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 Aspen, which operates in about 56 countries, has said before that it
views the United States as presenting targeted growth opportunities
for its niche women's health products such as conjugated estrogens,
which is used in menopausal hormone therapy.
Aspen got the FDA abbreviated new drug application approval in early
August for a preservative-free, single-dose vial, Chief Executive
Stephen Saad said at the pharmaceutical's annual result
presentation.
Aspen will manufacture the product and sell it to its partner to
market and distribute in the United States, where it does not have
representation.
"A profit-share agreement is in place for net sales above $30
million," Saad said.
It has already earned $10 million in milestone payment on receipt of
the approval. It will receive a further $20 million, subject to the
partner achieving $30 million in net sales on HPC, he added.
Aspen has also struck a deal with an Indian company to provide it
with the active pharmaceutical ingredients (API) used to make
antiretrovirals (ARV), deputy CEO Gus Attridge told Reuters in an
interview shortly after the presentation.
"They will supply us the chemicals, we will supply the product to
the state and when the state pays us we'll take a fee off the top
and we will pay them what is left," Attridge said without naming the
company.
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"Ultimately the model will evolve, subject to approval by the
competition authorities, to where we simply manufacture for them and
they'll have the tender and we'll get a fee for manufacturing."
This will eliminate exchange rate and working capital exposure, Saad
said. The largest input cost to ARVs is the API, which is priced in
U.S. dollars.
The country's biggest pharmaceutical manufacturer pioneered the
first African produced generic ARV, which it supplies to the state
and the private sector.
In November, it launched a new Emdolten drug, which is a once-a-day
tablet in the form of dolutegravir, an antiretroviral medication
that counters the drug resistance that often develops with older HIV
treatments.
On Wednesday Aspen reported a 4% decline in full-year normalised
earnings before interest, tax, depreciation and amortization due to
a lower contribution from its manufacturing business and said it
will not pay a dividend this year.
Shares closed 10.97% firmer at 94.25 rand on Thursday after it
lowered its full-year debt, which had concerned investors as levels
moved close to breaching debt covenants.
(Reporting by Nqobile Dludla; Editing by Lisa Shumaker)
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