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Ferring Acquires Commercialization Rights for Two Products, Expanding its Reproductive Health Portfolio

PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals (US) (Ferring) announced today an exclusive agreement to acquire the U.S. commercialization rights for a generic version of Ganirelix Acetate Injection from Sun Pharmaceutical Industries Ltd. (Sun Pharma). With the addition of Ganirelix, Ferring continues to offer the most complete reproductive medicine portfolio available, which includes MENOPUR® (menotropins for injection), NOVAREL® (chorionic gonadotropin for injection, USP) and ENDOMETRIN® (progesterone) Vaginal Insert.

Ganirelix is a GnRH antagonist used to prevent premature luteinizing hormone (LH) surges in women undergoing fertility treatment. On November 30, 2018, Sun Pharma received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL.

“When beginning a treatment process as individualized and complex as fertility, it is critical that patients and providers have a wide variety of treatment options available,” says reproductive endocrinologist Gaurang Daftary, MD, MBA, Senior Medical Director, Reproductive Medicine and Women’s Health at Ferring and adjunct professor in reproductive endocrinology at the Mayo Clinic and the Yale University School of Medicine, “With the addition of Ganirelix, Ferring continues to provide reproductive endocrinologists in the US with the most comprehensive suite of medications to support the in vitro fertilization process for patients.”

In addition, Ferring also finalized the transaction with INVO Bioscience Inc. to acquire the exclusive U.S. commercialization rights for the INVOcell™ Intravaginal Culture (IVC) System, which comprises the INVOcell Culture Device and Retention Device.1 The INVOcell Culture Device uses a woman’s own body as an incubator during fertilization and early embryo development. In 2015, INVO Bioscience received FDA clearance for the INVOcell IVC system, making it the first IVC system marketed in the US.

Through this acquisition, Ferring will use its resources and expertise in the field of assisted reproductive technologies (ART) to help reproductive endocrinology practices across the country expand their service offerings to include the IVC procedure, in addition to their current treatment offerings of intrauterine insemination (IUI) and in vitro fertilization (IVF).

In the US, statistics show that over 1.4 million women may benefit from advanced fertility treatment. However, only approximately 130,000 people begin such treatment.2

“Helping people to build families is at the heart of what we do at Ferring and as the leader in reproductive medicine, we will help shape the future of fertility,” says Paul Navarre, CEO, Ferring Pharmaceuticals (US). “I am thrilled to welcome two new products to the Ferring family. With Ganirelix, Ferring has added another proven treatment to what is already the most comprehensive reproductive health portfolio available. And with INVOcell, we will further expand treatment options for women and their healthcare providers.”

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology and orthopaedics. For nearly two decades, Ferring has provided a range of therapies to help women along every step of the fertility journey. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com

About Ganirelix Acetate Injection
Ganirelix Acetate Injection is used to prevent premature ovulation during controlled ovarian stimulation.

Important Safety Information:
Do not use Ganirelix Acetate Injection if you:

  • are allergic to Ganirelix acetate or to any of its components or to any medicines similar to Ganirelix
  • are pregnant or think you might be pregnant

The product packaging (needle shield covering the injection needle affixed to the pre-filled syringe) contains natural rubber latex which may cause allergic reactions.

Ganirelix should not be used by breastfeeding women.

Side effects reported in clinical studies of patients undergoing controlled ovarian stimulation and administered Ganirelix include abdominal pain, fetal death, headache, ovarian hyperstimulation syndrome (OHSS) which is a serious medical condition in which the ovaries are swollen, vaginal bleeding, injection site pain and nausea.

These are not all the side effects with Ganirelix. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effects that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.

Please see accompanying full prescribing information.

About INVOCell
INVOcell™ Intravaginal Culture System contains the INVOcell Culture Device and INVOcell Retention Device. The Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC). The Retention Device is used during the incubation period to aid in holding the Culture Device in the vagina. The Culture and Retention Devices are not indicated for periods of use exceeding 72 hours.

Important Safety Information:

  • Do not use the Culture or Retention devices if you are unable to tolerate having a device placed within your vagina.
  • Do not use the Culture Device if you are sensitive to medical grade silicone or polystyrene or if you have a severe case of vaginitis or a history of toxic shock syndrome. Tell your doctor if you have had any recent pelvic surgery.
  • Avoid any activity such as sexual intercourse, strenuous physical activity, swimming, bathing in a tub (a shower is permissible), use of a douche, sauna, or any other activity that may alter the temperature of the vaginal cavity and avoid handling or removing the Culture and Retention Devices while in place.
  • Your doctor should explain to you what to do if the Culture and Retention Device should shift in the vagina or fall out. Call your doctor right away should this occur.

