PHARMA DEALS DURING AUGUST 2014

(Part 2 out of 3)

by Margaret Beer

August brought a mixed bag of deals covering several therapeutic areas (oncology, CNS, diabetes, respiratory, allergies, dermatology), modalities (small molecules, biologics, RNA, stem cells), technologies (platform and therapeutic), drug delivery, formulations, diagnostics, generics and many deal types (acquisitions of companies, products and royalties, options, licences and even a termination)

… with CNS in hot pursuit

Five of the announced deals involved CNS targets with again both conventional and alternative approaches in the mix.

The highest value CNS deal was the exclusive licence agreement collaboration between Daiichi Sankyo and Charleston Laboratories, a company that specialises in drugs that reduce side effects associated with opioid analgesics and other products. The companies will co-develop and commercialise novel, fixed-dose hydrocodone combinations for pain relief and opioid-induced nausea and vomiting (OINV) in the US. Among the drugs is CL-108 a fixed-dose, bi-layered tablet combining immediate-release promethazine with a modified release hydrocodone and acetaminophen. CL-108 has recently successfully completed a phase 3 study in the treatment of moderate to severe acute pain and the reduction of OINV.

Under the terms of the agreement Charleston will receive an upfront payment of $100 m plus $100 m tied to an undisclosed near-term milestone and $450 m to future approved novel fixed-dose hydrocodone products. Charleston will receive escalating, tiered, double-digit royalties.

An appetite for less conventional approaches to the treatment of CNS disorders is exemplified by the acquisition of the neuromodulation company Sapiens by Medtronic for $200 m. Sapiens is developing a Deep Brain Stimulation (DBS) system that features 40 individual stimulation points designed to allow more precise targeting. This should reduce procedure time and stimulation-induced side effects and has utility in conditions such as Parkinson's disease and essential tremor. This acquisition will compliment and strengthen Medtronic's neuromodulation leadership position in the areas of chronic pain management, common movement disorders, spasticity and urologic and GI disorders. 

The growing interest in neuromodulation is also highlighted by St Jude Medical's acquisition of NeuroTherm earlier this month giving access to its radiofrequency ablation technology allowing minimally invasive procedures to reduce chronic pain in the neck and back.

Will the fools or angels win out?

The prospect of lost revenues resulting from Lantus' tumble off the patent cliff next year seems to be sufficient motivation for Sanofi, one of the leading pack diabetes drug companies, to ignore any lurking concerns caused by Pfizer's woeful experience with inhaled insulin (Exubera) and jump into this precarious game with MannKind. 

Having said that nerves must still be twitching given the relatively modest $150 m upfront payment and MannKind's 10-year struggle to get Afrezza to this point. The long process involved three FDA approval attempts and MannKind will need to exercise patience with the promised profit share down the line.

The deal, a global licence to develop and market Afrezza, comes less than seven weeks after FDA approval was finally achieved, albeit with regulatory restrictions. The drug-device combination consists of a dry formulation of fast-acting human insulin delivered through a small, discreet inhaler for use at meal times to improve glycaemic control in adult patients with type 1 and type 2 diabetes.

As well as the $150 m upfront MannKind will receive up to $775 m in milestones and a 35% profit share on sales. Peak sales predictions range from $600 m to $1 bn. Perhaps it will take Sanofi's marketing might to overcome the boxed warnings, risk of acute bronchospasm and the memories of prescribing physicians to realise the higher end.  MannKind can only hope. The planned launch is the first quarter of next year. 

The second diabetes deal this month is ViaCyte's rights agreement with Janssen. 

This is also the second deal involving stem cells to be announced this month. Janssen is a long-standing investor in ViaCyte and this additional $20m ensures a future stake in the company and the right to acquire VC-01, a stem cell derived islet replacement therapy for insulin-dependent diabetes. VC-01 is a combination product consisting of pancreatic progenitor cells derived from proprietary human embryonic pluripotent stem cells which are encapsulated in ViaCyte's proprietary Encaptra device.  The product has recently secured IND status. When implanted under the skin, the cells mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar to normal islet cells. 

The e-world invasion

Finally, although not areas normally covered in Deal Watch, both the number and value of several deals outside pharma are worthy of mention. These include Cerner's $1.3 bn acquisition of Siemens' Health Information Technology unit and Venn Life Sciences' majority acquisition of Cardinal Systems and its Data Management and Randomisation Systems for $900 m. As in all other spheres of life we predict the electronic age and all that is associated with it will increasingly creep into pharma deal making activity going forward.

Fuente: PMLiVE

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