ROCKLAND, Mass., Jan. 17, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that Richard R. Smith has joined the company as Senior Vice President and Head of US Fertility and Endocrinology. In this role, Mr. Smith will oversee the Fertility and Endocrinology businesses in the U.S., including the U.S. Fertility Technologies division, which launched its first product last year with Gidget, a hand-held witnessing system for the IVF laboratory that provides visual lab workflow management and support for traceability and audit reporting.
Mr. Smith joins EMD Serono from Novartis, where he was most recently Vice President and US Head of Sales & Operations of the Cardiovascular franchise. During his 18 years with Novartis, Mr. Smith held roles of increasing responsibility across the commercial business including Executive Director and Head of the organization’s Transplant franchise as well as positions in Customer Segment Marketing, Strategy & Commercial Operations for the US Specialty Medicines franchise, Brand Managed Markets strategy, pricing and contracting for the Neuroscience franchise. He began his career at Novartis as a sales representative.
“We have a longstanding focus on providing comprehensive solutions in the areas of fertility and endocrinology care through innovative products as well as financial, educational and emotional support,” said Gary Zieziula, President and Managing Director of EMD Serono. “Adding Richard’s expertise, passion and industry knowledge to our strong and committed team will ensure that we are well-positioned to further meet the needs of patients and customers.”
EMD Serono is a long-standing leader in commercializing biologic and specialty pharmaceuticals in fertility and endocrinology. EMD Serono’s GONAL-f® [follitropin alfa for injection] is the world’s first and most-widely prescribed recombinant human follicle stimulating hormone (r-hFSH). In 2016, EMD Serono celebrated the 20th anniversary of the U.S. Food and Drug Administration’s approval of Serostim® [somatropin (rDNA origin) for injection]. Serostim® has been an important treatment for a subset of HIV positive patients affected by HIV Associated Wasting. EMD Serono also markets Saizen® [somatropin (rDNA origin) for injection] for the treatment of growth hormone deficiency.
Mr. Smith succeeds Craig Millian, who was recently appointed Senior Vice President, U.S. Neurology and Immunology.
Mr. Smith received his Bachelor of Science (BS) in Business Management from Carson-Newman College.
CONSUMER INDICATION and IMPORTANT RISK INFORMATION
GONAL-f® (follitropin alfa for injection) and GONAL-f® RFF (follitropin alfa for injection)
IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF GONAL-f® (follitropin alfa for injection) and GONAL-f® RFF* (follitropin alfa for injection)
What are the uses of Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa for injection)?
Gonal-f® Multi-Dose and Gonal-f® RFF are 2 products that contain follitropin alfa, which is similar to the human hormone follicle-stimulating hormone, referred to as FSH. FSH belongs to a group of human reproductive hormones.
Gonal-f® Multi-Dose and Gonal-f® RFF are used in certain infertile women to help with ovulation (production and release of a mature egg) and pregnancy. Gonal-f® will not help women whose ovaries no longer work because of a condition called Primary Ovarian Failure. Gonal-f® may also be used in women who are in an Assisted Reproductive Technology (ART) program such as in vitro fertilization to help their ovaries make more eggs.
Gonal-f® Multi-Dose can also be prescribed to increase sperm production in men with a rare condition that affects sperm production.
Both products should be prescribed only by doctors specializing in infertility problems and their treatment.
Who should not use Gonal-f® and Gonal-f® RFF?
Gonal-f® Multi-Dose and Gonal-f® RFF should not be used in patients who are pregnant or think they might be pregnant, in patients with primary ovarian failure (the ovaries no longer produce eggs), or in patients with allergies to recombinant human FSH products or any other ingredients in the medication. Patients with cancer of the sex organs or brain, or with uncontrolled thyroid or adrenal disease, should not use Gonal-f® Multi-Dose or Gonal-f® RFF. Women with a history of abnormal bleeding from the uterus or vagina or with swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.
What are the possible side effects of Gonal-f® and Gonal-f® RFF?
The lowest dose expected to achieve the desired results should be used. A doctor should monitor a woman’s response often to avoid overdose, which can lead to serious side effects, including blood clots. Women should contact their doctor if severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain are experienced during treatment. These could be signs of a rare but serious condition known as Ovarian Hyperstimulation Syndrome, or OHSS, which can result in hospitalization.
Use of Gonal-f® Multi-Dose or Gonal-f® RFF by a woman can be associated with fertilization of more than 1 egg. This can lead to complications for the woman and the birth of 2 or more babies.
The most common side effects reported by women were headache, ovarian cysts, upset stomach, and sinus infection. The most common side effects reported by men taking Gonal-f® Multi-Dose were skin pimples, breast pain and growth, and tiredness. Injections may cause some discomfort.
