Thanks To Salmon — Reported April 27-28 FDA Reviews For MRK & JNJ Next Gen Hep C Candidates


The ever erstwhile Salmon points us tonight in the direction of this item, from Dow Jones newswires (do go read it all).

I concur with Salmon’s comments — the FDA’s website doesn’t indicate any such review date yet.

And so, given that this news is plainly material to Vertex, we both wonder what was the source for it — was it in the latest Vertex SEC Form 10-K filing? Nope. [However, page 1 of that Vertex Form 10-K, Business section, does recite the expectd May 23, 2011 completed FDA review date. It doesn’t say that would be the date of FDA approval, however. So, I suspect this is a reporter’s naive eye, simply misreading the 10-K’s accurate and precise disclosures.]

In any event, here’s a bit of the item — thanks to Salmon:

. . . .The agency’s Antiviral Drugs Advisory Committee will review Merck’s boceprevir on April 27 and Vertex’s telaprevir on April 28. The widely expected reviews will have outside experts recommend whether the agency should allow the drugs on the market. . . .

Vertex. . . expects a decision [from the full Commission] by May 23, 2011. . . .

Do stay tuned — I’d bet Vertex will be well-ahead — in US Market uptake — by mid-Summer 2011. In that regard, note that commercial batch size production is already well-underway, through third parties, per that last Form 10-K, at page 10:

. . . .Manufacture of Telaprevir Clinical and Commercial Supplies

We [Vertex] require a supply of telaprevir for our clinical trials and have agreed to exercise our contractual rights from our third-party manufacturers to provide a supply of telaprevir to Janssen and Mitsubishi Tanabe for their clinical trials. We also will require a supply of telaprevir for sale in North America if we obtain marketing approval. In addition, we have agreed to exercise our contractual rights from our third-party manufacturers to provide, until April 2012, a supply of telaprevir drug substance to Mitsubishi Tanabe for their use in manufacturing telaprevir in final dosage form for sale, if approved, in its territory. We also have agreed to supply telaprevir drug substance, intermediates and final drug product to Janssen [a J&J subsidiary] as a secondary source until June 2011.

We are manufacturing telaprevir, through our third-party manufacturing network, to meet our, Janssen’s and Mitsubishi Tanabe’s clinical supply needs and our needs for commercial supplies of telaprevir, if approved. We believe our past and continuing efforts to expand our relationships with third-party manufacturers and oversee their activities will be important to support a timely and effective commercial launch of telaprevir and its consistent supply in subsequent years.

We have completed the transfer of technical information regarding the manufacture of telaprevir to Janssen so that Janssen will be able to manufacture telaprevir, if approved, for sale in Janssen’s territories and as a secondary supply source of drug substance for us. While we believe there are multiple third parties capable of providing most of the materials and services we need in order to manufacture and distribute telaprevir, and that supply of materials that cannot be second-sourced can be managed with inventory planning, there is always a risk that we may underestimate demand, and that our manufacturing capacity through third-party manufacturers may not be sufficient. In addition, because of the significant lead times involved in our supply chain for telaprevir, we may have less flexibility to adjust our supply in response to changes in demand than if we had shorter lead times. . . .

Fascinating — and buckle up, for a busy late May 2011 at FDA.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s