In 2005, Switzerland-based Biopartners and UK-based The Medical House (TMH) signed a 10-year supply agreement for the license and supply of TMHs GH1 reusable, spring-powered, needle-free delivery system.
According to Biopartners, the company had been waiting since the summer of 2006 for a device to be used in the delivery of Biopartners human growth hormone product Valtropin.
Having received EMEA approval in April 2006, we had planned to launch Valtropin at the end of that year.
However, with the GH1 device not functioning correctly, we have had to end our agreement with The Medical House in order to seek a suitable and robust alternative delivery system, Biopartners chief executive Jean-Noel Treilles said in a statement.
The company was set to initiate a comparative bioavailability/bioequivalence study in 2006 in volunteers to assess Valtropin delivered by the GH1 device, but TMH was unable to supply the device.
The Medical House never provided Biopartners with the final GH1 devices made available for use in delivering Valtropin to patients . . .
We have lost definitely any hope to get functional devices from TMH, Biopartners head of commercial operations Marie-Joelle Gaufrs told in-PharmaTechnologist.com.
The device was looking promising even if all development had to be done, she said.
While the financial fallout of terminating the 10-year contract early was not disclosed, Gaufrs said: It is costing to the company the failure in the drug launch, the loss of revenues and all development costs paid to The Medical House to make this device suitable for delivery of Valtropin to patients.
Biopartners has found another undisclosed company to replace TMH and will use an autoinjector and cartridge device for the delivery of Valtropin instead, Gaufrs said.
The company is now working on modifying the system to be compatible with the new device.
The new product launch is now expected to be in the first half of 2009.
In a statement released by TMH, the company responded by saying: "The statement made by Biopartners is not only wholly incorrect but also misleading and has seemingly been made following commencement of legal proceedings by The Medical House against Biopartners."