Key Developments For Optimer Pharmaceuticals, Inc.
Optimer Pharmaceuticals, Inc. (OPTR.O) (Consolidated Issue listed on NASDAQ Global Market)
Optimer Pharmaceuticals, Inc. Announces Additional Data From Fidaxomicin Phase 3 Study for Treatment of Clostridium Difficile Infection
Optimer Pharmaceuticals, Inc. announced that new data highlighting fidaxomicin's (OPT-80) lower CDI recurrence rates and reduced risk of vancomycin-resistant enterococci (VRE) acquisition from Optimer's North American phase 3 study. The additional data highlight fidaxomicin's profile as a new antibiotic class with beneficial characteristics for treating CDI.
Optimer Pharmaceuticals, Inc. Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin in Subgroup Analyses from Its Phase 3 Study for Treatment of CDI
Optimer Pharmaceuticals, Inc. announced additional results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI). The additional data presented focused on other patient risk factors believed to be predictive of CDI recurrence following treatment. These risk factors include serum albumin levels, white blood cell (WBC) count and temperature, and non-BI (NAP1/027) strains. The data showed that fidaxomicin overall demonstrated a lower recurrence rate compared to oral vancomycin (Vancocin) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains. 629 adult subjects were enrolled in this multi-center, randomized, double-blind Phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI. The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator.
Optimer Pharmaceuticals, Inc. Presents Results From Fidaxomicin Phase 3 Study For The Treatment Of Clostridium Ddifficile Infection
Optimer Pharmaceuticals, Inc. announced that the results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator Thomas J. Louie, M.D. for the first time in an oral presentation at the 19th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Helsinki, Finland. The trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin(R). In addition, patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to Vancocin (p=0.006). This study showed that fidaxomicin is as effective as vancomycin for treatment of C. Difficile diarrhea, including treatment of infection by the hyper virulent NAP1/ribotype 027 outbreak strain. Moreover, compared to vancomycin, recurrence of CDI is significantly less likely to occur following fidaxomicin therapy. Combining cure of CDI and freedom from recurrence, fidaxomicin is superior to vancomycin as treatment for this serious and common cause of infectious diarrhea.
Optimer Pharmaceuticals, Inc. Receives Production Patent For Lead Product Candidate Fidaxomicin
Optimer Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office issued a production patent (U.S. Patent No. 7,507,564) covering steps used in the manufacture of fidaxomicin, which is currently in its second Phase 3 clinical trial for the treatment of Clostridium difficile infection, or CDI.
Optimer Pharmaceuticals, Inc. To Raise $32.9 Million In Registered Direct Offering
Optimer Pharmaceuticals, Inc. announced that it has received commitments from institutional investors to purchase approximately $32.9 million of its securities pursuant to an effective shelf registration statement. Under the terms of one of two types of purchase agreements, Optimer will sell 2,794,700 newly issued shares of its common stock at a purchase price of $10.00 per share. In the other purchase agreement Optimer will sell 457,666 newly issued units at a purchase price of $10.925 per unit, with each unit consisting of one share of common stock and one warrant to purchase 0.20 of a share of common stock. The warrants are exercisable six months after the date of issuance at $10.93 per share and will expire five years from the date of issuance. The closing of this offering is expected to take place on March 9, 2009. Proceeds from the transaction will be used in the further development of Optimer's ongoing programs, as well as for other general corporate purposes.
