PHARMA DEALS DURING OCTOBER 2014

(Part 2 out of 3)

by Roger Davies

First closed in May 2013, Novartis has expanded its collaboration with Oxford BioMedica. This is focused on the manufacture and supply, using Oxford's LentiVector gene delivery technology, to express Novartis' chimeric antigen receptor T cell [CAR-T] therapy for the treatment of leukaemia. Novartis is now investing via an upfront of $14 m which includes a $4.3 m for 2.8% equity. The total deal headline is $90 m.

Moving to the respiratory field, Five Prime and GSK announced an expansion of their second discovery collaboration to identify first in class agents in refractory asthma and COPD.  Building on the original deal signed in April 2012, Five Prime secured $2 m for this expansion, the agreement carries a potential $193.8 m through option fees and milestones.

Keeping it flexible, Roche extended its 2013 licence agreement with Heidelberg Pharma [a subsidiary of Wilex] under which Roche has options to licences for selected antibody targeted amantin conjugates. Heidelberg Pharma receives an undisclosed upfront and further fees. 

Options, options, options ...

A major feature throughout 2014 has been the deployment of options.  This month is no exception with Bristol-Myers Squibb (BMS) securing an exclusive option to acquire F-star Alpha gaining access to its lead candidate FS102 for HER-2 positive patients in breast and gastric cancer. The option is exercisable when phase 2b is reached and the option fee is $50 m, with further payments bringing the headline value to a total of $475 m.

Options also feature in the Celgene/Sutro deal and Roche/Heidelberg as noted above.

But the classic licence deal lives on...

Several classic licences were reported this month, notably NewLink Genetics and Genentech; Curetech and Medivation; Forendo and Apricus as well as Lexicon and Ipsen. 

Leading the pack, NewLink Genetics secured a $1 bn headline which included an upfront payment of $150 m for NLG919 which is in phase 1 development.

Medivation closed an exclusive worldwide licence with rights to CureTech's pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody. CureTech gains an upfront payment of $5 m with development milestones of $85 m and sales based milestones of up to $245 m and tiered royalties [range 4-11%].

The Forendo deal with Apricus for fispemifene, an oral once daily selective estrogen receptor  modulator  [SERM] is for the US development and commercialisation rights only but brings an upfront payment of $12.5 m [$5 m cash with $7.5 m of Apricus stock] plus development milestones of $45 m and sales based milestones of $260 m.

With the opposite territorial rights to the Forendo deal above, Ipsen secured ex-North America/Japan rights for telotristat etiprate from Lexicon. Telotristat etiprate, an orphan drug, is in phase 3 for carcinoid syndrome. The deal headline value is $145 m plus royalties.

Big pharma co-operations continue

A consistent feature has been the steady flow of big pharma / big pharma development and commercialisation collaborations. These are not always captured in the monthly DW tables as frequently no financial terms are disclosed. This month's big pharma collaborations are in oncology, firstly where Novartis and BMS have entered a clinical collaboration for a combination of drugs in non-small cell lung cancer (NSCLC). The phase 1/2 studies will assess Novartis' Zykadia [ceritinib], INC 280 and EGF 816 in combination with BMS's PD-1 immune checkpoint inhibitor nivolumab [Opdivo]. Zykadia is approved in the US for patients with anaplastic lymphoma kinase (ALK) and metastatic NSCLC but not approved elsewhere; INC 280 and EFG 816 are in phase 1 development; the trials are to be conducted by Novartis. 

A tri-partite arrangement between BMS, J&J and Pharmacyclics has been put in place again around Opdivo. This clinical trial collaboration will look at a phase 1/2 study for Opdivo in combination with Imbruvica [ibrutinib – an oral Bruton's kinase inhibitor] as a treatment option for Non-Hodgkin's lymphoma. Imbruvica was one of the first products to gain approval via the breakthrough designation pathway and has European approval for use in mantle cell leukaemia and chronic lymphocytic leukaemia. Originally the subject of a deal signed in December 2011 [upfront $150 m plus $825 m milestones], sales of Imbruvica are on a 50:50 profit sharing basis.

With cash in the pocket and shareholders up for acquisitions, it will be interesting to see how the deal flow will roll out through to the end of 2014.

Fuente: PMLiVE

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