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NEW YORK, NY / ACCESSWIRE / April 26, 2017 / Levi & Korsinsky, LLP announces it has commenced an investigation of Versartis Inc. (NASDAQ: VSAR) concerning possible breaches of fiduciary duty. To obtain additional information, go to: http://zlk.9nl.com/versartis-vsar, or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212) 363-7500, toll-free: (877) 363-5972. There is no cost or obligation to you. Levi & Korsinsky is a national firm with offices in New York, Connecticut, California, and Washington D.C. The firm's attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities lawsuits and have recovered hundreds of millions of dollars for aggrieved shareholders. For more information, please feel free to contact any of the attorneys listed below. Attorney advertising. Prior results do not guarantee similar outcomes.


Rare Diseases affect 30 million people in the United States and 350 million people globally. Despite this size, it lacks a strong unified voice as only 15% of rare diseases have organizations or foundations providing support or driving research, halting the progress that could be made. Mediaplanet’s cross-platform edition of “Rare Diseases” will call upon researchers, universities, students, companies, policy makers, and clinicians to do more research and to make readers aware of the importance of advocating for the rare disease community. Sam Buck, a child fighting VWM, graces the cover of the print publication. Through an exclusive interview with Mediaplanet, his mother Allyson opens up about her families struggle with rare diseases “The pediatrician told us that there’s no treatment, no cure- there’s nothing” Allyson recalls. Allyson shares how to make the best of such a difficult situation, and how to answer an unlucky diagnosis with rare courage. "It does get easier” Allyson shares. The print component of “Rare Diseases” is distributed within the weekend edition of USA Today with a circulation of approximately 750,000 copies and an estimated readership of 1.5 million. The digital component is distributed nationally through a vast social media strategy and across a network of top news sites and partner outlets. To explore the digital version of the campaign, click here. This edition of “Rare Diseases” was made possible with the support of The Buck Family, NORD (National Organization for Rare Disorders), NIH office of Rare Disease Research, Global Genes, C1 Consulting, Alexion Pharmaceuticals, Aegerion Pharmaceuticals, Incyte, Versartis, Fibrocell, Amicus Therapeutics, AmeriSourceBergen, and Illumina. About Mediaplanet Mediaplanet is the leading independent publisher of content marketing campaigns covering a variety of topics and industries such as Health, Education, Lifestyle, Business and Technology, and Corporate Social Responsibility. We turn consumer interest into action by providing readers with motivational editorial, pairing it with relevant advertisers and distributing it within top newspapers and online platforms around the world. Please visit http://www.mediaplanet.com for more on who we are and what we do.


