Is anyone aware of a Merck new compound MK-1293? Although it has never appeared in the pipeline shown to investors, it is rumored to be a bio-equivalent form of GLARGINE insulin to compete with Sanofi's Lantus. I have heard a rumor it is already in late phase II trials although there are no trials listed on ClinicalTrials.gov?? That's odd. Could a company develop a product under a shroud of secrecy? Does anyone know anything about this compound????? a) Does MK-1293 exist? Does it have another identification number or alias? b) What phase is it in? c) Where have ph I and II trials been done? Name of any investigators? d) When phase III trials will begin e) What is Merck's best estimate to launch? f) Where would Merck manufacture such a compound?
http://www.nres.nhs.uk/researchsummaries/?entryid29=155440&p=44 Study to Evaluate the Safety, Tolerability, PK and PD of MK-1293 REC Name: Yorkshire Independent research Ethics Committee REC reference: 10/IEC07/29 Title: Study to Evaluate the Safety, Tolerability, PK and PD of MK-1293 Contact name: Dr Anthony Priestley Contact email: anthony.priestley@iconplc.com Research summary The study has the following 3 aims:1) To test the safety and tolerability of single doses of the research study drug, MK-1293.2) To measure and compare the action of MK-1293 and Lantus© (insulin glargine) with regareas to removing glucose (sugar) from the blood after they are injected in the skin.Each drug will be tested separately.3) To measure and compare the amount of MK-1293 and Lantus© (insulin glargine) in your blood after after they are injected in the skin.Each drug will be tested separately.MK-1293 and Lantus© (insulin glargine) are both insulin preparations that will be used in this study. MK-1293 is a new drug that has not yet been approved formsale. Lantus© has been available on the market for a number of years.This is a single centre, doubleblind, randomised 2-way Crossoverestudy. Each subject will participate in a screening visit, two study visits and 3 follow up visits. Duration of study: Years: 5, Months: Opinion: Favourable Opinion Date of REC opinion: 24/01/2011
Another misguided effort by Peter Kim. The biosimilars space is low margin and much more difficult to get into than is thought. Pfizer killed their biosimilar insulin program last year after spending several $hundred million trying to produce them in India.
Pfizer has been cutting selectively and the glargine was one of them. Not because it's too difficult or not profitable.
Wall street and shareholders expect Pharma style blockbuster profits, not the thin margins afforded by biosimilar (essentially generic biologicals).
If you look hard for bits and pieces of information on the internet, you will find: Merck started work on glargine in 2011 under the defunct Merck BioVentures group in house. Bioventures dissolved followed by 2012 agreement with Samsung Biologics of S Korea to work on a biosimilars portfolio for them. In Feb 2014 Merck announced they and Samsung were jointly working to develop glargine and it was added to company new product portfolio as a Phase III compound. Merck conducted Ph I in UK with Priestly as indicated. Ph II done in New Zealand. Ph III trials now underway globally.(see ClinTr.gov) It does appear this is a quiet/stealth-like program with the company saying little publically. Investment analysts indicate a mid 2016 US launch and only forecast $1B in sales by 2020 assuming 10% market share with a 30%price erosion -- hardly a block buster. Therefore, Merck has not mentioned the compound in recent public financial review presentations. There are rumors Merck actually re-engineered one of their Virginia manufacturing facilities to have capability to make the stuff. Has anyone else heard this rumor? They also have an old existing contract with Medimmune to manufacture biosimilar compounds for them. Has anyone else heard how Merck plans to supply glargine? Then there is the issue of providing it in a pen format. How will they do that?
Biosims was not a "misguided" strategy. It was only screwed up when Merck lobbied AGAINST a reg pathway for biosims in the US. You can thank Dick Clark who was head of PhRMA at the time for screwing up what should have been a $75 billion industry in the US.
India is the problem. They can't really get anything right. Look at all the debacles with call centers, data Analytics, clinical trials, etc.
Biocon has insulin, but no clue about quality. Pfizer has money, but no brains Bad combination for a biosimilar JV.
You are right. Merck is doing Phase 3 trials for Glargine in the US. Not sure where they will make the stuff. Maybe buy it from somebody in India or their partner Samsung from S Korea. If they are doing Phase 3 trials they have to have a injection pen for use in the trials but I haven't heard if they will make the pen of have someone else put their Glargine into a cartridge and then a pen. Seems to me if they plan to do the cartridge filling and pens themselves, it would be very expensive to buy the equipment. An Indian company called Biocon is also ready to start Glargine Phase 3 trials in the US.
Yes, Merck was ( not sure if they still are) manufacturing it in Virginia. They did revamp the facility for it. I was a scientist on the project, but, was laid off.
