Press Release: Paratek Pharmaceuticals to Acquire Optinose, Creating Significant Commercial Expansion Opportunities for XHANCE(R) in Chronic Rhinosinusitis (CRS)

Dow Jones
20 Mar
Paratek Pharmaceuticals to Acquire Optinose, Creating Significant 
Commercial Expansion Opportunities for XHANCE$(R)$ in Chronic 
Rhinosinusitis $(CRS)$ 
 
 
 
   -- Paratek will accelerate access for XHANCE beyond specialists to primary 
 
      care providers maximizing the recent label expansion for CRS in a 
 
      10--million--patient market 
 
 
 
   -- Acquisition advances Paratek's vision to become a multi-product company 
 
      focused on innovative specialty therapies 
 
 
 
   -- Total transaction value of up to $330 million 
 
 
 
   -- Potential consideration of up to $14 per share, including upfront 
 
      consideration of $9 per share, representing a 50% premium to Optinose's 
 
      closing trading price on March 19, 2025 
 
 
   BOSTON and YARDLEY, Pa., March 19, 2025 (GLOBE NEWSWIRE) -- Paratek 
Pharmaceuticals and Optinose, Inc. $(OPTN)$ today announced they 
have entered into a definitive merger agreement under which Paratek will 
acquire Optinose, including its approved product XHANCE(R) (fluticasone 
propionate). The transaction value is up to $330 million, with 
consideration payable to shareholders of up to $14 per share, including 
the payment of contingent value rights (CVRs) tied to future commercial 
milestones. This acquisition expands Paratek's commercial portfolio 
beyond its flagship antibiotic, NUZYRA(R) (omadacycline), and 
strengthens its position as a multi-product company focused on 
innovative specialty therapies for primary care providers and 
specialists, addressing important medical health threats. 
 
   XHANCE is an innovative, drug-device combination product approved for 
the treatment of CRS with or without nasal polyps. By optimally 
targeting the site of inflammation with a proven corticosteroid using 
its proprietary Exhalation Delivery System$(TM)$ (EDS(R) ), XHANCE 
addresses a significant unmet clinical need, improving CRS symptoms with 
the potential to avoid and/or delay more invasive or expensive treatment 
options. Originally approved in 2017 for CRS with nasal polyps with a 
commercial focus on ear, nose, and throat $(ENT.UK)$ and allergy specialists, 
the XHANCE label was broadened in 2024 to include an additional 
indication for CRS without nasal polyps. This approval expanded the 
potential addressable market 10-fold, the majority of which is treated 
by primary care providers. 
 
   Over the past 15 months, Paratek has significantly expanded its primary 
care field force to have a national footprint. Paratek will leverage its 
expanded commercial infrastructure along with existing Optinose 
specialist sales expertise to accelerate awareness and adoption of 
XHANCE among both ENT and allergy specialists and primary care 
providers. 
 
   "With its recent label expansion, XHANCE is now the first and only 
product approved for patients with CRS with or without nasal polyps. The 
XHANCE indications represent overlapping call points with NUZYRA, 
creating opportunities for Paratek to broaden reach and awareness beyond 
specialists to primary care providers that Paratek is uniquely suited to 
maximize. Importantly, the majority of the primary care physicians 
Paratek calls on for NUZYRA and its approved indications are also 
treating patients with CRS, offering a key overlap in targets for our 
salesforce," said Evan Loh, MD, Chief Executive Officer of Paratek. 
"This transaction creates a stronger platform for future product 
acquisitions as we leverage our capabilities and further expand our 
portfolio." 
 
   Ramy Mahmoud, MD, MPH, Chief Executive Officer of Optinose, said, "We 
have long recognized the potential of XHANCE to transform how CRS is 
treated. We have been exploring opportunities to make more patients and 
doctors aware of XHANCE and the benefits it can offer to patients 
suffering from this common condition. Paratek, with its robust 
commercial and medical capabilities, has the potential to rapidly extend 
awareness of XHANCE to primary care providers who treat the majority of 
patients with CRS. We are excited about the many ways in which this 
transaction creates opportunities for XHANCE to help more patients 
achieve better symptom control while creating near- and long-term value 
for Optinose's shareholders." 
 
