Paratek Pharmaceuticals, Inc.

SHANGHAI & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2024 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications: AUGTYRO ® (repotrectinib) is included in the NRDL for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC); NUZYRA ® (omadacycline) is renewed for its intravenous (IV) formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); and QINLOCK ® (ripretinib) is renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. “The NRDL inclusion of AUGTYRO significantly expands access to patients living with ROS1 + NSCLC in China to a new treatment option with promising durability. We look forward to launching AUGTYRO by the end of 2024,” said Andrew Zhu, Chief Commercial Officer of Zai Lab. “The addition of AUGTYRO, as well as the renewals of NUZYRA and QINLOCK, further support patient access to these important medications throughout China at more affordable treatment costs for patients and their families.” “A key part of Zai Lab’s mission is to bring innovative medicines to patients with significant unmet medical needs,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are pleased that we now have six products included in the NRDL, and we will continue our efforts to broaden patient access to our innovative treatments across China. We look forward to continuing to work with the NHSA to improve affordability and accessibility for differentiated innovative treatments in China, with the goal of improving patient lives.” About ROS1 + NSCLC in China Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 1,060,600 new cases and 733,300 cases of deaths from lung cancer in China in 2022. 1 NSCLC accounts for approximately 85% of lung cancer, and approximately 70% of NSCLC is locally advanced or metastatic at initial diagnosis. In China, ROS1 rearrangements occur in approximately 2% of patients with advanced NSCLC. 2 1 Bingfeng Han, et al. Cancer incidence and mortality in China, 2022. 2 Zhang, et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer, Thoracic Cancer January 2019. About AUGTYRO AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI) that targets ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 or NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. AUGTYRO is the first next-generation TKI that targets ROS1 oncogenic fusions in NSCLC and provides improved durability of benefit, including in metastases to the brain. In November 2023, AUGTYRO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic ROS1 -positive NSCLC. In May 2024, AUGTYRO was approved by China’s National Medical Products Administration (NMPA) for the same indications. Additionally, in August 2023, the NMPA granted AUGTYRO Breakthrough Therapy Designation for the treatment of patients with advanced solid tumors harboring a NTRK gene fusion. Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively). Zai Lab expects to commercially launch AUGTYRO in mainland China by the end of 2024. About CABP and ABSSSI in China CABP is the most common type of pneumonia that is acquired outside of the hospital. It is one of the most common infectious diseases and is a significant cause of mortality and morbidity worldwide. ABSSSI are bacterial infections of skin and associated soft tissues, such as loose connective tissue and mucous membranes. ABSSSI are common and encompass a variety of disease presentations and degrees of severity. In 2020, the estimated incidence of CABP in mainland China was approximately 10 million patients 3 , and in 2015, the estimated incidence of ABSSSI was 2.8 million patients 4 . There are significant unmet needs for broad-spectrum antibiotics addressing multi-drug resistance infections with a favorable safety profile. 3 Incidence of community-acquired pneumonia in urban China: A national population-based study, 2020. 4 2015 estimates, Zai Lab analysis. About NUZYRA NUZYRA (omadacycline), a novel tetracycline-class antibacterial with both oral and IV formulations, is active across a broad spectrum of bacterial infections, such as those caused by Gram-positive, Gram-negative, atypical, and many other pathogens. The NMPA approved NUZYRA as a Category 1 innovative drug for both oral and IV formulations for the treatment of CABP and ABSSSI in adult patients, and Zai Lab launched NUZYRA in mainland China for these indications in December 2021. It was included in the NRDL for the treatment of adult patients with CABP and ABSSSI in January 2023 for its IV formulation and in January 2024 for its oral formulation. Zai Lab has an exclusive license from Paratek Pharmaceuticals, Inc. (acquired by Novo Holdings A/S) to develop, manufacture, and commercialize NUZYRA in Greater China. About GIST in China It is estimated that approximately 30,000 GIST patients are newly diagnosed each year in China. Treatment of GIST remains an important unmet medical need in China as many GIST patients, who initially respond to traditional TKIs, ultimately develop tumor progression due to secondary mutations. About QINLOCK QINLOCK (ripretinib) is an orally administered switch-control TKI that inhibits KIT and PDGFRA kinases, including wild-type and forms with multiple primary and secondary mutations, by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. The NMPA approved QINLOCK in March 2021 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib, and Zai Lab launched QINLOCK in mainland China for this indication in 2021. It was included in the NRDL in January 2023 for the treatment for GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. Zai Lab has an exclusive license agreement with Deciphera Pharmaceuticals, Inc. (a member of ONO Pharmaceutical) for the development and commercialization of QINLOCK in Greater China. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements relating to the benefits and potential of AUGTYRO (repotrectinib), NUZYRA (omadacycline), and QINLOCK (ripretinib) and the treatment of ROS1 + NSCLC, CAPB, ABSSSI and GIST in Greater China. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov .

