Cempra Pharmaceuticals hopes to raise $89.7 million by going public with an IPO of 6 million shares.
Cempra is advancing two anti-infective products through clinical trials and also is pursing preclinical development of other inflammation and gastrointestinal compounds. Investors include Durham-based Intersouth Partners.
The IPO target price is between $11 and $13 per share, according to an SEC filing Cempra made on Jan. 13.
Underwriters would have the right to sell another 900,000 shares.
If successful, Cempra shares would be traded on the Nasdaq under the symbol CEMP.
Backers of the IPO include Stifel Nicolaus Weisel, Lerrink Swann, Cowen and Company, and Needham & Company.
Product Targets, Progress
In its filing, Cempra laid out an update of the company’s focus and product progress:
“We are a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, particularly respiratory tract infections and chronic and acute staphylococcal infections. Our lead program is CEM-101, which we are developing in both oral and intravenous, or IV, formulations initially for the treatment of community-acquired bacterial pneumonia, or CABP, which is one of the most serious infections of the respiratory tract. We recently completed a successful Phase 2 clinical trial in which the oral formulation of CEM-101 demonstrated comparable efficacy to the current standard of care, levofloxacin (commonly marketed as LevaquinTM), with a favorable safety and tolerability profile. We expect to initiate a pivotal Phase 3 trial for oral CEM-101 in 2012, which will be designed to serve as the basis for our planned new drug application, or NDA. Our second program is Taksta, which we are developing in the U.S. as an oral treatment for bacterial infections caused by Staphylococcus aureus, orS. aureus, including methicillin-resistant S. aureus, or MRSA, such as prosthetic joint infections and acute bacterial skin and skin structure infections, or ABSSSI. Taksta has successfully completed a Phase 2 clinical trial in patients with ABSSSI, demonstrating a favorable safety and tolerability profile and comparable efficacy to linezolid (sold under the brand name Zyvox®), the only oral antibiotic for treatment of MRSA approved by the U.S. Food and Drug Administration, or FDA. In 2012, we expect to initiate a Phase 2 trial with Taksta in patients with prosthetic joint infections, which often are caused by MRSA. We have global rights (other than in certain Southeast Asian countries) to CEM-101 and are developing Taksta for the U.S. market.
“According to Datamonitor, $19.6 billion was spent on antibiotics in 2009 in the U.S., Japan, and the five major European markets (the U.K., Germany, France, Italy and Spain) of which $10.2 billion was spent in the U.S. There are numerous classes of antibiotics, each having a different mechanism of action and resulting spectrum of activity. According to IMS Health, macrolides, the class of antibiotics to which CEM-101 belongs, generated global sales of $4.8 billion in 2009. Antibiotics for MRSA, which is the target market for Taksta, generated U.S. sales of $1.8 billion in 2010, according to IMS Health. Despite the many antibiotics available and the size of the market for antibiotics, we believe that there continues to be a need for new antibiotics for several reasons. First, the effectiveness of many antibiotics has declined worldwide due to bacterial resistance to the currently available antibiotics. The World Health Organization stated in 2010 that antibiotic resistance is one of the three greatest threats to human health, and the Centers for Disease Control and Prevention estimates that more than 70% of U.S. hospital infections are resistant to at least one of the antibiotics most commonly used to treat them. Second, many existing antibiotics have known side effects that limit their use. Third, some antibiotics do not adequately fight all of the types of bacteria that could be involved in a particular disease. Finally, many of the existing antibiotics used to treat serious infections are difficult or inconvenient to administer, often requiring IV treatment in the hospital. The clinical data we have generated suggest that CEM-101 and Taksta address each of these challenges. As a result, we believe CEM-101 and Taksta have the potential to be important products in the antibiotics market.”
Red the SEC filing here.
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