establish the therapeutic potential of OTO-104 to help patients suffering from the debilitating symptoms of Ménière’s disease.”</p>
<p><strong>About OTO-104</strong><br />
OTO-104 is a sustained release formulation of the steroid dexamethasone that has been designed for intratympanic (IT) injection into the middle ear for the potential treatment of a broad range of inner ear disorders including vertigo, hearing loss and tinnitus. OTO-104 is based on Otonomy’s proprietary formulation technology which is intended to overcome the limitations associated with the use of unapproved short acting solutions in the ear. These include limited drug exposure, large variability of delivered dose and the need for multiple IT injections.</p>
<p><strong>About Ménière&#8217;s Disease</strong><br />
Ménière&#8217;s disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. The underlying cause of Ménière&#8217;s disease is unknown and there are currently no FDA-approved drug treatments. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 615,000 individuals have been diagnosed with Ménière&#8217;s disease in the United States.</p>
<p><strong>About Otonomy</strong><br />
Otonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear. There are currently no FDA-approved drug treatments for the nearly 30 million Americans that are affected by debilitating hearing and balance diseases and disorders such as Ménière&#8217;s disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment and tinnitus. Otonomy’s core technology is a sustained release formulation developed for optimal delivery of drugs to the middle and inner ear with a single IT injection. This technology has broad applicability across a range of therapeutic classes and two products based on this platform are in active development.</p>
<p>Otonomy&#8217;s lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone. The company has finalized plans for a Phase 2 clinical trial in Ménière’s disease patients and plans to initiate the study during the fourth quarter of 2011. Additional future studies of OTO-104 are being planned in other inner ear disorders. OTO-201, the company’s second product candidate, is a novel sustained release antibiotic being developed in the field of otitis media. OTO-201 clinical trials are expected to begin in 2011. Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.</p>
<p>For more information visit: www.otonomy.com.</p>
<p># # #</p>
<p><strong>Contact:</strong><br />
Vida Communication (On behalf of Otonomy)<br />
<a   rel="nofollow" id="sto_emailShroud6" href="http://www.somethinkodd.com/emailshroud/emailaddress.php?domainName=vidacommunication.com&amp;userName=sdiaz&amp;ver=2.2.0"  target="_blank">Stephanie Diaz</a> (investors)<br />
415-675-7400</p>
<p><a   rel="nofollow" id="sto_emailShroud7" href="http://www.somethinkodd.com/emailshroud/emailaddress.php?domainName=vidacommunication.com&amp;userName=tbrons&amp;ver=2.2.0"  target="_blank">Tim Brons</a> (media)<br />
415-675-7400</p>
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		<title>Varian Medical Systems Signs Agreement to Acquire Calypso Medical Technologies;  Acquisition Adds Products for Tracking Tumor Motion During Radiosurgery and  Radiotherapy</title>
		<link>http://www.rivervest.com/varian-medical-systems-signs-agreement-to-acquire-calypso-medical-technologies-acquisition-adds-products-for-tracking-tumor-motion-during-radiosurgery-and-radiotherapy/</link>
		<comments>http://www.rivervest.com/varian-medical-systems-signs-agreement-to-acquire-calypso-medical-technologies-acquisition-adds-products-for-tracking-tumor-motion-during-radiosurgery-and-radiotherapy/#comments</comments>
		<pubDate>Mon, 19 Sep 2011 13:27:37 +0000</pubDate>
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		<description><![CDATA[PALO ALTO, CA and SEATTLE, WA – Varian Medical Systems, Inc., (NYSE:VAR) and Calypso Medical Technologies, Inc., today announced they have signed a definitive agreement under which Varian will acquire Calypso, a privately-owned, Seattle-based developer and supplier of specialized products and software for real-time tumor tracking and motion management during radiosurgery and radiotherapy. The acquisition, [...]]]></description>
			<content:encoded><![CDATA[<p><strong>PALO ALTO, CA and SEATTLE, WA</strong> – <a href="http://www.varian.com" target="_blank">Varian Medical Systems, Inc.</a>, (NYSE:VAR) and <a href="http://www.calypsomedical.com" target="_blank">Calypso Medical Technologies, Inc.</a>, today announced they have signed a definitive agreement under which Varian will acquire Calypso, a privately-owned, Seattle-based developer and supplier of specialized products and software for real-time tumor tracking and motion management during radiosurgery and radiotherapy. <span id="more-2671"></span>The acquisition, which is anticipated to close in early October subject to the satisfaction of certain closing conditions, provides that Varian will pay approximately $10 million for Calypso plus potential earnouts based on unit sales of Calypso products achieved beyond thresholds over the next 30 months.</p>
<p>“With Calypso’s technology, Varian will be able to offer cancer treatment centers realtime, non-ionizing tumor tracking tools for enhancing the precision of their treatments,” said Timothy E. Guertin, president and CEO of Varian Medical Systems. “These products are a perfect complement for Varian’s motion management technology, including our TrueBeam™ platform, respiratory gating and dynamic imaging tools for highly focused radiosurgery. These products should enhance Varian’s growth as we integrate them and make them more broadly<br />
available to the clinical community through our global marketing and sales channels.”</p>
