Medivation, Inc.
(
MDVN
) and
Pfizer Inc.
(
PFE
) are finally giving up on their efforts to develop Alzheimer's
candidate, dimebon (latrepirdine), with the companies reporting
disappointing results yet again on the candidate. This time,
dimebon failed to achieve the co-primary endpoints in a phase III
study, CONCERT, which was conducted in patients with
mild-to-moderate Alzheimer's disease.
Medivation and Pfizer said that dimebon failed to achieve
statistical significance for either of the two co-primary endpoints
(Alzheimer's Disease Assessment Scale and Alzheimer's Disease
Cooperative Study - Activities of Daily Living [ADCS-ADL]) of
the study.
Expectations Were Already Low
The study results did not come as a huge surprise. We had low
expectations from the CONCERT study given dimebon's dismal
track record. Medivation and Pfizer had already suffered two major
setbacks where dimebon's development program is concerned.
Way back in March 2010, dimebon had failed to achieve both its
primary and secondary endpoints in a phase III study for
Alzheimer's. Then, in April 2011, dimebon failed to achieve the
primary endpoints in a phase III study for Huntington disease.
With dimebon failing in the CONCERT study, Medivation and Pfizer
have decided to discontinue the development of the candidate for
all indications, including an ongoing open label extension study in
Alzheimer's disease.
End of the Road for Pfizer-Medivation
Collaboration
The disappointing CONCERT data also marked the end of the
collaboration agreement between Medivation and Pfizer for dimebon.
Once again, the termination of the agreement did not surprise us -
firstly, Pfizer already has another Alzheimer's candidate,
bapineuzumab, in its portfolio that is being developed with
Johnson & Johnson
(
JNJ
).
Secondly, Medivation's future lies with its prostate cancer
candidate, MDV3100, which delivered impressive interim data in Nov
2011. The company and partner Astellas could be in a position to
file for US approval in 2012.
Our Take
The termination of the dimebon deal signifies yet another
pipeline failure for Pfizer. At the time of signing the agreement,
Pfizer had made a payment of $225 million to Medivation. As far as
Medivation is concerned, the shares were not affected significantly
by the CONCERT results - this indicates that expectations from this
study and the candidate were already very low.
Investor focus had already shifted to MDV3100. Medivation and
partner Astellas are all set to conduct a pre-NDA meeting with the
FDA in early 2012. We believe the companies will file for
regulatory approval soon thereafter and expect MDV3100 to hit the
market in 2013.
Based on the data that we have seen so far, we believe MDV3100
has blockbuster potential and could be a game-changer for
Medivation. We currently have Neutral recommendations on both
Pfizer and Medivation. Both companies carry a Zacks #3 Rank
(short-term Hold rating).
JOHNSON & JOHNS (
JNJ
): Free Stock Analysis Report
MEDIVATION INC (
MDVN
): Free Stock Analysis Report
PFIZER INC (
PFE
): Free Stock Analysis Report
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