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Two New Publications Support the Safety and Efficacy of Slynd™ (drospirenone) tablets, 4 mg

FLORHAM PARK, N.J. July 7, 2020 – Exeltis USA, Inc., a division of Insud Pharma, today communicated that 2 new articles published in Contraception and The European Journal of Contraception & Reproductive Health Care,  reviewed the US Phase III clinical study involving Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive in a physician and patient communication letter.

The publications highlighted the safety and efficacy of drospirenone 4 mg, similarly to the FDA which approved the Slynd™ NDA in May 2019.The first in Contraception, “A one-year prospective, open-label, single arm, multicenter phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only drospirenone 4 mg using a 24/4 daily regimen” (Kimble et al; February 21, 2020), indicated that drospirenone provides a contraceptive option for the majority of women regardless of blood pressure and BMI. The second, “Estrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and review of the literature” (Palacios et al; April 21, 2020), published in The European Journal of Contraception & Reproductive Healthcare-, concluded that drospirenone 4mg has shown contraceptive effectiveness similar to that of currently available COCs (combined oral contraceptives), very low cardiovascular side effects and a favorable bleeding pattern.

“We are pleased to see the Slynd™ clinical study  results being reported in renowned journals,” said  Randi Rievman, Senior Director, Marketing and Sales Training for Exeltis. “The data validates what we have known for some time: Slynd™ is an attractive option for many women who want or need an estrogen-free oral contraceptive. It offers  the right balance of safety and efficacy to address the needs of many women, especially for those who may not be good candidates for other  currently available oral contraceptive options.”

In addition to these findings, Exeltis USA President Salustiano Perez added, “Slynd™ is further differentiated in the market because it is an estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and allows a 24-hour missed pill window.

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd™ may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd™ if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd™ please see full  Slynd™ Prescribing Information.

About Exeltis:
Exeltis is a fast-growing division of Madrid-based Insud Pharma, an integrated health sciences group. It has developed a leading position in the women’s health sector, where it continues to discover, develop, produce and seek new medicines and medical devices to improve the health and wellbeing of women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network. Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in Women’s Health including contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to Central Nervous System (CNS), ophthalmology and endocrinology. In addition, to learn more, please visit us at exeltisusa.com.

For more information on Slynd™ and Important Risk Information, please visit slynd.com or contact Randi Rievman, Senior Director, Marketing and Sales Training| Exeltis USA| Phone: 973-803-5505.

Slynd™ is a trademark of Exeltis USA, Inc.

©2020 Exeltis USA, Inc. All rights reserved. EXP-20-0021 R00

Slynd™ (Drospirenone) tablets, 4 mg Updated Website Launches for Patients and Physicians

FLORHAM PARK, N.J, June 23, 2020 – Exeltis USA, Inc, a division of Insud Pharma, today announced the launch of the updated slynd.com, the website for Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive, in a physician and patient communication letter.

The updated Slynd™ website provides patients and healthcare professionals a rich array of information in a user-friendly format to familiarize visitors with this new progestin-only pill and educate them on Slynd™ safety and efficacy while pointing out the unique aspects that differentiate Slynd™ from other birth control options.

The website offers information about patients for whom Slynd™ is an option, with educational videos for each patient type. The website also includes video commentary from three well-respected obstetricians and gynecologists who, with their endorsement,  share their perspective on Slynd™ and why they perceive it as a meaningful contraceptive option for their patients.

Slynd™, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive with a 24 active and 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to a 24-hour window in the event of a delayed or missed dose, which is particularly beneficial for breastfeeding mothers.

“We are excited to share the website with patients and physicians.  Slynd™ is an appealing option for women who can’t or don’t wish to take oral contracptives with estrogen,” said Salustiano Perez, president of Exeltis USA. “It is a good option for women who are breastfeeding, overweight, smokers or those who want estrogen-free oral contraceptive choices. It also has a less rigid dosing schedule than other progestin-only oral contraceptives on the market.”

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd™ may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd™ if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd™ please see full Slynd™ Prescribing Information. 

About Exeltis:
Exeltis is a fast-growing division of Madrid-based Insud Pharma, an integrated health sciences group. It has developed a leading position in the women’s health sector, where it continues to discover, develop, produce and seek new medicines and medical devices to improve the health and wellbeing of women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network. Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in Women’s Health including contraception, pregnancy, birth, and menopause and has expanded its research in recent years to Central Nervous System (CNS), ophthalmology and endocrinology. In addition, to learn more, please visit us at exeltisusa.com.

For more information on Slynd™ and Important Risk Information, please visit slynd.com or contact Randi Rievman, Senior Director, Marketing and Sales Training | Exeltis USA | Phone: 973-803-5505.

Slynd™ is a trademark of Exeltis USA, Inc.
©2020 Exeltis USA, Inc. All rights reserved. EXP-19-0068 R01

Peer-Reviewed Publication Reinforces Safety and Efficacy of Slynd™ (Drospirenone) tablets, 4 mg

FLORHAM PARK, N.J., June 11, 2020 — Exeltis USA, Inc, a division of Insud Pharma, today released a physician and patient communication letter announcing a recent publication in Drugs of Today 2020 that highlights the Slynd™ safety data and the efficacy of drospirenone to inhibit ovulation, reinforcing the features and benefits of Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive.

The published article, “Drospirenone: a novel progesterone used as an oral contraceptive without an estrogen component” (D.M. Paton, 56(5): 321-328) reviews two phase III clinical studies of Slynd. The paper concludes that “it was a logical development to determine the efficacy of a tablet that only included [drospirenone] DRSP as an oral contraceptive” which gained approval by the Food & Drug Administration in May, 2019.

