Altus and Althea pair up
to produce Phase III quantities of a crystallised formulation of
human growth hormone (hGH) which can be administered subcutaneously
weekly instead of daily.
Althea will produce the growth hormone deficiency drug ALTU-238 at its newly expanded current good manufacturing practice (cGMP) manufacturing facilities in San Diego, working with Altus in technology transfer and the installation and qualification of the necessary equipment.
Altus is already supplied with hGH by Novartis's generic unit Sandoz, so the challenge for Althea will be to scale up Altus's protein formulation technology which allows control of the release profile of ALTU-238, since protein crystallisation is significantly more complex than small molecule crystallisation and for this reason it has not historically been a commercially scalable process.
"Our formulation method does not chemically modify the molecule neither does it involve the use of polymers or fusion proteins," Robert Gallotto, vice president for strategic planning at Altus, told In-PharmaTechnologist.com, refusing to describe the science behind the technology.
"We selected Althea because of their experience in protein formulation and we do have the option to commercialise the drug with them, though we have issued no guidance on the timeframe."
There are currently eight approved hGH products in the US market, all essentially identical according to Altus, since they are differentiated solely through variations in their respective delivery devices and formulations.
ALTU-238 is a crystallised long-lasting formulation of hGH that is designed to be administered once weekly through a fine gauge needle for the treatment of hGH disorders in both pediatric and adult populations.
According to industry estimates the market for hGH in the US was approximately $900m (€705m) in 2005, the largest hGH market in the world.
Although Altus has so far used its crystallisation technology in-house for its oral and parenteral products under development, it says it will consider licensing agreements with partners.
An extension of its crystallisation technology, useful in oral formulations, allows Altus to enhance the stability of the crystal by cross-linking the molecules within the crystal lattice, thereby creating stronger intramolecular bonds and adding significantly greater stability.
By optimising the formulation, Altus is able to exert control over where a product is going to be most active and therefore most effectively exert its therapeutic effect.
This finds use in the drugmaker's cystic fibrosis drug ALTU-135, allowing delivery of the medicine's three protein-based active ingredients to the gastrointestinal tract without degrading in the harsh pH and proteolytic environment of the gut.
Altus has assigned the production of ALTU-135 for Phase III studies, which are scheduled to begin soon, to Japan's Amano Enzyme.