MENLO PARK, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), presented safety, efficacy, and IGF-I data from somavaratan treatment in the combined Phase 2a and ongoing VISTA long-term safety study for pediatric GHD today during the 8th International Congress of the GRS & IGF Society. Will Charlton MD, MAS, FAAP, Senior Medical Director at Versartis, delivered an oral presentation and was the lead author on the featured poster, both of which will be made available on the Versartis website: http://ir.versartis.com/events.cfm. "These results from patients in the somavaratan Phase 2a and long term VISTA study indicate that increasing the dose to 3.5mg/kg twice-monthly safely improved IGF-I SDS and height velocity. This is the dose now being evaluated in the Phase 3 VELOCITY trial,” said Nancy M. Wright, MD, Assistant Clinical Professor at the Florida State University College of Medicine, a co-author on the presentation and a somavaratan trial investigator. "Additionally, the safety profile following 2½ years of therapy is consistent with daily rhGH treatment showing that somavaratan was safe and well tolerated. We look forward to the results of the ongoing Phase 3 trial in the third quarter of 2017.” Oral Presentation The oral presentation entitled, “Results of Somavaratan (VRS-317) dose increase in the first two years of treatment in pre-pubertal children with growth hormone deficiency (GHD)”, highlighted the changes in mean IGF-I SDS and height velocity (HV) between treatment duration at the lower initial doses totaling 5.0 mg/kg monthly and subsequently increased to a total of 7.0 mg/kg monthly in the Phase 2a and subsequent VISTA long-term safety study. Dosing frequency varied in Year 1; however, all 64 subjects initially received 5.0 mg/kg monthly in divided weekly, monthly or twice-monthly doses. Subjects initially in the weekly cohort increased to 7.0 mg/kg divided twice-monthly during the first treatment year, 5 subjects at month 6 and 15 subjects at month 9 and by Year 2, all had increased to the 3.5 mg/kg twice-monthly dose. Baseline mean IGF-I SDS for the total cohort was -1.7 (±0.78).  The dose increase to 3.5 mg/kg twice-monthly resulted in increased mean IGF-I SDS peak from 0.09 (±1.35) during treatment duration at 5.0 mg/kg monthly to 0.60 (±1.42) at 7.0 mg/kg monthly – the upper end of the therapeutic range – and trough from -1.4 (±1.03) to -0.7 (±1.25). On the lower dose, transient IGF-I SDS excursions >2 were observed in 7 subjects, all in the monthly cohort. After the dose increase and move to twice-monthly dosing, IGF-I SDS excursions were observed in 9 subjects (range 2.01, 3.67). All peaks >2 SDS were transient and none were associated with AEs. Fewer subjects reported related AEs after the dose increase than before and no related SAEs were reported. The dose increase also maintained annualized HV into the second year of treatment at 5.0 mg/kg vs. 7.0 mg/kg total monthly dose (8.04±2.59 cm/yr vs. 7.96±2.32), and height SDS continued to improve (-2.3±0.63 vs. -1.7±0.76). Poster Session The poster entitled, “Safety Profile of Somavaratan (VRS-317), a Novel Long-Acting rhGH Fusion Protein, in Pre-Pubertal Children with Growth Hormone Deficiency (GHD),” reviewed safety data from 30 months of dosing in the Phase 1b/2a clinical trial and subsequent VISTA study. As reported previously, related adverse events (AEs) were all mild/moderate and transient. The most commonly reported AEs were injection site pain (31/64, 48%), injection site erythema (6/64, 9%), and headache (5/64, 8%). The frequency of related AEs declined substantially after the initial 6-month exposure period, and no related serious AEs were reported. About Somavaratan Somavaratan is Versartis' investigational, novel, long-acting form of recombinant human growth hormone (rhGH). This fusion protein consists of rhGH and specific sequences of naturally-occurring hydrophilic amino acids based on a proprietary XTEN®1 technology. Somavaratan has been designed with the goal of improving therapeutic outcomes for children and adults with growth hormone deficiency (GHD), including enhanced adherence and convenience with a twice-monthly dosing schedule, fine gauge needle autoinjector device and room temperature storage. Somavaratan is currently being evaluated for the treatment of pediatric GHD in the pivotal Phase 3 VELOCITY trial in the U.S., Canada and Europe, for which data are anticipated in Q3 2017, and the J14VR5 Phase 2/3 trial in Japan. Confirmatory safety and efficacy data from up to 30 months of dosing in the Phase 2 trial and VISTA long-term safety study were presented during the Endocrine Society and European Society of Paediatric Endocrinology 2016 annual meetings. In adult GHD, results have been reported from the Phase 2 VITAL trial in the U.S., Europe and Australia and a Phase 3 trial is expected to begin during the second half of 2017. 