miércoles, 1 de marzo de 2017

Intrarosa: Sexo sin dolor en la menopausia. Y añadiendo Fuerzas...en ventas


Do we really need another steroid hormone to treat women? If yes, does it have to be DHEA? The American Food & Drug Administration (FDA) thinks so. FDA just approved Prasterone (Intrarosa) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Intrarosa is the first FDA approved product containing the active ingredient Prasterone, which is also known as dehydroepiandrosterone (DHEA).

“El dolor durante las relaciones sexuales 
es uno de los síntomas más frecuentes 
de la AVV del que informan 
las mujeres posmenopáusicas”
Dra. Audrey Gassman, M.D.
CDER, FDA.

Ver:
FDA approves Intrarosa for postmenopausal women experiencing pain during sex


 During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse. 

Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). “Prasterone (Intrarosa) provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.” 

Efficacy of Prasterone (Intrarosa), a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. 
Women were randomly assigned to receive Prasterone (Intrarosa) or a placebo vaginal insert. Prasterone (Intrarosa), when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. 

The safety of Prasterone (Intrarosa) was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. 

 (Más)


Y AMAG le pone "Fuerza...de ventas" al empeño... 

At a time when many drugmakers are laying off salespeople, AMAG Pharmaceuticals plans to hire 150 reps to help launch a newly licensed med.
Initially, the company's payer-focused marketers and Makena reps will start prepping the ground for launch. Meanwhile, AMAG is working with a recruiting firm to bring on the new reps. "We're actively working with them to make sure that we're getting sales reps in place prior to launch," said Nik Grund, the company's chief commercial officer, during the company's earnings call this week. 

The company clearly sees big potential for Intrarosa. AMAG will pay Endoceutics $50 million up front, plus 600,000 shares of newly issued common stock, which closed Tuesday at $22.65. Follow-up sales milestones add up to $45 million if Intrarosa surpasses $300 million in sales over time. 

And if sales grow past $500 million—a big target in a market now worth about $1 billion—additional milestones could add up to a whopping $850 million. The deal also includes tiered royalties and a supply arrangement, and Endoceutics will net up to $10 million for up-front launch supplies. 

The company plans to tout Intrarosa’s safety profile to set it apart from established estrogen-based treatments such as Pfizer’s Premarin cream and Estring vaginal ring. 
The AMAG drug, which contains the hormone precursor prasterone, has a “similar efficacy profile,” CMO Julie Krop said on the company’s fourth-quarter earnings call this week. “[F]rom an efficacy standpoint, I don’t see that there is particularly differentiating advantage,” Krop said. “It’s really on the safety side.” 

Competing with those heavily marketed products is one reason AMAG needs to more than double the size of its sales team, Grund said during the call. "This is a competitive marketplace," he said. "There are other folks out there who have sales forces, and making sure that we're getting the appropriate share of voice across all the targets is going to be important." (Más)
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