surf1944
14 years ago
Trubion Pharmaceuticals, Inc. Announces Acceptance of Two Presentations on Its SBI-087 Product Candidate at EULAR 2010
Press Release Source: Trubion Pharmaceuticals, Inc. On Wednesday May 12, 2010, 4:00 pm EDT
SEATTLE, May 12 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN - News) today announced the acceptance of two Phase 1 data presentations on SBI-087 (PF-05230895) at the 2010 annual congress of the European League Against Rheumatism (EULAR) in Rome, Italy. Presentations will include promising data from a Phase 1 study of SBI-087 for the treatment of rheumatoid arthritis (RA) and a Phase 1 study of SBI-087 for the treatment of systemic lupus erythematosus (SLE). Copies of both abstracts are available at http://www.eular.org. SBI-087 is Trubion's next-generation CD20-directed small modular immunopharmaceutical (SMIP™) product candidate and is being developed in collaboration with Pfizer.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO)
Abstract OP0053: Subcutaneous (SC) administration of SBI-087 provides potent B-cell depletion in subjects with controlled RA
Oral Presentation
June 17, 2010; 10:30 a.m.–Noon
Room 8 B
Roy Fleischmann
The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled RA. At the time of the abstract submission, 60 patients enrolled in the open-label Phase 1 trial had received intravenous doses of SBI-087 ranging from 0.15 to 2 mg/kg or subcutaneous doses of 50, 100, 200 and 300 mg. All of the patients studied had well-controlled RA.
Data demonstrate that SBI-087, given as a single subcutaneous dose with a day-of-treatment oral steroid regimen, is generally well-tolerated and induces potent B-cell depletion. The most frequently reported adverse events were upper respiratory infection, headache, diarrhea, chills, fever, fatigue and bruising at the injection site. SBI-087 administered at subcutaneous doses of at least 100 mg depleted peripheral blood B-cell levels to less than 5 cells/uL for at least 12 weeks. Trubion's collaboration partner, Pfizer, initiated a Phase 2 study of SBI-087 for RA in January to evaluate safety and efficacy of SBI-087. The 200 mg subcutaneous dose was selected to be further investigated as part of this trial.
Abstract SAT0188: B-cell depletion in subjects with controlled systemic lupus erythematosus (SLE) after intravenous or subcutaneous administration of SBI-087
Poster Presentation
June 19, 2010; 10:15–Noon
Fiera Roma – Poster Areas in Halls 5 & 6
At the time of abstract submission, data was available for 18 patients enrolled in an open-label Phase 1 study of SBI-087 for SLE. Patients received intravenous doses of 0.5 mg/kg or subcutaneous doses of 25 mg or 75 mg of SBI-087. All patients had well-controlled SLE.
Preliminary data demonstrate that SBI-087 was generally well-tolerated by patients with well-controlled lupus when administered as a single subcutaneous dose with a day-of-treatment oral steroid regimen. Adverse events included chills, extreme fatigue, upper respiratory tract infection and muscle spasms. Subcutaneous doses of 75 mg of SBI-087 depleted peripheral blood B-cell levels in all subjects to below 20 cells/uL. Five of six subjects in this cohort had B-cell levels below 5 cells/uL by week two. By week 10, B-cell levels increased to above 20 cells/uL in four of six subjects. The Phase 1 trial is ongoing and is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled SLE.
"Data to be presented at EULAR reinforce the need for differentiated treatments for RA and SLE," said Scott Stromatt, M.D., chief medical officer of Trubion. "We look forward to continued evaluation of our second generation CD20 compound and further defining its role in the treatment of RA and SLE."
surf1944
15 years ago
Trubion Announces Dates for First-Quarter 2010 Earnings Conference Call
Press Release Source: Trubion Pharmaceuticals, Inc. On Thursday April 29, 2010, 4:00 pm EDT
SEATTLE, April 29 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq:TRBN - News) today announced that it plans to issue earnings results for the first quarter ended March 31, 2010, after the close of market on May 6, 2010. The company's earnings conference call will take place May 6, 2010 at 2 p.m. Pacific Time, 5 p.m. Eastern Time.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO)
Both live events will be available for viewing on Trubion's website at http://investors.trubion.com.
First-Quarter 2010 Earnings Conference Call: 2 p.m. PDT / 5 p.m. EDT, May 6, 2010
Trubion will host a conference call and webcast to discuss its first-quarter 2010 financial results. The call will be held May 6 at 2 p.m. PDT (5 p.m. EDT). The live event will be available on Trubion's website at http://investors.trubion.com/events.cfm, or by calling 1 (877) 564-1186 or 1 (973) 409-9686. A replay of the discussion will be available beginning the evening of May 6 on Trubion's website or by calling 1 (800) 642-1687 or 1 (706) 645-9291, and entering 71357019. The telephone replay will be available through May 13, 2010.
surf1944
15 years ago
Trubion Pharmaceuticals, Inc. Reports Fourth-Quarter and Year-Ended 2009 Financial Results
Press Release Source: Trubion Pharmaceuticals, Inc. On Monday March 15, 2010, 4:00 pm EDT
SEATTLE, March 15 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN - News) today announced financial results for its fourth quarter and year ended Dec. 31, 2009.
Fourth-Quarter and Year-Ended 2009 Financial Results
Revenue for the fourth quarter of 2009 was $5.2 million compared with $4.3 million for the fourth quarter of 2008. Revenue for the year ended Dec. 31, 2009, was $18.0 million compared with $16.5 million for the year ended Dec. 31, 2008. The increase in 2009 revenue resulted primarily from Trubion's strategic collaboration with Facet Biotech, including $0.8 million for recognition of the $20 million upfront fee and $1.4 million equity premium, and $1.3 million for collaborative research funding.
The increase in revenue related to the Facet Biotech collaboration was partially offset by a decrease in revenue recognized from Trubion's collaboration with Pfizer. The decrease in revenue related to an extension of the recognition period of the upfront fee and lower costs for the Phase 2b clinical trial for TRU-015 in the treatment of rheumatoid arthritis. Revenue from the Pfizer collaboration for the year ended Dec. 31, 2009, included $11.0 million for collaborative research funding and $4.9 million for recognition of the $40 million upfront fee. Pfizer completed its acquisition of Wyeth in October, and reaffirmed its commitment to comply with the terms of the original collaboration agreement between Wyeth and Trubion.
Total operating expenses for the fourth quarter of 2009 were $10.4 million compared with $10.7 million for the fourth quarter of 2008. Total operating expenses for the year ended Dec. 31, 2009, were $46.8 million compared with $43.0 million for the year ended Dec. 31, 2008. The fourth-quarter decrease in operating expenses was primarily due to decreased outside manufacturing and lab expense. The 12-month increase in operating costs was primarily due to higher outside manufacturing and clinical development costs related to Trubion's TRU-016 product candidate, partially offset by decreased lab expense and personnel costs resulting from the 25 percent work force reduction in February 2009.
Net loss for the fourth quarter of 2009 was $5.3 million, or $0.29 per diluted common share, compared with a net loss of $6.4 million, or $0.36 per diluted common share, for the fourth quarter of 2008. For the year ended Dec. 31, 2009, net loss was $29.2 million, or $1.55 per diluted common share, compared with a net loss of $25.6 million, or $1.43 per diluted common share, for the year ended Dec. 31, 2008.
Trubion had $54.8 million in cash, cash equivalents and investments as of Dec. 31, 2009, compared with $52.9 million as of Dec. 31, 2008.
"In 2009, Trubion continued to aggressively pursue development of its product candidates that we believe have the greatest opportunity for success while prudently managing our resources," said Steven Gillis, executive chairman, acting president, and chairman of the board of directors at Trubion. "We announced a strategic collaboration with Facet Biotech for the joint development of TRU-016 and CD37-directed therapies, and announced positive data from TRU-016's ongoing evaluation in CLL. In addition, we reported positive ongoing TRU-015 retreatment data for patients with rheumatoid arthritis, and announced the initiation of two studies evaluating our second-generation CD20 product candidate, SBI-087 — a Phase 2 study in RA and a Phase 1 study in systemic lupus erythematosus. In addition to our clinical assets, we also presented positive preclinical data on our SCORPION™ and TRU-ADhanCe™ technology platforms and look forward to presenting further data later this year."
