Replies to post #163150 on Biotech Values

[jq1234]

EPIRUS Biopharmaceuticals Announces Positive Phase 3 Data Supporting Biosimilarity of BOW-015 to Remicade®

[Never heard of EPIRUS until today]

•Comparability to Remicade as measured by ACR20 response in severe rheumatoid arthritis (RA) patients
•No meaningful differences observed in safety or immunogenicity
•First market authorization filing in Q4 2013

Boston, MA, August 28, 2013 — EPIRUS Biopharmaceuticals, Inc. (EPIRUS), a privately held biotechnology company focused on the development and production of biosimilar products for major emerging markets, today announced positive Phase 3 data from a clinical trial comparing the EPIRUS infliximab molecule BOW-015 to Remicade™ for the treatment of rheumatoid arthritis (RA).

This study in severe RA patients was designed as an equivalence trial comparing BOW-015 to Remicade. BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.

No meaningful differences were observed in safety or immunogenicity. Complete details of the study, including secondary endpoints and full safety and immunogenicity data, will be released at an upcoming major medical meeting.

“Our mission at EPIRUS is to improve access to safe and effective biologic therapeutics for patients in emerging markets,” said Amit Munshi, the Company’s President and Chief Executive Officer. “The Phase 3 data announced today is an important milestones for us and underscores the technical competency of the EPIRUS team. We plan to submit regulatory filings in targeted emerging markets over the next 12 months.”

“The data supporting BOW-015’s clinical comparability to Remicade, combined with the focus of EPIRUS on emerging markets, will help expand patient access to this important medicine," added Jonathan Kay, MD, Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School. Dr. Kay serves as a clinical advisor to EPIRUS.

http://www.epirusbiopharma.com/news-articles/BOW-015-Positive-P3-Data.html

[DewDiligence]

Major FoB Collaborations

[Added BAX-Coherus.]


Items are shown in reverse chronological order.

 
                    Date   Targets   Geography     iHub References 
 BAX-Coherus        9/13   Enbrel    ex-US         #msg-91645674 
 Oncobiolgcs-Huahai 5/13   #         global        #msg-87734336, #msg-87744882 
 Strides-Pfenex     4/13   Betaseron global        #msg-87014470 
 MRK-Samsng/BIIB    2/13   @         unspecified   #msg-84781042, #msg-69629103 
 Catalent-UMN      12/12   various   Asia          #msg-82556713 
 Merck KGaA-RDY     6/12   oncology  global        #msg-76359649 
 Daiichi-Coherus    5/12   *         Asia          #msg-75397629 
 Fujifilm-Kyowa     3/12   Humira    unspecified   #msg-73800486 
 ACT-Bioton         2/12   insulin   US & Europe   #msg-74987123 
 ACT-AMGN          12/11   †         global        #msg-70097496, #msg-84340328 
 BAX-MNTA          12/11   ‡         global        #msg-70212854, #msg-70258421 
 HSP-Celltrion     10/09   z         global        #msg-84519981, #msg-77816122 
 MYL-Biocon         6/09   x         global        #msg-72421544, #msg-84561737 
 Procognia-UTR      n/a    Humira    unspecified   #msg-84340976 

*Enbrel and Rituxan.

†Humira, Remicade, Herceptin, Avastin, Rituxan, Erbitux; excludes AMGN FoB’s for AMGN’s branded drugs.

‡Three products in development: 2 auto-immune and 1 oncology—my guesses are Humira, Orenica, Erbitux; may include up to 6 products eventually.

@ Samsung/BIIB subordinate collaboration known as Samsung Bioepis; Rituxan program terminated (#msg-80622249); presumably excludes FoB’s for BIIB’s branded drugs.

#Humira, Rituxan, Avastin, Herceptin.

x Nine products: Herceptin, Neulasta, Avastin, Humira, Enbrel, Lantus, Novolog, Humalog, one undisclosed.

y Rituxan program terminated (#msg-80236315); status of other programs unknown.

z Each company received a distinct EU/CHMP approval for Remicade on 6/28/13; partnership includes seven (other) products: Rituxan, Herceptin, Enbrel, Erbitux, Synagis, Humira, Avastin.