Friday, March 18, 2011

Manufacture of Telaprevir Clinical and Commercial Supplies

With the FDA Advisory Committee Meeting On Boceprevir and Telaprevir April 27 and 28, we all wonder how far along the drug companies are in regards to manufacturing. According to "shearlings plowed" the blogger is saying Vertex/telaprevir is well underway.
The blogger writes;
"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,"

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. . . .

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