Facet Collaboration: CD37-Directed Therapies
On Aug. 28, 2009, Trubion announced it had entered into a collaboration agreement with Facet for the joint worldwide development and commercialization of TRU-016. TRU-016 is a CD37-directed SMIP™ protein therapeutic. The collaboration agreement includes TRU-016 in all indications and all other CD37-directed protein therapeutics.
As part of the agreement, Trubion received an upfront payment of $20 million in cash in September 2009 and may receive up to $176.5 million in additional payments upon certain development, regulatory and sales milestones. In December 2009, Trubion and Facet announced positive data from a Phase 1 study of TRU-016 in patients with relapsed or refractory CLL.
On March 9, 2010, Abbott announced a definitive agreement to purchase Facet. Abbott expects the transaction to close in the second quarter of 2010 subject to certain conditions. Following the announcement, Abbott has informed Trubion that it remains interested in TRU-016 and intends to proceed with its development following the close of the transaction.
Anticipated TRU-016 2010 milestones based on the current development plan include these:
Expand the ongoing Phase 1 monotherapy study to include NHL patients
Initiate a Phase 1/2 chemotherapy-TRU-016 combination study in relapsed CLL patients
Initiate a Phase 1 chemotherapy-TRU-016 combination study in relapsed NHL patients
Pfizer Collaboration: CD20-Directed Therapies
In October 2009, Trubion announced positive data from the second course of re-treatment in the first Phase 2b clinical trial for RA demonstrating that administration of TRU-015 every 24 weeks produces well-tolerated results that are comparable with the more than four and a half years of re-treatment data compiled to date from the Phase 1/2a study.
In September 2009, enrollment was completed in the ongoing second Phase 2b dose-regimen finding clinical trial (2203) for rheumatoid arthritis (RA) with final data expected in mid-2010. The interim analysis of the second Phase 2b clinical trial of TRU-015 in RA (2203) met the pre-defined primary endpoint demonstrating superiority of TRU-015 over placebo. The study's pre-defined primary endpoint is American College of Rheumatology (ACR) 50 response at week 24.
In collaboration with Trubion, Pfizer is also developing SBI-087, Trubion's next-generation CD20-directed product candidate. Enrollment was completed in a Phase 1 study of SBI-087 for RA and patient dosing commenced in a Phase 2 study of SBI-087 in RA in December 2009. In addition, patient recruitment is under way in an additional Phase 1 study of SBI-087 for RA in Japan. Finally, Pfizer is conducting a Phase 1 clinical trial of SBI-087 in systemic lupus erythematosus in which patient dosing has commenced and recruitment is ongoing.
Pfizer has informed Trubion that it will determine whether to commence a Phase 3 study of TRU-015 for the treatment of RA after reviewing data from the ongoing Phase 2 SBI-087 RA study, in addition to final data from the ongoing Phase 2b TRU-015 (2203) RA study. An interim data review for the Phase 2 SBI-087 RA study is planned that Trubion believes could occur in late 2010 or early 2011. Final data is anticipated at the end of 2011.
Trubion 2010 Financial Guidance
Based on its current forecast, and excluding any proceeds from potential new partnerships or financings, Trubion expects that its existing capital resources will support the company's operations for at least the next 18 months. The following guidance includes an anticipated milestone of $6 million from Facet Biotech for the initiation of the Phase 2 portion of the TRU-016 study in CLL patients. This milestone is expected to be achieved in the second half of 2010. Trubion's 2010 financial guidance is as follows:
Trubion anticipates 2010 revenues to be approximately $25 million-$30 million earned through the company's Pfizer and Facet collaborations.
Operating cash requirements in 2010 are expected to be approximately $27 million-$32 million.
Earnings Conference Call Details
Trubion will host a conference call and webcast to discuss its fourth-quarter and year-ended 2009 financial results and provide an update on business activities. The call will be held March 15 at 2 p.m. Pacific Time, 5 p.m. Eastern Time. The live event will be available from Trubion's website at http://investors.trubion.com, or by calling (877) 564-1186 or (973) 409-9686. A replay of the discussion will be available beginning at 8 p.m. Eastern Time from Trubion's website or by calling (800) 642-1687 or (706) 645-9291 and entering 58716679. The telephone replay will be available until March 22, 2010.
http://finance.yahoo.com/news/Trubion-Pharmaceuticals-Inc-prnews-730525555.html?x=0&.v=1
surf1944
15 years ago
Trubion Pharmaceuticals, Inc. Announces Initiation of a Phase 2 Study of SBI-087 for the Treatment of Rheumatoid Arthritis (RA)
Press Release Source: Trubion Pharmaceuticals, Inc. On Monday January 11, 2010, 8:00 am EST
SEATTLE, Jan. 11 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).
2 multi-center, randomized, placebo-controlled, double-blind, parallel-group, outpatient dose regimen-finding study will enroll approximately 200 patients who meet the criteria for RA with American College of Rheumatology (ACR) Functional class I, II or III, are seropositive, and who have been diagnosed with RA more than six months before trial initiation. Participants will be randomly assigned to receive either placebo or one of four SBI-087 dosing regimens. This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active RA, who are on a stable dose of methotrexate. The primary outcome measure will include responses based on the ACR criteria (ACR 20 response).
"Initiating the Phase 2 trial of SBI-087 for RA is an important milestone for Trubion," said Scott Stromatt, M.D., senior vice president and chief medical officer of Trubion. "We look forward to evaluation of our next-generation CD20 compound in a larger patient population and further definition of its role in helping Trubion to establish category leadership in autoimmune and inflammatory diseases."
americano
15 years ago
News out on TRBN
Trubion Announces Acceptance of Two Presentations on Its TRU-016 Product Candidate at the 2009 ASH Annual Meeting
Last update: 11/11/2009 4:00:00 PM
--Phase 1: Positive Results Observed in More CLL Patients Treated With TRU-016--Preclinical: Trubion's Tru-ADhanCe(TM) Technology Promotes Enhanced Natural Killer Cell Mediated Cytotoxicity Against Primary CLL Cells
SEATTLE, Nov 11, 2009 /PRNewswire-FirstCall via COMTEX/ -- Trubion Pharmaceuticals, Inc. (TRBN) announced today the acceptance of two data presentations on its product candidate, TRU-016, at the 2009 American Society of Hematology (ASH) Annual Meeting Dec. 5-8, 2009 in New Orleans, Louisiana. The presentations will include additional positive data from 1) an ongoing Phase 1 clinical trial of TRU-016 for the treatment of chronic lymphocytic leukemia (CLL), and 2) a preclinical study demonstrating the effect of Trubion's Tru-ADhanCe(TM) technology in promoting enhanced natural killer cell mediated cytotoxicity against primary CLL cells. TRU-016 is Trubion's novel CD37-targeted therapy for the treatment of B-cell malignancies and is being developed in collaboration with Facet Biotech Corporation.
Presentation 3424: A Phase 1 Trial of TRU-016, An Anti-CD37 Small Modular Immunopharmaceutical (SMIP(TM)) Protein in Relapsed and Refractory CLL: Early Promising Clinical Activity
Monday, Dec. 7, 2009, 6:00 PM-8:00 PM Hall E (Ernest N. Morial Convention Center) Poster Board III-361
Conclusions: To date, TRU-016 is a well-tolerated treatment with minimal infusional toxicity and the maximum tolerated dose (MTD) has not been reached. One partial response (PR) and a median reduction of 83% in peripheral lymphocytosis have been observed. Encouraging reduction in lymph node/spleen size and improvement in normal hematopoietic function in patients with high-risk genomic CLL have been observed at low doses of CD37. The protocol has been amended to explore higher saturating doses of CD37. Future single-agent and combination studies of TRU-016 in CLL are warranted.
