Valeant Statement on D.H.E. 45 (UPDATED)

March 1, 2016

After being made aware of this patient's story in January, we reached out to her to see if we could provide any assistance with the cost of the medicine, as we do for many patients through our patient assistance programs. She informed us that her insurance provider covers the drug, so it is not a significant out-of-pocket expenditure for her.

D.H.E. 45 is an injectable treatment for migraines that is primarily administered in the hospital setting.

The product was acquired in 2005, and a generic version of D.H.E. 45 has been available since 2003. Due to that competition, Valeant's share of the overall market for D.H.E. 45 has declined significantly. In fact, we now have less than 1% percent of the market for this drug.

We expect 2016 net revenues of approximately $1 million for D.H.E. 45, or approximately 200 units sold.

Whenever the sales volume of a drug declines, manufacturers must consider pricing adjustments to keep production of the drug viable. Patients are able to choose generic versions of the drug, however, at significantly lower prices.

The chart below shows monthly unit sales of D.H.E. 45 by each of the three manufacturers. The generic version of D.H.E. 45 (manufactured by Perrigo) is widely available and outsells the branded product by more than 250 to 1.

CHART

In addition, we must purchase minimum sized batches from our contract manufacturer that far exceed what we sell (1,000 units versus 200 units).

When we make decisions about the pricing of any one drug, we do so in the overall context of our portfolio of over 1,600 products, including more than 200 prescription drugs in the United States, and the need to fund our robust research and development programs, our expanding U.S. manufacturing base, and our patient assistance programs. In 2016, we expect to invest approximately $400 million on R&D and $1 billion in our patient assistance programs that seek to ensure that out-of-pocket expenses do no prevent eligible patients from receiving medicines they need.

***

In addition to D.H.E. 45, Valeant also sells both the brand and an authorized generic for Migranal (dihydroergotamine mesylate, USP), a nasal spray used to treat an active migraine headache with or without aura. D.H.E. 45 and Migranal are different formulations with different mechanisms for delivery and although they do have the same active ingredient, the products are not used interchangeably and are manufactured for Valeant by different suppliers.

Read more on