“There is an important place in the market for this next generation progestin-only pill for prevention of pregnancy”, notes Randi Rievman, Senior Director, Marketing and Sales Training at Exeltis USA. “Slynd, which is proven safe and effective for contraception, is truly fitting a patient need in today’s environment. Using telemedicine service providers, it can be prescribed without an office visit.  It doesn’t require a blood pressure check before prescribing as the CDC guidance stipulates for other estrogen-containing oral contraceptives or need to be inserted like the IUDs.”

Exeltis, the license holder of Slynd™, has taken additional measures during the current COVID-19 environment to make the progestin-only pill easily available to women in need of an oral contraceptive. The company has made sampling delivery safe and convenient for physicians and patients by enabling physicians to order samples sent directly to their offices or direct shipments to patient homes to further facilitate their ability to start their patients on Slynd™.

“In the current COVID-19 environment, where there are many women physically distancing and unable to go to physician offices for visits, our program enables their doctors to help them access oral contraceptives without an office visit,” said Rievman.

Slynd™, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive that has a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to a 24-hour window in the event of a delayed or missed dose, which is also very beneficial for breastfeeding mothers.

Slynd is indicated to prevent pregnancy among females of reproductive potential. Slynd is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd please see full Slynd Prescribing Information.

About Exeltis:
Exeltis is a fast-growing division of Madrid-based Insud Pharma, an integrated health sciences group. It has developed a leading position in the women’s health sector, where it continues to discover, develop, produce and seek new medicines and medical devices to improve the health and wellbeing of women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network. Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in Women’s Health including contraception, pregnancy, birth, and menopause and has expanded its research in recent years to Central Nervous System (CNS), ophthalmology and endocrinology. In addition, to learn more, please visit us on exeltisusa.com.

For more information on Slynd™ and Important Risk Information, please visit slynd.com or contact Randi Rievman, Senior Director, Marketing|Exeltis USA|Phone: 973-803-5505.

Slynd™ is a trademark of Exeltis USA, Inc.
©2020 Exeltis USA, Inc. All rights reserved. EXP-20-0020 R00

Exeltis USA, Inc. Announces the Launch of Slynd™(drospirenone) tablets, 4 mg, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24-hour missed pill window and 24/4 Dosing Regimen

FLORHAM PARK, N.J., Sept. 16, 2019 /PRNewswire/ — Exeltis USA, Inc. a division of Insud Pharma (headquartered in Madrid, Spain) today announced the commercial launch of its oral contraceptive tablet Slynd™ (drospirenone) tablets, 4 mg in the US market.

Slynd™, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy, but an improved bleeding profile and contraceptive efficacy for up to a 24 hour window in the event of a delayed or missed dose.

Slynd™ contains the active ingredient drospirenone—a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone.  In clinical trials, Slynd™ showed no instances of thromboembolic events which some women taking combined oral contraceptives (COCs) with estrogen experience.  In addition, the safety of Slynd™ is supported by its approval by the Food and Drug Administration (FDA) with no Boxed Warning unlike the COCs.

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding.

“The Slynd™ safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and women with a Body Mass Index (BMI) >30,” observed Enrico Colli, MD, Chief Scientific Officer.

In addition, Salustiano Perez, President of Exeltis USA, Inc. noted that “Slynd™ is a POP that may fit the lifestyle of more patient types, especially breastfeeding mothers seeking a safe and effective oral contraceptive without the risks of estrogen and some of the dosing challenges.”

The launch of Slynd™ will be backed by a strong sales and marketing effort directed toward healthcare professionals in the field of Obstetrics and Gynecology, the medical specialty most involved in contraceptive patient consultation and prescribing.

About Exeltis:
Exeltis is a fast growing division of Insud Pharma, an integrated health sciences group. It has developed a leading position in the women’s health sector, where it continues to discover, develop, produce and seek new medicines and medical devices to improve the health and wellbeing of women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network.  Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in Women’s Health including contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to Central Nervous System (CNS), ophthalmology and endocrinology. In addition, to learn more, please visit us on Exeltis.com and follow us on Twitter or Facebook.

For more information on Slynd™ and Important Risk Information, please visit slynd.com or contact Randi Rievman, Senior Director, Marketing|Exeltis USA|Phone: 973-803-5505.

Exeltis USA, Inc. Announces the Approval of Slynd™, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window

FLORHAM PARK, N.J., June 6, 2019 /PRNewswire/ — Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd™ (pronounced “slind”) containing drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.Slynd™, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive that is intended as a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to 24 hours in the event of a delayed or missed dose.

In clinical trials, Slynd™ (a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone) showed no instances of thromboembolic events experienced by some women taking COCs, which by definition contain estrogen.  In addition, the safety of Slynd™ is supported by its approval with no black box warning unlike other combined oral contraceptives.  But for females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency), Slynd™ is contraindicated due to its anti-mineralocorticoid activity.

“This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index (BMI) >30,” said Enrico Colli, MD, Chief Scientific Officer.

Salustiano Perez, President of Exeltis USA, Inc. observed “Slynd™ may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother.”

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Contraindications include renal impairment, adrenal insufficiency, presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or hepatic impairment, or undiagnosed abnormal uterine bleeding.

The commercial launch of Slynd™ is anticipated in early Fall 2019.

About Exeltis:
Exeltis is a fast growing division of Insud Pharma, an integrated health sciences group. It has developed a leading position in the women’s health sector, where it continues to discover, develop, produce and seek new medicines and medical devices to improve the health and wellbeing of women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network.  Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in the fields of fertility, reproductive health, contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to CNS, ophthalmology and endocrinology. In addition, to learn more, please visit us on Exeltisusa.com and follow us on Twitter or Facebook.

For further information: contact Randi Rievman, Senior Director, Marketing|Exeltis USA|Phone: 973-803-5505

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