Replies to post #17980 on Biotech Values

[terry hallinan]

DewDiligence - Clinical-trial / regulatory calendar

By about mid-December it's not only the routine do or die for SCLN as a small cap biotech but there are suddenly more than one of many big items hitting the wires.

I thought about adding SCLN to your regulatory calendar but as new kid on the block I was not overly eager to add another "HEB" to the list. (Obviously I have others that some here might consider in a class with HEB or worse. :-))

By about mid-December SCLN will report the results of the topline analysis of the first of the crucial HCV trials. The second will be due within 6 months. A Phase II melanoma trial that may have caused the Cavazza brother to buy 23% of the O/S will report. News on progress of the pegylation formula for Zadaxin that will give SCLN worldwide composition-of-matter patents will be first reported. A Phase II liver cancer trial that some think the biggest of all will report in. Oh yeah, the incredible screw-up with SGP-Japan losing data from a Japanese pivotal trial that prevented an NDA for treating HBV as monotherapy may complete mediation about that time frame or go to arbitration.

The timing is so conspicuous that there is rampant speculation that it has to do with the due date for a convert and warrants on the 19th of December. (Black helicopters, anyone? :-))

I am not normally real big on timing but all this seems to have the potential of a supernova in both senses. As you know a supernova is not just a spectacular but essentially the death of a star as well.

All just in case anyone is interested in an old timey bad boy with a bad rep for very good reasons in the past.

My persuasion is that new scientific evidence and a wealth of data now supports a drug that previously had none. Bad old management has flown off on golden parachutes.

Best, Terry

[terry hallinan]

Clinical-trial / regulatory calendar:

[Please see updating procedure at the end of this post.]


Edits: Add SCLN trials

ABGX - PACCE trial (chemo+Avastin+/-Pani) in 1st-line CRC: first interim RR 4Q05; Pani “408” trial in 3rd-line CRC (the trial that just caused all the commotion) final survival: 2Q06.

AGEN - Ph III in RCC 1H06.

AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.

ALKS – 12/30/05 PDUFA date for Vivitrex NDA.

AMGN – See ABGX

AORMF -pivotal AMD3100 results 2nd half 06.

AVN – FDA acceptance for filing of NDA for PBA: delayed (was 10/10/05).

AXCA -pivotal Itax results 1st half 06.

BMY – 12/31/05 revised action date for Orencia (CTLA-4).

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.

COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: PET scan results - IIa Alzheimer's CX-717 Ampakine trial.
COR - Early 2006: Results of IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA).

CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD

CRME - Phase III RSD1235 ACT 2 CABG data in Q4/05 or Q1/06

CYAHF -20 patient IDE results 4th qtr, then begin the pivotal phase 1st half 06 as well as commercial launch in Europe later this year.

CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 study (either 3-mo or 6-mo of follow-up) 3Q06 (maybe —Dew).

DNA - Rituxan ph III results in RA in Q3 05
DNA- Rituxan in RA PDUFA 2/28/06
DNA- Rituxan in FL Agg NHL PDUFA 2/22/06
DNA - Lucentis phase-3 ANCHOR (predom.-classic AMD) in 4Q05.
DNA- Lucentis sblA filing 4Q 05
DNA- Avastin 2nd line mCRC sBLA filing 4Q 05
DNA- Avastin 1st line mNSCLC sBLA filing 1Q 06
DNA- Avastin 1st line MBC sBLA filing 1Q 06
DNA- Herceptin adjuvant breast cancer sBLA filing 1Q 06

DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC

FRX - Milnacipran in fibromyalgia: see CYPB.

GENR – Interim data in phase-2 “209” study: early 2006.

GPCB – Satraplatin SPARC trial: interim PFS 1Q06, final PFS 2Q04, final survival 2007.

GTCB – EMEA opinion on ATryn: Feb. 2006; Merrimack phase-2b MM-093 in RA: mid 2006.

IDBE -begin pivotal Fluinsure trials this winter.

IMCL – Erbitux PFS in (Merck KGaA) CRSYTAL trial in first-line CRC: 2H06; Erbitux H&N PDUFA date: end of Feb 06 (sBLA submitted 8/30/05).

INSM – Approvable letter received—orphan status pending.

ISTKF – 12-week Phase III ISA247 psoriasis results reported in August. 24-week results due in 4Q05.

LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.

Merrimack: see GTCB

MYOG - Top-line data from Ambrisentan phase-3 trials in PAH: ARIES-2 in 4Q05, ARIES-1 in 2Q06.

NABI - ph iii results for vaccine against staph in Q4 05

NKTR – Exubera: endorsed by advisory panel 9/8/05 by 7-2 vote; FDA action by late 1/06.

NVS – LAF237 pivotal data in diabetes: early 2006.

PDLI - Q2 06 volociximab ph II for solid tumors

PTIE - All are 2H05
Oxytrex(TM) Osteoarthritic Pain - Phase III Report top-line results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line results in women

PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction

SCLN: Top line results for first HCV pivotal trial by Mid-December 2005
Top line results for second HCV pivotal trial due 1stH06

SPPI – See GPCB.

SRDX - Phase-1 DME data for I-vation w Triamcinilone: mid 2006; Novocell start of phase-1/2 trial in type-1 diabetes: imminent.

TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06

Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 1Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 1Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 1H06.

TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.

VSGN - Celacade phase-3 in chronic HF (ACCLAIM) fiscal 1Q06 (Dec 05-Feb 06).

YMI - early 2006?--672 patients enrolled, 28 to go.YM anticipated that the trial might be completed as early as mid-2006, but seems to be potentially ahead of schedule.
YMI - report pivotal Tesmilifine breast cancer results possibly 2nd qtr 06.
YMI – AeroLEF phase-2b data report: 2Q06.


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