   Under the terms of the agreement, Paratek will acquire all of Optinose's 
outstanding shares for $9 per share in cash, plus up to $5 per share in 
CVRs payable in the event that certain net revenue milestones are 
achieved by XHANCE. Pursuant to the CVRs, Paratek would pay $1 per share 
if XHANCE achieves $150M in net sales in any calendar year prior to 
December 31, 2028, and $4 per share if XHANCE achieves $225M in net 
sales in any calendar year prior to December 31, 2029. The upfront 
consideration of $9 per share represents a 50% premium to Optinose's 
closing trading price on March 19, 2025. 
 
   The transaction will be financed with capital from Paratek, B-FLEXION 
Life Sciences, and Novo Holdings, and debt financing from funds managed 
by Oaktree Capital Management, L.P. ("Oaktree"). 
 
   The Boards of both Paratek and Optinose have unanimously approved the 
transaction. It is expected to close as early as mid-2025, subject to 
customary closing conditions, including approval by Optinose 
shareholders and receipt of required regulatory clearances, if 
applicable. Upon completion, Optinose's common stock will be delisted 
from the NASDAQ Global Market. 
 
   Advisors 
 
   Lazard acted as the exclusive financial advisor to Paratek 
Pharmaceuticals, and Skadden, Arps, Slate, Meagher & Flom LLP is serving 
as legal advisor. Evercore acted as the exclusive financial advisor to 
Optinose, and Hogan Lovells is serving as legal advisor. 
 
   About Paratek Pharmaceuticals, Inc. 
 
   Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company 
providing innovative specialty therapies for community care providers 
and specialists, addressing important medical and public health threats. 
Paratek's lead product, NUZYRA (omadacycline), is a once-daily oral and 
intravenous antibiotic indicated for adults with community-acquired 
bacterial pneumonia $(CABP.UK)$ and acute bacterial skin and skin structure 
infections (ABSSSI). Paratek continues to diversify its portfolio to 
address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION 
and Novo Holdings. For more information, visit www.ParatekPharma.com or 
follow us on LinkedIn and X. 
 
   About Optinose 
 
   Optinose is a specialty pharmaceutical company focused on serving the 
needs of patients cared for by ear, nose, and throat $(ENT.AU)$ and allergy 
specialists. To learn more, please visit www.optinose.com or follow us 
on X and LinkedIn. 
 
   Additional Information about the Combination and Where to Find It 
 
   In connection with the proposed transaction, Optinose will be filing 
documents with the SEC, including preliminary and definitive proxy 
statements relating to the proposed transaction. The definitive proxy 
statement will be mailed to Optinose's stockholders in connection with 
the proposed transaction. BEFORE MAKING ANY VOTING DECISION, INVESTORS 
AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT 
AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE 
PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN 
THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION 
ABOUT THE PROPOSED TRANSACTION. Investors and security holders may 
obtain free copies of these documents (when they are available) and 
other related documents filed with the SEC at the SEC's web site at 
www.sec.gov, and on Optinose's website at www.optinose.com and clicking 
on the "Investors" link and then clicking on the "SEC Filings" link. In 
addition, the proxy statement and other documents may be obtained free 
of charge by directing a request to OptiNose, Inc., Corporate Secretary, 
777 Township Line Road, Suite 300, Yardley, PA 19067, telephone: (267) 
364-3500. 
 
   Participants in the Solicitation 
 
   Optinose and its directors and executive officers may be deemed 
participants in the solicitation of proxies from the stockholders of 
Optinose in connection with the proposed transaction. Information 
regarding Optinose's directors and executive officers can be found in 
Optinose's definitive proxy statement filed with the SEC on April 26, 
2024. Additional information regarding the interests of Optinose's 
directors and executive officers in the proposed transaction will be 
included in the proxy statement described above. These documents are 
available free of charge at the SEC's web site at www.sec.gov and 
Optinose's website at www.optinose.com. 
 
