• Regulatory
A1M Pharma has signed an agreement to further extend and widen the cooperation agreed in June 2015 with an unnamed leading European pharmaceutical manufacturer. The new agreement includes continued process development and technology transfer, as well as subsequent manufacture of batches for toxicological studies and A1M Pharma’s pre-eclampsia drug candidate in compliance with GMP for its upcoming phase I study.

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In June 2015, A1M Pharma announced that they had entered into cooperation with a leading European manufacturer of pharmaceuticals. The purpose of the project is to develop and increase the production of the company's candidate drug to an industrial scale in compliance with existing regulations for pharmaceutical manufacturing (GMP).

So far, the project has developed well and the two parties have now chosen to deepen as well as prolong the cooperation in order to secure a large scale industrial production capacity in compliance with GMP through continued process development and technology transfer. At a later stage, the cooperation will also include manufacturing of batches for toxicological studies as well as manufacturing of A1M Pharma's candidate drug for the company's future phase I study. The development costs will be dealt with within the existing financial framework.

– We are pleased with what we have achieved so far, and having established mutual trust, both parties now feel sufficiently confident to advance this cooperation. It is therefore satisfying to announce an extension of the cooperation which will also include manufacturing of our candidate drug for our upcoming phase I study. It is an important step for the company to be able to secure the manufacturing and it is closely in line with our clinical development program, says A1M Pharma’s CEO, Tomas Eriksson.

As announced earlier, A1M Pharma is not allowed to state the name of the manufacturing partner in press releases due to directives regarding this type of cooperation from the other party's owner, a global pharmaceutical company. The agreement will remain in force in its current form until the necessary material for the upcoming phase I study has been manufactured.

For more information, please contact
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

About A1M Pharma
A1M Pharma develops a diagnostic method and treatment for pre-eclampsia, a condition that affects around 10 million pregnant women worldwide each year. This disorder is responsible for 76,000 maternal and 500,000 infant deaths each year and it is the cause of 15 % of all premature births. Currently, there is no effective diagnostic method or curative treatment for impaired kidney function associated with pre-eclampsia. The only option is therefore to terminate pregnancy by inducing delivery which leads to premature infants and substantial health care costs. Several studies indicate that A1M Pharma’s candidate drug, the protein A1M (alpha-1-microglobulin), restores the impaired kidney function by repairing damaged tissue and protect against oxidative stress. New findings indicate that the cells within the heart are protected in a similar way. Apart from the connection with pre-eclampsia, kidney injury is a condition often accompanying major surgery and transplantation and the company is therefore also developing a treatment for the closely related indication acute kidney injury. Acute kidney injury that can lead to permanent kidney damage affects 12 million people every year.

This is the English version of a press release that was originally published in Swedish on January 18 2016, at 10:19 a.m.
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