GlobeNewswire Inc | Dec 16, 2021 11:36AM EST

December 16, 2021

BOSTON, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the companys partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval from the National Medical Products Administration (NMPA) of China of NUZYRA(omadacycline) for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek commercially launched NUZYRA in the United States in February 2019.

Paratek grantedZaiLab an exclusive license to develop, manufactureand commercialize NUZYRAinthe greater China territory, specifically the Peoples Republic of China, Hong Kong, Macau and Taiwan markets. Paratek retainsall remaining global rights.Pursuant totheterms of the licenseagreement, Paratekearneda $6 million milestone payment upon NMPA approval.All milestone payments under theZaiLabLicense and Collaboration Agreementareretained by Paratek andexcluded fromthe companysloanfacilitywithR-BridgeHealthcare Investment Advisory.

Approved by the U.S. Food and Drug Administration (FDA) in October 2018,NUZYRAis anovel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and ABSSSI. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative,atypicals and other drug-resistant strains.

The NMPA approval further validates the safety and efficacy ofNUZYRAin treating pneumonia and serious skin infectionsat a time when antimicrobial resistance remains one of the worlds most pressing public health threatsand provides further validation that antibiotics are truly global products.TheU.S.launch of NUZYRA hasproven to be one of the most successfulantibioticlaunches of the last five years, driven byNUZYRAswell-definedproduct profile,including its once-daily oral formulation, broad spectrum of coverageanddosing flexibility, said Evan Loh, M.D.,Paratek chief executive officer. We anticipate that NUZYRA will play an important role inhelping physicians stay ahead of the evolving resistance landscape in China.We are excited that our partner,ZaiLab,will be bringing this life-saving medication to clinicians and patientsinChinaat a timewhen the need for new treatment optionsto address antimicrobial resistanceis more urgent than ever.

About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

The companys lead commercial product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement withZaiLab for the development and commercialization ofomadacyclinein the greater China region and retains all remaining global rights.

Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused byMycobacteriumabscessuscomplex with NUZYRA. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, toAlmirall, LLC. Paratek retains the development and commercialization rights forsarecyclinein the rest of the world.

In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), now valued at up to approximately $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax.For more information, visitwww.ParatekPharma.comor follow us on LinkedIn and Twitter.

About NUZYRANUZYRA(omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative,atypicalsand other drug-resistant strains.

Indications and UsageNUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

Community-Acquired Bacterial Pneumonia (CABP) caused by the following:Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae.

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused bythe following:Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae and Klebsiella pneumoniae.

UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Important Safety Information

ContraindicationsNUZYRA is contraindicated in patients with known hypersensitivity toomadacyclineor tetracycline class antibacterial drugs, or to any of the excipients.

Warnings and PrecautionsMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

The use of NUZYRA during tooth development (last half of pregnancy,infancyand childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of NUZYRA during the second and third trimester of pregnancy,infancyand childhood up to the age of eight years may cause reversible inhibition of bone growth.

Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurallysimilar toother tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

NUZYRA is structurallysimilar totetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse ReactionsThe most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea,insomniaand constipation.

Drug InteractionsPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

Use in Specific PopulationsLactation: Breastfeeding is not recommended during treatment with NUZYRA.

To report SUSPECTED ADVERSE REACTIONS, contactParatek Pharmaceuticals, Inc.at 1-833-727-2835 orFDAat 1-800-FDA-1088 orwww.fda.gov/medwatch.

Please see full Prescribing Information for NUZYRA atwww.NUZYRA.com.

Forward Looking StatementsThis press release contains forward-looking statements related tothe approval of NUZYRA in China by theNMPA, and that such approval further validates the safety and efficacy of NUZYRA in treating pneumonia and serious skin infections, that such approvalreflects the significant need for such an agentand thatNUZYRA will playan important role inhelping physicians stay ahead of the evolving resistance landscape in China.All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statementsas a result ofthese risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31,2020and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

CONTACT:

For Investors:Hans VitzthumLifeSci Advisorsir@ParatekPharma.comPhone: 617-430-7578

For Media:Christine FanelleScient PRChristine@scientpr.comPhone:215-595-5211