Monday, September 28, 2009

Abbott's Deal for Solvay: A [Partial] Vytorin® Reverb?


Matt Herper, at Forbes has a very well-thought-out story this morning (do go read it all, here), on the similarities he now sees between some parts of Abbott's $6.6 billion deal for Solvay, and the problems besetting various cardiac medicines -- especially those without verified clinical outcomes benefits -- like Vytorin®, thus:

. . . .Catherine Arnold, the pharmaceuticals analyst at Credit Suisse, says it is more about financial engineering, using cheap cash to buy out a firm Abbott now pays royalties to for a lucrative heart franchise. That will boost earnings per share by 10 cents, or 3%, in 2010 and eventually by as much as 9%, or 30 cents per share.

But the increased bet on the franchise of heart drugs is risky. Generic versions of the $1.3 billion drug TriCor are expected as soon as next year. A newer drug, TriLipix, isn't expected to make up for the loss. And some doctors are starting to have doubts about the usefulness of some drugs, which have failed to prove their benefits in large clinical trials. . . .

The worry is that sales could drop even faster, just as sales of Merck and Schering-Plough's Vytorin have dropped after a few studies led doctors to realize the paucity of evidence for that drug.

[Still, it's] hard to criticize Abbott's decision to purchase the Solvay drug unit. The deal will add to earnings almost instantly, and the price was actually cheap. . . .

Also, on Merck/Abbott interfaces and connections, see my story of yesterday -- indicating it was a near-winner for the Merial assets earlier this summer -- and suggesting it might surface, once again with even more cash in hand, to bid on various parts of Intervet, after the bust-up/reverse merger is closed. Also this morning, Merck annouced it would distribute CSL's regular seasonal vaccine lines in the US for the next six years, at least -- so far, this doesn't include commercial scale batches of H1N1 vaccine. The two already had a deal along these lines -- they've simply extended the would-be termination date.

Finally, last week the ECC had indicated that the earliest possible clearance date for the Merck-Schering deal would be October 23, 2009 (but most papers are only now reporting it). However, the clearly more-important US FTC/DoJ antitrust division hasn't made any such forward looking announcement, on the deal's prospects. Nor will it.

4 comments:

Anonymous said...

There are other similarities.

SP - Asenapine - an antipsychotic whose approval was delayed.

Solvay - bifeprunox - an antipsychotic whose approval was delayed. (Nonapprovable - but then again Vanda's iloperidone was nonapprovable and then was approved later).

See http://invivoblog.blogspot.com/2008/07/antipsychotics-and-comparative.html which quotes Bob temple apparently referring to the nonapproval of bifeprunox as it wasn't as effective as the active comparator.

http://www.schizophrenia.com/sznews/archives/005439.html

But low and behold iloperidone has since been approved due to an about face by Tom Laughren and Bob Temple on the acceptability of the exact same studies which they previously said didn't support approval of iloperidone. (see my previous comments)

Press reports and quotes on websites from Spring of 2008indicate Solvay was working on the deficiencies.

http://www.naturalnews.com/023041_Wyeth_drugs_the_FDA.html

http://carlatpsychiatry.blogspot.com/2007/08/bifeprunox-out-for-count-phony-cme-and.html

(Notice the quotes from Esser the ex-CEO of Wyeth that was copromoting bifeprunox and the CEO of Novartis which was developing iloperidone until Titan/Vanda took it over)


Also slightly after this Janet Woodcock indicated that there would be delays in approvals but the problems would go away in time.

And FDA would be shifting safety from pre-approval to post-marketing evaluation. (Hmmm) This seems almost as if she's talking about asenapine and iloperidone.

http://www.reuters.com/article/newsOne/idUSN2739064620080527?pageNumber=2&virtualBrandChannel=0

This also seems to coincide with the delays in the approvals for asenapine and iloperidone.

More recently Lundbeck and Solvay seem to have dropped the maintanance study approach with bifeprunox.

http://www.pharmaceutical-business-review.com/news/lundbeck_presents_pipeline_update_for_bifeprunox_studies_090730

But then who knows what will happen to bifeprunox under Abbott.

Perhaps it will be resurrected just like iloperidone without the need for additional studies.

Remember drugs have a strange way of coming back to life. Just like vampires in the old movies they never really die. For if they were really dead the companies would say so and then FDA could release the data. Now considering the slide on bifeprunox in the asenapine background package and other information that can be gleaned from public information and from comparing it to public info on structurally similar drugs such as iloperidone and ziprasidone. I'd say that I could come up with be some pretty interesting information just as I was able to make inferences about asenapine from Lilly's olanzapine and from AZ's quetiapine data.

Salmon

Condor said...

Wow! -- Salmon, I think this is going to be a new post, at the top, as soon as I get the time -- perhaps tomorrow, Friday.

Namaste

Joshua Sophy said...

The latest on Vytorin can be found here: http://www.newsinferno.com/archives/13364#more-13364

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