Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Astion Pharma A/S* (Denmark) ASF-1096 An R-enantiomer of sal-butamol formulated as a topical cream Cutaneous lupus erythematosus The EMEA recommended the drug for orphan drug status (8/1)
CANCER
Antigenics Inc. (AGEN) Oncophage Vitespen; cancer vaccine Kidney cancer Completed the submission of a regulatory application seeking approval to market Oncophage in Russia (8/2)
Bioenvision Inc. (BIVN) Evoltra Clofarabine Acute myeloid leukemia Company's MAA now includes a new indication for the treatment of AML in elderly patients who have one or more of the following: adverse cytogenetics, secondary AML, greater than or equal to 70 years old or significant co-morbidities (8/16)
Genentech Inc. (NYSE:DNA) and F. Hoffmann-La Roche Ltd.(Switzerland) Avastin (FDA-approved) An antibody designed to inhibit vascular endothelial growth factor Advanced non-small-cell lung cancer Gained approval in Europe for the first-line treatment of patients in combination with platinum-based chemotherapy (8/28)
GW Pharmaceuticals plc (UK; LSE:GWP) and Bayer Inc.(Canada) Sativex A cannabis-derived product delivered through an oral spray Persistent back-ground pain in advanced cancer patients Health Canada approved a new indication for Sativax as an adjunctive analgesic treatment (8/7)
ImClone Systems Inc. (IMCL) factor receptor IMC-11F8 A fully human IgG1 monoclonal antibody to the epidermal growth Metastatic colorectal cancer Began enrolling patients in a European Phase II study (8/9)
Marshall Edwards Inc. (subsidiary of Novogen Ltd.; Australia; NVGN) Phenoxodiol Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP Recurrent ovarian cancer Began European enrollment in its Phase III OVATURE trial, which started U.S. enrollment in June (8/27)
MediGene AG (Germany; FSE:MDG) Eligard (FDA-approved) A luteinizing hormone-releasing hormone agonist Prostate cancer The six-month dosage form of the drug was approved in Europe (8/31)
Onyx Pharmaceuticals Inc. (ONXX) and Bayer HealthCare Pharmaceuticals Inc. Nexavar (FDA-approved) Sorafenib Advanced liver cancer A DMC recommended the Asia-Pacific regional Phase III trial be halted so all patients can receive treatment; the DMC found that Nexavar significantly improved overall survival, progression-free survival and time to progression (8/27)
Peregrine Pharmaceuticals Inc. (PPHM) Cotara Links a monoclonal anti-body to a radioactive isotope Glioblastoma multiforme Started a 40-patient, open-label Phase II trial in India (8/2)
pSivida Ltd. (Australia; PSDV) BrachySil Consists of a combination of BioSilicon and the isotope 32Phosphorus Inoperable pancreatic cancer Completed the recruitment stage of a Phase IIa study in the UK and Singapore (8/13)
CARDIOVASCULAR
Chelsea Therapeutics International Ltd. (CHTP) Droxidopa A synthetic precursor of norepinephrine Orthostatic hypotension and multiple systems atrophy Received orphan product designations from the European Commission (8/14)
GTC Biothera-peutics Inc.(GTCB) and LEO Pharma A/S (Denmark) ATryn A recombinant antithrombin product Disseminated intravascular coagulation in association with severe sepsis Enrolled the first patient in a Phase II study (8/6)
Sirtris Pharmaceuticals Inc. (SIRT) SRT501 Agent that targets SIRTI, a member of the human sirtuin family of enzymes Mitochondrial Encephalopathy Lactic Acidosis and Stroke-like episodes (MELAS syndrome) Started a Phase Ib trial in Europe (8/9)
Speedel Holding AG (Switzerland; PK:SPDHF) and Novartis AG (Switzerland) SPP100 (FDA-approved as Tekturna) Rasilez; an oral direct renin inhibitor; aliskiren High blood pressure European Commission approved it for use alone or in combination with other high blood pressure therapies (8/27)
CENTRAL NERVOUS SYSTEM
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) Tysabri Natalizumab Highly active relapsing remitting multiple sclerosis The National Institute for Health and Clinical Excellence in the UK issued final guidance recommending the use of Tysabri (8/22)
Biopartners Holdings AG*(Switzerland) Biferonex Interferon beta-1a, a pH neutral and human serum albumin-free formulation Relapsing-remitting multiple sclerosis Submitted an MAA (8/20)
Merck Serono (Switzerland; a division of Merck KGaA) Rebif (FDA-approved) Interferon beta-1a Relapsing multiple sclerosis European Commission granted marketing authorization for a new formulation (8/30)
Santhera Pharmaceuticals (Switzerland; SWX:SANN) and Takeda PharmaceuticalCo. (Japan) SNT-MC17 INN: idebenone Friedreich's ataxia EMEA accepted the filing of the MAA (8/16)
DIABETES
Sirtris Pharmaceuticals Inc. (SIRT) SRT501 A version of resveratrol designed to activate the sirtuin SIRTI Type II diabetes Started a Phase IIa trial in India (8/21)
INFECTION
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Ceftobiprole Broad-spectrum, anti MRSA cephalosporin antibiotic Complicated skin and skin structure infections Submitted an MAA (8/24)
BioMarin Pharmaceutical Inc. (BMRN) and AnGes MG Inc. Naglazyme Galsufase MPS VI (Maroteaux-Lamy syndrome) Submitted a BLA in Japan (8/13)
Cubist Pharmaceuticals Inc. (CBST) Cubicin Daptomycin for injection Staphylococcus aureus bacteremia Received approval to market Cubicin in South Korea (8/1)
NasVax Ltd. (Israel; Tel Aviv: NSVX) Influenza vaccine Influenza Company began a Phase I/IIa study in Israel and Finland (8/14)
Pharmaxis Ltd. (Australia; PXSL) Bronchitol Administered by inhalation to the patient's lungs Bronchiectasis Phase III trial met its two primary efficacy endpoints: quality of life and mucus clearance; it was conducted in Australia, New Zealand and the UK (8/29)
Targeted Genetics Corp. (TGEN) tgAAC09 Preventive vaccine based on HIV subtype C; uses a recombinant adeno-associated viral vector HIV Phase II interim data from a trial in Africa demonstrated safety and tolerability (8/21)
MISCELLANEOUS
Orexo AB (Sweden; SSE:ORX) OX19 Sublingual desmopressin Nocturia and urinary incontinence Began Phase I trials in Sweden (8/29)
Tercica Inc. (TRCA) and Ipsen SA (France; PARIS:IPN) Increlex (FDA-approved) deficiency Mecasermin, recombinant human insulin-like growth factor-1 Severe primary insulin-like growth factor-1 Received approval from the EMEA (8/9)
Notes:
* Privately held.

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

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