API and IP Newsletter
Contents
FDA approvals in November 2020.
General information.
Will take some time to shift API volumes from China to India: Granules India.
Indoco Remedies wins tenders worth INR 140 Cr for supply of kidney stones treatment drug in Germany.
Intellectual Property.
Melatonin: Neurim vs Mylan UK High Court case.
FDA approvals in November 2020
Two approvals would be of interest of this write-up, two chemically synthesised APIs!
1.) Setmelanotide
Setmelanimide MC4R agonist (also called RM-493), the sequence of Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2.
The structure of Setmelanotide is shown below.
Setmelanotide is an 8 amino acid cyclic peptide that is efficient in activating MC4R. See, e.g., US 8,039,435B2 and example 2. Neuland Laboratories in importing small quantities of sample and must be active in API development.
No DMF is filed yet by any generic company. This could be difficult to manufacture API and companies who are experts in peptide synthesis could be active in generic API development. Many Chinese companies are filing process patent applications. For example, CN111718408A.
2.) Lonafarnib
There are several references of Lonafarnib in literature. Let us confine this discussion here to API synthesis.
Good review of various synthetic routes of Lonafarnib is published in Org. Lett. 2011, 13, 19, 5220–5223
No DMFs filed so far by generic companies.
Sai Lifesciences, GVK and Jubilant are importing tert-Butyl 4-[2-(4-methanesulfonyloxy-piperidin-1-yl)-2-oxo-ethyl]-piperidine-1-carboxylate or its derivatives. This could be potential intermediates for synthesis of Lonafarnib and these companies could be active and could be at various stages of development.
General information
Will take some time to shift API volumes from China to India: Granules India
In an interview to CNBC-TV18, Krishna Prasad Chigurupati, Chairman and Managing Director of Granules, said, “As Granules, we were not interested in PLI scheme. We did not want to participate as we wanted to do something on a larger scale for some of the APIs and the PLI scheme is not conducive.” (Read more)
Indoco Remedies wins tenders worth INR 140 Cr for supply of kidney stones treatment drug in Germany
Indoco manufactures Allopurinol API (active pharmaceutical ingredient) at its manufacturing site at Patalganga in Maharashtra. (Read more)
Intellectual Property
Melatonin: Neurim vs Mylan UK High Court case.
Neurim holds EP 1441702
Use of a prolonged release formulation comprising melatonin in unit dosage form, each unit dosage comprising 0.025 to 10 mg of melatonin, in the manufacture of a medicament for improving the restorative quality of sleep in a patient suffering from primary insomnia characterized by non-restorative sleep, wherein the medicament comprises also at least one pharmaceutically acceptable diluent, preservative, antioxidant, solubilizer, emulsifiers, adjuvant or carrier.
The closest prior art was Haimov 1995. It disclosed effects of melatonin replacement therapy on melatonin-deficient elderly insomniacs by administering 2 mg sustained-release melatonin.
Court held that Haimov does not anticipate the patent because Haimov study was directed to a completely different matter. Their focus was on melatonin-deficient individuals and there was no focus on restorative sleep or quality of sleep, so patent is valid in view of cited prior art.
There was an insufficiency argument by Mylan and the Court rejected that argument too. Details 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.
