DGAP-Adhoc: Biotest AG: Biotest Phase IIb study of

New Post Public Reply Private Reply Replies (0) Message Board

News Desk 2018

Apr 24, 2015 at 3:15 AM

DGAP-Adhoc: Biotest AG: Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe rheumatoide Arthritis did not meet the primary endpoint - potential one time effect of - EUR 30 million

Biotest AG / Key word(s): Research Update 24.04.2015 09:00 Dissemination of an Ad hoc announcement according to Â§ 15 WpHG, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Ad-hoc RELEASE Announcement according to Â§ 15 Sec. 1 Securities Trading Act (WpHG) Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe rheumatoide Arthritis did not meet the primary endpoint - potential one time effect of - EUR 30 million Dreieich, April 24, 2015 - Biotest today announced top line results from the TREAT 2b study [T cell REgulating Arthritis Trial 2b], evaluating the efficacy, safety and tolerability of its investigational monoclonal antibody tregalizumab (BT-061) in patients with moderate to severe rheumatoide Arthritis. Initial results indicated that none of the three dosing arms of tregalizumab showed a statistically significant improvement in ACR 20 scores when compared to placebo, the primary efficacy end point of the trial at week 12. Patient safety in the TREAT IIb trial was monitored frequently by an independent data safety monitoring board (DSMB) and no safety concerns were noted for the study. Dr. Ehmer, CEO of Biotest, says that he is disappointed that the Phase IIb study did not meet the primary endpoint. The entire statistical analysis will be available until end of May and the data will be evaluated in depth to fully understand the outcomes of this trial. Over the coming weeks the results will be discussed with external experts and the collaboration partner AbbVie. Biotest is in the process of sharing the data with AbbVie, who will decide within 90 days whether to continue the co-development on tregalizumab. More detailed results from the TREAT IIb trial will be submitted for publication in a peer reviewed journal and for presentation on upcoming scientific meetings. If the evaluation leads to a decision to discontinue the development of tregalizumab, Biotest's earnings would be reduced by EUR 25-30 million in 2015. Biotest Aktiengesellschaft The Executive Management Board Biotest AG Landsteinerstr. 5 D-63303 Dreieich www.biotest.de Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so. About Biotest Biotest is a provider of plasma proteins and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2,100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange. Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 Securities' ID No., ISIN preference shares: 522723, DE0005227235 Listing: Prime Standard Open market: Berlin-Bremen, DÃ¼sseldorf, Frankfurt, Hamburg, Hannover, MÃ¼nchen, Stuttgart 24.04.2015 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Biotest AG LandsteinerstraÃe 5 63303 Dreieich Germany Phone: 0 61 03 - 8 01-0 Fax: 0 61 03 - 8 01-150 E-mail: investor_relations@biotest.de Internet: http://www.biotest.de ISIN: DE0005227235, DE0005227201 WKN: 522723, 522720 Indices: SDAX Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Jacquie Lawson's Advent Calendar Delights Fans for 17th Year

A Festive Tradition with a Twist The Jacquie Lawson Advent calendar is back for its 17th season, and it's no ho-hum affair. This time, the scene is set against the breathtaking backdrop of England's Lake District. If you've been yearning for a bit of that classic literary and natural charm, this is your ticket—minus the airfare. The calendar isn't just a countdown; it's...

YSS Faces Legal Heat Over Misleading Investor Claims

YSS Investors Navigate Legal Waters as Class Action Looms Taking a slug of coffee this morning and diving right into it—York Space Systems has found itself in hot water. They went public earlier this year with what was supposed to be a shining opportunity under the NYSE:YSS ticker, but it turns out that not everything in their IPO shined—and now SBS Law is stepping up...

Tata's $450M Bet on India's AI Infrastructure

The Big Bet on AI Infrastructure Here comes Tata Communications, tossing nearly USD 450 million into the pot, betting on a vision that could change India's digital backbone. This isn't just some drop in the bucket; they're talking about laying down 10,000 kilometers of fiber for India's AI super highway. It's a gutsy move, and frankly, it's about time someone shook things...

Cohere's CAD $7 Billion Raise Signals AI Power Shift

Changing the Game: Cohere's Massive Series E Raise There's a seismic shift happening up north, and it’s not the aurora borealis. Cohere just announced the initial close of a staggering CAD $7 billion Series E funding round, eyeing a CAD $35.7 billion valuation. If it pans out, it’d be the kind of cash grab that's never been seen in Canadian tech history. Why This...

BioMarin Strikes Deal for New Fabry Disease Therapy

BioMarin's Latest Moves in Rare Disease Therapies Now here's a plot twist in the biotechnology landscape. BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) just did what they do best—snagging rights to a promising enzyme therapy aimed at turning the tide for Fabry disease. In a deal that spoke volumes about their intentions, BioMarin is forking over a cool $70 million upfront...

Ball Corp to Steal the Spotlight at 2026 Baird Event

Ball Corporation's Big Moment at Baird 2026 Did you hear the rumble in the aluminum jungle? That's Ball Corporation (NYSE: BALL) gearing up to take the stage at the Baird 2026 Global Industrial Conference on November 12. The big wigs, Ron Lewis and Dan Rabbitt, CEO and CFO respectively, will throw down some serious wisdom at 7:55 a.m. Central Time. What'll they cover?...

IDrive Fortifies Data Protection with Top Certifications

Ramping up Security in a Complex World Data protection isn’t just yesterday’s crucial task—it's today's battlefield and tomorrow's war. Companies like IDrive are stepping up to the plate, offering solutions that are as sturdy as a brick wall. In a world where data breaches and hackers lurk like wolves in the shadows, the demand for secure, compliant data protection...

NeuroSense's Phase 3 Strategies for PrimeC Unveiled

How NeuroSense Is Poised to Tackle ALS Treatment Picture this: a room full of people holding their breath, hoping that NeuroSense can deliver the breakthrough they’ve been inching toward. It’s the kind of moment that gives you goosebumps if you've been sloggin' through the biotech trenches. NeuroSense’s pitch at NEALS is more than just a dog and pony show—it's a...

Bandwidth Welcomes Chip Schroeder: Key Board Makeover

Turning the Page at Bandwidth Bandwidth Inc. (NASDAQ:BAND) just shook up its executive roster by bringing in a heavy hitter. Chip Schroeder's landing on the board is a bold move from a strategic player in the cloud communications space. This guy's not your average board member; he's a veteran navigator through stormy market waters, and at Bandwidth, it seems he'll be...

Florida's Natural, Johnsonville Settle Bet Over Juice

No Such Thing as a Safe Bet When Milwaukee's Brewers edge out Tampa, it's not just about the wins and losses—it's about pride and a truckload of Florida's Natural orange juice cruising into Wisconsin. Who knew baseball could drive trades not just between players, but entire industries? In this friendly wager, the stakes were both flavorful and steep, paying homage to...