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FIDIA PHARMA USA Inc. Continues to Expand U.S. Presence as Fidia Farmaceutici S.p.A. Leads European Orthopedic Biomaterials Market

Global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021

PARSIPPANY, N.J., June 28, 2017 – Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronan (HA)-based products, and its wholly owned subsidiary, FIDIA PHARMA USA Inc., are projecting continued growth in 2017. The global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021, according to a research study by RnR Market Research1.

Fidia Farmaceutici S.p.A. now leads the orthopedic biomaterials market in Europe after increasing its market share over the past few years. The largest segment of the biomaterials market internationally is HA viscosupplementation, to inject lubricating fluid into a joint. The company's strong presence in the HA viscosupplementation market, with its product HYALGAN®, and Fidia's entrance into the German market have contributed to the expansion.

"Fidia is building upon its structure and experience to expand its business and strengthen its presence in the U.S. and globally," said Aldo Donati, president, FIDIA PHARMA USA. "Fidia Farmaceutici has invested in research and development of hyaluronic acid-based products for more than 70 years. Today, Fidia is growing its product portfolio with new, innovative solutions to meet challenges in the field of osteoarthritis using science, our legacy and our drive."

In the United States, FIDIA PHARMA USA Inc. offers HYMOVIS® and HYALGAN®, which are viscoelastic hyaluronan injection treatments for osteoarthritis (OA) knee pain that may help to delay total knee replacements2.

More than 20 million Americans suffer from knee OA. By 2030, 20 percent of Americans over the age of 65 will be at risk for developing OA, according to the U.S. National Library of Medicine. The rise in OA of the knee diagnoses is reported to be attributed to an increase in life expectancy, obesity and sedentary behavior3.

The United States continues to hold the largest market share in the global viscosupplementation market. Growth is anticipated to be based off of the latest health care infrastructure, well-established reimbursement, aggressive marketing efforts on supply, and trends toward early intervention and demand for nonsurgical OA treatment.

HYMOVIS® is a breakthrough in HA-based intra-articular (IA) therapy for the treatment of OA knee pain. Specifically engineered to fulfill a need of having a true viscoelastic hydrogel that is non-crosslinked and naturally derived from non-avian sources, HYMOVIS® maintains enhanced properties of improved lubrication to decrease friction, exhibits greater elasticity in recovering its original structure even after repeated mechanical stresses, and demonstrates increased residence time in the knee joint*. HYMOVIS® is delivered as an IA injection in a convenient two-dose regimen, with each injection given one week apart.

HYALGAN® is a solution that contains a natural substance called hyaluronate, which is normally found in the fluid that lubricates and cushions the knee joint. HYALGAN® is injected into the knee to relieve pain due to osteoarthritis. It is a five-injection regimen given at weekly intervals that provides long-lasting pain relief for up to six months. Some patients get benefits with three injections given at weekly intervals as reported in the published literature in which patients were followed for 60 days.

About FIDIA PHARMA USA Inc.
FIDIA PHARMA USA Inc. is a wholly owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment. FIDIA PHARMA USA Inc. is focused on expanding Fidia's position in the U.S. and Canadian market, while upholding the company's mission to provide consumers with innovative products that offer quality, safety and performance. FIDIA PHARMA USA Inc. is headquartered in Parsippany, N.J. For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.
Fidia Farmaceutici Fidia Farmaceutici is an Italian company founded in 1946 with proven expertise in Neuroscience, acquired over the years thanks to an activity of Research and Development unique in the Italian pharmaceutical scenario. It is also a top leading company in marketing products based on hyaluronic acid, which have many applications in the biomedical field, in areas such as rheumatology, orthopaedics, wound care, tissue repair and dermo-aesthetics, with worldwide leadership in viscosupplementation. Fidia Farmaceutici is part of the Milanese P&R Holding group. The company is well established in Italy, with R&D activities carried out both in Abano (where the company's headquarter is located) and at the Research Unit in Noto (Sicily, Italy). The turnover will amount over 300 million Euros in 2017, of which 70% generated in international markets. Fidia Farmaceutici's products are marketed in over 100 countries, through wholly-owned subsidiaries – in USA, Kazakhstan, Germany, Spain, Russia and the Middle East – and a comprehensive network of international partners and distributors. Thanks to its investment in R&D, it has managed to create a time-honored legacy of products, with over 900 patents to its name.

For more information, contact:
Carolyn Kong
FIDIA PHARMA USA Inc.
Morris Corporate Center 1
Building C, 1st floor
300 Interpace Parkway
Parsippany, NJ 07054
1-973-507-5120
ckong@fidiapharma.us

Indications: HYALGAN® and HYMOVIS® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

Important Safety Information: HYALGAN® and HYMOVIS® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (HYMOVIS® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.com and www.Hymovis.com. Rx Only

HYMOVIS® and HYALGAN® are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 FIDIA PHARMA USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID523-06.2017

*Data on file - Preclinical studies may not be indicative of human clinical outcomes.

Rx Only
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  1. http://www.rnrmarketresearch.com/medipoint-viscosupplementation-global-analysis-and-market-forecasts-market-report.html
  2. Turajane T, Tanavaree A, Labpiboonpong V, Maungsiri, S. Outcomes of intra-articular injection of sodium hyaluronate for the treatment of osteoarthritis of the knee. J Med Assoc Thai. 2007;90(9):1845-1852.
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612336/

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