Earning Calls: Savient, Pacira, Idera, BioSante, Jazz Pharma

Earning Calls  - what seems to be a string of net losses with one positive light from Jazz Pharma

• Savient Pharmaceuticals released its first quarter 2012 financial earnings with a net loss of 34.2M ( a big increase in net loss compared to the $13.5M in net loss of the same quarter of last year). The company had $3.5M in total revenues (increased from $1.3M in the same period of 2011). The company currently has Krystexxa (pegloticase) in the market with the net sales of $3.1M in the first quarter. 
• Pacira Pharmaceuticals released the results of its first quarter 2012 with a net loss of 11.9M (an increase from 9.7M from the same quarter of last year. The company has its revenues increased from 3.86M of last year to 7.8M this year.  The company currently has

Clinical hold lifted on Insmed 's ARIKACE

Insmed announced that the US FDA has lifted the clinical hold previously placed on ARIKACE (liposomal amikacin for inhalation) which is being evaluated as a treatment of Pseudomonas lung infections in cystic fibrosis patients.

The company has worked with the FDA and revised the CF clinical trial population that is going to be studied in the trial. The patient population will include adult patients who have chronic Pseudomonas lung infections and the FEV-1 % predicted between 25% and 75%.

Insmed said it is still in discussion with tthe FDA to finalize additional details about the phase 3 study protocol for the potential clinical trial. It is also working to evaluate the next steps for ARIKACE US CF clinical program and assessed the resource needed for the ongoing ARIKACE CF and the US non-tuberculousis mycobacteria clinical program.

Earning calls on May 8

Earning calls! Just because I haven't posted much about them, doesn't mean I completely forget.. it's just been busy so a new format will be presented instead.

• Progenics announced a net loss of $13.1M in the first quarter of 2012 which was a decrease from $22.9M of the same quarter in 2012. The company has a total revenue of $2.226 M ( down from $2.388M of the same quarter of last year).  The company had 66.(M in total assetts (down from $80.1M from the same quarter of last year). 
•  Par Pharmaceutical announced a $28.7M in net loss of its first quarter of 2012 ( a decrease from 108M from the net loss in the same quarter of last year).  The company had

Rexahn submitted the phase II protocol for Archexin to the US FDA

Rexahn Pharmaceuticals announced that it has submitted the phase II protocol to evaluate Archexin for the treatment of ovarian cancer to the US FDA.

The company plans to assess the efficacy and safety of Archexin when used in combination with carboplatin and paclitaxel as a second-line therapy in patients

Enzon entered into a strategic alliance with Hisun of China

Enzon announced that it has entered into a strategic alliance with Zhejiang Hisun Pharmaceuticals. The agreement will allow Hisun to research and develop compounds using Enzon's customized PEGylation linker technology. Hisuin will also have development and commercialization rights to Enzon's PEG-SN38 (EZN-2208), a novel, phase II PEGylated version of SN38 in China.

Under the terms of the collaboration, Enzon will receive payment

Vertex released positive interim phase II data evaluating VX-809

Vertex announced positive interim data from the phase II data evaluating VX-809 and Kalydeco (ivacaftor) in cystic fibrosis patients with two copies of the F508del mutation.

The phase II trial is a randomized, double-blind, placebo-controlled study. The data released this time involved in 108 adult patients with cystic fibrosis with one or two copies of the F508del mutation. Patients were divided into five treatment groups of 20

Idera intends to submitted the Investigational New Drug Application for IMO-8400 following positive preclinical results

Idera Pharmaceuticals announced positive preclinial results of IMO-8400 in lupus and psoriasis mouse model at the American Association of Immunologists meeting being held in Boston, MA from May 4 to May 8, 2012.

IMO-8400 was tested in lupus-prone NZBW/F1 mice and was shown to effectively inhibit TLR7, 8, and 9 without treatment-related side effects.

Idera said it intends to submit an investigational new drug application for IMO-8400 to the FDA in the fourth quarter of 2012 seeking to develop IMO-8400 as a potential treatment for lupus.

Systemic Lupus Erythematosus is a chronic autoimmune disease where the body's immune system is hyperactive and starts attacking normal healthy tissue. The common symptoms include inflammation, swelling, and damage to joints and other major organ in the body.