Presentation 1744: Glycovariant CD37 Small Modular Immunopharmaceutical (Tru-ADhanCe(TM) SMIP) Promotes Enhanced Natural Killer Cell Mediated Cytotoxicity against Primary CLL Cells
Saturday, Dec. 5, 2009, 5:30 PM-7:30 PM Hall E (Ernest N. Morial Convention Center) Poster Board I-766
Conclusions: Results of this study suggest that Tru-ADhanCe(TM) technology promotes enhanced natural killer cell mediated cytotoxicity against primary CLL cells and the potential use of Tru-ADhanCe versions of TRU-016 with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) function as an alternate for TRU-016 in B cell malignancies, including CLL therapy.
Copies of the TRU-016 abstracts are now available on ASH's website at or Trubion's website at . Copies of the full data presentations will be available on Trubion's website after the data is presented at the 2009 ASH Annual Meeting.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company's mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient experiences. Trubion's current product candidates are novel single-chain protein, or SMIP, therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company's Pfizer collaboration. Trubion's product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company's Facet collaboration. In addition to Trubion's current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6. More information is available in the investors section of Trubion's website: .
Forward-Looking Statements
Certain statements in this release may constitute "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the potential development and commercialization of TRU-016. These statements are based on current expectations and assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the company's ability to develop TRU-016 with Facet and such other risks as are identified in the Company's quarterly report on Form 10-Q for the period ended Sept. 30, 2009, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the company's corporate website at . Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.
Contact: Jim DeNike Senior Director, Corporate Communications Trubion Pharmaceuticals, Inc. (206) 838-0500 jdenike@trubion.com Waggener Edstrom Worldwide Healthcare Amy Petty Senior Account Executive (617) 576-5788 amyp@waggeneredstrom.com
TRBN-016CLL
SOURCE Trubion Pharmaceuticals, Inc.
surf1944
15 years ago
Facet Biotech and Trubion Announce Worldwide Collaboration for the Development and Commercialization of TRU-016
-- Preliminary clinical data show promise in chronic lymphocytic leukemia; preclinical data support additional indications --
Press Release
Source: Trubion Pharmaceuticals Inc.
On Friday August 28, 2009, 8:00 am EDT
Companies:Facet Biotech CorporationTrubion Pharmaceuticals Inc.
REDWOOD CITY, Calif. and SEATTLE, Wash., Aug. 28 /PRNewswire-FirstCall/ -- Facet Biotech Corporation (Nasdaq: FACT - News) and Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced an agreement for the joint worldwide development and commercialization of TRU-016, a product candidate in phase 1 clinical development for chronic lymphocytic leukemia (CLL).
(Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO)
TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic. The collaboration agreement includes TRU-016 in all indications and all other CD37-directed protein therapeutics.
"TRU-016 is a promising therapeutic with impressive preclinical and preliminary clinical data for CLL that will greatly enhance our pipeline and support a key strategic objective, which is to build a robust oncology portfolio," said Faheem Hasnain, president and CEO of Facet Biotech. "After a thorough evaluation of a number of programs over the past several months, we concluded that TRU-016 was a particularly compelling program and a great fit with our pipeline and expertise. While the novel approach to protein therapeutics is supported by a solid biological rationale and validated clinical data in CLL, TRU-016 may have broad utility in additional indications, including non-Hodgkin's lymphoma and multiple sclerosis. Through this collaboration, we can leverage and extend our significant expertise in the research and development of protein therapeutics and we look forward to playing a key role in advancing this important program with our partners at Trubion."
"In considering alliance opportunities for TRU-016 we sought to retain meaningful economics in this exciting first-in-class product candidate, while enabling aggressive joint development with a partner who shared our vision and brought complementary experience and resources to the alliance," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "We are delighted to have Facet as our partner. Coupled with our own strengths in the discovery and development of novel protein therapeutics, their expertise will afford us the opportunity to pursue the clinical development and commercialization of TRU-016 and other CD37-directed therapeutics in the most aggressive manner possible."
Under the terms of the collaboration agreement, Trubion will receive an upfront payment of $20 million and may receive up to $176.5 million in additional contingent payments upon the achievement of certain development, regulatory and sales milestones. The companies will share equally the costs of all development, commercialization and promotional activities and all global operating profits. In addition, Facet will purchase 2,243,649 shares of newly issued Trubion common stock for an aggregate purchase price of $10 million.
About TRU-016
TRU-016 is a novel CD37-directed therapy for the treatment of B-cell malignancies, such as chronic lymphocytic leukemia, or CLL, as well as certain autoimmune and inflammatory disease indications. TRU-016 uses a different mechanism of action than CD20-directed therapies. As a result, its novel design may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or CD20-directed therapeutics. In June 2009, positive results following preliminary analysis from the Phase 1 clinical trial of TRU-016 for the treatment of CLL were announced. The objectives of the Phase 1 TRU-016 CLL study were to define safety and tolerability, identify a maximum tolerated dose, evaluate pharmacology and pharmacodynamics, and assess preliminary clinical activity.
About Facet Biotech
Facet Biotech is a biotechnology company dedicated to advancing its pipeline of four clinical-stage products, leveraging its research and development capabilities to identify and develop new oncology drugs and applying its proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics. Facet Biotech Corporation launched in December 2008 as a spin-off from PDL BioPharma, Inc.
surf1944
15 years ago
Trubion Pharmaceuticals Inc. Reports Second Quarter and First Half 2009 Financial Results
Press Release
Source: Trubion Pharmaceuticals Inc.
On Thursday August 6, 2009, 4:00 pm EDT
Companies:Trubion Pharmaceuticals Inc.
SEATTLE, Aug. 6 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN - News) today announced financial results for its second quarter and six months ended June 30, 2009.
Second Quarter and Six Months 2009 Financial Results
Revenue for the second quarter and six months ended June 30, 2009 was $4.1 million and $8.3 million, respectively, compared with $4.5 million and $8.4 million, respectively, in 2008. Revenue was earned through the company's strategic collaboration with Wyeth Pharmaceuticals.
Of the $8.3 million in revenue Trubion recognized during the first half of 2009, $5.9 million was for collaborative research funding and $2.4 million reflected amortization of the $40 million up-front fee received from Wyeth in January 2006. This is compared with revenue of $8.4 million recognized in the first half of 2008, which was composed of $5.5 million for collaborative research funding and $2.9 million for amortization of the $40 million upfront fee.
On June 22, 2009, Wyeth exercised its option to extend the research portion of its strategic collaboration for an additional one-year period. Under the terms of the extension, Wyeth will pay Trubion approximately $3.4 million in exchange for research services through Dec. 22, 2010.
Total operating expenses for the second quarter and first half of 2009 were $10.7 million and $25.9 million, respectively, compared with $11.4 million and $21.9 million in 2008.
Net loss for the second quarter and six months ended June 30, 2009 was $6.7 million, or $0.37 per diluted common share, and $17.7 million, or $0.99 per diluted common share, respectively. This is compared to a net loss of $6.6 million, or $0.37 per diluted common share, and $12.6 million, or $0.71 per diluted common share, in 2008.
Trubion had $37.5 million in cash, cash equivalents and investments as of June 30, 2009, compared with $44 million as of March 31, 2009.
"We are pleased with the advancement of our partnered and proprietary product candidates in the first half of 2009. Data from our ongoing maintenance therapy studies with TRU-015 in RA continue to demonstrate sustained and robust clinical responses with a convenient single dose regimen given every six months," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. "We look forward to the results later this year of our second Phase 2b regimen-finding study (2203) after observation of enhanced ACR responses following the first course of re-treatment in the Phase 2b 15002 study. Wyeth's decision to extend the research portion of our collaboration agreement is further endorsement of our technology and we look forward to continuing to advance TRU-015, SBI-087 and the other novel therapeutics currently under joint development."
Dr. Thompson added, "In addition, results from a single agent study of our proprietary CD37-directed SMIP(TM) therapeutic, TRU-016, reported at ASCO showed promising activity in a heavily pre-treated patient population that included a substantial portion of patients with molecular markers known to be predictive of resistance to other therapies. We are also pleased by our continued progress in the development of our multi-specific SCORPION(TM) technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6."
Recent milestones
Trubion announced positive preliminary data from a Phase 1 / 2 study of its proprietary candidate, TRU-016, for the treatment of chronic lymphocytic leukemia (CLL). Data shows promise that TRU-016 is safe and effective in reducing tumor lymphocyte blood counts and induced a reduction in lymph node and spleen size and/or an improvement in the production of red blood cells and platelets. Data were presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting.
Also at ASCO, Trubion presented preclinical data demonstrating that TRU-016 is synergistic in combination with established therapies such as rituximab, and that the product candidate has a unique mechanism of action compared to other therapies that mediates apoptosis in CLL cells.
Trubion presented data from the re-treatment portion of a Phase 2b study (15002) of TRU-015 for rheumatoid arthritis (RA) at EULAR. Data demonstrate that TRU-015 is well-tolerated and improves the signs and symptoms of RA as measured by American College of Rheumatology (ACR) rates. The Phase 2b trial is designed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and clinical activity of repeat doses of TRU-015. Trubion announced preliminary results from this study in Q4 2008.
Trubion discussed preliminary data regarding its SCORPION multispecific therapeutic technology at the Annual Meeting of the American Association of Cancer Research (AACR). Data show the selectivity and high potency of the CD79BxDR SCORPION molecule, including its differentiation from monospecific approaches and its potential for B-cell depletion, particularly in diseases refractory to CD20-targeted therapies.
2009 Financial Guidance
Trubion's current 2009 financial guidance includes the following:
Anticipated 2009 revenues of approximately $15 million to $20 million earned through the company's Wyeth collaboration; and,
Anticipated 2009 operating cash requirements of approximately $30 million to $35 million.
This guidance does not include any additional cash receipts associated with potential new partnerships.
Conference Call Details
Trubion will host a conference call and webcast to discuss its second quarter and six months ended 2009 financial results and provide an update on business activities. The call will be held Aug. 6 at 2 p.m. Pacific Time, 5 p.m. Eastern Time. The live event will be available from Trubion's website at http://investors.trubion.com, or by calling 877-440-5785 or 719-325-4854. A replay of the discussion will be available beginning 8 p.m. Eastern Time from Trubion's website or by calling 888-203-1112 or 719-457-0820 and entering 9291496. The telephone replay will be available until midnight, Aug. 13, 2009.
surf1944
15 years ago
Trubion Pharmaceuticals Announces Extension of Research Period Under Its Wyeth Collaboration
Press Release
Source: Trubion Pharmaceuticals, Inc.
On Monday June 22, 2009, 4:00 pm EDT
Companies:Trubion pharmaceuticals inc.Wyeth
SEATTLE, June 22 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced that Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), has exercised its option under the terms of its collaboration agreement with Trubion to extend the research period for an additional one-year period through Dec. 22, 2010. Under the terms of the research period extension, Wyeth's obligations to Trubion include collaboration research funding commitments of approximately $3.3 million in exchange for committed research services through Dec. 22, 2010.
"We are pleased that Wyeth has extended the research period of our collaboration," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "Wyeth's ongoing commitment to the collaboration underscores the potential of our technology, and we look forward to continuing our efforts with Wyeth as we pursue the development of additional first-in-class and best-in-class compounds."
In December 2005, Trubion entered into a collaboration agreement with Wyeth for the development and worldwide commercialization of TRU-015 and other CD20-directed therapeutics. The agreement also includes the development and worldwide commercialization of certain other product candidates directed to a small number of targets other than CD20 that have been established pursuant to the agreement. Unless earlier terminated, the agreement will remain in effect on a product-by-product basis and on a country-by-country basis until the later of the date that any such product shall no longer be covered by a valid claim of a U.S. or foreign patent or application and, generally, 10 years after the first commercial sale of any product licensed under the agreement. Wyeth may terminate the agreement without cause at any time upon 90 days' written notice.
Trubion retains the right to develop and commercialize, on its own or with others, product candidates directed to all targets not included within the agreement, including CD37.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company's mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient experiences. Trubion's current product candidates are novel single-chain protein, or SMIP(TM), therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company's Wyeth collaboration. Trubion's product pipeline also includes Trubion's proprietary product candidate, TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies that is currently in Phase 1 / 2 clinical evaluation. In addition to Trubion's current clinical stage product pipeline, the Company is also developing additional product candidates that build on its product development experience. More information is available in the investors section of Trubion's website: http://investors.trubion.com/index.cfm.
surf1944
15 years ago
Trubion Pharmaceuticals, Inc. to Present Positive Data From a Phase 2b Re-treatment Study of TRU-015 at the 2009 EULAR Annual Meeting
On Monday May 18, 2009, 4:28 pm EDT
SEATTLE, May 18 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) announced today that data from the re-treatment portion of a Phase 2b study (15002) of TRU-015 for rheumatoid arthritis will be presented on June 11 at the 2009 European League Against Rheumatism (EULAR) annual meeting in Copenhagen, Denmark. A copy of the abstract is now available at http://www.eular.org/.
Data from the first course of re-treatment demonstrate that TRU-015 for rheumatoid arthritis (RA) is well-tolerated and improves the signs and symptoms of RA as measured by American College of Rheumatology (ACR) response rates. The Phase 2b trial was designed to evaluate the safety, tolerability, pharmacodynamics (PD), pharmacokinetics (PK) and clinical activity of repeat doses of TRU-015. Trubion announced preliminary results from this study in Q4 2008.
TRU-015 is Trubion's lead Small Modular Immunopharmaceutical (SMIP(TM)) product candidate directed against CD20+ B-cells. Wyeth Pharmaceuticals and Trubion are collaborating on the development of TRU-015 for the treatment of autoimmune and inflammatory diseases, including RA.
In the initial portion of this double-blind, placebo-controlled, randomized Phase 2b clinical trial, 276 patients received a single intravenous infusion of either placebo, 200 mg, 400 mg, 800 mg or 1,600 mg of TRU-015. Of the 276 original patients who began the study, 240 (204 of whom were rheumatoid-factor positive, or RF+) entered the open-label re-treatment portion of the trial.
At 24 weeks after the first re-treatment, ACR 20, 50 and 70 response rates for subjects in the group (n=40) that had initially received an 800 mg dose and were re-treated with 800 mg of TRU-015 were 70%, 40% and 23%, respectively. ACR 20, 50 and 70 response rates in the group that had received an initial 1,600 mg dose and were subsequently re-treated with 800 mg were 68%, 30% and 14%, respectively. The safety and PD effects after re-treatment were comparable to those seen after initial therapy.
Numeric reductions in the Disease Activity Score 28 (DAS28), the Health Assessment Questionnaire (HAQ), and C-reactive protein (CRP) seen at the end of the double-blind treatment period were maintained or continued to improve during the open-label re-treatment period.
Infusions were generally well-tolerated and no patient experienced a serious adverse event on the day of infusion. Eight patients (3%) enrolled in the trial experienced serious adverse events during the first re-treatment period. This is similar to observations made during the initial double-blind phase of the study (placebo 2%, 800 mg group 4%).
"We are encouraged to see such strong results upon re-treatment of trial participants with TRU-015," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "TRU-015 is an important clinical candidate for Trubion and Wyeth. The positive data we've seen from the program to date demonstrate that TRU-015 may fill a distinct need for additional treatment options in the RA community. We look forward to the presentation of the full re-treatment data at the conference."
The full EULAR presentation will be available in the investor section of Trubion's website (http://investors.trubion.com/index.cfm) after the presentation on June 11, 2009.
surf1944
15 years ago
Trubion Pharmaceuticals, Inc. Reports First-Quarter 2009 Financial Results
On Thursday May 7, 2009, 4:00 pm EDT
SEATTLE, May 7 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced financial results for its first quarter ended March 31, 2009.
First-Quarter 2009 Financial Results
Revenue for the first quarter of 2009 was $4.2 million compared with $4.0 million for the first quarter of 2008. Revenue in the first quarter of 2009 was earned through the company's strategic collaboration with Wyeth Pharmaceuticals, including $3.0 million for collaborative research funding and $1.2 million for amortization of the upfront fee of $40 million received in January 2006.
