Replies to post #118457 on Biotech Values

[poorgradstudent]

~60-70 million to mnta?

[jq1234]

There are lots of information in NVS earning press release not otherwise disclosed before:

Two RTFs from FDA:

Novartis received a Refusal to File letter from the FDA for LBH589 in relapsed/refractory
Hodgkin’s lymphoma and will not proceed with the EU submission for LBH589 in this
indication. Novartis remains committed to the continued development of LBH589 across
multiple indications, including multiple myeloma.

Novartis received a Refusal to File letter from the FDA for the use of Menveo in infants aged 2
to 12 months. In April, we have submitted a new file in infants and toddlers for the age from 2 to
24 months and are awaiting acceptance from the FDA of our resubmitted application for the
expanded use of the vaccine.

One trial success - SOM230 in Cushing result was announced last year:

Results of a Phase III head-to-head study comparing SOM230 long-acting release (LAR)
(pasireotide) to Sandostatin LAR (octreotide), representing the current standard of care, met the
primary endpoint of normalization of IGF-1 and growth hormone levels in the treatment of patients
with acromegaly.

[DewDiligence]

2Q11 generic Lovenox sales = $284M:

http://www.novartis.com/downloads/investors/financial-results/quarterly-results/q2-2011-media-release-en.pdf (page 16)

Generic Lovenox sales for the 343-day period from the 7/23/10 launch to the end of 2Q11 on 6/30/11 were $993M ($292M+$170M+$247M+284M).

Nicely done.