Proteomics International Laboratories (ASX: PIQ) has secured a major commercial contract which propels the company into “nearing” cash flow positive status.
Earlier this morning, the medical technology company announced it had secured a contract with Dutch/Australian company BiosanaPharma to conduct an analytical comparability study on a drug treatment for allergic asthma. The contract is Proteomics’ largest biosimilars analytical services deal in its history with a value of US$260,000.
One of the outcomes of the study is to examine BiosanaPharma’s good manufacturing practice (GMP) production run to establish product quality by comparison against existing reference products from around the world.
BiosanaPharma’s biosimilar drug for treatment of allergic asthma is destined for clinical trials in January 2019 with Proteomics playing a key technical role, having completed successful stability studies on earlier batches of the drug which support its safety approval.
The analytical comparability study announced today adds to Proteomics strong year so far with a “bumper” fourth quarter positioning the company to become cash flow positive, according to Dr Richard Lipscombe, current managing director of Proteomics International.
The MD says that analytical services could generate the revenue needed to develop new diagnostic tools and that the company was “poised” to commence development.
BiosanaPharma’s biosimilar drug for treatment of allergic asthma is destined for clinical trials in January 2019.
The drug is a biosimilar monoclonal antibody, which are complex generic drugs that copy existing biological medicines periodically coming off patent. Biosimilars are required to show robust chemical comparability to the original product at every stage of development and require precise quality control testing.
According to analysts, the global biosimilars drug market swell to US$23.63 billion by 2023 from around US$6 billion this year. Part of the reason for the huge spike is biopharmaceutical companies seeking to replicate a host of “blockbuster” drugs coming off patent.
“There are multiple stages of the drug development pipeline, with quality and precision being key to bringing our exciting new drug to market,” said Dr Jaap Wieling, chief operating and chief scientific officer of BiosanaPharma.
Merely a few weeks ago, Proteomics signed licence agreements for its world-leading PromarkerD predictive test for diabetic kidney disease with US and Mexico partners PrismHealthDx and Patia Biopharma.
There is also the deal with Texas-based company PHDx, for the company to market its PromarkerD across the US under a national licence agreement.
Earlier this year, Proteomics anticipated sales revenues of its test would occur in “four to six months,” with PHDx leading a significant portion of its US operations. PHDx has agreed to develop and commercialise the PromarkerD mass spectrometry ‘Laboratory Developed Test’ (LDT) at its specialist certified laboratories.
PromarkerD is a breakthrough method for predicting the onset of diabetic kidney disease and able to warn of a decline in kidney function for up to four years in advance. According to its developers, it can offer accurate testing of the more than 43 million people with diabetes in the US and Mexico alone.
Under each national licence agreement, the partner will develop and commercialise the PromarkerD test in its specialist certified laboratories.
First sales under each agreement are anticipated to be in four to six months, and Proteomics International will receive a royalty on all tests sold.