1XTEN is a registered trademark of Amunix Operating Inc. About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new molecular entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended June 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Similar PK/PD data between US and Japanese children treated with somavaratan support using the same dose in the ongoing US and Japan Phase 3 trials MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that a comparison of data from its U.S. and Japanese Phase 2 studies was accepted as a late-breaking poster presentation at the Endocrine Society's 99th Annual Meeting & Expo (ENDO 2017), to be held April 1-4, in Orlando, Florida. The abstract has been published online and is available on the ENDO 2017 website. This is the sixth Versartis abstract that has been accepted for presentation at the conference, including five that were announced previously. Comparison of the pharmacokinetic and pharmacodynamic (PK/PD) properties between U.S. and Japanese pediatric subjects showed similar responses achieved at the same range of somavaratan doses in both populations. In addition, variability between the two patient sets was minor, with no effect on treatment outcomes. These similarities support the utilization of the same 3.5 mg/kg twice-monthly US Phase 3 dose in the ongoing Japanese Phase 3 trial, which has been reviewed with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Below are details on each of the presentations. ORAL PRESENTATION (Oral Session: OR31-1) Monday, April 3, 2017 - 11:15 AM - 12:45 PM 31135 - Safety and Efficacy of Somavaratan (VRS-317), a Long-Acting Recombinant Human Growth Hormone (rhGH), in Children with Growth Hormone Deficiency (GHD): 3-Year Update of the VERTICAL & VISTA Trials (NCT01718041, NCT02068521) POSTER PRESENTATION (Poster Board: SAT 016) Saturday, April 1, 2017 - 1:00 – 3:00 PM 31202 - Achievement of a Suitable Basis of Comparison in Phase 2 and Phase 3 Pediatric Somavaratan Clinical Trials (VERTICAL, VISTA, and VELOCITY Studies) and for the Comparison of Somavaratan to Daily Recombinant Human Growth Hormone (rhGH) POSTER PRESENTATION (Poster Board: SAT 015) Saturday, April 1, 2017 - 1:00 – 3:00 PM 29268 - IGF Family Biomarkers in the Diagnosis of Pediatric Growth Hormone Deficiency (PGHD) in Somavaratan Clinical Trials About Somavaratan Somavaratan is Versartis' investigational, novel, long-acting form of recombinant human growth hormone (rhGH). This fusion protein consists of rhGH and specific sequences of hydrophilic amino acids based on a proprietary XTEN®1 technology. Somavaratan has been designed with the goal of improving therapeutic outcomes for children and adults with growth hormone deficiency (GHD), including enhanced adherence and convenience with a twice-monthly dosing schedule, fine gauge needle autoinjector device and room temperature storage. Somavaratan is currently being evaluated for the treatment of pediatric GHD in the pivotal Phase 3 VELOCITY trial in the U.S., Canada and Europe, for which data are anticipated in September 2017, and the J14VR5 Phase 2/3 trial in Japan. Confirmatory safety and efficacy data from 36 months of dosing in the Phase 2 trial and VISTA long-term safety study are scheduled to be presented during the Endocrine Society 2017 annual meeting. In adult GHD, results have been reported from the Phase 2 VITAL trial in the U.S., Europe and Australia and a Phase 3 trial is expected to begin by the end of 2017. 1XTEN is a registered trademark of Amunix Operating Inc. About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new molecular entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


