03-16-2022
Washington, D.C., March 16, 2022
– Modavar Pharmaceuticals announced today that it has launched Nebivolol
Tablets. The launch of the four
strengths of Nebivolol (2.5mg, 5mg, 10mg and 20mg) is the second of many
launches the company anticipates in the next 6 months under the Modavar label. The product is available immediately and is
AB-rated to Allergan’s Bystolic®. Total
market sales for this product are approximately $733.5 million (IMS MAT 2/2022). Bystolic® is indicated as an antihypertensive.
Bystolic® belongs to a class of drugs known as beta blockers which lower the blood pressure by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers heart rate, blood pressure, and strain on the heart. High blood pressure (BP), or hypertension, is a common condition in which the long-term force of the blood against your artery walls is high enough that it may eventually cause health problems, such as heart disease. Nearly half of American adults have high BP. High BP is known as the “silent killer” because most of the time there are no obvious symptoms. When left untreated, the damage that high BP does to your circulatory system is a significant contributing factor to heart attack, stroke and other health threats. High BP is responsible for 7.6 million deaths per annum worldwide (13.5% of the total), more than any other risk factors. Around 54% of stroke and 47% of coronary heart disease are attributable to high BP. Approximately 10% of all global healthcare spending is attributable to high BP, and the annual worldwide cost of hypertension is estimated at $370 billion.
Jaswinder (Manji) Matharu, Chairman, stated, “We are delighted to be launching our second product in the Modavar label. Nebivolol is one of many exciting products we will be launching in the near future. We are pleased to be able to offer a full line of this important product to our customers and patients.”
About Modavar Pharmaceuticals
Modavar Pharmaceuticals is an
emerging vertically integrated specialty pharmaceutical company that develops, manufactures,
and markets generic prescription pharmaceutical products. In collaboration
with Cadila Pharmaceuticals Limited, Modavar
has a strong pipeline of products, and plans to manufacture ANDA and 505(b)(2)
products in its Frederick, Maryland plant as well.
For further information about Modavar Pharmaceuticals, please visit the Company’s corporate website at www.modavar.com.
The information in this release may contain various forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995 (“PSLRA”) and which may be based on or include
assumptions concerning Modavar’s operations, future results, and
prospects. Such statements may be
identified using words like “plans”, “expect”, “aim”, “believe”, “projects”,
“anticipate”, “commit”, “intend”, “estimate”, “will”, “should”, “could” and
other expressions that indicate future events and trends.
All statements that address expectations or projections about the future, including without limitation, statements about the Company’s strategy for growth, product development, regulatory approvals, market position, acquisitions, revenues, expenditures, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the “safe harbor” provisions, Modavar provides the following cautionary statements identifying important economic, political and technology factors which, among others, could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include (but are not limited to) the following: (1) changes in the current and future business environment, including interest rates and capital and consumer spending; (2) the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the possibility that any product launch may be delayed or that product acceptance may be less than anticipated; (6) reliance on key strategic alliances; (7) the availability of raw materials; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in operating results; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company’s customers; (12) the impact of competitive response to the Company’s sales, marketing and strategic efforts; (13) risks that the Company may not ultimately prevail in litigation; and (14) the risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
This discussion is by no means exhaustive but is designed to highlight important factors that may impact the Company’s outlook. We are under no obligation to update any of the forward-looking statements after the date of this report.