PETER R. MACK & CO., INC.
19 EAST 71ST
STREET, SUITE 3
NEW YORK, N.Y. 10021
TEL: (212) 744-3939 FAX: (212) 744-8484 EMAIL: PRMCO@AOL.COM
MEMBER FINRA & SIPC
April
9, 2008
MannKind Corporation (Nasdaq:MNKD
- $2.35) is a biopharmaceutical company that focuses on the discovery,
development and commercialization of therapeutic products for diseases such as
diabetes and cancer. The company’s lead development product is an inhaled
insulin, Technosphere, which is currently in advanced, large-enrollment Phase
III trials.
Today, the stock declined
about 60%, closing at $2.35 (NASDAQ-MNKD) on the release of adverse news from
Pfizer regarding its inhaled insulin drug, Exubera, which had been approved by
the FDA but abandoned in October 2007, in my opinion because of poor sales and
doubtful advantage. Although the drug is not currently in development or
marketing by Pfizer, the company today announced some post-trial results from a
prior Phase III trial as follows: “Over the course of the clinical trial
program, 6 of the 4,740 Exubera-treated patients (.0012) versus 1 of the 4,292
patients not treated with Exubera (.0002) developed lung cancer….all patients
who developed lung cancer had a prior history of cigarette smoking and that
there were too few cases to determine whether the development of lung cancer is
related to the use of Exubera.”
On March 7th
of this year, Eli Lilly (LLY) abandoned its development of an inhaled insulin
product citing “increased uncertainties in the regulatory environment” and
uncertain commercial potential of the new drug.
In response to the
abandonment of the inhaled insulin space by both Pfizer and Lilly, on March 17, 2008 MannKind released a
statement, part of which is excerpted below.
“ MannKind is absolutely committed to
the continued development of its lead development product Technosphere®
Insulin….MannKind believes that the resulting efficiency and safety profile is
unique and clearly differentiated from all existing diabetes
treatments….MannKind recognizes that to be successful in today’s health care
market a product must offer improved efficacy and safety, not just improved
convenience. The decisions of Eli Lilly and Company as well as Pfizer and Novo
Nordisk to discontinue the development of their inhaled insulin products
reinforce this view. None of those products offer any advantages over
injectable insulin analogs .”
“By contrast, in clinical trials to
date, Technosphere ®Insulin has shown important advantages over the treatment
that is presently considered to be the most effective meal-time therapy for
patients – rapid-acting insulin analogs….and no adverse effect on the measures
of pulmonary function that have been reported to occur with other inhaled
insulins.”
Today’s announcement
by Pfizer of increased lung cancer risk (which seems questionable in light of
the number of ex-smokers in the study and to a layman, an infinitesimal risk
compared to Alzheimers, cancer, AVM, auto accidents and even equity investing)
provoked a Wall Street analyst (as reported on the Street.com) to state that
the data were an “absolute disaster” for MannKind and (we) “do not see a
believable scenario in which the FDA would approve another inhaled insulin”
From my point of view,
I am going to wait for the clinical data from the Phase III Technosphere
Insulin trials currently underway to be released later in the year MannKind has
repeatedly stressed the differentiation in chemistry, mechanism, delivery,
safety etc. for its product compared to the others and if these claims are
correct, the data will bear it out. If these claims are true, and Technosphere
can get past the FDA successfully, MannKind’s Technosphere Insulin will have
this entire multi-billion dollar drug category all to itself.
Full Disclosure: I and
members of my family are long MNKD.
Although the information contained herein is believed
to be accurate, neither the Firm nor its principals make any representation as
to the accuracy of any information contained herein and the reader should not
rely on the statements contained herein for any purposes.
