Biotechs_Maven

Vivus: A Bet on Well-Funded, Late-Stage Pipeline

Thank you for your kind invitation Mike,
I will visit your new website soon.

Best regards,
Biotechs_maven

ps: another disclosure I am NOT and NEVER had any SHORT position on VVUS or OREX.

Vivus: A Bet on Well-Funded, Late-Stage Pipeline

Take a look at VVUS Phase 2 trial.At that time they actually use the same Generic Topiramate 100mg dose and Generic Phentermine dose too.They even do not bother to mix the two drug into one tablet at all.But the way they dose it was,
they give one drug in the morning and the other in the afternoon.
Only from Phase 3 that they change the formulation slightly, that because They need to make it different then the Generic formulation.
That show if the Phase 2 trial is doing just fine with generic dose, then most people will buy the generic Topiramate and Phentermine dose and use it just like the way VVUS use it in their Phase 2 trial.

also Topiramate had received FDA warning on 2001, that it might cause adverse event to the eye, and just few months ago, receive another FDA warning that Topiramate could cause 1 out of 500 patients with Suicide thought.

This same Suicide thought was the one that make Acomplia (another diet drug) do not get approved by FDA, and later Acomplia even get pulled back from European market where it were already approved.

Plus the fact that from Qnexa Diabetic 1 year trial, it is shown that Qnexa start to loss efficacy after only 28weeks of use, and then at week 44, the arm taking Qnexa actually start to GAIN Weight instead.

The Insider also had been selling lot of shares lately, in fact the CEO of VVUS is selling his shares the same day as VVUS R&D day. So during that day while VVUS is presenting the result of Qnexa Phase 3 Equate trial, VVUS CEO is selling his shares,
and had been selling more then $2.5million worth of VVUS shares for the last 18months.
and the insider that is selling is not limited to only VVUS CEO but many other insider also sell.

There is no doubt that Qnexa have decent efficacy, but efficacy alone is not enough to guarantee approval of Qnexa.

VVUS share price also had been trending down this past few months after the result of Equate phase 3 study (a short 6months study with not large patients involved).

so maybe VVUS is a good short term play, but before you decide your self for long term hold on VVUS, you got to do more due dilligence on the data itself.

My bet is on ARNA instead, because ARNA is brand new drug (not generic combo), and management of ARNA mostly buying shares or holding to ARNA shares, (very dismal selling).
ARNA also had enough money to last until NDA on early 2010,
and the CEO of ARNA even decide to pay up the convertible holder with CASH instead of diluting shareholder by paying with shares.That show ARNA is very confident with the result of Lorcaserin.ARNA also enrolled more then 7100 patients in their Two Phase 3 trial, far larger then VVUS or OREX Phase 3 study.
and their First Phase 3 trial is a 2 year trial, so this should satisfy the FDA about Lorcaserin long term use.

Disclosure: I holds a LONG positions in ARNA