Total operating expenses for the first quarter of 2009 were $15.2 million compared with $10.5 million for the first quarter of 2008. The three-month increase in operating costs was primarily due to 1) an increase in outside manufacturing costs related to Trubion's proprietary product candidate, TRU-016; and 2) a charge of $0.8 million in connection with one-time work-force reduction costs, including severance and other benefits.
Net loss for the first quarter of 2009 was $11.0 million, or $0.61 per diluted common share, compared with a net loss of $6.0 million, or $0.33 per diluted common share, for the first quarter of 2008.
Trubion had $44.0 million in cash, cash equivalents and investments as of March 31, 2009, compared with $52.9 million as of Dec. 31, 2008.
"In the first quarter, we continued to advance the development of our proprietary and partnered product candidates," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "In addition, we continued to take proactive steps to reduce our costs and align our current resources with the strongest near-term opportunities while positioning the company for long-term sustainability and success. We believe the actions taken in the first quarter should improve our financial standing and support operations into the second half of 2010."
Recent milestones
In April 2009, Trubion announced the presentation of preclinical data regarding its SCORPION(TM) multispecific therapeutic technology at the 100th Annual Meeting of the American Association of Cancer Research (AACR) in Denver. The data presented demonstrated the selectivity and high potency of the bispecific CD79BxDR SCORPION molecule, its differentiation from monospecific approaches, and its potential as a therapeutic for B-cell depletion, particularly in diseases refractory to CD20-targeted therapies.
Trubion announced in March 2009 that Wyeth has initiated a Phase 1 clinical trial of SBI-087 for the treatment of systemic lupus erythematosus (SLE). SBI-087 is Trubion's next-generation CD20 drug candidate; it is also being evaluated in a Phase 1 clinical trial for rheumatoid arthritis (RA).
In an effort to proactively reduce costs and extend capital, Trubion announced work-force reductions of approximately 25% and a corporate restructuring in February 2009. Based on the company's current forecast, and excluding any proceeds from potential new partnerships or financings, the work-force reductions and targeted investments in preclinical and clinical programs are expected to support the company's operations into the second half of 2010.
2009 Financial Guidance
Trubion's current 2009 financial guidance includes the following:
Anticipated 2009 revenues of approximately $15 million to $20 million earned through the company's Wyeth collaboration; and,
Anticipated 2009 operating cash requirements of approximately $30 million to $35 million.
This guidance does not include any additional cash receipts associated with potential new partnerships.
Conference Call Details
Trubion will host a conference call and webcast to discuss its first quarter 2009 financial results and provide an update on business activities. The call will be held May 7 at 2 p.m. Pacific Time, 5 p.m. Eastern Time. The live event will be available from Trubion's website at http://investors.trubion.com, or by calling (877) 795-3638 or (719) 325-4816. A replay of the discussion will be available from Trubion's website or by calling (888) 203-1112 or (719) 457-0820 and entering 6540657. The telephone replay will be available until midnight, May 14, 2009.
surf1944
16 years ago
Trubion Pharmaceuticals, Inc. Announces Initiation of Phase 1 Study of SBI-087 for the Treatment of Systemic Lupus Erythematosus (SLE)
SEATTLE, March 25 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) announced today that its collaboration partner Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), has initiated a Phase 1 clinical trial of SBI-087, Trubion's next generation CD20 drug candidate, for the treatment of systemic lupus erythematosus (SLE). Based on Trubion's Small Modular ImmunoPharmaceutical (SMIP(TM)) technology, SBI-087 is also being evaluated in a Phase 1 clinical trial for rheumatoid arthritis (RA).
OGO)
SBI-087 is a humanized SMIP drug candidate that is directed against the CD20 antigen. The Phase 1 SBI-087 dose escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous or intravenous dose of SBI-087 in patients with SLE. The study will enroll patients who were diagnosed with SLE, based on the American College of Rheumatology Revised Criteria, more than six months prior to study initiation.
Preclinical data demonstrated that a single dose of SBI-087 resulted in more potent B-cell depletion in peripheral blood and lymphoid tissues than rituximab. The objective of the preclinical study conducted by Wyeth was to evaluate the pharmacokinetics and pharmacodynamics of SBI-087 following a single intravenous dose. Administration of SBI-087 resulted in dose-dependent B-lymphocyte depletion in peripheral blood and lymphoid tissues that was more profound and sustained in SBI-087-treated groups compared with rituximab.
"Initiation of the SBI-087 Phase 1 SLE clinical trial marks another important milestone in advancing our products developed in collaboration with Wyeth," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "We believe that SBI-087, along with our lead candidate TRU-015, have the potential to play an important role in improving patient care and helping us establish category leadership in autoimmune and inflammatory disease markets."
surf1944
16 years ago
Trubion Pharmaceuticals, Inc. Reports Fourth Quarter and Year-Ended 2008 Financial Results
Thursday March 12, 4:00 pm ET
SEATTLE, March 12 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced financial results for its fourth quarter and year ended Dec. 31, 2008.
Fourth Quarter and Year-Ended 2008 Financial Results
Revenue for the fourth quarter of 2008 was $4.3 million compared with $5.7 million for the fourth quarter of 2007. Revenue for the year ended Dec. 31, 2008, was $16.5 million compared with $20.1 million for the year ended Dec. 31, 2007. Revenue in 2008 was earned through the company's strategic collaboration with Wyeth Pharmaceuticals and was composed of $11.1 million for collaborative research funding and $5.4 million for amortization of the upfront fee of $40 million received in January 2006.
The three-month and 12-month decreases in revenue under Trubion's Wyeth collaboration were due to 1) a decrease in reimbursable costs related to the Phase 2b clinical trial for its lead product candidate, TRU-015, for the treatment of rheumatoid arthritis (RA), 2) an extension of the recognition of the $40 million upfront fee due to an extension in the estimated research and development period, and 3) a decrease in reimbursable legal costs.
Total operating expenses for the fourth quarter of 2008 were $10.7 million compared with $11.4 million for the fourth quarter of 2007. Total operating expenses for the year ended Dec. 31, 2008, were $43.0 million compared with $47.3 million for the year ended Dec. 31, 2007. The three-month decrease in operating expenses was primarily due to decreased legal and personnel-related costs, partially offset by an increase in manufacturing costs related to Trubion's TRU-016 product candidate. The 12-month decrease in operating costs was primarily due to 1) decreased outside manufacturing costs related to TRU-016, 2) decreased clinical costs related to the Phase 2b clinical trial for TRU-015 and 3) decreased lab expenses for TRU-016.
Net loss for the fourth quarter of 2008 was $6.4 million, or $0.36 per diluted common share, compared with a net loss of $4.9 million, or $0.28 per diluted common share, for the fourth quarter of 2007. For the year ended Dec. 31, 2008, net loss was $25.6 million, or $1.43 per diluted common share, compared with a net loss of $23.3 million, or $1.32 per diluted common share, for the year ended Dec. 31, 2007.
Trubion had $52.9 million in cash, cash equivalents and investments as of Dec. 31, 2008, compared with $78.5 million as of Dec. 31, 2007.
"We delivered on our 2008 commitments by initiating new clinical trials evaluating our lead product candidates for autoimmune and infectious diseases and cancer while augmenting our portfolio of proprietary technologies and advancing preclinical assets that we believe have the greatest opportunity for value creation," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. "As a result, we now have three product candidates being evaluated in human clinical trials, as well as two new proprietary technologies that expand the foundation for Trubion's product development efforts -- SCORPION(TM) multi-specific protein therapeutics and TRU-ADhanCe(TM) potency enhancing technology for immunopharmaceuticals. In 2009 we expect to report data for a number of our key programs as they continue to advance in the clinic."
Work-Force Reductions
On February 25, 2009 Trubion announced a work-force reduction of approximately 25 percent and a corporate restructuring. In the face of continuing uncertainty in the capital markets and the global economy, Trubion is proactively taking steps to reduce its costs and align its current resources with its strongest near-term opportunities while positioning the company for long-term sustainability and success.