MENLO PARK, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the Company is scheduled to present at two upcoming investor conferences. Details are as follows: Audio webcasts of the Company’s presentations will be available on the investor relations section of the Versartis’ website at www.versartis.com.  A replay of the presentation will be available for 90 days. About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com.


News Article | February 21, 2017
Site: globenewswire.com

MENLO PARK, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided an update on its clinical development programs. “As we enter a pivotal year for the Company, our achievements in 2016 have positioned us very well,” said Jay Shepard, Versartis’ Chief Executive Officer. “We now have compelling safety and efficacy data from up to three years of somavaratan dosing in pediatric patients, have established a strong alliance with Teijin for commercialization in Japan — one of the largest global markets for GHD — and reinforced our strong financial position which supports somavaratan development beyond near-term data and a planned BLA filing next year.” “We are approaching a number of important milestones in 2017, the most significant of which is the top-line data from our pivotal Phase 3 VELOCITY trial in children with GHD, expected in September. Also during the year, we plan to evaluate pediatric patients switching from daily rhGH to somavaratan, complete enrollment in our Phase 3 pediatric trial in Japan, and initiate a Phase 3 trial in adults with GHD. We are excited about the potential catalysts taking place during the year and look forward to our five presentations scheduled for ENDO 2017 in just a few weeks.” For the fourth quarter ended December 31, 2016, Versartis reported a net loss of approximately $22.1 million, or $0.64 per share, basic and diluted, compared to a net loss for the fourth quarter ended December 31, 2015 of $20.1 million, or $0.69 per share, basic and diluted. Total operating expenses for the quarter ended December 31, 2016 were $22.5 million compared to $20.2 million for the quarter ended December 31, 2015. Research and development (R&D) expenses for the quarter ended December 31, 2016 were $16.7 million, compared to 15.6 million for the quarter ended December 31, 2015. The increase in R&D expenses was primarily due to manufacturing costs to support our ongoing Phase 3 clinical trials for somavaratan, including the Phase 3 VELOCITY pediatric trial and the Phase 3 portion of the Phase 2/3 pediatric GHD trial in Japan. General and administrative (G&A) expenses were $5.8 million for the quarter ended December 31, 2016, compared to $4.6 million for the quarter ended December 31, 2015. The increase in G&A expenses was primarily due to additional fees related to consulting and professional services to support our continued growth. Total operating expenses for the year ended December 31, 2016 were $96.3 million compared to $82.5 million for the year ended December 31, 2015. R&D expenses for the year ended December 31, 2016 were $72.0 million, compared to $60.0 million for the year ended December 31, 2015. The increase in R&D expenses was primarily due to manufacturing and clinical costs related to the Company's Phase 2 and ongoing Phase 3 clinical trials, including the VITAL Phase 2 trial for adults, the VELOCITY global Phase 3 trial and the Phase 2/3 trial of somavaratan in pediatric patients in Japan. G&A expenses were $24.3 million for the year ended December 31, 2016, compared to $22.5 million for the year ended December 31, 2015. The increase in G&A expenses was primarily due to additional fees related to consulting and professional services to support our continued growth, including the work associated with our strategic alliance with Teijin, partially offset by a one-time non-recurring expense of $2.4 million associated with our CEO transition in May 2015. Total operating expenses for the quarter ended December 31, 2016 include non-cash stock-based compensation expense of $2.9 million compared to $2.2 million of non-cash stock-based compensation expense for the quarter ended December 31, 2015. Total operating expenses for the year ended December 31, 2016 include non-cash stock-based compensation expense of $10.9 million, compared to $10.7 million of non-cash stock-based compensation expense for the year ended December 31, 2015, which includes a one-time non-recurring charge of $2.0 million associated with our CEO transition. Cash, cash equivalents, and short-term investments were $201.2 million as of December 31, 2016. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. For more information on Versartis and Versartis sponsored clinical trials, visit www.versartis.com. This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new molecular entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


News Article | October 31, 2016
Site: globenewswire.com

MENLO PARK, Calif., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that Jay Shepard, President and CEO, is scheduled to present at the 25th Annual Credit Suisse Healthcare Conference on November 7, 2016 in Scottsdale, AZ and the 28th Annual Piper Jaffray Healthcare Conference on November 29, 2016 in New York City. An audio webcast of the Company's presentations will be available on the investor relations section of the Versartis website at www.versartis.com. A replay of the presentation will be available for 90 days. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com. This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended June 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release and we assume no obligation to update our forward-looking statements after the date of this press release.


News Article | August 18, 2014
Site: venturebeat.com

For device makers and drug companies, going through the process of clinical trials for new treatments is expensive and time consuming. But they have to do it to get FDA approval. Part of the problem is a data problem. Biosciences companies need a virtual hub where all the clinical information lives, and where it can be accessed and collaborated on. That’s what Comprehend Systems is building a clean, well-lighted place for clinical data. Perhaps where Comprehend can make the biggest difference is providing enough data to drug and device makers to allow them to iterate during clinical trials, or cut trials short if the data shows the trial is headed for a failure. In the old system, Comprehend Systems CEO Rick Morrison explains, it could take up to a month to get a report on the progress of a trial after it had started. The Redwood City, Calif.-based company has just raised another $21 million in venture funding. The round was led by Lightspeed Venture Partners with support from existing investor Sequoia Capital. Comprehend took a $8.4 round of seed funding from Sequoia in July 2013. The company will use the new funds to expand the development of the platform, as well as add more people to assist customers. “Life science companies spend more than $4 billion to bring a single product to market, largely because they cannot access the information they needed to manage their clinical trials,” said Lightspeed Venture Partners partner Peter Nieh in a statement. “Comprehend’s analytical solutions enable life science companies to execute the clinical research process in a fundamentally new way, and the market is responding with great enthusiasm.” The platform makes trials information available to executives, clinical operations staff, data management people, and clinical monitors. They can see information on all aspects of work being done on the trial. Comprehend says the main problem with the way clinical trials is done now is that information is kept in separate places that can be accessed by different people. Putting it all in one place, Comprehend says, creates more effective trials, increased collaboration, improved audits, and reduced research timelines and study costs for drug and device companies. In the past year, Boston Scientific, Karyopharm, MERGE, Atlantic Research Group, and Versartis have all begun using Comprehend’s platform.