   Cautionary Note on Forward-Looking Statements 
 
   This press release contains forward-looking statements within the 
meaning of the U.S. Private Securities Litigation Reform Act of 1995. 
All statements that are not historical facts are hereby identified as 
forward-looking statements for this purpose and include, among others, 
statements relating to: the benefits of XHANCE; the benefits of the 
Exhalation Delivery System (EDS); the timing of the transaction and when 
and whether the transaction ultimately will close; the potential 
contributions the transaction is expected to bring to Optinose and 
Paratek; potential strategic benefits, synergies or opportunities 
expected as a result of the transaction; and other statements regarding 
the future operations, financial performance, financial position, 
prospects, objectives and strategies of Optinose and Paratek, and other 
future events. Forward-looking statements are based upon management's 
current expectations and assumptions and are subject to a number of 
risks, uncertainties and other factors that could cause actual results 
and events to differ materially and adversely from those indicated by 
such forward-looking statements including, among others: the risk that 
the conditions to the closing of the transaction are not satisfied, 
including the risk that Optinose's stockholders do not approve the 
transaction; the possibility that competing offers will be made; 
litigation relating to the transaction; uncertainties as to the timing 
of the consummation of the transaction and the ability of each of 
Paratek and Optinose to consummate the transaction; the occurrence of 
any event, change or other circumstance that could give rise to the 
termination of the merger agreement entered into between the companies; 
other business effects, including the effects of industry, economic or 
political conditions outside of the companies' control; the impact of 
competitive products and pricing; the effect of the announcement or 
pendency of the transaction on the ability of Optinose and Paratek to 
retain and hire key personnel; competitive responses to the transaction; 
unexpected costs, charges or expenses resulting from the transaction; 
potential adverse reactions or changes to business relationships 
resulting from the announcement or completion of the transaction; 
Paratek's ability to achieve the XHANCE net sales milestones, growth 
prospects, and synergies expected from the transaction, as well as 
delays, challenges and expenses associated with integrating Optinose 
with its existing businesses; legislative, regulatory and economic 
developments; continued physician and patient acceptance of XHANCE; the 
ability to maintain adequate third-party reimbursement for XHANCE; the 
prevalence of chronic sinusitis and market opportunities for XHANCE may 
be smaller than expected; and the risks, uncertainties and other factors 
discussed under the caption "Item 1A. Risk Factors" and elsewhere in the 
Optinose's most recent Form 10-K and Form 10-Q filings with the 
Securities and Exchange Commission - which are available at www.sec.gov. 
As a result, you are cautioned not to place undue reliance on any 
forward-looking statements. Any forward-looking statements made in this 
press release speak only as of the date of this press release (March 19, 
2025), and neither Optinose, nor Paratek, undertake any obligation to 
update such forward-looking statements, whether as a result of new 
information, future developments or otherwise. 
 
   About B-FLEXION Life Sciences 
 
   B-FLEXION Life Sciences is part of the B-FLEXION group, a private, 
entrepreneurial investment firm with offices in Europe and the United 
States. B-FLEXION seeds, acquires and builds investment partnerships 
across a number of focused fields and makes principal investments into 
operating businesses in transformative industries. Through B-FLEXION 
Life Sciences there is also targeted investment across biopharma, 
diagnostics and a broad spectrum of innovative healthcare services.   It 
is an active owner, applying the experience and skills of its investment 
and operationally experienced team to work closely with management to 
build its portfolio companies. 
 
   www.bflexion.com 
 
   About Novo Holdings A/S 
 
   Novo Holdings is a holding and investment company that is responsible 
for managing the assets and the wealth of the Novo Nordisk Foundation. 
The purpose of Novo Holdings is to improve people's health and the 
sustainability of society and the planet by generating attractive 
long-term returns on the assets of the Novo Nordisk Foundation. 
 
   Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the 
controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes 
A/S) and manages an investment portfolio with a long-term return 
perspective. In addition to managing a broad portfolio of equities, 
bonds, real estate, infrastructure and private equity assets, Novo 
Holdings is a world-leading life sciences investor. Through its Seed, 
Venture, Growth, Asia, Planetary Health and Principal Investments teams, 
Novo Holdings invests in life science companies at all stages of 
development. 
 
