PHARMA DEALS DURING AUGUST 2014

(Part 1 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)

Roche – in and out and round about

Following on from last month's $1.73 bn acquisition of Seragon Pharmaceuticals, Roche seems to be in mood-swing mode backing out of one deal, entering into two new deals and seemingly unable to clinch or decide against the biggest deal of all, that to acquire the remaining (40%) stake in Chugai Pharmaceuticals. Rumours of a $10 bn Chugai bid have swirled for weeks but to no avail. Is this another example to add to Roche's reputation of “walking away rather than overpay”?

Instead came the news that Roche had beaten a host of companies including Sanofi, GSK, Actelion and Gilead in the acquisition of InterMunefor $8.3 bn ($74.00 a share, representing a very respectable 63% premium). This brings a much needed boost to its respiratory portfolio, which currently consists of Pulmozyme (cystic fibrosis) and Xolair (severe asthma) and products in clinical development, eg lebrikizumab (severe asthma).

The prize: the FDA designated “breakthrough therapy” pirfenidone (Esbriet), an orally active small molecule, anti-fibrotic agent that inhibits the synthesis of both TGF-beta and TNF-alpha.  Pirfenidone is under regulatory review in the US and approved in Europe and Canada for the treatment of idiopathic pulmonary fibrosis (IPF), a relatively rare but progressive, irreversible and ultimately fatal lung scarring condition for which there are no approved drugs in the US. It also has potential utility in treating systemic sclerosis-related Interstitial Lung Disease. The drug is predicted to take a 50% share of the estimated $2 bn IPF market, the main competitor being Boehringer Ingelheim's nintedanib currently in late stage development.

InterMune is also developing a pirfenidone analogue to treat specialty fibrotic diseases and has other small molecule research programmes targeting IPF and other orphan fibrotic diseases. 

This is Roche's largest acquisition since 2009 when the remaining stake in Genentech was acquired and may well have put paid to plans to fully acquire Chugai.

August also saw Roche's pRED group acquire Santaris Pharma for $450 m - $250 m upfront and $200 m contingent on predetermined research milestones. Santaris' LNA (locked nucleic acid) platform claims to overcome the delivery challenges that have dogged antisense and siRNA technologies for years; it claims not only to be able to “ silence" mRNA and microRNA but, unlike siRNA approaches, it can also “correct” RNA, expanding the “undruggable” target's range.  The unique combination of small size, high binding affinity and metabolic stability enables LNAs to achieve cellular access without the need for complex delivery vehicles. Clearly it has not taken Roche long to be convinced of these claims given its $10 m discovery alliance with Santaris was announced in January of this year. This deal on top of the 2013 $392 m ISIS deal clearly signals that Roche's interest in RNA-based drugs has been reignited.

Not all planned alliances however run a smooth course as was the case with the Chiasma/ Roche $600 m commercial agreement for Octreolin, the orally acting acromegaly drug. Despite favourable phase III results, following consultation with regulators Roche has pulled the plug. Chiasma will soldier on regardless hoping to release the drug by 2015.

More than one way to skin a cat – or deliver a molecule

Not all have given up on tackling the thorny issue of siRNA/ mRNA delivery as illustrated by the acquisition of Alpine Biosciences by the oncology specialist Oncothyreon. This was a share exchange deal (approximately 10% Oncothyreon fully-diluted common stock valuing Alpine at approximately $27 m). The draw - Alpine's Protocell nanoparticle technology platform based on a silica core and a supported lipid surface layer, which is able to encapsulate large quantities of nucleic acids, proteins, peptides etc and deliver them in a highly-targeted fashion, both to specific cells and to organelles within cells. Oncothyreon's specific interest is in utilising the technology for cancer/ cancer immunotherapy therapeutics.  

Partners to exploit the potential in other areas such as gene therapy, siRNA and mRNA therapy, enzyme replacement etc will be sought.  Oncothyreon's clinical stage pipeline includes the immunotherapy candidates tecemotide (phase III - Stage III non-small cell lung cancer) and ONT-10 (phase 1 - solid tumour treatment), and the only HER-2 small molecule inhibitor in clinical development, ONT-380 in phase Ib for metastatic breast cancer.

Oncology remains ever popular…

Oncology remains a firm favourite when it comes to attracting partners with six deals announced this month. These include the usual sprinkling of small molecule (Millennium/ Infinity, Hanmi/ Luye, Ziopharm/ Solasia) and antibody (Emergent/ Morphosys) approaches but also more alternative approaches as exemplified by the Gamida/ Novartis agreement.

Novartis came close to acquiring Gamida Cell, a leader in stem cell expansion technologies for $600 m ($170 m upfront) last year, but not quite. Interest clearly remained resulting in the investment and option to acquire agreement announced in August whereby Novartis will pay just $35 m for a 15% stake in Gamida whilst retaining the option to acquire the remaining equity for $600 m, part as a $165 m upfront payout with the rest dependent on milestones, including phase 1/2 success. The option expires in the first half of 2016.

NiCord a novel stem cell treatment is derived from a single cord blood unit and is expanded and enriched with stem cells using Gamida Cell's proprietary Nicotinamide (NAM) technology. It is currently being investigated as the sole stem cell source in a phase I/II study to treat haematological malignancies such as leukaemia and lymphoma and also paediatric sickle cell disease.

Fuente: PMLiVE

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