August 23, 2017
By Alex Keown, BioSpace.com Breaking News Staff
The sale action, first reported by Bloomberg, comes about a month after the company announced its oral antibiotic Omadacycline met all primary and secondary endpoints in a late stage trial in treating patients with acute bacterial skin and skin structure infections. While there were few problems with tolerability, Paratek said in July that some patients experienced nausea and vomiting in the first few days of dosing. However, few patients discontinued during the trial, the company said. The company plans to submit a New Drug Application to the U.S. Food and Drug Administration by early 2018. If all goes well with the NDA, the company hopes to see the product launched by 2019.
Michael Bigham, chief executive officer of Paratek, said the company believes omadacycline represents a much-needed new antibiotic treatment option in an era of rising bacterial resistance.
The pending sale does not appear to be related to a cash crunch. Earlier this month, the company said it had enough funds on hand to finance operations through the second quarter of 2019. However, there have been reports of takeover interest, Bloomberg noted in its report. Allergan, which has a licensing deal for Paratek’s second Phase III product candidate, sarecycline, has been reported as a company interested in acquiring Paratek, according to a post on Seeking Alpha. Sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. In March 2017, the two companies reported positive results from two identical Phase III registration studies of sarecycline for the treatment of moderate to severe acne vulgaris. Allergan has plans to submit a NDA with the FDA for sarecycline later this year.
The last two years have been ones of explosive growth for Paratek. The company started 2015 with 15 employees and as of the end of 2016, employed 50 people. It looks like 2017 will continue the growth trend as the company is expecting a “milestone heavy year.”
The basis of Paratek’s research is based on tetracycline, the 70-year-old antibiotic that is prescribed for a wide variety of uses. Paratek is using tetracycline to keep ahead of bacterial infections. The company is focused on developing the next generation of antibiotics. Bigham told BioSpace in an exclusive interview earlier this year that tetracycline was selected because it’s well-tolerated and its efficacy is well-known. Following a decade of research the company settled on two tetracycline models — currently in Phase III development – Sarecycline for use in skin infections and Omadacycline.
Now that Paratek is reportedly in play, the question is whether or not companies will line up to acquire it. Writing in , John Carroll pointed out that big pharma has “remained leery” of the antibiotics market due to it being “a field where cheap generics maintain a tight grip on the bulk of the market.”
Shares of Paratek are trading at $19.05 as of 9:13 a.m.