   As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. 
 
   www.novoholdings.dk 
 
   About Oaktree 
 
   Oaktree is a leader among global investment managers specializing in 
alternative investments, with $202 billion in assets under management as 
of December 31, 2024. The firm emphasizes an opportunistic, 
value-oriented, and risk-controlled approach to investments in credit, 
equity, and real estate. The firm has more than 1,200 employees and 
offices in 23 cities worldwide. For additional information, please visit 
Oaktree's website at http://www.oaktreecapital.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 INFORMATION 
 
   CONTRAINDICATIONS 
 
   NUZYRA is contraindicated in patients with known hypersensitivity to 
omadacycline or tetracycline-class antibacterial drugs or to any of the 
excipients. 
 
   WARNINGS AND PRECAUTIONS 
 
   Mortality 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 REACTIONS 
 
   The 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 INTERACTIONS 
 
   Patients 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 POPULATIONS 
 
   Lactation: Breastfeeding is not recommended during treatment with 
NUZYRA. 
 
   See full prescribing information here. 
 
   About XHANCE 
 
   XHANCE is a drug-device combination product that uses the Exhalation 
Delivery System(TM) (also known as the EDS(R)) designed to deliver a 
topical steroid to the high and deep regions of the nasal cavity where 
sinuses ventilate and drain. XHANCE is approved by the U.S. Food and 
Drug Administration for both the treatment of chronic rhinosinusitis 
without nasal polyps (also called chronic sinusitis) and chronic 
rhinosinusitis with nasal polyps (also called nasal polyps) in patients 
18 years of age or older. 
 
   IMPORTANT SAFETY INFORMATION 
 
   CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. 
 
   WARNINGS AND PRECAUTIONS: 
 
 
 
   -- Local nasal adverse reactions, including epistaxis, erosion, ulceration, 
 
      septal perforation, Candida albicans infection, and impaired wound 
 
      healing, can occur. Monitor patients periodically for signs of possible 
 
      changes on the nasal mucosa. Avoid use in patients with recent nasal 
 
      ulcerations, nasal surgery, or nasal trauma until healing has occurred. 
 
 
 
   -- Glaucoma and cataracts may occur with long-term use. Consider referral to 
 
      an ophthalmologist in patients who develop ocular symptoms or use XHANCE 
 
      long-term. 
 
 
 
   -- Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, 
 
      contact dermatitis, rash, hypotension, and bronchospasm) have been 
 
      reported after administration of fluticasone propionate. Discontinue 
 
      XHANCE if such reactions occur. 
 
 
 
   -- Immunosuppression and infections can occur, including potential increased 
 
      susceptibility to or worsening of infections (e.g., existing 
 
      tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular 
 
      herpes simplex). Use with caution in patients with these infections. More 
 
      serious or even fatal course of chickenpox or measles can occur in 
 
      susceptible patients. 
 
 
 
   -- Hypercorticism and adrenal suppression may occur with very high dosages 
 
      or at the regular dosage in susceptible individuals. If such changes 
 
      occur, discontinue XHANCE slowly. 
 
 
 
   -- Assess for decrease in bone mineral density initially and periodically 
 
      thereafter. 
 
 
   ADVERSE REACTIONS: 
 
 
 
   -- Chronic rhinosinusitis without nasal polyps: The most common adverse 
 
      reactions (incidence >=3%) are epistaxis, headache, and nasopharyngitis. 
 
 
 
   -- Chronic rhinosinusitis with nasal polyps: The most common adverse 
 
      reactions (incidence >=3%) are epistaxis, nasal septal ulceration, 
 
      nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal 
 
      congestion, acute sinusitis, nasal septal erythema, headache, and 
 
      pharyngitis. 
 
 
   DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., 
ritonavir, ketoconazole): Use not recommended. May increase risk of 
systemic corticosteroid effects. 
 
   USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for 
signs of increased drug exposure. 
 
   Please see full Prescribing Information, including Instructions for Use 
 
   MEDIA CONTACT: 
 
   Paratek 
 
   Adam Silverstein 
 
   adam@scientpr.com 
 
   Optinose 
 
   Jonathan Neely 
 
   jonathan.neely@optinose.com 
 
   267.521.0531 
 

(END) Dow Jones Newswires

March 20, 2025 05:27 ET (09:27 GMT)

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