Your doctor will determine if this product is right for you and will provide you with more detailed information about the risks and benefits associated with using this device. Always follow your doctor’s instructions. Contact your doctor immediately if you have any questions or concerns before, during, or after treatment.

Please see accompanying instructions for use.

About MENOPUR® (menotropins for injection)
MENOPUR® (menotropins for injection) is a prescription medicine that contains hormones. MENOPUR contains follicle stimulating hormone and luteinizing hormone activity. These hormones stimulate healthy ovaries to make eggs. MENOPUR is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

Important Safety Information:

  • Do not use MENOPUR if you: have ovaries that are not able to make eggs even with the use of hormones, are pregnant or think you may be pregnant, have problems with your thyroid gland or adrenal gland that are not controlled by taking medicine, have tumors in your female organs (including breasts), have a tumor of your pituitary gland or any other tumor in your brain, or have heavy or irregular vaginal bleeding and the cause is not known. Do not use MENOPUR if you have a known previous allergic reaction to these medications.
  • MENOPUR may cause serious side effects. They sometimes stimulate the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. MENOPUR can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination.
  • MENOPUR may cause pregnancies with twins or more than two babies at the same time, miscarriages, birth defects, and pregnancies located outside the uterus.
  • Do not use MENOPUR if you are nursing.
  • The most common side effects with MENOPUR are headache, stomach pain, and upset stomach. Sometimes there is an injection-site reaction that can cause bruising, pain, or redness.

These are not all the side effects of MENOPUR. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effects that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088

Please see accompanying full prescribing information.

About NOVAREL® (chorionic gonadotropin for injection, USP)
NOVAREL® (chorionic gonadotropin for injection, USP) is a prescription medicine that contains a hormone to help stimulate healthy ovaries to make eggs. NOVAREL is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

Important Safety Information:

Do not use NOVAREL if you have begun puberty at an unusually early age, have prostate cancer, or have had a prior allergic reaction to this hormone. This hormone may cause harm to an unborn baby when given to a pregnant woman.

NOVAREL may cause serious side effects. It sometimes stimulates the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. NOVAREL can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination. NOVAREL may cause you to be pregnant with twins or more than two babies at the same time.

Other side effects of NOVAREL include headache, irritability, restlessness, depression, fatigue, swelling, and pain at the site of injection.

Anaphylaxis has been reported with urinary-derived hCG products.

These are not all the side effects with NOVAREL. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.

Please see accompanying full prescribing information.

About ENDOMETRIN® (progesterone)
ENDOMETRIN® (progesterone) is a vaginal insert that contains the hormone progesterone, one of the hormones essential for helping you to become and to stay pregnant. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.

Important Safety Information:

Do not use ENDOMETRIN if you:

  • Are allergic to anything in ENDOMETRIN
  • Have unusual vaginal bleeding that has not been evaluated by a doctor
  • Currently have or have had liver problems
  • Have or have had blood clots in the legs, lung, eyes, or elsewhere in your body

Common side effects seen with ART and ENDOMETRIN include pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome). Other reported side effects include abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness and vaginal bleeding. Vaginal products with progesterone may also cause vaginal irritation, burning and discharge.

Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Serious blood clots include those in the: legs, lungs, eyes, heart, and brain.

Call your doctor and get medical help right away if you have; Persistent lower leg pain, sudden shortness of breath, coughing up blood, sudden blindness(partial or complete, severe chest pain, sudden severe headache, vomiting, dizziness, or fainting, weakness in an arm or leg, or trouble speaking, yellowing of the skin and/or white of the eyes indicating possible liver problems.

Other risks of progesterone include: Headache, breast tenderness, bloating or fluid retention, mood swings and depression, irritability and drowsiness.

Call your doctor immediately if you have abnormal vaginal bleeding.

These are not all the side effects with ENDOMETRIN. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effects that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088

Please see accompanying full prescribing information.

References:

1. Indications for Use: The INVOcell™ Intravaginal Culture System
2. Fertility Dynamics, an independent data analytics, research and strategic advisory firm based in Washington, DC; data on file

RH/3036/2018/US January 2019

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