Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course!

An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

From where Allergan’s sitting, forthcoming uterine fibroid treatment Esmya could become a flagship product. But the company knows that getting it there won’t be easy—or cheap.

 

For one, there’s going to be “a lot of education required” to make Esmya successful, company commercial chief Bill Meury said in an interview. Currently, there are no FDA-approved treatments for uterine fibroids, and Allergan’s research suggests that many women living with the condition aren’t aware of treatment options.

 

“They’re employing various coping strategies, or just normalizing symptoms,” Meury said.

 

Allergan, though, is up for the task. The product is going to get “a great deal of investment,” starting with backing from a women’s health field force of roughly 300 representatives—an army Meury said is one of, if not the, largest in the industry. They’ll call on 20,000 OB-GYNs nationwide, and that’s where Allergan things its “excellent relationships” with OB-GYNs around the country will come into play.

 

“They know us and we know them,” thanks to oral contraceptive Lo Loestrin and estrogen replacement product Estrace, Meury said. “Esmya will fit right into that group.”

 

The company is also plotting a branded DTC campaign that will put Esmya “front and center,” Meury said, and that effort will include TV, print and social media components.

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Will Women's Drug Market Recover from Addyi "Non-Starter?"

Will Women's Drug Market Recover from Addyi "Non-Starter?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Women's health is spreading its wings beyond the standard gynecological vertical to raise awareness of and develop treatments for cancer, osteoporosis, and other diseases. But when measured against other therapeutic categories, the sector's sales figures fail to impress. Its pace of innovation — outside breast cancer — remains somewhat stagnant.

 

What gives? Women are increasingly interested in health and wellness and prepared to open their wallets. Yet their medical needs are too often swept under the carpet.

 

Leslie Sandberg Orne, Trinity Partners' senior partner, is concerned about declines in R&D, funding, and general innovation in the category. Though she notes a few exceptions, Sandberg Orne feels the maturity and largely generic nature of the markets, including oral contraceptives and hormonal treatments, don't bode well for women's health.

 

Meanwhile, on the heels of Addyi's 2015 flop, S1 Biopharma is boldly entering the hypoactive sexual desire disorder (HSDD) fray with female libido pill Lorexys. Addyi, developed by Sprout Pharmaceuticals and subsequently acquired by Valeant Pharmaceuticals for $1 billion, took one lap around the proverbial racetrack before crashing and burning.

 

From low blood pressure and fainting to a contraindication in alcohol, the risks and inconvenience associated with Addyi weren't worth the limited benefit for many women. “Basically, women have to take a pill every day and abstain from alcohol for only one more satisfying sexual experience per month,” explains Nadine Leonard, chief strategy officer, Heartbeat Ideas.

 

Sandberg Orne points to an even longer list of issues with the overhyped first arriver to the HSDD market: marginal efficacy, questionable tolerability, and overbearing side effects [for more on that, read: “The Addyi Report Card: Crooked Valeant Fools FDA Again”; http://sco.lt/5Ie7hR]. “Combined with a high price point and low insurance coverage, Addyi's launch not only disappointed its new ownership [Valeant], but also the makers of future competitors,” she says. “The female sexual dysfunction market may never recover from this nonstarter.”

Pharma Guy's insight:

Here are 18 more stories about Addyi: http://bit.ly/AddyiScoops

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Women A-List Celebs Hold a Special Place in Allergan's Multi-Channel Marketing Strategy

Women A-List Celebs Hold a Special Place in Allergan's Multi-Channel Marketing Strategy | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As it looks for new ways to connect consumers with its dermatology, women's health, and aesthetics portfolios, Allergan is increasingly calling on celebrity heavyweights to promote its products. In the past year alone, the drugmaker has partnered with TV and stage star Lea Michele, movie star Kate Bosworth, and reality-TV personality Khloé Kardashian.

Allergan, which estimates that 62% of its customers are women, sees the celebrity involvement as a way to create authenticity and draw attention to its brands.“It's part of a multi-channel strategy,” said Jag Dosanjh, SVP, medical dermatology for Allergan, who developed the partnership with Kate Bosworth for its acne treatment Aczone. “People consume their media in many ways, they look for different sources. Whether it's in their Facebook feeds or anything else, having other ways to connect with consumers — so they can understand the issues — is important for us to look at.”

Celebrity partnerships are an important part of the media mix for Allergan because they help break down stigmas around certain disorders, Dosanjh added. 

Last July, Allergan launched #ActuallySheCan, a campaign that was directed at millennial women (read“Allergan's #ActuallySheCan Campaign: Brand Promotion Disguised as Social Media”; http://sco.lt/684Xhp). That initiative drew on a network of female celebrities, including Michele, to foster a discussion among women. Other popular celebrities, like Emmy Rossum (“Shameless”) and model Miranda Kerr, posted content with the hashtag in support of the campaign. While an unbranded initiative, ActuallySheCan's website featured product information for the company's birth control pill Lo Loestrin Fe.

Kardashian, for her part, helped kicked off the Live Chin Up campaign in March for Kybella, a chin fat reducing injection, at a New York event (read“Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV”; http://sco.lt/6TW6qX). There, she moderated a panel, which also featured a dermatologist and a patient, who discussed her experiences with submental fullness — commonly referred to as a double chin.

