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EPRS Epirus Biopharmaceuticals (ex Zalicus)

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10 Marzo

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Ripartirei da qui sperando che il 3D porti più fortuna del precedente

:ops:
 
Ma possibile che di sto titolo non si riesca ad avere nessuna info?
 
Il 12 agosto l'ultimo segno di vita.

Wedbush Life Sciences Management Access Conference - Investors - Epirus Biopharmaceuticals

L'evento era stato presentato così qualche giorno prima:

Aug 7, 2014

EPIRUS to Present at Wedbush Life Sciences Management Access Conference

BOSTON--(BUSINESS WIRE)-- EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced that the company will present at the Wedbush Life Sciences Management Access Conference at 4:15 p.m. EDT, Tuesday, Aug. 12, at the Le Parker Meridien in New York City. The presentation will include discussion of the company's recent developments, business model and pipeline.



EPIRUS to Present at Wedbush Life Sciences Management Access Conference (NASDAQ:EPRS)
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Può interessare questo. Un estratto della comunicazione del 12.8:


Table of Contents

As of June 30, 2014, we had an accumulated deficit of $380.1 million. We had a net loss of $0.4 million and $18.6 million for the six months ended June 30, 2014 and 2013, respectively.

Our management currently uses consolidated financial information in determining how to allocate resources and assess performance. We have determined that we conduct operations in one business segment. For each of the six months ended June 30, 2014 and 2013, all of our revenues were from customers located in the United States.
 
$claudiano ha scritto:
Può interessare questo. Un estratto della comunicazione del 12.8:


Table of Contents

As of June 30, 2014, we had an accumulated deficit of $380.1 million. We had a net loss of $0.4 million and $18.6 million for the six months ended June 30, 2014 and 2013, respectively.

Our management currently uses consolidated financial information in determining how to allocate resources and assess performance. We have determined that we conduct operations in one business segment. For each of the six months ended June 30, 2014 and 2013, all of our revenues were from customers located in the United States.
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Ok grazie. Adesso leggo un po'
 
Qualcuno riesce anche a capire se capitalizza 25 o 120 M???
 
Ragazzi siete voi che comprate? Io no
 
Io neanche. :o
 
Il tracollo di oggi (-8,77%) a che cosa è dovuto? Sul sito dell'azienda non ho trovato nulla... :boh:
 
Tentativo di rimbalzo, oggi.






PS: ci sono rimasto solo io? :confused:
 
ieri era venuta fuori una notizia buonissima, che un farmaco aveva avuto il via libera al nuovo step per la sua commercializzazione in india. di solito queste notizie agli altri farmaceutici fa schizzare le quotazioni anche del 200 per cento. e invece al ns epirus ha fatto fare il gambero. io non capisco. voi che dite? mi son sbagliato e la notizia non era buona ma cattiva? boh
 
Anarca ha scritto:
Tentativo di rimbalzo, oggi.



PS: ci sono rimasto solo io? :confused:
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Ci siamo.. Sempre in ptf ma messa nel dimenticatoio.. :(

Chissà se si avvicinerà mai al mio pmc di 24,4..

Anche volendo come si fa ad incrementare per abbassare pmc.. non si sa niente, nessuna news.. IMHO
 
Anche i volumi non fanno sperare niente di niente... in altre parole sembra una nave sperduta in mezzo al mare
 
Questa è stata l'ultima comunicazione rintracciata dell'azienda, data 15 settembre.
Attenzione alla parte che ho evidenziato in rosso.

EPIRUS' Remicade® Biosimilar Receives Final Approvals in India (NASDAQ:EPRS)

Sep 15, 2014


EPIRUS' Remicade® Biosimilar Receives Final Approvals in India

BOW015 is the first infliximab biosimilar approved in India

BOSTON--(BUSINESS WIRE)-- EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has received final marketing and manufacturing approvals for its Remicade® (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India.

"With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options," said Amit Munshi, president and CEO of EPIRUS. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets."

BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories Limited (Ranbaxy) expect to launch the drug, under the brand name Infimab®, by the first quarter of 2015.

