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DewDiligence

07/09/14 2:49 PM

#180230 RE: DewDiligence #179807

NeuClone, Serum Institute of India ink global FoB collaboration:

http://lifescientist.com.au/content/biotechnology/news/neuclone-signs-biosimilar-deal-with-serum-institute-972901099

Sydney-based biotech NeuClone has signed a…licensing agreement and joint development partnership with The Serum Institute of India covering the manufacturing of 10 biosimilar drugs.

Under the agreement, NeuClone will use its NeuMAX cell line development platform to manufacture and supply 10 biosimilar monoclonal antibody drugs. The Serum Institute, the world’s largest vaccine producer, will provide its biologics manufacturing capability

The drugs will have targets including cancer and autoimmune disorders, and each will address markets worth hundreds of millions to billions of dollars…

NeuClone will retain the licence to the biosimilars for the markets of the US, Europe, Canada, Australia, Taiwan, Japan and South Korea. The company said it will seek partnerships with large pharmaceutical and generics companies in these markets. The Serum Institute will meanwhile receive an exclusive worldwide licence for marketing and sales of the drug in the rest of the world.

…The partners plan to develop multiple biosimilars simultaneously and eventually take all 10 products through clinical trials and onto the market.

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DewDiligence

07/09/14 2:52 PM

#180231 RE: DewDiligence #179807

Announced FoB Collaborations

[Added entry for NeuClone–Serum Institute of India.]


Items are shown in reverse chronological order. This table does not purport to be exhaustive.


Date Targets Geography iHub References

NeuClone-Serum Inst 7/14 10 mAbs global #msg-104136710
Liomont-Oncobiolgcs 6/14 2 mAbs Mexico #msg-103754486
PlantForm-PhrmaPrxs 6/14 Avastin+ Brazil #msg-103576633
Lupin-Yoshindo 4/14 Enbrel+ Japan #msg-101018361
BAX-Coherus 9/13 Enbrel ex-US #msg-91645674
Oncobiolgcs-Huahai 5/13 # global #msg-87734336,#msg-87744882
Strides-Pfenex 4/13 Betaseron global #msg-87014470
MRK-Samsng/BIIB 2/13 @ Europe+ #msg-84781042,#msg-69629103,#msg-95065880
Catalent-UMN 12/12 various Asia #msg-82556713
Merck KGaA-RDY 6/12 oncology global #msg-76359649
Daiichi-Coherus 5/12 * Asia #msg-75397629
Fujifilm-Kyowa 3/12 Humira unspecified #msg-73800486
ACT-Bioton 2/12 insulin US & Europe #msg-74987123
ACT-AMGN 12/11 † global #msg-70097496,#msg-84340328
BAX-MNTA 12/11 ‡ global #msg-70212854,#msg-70258421
HSP-Celltrion 10/09 z global #msg-84519981,#msg-77816122
MYL-Biocon 6/09 x global #msg-72421544,#msg-84561737
Procognia-UTR n/a Humira unspecified #msg-84340976

*Enbrel and Rituxan.

†Humira, Remicade, Herceptin, Avastin, Rituxan, Erbitux; excludes AMGN FoB’s for AMGN’s branded drugs.

‡Three products in development: 2 auto-immune and 1 oncology—my guesses are Humira, Orenica, Erbitux; may include up to 6 products eventually.

@ Samsung/BIIB subordinate collaboration known as Samsung Bioepis developing Remicade and Enbrel FoB’s in Europe (#msg-95065880); Rituxan program terminated (#msg-80622249).

#Humira, Rituxan, Avastin, Herceptin.

x Nine products: Herceptin, Neulasta, Avastin, Humira, Enbrel, Lantus, Novolog, Humalog, one undisclosed.

y Rituxan program terminated (#msg-80236315); status of other programs unknown.

z Each company received a distinct EU/CHMP approval for Remicade on 6/28/13; partnership includes seven (other) products: Rituxan, Herceptin, Enbrel, Erbitux, Synagis, Humira, Avastin.