surf1944
11 years ago
8:53AM Synageva Biopharma provides clinical trial updates with Sebelipase ALFA in LAL deficiency (GEVA) 66.13 : Co announces total enrollment is complete in ARISE (Acid Lipase Replacement Investigating Safety and Efficacy), a global Phase 3 trial with sebelipase alfa in children and adults with lysosomal acid lipase deficiency (LAL Deficiency). Enrollment exceeded the original target of 50 patients with 66 randomized as of December 31, 2013. As previously announced, the company expects to report top-line results from the ARISE trial during the second half of 2014.
In addition, the company announces that it met the enrollment target in the Phase 2/3 trial in infants with LAL Deficiency. Nine patients enrolled in this open-label trial and preliminary results will be presented at the 10th Annual Lysosomal Disease Network WORLD Symposium being held February 11-13 in San Diego, California.
Phase 3 ARISE trial with sebelipase alfa in children and adults with LAL Deficiency
The ARISE trial is a randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with LAL Deficiency and is designed to assess the effects of sebelipase alfa on a broad range of abnormalities associated with the disease. Patients enrolled in the trial are randomized to infusions of sebelipase alfa (1 mg/kg, every other week) or placebo for the 20-week, double-blind treatment period and then allowed to enter into a long-term, open-label extension period. The efficacy and safety results from the double-blind treatment period are expected to support global submissions for product registration.
Phase 2/3 trial with sebelipase alfa in infants with LAL Deficiency
The Phase 2/3 trial is an open-label, multicenter study of sebelipase alfa in infants with LAL Deficiency. Infants with growth failure before six months of age were eligible to enroll and receive weekly infusions with sebelipase alfa. The primary endpoint of the trial is survival at 12 months of age.
surf1944
11 years ago
7:01AM Synageva Biopharma highlights data from Phase 1/2 extension study with sebelipase alfa in adults with LAL Deficiency; results show sustained improvements in biochemical markers of liver damage (GEVA) 58.91 : Co reportes 78-week results from an ongoing extension study with sebelipase alfa in adults with Lysosomal Acid Lipase Deficiency.
Nine adults with LAL Deficiency with a median age of 29 years (range 19-45) enrolled in the Phase 1/2 trial. Seven of nine patients had a history of hepatomegaly and/or splenomegaly, and two of nine patients had evidence of more advanced liver disease, including cirrhosis and portal hypertension.
At 78 weeks of treatment with sebelipase alfa, patients continued to have sustained reductions in both ALT and AST, frequently into the normal range, from the pre-treatment baseline. In addition, sebelipase alfa maintained improvement in dyslipidemia associated with LAL Deficiency with decreases in LDL and triglycerides and increases in HDL from the pre-treatment baseline to week 78 of the extension study. Sebelipase alfa also reduced patients' liver fat fraction and liver volume from the beginning of the extension study to week 52, the latest time point for these assessments. Liver fat fraction and liver volume were measured by multi-echo magnetic resonance imaging.
Sebelipase alfa was generally well tolerated through 78 weeks of the extension study. Most adverse events were mild and unrelated to sebelipase alfa.
surf1944
12 years ago
Synageva BioPharma™ to Present at the 31st Annual J.P. Morgan Healthcare Conference
Press Release: Synageva – Wed, Dec 19, 2012 4:01 PM EST
LEXINGTON, Mass.--(BUSINESS WIRE)--
Synageva BioPharma Corp. (“Synageva”) (GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today its presentation at the upcoming J.P. Morgan Healthcare conference being held in San Francisco, CA.
Sanj K. Patel, President and Chief Executive Officer of Synageva, will present on Wednesday, January 9, 2013, at 10:30 AM PDT (1:30 PM EST). The presentation will be webcast live and may be accessed from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at www.synageva.com.
About Synageva’s Lead Program
Sebelipase alfa is a recombinant form of the human LAL enzyme under development by Synageva as an enzyme replacement therapy for LAL Deficiency, a lysosomal storage disorder (LSD). Synageva is currently evaluating sebelipase alfa in global clinical trials and sebelipase alfa has been granted orphan designations by the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received “fast track” designation by the FDA.
