09.11.2021, Warngau / Chenôve
- Strategic partnership in the field of transdermal delivery systems (TDS)
- AMW to focus on its TDS development expertise and to broaden its pipeline on biodegradable slow-release implants
- AdhexPharma to focus on TDS development and manufacturing as a CDMO and to strengthen its position to become a leading global patch manufacturer
Today a strategic partnership between AMW GmbH and AdhexPharma SAS on AMW’s transdermal delivery systems technology platform and product portfolio was announced, combining the strengths of both companies in the field of TDS. Under the partnership, AMW will focus on development, marketing authorization and licensing of novel transdermal delivery systems. AdhexPharma will focus on the commercial manufacturing and lifecycle management of the products. AdhexPharma will take over the manufacturing equipment and the IP for AMW’s products Buprenorphine and Rivastigmine and following a transition phase of up to 30 months the contract manufacturing of these Products from AMW.
Both companies have built very good relationships and are looking to expand their cooperation. AMW has appointed AdhexPharma as preferred contract manufacturing organization to produce any new transdermal delivery system under development by AMW.
“This exciting partnership will provide a unique opportunity to leverage AMW’s transdermal product portfolio with AdhexPharma’s expertise and manufacturing capabilities to enable broader market and patient access for the products.” commented Dr. Konstantin Petropoulos, recently appointed CEO of AMW. “Furthermore, it is a great opportunity for us to focus on our fast-growing core business, the formulation, development, registration, selling and manufacturing of biodegradable implants.”
“With this partnership we will realize many synergies with the Rivastigmine product and broaden our portfolio with regards to the narcotic transdermal system Buprenorphine. By acquisition of the contract manufacturing business of AMW, we can continue and accelerate our successful growth path to become leading global patch manufacturer. This way we can support AMW with sufficient capacity for future transdermal products to come” said Roland de la Brosse, President of AdhexPharma.
AMW is a specialty pharmaceutical company and market leader in developing and manufacturing biodegradable slow-release drug delivery systems such as implants as well as first-to-market generics. In addition, AMW is using its leading-edge formulation expertise and proprietary technology platform for both own and partnered development of new therapeutic solutions in oncology, neurology, dermatology, pain management, and ophthalmology. Founded in 2008, AMW already has four marketed products, including the first generic Goserelin implant to Astra Zeneca’s Zoladex®.
AMW is headquartered in Warngau, south of Munich.
AdhexPharma is an independent pharmaceutical company specializing in the development and manufacturing of patches and oral thin films. As such AdhexPharma provides its customers with an industrial, technology expertise and know-how in the formulation, development and production of such systems. It is cGMP compliant, for both Europe and US and can handle highly potent APIs.
Founded in 2007 for the purpose of acquiring the transdermal patch unit of Solvay in France, AdhexPharma currently manufactures five approved products representing more than 70 million units per year. AdhexPharma is headquartered in Paris and operates industrial activities in 2 buildings south of Dijon, Burgundy.
Rivastigmine is an active ingredient for reducing the symptoms of mild to moderate Alzheimer’s dementia. In patients with Alzheimer’s disease, certain neurons in the brain die, resulting in a low level of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Cholinesterase enzymes promote the breakdown of acetylcholine. Rivastigmine blocks these enzymes and causes an increase in acetylcholine in the brain and helps to delay the breakdown of mental performance.
The patent for the active substance Rivastigmin held by Novartis expired in 2008, and Novartis also held the patent for the transdermal system in 2012. AMW GmbH has developed a Rivastigmin TDS (dosages 4.6 mg/24h, 9.5 mg/24h, 13.3 mg/24h), which has successfully conducted two clinical trials and received approvals in 2015.
Buprenorphine is a highly effective analgesic for the treatment of tumor pain in cancers and other very severe pain. Depending on the dosage form, buprenorphine can be used in different areas. In the case of actual pain, buprenorphine is injected into the bloodstream. Since a buprenorphine tablet is too much metabolized / metabolized in the liver and then no longer works properly, sublingual tablets are placed under the tongue until they have dissolved. This increases bioavailability/efficiency.
A parenteral transdermal patch with the active substance buprenorphine significantly increases the bioavailability / effect. In addition, in case of chronically severe tumor pain, it is important to be able to release the active substance constantly and in a controlled manner (even overnight).
AMW GmbH has independently developed the buprenorphine patch with the dosages 35 µg/h, 52.5 µg/h, 70 µg/h.