Busy Biotech-Drug Calendar for Next Week: BioBuzz

BOSTON, Mass. (TheStreet) -- As we head into the weekend, I want to offer a heads-up for what will be a busy week in biotech- and drug-land.

On Monday, FDA is expected to announce its approval decision on Amgen's(AMGN Quote) osteoporosis drug Prolia.

Tuesday brings third-quarter earnings reports from Biogen Idec(BIIB Quote), Gilead Sciences(GILD Quote) and Pfizer(PFE Quote). Also on Tuesday, Human Genome Sciences(HGSI Quote) and Rigel Pharmaceuticals(RIGL Quote) are holding investor briefings on drug data being presented at the American College of Rheumatology (ACR) meeting, which starts this weekend. Pfizer has some data being presented at ACR, too.

Wednesday brings more earnings from Amgen, Elan(ELN Quote), Eli Lilly(LLY Quote), Genzyme(GENZ Quote) and OSI Pharmaceuticals(OSIP Quote).

On Thursday, we get ... yes, more earnings: Bristol-Myers Squibb(BMY Quote), Merck(MRK Quote), Schering-Plough(SGP Quote) and Novartis(NVS Quote). Thursday is also the FDA's deadline for its approval decision on Acorda Therapeutics'(ACOR Quote) multiple sclerosis drug Amaya, although a delay is expected.

Targacept Unveils Stellar Depression Drug Data

(At 7:02 AM EDT)

There are times when clinical data crosses the wire and you do a double take, not quite believing what you're seeing.

Last night, after Targacept(TRGT Quote) announced the data from its phase II study of TC-5214, was one of those times.

Depression patients treated with the combination of TC-5214 plus Celexa (marketed by Forest Labs(FRX Quote)) demonstrated a 6-point improvement on the Hamilton Rating Scale for Depression, or HAM-D, compared to patients treated with Celexa alone.

A reporter from a Winston-Salem newspaper emailed me last night to get my impression of this result. The only thing I could think to respond back with was, "Holy $%@!! That's kick-a-- good!"

As I wrote last week in a preview note on the TC-5214 data, investor expectations going into Thursday night's data presentation in Chicago were high, but not 6-points-on-the-HAM-D high. I think people would have been happy with anything greater than a 2-3 point improvement.

TC-5214 hit all the secondary endpoints of the study, too, including the Montgomery-Asberg Depression Rating Scale, or MADRS, where TC-5214 plus Celexa demonstrated a greater than seven-point improvement over Celexa alone.

The safety and tolerability of TC-5214 was clean, with resolvable adverse event rates of nausea, constipation and dizziness in the single digits.

This is a phase II study, so TC-5214 still has to prove itself in large phase III studies, but right now, Targacept's drug looks a lot better than Bristol-Myers Squibb's(BMY Quote) Abilify, which received an expanded FDA approval as an add-on treatment to anti-depressant therapy in late 2007.