• Regulatory
A1M Pharma are pleased to announce that the company has obtained a patent approval in New Zealand. The approved patent covers the use of the company's candidate drug A1M, Alpha-1-microglobulin, for treatment of mitochondrial-related diseases. This is the company's first patent within the patent family for mitochondrial-related diseases and it is in force until September 4, 2033.

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A1M Pharma's application entitled "Alpha-1-Microglobulin for use in the treatment of mitochondria-related diseases" has been approved by the Intellectual Property Office of New Zealand. The patent covers the use of the candidate drug A1M for treatment of mitochondrial-related diseases and consequently strengthens the company's intellectual property rights.

"We know that our candidate drug A1M has a wide range of applications and that is why we are working actively to further strengthen our patent protection. It is gratifying that we are able to extend our patent portfolio to cover mitochondrial function, an area where our research has shown the positive effects of A1M. This patent is an important step forward in realising the wide range of use and future commercial development potential of A1Ml", says Tomas Eriksson, CEO of A1M Pharma.

Mitochondrial diseases are caused by impaired function of the mitochondria within the cells in the body. Mitochondria are "the powerhouse of the cell" and an impaired function primarily affects the most energy consuming organs such as the brain, the liver, the skeletal muscles, the kidneys and the endocrine and respiratory systems. However, the patent is not limited to the disorders mentioned above, but also covers other mitochondrial-related diseases.

This is A1M Pharma's first patent within the patent family for treatment of mitochondrial-related diseases. The company already has an ongoing research cooperation within mitochondrial medicine with the listed pharmaceutical company NeuroVive Pharmaceuticals.

"The approved patent for treatment of mitochondrial-related diseases does not mean that we will change our main focus which is on developing a diagnostic method and treatment for pre-eclampsia and a treatment for acute kidney injury. It is important for the future, however, to strengthen the company's intellectual property rights, and within mitochondrial medicine there is both extensive unmet medical need and a compelling market potential", says Tomas Eriksson.

Summary of A1M Pharma's patent portfolio A1M Pharma currently holds four international patents, including approved patents for treatment and a diagnostic method for pre-eclampsia within the EU and the US. The company conducts their patent work based on an internally established patent strategy which includes all the technologies and markets of relevance for the company. The following is a summary of A1M Pharma's patent protection:

Region/Country

Patent on medical use of A1M Patent diagnostic method* Patent diagnostic method and treatment* Number of people affected annually

Patent treatment of mitochondrial disorders

Japan

Yes   Yes 28,000  

Australia

Yes Yes Yes 12,400  

Europe**

Yes Yes  

191,300

 
Russia***   Yes Yes

270,000

 
Mexico   Yes Yes

121,200

 

New Zealand

  Yes Yes 2,000 Yes

China

  Yes   400,000  

South Africa

  Yes Yes 100,900  
South Korea     Yes

8,200

 
USA     Yes

150,200

 
Total      

1,284,200

 
*Applies to pre-eclampsia
** Includes the countries Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Croatia, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Switzerland / Liechtenstein, Slovakia, Slovenia, Spain, Sweden, Czech Republic, Turkey, Germany, Hungary, Austria.
*** Also includes the neighbouring countries Turkmenistan, Belarus, Tajikistan, Kazakhstan, Azerbaijan, Kyrgyzstan, Moldova and Armenia.

The above mentioned concerns approval or notification of approval of the patents ”Medical use of A1M”, ”HBF and A1M as early stage markers for Preeclampsia” (Patent diagnostic method), ”Diagnosis and treatment of preeclampsia” (Patent diagnostic method and treatment) and ”Alpha-1-microglobulin for use in the treatment of mitochondria-related diseases” (patent treatment of mitochondrial disorders). Orphan drug designation for the European market (EU) was obtained in May 2014, which guarantees ten years of market exclusivity from the day of marketing authorisation even if the patent has expired. A1M Pharma is considering the possibilities to apply for orphan drug designation in the US and the company also has pending patent applications in most major markets in the world.

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.

For more information, please contact
Tomas Eriksson, CEO of A1M Pharma AB
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Telephone: +46 46-286 50 30

This is the English version of a press release that was originally published in Swedish on January 14 2016, at 08:42 a.m.
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