Late yesterday afternoon, biopharmaceutical company Paratek Pharmaceuticals Inc. (PRTK:NASDAQ), which is focused on the development and commercialization of innovative therapeutics, announced that "the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a 5-year contract, with an option to extend to 10-years, to support the development of Paratek's NUZYRAŽ (omadacycline) for the treatment of pulmonary anthrax, FDA post-marketing requirements associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats."
The firm outlined in the report that the BARDA BioShield program was created to accelerate the research, development, purchase and availability of effective medical products against chemical, biological, radiological or nuclear agents.
Dr. Rick Bright, BARDA Director and Deputy Assistant Secretary for Preparedness and Response, commented, "BARDA is encouraged by the opportunity to partner with Paratek Pharmaceuticals to further develop this critical antibiotic that will help us to combat antimicrobial resistance and treat anthrax infections...This award is an important step in BARDA's efforts to enhance our national health security preparedness."
The agreement provides for initial funding of approximately $59 million for NUZYRA development for treatment of pulmonary anthrax and the purchase of 2,500 treatment courses of NUZYRA to add to the current SNS. Additional potential time-based funding includes approximately $77 million for existing FDA PMR commitments and $20 million for manufacturing-related requirements. The remaining staged, milestone-based funding includes the potential for approximately $13 million to support development of NUZYRA for prophylaxis of anthrax and a maximum of around $115 million to provide for three additional purchases of NUZYRA for the SNS subject to anthrax development program milestones.
Paratek's Chief Executive Officer Evan Loh, M.D., commented, "Through Project BioShield, BARDA has identified and validated the important role that Paratek and NUZYRA will play in helping to enhance the biodefense preparedness of our country, saving lives and protecting Americans...Paratek has been studying the potential utility of antibiotics against bioterrorism threats for over a decade. Through these activities, we have generated promising in vitro and in vivo animal data with NUZYRA against select biothreat pathogens. For these reasons, we believe that NUZYRA is well-positioned to help address potential public health emergencies at a time when antibiotic resistance is a growing global threat."
The company identifies NUZYRA (omadacycline) as a broad spectrum, novel antibiotic with both once-daily intravenous and oral formulations for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has entered into a collaboration agreement with Shanghai-based Zai Lab Ltd. (ZLAB:NASDAQ-ADR) for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek Pharmaceuticals is headquartered in Boston, Mass., and describes its business as a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The firm's lead commercial product, NUZYRA (omadacycline), is utilized in the treatment of adults with "community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections" and is also being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax. The company's second FDA approved commercial product, SEYSARA (sarecycline), is used in the treatment of moderate to severe acne vulgaris.
Paratek Pharmaceuticals began the day with a market capitalization of about $98.2 million with approximately 33.29 million shares outstanding along with a 30% short interest. PRTK shares opened much higher today at $4.31 (+$1.36, +46.10%) over yesterday's $2.95 closing price. The stock has traded today between $3.69 and $4.32 per share and is currently trading at $4.19 (+$1.24, +42.03%).[NLINSERT]
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.