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Cempra Pharmaceuticals

cempra.com

Founded Year

2006

Stage

IPO | IPO

Total Raised

$78M

Date of IPO

2/3/2012

About Cempra Pharmaceuticals

Cempra Pharmaceuticals is 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. The company's lead program is CEM-101, which is being developed 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. The company's second program is Taksta, which is being developed in the U.S. as an oral treatment for bacterial infections caused by Staphylococcus aureus, or S. aureus, including methicillin-resistant S. aureus, or MRSA, such as prosthetic joint infections and acute bacterial skin and skin structure infections, or ABSSSI.In February 2012, Cempra Pharmaceuticals went public with a valuation of $94 million.

Headquarters Location

6340 Quadrangle Drive Building Four Quadrangle Suite 100

Chapel Hill, North Carolina, 27517,

United States

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Expert Collections containing Cempra Pharmaceuticals

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Cempra Pharmaceuticals is included in 1 Expert Collection, including Biopharma Tech.

B

Biopharma Tech

5,241 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

Cempra Pharmaceuticals Patents

Cempra Pharmaceuticals has filed 1 patent.

The 3 most popular patent topics include:

  • Antibiotics
  • Macrolide antibiotics
  • Macrolides
patents chart

Application Date

Grant Date

Title

Related Topics

Status

3/27/2013

1/29/2019

Macrolide antibiotics, Calcium channel blockers, Antibiotics, Amines, Prodrugs

Grant

Application Date

3/27/2013

Grant Date

1/29/2019

Title

Related Topics

Macrolide antibiotics, Calcium channel blockers, Antibiotics, Amines, Prodrugs

Status

Grant

Latest Cempra Pharmaceuticals News

Cempra Pharmaceuticals negotiates with FDA while it examines its future

May 4, 2017

Posted May. 4, 2017 at 2:06 p.m. Cempra Pharmaceuticals negotiates with FDA while it examines its future Published: 2017-05-04 14:06:05 Image 1 of 3 · Next Image… Related Blog Posts Tags: Biotech & Life Science Editor's note: Cempra has $203 million in cash reserves, enough to fund the company through 2017. But what's next for the Chapel Hill-based drug development firm remains very unclear. Chris Roush, the business professor at UNC-Chapel Hill who launched the North Carolina Business News Wire last year, takes a look at the company and its former CEO/founder Dr. Prabhavathi Fernandes. CHAPEL HILL - Cempra Pharmaceuticals, founded by Dr. Prabhavathi Fernandes in 2006, currently has no drugs on the market and has spent more than $300 million developing its flagship pneumonia drug Solithera to address growing antibiotic resistance. Last year, the U.S. Food and Drug Administration declined to approve the drug after reviewing phase III trials and asked the company to expand its clinical trials to from 920 patients to 9,000 patients. The FDA held reservations on the drug due to risk of liver damage to patients. Acting Chief Executive Officer Dr. David Zaccardelli, most recently chief operating officer at Silver Spring, Maryland-based United Therapeutics, told analysts during the company’s first quarter earnings conference call on Friday, April 28 that expanding clinical trials to 9,000 patients would not be practical for Cempra. He added that the company had submitted a new proposal with fewer than 9,000 patients, and that it is waiting to discuss the new proposal with the regulator. If the company reaches an agreement with the FDA, Cempra will seek additional financing for any additional clinical study, he said. “The FDA encouraged us to submit a protocol that we would find acceptable so that they could evaluate it,” Zaccardelli said during the call. Meanwhile, Cempra is enacting cost-saving measures while it negotiates with the FDA. The company hired the bank Morgan Stanley to evaluate “external clinical and commercial asset and other potential strategic business opportunities.” Cempra is chaired by Garheng Kong, managing partner of Menlo Park, California-based Sofinnova HealthQuest, a health care focused investment firm. There is no official word from Cempra or Morgan Stanley on a timetable for completion of this process. The board’s “review of strategic business options” could mean a sale, as it did for Houston, Texas-based Encysive Pharmaceuticals. The vascular disease pharmaceutical company retained Morgan Stanley to help review strategic options in July 2007. Pfizer acquired Encysive in June 2008. In February 2014, another vascular disease drug developer, ThromboGenics, decided to “explore strategic options” with Morgan Stanley, which did not result in a sale. At the time, the company had current cash resources of around $87 million. Cempra has $203 million in cash reserves, enough to fund the company through 2017. For the quarter ended in March 31, Cempra reported a net loss of $22.9 million, or 44 cents per share. A year prior, the company had reported a quarterly loss of $29.4 million, or 61 cents per share. Part of the reason the loss is smaller this quarter is that the company has reduced its research and development expenses significantly as it attempts to sustain cash, decreasing R&D by 34.5 percent during the quarter to $15.4 million from $23.5 million in the same quarter last year. In an effort to reduce expenses by more than 70 percent in the second half of 2017, the company has reduced its workforce by 67 percent, from 136 to 45 employees. Cempra also withdrew Solithera’s application from a European regulator. “Our goal is to make solithromycin available in the EU to address an important unmet medical need. We believe the most efficient path to approval is to withdraw [the application] at this time and to resubmit it with the additional data requested by the FDA,” Zaccardelli said. Shares of Cempra were trading at $3.83 on Thursday afternoon, down 2 cents. Changes at Cempra A filing with the Securities and Exchange Commission revealed on Friday that David Moore, who has been chief commercial officer of Cempra since 2014, will resign on Friday, May 5 to take a management job at another pharmaceutical company. Moore, who was previously the chief business officer of Durham, North Carolina-based Ocera Therapeutics, was elevated to president after former CEO Fernandes retired on Dec. 9. The change in the company’s C-suite, just ahead of a crucial FDA vote, came days after shares of the company