March 27, 2015 | By Márcio Barra

Kalydeco, a new orphan drug priced at over US$300,000 per year

A new study released today by the WHO Regional Office for Europe provides an in depth look at the challenges faced by European Member States health systems by the introduction of new, costly therapeutic entities, and the troubling economic burden they bring to the Member States.

As an array of new drugs reach Europe, healthcare expenditure with new drugs is increasing at an accelerated pace. Some of new, costlier drugs include Gilead’s Hepatitis C drug Sofosbuvir (Sovaldi), orphan drugs with prohibitive price tags, and new anti-cancer agents costing $6,000-10,000 a month.

The report’s main takeaway message is that European governments need to cooperate and encourage collaboration between payers on standards and criteria for evaluation of benefits and cost–efficiency of new medicines, seeing as some member states do not have mechanisms in place to evaluate…

Sri Lanka has its own indigenous scheme of traditional medicine (Ayurveda).^[1][2] This system has been practised for many centuries in the island nation. The Sri Lankan Ayurvedic tradition is a mixture of the Sinhala traditional medicine, Ayurveda and Siddha systems of India, Unani medicine of Greece through the Arabs, and most importantly, theDesheeya Chikitsa, which is the indigenous medicine of Sri Lanka.

History

Sri Lanka developed its own Ayurvedic system based on a series of prescriptions handed down from generation to generation over a period of 3,000 years. The ancient kings, who were also prominent physicians, sustained its survival and longevity. King Buddhadasa (398 AD), the most influential of these physicians, wrote the Sarartha Sangrahaya, a comprehensive manuscript which Sri Lankan physicians still use today for reference. 

1. Sri Lanka

Ancient inscriptions on rock surfaces reveal that organized medical services…

By Sai Chamarthy, Philip Kuehl, and Jayne Hastedt

Since 2000, developers of immediate-release oral drugs have been able to request waivers of in vivo bioequivalence studies based on the Food and Drug Administration’s (FDA’s) Biopharmaceutics Classification System (BCS). Based on the work of University of Michigan professor Gordon Amidon, the BCS has allowed more efficient development and regulatory review of immediate release oral drug products based on in vitro data. The oral BCS was originally published in 1995 and has been revisited several times by Amidon and his team(s): Dahan et al and Amidon et al. For oral products, the BCS approach has provided an effective means to develop high-throughput screening paradigms in early discovery, prioritizing development resources in early development and increasing market access due to generics through the waivers of in vivo bioequivalence studies.

AMG 925

1401033-86-0

2-Hydroxy-1-(2-((9-((1r,4r)-4-methylcyclohexyl)-9H-pyrido[4′,3′:4,5]pyrrolo[2,3-d]pyrimidin-2-yl)amino)-7,8-dihydro-1,6-naphthyridin-6(5H)-yl)ethanone

2-Hydroxy-l-(2-((9-((lr,4r)-4-methylcyclohexyl)-9H- pyrido [4′,3 ‘ :4,5] pyrrolo [2,3-d] pyrimidin-2-yl)amino)-7,8-dihydro-l ,6- naphthyridin-6(5H)-yl)ethanone

2-Hydroxy-1-(2-((9-((1R,4R)-4-methylcyclohexyl)-9H-pyrido[4′,3′:4,5]pyrrolo[2,3-d]pyrimidin-2-yl)amino)-7,8-dihydro-1,6-naphthyridin-6(5H)-yl)ethanone (AMG 925)

FLT3/CDK4 inhibitor,potent and selective

AMG 925 is a dual kinase inhibitor of FLT3 and CDK4 with IC50 value of 1 nM and 3 nM, respectively

C26H29N7O2., 471.55

Amgen Inc.   Innovator

STEP C

STEP D

9-((lr,4r)-4-methylcyclohexyl)-9H- pyrido[4′,3′:4,5]pyrrolo[2,3-d]pyrimidin-2-amine

COUPLER 1

tert-butyl 2-chloro-7,8-dihydro-l,6-naphthyridine-6(5H)-carboxylate

STEP E

tert-butyl 2-((9-((lr,4r)-4-methylcyclohexyl)-9H- pyrido [4′,3 ‘ :4,5] pyrrolo [2,3-d] pyrimidin-2-yl)amino)-7,8-dihydro-l ,6- naphthyridine-6(5H)-carboxylate

STEP F

COMPD 1

9-((l r,4r)-4-methylcyclohexyl)-N-(5,6,7,8-tetrahydro- l,6-naphthyridin-2-yl)-9H-pyrido[4′,3′:4,5]pyrrolo[2,3-d]pyrimidin-2-amine (1)

SECTION B

AMG 925

AMG 925 HCL MONOHYDRATE

IN WO2012129344

AMG 925…