PB PER.C6® Licensing Agreement with UMN Phar

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gocrucellgo
4
Kom net weer thuis na kort weekje buitenland is dit wel gepost 2 november?


DSM Biologics Will Produce UMN Pharma’s Diabetes Treatment
Nov 2 2006, 2:34 PM EST
GEN News Highlights


DSM Biologics and UMN Pharma signed a biopharmaceutical manufacturing agreement based on Crucell’s PER.C6® manufacturing platform. DSM Biologics will provide UMN Pharma with process development services, analytical development services, and cGMP manufacturing for UMN Pharma’s UMN-03 fusion protein.

UMN Pharma developed the UMN-03 fusion protein for the treatment of muscular dystrophy and metabolic diseases, such as obesity and type 2 diabetes.

The services will be provided out of DSM Biologics’ manufacturing facility in Groningen. The Agreement follows the license agreement that was signed in March, 2006 between UMN Pharma, DSM Biologics, and Crucell.

www.genengnews.com/news/bnitem.aspx?n...
gocrucellgo
12
Press release
DSM Pharmaceutical Products November 2, 2006
45 Waterview Blvd
Parsippany, NJ 07054-1298
DSM Biologics and UMN Pharma Inc. Sign a Biopharmaceutical Manufacturing Agreement based on the PER.C6® Manufacturing Platform
Parsippany, November 2, 2006
DSM Biologics (headquartered in Parsippany, NJ) and UMN Pharma, Inc. (headquartered in Akita, Japan) have signed a Biopharmaceutical Manufacturing Agreement based on the PER.C6® Manufacturing Platform. Under the terms of the Agreement DSM Biologics will provide UMN Pharma with (a) full process development services, (b) full analytical development services and (c) cGMP manufacturing batches for UMN Pharma’s UMN-03 fusion protein. UMN Pharma develops the UMN-03 fusion protein for the treatment of muscular dystrophy and metabolic diseases such as obesity and type II diabetes mellitus.
The services will be provided out of DSM Biologics’ FDA-approved manufacturing facility in Groningen. The Agreement follows the License Agreement that was signed in March this year between UMN Pharma, DSM Biologics and Crucell.
Both parties are very pleased with the results of the collaboration to date. “The Agreement builds further on the PER.C6® License Agreement that is in place between UMN Pharma, DSM Biologics and Crucell. We gladly entrust DSM Biologics with the execution of this Manufacturing Agreement that is crucial for the success of our UMN-03 fusion protein” says Yasunari Kashihara, President & CEO of UMN Pharma, Inc.
“DSM Biologics is very happy to be involved in this exciting project. The agreement is a further example of the broad use of the PER.C6® manufacturing platform. It is also a clear recognition of the value that DSM Biologics and the PER.C6® manufacturing platform are expected to bring to UMN Pharma, an important client for DSM Biologics” says Terry Novak, Business Director and Chief Marketing Officer for DSM Biologics.
About DSM Biologics
DSM Biologics, a business unit of DSM Pharmaceutical Products, is a leading provider of manufacturing technology & services to the biopharmaceutical industry. In addition to offering world-class biopharmaceutical manufacturing services, DSM Biologics has co-exclusive rights, along with Dutch biotech company Crucell N.V., to license the high-producing PER.C6® human cell line as a production platform for recombinant proteins and monoclonal antibodies. DSM Biologics’ FDA-approved facility in Groningen, the Netherlands was established in 1986, and has a strong track record in using a broad range of cell lines (PER.C6®, CHO, hybridoma, etc.) in biopharmaceutical manufacturing, and has a wide-range of experience using multiple manufacturing (batch, fed-batch and continuous perfusion) and purification techniques. The combination of the PER.C6® human cell line and DSM’s manufacturing services provides companies with a turn-key biologic manufacturing solution reducing cost, risk and time to market. DSM Biologics is being represented
Press release
in Japan by Asahi Glass & Co., Ltd. For more information, please visit www.dsmbiologics.com.
About UMN Pharma
UMN Pharma, a pharmaceutical company, is dedicated to developing innovative disease preventives and therapeutics to satisfy unmet medical needs. UMN’ leverages extensive pharmaceutical industry experience to generate time-efficient, focused development plans followed by rapid preclinical and clinical development to meet both Japanese and international regulatory specifications. UMN has a diverse pipeline of novel small molecule and protein drug candidates targeted to cancer, diabetes and other major therapeutic markets. Four products are currently in preclinical development with the first clinical study scheduled for early 2007. UMN anticipates that four products will be in the clinical stage within a two-year timeframe. For more information, please visit www.umnpharma.com.
For more information:
DSM Pharmaceutical Products
Terry Novak
Chief Marketing Officer
973-257-8471
Terry.Novak@dsm.com
DSM Biologics
Marcel Lubben
Manager, New Business Development
Europe & Asia
+31 46 47 73343
Marcel-m.lubben@dsm.com
DSM Biologics
Brad Carlson
Vice President, Marketing, Sales & NBD
Tel. +1 (585) 624-3844
Brad.Carlson@dsm.com
UMN Pharma, Inc.
Yasunari Kashihara
President & CEO
+81 (3) 5728-5420
ykashihara@umnpharma.com
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0
quote:

