Thursday, January 20, 2011

Two "Told Ya' So" Items -- From The Road

As I (and many others) had earlier guessed, Merck has disclosed that intracranial hemorrhage, or brain-bleeds were the issue with stroke patients taking Vorapaxar. This confirmation is a significant problem for the lead legacy Schering-Plough drug candidate. Expect more selling off of Merck stock on the NYSE, today.

In addition (also as I predicted), Vertex said it expects to hear fron FDA -- on Telaprevir in four months, per Reuters:

. . . .Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval. . . .

I'll be back in full-post mode tomorrow.


Anonymous said...

The May 23rd due date was expected.

From your Nov 23rd posting we know that Merck filed telaprevir no later than Nov 23rd, 2 days before Thanksgiving.

As Nov 23rd was a Tuesday the filing was likely that day or the day before, Nov 22nd.

As a significant therapeutic advancement first in class drug a priority review is expected. This gives a review time of 180 days.

However 180 days from Nov 22nd or 23rd are a Saturday and Sunday, thus the due date was expected on the first business day following this, i.e. Monday, May 23rd.

No surprise here.


Anonymous said...

The announcement indicates that the FDA has formally notified Vertex of the acceptance of the NDA for review.

The meeting to make the decision to accept the NDA for review has to occur by Day 45 and the company has to be notified of the decision by day 60.

If the filing was Monday Nov 21st today would be day 60.

All these timelines have been part of the Food Drug and Cosmetics Act for decades.


Anonymous said...

Approval letters are typically received late in the day, i.e. after 5 PM.

So I would expect that a letter to be received anywhere from late on Friday May 20th to late on Monday May 23rd and a public announcement of a decision no later than Tuesday morning the 24th.

Assuming the efficacy information we hear is correct the only thing to delay an approval would either be a major toxicity issue, which is not very likely, a chemistry issue such as stability etc., or that they haven't worked all the kinks out of the commercial manufacturing procedures. The latter two are more likely reasons for a delay in approval, and the last reasone is more likely to occur with a company such as Vertex than with Merck. However as we are talking about a legacy SP compound and knowing the problems SP has had with manufacturing issues it's not so certain Merck won't have problems in this regard either.

The decision about the acceptability of the commericial manufacturing is made by the people who inspect the manufacturing facilities and not the review division. Thus there is still a chance Merck's compound could come to market as soon as or sooner than Telapravir. Both the companies and we need to wait and see what will happen.


Anonymous said...

From the Local Paper January 20 2011 in Oss:

I will translate (as good as I can) the dutch article in English.

Organon fires 375 people

MSD/Organon will fire 375 people from the productiondepartment.
It's part of a program where the location Oss has to copy the way the American company works.

The employees are briefed about the reorganisation at this moment.
Earrlier last year at july 8th 2010 the company announced that 925 jobs would be cut with Production.
In this number the jobs related to the effiencyprogram (775) were already calculated.

"It's not only the jobreduction, we want to save money in another way, where the expertise and wisdom of the employees is needed.
We will use their knowledge and expertise. As a PR man of Merck told the newspaper.

A big part of the reduction of employees is alreadt achieved, temporay contracts are ended, and temporary woorkers are not hired anymore.
Vacancies are not filled anymore.
Now there only 375 jobs to be cut.
The Worker's Council is asked for advice in this matter.

This reorganisation is part of the layoffs nnounced at july 8th 2010.
Second part of february the PR man expects more clarity in the reorganisation at R&D.

My own comment:
It still are 900 jobs lost. It does not make any difference if for a year positions are not filled or filled with temporary workers. the jobs are ultimately lost.