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Women Don't Trust Pharma, Study Shows

Women Don't Trust Pharma, Study Shows | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When 94% of women describe themselves as healthcare decision makers but only 9% feel the biopharma industry is trustworthy, it’s time for action. This session will review results from two surveys. First, the 2015 WEST Survey on Pharma: Women’s Engagement, Satisfaction and Trust will reveal how 300 women making healthcare decisions measure their trust of the pharma industry and explore how patient engagement can help build a foundation of trust with this important audience. Then, new results of a followup survey conducted Spring 2016 share further insights on how price increases and other timely topics have impacted women’s perceptions of pharma since the 2015 survey.

Pharma Guy's insight:

Perhaps this has nothing to do with trusting pharma, but IMHO, women should be concerned about how they are portrayed in some drug DTC ads. For more on that, read "Women Need More Love, Less Drugs"; http://bit.ly/morelovelessdrugs 

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Women Lack Confidence Managing Chronic Conditions

Women Lack Confidence Managing Chronic Conditions | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to a recent study by West and Kelton Global, only about half (52%) of women with a chronic illness feel very confident in their ability to manage their chronic condition. Less than half (48%) say they're at least somewhat confident that they know what their current health metrics are, and just 28 percent are confident that they know what their target metrics should be. More than one-quarter (26%) of women feel that managing their condition is brining on stress and anxiety, which only exacerbates health challenges. Around 38 percent of women say they want more individualized care, including tips and tools specific to them.

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Venture Funding for "Bikini Medicine" (Whaa?!) Doubled Last Year

Venture Funding for "Bikini Medicine" (Whaa?!) Doubled Last Year | Pharmaguy's Insights Into Drug Industry News | Scoop.it

More female entrepreneurs and investors are focusing on largely unmet medical needs: their own.


Women are the health-care industry’s biggest customers, due in part to their need for reproductive care, and make 80 percent of the health-care decisions for their families. Tired of having their conditions misunderstood or dismissed as “bikini medicine,” they are starting up and investing in female-focused companies, many of them in digital health, a market valued at $55 billion in 2014, according to KPMG.


“Obviously women have unique health experiences that men don’t,” says Halle Tecco, who was a co-founder of venture-capital fund Rock Health and is now an adjunct professor for digital health at Columbia Business School. “It is a huge market.”


And therein lies the rub: More than 90 percent of investing partners at the top 100 VC firms are men, research by startup-tracker CrunchBase shows. People invest in ideas that they feel comfortable with, and that’s why women are leading the charge on female health, says Albert Wenger, a partner at Union Square Ventures in New York.


“There is a bias that results from the fact that a lot of venture investors are male,” Wenger says. "We are five white guys who are exhibit A in the non-diverse case. It’s just the reality of it."

That’s changing, but slowly. Female health is attracting more investors of both sexes. Nine digital-health companies focused on women raised $82 million through the third quarter of last year, up from $29 million in 2014, according to Rock Health, whose board and investment team are mostly female. One of them, Progyny Inc., raised $34 million from investors including Kleiner Perkins Caufield & Byers and TPG Biotech.


That amount pales in comparison to the $4.5 billion that poured into digital-health companies overall. So women are once again trying to shrink the gap by investing in female-focused enterprises.

Pharma Guy's insight:

I never heard the expression "Bikini Medicine" before. Did you?

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Study: Elderly Women More Likely Than Men To Be Overprescribed Rx Drugs

Study: Elderly Women More Likely Than Men To Be Overprescribed Rx Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly one in three British Columbia women over age 65 received inappropriate prescription medicines in 2013, according to a University of British Columbia study. One in four men of the same age received similar prescriptions.

 

The work analyzed population-based health-care datasets to find out which medical and non-medical factors influence patients' risk of receiving prescription drugs on the American Geriatrics Society's list of drugs that should be avoided for older patients. The biggest non-medical risk factor was an individual's sex.

 

The authors found that, even when results were adjusted for all other risk factors, women were as much as 23 per cent more likely than men to be prescribed inappropriate drugs.

 

"Being a woman is double jeopardy when it comes to taking medications," said Dr. Cara Tannenbaum, scientific director of the Canadian Institutes of Health Research's Institute of Gender and Health. "Women metabolize drugs differently than men. Gender roles and social circumstances also place them at risk. However, I expect that by empowering women with knowledge about the harms of sleeping pills and other medications, we can help drive decisions to try switching to safer therapies."

 

"For men, being married or in a high income bracket reduced the risk of receiving inappropriate prescriptions. These factors had no significant effect for women. On the other hand, being Chinese or South Asian significantly lowered women's risk of receiving an inappropriate prescription, but did not affect men's risks," said Morgan.

 

The study looked at 660,679 British Columbian residents aged 65 and older in 2013.

 

Pharma Guy's insight:

I think more women of any age are more likely to be overprescribed Rx drugs! I base this in the DTC advertising that seems to be aimed at women (see here; http://bit.ly/sadwoman).  There seems to be a proliferation of "real" diseases that "primarily affect middle-aged women." Of course, DTC advertising is not legal in Canada. It would interesting to know, therefore, why more elderly BC women are overprescribed drugs. Can it be due to physician detailing by pharma sales reps?

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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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