EMD Serono Launches Easypod, New Electronic Growth Hormone Injection Device

Main Category: Medical Devices / Diagnostics
Also Included In: Endocrinology;  Regulatory Affairs / Drug Approvals;  Pediatrics / Children's Health
Article Date: 08 Dec 2007 - 1:00 PDT

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EMD Serono, Inc. has announced the availability of easypod®, the first of its kind automated device in the growth hormone therapeutic area. easypod® was developed for the administration of Saizen® [somatropin (rDNA origin) for injection], the company's treatment for growth hormone deficiency. A 2007 Gold Medal recipient of the Medical Design Excellence Awards®, easypod® was designed in conjunction with patients, caregivers and healthcare professionals to answer the need for a device that provided simple everyday use while monitoring patient adherence. On October 31, 2007, easypod® received approval from the US Food and Drug Administration (FDA) and is now available to patients through their healthcare providers.

"As a physician who treats children with growth hormone deficiency, I am encouraged by the new technology in easypod®," said Henry Anhalt, D.O., FAAP, FACOP, FACE, CDE, Director of the Division of Pediatric Endocrinology and Diabetes at Saint Barnabas Medical Center. "It is the first growth hormone delivery device that allows healthcare professionals to preset their patient's daily dose in advance and then monitor their compliance to the treatment schedule."

Over seven hundred patients, caregivers and healthcare professionals were surveyed for input on how to improve upon delivery systems for growth hormone therapy during the development phase of easypod®. One of the key features of easypod® is preset dosing, which means patients no longer have to set their dose each day. Another unique feature is the dose confirmation screen that notifies patients when they have properly administered their treatment. easypod® also logs the date and dose of each injection, allowing healthcare professionals to monitor patient adherence.

"We are proud to bring products like easypod® to market that utilize breakthrough technology to provide patients and healthcare professionals with devices that are simple to use," said Jim Hoyes, Chief Commercial Officer, EMD Serono, Inc. "The collaboration and research used for the design of easypod® allowed us to develop an innovative device that provides more real-time data for physicians than ever before, meeting the unmet needs of patients and caregivers."

As with other EMD Serono growth hormone delivery deficiency devices, easypod® was designed with patients in mind. easypod® has a sleek, ergonomic shape and is similar in size to a juice box. The device also features a hidden needle intended to help reduce patient anxiety.

easypod® was the recipient of a 2007 Gold Medal from the Medical Design Excellence Awards®, the premier awards program for the medical technology community. The Awards recognize the achievements of medical product manufacturers who are responsible for the groundbreaking innovations that are changing the face of healthcare. easypod® was recognized for its ergonomic design as a self-care product.

"Parents and patients are always looking for ways to make taking their medicine and staying on therapy as convenient as possible," said Mary Andrews, co-founder and CEO of the MAGIC Foundation. "It's a win for parents and patients whenever there's a new product, like easypod®, that helps with these treatment goals."

EMD Serono is supporting the introduction of easypod® with a comprehensive training program intended to provide training for healthcare professionals who specialize in the treatment of growth hormone deficiency. Interested healthcare professionals can request a training session on the setup, use and features of easypod® by contacting the company. In addition, after an initial training by their healthcare professional, patients using easypod® will have access to ongoing support through EMD Serono's Connections for Growth® program, by calling 1-800-582-7989.

easypod® is currently available in a number of European and Latin American countries, as well as Australia and Canada and now the United States.

easypod® is intended for use with Saizen® click.easy cartridges after training from a healthcare provider. Refer to instructions for use on www.easypodus.com for more information. Infrequent injection site reactions can occur. easypod® and Saizen® click.easy are available by prescription only. Refer to http://www.saizenus.com/ for full prescribing information.

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About Saizen® [somatropin (rDNA origin) for injection]

Saizen® is indicated for the treatment of children and adults with growth hormone deficiency. Saizen® should not be used in patients with active malignancy, diabetic retinopathy, or in Prader-Willi syndrome patients with severe obesity or respiratory impairment.

EMD Serono also offers the only needle-free drug delivery device for growth hormone. cool.click® , exclusively for use with Saizen® , lessens the fear and anxiety that patients may experience with subcutaneous injections. one.click® is the first auto-injector pen with a hidden needle for growth hormone in the US and allows the insertion of the needle and injection of medication all in one step, with the simple click of a button.

About Growth Hormone Deficiency

Growth hormone deficiency occurs when the pituitary gland in the brain is unable to release or produce adequate amounts of growth hormone. In children, growth hormone deficiency causes slow growth, and without treatment, few will reach their full height potential as an adult. It is estimated that the incidence of growth hormone deficiency in children is between 1 in 4,000 and 1 in 10,000. For more information about growth hormone deficiency in children, please visit http://www.howkidsgrow.com/.

Adult growth hormone deficiency can also be a significant problem. More than 50,000 adults in the United States are growth hormone deficient, and 6,000 new cases are reported each year.

About EMD Serono

EMD Serono, Inc., headquartered in Rockland, Massachusetts, is an affiliate of Merck KGaA in Darmstadt, Germany. EMD Serono is a leader in fertility treatments, with Gonal-f® (follitropin alpha for injection), Luveris® (lutropin alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alpha injection). The company has strong market positions in neurodegenerative diseases, with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA origin) for injection), Serostim® (somatropin (rDNA origin) for injection) and Zorbtive™ (somatropin (rDNA origin) for injection).

About Merck KGaA, Darmstadt, Germany

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,962 employees in 61 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.emdserono.com/ or http://www.merck.de/

Source: Michele Baer
Baer Consulting

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