Company*
(Country; Symbol)		 Product Description Indication Status (Date)
AUTOIMMUNE
 
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Toctino Alitretinoin; a once-daily oral treatment Chronic hand eczema Approved in the UK (9/9); approved in Denmark (9/22)
 
CANCER
 
Debiopharm Group* (Switzerland) Decapeptyl Triptoerelin pamoate 22.5 mg; a luteinizing hormone-releasing hormone agonist Prostate cancer Submitted an application to European regulators for the approval of its new six-month formulation (9/25)
 
Enzon Pharmaceuticals Inc. (ENZN) Oncaspar-IV A next-generation PEGylated L-asparaginase Cancer Received approval in Europe for designation of Oncaspar-IV as an orphan medicinal product (9/30)
 
Janssen-Cilag and Ortho Biotech (subsidiaries of Johnson & Johnson) Velcade (FDA-approved) Bortezomib Multiple myeloma Received European Commission approval as a first-line treatment for patients not eligible for high-dose chemotherapy (9/8)
 
CARDIOVASCULAR
 
China Biologic Products Inc. (OTC BB:CBPO) ­ Human coagulation Factor VIII product Hemophilia and mass hemorrhaging Company received approval in China to begin clinical testing (9/17)
 
Neurobiological Technologies Inc. (NTII) Viprinex Ancrod Acute ischemic stroke Previously found excess symptomatic intracranial hemorrhage in an earlier European trial may be minimized with avoidance of prolonged low levels of fibrinogen and use of common blood pressure entry criteria (9/25)
 
DIABETES
 
UCB SA (Belgium; BR:UCB) Vimpat Lacosamide Diabetic neuropathic pain UCB withdrew its MAA in Europe (9/25)
 
INFECTION
 
Arpida Ltd. (Switzerland; SWX:ARPN) Iclaprim Intravenous antibiotic Complicated skin and skin structure infections Filed a new drug submission seeking Canadian approval (9/2)
 
Sinovac Biotech Ltd. (China; AMEX:SVA) Healive Inactivated hepatitis A vaccine Hepatitis A Began clinical trials in the Ukraine (9/15)
 
MISCELLANEOUS
 
Alseres Pharmaceuticals Inc. (ALSE) Cethrin Contains a recombinant protein that inactivates the Rho-enzyme to promote axon regeneration Traumatic spinal cord injury Was granted orphan designation by the European Commission (9/18)
 
KeyNeurotek Pharmaceuticals AG* (Germany) KN38-7221 A cannabinoid receptor agonist Traumatic brain injury Was granted orphan drug status by the European Medicines Agency (9/22)
 
Kiadis Pharma BV* (the Netherlands) ATIR  Designed to enable the use of mismatched donor transplants by selectively eliminating alloreactive T cells To prevent acute graft-vs.-host disease following allogeneic bone marrow transplantation Was granted orphan drug designation by the EMEA (9/22)
 
Merck Serono SA (Switzerland) Kuvan (FDA-approved) Sapropterin dihydro-chloride Hyperphenyl-alaninemia in patients with phenylketo-nuria CHMP issued a positive opinionrecommending approval (9/26)
 
Sucampo Pharmaceuticals Inc. (SCMP) Amitiza (FDA-approved) Lubiprostone Chronic idiopathic constipation Data from a Japanese Phase IIb study demonstrated a statistically significant increase in mean change in spontaneous bowel movements from baseline after one week on treatment (9/19)
 
Tengion Inc.* Neo-Bladder Augment Uses biocompatible materials and a patient's own cells to create a functional neo-organ or cord injury neo-tissue that is designed to harness an individual's ability to regenerate specific organ tissue Neurogenic bladder  associated with spinal EMEA and the European Commission designated its Neo-Bladder Augment as an orphan product (9/22)
Notes:

* Privately held.

CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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

AMEX = American Stock Exchange; BR = Brussels Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange.