Pharmacosmos Therapeutics Inc. established as a new specialty pharmaceutical company to bring recently approved treatment option to iron deficiency anemia patients

MORRISTOWN, N.J., Feb. 10, 2020 /PRNewswire/ -- Pharmacosmos Therapeutics Inc. announced today that it has been established as a newly formed specialty pharmaceutical company dedicated to commercializing Monoferric® for Iron Deficiency Anemia (IDA) patients in the US. The new company is a subsidiary of the Pharmacosmos Group, a profitable, fast-growing specialty pharmaceutical company headquartered in Denmark.

Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients, who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.

"For decades, Pharmacosmos Group has been committed to improving the lives of patients with iron deficiency anemia," said Michael Ryde, Chief Executive Officer of Pharmacosmos Therapeutics Inc. "It is with that same dedication that our company aims to bring new treatment options to patients in the United States, as we pursue our vision of becoming a leader in the treatment of iron deficiency anemia in this country."

"The opportunity to be a part of a collaborative culture with the focused goal of helping patients is what attracted many of us to this industry early in our careers," said Josh Franklin, Chief Commercial Officer, Pharmacosmos Therapeutics Inc.  "We are thrilled to begin the work of building that kind of team and that kind of culture here at Pharmacosmos Therapeutics Inc."

About Pharmacosmos Therapeutics Inc.

Pharmacosmos Therapeutics Inc. has been established to commercialize Monoferric® in the rapidly growing U.S. intravenous iron market.  Structured to be agile and fast-moving, Pharmacosmos Therapeutics will bring together the resources required to drive growth and an experienced, high-performing team with the shared purpose of bringing a new treatment option to patients in need of intravenous iron.

The company is creating a collaborative, performance-based culture in which employees are recognized and rewarded for the value they bring to the organization and empowered to do meaningful work.  Built upon the heritage of the global Pharmacosmos Group, Pharmacosmos Therapeutics Inc. has the benefit of singular focus with all efforts directed toward the shared objective of helping patients suffering from IDA.

Initial members of the leadership team of Pharmacosmos Therapeutics Inc. include:

• Michael Ryde, Chief Executive Officer.  Michael has more than 20 years of experience from commercial roles in the pharmaceutical industry, including more than 15 years with Lundbeck, where he was responsible for setting up and leading Lundbeck's organization in China. During the last 5 years, Michael has been a vice president at Pharmacosmos A/S with responsibility for the commercialization of intravenous iron products internationally. For the past 3 years, Michael's work has focused primarily on the go-to-market strategy for intravenous iron in the U.S.
• Josh Franklin, Chief Commercial Officer.  Josh has more than 20 years of specialty pharmaceutical industry experience, including 15 years in senior commercial executive roles covering corporate development, marketing, and sales. Josh joins Pharmacosmos Therapeutics Inc. from a role as Senior Vice President of marketing and corporate development of Chiesi USA, Inc.
• Lauren Falcetta, Head of Human Resources.  Lauren has more than 20 years of human resources experience in life-sciences industries.  Her expertise lies in human resource strategy and design, talent acquisition and development, and linking human resources functions to overall business results.  Lauren joins Pharmacosmos Therapeutics Inc. from a role as Director, Human Resources of Ferring Pharmaceuticals.    

Recruiting is ongoing for several positions including senior roles in legal, marketing, sales, and market access.  If interested in joining the Pharmacosmos Therapeutics Inc. team, please email [email protected].

Pharmacosmos Therapeutics Inc. is based in Morristown, New Jersey.

About Pharmacosmos Group

Pharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anaemia. With companies in the UK, Nordics, Germany and recently also in the US, and through partners, Pharmacosmos markets its products across the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes.

About Monoferric®

Monoferric® is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease. 

Monoferric® was first approved outside North America in 2009 as Monofer® (iron isomaltoside 1000 injection) and is currently marketed in more than 30 countries worldwide, including in the EU, Canada, and Australia. In the full, global development program, Monoferric® has been evaluated in twenty-five clinical trials enrolling more than 5,800 patients.

Important Safety Information                                                  

Monoferric® (ferric derisomaltose) injection 100 mg/mL is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney disease. 

Monoferric® is contraindicated in patients with a history of serious hypersensitivity to Monoferric® or any of its components.

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric®. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric® treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.  Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric®. Adverse reactions related to treatment and reported by ≥ 1% of the treated patients in the clinical trials include nausea and rash.

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric® to patients with iron overload.

Please see full prescribing information at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf

To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About iron deficiency anemia

Iron deficiency anemia (IDA) is a debilitating condition that affects almost 1 billion people worldwide. IDA is often associated with many chronic disorders such as renal diseases (including chronic kidney disease), cancers (including chemotherapy-induced anemia), gynecologic disorders (including abnormal uterine bleeding), and inflammatory bowel disease.

SOURCE Pharmacosmos Therapeutics Inc.