API and IP Newsletter
Content
FDA approvals in August 2021.
General information.
U.S. FDA seeks new warnings on arthritis drugs from Pfizer, Lilly and AbbVie.
Ami Organics Limited Looking To Raise Rs 570 crore Through IPO..
Intellectual Property.
Vasopressin decision by Delaware Court in favor of Eagle.
FDA approvals in August 2021
We study FDA approvals every month and analyse the chemistry of small molecules.
This week let us look at the chemistry of difelikefalin.
It is reported as example 2 and Synthesis of compound 2 in para [00288] of WO2008057608A2 family. D-Phe-D-Phe-D-Leu-D-Lys-[ω(4-aminopiperidine-4-carboxylic acid)]-OH (SEQ ID NO: 2):
The compound is individualized in claim 55 of WO2008057608A2 family.
U.S. equivalent patent 7,402,564, of WO2008057608 family, which is the earliest issued U.S. patent claiming CR845/difelikefalin compositions is due to expire 12 November 2027, the patent term is expected to be extended for up to a further five years in US, i.e., to 12 November 2032.
The innovator is planning to submit its initial MAA in Europe in early 2021, followed by applications in Canada, Switzerland, and Australia in H2 2021 through consortium filing. Approval in Europe is expected in Q2 2022, followed by first European launches in mid-H2 2022. Difelikefalin would be the first medicine indicated for the treatment of CKD-aP in the US and Europe.
General information
U.S. FDA seeks new warnings on arthritis drugs from Pfizer, Lilly and AbbVie
The warnings on Wednesday stem from the U.S. Food and Drug Administration's review of Pfizer's arthritis drug Xeljanz after initial results from a February trial showed an increased risk of serious heart-related problems and cancer with the drug. (Read more)
Ami Organics Limited Looking To Raise Rs 570 crore Through IPO
Ami Organics Limited (Ami Organics) is a chemicals manufacturer incorporated in 2004. The company is looking to raise around Rs 570 crore through a fresh issue of Rs 200 crore and an offer for sale of Rs 370 crore. (Read more)
Intellectual Property
Vasopressin decision by Delaware Court in favor of Eagle
Eagle is first to file an Abbreviated New Drug Application (ANDA) for Vasopressin, which had total U.S. sales of $786 million in 2020.
OB listed patents are as below.
In May 2018, Par sued Eagle for infringement of several patents. Mainly the claims 1, 4, 5, and 7 of the #209 patent and claims 1, 5, and 8 of the #785 patent were asserted.
The trial was held in July 2021.
A broad claim 1 of the #209 patent is as below:
A method of increasing blood pressure in a human in need thereof, the method comprising administering to the human a unit dosage form, wherein the unit dosage form comprises from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically acceptable salt thereof, wherein: the unit dosage form has a pH of 3. 7-3.9;…………
During the stability study of batches, for one of the batches (SVA-001), Eagle recorded a pH level of 3.69 (which rounds to 3.7) at the 24-month mark-i.e., at the very end of a shelf life.
In response to the single out-of-specification pH test result for one batch,
1. Eagle "optimized" its manufacturing process "to assure tighter control of pH. To achieve this optimization, Eagle adjusted its manufacturing process.
2. Eagle added a new pH stabilization step after the pH adjustment step to ensure pH uniformity.
3. Further, Eagle narrowed the in-process pH specifications for the pH measurements taken immediately before and after a filtration step from 2.5-4.5 (for the pre-optimization batches) to 3.42-3.54 (for the post-optimization batches).
Thus, Eagle's optimized manufacturing process achieved its goal of assuring a tighter control over pH.
On the other hand, Par has not demonstrated by a preponderance of the evidence that vasopressin manufactured according to Eagle's optimized process will have a pH that does not meet the stability pH specification.
So, Court found that Eagle does not infringe claims 1, 4, 5, and 7 of the #209 patent and claims 1, 5, and 8 of the #785 patent. This is the gist of the case; more details could be found here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