Estimated charges of approximately $0.8 million will be recorded in the first quarter of 2009 in connection with one-time work-force reduction costs, including severance and other benefits. Trubion will continue to support the programs developed under its collaboration with Wyeth and all expenses incurred will continue to be reimbursed by Wyeth.
Trubion 2009 Financial Guidance
Based on its current forecast, and excluding any proceeds from potential new partnerships or financings, the reductions announced on February 25, 2009, in combination with targeted investments in preclinical and clinical programs, are expected to support the company's operations into the second half of 2010.
Trubion anticipates 2009 revenues to be approximately $15-20 million earned through the company's Wyeth collaboration.
Operating cash requirements in 2009 are expected to be approximately $30-35 million.
This guidance does not include any additional cash receipts associated with potential new partnerships.
surf1944
16 years ago
Trubion Pharmaceuticals Inc. Announces Work-Force Reductions and Restructuring
Wednesday February 25, 4:00 pm ET
SEATTLE, Feb. 25 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN - News) today announced a work-force reduction of approximately 25 percent, or 25 employees, and a corporate restructuring. In the face of continuing uncertainty in the capital markets and the global economy, Trubion is proactively taking steps to reduce its costs and align its current resources with its strongest near-term opportunities while positioning the company for long-term sustainability and success.
Following the restructuring, Trubion will continue to invest in the development of its proprietary program, TRU-016, and the efficient and timely advancement of select preclinical assets that it believes will have the greatest opportunity for value creation.
The company will also continue to support the programs developed under its collaboration with Wyeth, including TRU-015, SBI-087 and other undisclosed product candidates. Trubion remains dedicated to its Wyeth partnership and will continue to allocate resources to support its clinical and research commitments under the collaboration.
In 2009, Trubion anticipates the following milestones for its proprietary and partnered product candidates:
-- Announce TRU-016 Phase 1 chronic lymphocytic leukemia dose escalation trial data by end of Q2 2009
-- Announce TRU-016 Phase 2a chronic lymphocytic leukemia expanded cohort trial data by end of Q4 2009
-- Disclose next investigational new drug candidate by end of Q2 2009 for application in 2010
-- Announce TRU-015 Phase 2b (15002) rheumatoid arthritis re-treatment data at the annual meetings of the European League Against Rheumatism and the American College of Rheumatology (ACR)
-- Announce TRU-015 Phase 2b (2203) rheumatoid arthritis trial data by end of Q4 2009 (currently enrolling; conducted by Wyeth)
-- Announce SBI-087 Phase 1 rheumatoid arthritis trial data by end of Q4 2009 (currently enrolling; conducted by Wyeth)
-- Initiate SBI-087 Phase 1 systemic lupus erythematosus trial by end of Q1 2009 (conducted by Wyeth)
"Concentrating our resources on our clinical stage product candidates, as well as our preclinical programs that we believe have the greatest potential for value creation, while streamlining operations will increase our financial flexibility by reducing ongoing operating expenses and decreasing the need for additional financing in the short term," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "While this type of action is always very difficult, we believe these actions will provide us with the best opportunity for near-term success and establish a foundation for building long-term stockholder value. I would like to thank all Trubion employees for their ongoing dedication to our mission of becoming a leading provider of protein therapeutics for the treatment of autoimmune and inflammatory diseases and cancer."
Estimated charges of approximately $0.8 million will be recorded in the first quarter of 2009 in connection with one-time work-force reduction costs, including severance and other benefits. Trubion will continue to support the programs developed under its collaboration with Wyeth and all expenses incurred will continue to be reimbursed by Wyeth. Based on its current forecast, and excluding any proceeds from potential new partnerships or financings, the reductions announced today, in combination with targeted investments in preclinical and clinical programs, are expected to support the company's operations into the second half of 2010.
Trubion will announce financial results for the fourth quarter and year ended Dec. 31, 2008, on March 12, 2009, after market close.
surf1944
16 years ago
Trubion Pharmaceuticals Wins Patent Opposition - Genentech / Biogen Idec European Patent Revoked
Thursday September 11, 1:56 pm ET
SEATTLE, Sept. 11 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News), today announced that the Opposition Division (OD) of the European Patent Office (EPO) has revoked Genentech and Biogen Idec's European Patent 1176981, in its entirety. This patent was generally directed to the use of an anti-CD20 antibody for the treatment of rheumatoid arthritis (RA). The revocation was the result of an opposition proceeding brought by Trubion and several other parties.
The OD, presiding in oral proceedings on Thursday, Sept. 11, 2008, ruled that the patent as granted did not meet the requirements for patentability under the European Patent Convention. Genentech and Biogen Idec have the right to appeal the decision.
"We are extremely pleased with the EPO's decision as it supports the continued development of new and innovative therapies that have the potential to improve patient outcomes for autoimmune and inflammatory diseases. Continued innovation will ultimately provide patients with more effective, convenient, and safer therapies," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion.
surf1944
16 years ago
Trubion Pharmaceuticals Announces Appointment of New Chief Medical Officer
Monday August 18, 4:00 pm ET
SEATTLE, Aug. 18 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN - News) today announced that Scott C. Stromatt, M.D., has been appointed Trubion's senior vice president and chief medical officer (CMO). Dr. Stromatt replaces Daniel J. Burge, M.D., who will be resigning his position with the company for personal reasons in late August 2008.
Dr. Stromatt has extensive experience related to the development and commercialization of novel therapies. Most recently, he was executive vice president of clinical and regulatory affairs at Cell Therapeutics Inc. in Seattle. While at Cell Therapeutics, Dr. Stromatt managed global clinical research programs for several product candidates in a variety of oncology indications. Before holding this role at Cell Therapeutics, Dr. Stromatt was vice president of clinical research and chief medical officer at Northwest Biotherapeutics Inc. in Bothell, Wash.
"Dr. Stromatt's experience, particularly in the area of rheumatology and oncology drug development, is a great fit for Trubion as we continue to expand our product pipeline and develop new product candidates," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. "We're thrilled with Scott's decision to join the Trubion team, and we look forward to the positive impact he will have while leading our clinical development activities."
"At the same time," Dr. Thompson continued, "I would like to thank Dr. Burge for his many contributions to Trubion. During Dan's tenure as CMO, the company advanced several alliance-based and proprietary product candidates into clinical evaluation. Dan's leadership helped us build Trubion into a growing biopharmaceutical company, and we wish him the best in his future endeavors."
surf1944
16 years ago
Trubion Pharmaceuticals Inc. Reports Second Quarter and First Half 2008 Results
Thursday August 7, 4:00 pm ET
SEATTLE, Aug. 7 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN - News) today announced financial results for its second quarter and six months ended June 30, 2008.
Second Quarter and Six Months 2008 Financial Results
Revenue for the second quarter and six months ended June 30, 2008, was $4.5 million and $8.4 million respectively, compared with $5.0 million and $9.8 million respectively in 2007. Revenue in the second quarter and first half of 2008 was earned through Trubion's strategic collaboration with Wyeth, including research and development services. The $8.4 million in revenue recognized in the six months ended June 30, 2008, is composed of $2.9 million for amortization of the $40 million up-front fee received from Wyeth and $5.5 million for collaborative research funding from the Wyeth collaboration. This is compared with revenue of $9.8 million recognized in the six months ended June 30, 2007, which was composed of $4.0 million for amortization of the $40 million up-front fee received from Wyeth and $5.8 million for collaborative research funding from the Wyeth collaboration.
On June 16, 2008, Wyeth exercised its option under the terms of its collaboration agreement with Trubion to extend the research period for an additional one-year period through Dec. 22, 2009. Under the terms of the research period extension, Wyeth will pay Trubion approximately $3.2 million in exchange for research services.
Total operating expenses for the second quarter and six months ended June 30, 2008, were $11.4 million and $21.9 million respectively, compared with $13.5 million and $24.4 million respectively in 2007. The decrease was primarily due to lower outside manufacturing costs for TRU-016, lower lab supply costs and lower contract licensing fees.