-- Onshoring of NUZYRA is a Key Deliverable in Company’s Partnership with U.S. Biomedical Advanced Research and Development Authority (BARDA) to Enhance National SecurityBOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that its U.S. supply and manufacturing capabilities for its novel antibiotic NUZYRA® (omadacycline) are now complete. NUZYRA is the company's broad-spectrum, novel antibiotic available in both intravenous and oral formulations approved by the U.S. Food and Drug Administration (FDA) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). “Establishing a U.S. manufacturing and supply chain is the culmination of one of the most important elements of our public-private partnership with BARDA, an agreement intended to strengthen our national security,” said Evan Loh, M.D., Paratek chief executive officer. “This onshoring milestone is significant because it ensures that NUZYRA has a secure domestic supply chain that reduces dependency on foreign production and decreases the national security risk for the manufacturing and supply of antibiotics.” Major onshoring milestones that established the U.S. capabilities included the successful technology transfer by Paratek and its manufacturing partners and related FDA approval/implementation for 1) U.S. manufacturing of NUZYRA tablets in 2022; 2) U.S. manufacturing of the active pharmaceutical ingredient (API) as of August 2024; and 3) U.S. manufacturing of NUZYRA’s IV formulation (vials) in October 2024. “Paratek continues to deliver on the milestones of this important agreement with BARDA, in many cases exceeding agreed-upon timelines, thanks to ongoing, highly productive collaboration and communication between BARDA and Paratek,” said Randy Brenner, Paratek's chief development and regulatory officer. “We are grateful to BARDA for their partnership and look forward to completing our studies to support our sNDA filing for NUZYRA for treatment and prophylaxis of pulmonary anthrax in the near term.” This project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00001. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company's 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 with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. Paratek is conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA®NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or 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, infancy and childhood to the age of 8 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, infancy and childhood up to the age of 8 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 structurally similar to other 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 structurally similar to tetracycline-class 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, insomnia, and 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. See full prescribing information here. MEDIA CONTACT: Christine Fanelle Scient PR Christine@ScientPR.com215-595-5211

First randomized placebo-controlled trial in NTM abscessusSymptom-based endpoints showed favorable improvement in frequency and severity of the most common symptomsMicrobiologic endpoints showed higher conversion to negative sputum culture, without emergence of resistance to omadacyclineIn this 12-week study, omadacycline appeared to be safe and well-tolerated with no new or unexpected safety signals BOSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for serious diseases, today announced top-line results from its Phase 2b study of oral omadacycline in adult patients with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc). “The results from this first-ever placebo-controlled trial in MABc patients are exciting and support the idea that omadacycline has clinical utility in this very challenging disease setting. Omadacycline treatment demonstrated positive results across multiple clinical and microbiological endpoints in the study,” said Kevin Winthrop, M.D., M.P.H., Center for Infectious Disease Studies, at Oregon Health and Science University and Principal Investigator in the study, “The results suggest its potential to become an important addition to the very limited treatment options currently available for patients with Mycobacterium abscessus, providing hope for improved patient outcomes. This is something that clinicians and patients in the NTM community should be very encouraged by.” The Phase 2b double-blind, placebo-controlled, randomized study evaluated the safety, efficacy, and tolerability of omadacycline in patients with Mycobacterium abscessus pulmonary disease. Sixty-six patients were randomized 1.5:1 to treatment with omadacycline (n= 41) or placebo (n=25) for 84 days, followed by a 30-day safety follow-up period. While the study was not designed to formally test for statistical differences between treatment arms, a trend favoring omadacycline was consistently observed across top line primary and secondary endpoints. The primary efficacy endpoint was the response on the NTM Symptom Assessment Scale at Day 84 and was evaluated 2 different ways. The first (Evaluation 1) defined a positive response as an improvement in at least 50% of the NTM symptoms present at baseline. The second (Evaluation 2) was a more stringent approach, requiring improvement in at least 50% of the NTM symptoms present at baseline AND no worsening of any baseline symptom. Omadacycline-treated subjects demonstrated a favorable trend towards higher response rates compared with placebo-treated subjects for both Evaluation 1 (34.1% vs 20%; p = 0.218) and Evaluation 2 (34.1% vs 12%; p = 0.046). The Quality of Life-Bronchiectasis (QOL-B), a patient-reported outcomes measure, favored omadacycline across all domains, particularly in vitality, physical functioning, social functioning, and respiratory symptoms. In addition, both patient and clinician assessments of clinical status improved over time in the omadacycline-treated group, while the placebo group showed worsening or no change. On microbiological endpoints, omadacycline-treated patients had a higher rate of negative sputum cultures for MABc (56.4% vs 29.2%, p=0.035) and a greater reduction in semi-quantitative sputum culture scores (76.5% vs 45.8%, p=0.017) at day 84 compared to placebo. Oral omadacycline administered for up to 12 weeks was generally safe and well-tolerated. The safety profile was consistent with the established profile for NUZYRA® (omadacycline), and no new safety signals were observed over this treatment period. The most common treatment-emergent adverse events were gastrointestinal symptoms. No deaths occurred in the study. Two subjects in the placebo-group experienced serious adverse events. Treatment discontinuation due to adverse events occurred in four (9.8%) omadacycline-treated patients. “These findings add to a growing dataset that supports the potential for symptomatic and microbiological improvement with omadacycline for those patients struggling with MABc pulmonary disease.” said Evan Loh, M.D., Chief Executive Officer of Paratek Pharmaceuticals. “This community needs better treatment options. I want to thank the patients, caregivers, and investigators who participated and made this encouraging outcome possible.” Analysis of all study data is ongoing and the complete data from this study will be presented in the future and published in a peer-reviewed journal. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative treatments for life-threatening diseases and other public health threats. Paratek’s lead product, NUZYRA® (omadacycline), is a novel antibiotic that addresses serious community-acquired infections. The company is dedicated to advancing solutions that address critical unmet medical needs, including those for rare and difficult-to-treat diseases such as NTM. For more information, visit www.paratekpharma.com or follow us on LinkedIn and Twitter. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X.com. About NUZYRA® NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or 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, infancy and childhood to the age of 8 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, infancy and childhood up to the age of 8 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 structurally similar to other 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 structurally similar to tetracycline-class 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, insomnia, and 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. See full prescribing information here. MEDIA CONTACT: Sarah Misheksmishek@scientpr.com