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Ablynx (ABLYF) Signs Exclusive License Agreement With Eddingpharm (Cayman) Inc. To Develop And Commercialise Its Anti-Tnfa Nanobody In Greater China


9/2/2014 7:50:35 AM

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GHENT, Belgium, Sept. 1, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it has expanded its relationship with Eddingpharm, one of the leading Chinese specialty pharmaceutical companies, by granting Eddingpharm an exclusive, royalty-bearing license to develop and commercialise Ablynx's anti-TNFa Nanobody®, ozoralizumab (ATN-103), in the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including rheumatoid arthritis (RA).

Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-TNFa Nanobody therapeutics. Ablynx will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions.

Ablynx will receive an upfront payment of €2 million, payable in two tranches, and is entitled to receive development and commercial milestone payments plus tiered, double-digit royalties of up to 20%, based on annual net sales of ozoralizumab generated by Eddingpharm in Greater China.

Ozoralizumab is a next-generation TNFa blocker with clinical proof-of-concept in RA. The molecule consists of two Nanobodies targeting TNFa, which are linked to a Nanobody that binds to human serum albumin, extending the drug's half-life in vivo and improving its distribution to inflamed joints. Clinical Phase IIa proof-of-concept was achieved in May 2011 in patients with active rheumatoid arthritis (RA), indicating that the highest dose of ozoralizumab (80 mg every 4 weeks) resulted in a statistically significant improvement of ACR20 responses compared with placebo at week 16. An open-label extension study over 48 weeks was well tolerated, adverse event rates were within expectations, serious infections remained rare, and no clinically meaningful immunogenicity could be observed. Clinical development of ozoralizumab was funded by Pfizer prior to Ablynx regaining the worldwide rights to develop and commercialise anti-TNFa Nanobodies in November 2011.

Dr Edwin Moses, CEO of Ablynx, commented:

"We are pleased to have expanded our relationship with Eddingpharm beyond the license agreement that we signed in 2013 for our anti-RANKL Nanobody, ALX-0141, for the treatment of bone related disorders. China is a huge and developing market, and we believe that Eddingpharm is well-positioned to further develop and commercialise ozoralizumab in Greater China based on their deep knowledge of the local market, clinical development expertise and our Nanobody's potential in the treatment of inflammatory diseases, including RA."

Mr Ni Xin, Founder, Chairman and CEO of Eddingpharm, added:

"We are delighted that Ablynx has entrusted Eddingpharm to develop and commercialise a second Nanobody in Greater China. This partnership represents another strategic achievement for our Company in our goal to become a fully-integrated pharmaceutical company and demonstrates that Eddingpharm is the partner of choice in China for biotechnology companies around the world. Together with Ablynx, we are committed to bringing this second innovative Nanobody-based medicine to millions of patients in the region."

The rheumatoid arthritis market in China

China is expected to rank #2 in drug sales in 2016, one place behind the US, according to a study performed by Deutsche Bank, with the growth driven by improving living standards, an increased aging population and rising health consciousness.

Data from the business intelligence agency Espicom indicate that the total pharmaceutical market in China is expected to reach $163 billion in 2017, increasing at a compound annual growth rate (CAGR) of 18.5% over the period 2012 to 2017. The RA market in China is expected to be ~1.8% of the total Chinese pharmaceutical market, amounting to ~$2.9bn in 2017.

About Ablynx

Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has more than 30 programmes in the pipeline and six Nanobodies at the clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium.

More information can be found on www.ablynx.com.

About Eddingpharm

Founded in 2001, Eddingpharm is a fast growing specialty pharmaceutical company in the Chinese market, committed to actively introducing quality products into China's pharmaceutical market. The Company focuses on the development and promotion of pharmaceutical products in four therapeutic areas: clinical nutrition, oncology, antibiotics and respiratory system. Eddingpharm has established long-term cooperative relationships with a number of multinational pharmaceutical companies and overseas specialty pharmaceutical companies, and has built up a competitive product portfolio and pipeline in the four major therapeutic areas. Eddingpharm recently established its US affiliate and set up a product development team with R&D capabilities in Los Angeles, CA, USA, to coordinate and communicate with leading global R&D institutions and explore opportunities for introducing innovative pharmaceutical products in China. The Company currently employs over 700 people.

More information can be found on www.eddingpharm.com

For more information, please contact

Ablynx:

Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
e: edwin.moses@ablynx.com

Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com
Follow us on Twitter @AblynxABLX

Ablynx media relations Consilium Strategic Communications:

Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
e: ablynx@consilium-comms.com

Eddingpharm:
United States:
Dr XiaomingZou
Chief Business Officer
t: +1 805 379 9880
e: zouxm@eddingpharm.com

Shanghai:
Ms Eva Bao
Public Relations
t: +86 21 3175 7995
e: baoxiao@eddingpharm.com

pdf format of the press release http://hugin.info/137912/R/1852452/647388.pdf

HUG#1852452

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