PTx picks up radiation drug and plant from Sanofi

pharmafile | February 6, 2018 | News story | Manufacturing and Production, Sales and Marketing Partnership Therapeutics, Sanofi, biotech, drugs, pharma, pharmaceutical 

A Boston-based biotech, only a few weeks old, has moved quickly to secure both the drug Leukine and the plant that manufactures it from Sanofi.

The biologics facility is located in Lynnwood, Washington, has been operational since 2012; the biotech revealed that the facility will become an integral part of the company’s manufacturing ability, as well as serving as a centre for its supply chain operations.

The drug itself is an interesting prospect – it is already approved for the use in the treatment of acute myelogenous leukaemia, and is the only FDA approved recombinant human granulocyte-macrophage colony stimulating factor.

Beyond that, though, the biotech is supporting the expansion of the drug’s indication into other areas, one of which includes it being used as a potential treatment for radiation poisoning.

This is based on data from 2016, which showed that Leukine was able to increase survival in rhesus monkeys when delivered within 48 hours of exposure to radiation.

The decision to take on the drug with this particular indication has many people drawing links between the indication and the public announcement by the Bulletin of the Atomic Scientists to move the ‘Doomsday Clock’ forwards to two minutes to midnight.

The clock is designed to reflect the higher risk calculated to be faced to the long-term future of humanity; this decision came in the light of increased rhetoric regarding the use and development of nuclear weapons by President Trump.

Leukine could potentially arrive on the market as a class-leader in treating radiation poisoning, given that it can be used up to 48 hours after exposure – beating Amgen’s two approved products, which must be delivered immediately.

“We are delighted to have the opportunity to build a new future for Leukine and welcome the talented and dedicated team in Lynnwood to the PTx family,” said Robert Mulroy, CEO of PTx. “The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections.”

As mentioned by Mulroy, the drug also holds potential to be used as part of combination therapies in the immuno-oncology space, with one potential tie-up with Yervoy being explored.

It is also being tested alongside Opdivo and Yervoy in Phase 3 trials, for use as a front-line treatment for melanoma. If this triple therapy succeeds, it could represent a major first step for the fledgling biotech.

Ben Hargreaves

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