"We believe that the data supporting BOW015's clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS' focus on emerging markets, will help expand patient access to this important medicine," added Jonathan Kay, M.D., 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.

Ranbaxy and EPIRUS signed a licensing agreement for BOW015 in January of 2014. Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.

About BOW015

BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity.

More data on the Phase 3 study is available at The European League Against Rheumatism Abstracts2View™: Login Page.

EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted global markets. EPIRUS also plans to initiate an additional Phase 3 trial in Europe in early 2015.
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Cioè, qua più escono buone notizie e più si scende!!! :wall::wall::wall:

Sep 23, 2014

EPIRUS Announces Positive 58 Week Follow up Data for BOW015 for Treatment of Rheumatoid Arthritis

BOW015 demonstrates therapeutic equivalence to Remicade® and confirms the safety of switching from Remicade to BOW015

BOSTON--(BUSINESS WIRE)-- EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced positive 58 week follow up data from its BOW015 efficacy and safety trial comparing BOW015, a biosimilar infliximab, to Remicade.

"The open label phase of the study was designed to provide data on long term safety and durability of response as well as long term safety for Remicade responders switching to BOW015. This data suggests the patients can safely be started and maintained on BOW015 and that patients can be safely switched from Remicade to BOW015," said Michael Wyand, DVM, PhD, senior vice president of clinical, regulatory and manufacturing.

The overall study was comprised of a 16 week, double blinded, head to head comparison with Remicade for safety and efficacy followed by an open label phase where Remicade responders were switched to BOW015 and all patients were followed for the duration of the study. The study met its primary endpoint of ACR20 response, the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.

In the open-label phase, patients who continued on BOW015 were compared to patients who received four doses of Remicade, followed by a switch to four doses of BOW015. Immune responses as well as overall safety and tolerability for BOW015 were comparable to the arm switched from Remicade to BOW015 and were consistent with the expected profile of Remicade. Further, ACR20 responses were durably maintained to 58 weeks from the week 16 primary endpoint previously reported.

The full data will be presented at an upcoming medical meeting.

About BOW015

BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial previously met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity.

More data on the Phase 3 study is available at The European League Against Rheumatism Abstracts2View™: Login Page.

Epirus is actively progressing applications for marketing approval for BOW015 in targeted global markets. In September 2014, EPIRUS announced final approval of BOW015 in India, the first infliximab biosimilar approved in India. Epirus also plans to initiate an additional Phase 3 trial in Europe in early 2015.



EPIRUS Announces Positive 58 Week Follow up Data for BOW015 for Treatment of Rheumatoid Arthritis (NASDAQ:EPRS)
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Comunque, annamo avanti... Tra qualche giorno, l'azienda sarà qui:

NewsMakers in the Biotech Industry conference

Sep 26, 2014
2:30 PM ET

NewsMakers in the Biotech Industry conference - Investors - Epirus Biopharmaceuticals
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Mi sembra un'ottima notizia.

Sep 25, 2014

EPIRUS and Livzon Mabpharm, Inc. Enter Collaboration Agreement for China

Partners to develop, manufacture and commercialize up to five biosimilars, including EPIRUS' BOW015, for Asian markets

BOSTON--(BUSINESS WIRE)-- EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ: EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has signed a royalty-bearing, multi-product collaboration agreement with Livzon Mabpharm Inc. (Livzon), a Chinese biotechnology company focused on the development, manufacture, and sale of antibody-based drugs. Livzon was also a principal investor in the $36 million private financing round EPIRUS closed in April 2014, prior to becoming a public company.

Under the terms of the agreement, EPIRUS and Livzon will work together to develop, manufacture, and commercialize up to five biosimilar products. The first collaboration product is EPIRUS' Remicade biosimilar BOW015 (infliximab), which was recently approved in India. Livzon will conduct any additional development work necessary for the approval of BOW015 in China and Taiwan. Livzon will also serve as the preferred supplier of BOW015 in these territories, following a transfer of EPIRUS' SCALE™ manufacturing platform. Livzon will be responsible for all commercialization activities in its territories.