About LAL Deficiency
LAL Deficiency is a rare, autosomal recessive LSD caused by a marked decrease in LAL enzyme activity. Late onset LAL Deficiency, sometimes called Cholesteryl Ester Storage Disease (CESD), affects both children and adults. In these patients, the buildup of fatty material in the liver, spleen and blood vessel walls leads to complications resulting in significant morbidity and mortality. Early onset LAL Deficiency, sometimes called Wolman disease, affects infants and is characterized by severe malabsorption, growth failure, and liver failure and is usually fatal within the first six months of life.
surf1944
12 years ago
7:03AM Synageva Biopharma announces SBC-102 data at upcoming SSIEM Meeting; SBC-102 continues to improve disease-related parameters in adults with late onset LAL Deficiency (GEVA) 38.88 : Co announced acceptance of data for oral presentation at the upcoming Society for the Study of Inborn Errors of Metabolism meeting being held in Birmingham, England, Sept 4-7, 2012. The presentation includes a preliminary analysis of the on-going Phase I/II extension study of SBC-102 in adults with late onset LAL Deficiency. Data from seven of the nine patients completing the first 12 weeks of dosing in the extension study are included in the preliminary analysis that has been accepted for oral presentation at the upcoming SSIEM meeting. These data demonstrate further evidence of the sustained impact of SBC-102 on reducing liver transaminase levels. In addition, total cholesterol, HDL cholesterol, and triglycerides significantly improved (p<0.05) from patients' original baseline (the beginning of the four week Phase I/II trial) to 12 weeks of the extension study. A reduction in LDL was also observed during the same time period. SBC-102 was well tolerated through 12 weeks of the extension study. The most frequently reported adverse events of headache and diarrhea were mild in severity. Mild infusion-related reactions have been reported in some patients, none of which required modification of the infusion rate or discontinuation of SBC-102. No antidrug antibodies were detected in any of the nine subjects in the four week Phase I/II trial or in the seven subjects tested in the extension study. A single patient during the extension study experienced acute cholecystitis classified as a serious adverse event but deemed unlikely related to SBC-102 by the investigator. This event was successfully managed and the patient remains in the study. Longer-term results from this on-going extension study, including other measures of efficacy, are planned for presentation at another medical conference later this year.
surf1944
12 years ago
Synageva BioPharma to Present at the Bank of America Merrill Lynch 2012 Health Care Conference
Business WirePress Release: Synageva BioPharma Corp. – Thu, May 10, 2012 7:00 AM EDT
LEXINGTON, Mass.--(BUSINESS WIRE)--
Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA - News), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, will present at the upcoming Bank of America Merrill Lynch 2012 Health Care Conference being held in Las Vegas, Nevada.
Sanj K. Patel, President and Chief Executive Officer of Synageva, is scheduled to present on Wednesday, May 16, 2012, at 10:40 a.m. PDT (1:40 p.m. EDT). The presentation will be webcast live and may be accessed from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at www.synageva.com.
About Synageva’s Lead Program
SBC-102 is being developed as an enzyme replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal storage disorder (LSD), and is a recombinant form of the human LAL enzyme. SBC-102 is currently being evaluated in global clinical trials and has been granted orphan designations by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency. Additionally, SBC-102 received fast track designation by the FDA.
About LAL Deficiency
Lysosomal Acid Lipase Deficiency is a rare, autosomal recessive lysosomal storage disorder (LSD) that is caused by a marked decrease in LAL enzyme activity. Late onset LAL Deficiency, sometimes called Cholesteryl Ester Storage Disease (CESD), affects both children and adults. In these patients, the buildup of fatty material in the liver, spleen and blood vessel walls leads to complications resulting in significant morbidity and mortality. Early onset LAL Deficiency, sometimes called Wolman Disease, affects infants in the first year of life and is characterized by growth failure, malabsorption, steatorrhea and hepatomegaly and is rapidly fatal, usually within the first year of life.
About Synageva BioPharma Corp.
surf1944
13 years ago
Synageva BioPharma to Host 2011 Fourth Quarter and Full Year Financial Results Conference Call on March 15
Business WirePress Release: Synageva BioPharma Corp. – Thu, Mar 8, 2012 4:05 PM EST
LEXINGTON, Mass.--(BUSINESS WIRE)--
Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA - News), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, will report 2011 fourth quarter and full year financial results after the NASDAQ Market closes on Thursday, March 15, 2012. Synageva management will conduct a conference call and audio webcast to discuss clinical development progress and financial results at 4:30 pm EDT on the same day.
The dial-in number for the conference call is 866-578-5784. The conference ID for callers is 74850064. A live webcast of the call will be available from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at www.synageva.com.