<p>The Calypso® System features GPS for the Body® technology and Beacon® electromagnetic transponders that together currently provide a solution to continuously and accurately track target location to improve precision of prostate cancer treatments. The transponders are implanted into the prostate or prostatic bed and then tracked with the 4D localization and tracking system so that beams can be precisely delivered to targeted tumors during radiotherapy and radiosurgery with medical linear accelerators such as Varian’s TrueBeam platform. “The confidence gained from this system supports accelerated, hypofractionated treatments of the prostate where dose escalation requires confirmation of target location at all times,” said Guertin. “We believe this technology could support a change in clinical practice to broader acceptance and use of radiosurgery for treating prostate cancer.”</p>
<p>The U.S. Food and Drug Administration (FDA) also has granted Calypso investigational device exemption (IDE) approval for its clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery. This study utilizes a proprietary transponder that includes an anchoring feature uniquely designed to lock into lung tissue to support very precise radiosurgery procedures. “If cleared by regulatory authorities, we are optimistic that this will globally impact the ability to target challenging lung tumors with accuracy and precision required to advance clinical outcomes,” said Guertin.</p>
<p>“We are extremely gratified by the confidence and promise of this acquisition by Varian.  It provides a tremendous opportunity to leverage our GPS for the Body technology as broadly as possible,” said Edward Vertatschitsch, Ph.D., president and CEO of Calypso Medical. “Motion management is critical to accurately targeting the cancer so patients can experience the curative benefits of radiation therapy while protecting adjacent healthy tissue. We believe our real-time tracking capabilities will help to close the gap on this clinical challenge and I look forward to joining the Varian team to advance innovations in these areas.”</p>
<p>“We are looking forward to having some of the world’s technical thought leaders in tumor tracking from Calypso join with us so that we can work together to develop and deploy this technology for more disease sites.” Guertin added.</p>
<p>The Calypso business currently generates more than $15 million in annual revenues from sales and service of its products. Calypso currently has an installed base of more than 110 systems in North America and Europe. The tracking system has been used in the treatment of an estimated 10,000 patients for cancer of the prostate.</p>
<p>It is expected that the Calypso business will be integrated into Varian’s Oncology Systems segment and will continue to operate in Seattle. Including transaction and integration costs, Varian anticipates that the Calypso acquisition will be slightly dilutive to earnings per diluted share in fiscal year 2012. The acquisition includes Calypso’s intellectual property portfolio with some 90 current or pending patents.</p>
<p><strong>About Varian Medical Systems</strong><br />
Varian Medical Systems, Inc., of Palo Alto, California, is the world&#8217;s leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection. Varian Medical Systems employs approximately 5,700 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world. For more information, visit http://www.varian.com or follow us on Twitter.</p>
<p><strong>About Calypso Medical Technologies, Inc.</strong><br />
Calypso Medical is a privately held medical device company headquartered in Seattle. Its proprietary tumor localization system is designed for body-wide cancers commonly treated with radiation. Utilizing miniaturized, nonionizing implanted devices called Beacon  electromagnetic transponders, the Calypso System continuously and accurately tracks the location of cancerous tumors for the improved precision and safe management of radiation for cancer treatment. The real-time position and motion information provided by the Calypso System offers objective reassurance that radiation treatment is delivered precisely to the prescribed target and not to surrounding healthy tissue, thereby improving safety and eliminating unnecessary radiation exposure to patients. Additional information can be found at www.calypsomedical.com.</p>
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<p><strong>FOR INFORMATION CONTACT:</strong><br />
Varian Medical Systems<br />
Meryl Ginsberg, 650-424-6444</p>
<p>Calypso Medical Technologies<br />
Lorraine Marshall Wright, 206-330-2621</p>
<p><strong>Forward Looking Statements:</strong><br />
Except for historical information, this news release contains &#8220;forward-looking&#8221; statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements concerning industry and market outlook, including customer demand and acceptance of products or technology for radiotherapy and radiosurgery; the outlook for certain geographic regions and markets; growth drivers; the outlook for our orders, sales, backlog, or earnings growth; future financial results and any statements using the terms “will,” “expect,” “anticipates,” “enable,” “should,” “plans,” or similar terms are forward-looking statements that involve risks and uncertainties that could cause our actual results to differ materially from those anticipated. Such risks and uncertainties include the ability to effectively integrate the products of Calypso into our product offerings and sales and marketing operations; the ability to retain the services of key Calypso personnel; demand for our and Calypso’s products; our ability to develop and commercialize new products or new indications for commercially available products; the impact of competitive products and pricing; our ability to maintain or increase operating margins; our ability to protect our intellectual property; the risk of operations interruptions due to events beyond our control; and the other risks listed<br />
from time to time in our filings with the Securities and Exchange Commission. We assume no obligation to update or revise the forward-looking statements in this release because of new information, future events, or otherwise.</p>
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