Net loss for the second quarter and six months ended June 30, 2008, was $6.6 million, or $0.37 per diluted share, and $12.6 million, or $0.71 per diluted share, respectively, compared with a net loss of $7.5 million, or $0.42 per diluted share, and $12.5 million, or $0.71 per diluted share, respectively, in 2007.
Trubion had $65.4 million in cash, cash equivalents and investments as of June 30, 2008, compared with $72.1 million as of March 31, 2008.
"We are pleased with our continued progress in the second quarter," said Peter Thompson, M.D., FACP, Trubion's president, chief executive officer and chairman. "Progress in our strategic alliance with Wyeth included its decision to extend its research contract with Trubion, initiation of additional clinical studies evaluating TRU-015 and SBI-087, and presentation of positive data at key scientific meetings. In addition, our proprietary clinical asset, TRU-016, is currently being evaluated in a Phase 1/2 study for chronic lymphocytic leukemia and we look forward to the results of this study."
Recent Milestones:
-- Trubion announced that Wyeth commenced patient dosing in the next Phase 2b clinical trial of TRU-015 in patients with rheumatoid arthritis (RA). The randomized, parallel, double-blind, placebo-controlled, dose-regimen-finding study will evaluate the safety and efficacy of two dosing regimens administered to approximately 216 patients with active, seropositive RA on a background of methotrexate.
-- Trubion announced that Wyeth initiated a Phase 1 clinical trial of SBI-087, Trubion's next-generation drug candidate for the treatment of RA.
-- Trubion presented positive TRU-016 for CLL data at the American Society of Clinical Oncologists (ASCO) 2008 Annual Meeting. Data demonstrated that TRU-016 has potent anti-tumor activity and induces significant long-term tumor eradication in a human tumor xenograft model in which rituximab failed to induce durable responses.
-- Trubion announced the presentation of positive data for TRU-015 for RA and SBI-087 for RA at the 2008 Annual European Congress of Rheumatology Meeting (EULAR). Data demonstrated that repeat administration with TRU-015, Trubion's lead candidate for RA, continues to produce responses and pharmacodynamic effects as measured by the American College of Rheumatology scores. In addition, pre-clinical data suggests that a single dose of SBI-087, Trubion's next-generation SMIP(TM) treatment for RA, resulted in more potent B-cell depletion in peripheral blood and lymphoid tissues than rituximab.
2008 Financial Guidance
As reported previously, Trubion anticipates 2008 revenues to be in the range of $15 million to $20 million earned through the company's Wyeth collaboration. Total operating expenses are expected to be approximately $53 million to $58 million for 2008. The planned increase in 2008 operating expenses is primarily attributable to clinical trial and manufacturing expenses associated with the re-treatment study being completed by Trubion for its lead product candidate, TRU-015, manufacturing and clinical costs associated with its TRU-016 product candidate, and increased personnel-related and research and development expenses. Operating cash requirements in 2008 are expected to be approximately $35 million to $40 million.
Conference Call Details
Trubion will host a conference call and webcast to discuss its second quarter and six months 2008 financial results. The call will be held today at 2 p.m. Pacific time (5 p.m. Eastern time). The live event will be available from Trubion's website at http://investors.trubion.com/events.cfm, or by calling 1 (719) 325-4916 or 1 (877) 397-0292. Beginning later today, a replay of the discussion will be available from Trubion's website or by calling 1 (719) 457-0820 or 1 (888) 203-1112 and entering 6969493. Replay will be available at 8 p.m. EDT until midnight, Aug. 14, 2008. The webcast replay will be available in the events section of Trubion's website.
surf1944
16 years ago
Trubion says Wyeth extends research collaboration
Friday June 20, 11:04 am ET
Trubion says Wyeth extends research deal on drug candidate for arthritis, cancer
SEATTLE (AP) -- Biopharmaceutical company Trubion Pharmaceuticals Inc. said Thursday Wyeth the companies' research partnership for an additional year, resulting in $3.2 million of additional funding from Wyeth.
Trubion shares rose 41 cents, or nearly 8 percent, to $5.69, while Wyeth shares shed 8 cents to $47.74 in morning trading.
The extension continues through Dec. 29, 2009 a collaboration on TRU-015, currently in mid-stage development for rheumatoid arthritis, and other candidates that target the protein CD20 found in B cells in the immune system.
TRU-015 is also in early-stage development for B-cell cancers such as non-Hodgkin's lymphoma and leukemia and is in pre-clinical development as a treatment for lupus.
Under an agreement signed in December 2005, Trubion received a $40 million upfront payment, and is eligible for development milestones and royalties up to $800 million.
surf's up......crikey
surf1944
17 years ago
Trubion Announces Initiation of Phase 1 Study of SBI-087 for the Treatment of Rheumatoid Arthritis
Monday April 21, 4:00 pm ET
First Patient Dosed in Phase 1 Trial of SBI-087, Trubion's Next-Generation Candidate
SEATTLE, April 21 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN - News) today announced that its collaboration partner Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), has initiated a Phase 1 clinical trial of SBI-087, a next-generation drug candidate for the treatment of rheumatoid arthritis (RA). In collaboration with Trubion, Wyeth Pharmaceuticals is developing SBI-087 and other CD20-directed products. SBI-087 for RA builds on Trubion and Wyeth's clinical experience with Trubion's lead compound, TRU-015, and is based on Trubion's Small Modular ImmunoPharmaceutical (SMIP(TM)) technology.
The Phase 1 SBI-087 dose escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of SBI-087 in patients with RA. Preclinical research suggests that SBI-087, a fully humanized CD20-directed SMIP, has enhanced potency in B-cell depletion in vivo compared with Rituxan. This Phase 1 trial is designed to enroll patients who meet the criteria for RA with Functional Class I, II or III, and who have been diagnosed with RA more than six months prior to the study with onset of RA after the age of 16.
With SBI-087, Trubion's pipeline now includes two differentiated compounds under development for the treatment of autoimmune and inflammatory diseases: TRU-015 and SBI-087. Trubion and Wyeth are leveraging Trubion's SMIP(TM) technology to create a portfolio of product candidates with customized mechanisms of action in an effort to optimize patient safety, efficacy and convenience.
"Initiation of the SBI-087 Phase 1 clinical trial marks an important milestone in advancing our pipeline through our collaboration with Wyeth," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "We believe SBI-087 and TRU-015 together will play an important role in improving patient care and helping us establish category leadership in autoimmune and inflammatory disease markets."
surf1944
17 years ago
Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
Thursday March 27, 4:00 pm ET
First Patient Dosed in Phase 1/2 Trial of TRU-016, Trubion's Proprietary Product Candidate
SBI-087 for RA Expands Trubion's Family of Customized, Differentiated Product Candidates
SEATTLE, March 27 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced that it has initiated a Phase 1/2 clinical trial of TRU-016, the company's lead proprietary Small Modular ImmunoPharmaceutical (SMIP(TM)) drug candidate, for the treatment of chronic lymphocytic leukemia (CLL). The company also announced a new, next-generation product candidate for clinical evaluation and provided an update on its product pipeline.
TRU-016 for CLL and NHL
Trubion today announced that patient dosing has commenced in its Phase 1/2 clinical trial of TRU-016 for CLL. The open label clinical trial is composed of two parts: a Phase 1 dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TRU-016; and a Phase 2 expansion cohort designed to further evaluate safety and to estimate clinical activity of TRU- 016 in patients with previously treated CLL or small lymphocytic leukemia. Trubion currently retains all development and commercialization rights for the TRU-016 program.
This Phase 1/2 clinical trial is designed to enroll patients who have undergone at least one prior therapy and have relapsed CLL or small lymphocytic leukemia. Efficacy will be evaluated according to disease response and progression status per the International Response Criteria for CLL. Participants will receive intravenous administration of TRU-016 over a four- week period.