About Synageva’s Lead Program
SBC-102 is being developed as an enzyme replacement for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal storage disorder (LSD), and is a recombinant form of the human LAL enzyme. SBC-102 is currently being evaluated in global clinical trials and has been granted orphan designations by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency. Additionally, SBC-102 received fast track designation by the FDA.
mlkrborn
13 years ago
Synageva BioPharma Announces Closing of Public Offering and Exercise of Over-Allotment Option
Business WirePress Release: Synageva BioPharma Corp. – Tue, Jan 10, 2012 8:55 AM EST
*
* Synageva BioPharma Corp.
RELATED QUOTES
Symbol Price Change
GEVA 37.275 +2.78
LEXINGTON, Mass.--(BUSINESS WIRE)-- Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA - News), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced the closing of a $90 million underwritten public offering of 3,574,266 shares of a common stock, including 466,209 shares of common stock which were issued pursuant to the exercise of the underwriters’ over-allotment option, at a price of $25.18 per share. Synageva received net proceeds, after deducting the underwriting discount and estimated offering expenses, of approximately $84 million from the offering.
surf1944
13 years ago
Synageva BioPharma Announces Pricing of Public Offering of Common Stock
Business WirePress Release: Synageva BioPharma Corp. – 4 hours ago
short sale
LEXINGTON, Mass.--(BUSINESS WIRE)-- Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA - News), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced the pricing of its previously announced underwritten public offering of common stock consisting of 3,108,057 shares at $25.18 per share. In connection with this offering, Synageva granted to the underwriters a 30-day option to purchase 466,209 additional shares of common stock to cover over-allotments, if any.
Morgan Stanley and J.P. Morgan are acting as joint book-running managers in the offering, and Cowen and Company, Leerink Swann and Wedbush PacGrow Life Sciences are acting as co-managers in the offering.
The securities described above are being offered by Synageva pursuant to a Form S-3 shelf registration statement (including a base prospectus) previously filed with, and declared effective by, the Securities and Exchange Commission (“SEC”). Before you invest, you should read the prospectus in the registration statement and related prospectus supplement that Synageva has filed with the SEC for more complete information about Synageva and this offering. The prospectus supplement is available for free by visiting EDGAR on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus may also be obtained from the offices of Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, Attn: Prospectus Department, by calling toll-free (866) 718 1649 or by email at prospectus@morganstanley.com, or from the offices of J.P. Morgan Securities LLC via Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling toll-free (866) 803-9204.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
surf1944
13 years ago
Synageva BioPharma(GEVA_), a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutic products for patients with rare diseases and unmet medical needs. This stock is trading down 0.40% to $17.50 in recent trading, after it hit a 52-week high of $17.70 earlier today.
Today's Range: $17.50-$17.70
52-week Range: $8.30-$17.70
Volume: 2,845
Three-Month Average Volume: 21,678
Synageva BioPharma has a market cap of $307.9 million This stock trades at a price-to-sales of 30.62. The current short interest as a percentage of the float for Synageva is notable at 4.8%.
http://www.thestreet.com/_yahoo/story/11329209/1/6-stocks-hitting-new-52-week-highs.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
surf1944
13 years ago
Trimeris Reports Financial Results for the Second Quarter 2011
Press Release Source: Trimeris, Inc. On Friday August 12, 2011, 5:00 pm EDT
DURHAM, N.C.--(BUSINESS WIRE)-- Trimeris, Inc. (NASDAQ:TRMS - News), today reported second quarter 2011 financial results. As previously reported, Trimeris entered into a new royalty arrangement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively, “Roche”) pursuant to an Amended and Restated Agreement dated as of May 25, 2011 and effective as of January 1, 2011 (the “New Roche Agreement”), which is described in footnote 1 to the attached statements of operations. Because the New Roche Agreement fundamentally changed the calculation of amounts payable to Trimeris, comparisons of financial results between the quarters and six month periods ended June 30, 2011 and June 30, 2010 are not directly comparable.
Net income for the quarter ended June 30, 2011 was $673,000 or $0.03 per share compared with net income of $1.3 million or $0.06 per share for the quarter ended June 30, 2010. For the six months ended June 30, 2011, Trimeris reported net income of $606,000, or $0.03 per share, compared with $2.3 million, or $0.10 per share for the six months ended June 30, 2010.
The overall decline in net income for the quarter and six months ended June 30, 2011 compared to the corresponding periods in 2010 resulted primarily from decreased worldwide net sales of FUZEON and increased general and administrative fees related to the Trimeris process to evaluate and identify a strategic partner as well as Trimeris’ proposed merger with Synageva BioPharma Corp. (“Synageva”) described below and other adjustments, offset by certain payments from Roche.