Full prescribing information for Gonal-f® can be found at: http://www.emdserono.com/ms.country.us/en/images/Gonal-f_RFF_Redi-ject_PI_tcm115_140008.pdf?Version=
CONSUMER INDICATION and IMPORTANT RISK INFORMATION
What is SEROSTIM® (somatropin) for injection?
Serostim is an injectable prescription medicine used for the treatment of HIV-positive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.
You should not take SEROSTIM if you have:
A critical illness from surgery, serious injuries, or a severe breathing problem, cancer or undergoing treatment for cancer, eye problems caused by diabetes, allergies to growth hormone.
What should I tell my doctor before using SEROSTIM?
If you have cancer or had cancer in the past. If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Serostim. If you are allergic to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol. If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to adjust the dose of Serostim or other medicines you are taking. If you are nursing, pregnant, or plan to become pregnant. It is not known if Serostim passes into your breast milk or could harm your unborn baby.
What are the most common side effects of SEROSTIM reported in clinical trials in patients treated for HIV-associated wasting or cachexia?
Swelling, especially in the hands or feet. Bone, muscle, and joint pain or stiffness. Tingling and numbness. Unusual skin sensations. Breast enlargement in men. Nausea. Extreme tiredness.
Other less common but serious side effects of SEROSTIM are:
Tumors or cancerous growths. High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, or trouble concentrating. Headaches, changes in vision, nausea or vomiting, which requires immediate medical attention. Serious allergic reactions that require immediate medical attention. Numbness and tingling in the hand or arm caused by a pinched nerve in the wrist. Injection site reactions (such as pain, numbness, redness, and swelling). Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas.
These are not all of the possible side effects. Let your doctor know about any side effects you experience.
How should you administer Serostim?
Patients and caregivers should be trained by a healthcare professional on how to mix and inject Serostim prior to use. Never share Serostim with another person, even if the needle is changed.Full prescribing information for Serostim® can be found at: http://www.emdserono.com/ms.country.us/en/images/Serostim_PI_tcm115_140011.pdf?Version=
CONSUMER INDICATION and IMPORTANT RISK INFORMATION
What is SAIZEN® (somatropin) for injection?
Saizen is a prescription medicine that is used to treat growth hormone deficiency (GHD) in:
1. Children with growth failure who produce low amounts of growth hormone.
2. Adults with GHD that started as a child or as an adult.
Saizen is an injectable form of a protein called growth hormone that is produced by your body.
Who should not take SAIZEN?
Saizen should not be used in children after the growth plates have closed. Saizen should not be used in children and adults with any of the following medical conditions because serious side effects can occur: A critical illness from surgery, serious injuries, or a severe breathing problem. Prader-Willi syndrome who are severely overweight or have a history of breathing problems including sleep apnea. Cancer or other tumors. Allergies to growth hormone. Eye problems caused by diabetes
What should patients tell their doctor before taking SAIZEN?
If you have or had cancer as a child. There is an increased risk of getting another tumor if you are a childhood cancer survivor. If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Saizen. If you are allergic to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol. If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to adjust the dose of Saizen or other medicines you are taking. If you are nursing, pregnant, or plan to become pregnant. It is not known if Saizen passes into your breast milk or could harm your unborn baby
Your doctor will perform certain tests before prescribing SAIZEN and will monitor progress during the course of treatment.
What are the most common side effects of SAIZEN reported in clinical trials in patients treated for GHD?
The most common side effects reported are:
An injection site reaction such as pain, numbness, redness, and swelling. Muscle and joint pain. Tingling and numbness. Unusual skin sensations. Headache. Adults also commonly report swelling associated with fluid retention especially in the legs, arms, and face.
Other less common but serious side effects of SAIZEN are:
Tumors or cancerous growths. High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, trouble concentrating and weight loss. Headaches, changes in vision, nausea or vomiting which requires immediate medical attention. Serious allergic reactions that require immediate medical attention. Hip and knee pain or a limp in children, which can be a sign that the thigh bone and hip joint may have slipped out of place. Curvature of the spine or backbone in children (scoliosis). Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas
These are not all of the possible side effects. Let your doctor know about any side effects you may experience.
How should you administer SAIZEN?
Patients and caregivers should be trained by a healthcare professional on how to mix and inject Saizen prior to use. Children should always be supervised.
Full prescribing information for Saizen® can be found at: http://www.emdserono.com/ms.country.us/en/images/Saizen_Ce_Pi_tcm115_140010.pdf?Version=
About EMD Serono, Inc.
EMD Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,200 employees around the country with commercial, clinical and research operations based in the company’s home state of Massachusetts. www.emdserono.com
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