IBSA Reacquires Commercial Rights to the Flector® Brand in the US

PARSIPPANY, N.J., Jan. 12, 2021 /PRNewswire/ -- IBSA Pharma Inc. has taken back marketing and distribution rights for Flector (diclofenac epolamine) topical system 1.3% from Pfizer as of January 1^st, 2021. With the return of the commercial rights of Flector, a product that IBSA has developed, IBSA now offers two prescription topical drugs to treat acute pain due to minor strains, sprains, and contusions. Both Flector and Licart are manufactured under strict IBSA Quality System control. In 2020, IBSA introduced Licart (diclofenac epolamine) topical system 1.3%, the only FDA-approved once-a-day topical NSAID therapy with next- generation patch technology.

IBSA Pharma Inc is Now Marketing and Distributing Flector in the US

As of January 2021, marketing rights for Flector have reverted to IBSA, the originator of the product. Flector is supported by more than 30 years of clinical experience and has been proven to deliver relief of acute pain for a wide variety of patients and pain sites with twice-a-day dosing. ¹ A promotional program is available to support Flector prescribers and patients with product samples, literature, and improved patient savings programs. IBSA's decision to lower the price of Flector and implement significant patient savings programs means that, for many patients, branded Flector will be available at the lowest cost of any diclofenac topical systems with the exception of Licart. Information about Flector and Flector savings programs can be found at www.Flector.com.

Licart™, Next-Generation Topical NSAID Therapy, Now Available by IBSA

At the end of 2020, IBSA also launched Licart (diclofenac epolamine) topical system 1.3% for the relief of acute pain associated with minor strains, sprains, and contusions. Licart is the first and only once-a-day topical nonsteroidal anti-inflammatory drug (NSAID) therapy approved by the FDA. Thanks to its patented next-generation patch technology which combines two innovative drug delivery systems, Licart's improved skin permeability delivers diclofenac epolamine, a widely used NSAID. This allows a fast onset and sustained pain relief. Licart is proven to provide significant pain relief within 1-3 hours after application and continues to relieve pain for 24 hours.²

Licart is the latest product to be launched by IBSA Pharma Inc., a fully owned subsidiary of IBSA Institut Biochimique SA which is headquartered in Lugano, Switzerland. IBSA is a world leader in topical pain management.

Like Flector, IBSA supports Licart with patient starter kits, product literature and patient savings programs. Most commercially insured patients using the Licart Copay Card can pay as little as $0 per month of therapy. Patients with or without commercial insurance coverage for Licart can use the Licart Direct Program, a network of mail order pharmacies, to get the lowest cash price available for Licart. Licart is also available on the TriCare formulary. Additional details about Licart and Licart patient savings programs can be found at www.Licart.com.

"We are excited to have Flector, the original diclofenac topical system and only branded diclofenac topical system indicated for children 6 years and older, back in the IBSA product portfolio," stated Aldo Donati, President and CEO of IBSA Pharma. "We are also excited to offer Licart, a product that features patented next-generation patch technology and is the only FDA approved once-a-day topical treatment for acute pain due to minor strains, sprains, and contusions. Licart and Flector, along with IBSA's unique products for hypothyroidism – Tirosint www.tirosint.com and Tirosint-SOL www.tirosintsol.com - allow us to offer patients and caregivers a broader range of unique therapeutic formulations for some of the most common health problems encountered in clinical practice."

About Acute Pain from Minor Strains, Sprains and Contusions

Acute pain from minor strains, sprains and contusions are common in clinical practice. While exact figures are not available, it is estimated that over 2 million ankle sprains occur annually in the US. ³ If not treated appropriately, soft tissue injuries like ankle sprains may lead to chronic complications and significant reductions in patient quality of life.

About IBSA Pharma

IBSA Pharma is part of the IBSA Group, headquartered in Lugano, Switzerland, a world leader in the topical treatment of acute pain and the treatment of hypothyroidism. With products on five continents and in over 80 countries, IBSA manufactures more than 46 million diclofenac patches, 14 million vials of thyroxine hormones, 300 million soft gel capsules and 60 million packages of finished products every year. IBSA has a commitment to scientific research and improving the health of patients.

References

1. Flector (diclofenac epolamine) topical system 1.3% (Package Insert); 2019, IBSA Pharma, Parsippany, NJ. 2. Rainsford KD et al; Curr Med Res Opin. 2018;24(10):2967-92. 3. Herzog M et al; Journal of Athletic Training, 2019;54(6) 603-610

To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800- FDA-1088

For more information about IBSA, visit www.ibsagroup.com/media 
For Full Prescribing Information, visit www.Licart.com or www.Flector.com

INDICATIONS AND USAGE
Flector® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
• Flector® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal bleeding, ulceration, and perforation

• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS

Flector® is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds.

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
• Heart Failure and Edema: Avoid use of Flector® in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
• Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Flector® in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
• Exacerbation of Asthma Related to Aspirin Sensitivity: Flector® is contraindicated in patients with aspirin- sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
• Serious Skin Reactions: Discontinue Flector® at first appearance of skin rash or other signs of hypersensitivity
• Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation
• Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia

ADVERSE REACTIONS
Most common adverse reactions for Flector® are application site pruritus and other application site reactions.

Please visit Licart.com and Flector.com for Full Prescribing Information including Boxed Warning

PM-03-21-0013

SOURCE IBSA Pharma Inc.

Related Links

http://www.ibsagroup.com