Proposed Synageva Merger
As previously reported, on June 13, 2011, the Company entered into an Agreement and Plan of Merger and Reorganization (the “Synageva Merger Agreement”) with Synageva. Pursuant to the terms and subject to the conditions set forth in the Synageva Merger Agreement, Synageva would become a wholly-owned subsidiary of Trimeris (the “Synageva Merger”). Completion of the Synageva Merger is subject to various conditions, including the approval of the stockholders of both Trimeris and Synageva. On July 13, 2011, Trimeris and Synageva filed a Registration Statement on Form S-4 with the Securities and Exchange Commission (the “SEC”). This Registration Statement provides additional information regarding the Synageva Merger.
Cash Position
As of June 30, 2011, cash and cash equivalents totaled $52.4 million compared to $45.2 million as of December 31, 2010. The increase in cash is primarily a result of a $4.9 million settlement payment from Roche in connection with the New Roche Agreement.
Revenue
Total revenue for the quarter ended June 30, 2011 was $3.4 million compared with $3.3 million for the same period in 2010. The slight increase in revenue for the quarter was attributable to certain payments and other adjustments recognized in the second quarter as well as declining sales of FUZEON. Total revenue for the six months ended June 30, 2011 was $5.0 million compared with $6.4 million for the same period in 2010, primarily due to a decline in sales of FUZEON and other adjustments, offset by certain payments from Roche.
FUZEON Sales
The tables below illustrate net sales of FUZEON in North America and ROW on a quarterly basis. Although worldwide net sales of FUZEON during the quarter ended June 30, 2011 increased $1.7 million from worldwide net sales of FUZEON in the quarter ended March 31, 2011, Trimeris believes that this quarter-to-quarter increase in net sales is more likely due to the continuation of historical variability in FUZEON sales rather than stabilization of the recent decline in net sales of FUZEON.
In the first half of 2011 worldwide net sales declined by $21.6 million or 46% from worldwide net sales in the first half of 2010. North American net sales of FUZEON for the quarter ended June 30, 2011 were $5.7 million, down 29% from $8.0 million for the same period in 2010. ROW net sales for the second quarter of 2011 were $7.9 million, down 46% from $14.7 million from the same period last year. North American net sales for the six months ended June 30, 2011 were $12.4 million, down 18% from $15.2 million for the same period in 2010. ROW net sales for the six months ended June 30, 2011 were $13.1 million, down 59% from $31.9 million for the same period last year.
We believe that the sales declines between 2010 and 2011 in North America have resulted mainly from patients switching to a more convenient dosing alternative, while the ROW declines stem in large part from the variability in buying patterns of certain countries that either do not purchase FUZEON every quarter (Brazil) or that purchase FUZEON in quantities that vary significantly from quarter to quarter.
($ millions) 2011
Q1 Q2 Q3 Q4 Total
North America Net Sales $6.7 $5.7 $12.4
ROW Net Sales 5.2 7.9 13.1
Worldwide Net Sales $11.9 $13.6 $25.5
Brazil Purchase* - - -
2010
Q1 Q2 Q3 Q4 Total
North America Net Sales $7.2 $8.0 $9.0 $7.8 $32.0
ROW Net Sales 17.2 14.7 9.3 15.2 56.4
Worldwide Net Sales $24.4 $22.7 $18.3 $23.0 $88.4
Brazil Purchase* $7.8 $8.0 - $7.4 $23.2
*included in ROW Net Sales and Worldwide Net Sales
Operating Expenses
Operating expenses for the quarter and six months ended June 30, 2011 were $2.6 million and $4.3 million, respectively, compared with $1.1 million and $2.6 million for the same periods in 2010 reflecting increased fees payable to legal and financial advisors, as well as other administrative expenses related to the proposed Synageva Merger.
Earnings Conference Call
The Company will not be conducting a conference call in connection with this earnings release.
surf1944
13 years ago
Trimeris Reports Financial Results for the First Quarter 2011
businesswire
Chart for Trimeris, Inc.
Press Release Source: Trimeris, Inc. On Friday May 13, 2011, 5:00 pm EDT
DURHAM, N.C.--(BUSINESS WIRE)-- Trimeris, Inc., (NASDAQ:TRMS - News) today reported first quarter 2011 financial results. Net loss for the quarter ended March 31, 2011 was $67,000 or $0.00 per share compared with net income of $988,000, or $0.04 per share for the quarter ended March 31, 2010. The Company reported adjusted net income for the quarter ended March 31, 2011 of $269,000 compared to adjusted net loss for the quarter ended March 31, 2010 of $68,000.
