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Aurigene and Pierre Fabre Pharmaceuticals Announce a Licensing Agreement for a New Cancer Therapeutic in Immuno-oncology: AUNP12, an Immune Checkpoint Modulator Targeting the PD-1 Pathway

Pierre Fabre are thus reinforcing their oncology portfolio which already enjoys a combination of chemotherapies, monoclonal antibodies and immuno-conjugates assets at various development phases

CASTRES, France and BANGALORE, India, February 13, 2014 /PRNewswire/ --

Pierre Fabre, the third largest French pharmaceutical company, and Aurigene, a leading biotech company based in India, today announced that the two companies have entered into a collaborative license, development and commercialization agreement granting Pierre Fabre global Worldwide rights (excluding India) to a new immune checkpoint modulator, AUNP-12.

     (Logo: http://photos.prnewswire.com/prnh/20130418/608115 )

AUNP-12 offers a breakthrough mechanism of action in the PD-1 pathway compared to other molecules currently in development in the highly promising immune therapy cancer space. AUNP-12 is the only peptide therapeutic in this pathway and could offer more effective and safer combination opportunities with emerging and established treatment regimens.  AUNP-12 will be in development for numerous cancer indications.

Under the terms of this agreement, Aurigene will receive an upfront payment from Pierre Fabre. Aurigene will also receive additional milestone payments based upon the continued development, regulatory progresses and commercialization of AUNP-12.

"We are pleased that Pierre Fabre see the PD-1 program as a strategic asset in their portfolio. Overall, the deal structure, in line with the financial terms that have been seen in this space, demonstrate the importance that Pierre Fabre attach to the program," said CSN Murthy, CEO, Aurigene.

"The plans that Pierre Fabre have detailed for the development of this differentiated asset highlight the long-term opportunities for this novel cancer therapeutic," added Murali Ramachandra, Sr VP, Research, Aurigene.

"This agreement, in the field of oncology, is fully consistent with our vision to build Pierre Fabre's future in prescription drugs, from a combination of cutting-edge internal R&D capabilities and license partnerships with innovative biotech companies like Aurigene," stated Bertrand Parmentier, CEO, Pierre Fabre.

"With this deal, Pierre-Fabre Pharmaceuticals are reinforcing their portfolio of oncology assets and capitalizing on their proven capabilities in developing biological compounds such as monoclonal antibodies and immuno-conjugates. We have been impressed by the science at Aurigene and encouraged by the differentiated profile reported for AUNP-12," added Frédéric Duchesne, President, Pierre Fabre Pharmaceuticals.

About immuno-oncology

Immuno-oncology is an emerging field in cancer therapy, where the body's own immune system is harnessed to fight against cancer. This approach of targeting cancer through immune response has had a breakthrough when robust and sustained responses were obtained only upon blocking the immune checkpoint targets (such as PD-1 and CTLA4). Recent successes in clinical trials performed with such therapies suggest that immunotherapy should be considered alongside surgery, chemotherapy, radiotherapy and targeted therapy as the fifth cornerstone of cancer treatment.

PD-1 (Programmed cell Death 1) is a receptor that negatively regulates T-cell activation by interacting with specific ligands PD-L1 and PD-L2. Tumor cells express these ligands and thereby escape from the action of T-cells.

About AUNP-12

AUNP-12  is a branched 29-amino acid peptide sequence engineered from the PD-L1/ L2 binding domain of PD-1 It blocks the PD-1/PD-L1, PD-1/PD-L2 and PD-L1/CD80 pathways. AUNP-12 is highly effective in antagonizing PD-1 signaling, with desirable in vivo exposure upon subcutaneous dosing. It inhibits tumor growth and metastasis in preclinical models of cancer and is well tolerated with no overt toxicity at any of the tested doses.

About Aurigene

Aurigene is a biotech focused on development of innovative small molecule and peptide therapeutics for Oncology and Inflammation; key focus areas for Aurigene are Immuno-oncology, Epigenetics and the Th17 pathway. Aurigene's PD-1 program is the first of several peptide-based immune checkpoint programs that are at different stages of Discovery.

Aurigene has partnered with several big pharma and mid-pharma companies in the US and Europe, and has delivered multiple clinical compounds through these partnerships. With over 500 scientists, Aurigene has collaborated with 6 of the top 10 pharma companies.

Aurigene's pre-clinical pipeline includes (1) Selective and pan-BET Bromodomain inhibitors (2) RoR gamma reverse agonists (3) EZH2 inhibitors (4) NAMPT inhibitors and (5) Several immune check point peptide inhibitor programs.

For more information:  http://aurigene.com/

About Pierre Fabre:

Pierre Fabre is a privately-owned health care company created in 1961 by Mr Pierre Fabre. It is the second largest French independent pharmaceutical group with 2013 sales amounting to about €2 billion (yet to be audited) across 140 countries. The company is structured around two divisions: Pharmaceuticals (Prescription drugs, OTC, Oral care) and Dermo-cosmetics. Prescription drugs are organized around four main franchises: oncology, dermatology, women's health and neuropsychiatry. Pierre Fabre employs some 10 000 people worldwide, including 1 300 in R&D. The company allocates about 20% of its pharmaceuticals sales to R&D and relies on more than 25 years of experience in the discovery, development and global commercialization of innovative drugs in oncology. Pierre Fabre has a long commitment to oncology and immunology with major R&D centers in France: the Pierre Fabre immunology Centre (CIPF) in Saint Julien en Genevois and the Pierre Fabre Research Institute (IRPF) located on the Toulouse-Oncopole campus  which has been officially recognized as a National Center of Excellence for cancer research since 2012.  

1989: Navelbine, the 1st chemotherapy to provide significant improvement in Non small cell lung cancer treatment that led to its registration in US and Europe.

1991: Navelbine registered in Metastatic Breast cancer.

2001: Oral Navelbine, the 1st oral chemotherapy approved in Europe in Non Small Cell Lung cancer, thereafter approved in Metastatic Breast cancer, subsequently allowing patients to be treated at home.

2003: Busilvex, a bone marrow transplantation conditioning treatment, co-developed and commercialized in Europe, Turkey, Middle-East and Latin America (under Otsuka License).

2004: a partnership agreement was signed with Merck. It covered a 1st monoclonal antibody for the treatment of cancers, including Colon, Pancreatic, and Non-small cell lung cancers.

2009: Javlor, the 1st chemotherapy approved in Europe in advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of prior platinum-containing regimens.

2010: a licensing agreement was signed with Abbott to develop a 2nd monoclonal antibody discovered by the Pierre Fabre researchers.  

2013: a 3rd monoclonal antibody CXCR4 has entered into phase 1 using pilot batches produced at the Pierre Fabre Immunology Centre.

For more information:  http://www.pierre-fabre.com

Press contacts:

Valérie Roucoules
Pierre Fabre
Directrice adjointe Relations Medias Médicament
Ph: +33-1-49-10-83-84
[email protected]

Rajshree KT
Director Strategic Alliances
Ph: +91-080-7102-4444
[email protected]

SOURCE Aurigene and Pierre Fabre Pharmaceuticals

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