"This is an important milestone for our proprietary program and we look forward to the results of TRU-016's ongoing clinical evaluation," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "Our proprietary product candidate, TRU-016, has demonstrated potent anti-tumor activity in pre-clinical evaluation and may provide patients with improved therapeutic options or benefits when used alone or in conjunction with chemotherapy or CD20-targeted immunopharmaceuticals."
http://biz.yahoo.com/prnews/080327/clth243.html?.v=1
surf1944
17 years ago
Competition and Pipeline Concerns for Trubion
Friday March 14, 2:54 pm ET
By Grant Zeng, CFA
Trubion Pharmaceuticals, Inc. (NasdaqGM: TRBN - News) is a clinical stage biopharmaceutical company focused on discovery, development and commercialization of protein therapeutics using its small modular immuno-pharmaceutical (SMIP) technology. However, we are concerned about substantial competitions Trubion will face in the RA and B-cell cancer markets. Trubion's weak pipeline is another reason that we rate its shares a Hold. We are optimistic with the company's SMIP technology and the two candidates TRU-015 and TRU-016 discovered using this technology.
We are also impressed by the collaboration agreement with Wyeth (NYSE: WYE - News) with respect to its lead drug candidate TRU-015 and related product candidates. The alliance not only provides much needed cash to advance its pipeline, but also validates the company's technology and research efforts. However, we are very concerned about fierce competition the company will face in the RA and B-cell cancer markets. Both candidates TRU-015 and TRU-016 will face substantial competition from both big pharma and giant biotech companies like GSK, Novartis, Genentech, Amgen, as well as emerging biotech companies such as Genzyme and Biogen Idec. We are also concerned about the company's weak pipeline and cash position.
Except for TRU-015 (phase II) and TRU-016 (phase I), Trubion has no other meaningful candidates under both pre-clinical and clinical development. If there is something wrong with TRU-015, the company has little to fall back on. We see a balanced risk/reward profile for Trubion at this point. We maintain our Hold rating on Trubion's shares with a price target is $8.50. We arrive at our price target of $8.50 by using 11x P/S ratio, multiplied by our estimated revenue of $25 million in 2009 and discounted at 25% for one year assuming outstanding shares of 25 million. This 11x P/S ratio is slightly lower than the biotech industry average P/S ratio of 15x. This is warranted because of the early stage of its pipeline.
surf1944
17 years ago
Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis
Results Show Improvements in RA Signs and Symptoms Compared to Placebo
SEATTLE, Sept. 10 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN) today announced preliminary analysis of results from a Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial of its TRU-015 product candidate for rheumatoid arthritis (RA). The results indicated that Trubion's TRU-015 product candidate, at well-tolerated dosages, provided statistically significant improvements in RA signs and symptoms compared to placebo at 24 weeks. Trubion is co-developing TRU-015 with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), for the treatment of rheumatoid arthritis.
TRU-015 Phase IIb Clinical Trial Protocol and Results
The Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial included 276 patients with rheumatoid arthritis who were also receiving methotrexate as background therapy. Patients in the Phase IIb study were randomized evenly into five groups that received either placebo, 200 mg, 400 mg, 800 mg or 1600 mg of TRU-015.
The study was designed to evaluate the safety and efficacy of a single intravenous infusion of TRU-015 compared to placebo for a 24-week period, with a primary endpoint of improvement on the Disease Activity Score (DAS)-28 scale at 12 weeks, and secondary endpoints including response rates at 24 weeks using American College of Rheumatology (ACR) criteria.
Preliminary analysis indicates the improvement in DAS-28 compared to placebo was statistically significant in the 800 mg dose group at 12 weeks and at all subsequent assessments, and in the 1600 mg dose group at 16 weeks and at all subsequent assessments. At 24 weeks, ACR 20, 50 and 70 response rates in the 800 mg dose group were 65 percent, 26 percent and 0 percent, respectively. ACR 20, 50 and 70 response rates in the 1600 mg dose group were 61 percent, 13 percent and 4 percent, respectively. ACR 20, 50 and 70 response rates at 24 weeks in the placebo group were 33 percent, 9 percent and 2 percent, respectively.
TRU-015 administered as a single dose was generally well tolerated, and only one subject in the 400 mg group experienced a grade 3 adverse event on the day of infusion.
'We are pleased that the positive results of this study confirm the activity seen in our prior study and demonstrate that TRU-015 can meaningfully improve disease activity in patients with RA,' said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. 'We are working with our partner to define the most effective development strategy for TRU-015 in RA that minimizes time-to-market while maximizing our competitive differentiation. We currently believe this will include additional clinical study before commencement of a Phase III trial.'
Conference Call Details
Trubion will host a conference call and webcast to discuss its preliminary analysis of the Phase IIb results with TRU-015 for RA. The call will be held today at 1:30 p.m. Pacific Time, 4:30 p.m. Eastern Time. The live event will be available from Trubion's Web site at http://investors.trubion.com/events.cfm, or by calling (800) 289-0494 or (913) 981-5520. A replay of the discussion will be available beginning later today from Trubion's Web site or by calling (888) 203-1112 or (719) 457-0820, and entering 5763754. The telephone replay will be available through Sept. 14, 2007.
About TRU-015 and SMIP(TM) Therapeutics
Trubion and Wyeth Pharmaceuticals are developing small modular immunopharmaceutical (SMIP(TM)) therapeutics directed to CD20, an antigen present on B cells. In addition to the ongoing development of TRU-015 for RA, investigational new drug applications have been filed for TRU-015 for systemic lupus erythematosus and non-Hodgkin's lymphoma. Trubion's SMIP drug candidates represent a novel class of immunotherapeutics that the company believes possess enhanced drug properties over monoclonal and recombinant antibodies. SMIP product candidates are novel single-chain polypeptide proteins designed using Trubion's custom drug assembly technology. Trubion's current product candidates bind to specific antigen targets on a cell's surface that have been clinically validated as important in disease management either by existing products or by potential products in clinical trials.
About Rheumatoid Arthritis
RA is a chronic disease, mainly characterized by inflammation of the lining, or synovium, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. According to Datamonitor, RA is estimated to affect approximately 4.3 million people in the United States, Japan and Europe. In 2006, total reported worldwide sales of protein therapeutics used for the treatment of RA were greater than $9.5 billion.
About Trubion
Trubion is a biopharmaceutical company creating a pipeline of product candidates to treat autoimmune disease and cancer. The company's product candidates are novel proteins known as single-chain polypeptides and are designed using its SMIP custom drug assembly technology. In less than 24 months, the company designed, developed and submitted to the FDA an Investigational New Drug (IND) application for its lead product candidate, TRU-015, which has completed a Phase IIb clinical trial for the treatment of rheumatoid arthritis. In December 2005, the company entered into a collaboration agreement with Wyeth for the development and worldwide commercialization of certain therapeutics, including TRU-015. In addition, Trubion's TRU-016 program targets CD37, an antigen present on B cells, for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Subject to satisfactory completion of preclinical testing of TRU-016, the company expects to file an IND for TRU-016 in the second half of 2007. Trubion currently retains all development and commercialization rights for the TRU-016 program. For additional information visit http://www.trubion.com.
Forward-Looking Statements
Certain statements in this release may constitute 'forward-looking statements' within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the company's future clinical development programs and the timing thereof, the company's expected financial and operating results, future clinical development plans, the details of the clinical trials and the results and timing thereof, and the timing of regulatory applications and action. These statements are based on current expectations and assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the company's Wyeth collaboration, including Wyeth's control over development timelines, and the risks associated with conducting additional clinical trials for TRU-015, the uncertainty of the FDA approval process and the therapeutic and commercial value of Trubion's drug candidates; and such other risks as identified in the company's quarterly report on Form 10-Q for the period ended June 30, 2007, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the company's corporate Web site at http://www.trubion.com. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the company's expectations.
Contact:
Jim DeNike
Senior Director, Corporate Communications
Trubion Pharmaceuticals Inc.
(206) 838-0500
jdenike@trubion.com
Waggener Edstrom Healthcare
Jenny Moede
Senior Vice President
(503) 443-7000
jmoede@wagged.com
TRBN-G
SOURCE Trubion Pharmaceuticals Inc.
Source: PR Newswire (September 10, 2007 - 3:00 PM EST)
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mlkrborn
14 years ago
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