Merry Xmas – Summary of pharma events week ending 12/23/12

Dec 23, 2011 No Comments by

A Merry Xmas to all readers of BioPharmCatalyst. Thank you all for your support over the past year and wish you all a relaxing break with friends and family!

See individual posts made in the last week for more detail.



Santarus, Inc. (NASDAQ: SNTS) submitted its NDA for UCERIS for mild to moderate active ulcerative colitis.

Repligen Corporation (NASDAQ: RGEN) submitted its NDA for SecreFlo (RG1068) for pancreatic imaging in patients with pancreatitis. A 6-month priority review was requested.

Impax Pharmaceuticals (NASDAQ: IPXL) filed its NDA for IPX066  for the treatment of idiopathic Parkinson’s disease.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) – Cardiovascular and Renal Drugs Advisory Committee is likely to review Northera NDA on February 23. TBC.

VIVUS, Inc. (NASDAQ: VVUS) – announced the Endocrinologic and Metabolic Drugs Advisory Committee will discuss the Qnexa NDA for obesity on February 22, 2012.

Zogenix, Inc. (Nasdaq:ZGNX) is set to submit NDA for Zohydro for patients having moderate to severe chronic pain requiring continuous around-the-clock opioid therapy in early 2Q 2012.

Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) said that it expects to file its NDA and MAA for RP103 in patients with nephropathic cystinosis, during 1Q 2012, seeking a 6-month priority review.


CLINICAL TRIAL DATA ( or notice of upcoming data)

VIVUS, Inc. (NASDAQ: VVUS) announced topline preliminary results from its FORTRESS study as part of the Qnexa NDA for obesity.Women who had taken topiramate during pregnancy had a prevalence rate of 0.29% (5/1,740) while those who had taken topiramate prior to pregnancy had a rate of 0.16% (21/13,512).

Trius Therapeutics, Inc. (Nasdaq:TSRX) announced that tedizolid phosphate just met the primary objective of non-inferiority for the efficacy outcome of early clinical response compared with linezolid (Zyvox) 79.5% vs $79.4%.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced positive data from their Phase 3 trial of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain.   They plan to file their NDA during mid 2012.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced results of its Phase 2 trial of droxidopa for the treatment of fibromyalgia. The 600 mg TID arm showed a 6.2-point average improvement from a baseline score of 23.00 on the Short Form McGill Questionnaire (SF-MPQ), the trial’s primary endpoint, a 3.2 unit improvement over placebo on the SF-MPQ total pain score.

Amicus Therapeutics (Nasdaq:FOLD) completed enrollment of its Phase 3 (Study 011) of migalastat HCl for Fabry disease. Results are due during 3Q 2012.

Celldex Therapeutics, Inc. (Nasdaq: CLDX) noted that data from its Phase 2b EMERGE study, evaluating CDX-011 (glembatumumab vedotin) in patients with previously treated metastatic or locally advanced breast cancer will be presented at a scientific conference in 1H 2012.



Geron Corporation (Nasdaq: GERN) initiated a Phase 2 trail of GRN1005 in patients with brain metastases arising from NSCLC.

Alkermes plc (NASDAQ: ALKS) initiated its Phase 3 trial of ALKS 9070 for the treatment of schizophrenia. Data due mid-2013.

Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) is set to initiate Phase 2b RP104 for non-alcoholic steatohepatitis (NASH) in 1Q 2012.

XOMA Ltd. (Nasdaq:XOMA) initiated its Phase 2 trial of gevokizumab (XOMA 052) for the treatment of the inflammatory lesions seen in moderate to severe acne vulgaris.

CytRx Corporation (Nasdaq: CYTR) initiated its Phase 2b clinical trial of INNO-206 in patients with late-stage soft tissue sarcoma.

AVEO Pharmaceuticals, Inc.(NASDAQ: AVEO) initiated its open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer.



Marina Biotech, Inc. (NASDAQ: MRNA) effected a 1:10 reverse split and also entered into a $5 million private placement.

ARCA biopharma, Inc.(Nasdaq: ABIO) raised net proceeds of approximately $1.5m through the issuance of stock and warrants.

ONCOTHYREON INC (Nasdaq: ONTY) filed a $150m shelf allowing it to issue shares and warrants from time to time.


Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN) intends to change the name of its company to Synthetic Biologics, Inc.

Zogenix, Inc.(Nasdaq:ZGNX) co-promotion of SUMAVEL DosePro Needle-free Delivery System with Astellas will end on March 31, 2012.

Poniard Pharmaceuticals, Inc. (NASDAQ: PARDD) today announced that its planned merger with Allozyne has been terminated.

Curis, Inc. (NASDAQ: CRIS) today announced that its partner Roche submitted a MAA for vismodegib to the EMA for the treatment of adults with advanced basal cell carcinoma (BCC).


About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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