"We have established a significant collaboration with a strong partner in a compelling market," said Amit Munshi, president and CEO of EPIRUS. "This agreement also reinforces the importance of our SCALE™ manufacturing platform for in market production globally."

Daotian Fu, Ph.D., CEO of Livzon Mabpharm, Inc., said, "EPIRUS' robust pipeline, business strategy and experienced management coupled with the market potential of biosimilars, made this an exciting collaboration for Livzon. We look forward to building a substantial biosimilars business for the China market." Dr. Fu is also a member of the EPIRUS board of directors.

About EPIRUS

EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS' pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates - Remicade®, Humira®, and Avastin®, respectively - together generated $26.2 billion in global sales in 2013.

EPIRUS' strategy for commercial success relies on targeted approaches for diverse global markets.

For emerging markets with accessible regulatory frameworks for biosimilars, EPIRUS develops partnerships with local companies to accelerate regulatory approval and commercialize its products.

For high-growth global markets where local manufacturing confers strategic and operational advantages, EPIRUS intends to use its SCALE™ platform to deliver an In Market, For Market™ manufacturing solution with local partners.

For large markets with an established biosimilar regulatory framework, such as Europe, EPIRUS plans to commercialize its products using a combination of direct sales and local distributors.

More information about EPIRUS can be found at Epirus Biopharmaceuticals

About BOW015

BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial previously met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity. Recently, Epirus announced 58 week data for its Phase 3 trial, which demonstrated therapeutic equivalence to Remicade and confirmed the safety of switching from Remicade to BOW015.

More data on the Phase 3 study is available at The European League Against Rheumatism Abstracts2View™: Login Page.

EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted global markets. EPIRUS also plans to initiate an additional Phase 3 trial in Europe in early 2015.

About Livzon Mabpharm, Inc.

Founded in 2010, Livzon Mabpharm, Inc. is one of the major biotechnology companies to enter biologics research and development in China. It is mainly focused on development, manufacturing and sale of antibody-based drugs. It is equipped with a world-class technical and scientific research team, core technology platforms, and advanced R&D facilities. The company's controlling shareholder is Livzon Pharmaceutical Group, Inc. ("Livzon", a pharmaceutical listed company in Mainland China and in Hong Kong (Stock code:000513.SZ, 01513.HK)), which holds 51% shares of Livzon Mabpharm, Inc. Livzon is a diversified pharmaceutical enterprise integrating development & research, production and sales of pharmaceutical products, operating to manufacture drug products, bulk medicines and intermediates, as well as diagnostic reagents and equipment. Livzon Mabpharm, Inc. was founded as the strategic R&D transformation of Livzon Pharmaceutical Group. Inc., focusing on development of antibody based drugs and vaccines.

More information about Livzon can be found at ????????????.

Forward Looking Statements

Any statements made herein relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including the development and prospects of BOW015 and EPIRUS' collaboration with Livzon, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this document, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to EPIRUS or its management, before or after the recent Zalicus merger, may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS' proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect EPIRUS' business, financial conditions and results of operations are contained in EPIRUS' filings with the U.S. Securities and Exchange Commission, which are available at U.S. Securities and Exchange Commission | Homepage.

Other risks and uncertainties are more fully described in EPIRUS' filings with the U.S. Securities and Exchange Commission, which are available at U.S. Securities and Exchange Commission | Homepage. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made herein speak only as of the date stated herein, and subsequent events and developments may cause EPIRUS' expectations and beliefs to change.

While EPIRUS may elect to update these forward-looking statements publicly at some point in the future, EPIRUS specifically disclaims any duty or obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing EPIRUS' views as of any date after the date stated herein.

Remicade® is a registered trademark of Johnson and Johnson (Johnson & Johnson Family of Companies | Johnson & Johnson)
Humira® is a registered trademark of AbbVie (AbbVie | Pharmaceutical Research & Development)
Avastin® is a registered trademark of Genentech (Genentech)



Russo Partners LLC
Tony Russo, 212-845-4251
tony.russo@russopartnersllc.com
or
Andrea Flynn, 646-942-5631
andrea.flynn@russopartnersllc.com

Source: EPIRUS Biopharmaceuticals, Inc.

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