Ann: Positive DEP Cabazitaxel Phase 2 Results in Multiple Cancer, page-63

Sanofi blocks Sandoz's Jevtana generic in patent win
By Zoey BeckerJun 30, 2023 8:15am


Sanofi previously protected Jevtana from several other generic rivals. (Shutterstock)
After years of back-and-forth with several generics makers, Sanofi came out on top in its latest Jevtana litigation, successfully blocking generic competition to the prostate cancer drug from Novartis’ Sandoz.
The drug was approved in 2010 to treat metastatic castration-resistant prostate cancer (mCRPC) and has since remained one of Sanofi’s top oncology products.



The patent case concerned Jevtana’s patent ‘777, which covers methods of increasing survival and expires in 2030. Sandoz argued that it didn’t infringe the patent because its generic's label didn't specifically intend to extend survival but instead stated its use “for the treatment of” mCRPC.





U.S. District Judge Richard G. Andrews sided with Sanofi on that argument, finding that Sandoz’s label does promote use of the product for increasing survival.
“I find that Plaintiffs have proven by a preponderance of the evidence that Defendant's label will induce infringement of the asserted claims of the '777 patent,” Andrews said in a trial opinion (PDF).
Next, Sandoz tried an obviousness argument, claiming that the patent in question is invalid as the treatment for increasing survival would be an “obvious modification” to the prior studies of the compound.

That effort also didn’t pass muster with the judge, who determined that the company’s arguments in that aspect weren’t clear or convincing and that administering the drug to increase survival in mCRPC patients wouldn’t have been obvious.
Now, Sanofi is vindicated by the District Court’s opinion that the ‘777 patent would be infringed upon with Sandoz’s product and is not invalid.


Sanofi has been vigorously defending its Jevtana patents for years now. In 2019, it prevailed in an appeal, overturning a prior ruling that invalidated several Sanofi claims on its ‘592 patent. That earlier judgment also blocked generics from Fresenius Kabi, Accord Healthcare, Apotex and others and was upheld on appeal by the generics makers.
Sandoz was the last standing Jevtana generic suit, Sanofi noted in its first-quarter earnings release (PDF).



The aging drug is still Sanofi’s top oncology money maker, bringing in 391 million euros ($425 million) in 2022.



Our version is a new formulation
Our version is patented in the USA
Our version once in the market in my opinion will be a block buster drug
Our version is superior in efficacy and has less side effects than Jevtana
Our version in my opinion will not have a black box warning


September 2021

US Patent and Trademark Office has granted a new patent in relation to DEP^® cabazitaxel. The composition of matter patent builds on Starpharma’s suite of existing international DEP^® patents for the product. It specifically covers a DEP^® dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker, with a patent term to 2039 and the potential for a further 5 year extension.


Therapeutic Dendrimer (DEP-Cabazitaxel) 19 July 2018 WO2020/014750

Patent granted
USA
The patent is valid until 2039 with a possible additional 5 years takes it to 2044

Patent pending
Australia, Brazil, Canada, China, Europe, India, Indonesia, Japan, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea

Below is a table referring to all sales globally of Jevtana
It does not include the generic versions of the drug
As you can see there is a substantial decline in sales in Europe 2021/2022 due mainly to generic competition and possibly covid-19


Except for 2022 the USA has shown only increases

All numbers are base on constant exchange rates (CER) and in Euro

It is obvious that the generic competition is causing heavy revenue losses for Jevtana  

From a peak of 536 (2020) to current (2022) 391 Euro loss revenue of 145 million euro (AU$242 million)

It is also obvious to me that whoever takes up the license will have control of the Cabazitaxel (Jevtana) market globally

If Sanofi do not take this opportunity they can say goodbye to not only AU$670 million on current indications.......but a lot more for the multiple possible further indications based on combination and monotherapy unmet needed indications that Starpharma's novel Dep Cabazitaxel will be good for

As stated in my last post, I hope there are several parties interested in the drug and a obvious bidding war to acquire it begins

	Column 1	Column 2	Column 3	Column 4	Column 5
0	year	row	usa	world	europe
1	2022	83 <4.4%>	275 <3.2%>	391 <20%>	33 <70.5%>
2	2021	90 <5.8%>	253 +6.5%	455 <12.3%>	112 <40.6%)
3	2020	103 +2.9%	246 +17.9%	536 +12.2%	187 +10.6%
4	2019	78 +17.7%	212 +12.3%	458 +11%	168   +7%