Press releases

Release issued 1st November 2010

Langenfeld/Rheinland, Germany

Labtec GmbH, Langenfeld, Germany announces the start of the phase II clinical development program for its sufentanil transdermal patch. The multicentric, randomized, open label study will evaluate efficacy and safety of Sufentanil TDS against standard treatment in patients with chronic cancer pain.  

Sufentanil TDS is a matrix-type transdermal patch with the active ingredient sufentanil, a highly potent and well-known opioid analgesic that is used as an injection or infusion for anesthesia and analgesia since decades. Compared to fentanyl, the advantages of sufentanil lie in its seven fold higher potency together with a superior side effect profile and higher safety margin. Due to its very small size of only 3 cm² and its textile backing the patch offers the high wearing comfort for the patient.

"After the huge success of our Fentanyl patch, which is marketed by our licensee ratiopharm and several other leading generic companies in Europe and Canada, we are expecting to see our Sufentanil TDS move forward. In our opinion this transdermal patch is the logical next generation product for severe chronic pain. Sufentanil is one of the most potent drugs in its class and at the same time offers various advantages in terms of safety and efficacy for chronic pain treatment with a transdermal system" says Labtec's Managing Director, Dr. Ingo Lehrke.

On June 4th, 2010 Labtec has entered into a strategic development partnership with hameln rds GmbH, Hameln, Germany. Under the agreement, hameln rds will perform all necessary development steps jointly with Labtec to bring the product through phase II.

Dr. Peter Klaffenbach, Managing Director of Labtec: "We are glad that we found in hameln rds a highly professional and competent partner for the development who will conduct all necessary pre-clinical studies as well as the clinical studies phase II. All studies will be organised and realised at hameln rds´s research and development site in Modra, Slovakia, where hameln rds holds large laboratory capacities with innovative equipment as well as its own in-house clinic."

Labtec is the manufacturer of the pilot batches for the pre-clinical and clinical studies. Labtec will also conduct the scale up process at its manufacturing site in Hamburg. The first toxicological studies are already in progress at the research and development site of hameln rds in Modra.

About hameln rds

hameln rds was spun off from hameln pharmaceuticals gmbh in 2005 under the name hameln pharma r&d gmbh. The company started off with 25 employees at the Group headquarters in Hameln, Lower Saxony. In 2006, hameln pharma r&d acquired the Slovakian company Vulm AG. The acquisition enabled hameln pharma r&d to expand its range of services by adding toxicological/clinical studies and extensive laboratory services to the mix, alongside its existing product development work, approval service and trading activities. In early 2007, the two sites in Hameln and Modra were brought together under the new name of hameln rds (hameln research, development, supply chain) and the number of employees was increased to a total of 180. Today, hameln rds offers a unique range of services that covers the entire value chain from drug development right through to drug sales and distribution. For further information: www.hameln-rds.com

About Labtec GmbH

Founded in 1990, Labtec has quickly become one of the leading drug delivery development companies in the transdermal and topical patch arena, later also leading the market with fast dissolving oral films in Europe. Since 2008 Labtec is a subsidiary of tesa SE - a member of the Beiersdorf group of companies - and represents tesa's pharmaceutical business. The company offers contract development and contract manufacturing of patches and oral film strips to the pharmaceutical industry. In 2009, Labtec started operations at tesa's new 3,000 m² GMP manufacturing site for patches and oral films. For press releases and more information about Labtec, please visit: www.labtec-pharma.com
 
Contact: 
 Dr. Ingo Lehrke; Managing Director
 Labtec GmbH, www.labtec-pharma.com/
 Raiffeisenstrasse 4, D-40764 Langenfeld, Germany
 T: +49 2173 9735-0

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