Modavar Pharmaceuticals Launches Raloxifene Tablets

Washington, D.C., September 27, 2022 - Modavar Phramaceuticals announced today that it has launched Raloxifene Tablets.  The launch of the three SKU's of Raloxifene 60mg (30's, 100's and 1,000's) adds to the growing line of products in the Modavar portfolio.  The product is available immediately and is AB-rated to Eli Lilly's Evista®.  Total market sales for this product are approximately $34.5 million (IMS MAT 7/2022).  Evista® is indicated as a treatment and prevention of osteoporosis in postmenopausal women, and also used to reduce the risk of breast cancer in those at high risk.

Evista® belongs to a class of drugs known as selective estrogen receptor modulators (SERMs), and hence is a mixed agonist and antagonist of the estrogen receptor (ER) in different tissues.  It has estrogenic activity in some tissues, such as bone and the liver, and antiestrogenic activity in other tissues, such as the breasts and uterus.  Raloxifene increases bone mineral density in postmenopausal women but decreases it in premenopausal women.  In 2017, it was the 330th most commonly prescribed medication in the U.S., with more than 900,000 prescriptions.  An estimated 53 million Americans either have osteoporosis or are at high risk of developing it.  Osteoporosis is a condition that can have serious effects.  It can lead to fractures, which can be painful, take a long time to heal, and lead to other complications.  For instance, treatment for a hip fracture can include staying in bed for long periods, which raises your risk of blood clots, pneumonia and other infections.  The direct annual cost of treating osteoporotic fractures of people on average is reported to be between $5-6.5B in Canada, Europe and the USA alone, not taking into account indirect costs such as disability and loss of productivity.

Jaswinder (Manji) Matharu, Chairman, stated, “Raloxifene is another important medication that we are launching to help treat and prevent a potential debilitating disease in patients.  We are pleased to be able to provide 3 flexible sizes 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.

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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.