Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Ester Neuroscience Ltd.* (Israel)

Monarsen (EN101)

Drug designed to control an isoform of the acetylcholinesterase enzyme

Myasthenia gravis

The FDA granted orphan designation to the drug (11/24)

CANCER

Antigenics Inc. (AGEN)

Oncophage (HSPPC-96)

Personalized vaccine based on heat-shock protein technology

Metastatic melanoma and renal cancer

The FDA lifted a partial clinical hold on two Phase III trials 13 weeks after asking for product characterization data (11/24)

Praecis Pharmaceuticals Inc. (PRXCS)

Plenaxis

Abarelix for injection, depot formulation; gonadotropin-releasing hormone antagonist

Prostate cancer

FDA approved Plenaxis for palliative treatment of advanced prostate cancer patients who meet various criteria (11/25)

CARDIOVASCULAR

Jerini AG* (Germany)

Icatibant (JE049)

BK2 receptor antagonist

Hereditary angioedema

The FDA granted orphan drug designation to the product, which is expected to begin trials in the U.S. in 2004 (11/18)

CENTRAL NERVOUS SYSTEM

Incara Pharmaceuticals Corp. (OTCBB:INCR)

AEOL 10150

Catalytic antioxidant compound

Amyotrophic lateral sclerosis

FDA granted orphan designation to drug, for which clinical testing is expected to begin in Q2:04 (11/10)

Sepracor Inc. (SEPR)

Estorra

Form of eszopiclone drug

Insomnia

FDA extended by three months its review period on the NDA; action now is expected by Feb. 29, 2004 (11/13)

INFECTION

Avanir Pharmaceuticals Inc. (AMEX:AVN)

Abreva

Docosanol 10% cream

Cold sore infections

Swedish regulatory authorities approved the product there for marketing (11/19)

InterMune Inc. (ITMN)

Oritavancin

Second-generation glycopeptide antibiotic

Gram-positive infections

The FDA requested an additional safety study of the drug, delaying the expected NDA filing from the first half of 2004 to after the end of 2004 (11/21)

Presutti Laboratories Inc.*

Tinidazole

Second-generation 5- nitroimidazole compound

Trichomoniasis, giardiasis, intestinal amebiasis and amebic liver abscess

Presutti filed an NDA for the drug, which has orphan status for giardiasis (11/3)

MISCELLANEOUS

Advanced Biotherapy Inc. (OTC BB:ADVB)

--

Antibodies to interferon- gamma administered as eye drops

Immunologic corneal allograft rejection

The FDA granted orphan drug designation to the product, which has been in an open-label trial (11/24)

Biosyn Inc.*

C31G vaginal gel (1 percent)

Gel designed to prevent sexually transmitted diseases

Reduction of HIV transmission

The FDA granted fast-track status to the product, which is nearing Phase III studies (11/17)

Lilly ICOS LLC. (a joint venture between ICOS Corp. and Eli Lilly and Co.)

Cialis

Tadalafil; oral PDE5 inhibitor

Erectile dysfunction

The joint venture gained FDA approval to market the drug (11/21)


Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.

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