Anthera second-quarter total operating expenses increase to $7.9 million

Anthera Pharmaceuticals, Inc.Aug 5 2010

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), today announced financial results and business highlights for the second quarter ended June 30, 2010.

Financial Results

Total operating expenses for the second quarter ended June 30, 2010, were $7.9 million, as compared to $3.3 million for the same period in 2009.  For six months ended June 30, 2010, total operating expenses were $14.4 million, as compared to $7.0 million for the same period in 2009. The increase in operating expenses during the quarter ended June 30, 2010 was primarily the result of initiating the Company's Phase 3 clinical study of A-002 - VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) and enrolling patients earlier than originally anticipated, in addition to start-up activities for Anthera's A-623 Phase 2b study, known as PEARL-SC (A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A623 AdministRation in Subjects with Systemic Lupus Erythematosus). The quarterly and year-to-date results also reflect the expected increase in professional services and other costs associated with operating as a public company.  

Anthera ended the second quarter of 2010 with approximately $51.0 million in cash and cash equivalents and short-term investments.

Recent Business Highlights

Regulatory

• A-623: Anthera successfully re-activated the Investigational New Drug Application (IND) for A-623.  
• The protocol allows for a minimum of six months of treatment with subcutaneous A-623 or placebo in up to 600 patients.
• Site selection and initiation continue for the PEARL-SC study which is examining the therapeutic benefit of A-623 in patients with systemic lupus erythematosus (lupus). The primary endpoint of the PEARL-SC study will be an SLE responder index.  Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681.  

Clinical

• Enrollment in VISTA-16 was initiated in the second quarter. Site activations and patient enrollment are ahead of plan as of the end of the second quarter.  Regulatory approvals and site initiations are ongoing in additional geographies. Stephen Nicholls, MD, John Kastelein, MD, and Greg Schwartz, MD, along with the Cleveland Clinic Coordinating Center for Clinical Research (C5), are providing executive oversight of the study.
• Subsequent to the second quarter, the PEARL-SC Phase 2b study was initiated in the United States and additional geographies are expected to be added throughout the second half of the year. The study remains on track for a biomarker analysis in the first half of 2011.
• Anthera expanded its Lupus Scientific Advisory Board in June 2010.  The Board now consists of Richard Furie, MD, Kenneth Kalunian, MD, Michelle Petri, MD, Lee S. Simon, MD, FACP, FACR, and David Wofsy, MD.

Manufacturing  

• The Company completed the transfer of A-623 material from Amgen for conversion into clinical study product. The first batch of high concentration subcutaneous A-623 clinical product has been manufactured, tested and released for clinical use.
• Provisioning for a second manufacturing campaign of A-623 clinical material was completed and is scheduled for August.

Management

• Anthera announced the promotion of Colin Hislop, MD, to the role of the Anthera's Chief Medical Officer. James E. Pennington, MD, will continue to serve as Anthera's Senior Clinical Fellow.   Dr. Hislop has served as Anthera's Senior Vice President of Cardiovascular Products since 2005.