Beloren | Updates

By Sven Schimansky-Wabra

Degode receives 6th confirmation from a European approval authority for its formula

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Dear Companists,

As announced, we will keep you up to date on value-adding and important topics.



1. Confirmation of formula and study "waiver" received

In addition to the regional approvals of BfArM (Germany), MHRA (England), AGES (Austria), Läkemedelsverket (Sweden), & NOMA (Norway), the Portuguese approval of INFARMED is now also granted. This means that only the feedback from 4 authorities is still outstanding.


2. method validation optimized

The method validation is comparable with the foundation of a house construction, therefore it is understandable that one has to proceed very carefully here. In recent days, it has emerged that we no longer have to outsource this sensitive issue, but that it is taken directly by the licensee. For Degode, this means savings in costs and a reduction in the number of participants. Since the whole issue of generic development and approval is already very complex, simplifications in the process are always welcome.

 

3. News Update on acquisitions

Almirall has bought 5 brands of Allergan, including the generic version of Skinoren Cream, which is only approved in the US. The value of this deal is about $650 million.

Only for those of you who are interested in the M&A backgrounds: Unfortunately I am not allowed to link Global Data's graphics here for licensing reasons, but here are two key figures that show how much movement there is in the pharmaceutical world without you really noticing it.

 

Beloren - Deals Pharmaindustrie

 

  • In August 2018, the pharmaceutical industry recorded a decline in the number of deals and a marginal increase in deal values. The industry reported 238 deals worth $28.4 billion in August 2018 compared to 273 deals worth $15.8 billion in July 2018.
  • The market for oncology therapeutics remained at the top of deal activities in August 2018 with 106 deals. In second place, the central nervous system therapeutics market reported 60 deals.
  • License agreements in the pharmaceutical industry recorded a decline in advance payments. The segment recorded $46.4 million in advance payments in August 2018 compared to $92.3 million in July 2018.
  • The pharmaceutical industry recorded a decrease in the number of mergers and acquisitions (M&As), including bond purchases, and an increase in value in August 2018 with 34 deals worth $4.7 billion compared to 46 deals worth $4.2 billion in July 2018.
  • License agreements recorded an increase in the number of deals and a decrease in deal values in the pharmaceutical industry with 27 deals worth $1.9 billion in August 2018 compared to 24 deals worth $2.3 billion in July 2018.
  • Partnerships reported 53 deals worth $5.7 billion in August 2018 compared to 71 deals worth $2.2 billion in July 2018.
  • The venture capital market recorded a marginal decline in the number of deals and an increase in deal values in August 2018 with 45 deals worth $1.9 billion compared to 46 deals worth $1.3 billion in July 2018.

 

As soon as we have the September data, we will of course keep you up to date.

Best regards
Sven



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