gocrucellgo schreef:


Kom net weer thuis na kort weekje buitenland is dit wel gepost 2 november?

Stelletje slaapkoppen hier....
mooi go, ab!
Dirk R. Wijnen
0
Ik vind wel dat Crucell hier toch ook wel een PB'tje aan had kunnen wijden. Crucell had toch beloofd elke voortgang te melden, betrekking hebbende op clinical trials betreffende PerC6, STAR etc. ???


Dirk
Crusader
0
quote:

Cybertom schreef:


AB verdiend Go! Goed speurwerk.


En wellicht een verklaring voor de grote hap in VS rond die tijd gisteren?
gogogoo
0
quote:

flosz schreef:


[quote=gocrucellgo]
Kom net weer thuis na kort weekje buitenland is dit wel gepost 2 november?
[/quote]
Stelletje slaapkoppen hier....
mooi go, ab!

Fundamenteel weer een mooi dagje vandaag voor Crucell.
Goed gevonden!
[verwijderd]
1
We plan to start the first clinical study in early 2008.
*************************


UMN-03
UMN-03 is a recombinant fusion protein, which neutralizes endogenous myostatin (growth and differentiation factor 8 or GDF-8), a protein whose role is to reduce the amount of muscle tissue that is formed. Substantial published data indicate that blocking the action of myostatin can promote extra muscle growth, thus providing potential therapeutic advantage for patients with muscular dystrophy. Furthermore, UMN-03 can reduce fat tissue and could thereby provide a new therapeutic approach for type II diabetes or obesity. We plan to start the first clinical study in early 2008.
umnpharma.com/eng/pipeline.html#EXP
[verwijderd]
0
DSM and UMN sign manufacturing deal

by Emilie Reymond


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09/11/2006 - DSM Biologics, the biopharma arm of DSM group, has signed a manufacturing deal with Japanese UMN Pharma based on the firm’s novel recombinant protein manufacturing platform.

Under the terms of the agreement, the contract manufacturer will provide UMN with full process and analytical development services and cGMP manufacturing batches for its recombinant fusion protein, UMN-03, using DSM's PERC6 cell line platform.
UMN-03 is a myostatin-inhibiting fusion protein aimed at the treatment of muscular dystrophy and metabolic diseases such as obesity and type II diabetes mellitus.

After finishing the manufacture of the clinical sample, the clinical study will be started in 2008, UMN said.

Dutch company DSM has co-exclusive rights, along with another Dutch biotech company, Crucell, to license the high-producing PER.C6 human cell line as a production platform for recombinant proteins and monoclonal antibodies.

The PER.C6 technology uses cell culture for the large-scale production of recombinant proteins and monoclonal antibodies, including influenza vaccine, where the virus is grown on specially selected cell lines instead of chicken eggs.

The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions. This cell culture process has the potential to reduce from four weeks to two or three weeks the start-up time for manufacturing and could result in a more predictable manufacturing process.

This latest agreement builds further on the PER.C6 license agreement that was signed in March between UMN Pharma, DSM Biologics and Crucell.

"The protein market is growing rapidly and may reach $200bn (€157bn) in 15 to 20 years and we believe that PER.C6 has the potential to become the technology of choice for an attractive part of that market," said Leendert Staal, president of DSM pharmaceutical products.

The services will be provided out of DSM Biologics' FDA-approved manufacturing facility in Groningen, Netherlands.


www.in-pharmatechnologist.com/news/ng...


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