Navigation Links
Amsterdam Molecular Therapeutics Provides Business Update for the Third Quarter 2011
Date:11/16/2011

AMSTERDAM, November 17, 2011 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today provided its non-audited business update in compliance with the EU transparency directive. This report summarizes material events and AMT's financial position for the third quarter of 2011.

3Q 2011 Highlights

  • Glybera® Marketing Authorisation Application filed for re-examination
  • Exclusive license signed with National Institutes of Health (NIH) for use of adeno-associated virus serotype 5 (AAV5)-based gene therapy vectors for liver and brain indications
  • Dr. Carlos R. Camozzi appointed as Chief Medical Officer

CHMP Decision on Glybera and Re-organization

  • Glybera Marketing Authorisation Application re-examination:
    • Committee for Advanced Therapies (CAT), Scientific Advisory Group (SAG) and new Rapporteur/Co-Rapporteur all recommended Glybera approvable under exceptional circumstances
    • CHMP concluded that there are no significant safety issues with Glybera
    • CHMP concluded that insufficient evidence of clinical benefit means Glybera is not approvable at this time
  • AMT will focus development efforts and financial resources on three gene therapy programs: hemophilia B, GDNF and acute intermittent porphyria
  • Company remains committed to participating in the Sanfilippo B program, which is fully funded by a consortium led by Institut Pasteur
  • Further investment in and development of Glybera and Duchenne's muscular dystrophy programs suspended
  • AMT management is working in close consultation with the AMT Works Council to assess the impact of the review on the Company's workforce
  • Management and board believe that for AMT to remain a viable business it needs to reduce the headcount by 50% to 45 full-time employees

Business Update

The Company continues partnering discussions with pharma companies. At this time, AMT anticipates that it may be possible to conclude a partnership for its hemophilia B program during the first half of 2012, provided that additional funding can be secured in the meantime. Therefore, AMT is exploring all options with regard to the business and its financing, with support from existing shareholders. AMT is also looking at additional collaborations with academic groups, which would contribute towards the short-term funding of its GDNF program for up to three indications.

AMT's cash position* on September 30, 2011 amounted to € 3.8 million compared to € 9.1 million on June 30, 2011. The cash outflow in the third quarter of 2011, € 5.3 million compared to € 3.4 million in the prior year, mainly represented operational cash flow impacted by certain non-recurring items: outstanding debtors at September 30, 2011 included two amounts totaling € 0.7 million which were due to AMT in the third quarter. In addition, payments to two third parties under an old grant were triggered, giving rise to a cash outflow of € 0.75 million. Adjusting for these on a pro forma basis, AMT's cash position would have been € 5.25 million, in line with budget, and the third quarter cash outflow would have been € 3.85 million. AMT employed 83 permanent staff as of September 30, 2011. Total expenses in the third quarter of 2011 were € 3.7 million compared to € 4.7 million in the same period last year.

*The Company's cash position is composed of cash and cash equivalents.

Material events after September 30, 2011

Since September 30, 2011, AMT was informed of the outcome of the Glybera re-examination process and has consequently initiated a reorganization of the company, in each case as described above. On November 16, 2011, AMT announced that its hemophilia B program was granted Orphan designation in the European Union.

About Amsterdam Molecular Therapeutics

AMT is a world leader in the development of human gene based therapies. AMT has a product pipeline of several gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson's disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world's first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows AMT to pursue its strategy of focusing on this sector of the industry.  AMT was founded in 1998 and is based in Amsterdam. Further information can be found at http://www.amtbiopharma.com.

Certain statements in this press release are "forward-looking statements" including those that refer to management's plans and expectations for future operations, prospects and financial condition. Words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of AMT only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT's business. AMT expressly disclaims any intent or obligation to update any forward-looking statements herein except as required by law. 



'/>"/>
SOURCE Amsterdam Molecular Therapeutics (AMT) B.V
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Amsterdam Molecular Therapeutics Reports Half Year Results 2008
2. Amsterdam Molecular Therapeutics Reports Full Year Results 2008
3. Amsterdam Molecular Therapeutics Reports Half Year Results 2009
4. The University of Amsterdam Joins the MetaMiner Metabolic Diseases Project
5. Amsterdam Molecular Therapeutics Reports Full Year Results 2009
6. Amsterdam Molecular Therapeutics Reports Half-Year Results 2010
7. Amsterdam Molecular Therapeutics Successfully Lowers Cholesterol In Vivo With Enhanced Novel MicroRNA AAV Gene Therapy
8. Amsterdam Molecular Therapeutics Appoints Dr. Carlos R. Camozzi as Chief Medical Officer
9. Amsterdam Molecular Therapeutics Files Glybera® European Marketing Application for Re-examination
10. Amsterdam Molecular Therapeutics Reports Half-Year Results 2011
11. Amsterdam Molecular Therapeutics Licenses Additional Novel Gene Therapy Vectors from National Institutes of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2017)... ... August 21, 2017 , ... ... leading Chinese bio security firm, to bring its proprietary CANARY pathogen detection technology ... the relationship, the Chinese firm has purchased an undisclosed number of PathSensors’ Zephyr ...
(Date:8/18/2017)... ... 18, 2017 , ... OAI, a leading Silicon Valley, CA-based ... announces the new Model 800E front and backside, semi-automatic mask aligner system. This ... OAI has already received and installed several orders for the Model ...
(Date:8/16/2017)... Yorba Linda, Ca (PRWEB) , ... August 16, ... ... resist treatment by changing into a different cell type. Many treatments for specific ... tissue. A prominent example of targeted treatment is androgen deprivation therapy for advanced ...
(Date:8/16/2017)... , Aug. 16, 2017  Kingfisher Talent, the ... development, and Virdis Group, global executive search specialists in the ... enables clients to leverage the expertise and reach of both ... here in the Boston biotech hub, ... leadership talent throughout the US, Canada ...
Breaking Biology Technology:
(Date:4/19/2017)... York , April 19, 2017 ... as its vendor landscape is marked by the presence ... market is however held by five major players - ... Together these companies accounted for nearly 61% of the ... the leading companies in the global military biometrics market ...
(Date:4/17/2017)... 17, 2017 NXT-ID, Inc. (NASDAQ: NXTD ... filing of its 2016 Annual Report on Form 10-K on Thursday ... ... available in the Investor Relations section of the Company,s website at ... website at http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/13/2017)... 2017 According to a new market research report ... Identity Administration, and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region ... expected to grow from USD 14.30 Billion in 2017 to USD 31.75 ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):