CHAPEL HILL, N.C. — Cempra, Inc. hopes an initial public offering will raise $200 million and enable it to move forward with development of Solithromycin — a macrolide the company hopes will be an effective replacement for Zithromax.

Encouraging test results prompted the manufacturer to pursue a New Drug Application with the Food and Drug Administration.

Macrolides are used to treat allergic reactions to Cocamidopropyl betaine (CAPB), a common organic compound used in shampoos and other personal care products. CAPB exposure is the number one cause of infection-related death among very young and very old patients.

Cempra admits that Solithromycin may cause possible serious side effects, but not nearly to the extent of Zithromax. In 2013, the Food and Drug Administration warned of a link between azithromycin (Zithromax) and potentially fatal irregular heart rhythms.

New Drug Costs

Even if it meets the revenue goal, Cempra’s IPO will raise only a fraction of the money needed to bring a new drug to market. Experts estimate that development costs now exceed $2.5 billion, a figure that has more than doubled in the past ten years, mostly due to structural changes at the FDA designed to improve consumer safety.

Because of the enormous investment, salespeople are under sizable pressure to move as much product as possible in order to recoup costs. In the drug business, as in most any other enterprise, such pressure often means cutting corners. Some specific issues include:

  • Inadequate Labels: All drugs are required to have clear labels that specify all the known side-effects, but to increase sales, the serious side effects are sometimes buried in the fine print.
  • Off-Label Use: The FDA often issues a limited approval for a new drug. To increase sales, the company may promote unapproved experimental drug uses and may even offer training and support.
  • Biased Safety Studies: If ABC Company commissions a safety study which concludes that a drug is safe, it is reasonable to at least question the researchers’ motivation and methodology.

Dangerous drug cases often are litigated as either class-action or Multidistrict Litigation matters, both of which substantially increase the possible damage awards in these matters.

Our Zithromax Attorneys Can Help

Our dangerous drug lawyers help if you or someone you care about was harmed while taking this drug. Lawsuits have been filed against the drug manufacturer by both patients and their families seeking compensation for injuries caused by the dangerous drug. You may be entitled to a cash settlement.

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