News Article | October 28, 2014
Site: www.xconomy.com

Another early-stage biotech investor has clocked in with a new fund. London-based Advent Life Sciences said Tuesday it has closed a $235 million vehicle, its second specialized fund since the tech and life science investors of Advent Venture Partners went separate ways last decade. The firm used to invest in tech and life sciences from a single fund, Advent Life Sciences general partner Raj Parekh said. But in the middle of last decade, as the old Advent began what Parekh (pictured) called a “generational handover,” the tech side looked toward mid-market, growth equity investments, while the life sciences partners wanted to be involved in company formation. Advent’s evolution is part of a larger trend toward venture specialization in recent years, which I explored last week. Atlas Venture’s decision to split its tech and biotech teams is the most recent example. As for Advent, keeping the teams together under one roof would have made for “a product offering quite different from previous Advent funds,” said Parekh. The second life sciences-only fund will be a bi-continental effort, with three of the firm’s partners based in the U.S.: Donald Drakeman is based in Princeton, NJ, and best known for co-founding antibody companies Medarex and Genmab; Alan Walts, who spent most of his biopharma career in various roles at Genzyme, is in Boston; and Dale Pfost, a biotech veteran who spends time on both East and West Coasts. As a ballpark guideline, the firm spreads its investments around, with one third in the U.S., one third in the U.K., and one third in continental Europe. The fund closed faster than expected and will begin investment in the coming months, Parekh said. Overall, Advent will aim for about 15 companies in the new portfolio, mainly starting with seed and Series A rounds. “We prefer to come in and help shape companies” with syndicate partners, Parekh said. He added that the firm’s early-stage description refers more to its preference for a company’s financing stage, not the age of its underlying technology, but Advent tends to look for riskier technology as well. In their previous two funds, “we’ve only done one Big Pharma spinout,” Parekh said, referring to Nerre Therapeutics, which Advent co-founded around a portfolio of preclinical and clinical assets from GlaxoSmithKline. The lead product entered Phase 2 testing in early 2014 as a treatment to alleviate the intense itching known as pruritus that certain cancer regimens can trigger. Advent Life Sciences closed its first dedicated fund at $158 million in 2011. The final Advent diversified fund, which closed in 2006, so far has produced three new therapeutic products and two medical device products either brought to market by the portfolio companies themselves or their acquirers. Some of its big exits or milestones include the $350 million acquisition of Avila Therapeutics by Celgene in 2012; Jazz Pharmaceuticals’ $650 million purchase of EUSA Pharma in 2012; Bayer Healthcare’s $2.9 billion buyout of Norwegian cancer drug maker Algeta, which closed this year; and the March 2014 IPO of Versartis, of which Advent owned 9.3 percent after the market debut. Shares opened at $21 apiece and rose quickly at first, but have come back down below that initial mark, ending Monday at $19.49.


News Article | February 18, 2014
Site: www.xconomy.com

Versartis is developing new therapeutic proteins utilizing the novel half-life extension technology, XTEN. Versartis has licensed the rights to three products (VRS-826, VRS-859, and VRS-317) from Amunix. The proceeds from this financing will primarily be used to prepare for an international Phase 3 pediatric GHD trial of VRS-317, the company’s proprietary long-acting rhGH for the treatment of GHD.

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