Starpharma's option agreement with AstraZeneca, FULL STOP
Is Faslodex the drug??? QUESTION MARKS
In early June 2019.......Starpharma entered into an option agreement with AstraZeneca to develop an enhanced version of an AstraZeneca currently marketed oncology drug which generated USD 1 Billion plus (blockbuster) last financial year
As it is now out of patent........revenue will diminish over time.....with evidence (if the drug is Faslodex) supporting lower income from AstraZeneca yearly results presented last week
Faslodex: fast US erosion after loss of exclusivity
The performance from legacy Oncology medicines in the year included a decline in Faslodex sales of 13% (11% at CER......constant exchange rate) to $892m; the fall in the fourth quarter of 39% (38% at CER) led to sales of Faslodex of $166m. These declines reflected the 2019 launch of multiple generic Faslodex medicines in the US. The Company anticipates continued declines for this medicine
Faslodex Product Sales in the year of $892m; a decline of 13% (11% at CER). Emerging Markets sales of Faslodex increased by 29% in the year (36% at CER) to $198m. US sales declined by 39% to $328m, reflecting the launch of multiple generic Faslodex medicines; in Q4 2019, Faslodex sales in the US declined by 88% to $17m. In Europe, where generic competitor medicines are established, sales in the year increased by 3% (9% at CER) to $229m, while in Japan, sales increased by 20% (19% at CER) to $131m.
Faslodex: US patent proceedings
As previously disclosed, AstraZeneca had filed and then resolved a series of patent infringement lawsuits in the US District Court for the District of New Jersey (the District Court) relating to four patents listed in the US FDA Orange Book with reference to Faslodex after receiving a Paragraph IV notices from several companies relating to Abbreviated New Drug Applications (ANDA) seeking US FDA approval to market a generic version of Faslodex prior to the expiration of AstraZeneca’s patents, and the District Court entered consent judgments ending all of those lawsuits. In October 2019, AstraZeneca filed a new patent infringement lawsuit in the District Court after receiving a Paragraph IV letter, relating to the same four listed patents, from another company that submitted an ANDA seeking US FDA approval to market a generic version of Faslodex prior to the expiration of AstraZeneca’s patents.
So you can see from the above financials, Faslodex is losing market share to generics.......especially in the USA.....where it declined by 88%
SPL is conducting pre-clinical studies on this molecule and once completed, AstraZeneca has an exercise option fee of US$5 million to take the improved version back and conduct clinical trials with milestones and royalties returning to Starpharma coffers.
Analyst estimates of cost of pre-clinical studies to Starpharma is between AU$1-2 million
Completion of pre-clinical is less than 12 months from June 2019........so within the next 4.5 months
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- Take 2) Starpharma's option agreement with AstraZeneca. Is Faslodex the drug???
Take 2) Starpharma's option agreement with AstraZeneca. Is Faslodex the drug???
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