Comparisons of net income between the quarters ended March 31, 2011 and March 31, 2010 are affected by several items detailed in the section below entitled “Adjusted (Non-GAAP) Financial Information.”
Cash Position
As of March 31, 2011, cash, cash equivalents and investment securities totaled $47.3 million compared to $45.2 million as of December 31, 2010.
Collaboration Income
Collaboration income from our collaboration with F. Hoffman-LaRoche, Ltd. (“Roche”) for the quarter ended March 31, 2011 was $1.3 million compared with $1.2 million for the quarter ended March 31, 2010. Net sales of FUZEON in the U.S. and Canada for the first quarter of 2011 declined seven percent to $6.7 million, from $7.2 million for the same period in 2010. This net sales decline was completely offset by reduced selling and marketing expenses and cost of goods sold.
Royalty Revenue
Royalty revenue from Roche for the quarter ended March 31, 2011 was $262,000 compared with $1.9 million for the same period in 2010. This decrease was primarily driven by lower sales outside the U.S. and Canada (“ROW”) and the reduction of the royalty rate from 12% to 6% for ROW sales imposed by Roche and described in more detail below.
ROW net sales of FUZEON for the first quarter of 2011 were $5.2 million, down 70 percent from $17.2 million for the same period in 2010. A significant portion of this decline in net sales resulted from the variability in quarterly buying patterns of specific countries that either did not purchase during the quarter (Brazil) or purchased significantly reduced quantities (Mexico and Romania).
Disagreement with Roche over FUZEON Cost of Goods Sold and Royalty Rate
In October 2010, Roche informed the Company that, in reliance on a clause in the Development and License Agreement between the Company and Roche which permits Roche to reduce its ROW royalty payments to the Company if the cost of goods sold outside the U.S. and Canada exceeds a certain proportion of those net sales, Roche would reduce the royalty paid to the Company from 12%, the amount previously paid, to 6% with application retroactive to January 1, 2010. As previously disclosed, in April 2009, the Company notified Roche that it did not agree with the manner in which FUZEON cost of goods sold were being calculated by Roche and charged to the collaboration. Roche and the Company have been in discussions regarding this calculation since that time.
The Company has notified Roche of its objection to the timing and application of the royalty reduction clause, both under the terms of the contract and in light of the parties’ ongoing discussion related to the calculation of cost of goods sold. While the Company is considering all available options for resolution of this issue, the Company currently intends to continue working with Roche to reach agreement on the appropriate cost of goods sold for FUZEON.
The effect of Roche’s imposition of a reduced royalty rate resulted in a $1.8 million reduction in royalty revenue for the first six months of 2010, which was recognized in the third quarter of 2010, and continues to result in significant reductions in expected royalty revenues for so long as the reduced royalty rate is in effect.
Operating Expenses
Operating expenses for the quarter ended March 31, 2011 were $1.7 million compared with $1.4 million for the same period in 2010 reflecting a non-recurring increase in legal fees and patent write-offs.
Earnings Conference Call
The Company will not be conducting a conference call in connection with this earnings release.
mlkrborn
14 years ago
Financials in second (earlier) quarter;
Trimeris posts flat earnings
Triangle Business Journal - by James Gallagher
Date: Friday, August 13, 2010, 11:04am EDT
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* Trimeris, Roche settle HIV drug suit with Novartis
Cost cuts allowed Trimeris Inc. to hold the line of second quarter earnings even as sales of its top drug fell, the drug maker announced.
The Durham-based company (NASDAQ: TRMS) posted earnings of 6 cents per share during the second quarter, the same as a year ago. The company held that profitability despite quarterly revenues falling from $3.6 million a year ago to $3.26 million in 2010.
Sales of HIV-treatment Fuzeon have been falling. Globally, sales totaled $22.7 million during the second quarter of 2010, down from $29.1 million during the same year-ago period. The drop in sales has hit Trimeris’s financials, cutting down royalty revenue to $1.6 million during the quarter, down from $2.1 million during the same year-ago period.
Trimeris was able to reduce its operating expenses to $1.1 million, down from $1.7 million a year ago. However, part of that $1.7 million was a $496,000 one-time payment to release the company from its lease obligations. Without that one-time cost, Trimeris would have earned 8 cents per share during the second quarter of 2009.
Read more: Trimeris posts flat earnings | Triangle Business Journal
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