Paladin Labs Announces Launch of Xydalba® (Dalbavancin for Injection) in Canada

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The new antibiotic treatment is intended for adult patients with acute bacterial infections of the skin and skin structures (ABSSI)³

MONTREAL, January 17, 2022 /CNW/ – Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ: ENDP), today announced the launch of Xydalba® (dalbavancin for injection), a 30-minute intravenous (IV) treatment for acute bacterial skin and skin structure infections (ABSSSI) that can be given in one or two doses. Xydalba® is now available to patients nationwide Canada.

“We are delighted to launch Xydalba® in Canada and to provide this new product to the appropriate Canadian patients,” says Livio DiFrancesco, vice president and general manager of Paladin. “It offers healthcare providers an important option for treating ABSSSI.”

Xydalba® was approved by Health Canada in September 2018 for the treatment of ABSSSI in adults caused by susceptible isolates of several gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).3 In April 2021, ADVANZ PHARMA Corp. Limited and Endo announced that Endo’s subsidiary, Endo Ventures Limited, has entered into a definitive agreement with Correvio International Sàrl, a subsidiary of ADVANZ PHARMA, to commercialize Xydalba® in Canada exclusively.

About Xydalba®
Xydalba® injection is a second generation semi-synthetic lipoglycopeptide antibiotic. Xydalba® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible strains resistant to methicillin), Streptococcus pyogenes, Streptococcus agalactiae , Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (strains sensitive to vancomycin).

About the ABSSI
Acute bacterial skin and skin structure infections (ABSSSI) include cellulitis, erysipelas, wound infection, and major skin abscesses. Worldwide, the most common cause of ABSSI is Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA). The spread of MRSA has made the management of ABSSSI more difficult. Patients with ABSSSI commonly present to emergency departments in Canada and this can lead to an average of five days of hospitalization1.2. ABSSSI due to MRSA may lead to longer stays 1.2.

About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing and sales organization that has helped it grow into one of Canada’s leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc. For more information, visit: www.endo.com or www.paladin-labs.com.

Caution Regarding Forward-Looking Statements
Certain information contained in this press release may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and all applicable Canadian securities laws, including, but not limited to, the statements of Mr. francesco and any statements regarding product launch or availability. Statements including words or phrases such as “believe”, “expect”, “anticipate”, “intend”, “estimate”, “plan”, “will”, “may”, “look future”, “intend”, “future”, “potential” or similar expressions are forward-looking statements. All forward-looking statements contained in this press release reflect Endo’s current expectations regarding the future events based on existing trends and information and represent the judgment of Endo only as of the date of this press release. Actual results may differ materially and adversely from current expectations depending on a number of factors affecting Endo’s business, including, but not limited to, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending litigation s or future, investigation or claim or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings; our ability to satisfy judgments or settlements or pursue appeals, including bond requirements; our ability to adapt to changing market conditions; our ability to attract and retain key personnel; our failure to maintain compliance with financial covenants and operating obligations that would expose us to potential events of default under our outstanding debt; our ability to secure additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or for general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short- or long-term revenues which could prevent us from financing our operations and our liquidity needs or repaying our debts. The occurrence or possibility of such an outcome has caused us to engage, and may cause further engagement, in strategic reviews which ultimately may cause us to pursue one or more material corporate transactions or other corrective actions, including on a preventive or proactive basis. These corrective actions could include possible corporate reorganization, restructuring or bankruptcy filing involving all or a portion of our business, asset sales or other divestments, cost reduction initiatives, corporate realignments or strategic partnerships. Some of these measures may take a long time to implement and others may require court or third party approval. Such actions may be complex, involve significant costs and expenses, or adversely impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or not at all, or that they will result in the expected benefits. Accordingly, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law. Additional information regarding risk factors, including those mentioned above, can be found in press releases issued by Endo, as well as in periodic public filings by Endo with the United States Securities and Exchange Commission. and with securities regulatory authorities in Canada, including the discussion under the heading “Risk Factors” in Endo’s most recent Annual Report on Form 10-K and all subsequent Quarterly Reports on Form 10-Q or other filings with the Securities and Exchange Commission the United States.

The references

  1. Kaye KS, Patel DA, Stephens JM, et al. Rising United States hospitalizations for acute bacterial infections of the skin and cutaneous appendages: recent trends and economic impact. PLoS One. 2015;10(11):e0143276.
  2. Lee BY, Singh A, David MZ, et al. The economic burden of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). Clin Microbiol Infect. 2013;19(6):528-536.
  3. XYDALBA® (dalbavancin for injection) Product Monograph. Markham, Ontario, Canada: Endo Ventures Ltd.; 2021: 1–33.

SOURCEEndo International plc

For further information: Endo International plc: Media: Heather Zoumas-Lubeski, (484) 216-6829, [email protected]; Investors: Pravesh Khandelwal, (845) 364-4833, [email protected]

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