plunged 60 percent on Nov. 2 to $7.30 from $18.65 the day before. Trading of the company ceased on Friday, Nov. 4 while an advisory committee to the FDA discussed the drug. On Dec. 30 after the FDA’s decision, shares hit an all-time low of $2.80, a 94 percent drop from their July 2015 peak of $45.34. During 2015, Cempra’s share price increased by over 32 percent, outperforming both the Nasdaq Composite Index and the Nasdaq Biotechnology Index. “I don’t want to live through another November like that,” Fernandes said, as she fought back tears in an interview with Business North Carolina. She said the straw that broke the camel’s back for her to leave was that her boss from Abbott, Dr. André Pernet, like a brother to her, died the day after Thanksgiving. In 1999, Pernet was awarded the Prix Galien International, considered one of the highest distinctions for medical and scientific contribution, for helping to reduce mortality in AIDS patients by 74 percent. Fernandes said she’ll never forget, back when she was working under Pernet, sitting in Abbott’s “midwestern pharma company style” cafeteria with a colleague who said, “Don’t focus on what the commercial guys want. You give them what the patients need, and they will sell it.” Easier said than done For every drug that ultimately receives approval from the FDA, some 5,000 to 10,000 compounds don’t make it through the process, according to a 2014 study by Pharmaceutical Research and Manufacturers of America. That’s partly because the FDA approved a drug that it later had to take off the market. Telithromycin, approved in 2003, is no longer used, owing to serious adverse events, collectively called the “Ketek effects” by Fernandes and three other authors in their published journal article, “The Solithromycin Journey.” In January 2008, the Wall Street Journal reported “heat directed at the FDA” in an ongoing investigation of Sanofi-Aventis’s antibiotic Ketek, involving fraudulent clinical data from a safety trial of the drug. After the large amount of negative publicity surrounding Ketek, changes were instituted by the FDA, making antibiotic approval harder. President Donald Trump’s pick to lead the FDA, a former staffer who left the agency to work in the business world, Scott Gottlieb, has faced questions on his ties to health-care companies. “The lives and the futures of families like mine are affected by the decisions made by the FDA,” Gottlieb said in his opening statement before the Senate Committee on Health, Education, Labor and Pensions in April. He pledged to make sure “the FDA puts their interests first in everything we do.” What’s next for Cempra “Assuming solithromycin obtains marketing approval,” Fernandes writes, “the shadow of Ketek will be left behind, to bring a much needed antibiotic to the market.” “I hope that with changes in the leadership at the FDA, it may be possible to have our drugs approved,” Fernandes said. Fernandes raised over half a billion dollars to date for Cempra and took the company’s first antibacterial product candidate, Solithera, from the lab bench to the FDA with the plan to launch the product in the U.S. and Europe. “A lot of people know the facts about our products. Many physicians have wanted to have it available for their patients. They know the data,” Fernandes said. “That’s the sad part. It’s a global drug that could have had the chance of being the biggest antibiotic ever.” “Most of us die from bacterial infections. Even though cancer is considered the killer, cancer patients usually die from infections. Influenza pneumonia is considered serious, but patients do not die from influenza per se, they die from pneumonia following influenza,” Fernandes said. Her face shows no signs of her 68 years or the wear and tear of having shepherded drugs through approval. During her 35 years in pharmaceutical discovery, she was directly involved in the development of antibiotics, four of which have been approved, with one, clarithromycin, achieving sales of more than $1 billion. “I broke the glass ceiling when I became a VP at Bristol Myers Squibb,” Fernandes said, “and was liked on Wall Street in spite of being a triple minority in the business world, a woman, an Indian and a scientist.” In December, the Nasdaq posted Fernandes’s retirement, unasked for and unpaid for, on Nasdaq tower in Times Square. “I was very touched,” Fernandes said. “The beauty of life is that I have had the privilege of having met so many good people and also for having the opportunity to help so many people.” WRAL TechWire any time: Twitter, Facebook Copyright 2017 The University of North Carolina at Chapel Hill. All rights reserved. The latest blog posts from our WRAL TechWire and WRAL editors. Read more articles…

Cempra Pharmaceuticals Frequently Asked Questions (FAQ)

  • When was Cempra Pharmaceuticals founded?

    Cempra Pharmaceuticals was founded in 2006.

  • Where is Cempra Pharmaceuticals's headquarters?

    Cempra Pharmaceuticals's headquarters is located at 6340 Quadrangle Drive, Chapel Hill.

  • What is Cempra Pharmaceuticals's latest funding round?

    Cempra Pharmaceuticals's latest funding round is IPO.

  • How much did Cempra Pharmaceuticals raise?

    Cempra Pharmaceuticals raised a total of $78M.

  • Who are the investors of Cempra Pharmaceuticals?

    Investors of Cempra Pharmaceuticals include InterSouth Partners, Aisling Capital, Devon Park Bioventures, Quaker BioVentures and Optimer Pharmaceuticals.

  • Who are Cempra Pharmaceuticals's competitors?

    Competitors of Cempra Pharmaceuticals include Advaxis, Paratek Pharmaceuticals, Cyclacel Pharmaceuticals, Potentia Pharmaceuticals, Ampla Pharmaceuticals and 10 more.

Compare Cempra Pharmaceuticals to Competitors

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Paratek Pharmaceuticals

Paratek is a biopharmaceutical company focused on the development, and commercialization of innovative antibiotics. Paratek's lead product candidate, omadacycline, is a novel tetracycline-derived, broad-spectrum antibiotic being developed in both oral tablet and intravenous formulations for use as a first-line monotherapy antibiotic for acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Omadacycline has Special Protocol Assessment agreements with the U.S. Food and Drug Administration for the phase 3 trials planned in ABSSSI and CABP.

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Arisyn Therapeutics

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