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Women’s Health

Independent from Merck, Organon CEO lays out newco’s women’s health ambitions, M&A plans

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Large pharmaceutical companies have withdrawn from women’s health in recent years. Merck & Co. are the latest example. But now is the perfect time for the CEO of Organon, the newly formed company that builds on this portfolio and others from Merck, to found a drug company specializing in this field.

Today, Merck Organon officially spun off its women’s health, legacy and biosimilars franchises, which totaled $ 6.53 billion in sales last year. The Newco will debut today on the New York Stock Exchange under the symbol “OGN”.

Given an overall decline in women’s interest in the health of large companies, how will the company grow? Is the company’s large ex-US presence a blessing or a curse? Is Organon interested in AbbVie’s alleged women’s health franchise for sale? Fierce Pharma recently sat down – in effect – with Organon CEO Kevin Ali to discuss his plan for the Newco.

The right timing for women’s health

Not many big drug companies these days have a women’s health segment. However, Ali believes that this is not an indication of the opportunities in the field and that it is certainly not a reason to belittle a company geared towards it.

The recent social movements have clearly given women a louder voice. “Never in my life have I seen a time when women’s voices were as sonorous as they are today,” said Ali. “As we speak, women are demanding change, demanding choice, demanding access to more innovation in women’s health.”

According to CB Insights, the global women’s health market is estimated at $ 50 billion by 2025. Ali pointed to the high unwanted pregnancy rate of 40 to 45% worldwide to illustrate a field of significant unmet need. For him, the problem is not the delay in innovation, but the lack of attention.

As a standalone drug maker, Ali says Organon can give the women’s health business the “prioritization and focus” that the franchise did not previously get from Merck as the big drug companies focused on oncology and vaccines. And with around 80% of Merck’s 10,000 plus employees coming from Organon, Organon will have a very strong corporate culture, he added.

RELATED: Merck Pulls the Curtain Back on Organon, With Declining Healthcare Portfolio For Women, But Determined Women In C-Suite, Board Of Directors

Even without the protection of a big pharma company, the name Organon has its own halo effect. The original Organon, founded in the Netherlands in 1923, pioneered contraceptive and fertility solutions until it was acquired in 2007 by Schering-Plow, which later merged with Merck. The high brand awareness will facilitate Newco’s commercial endeavors, Ali said.

“Obstetricians … have incredible respect and memories for the Organon name,” said Ali. “So we brought Organon back to version 2.0 because we wanted the world to know what it was about.”

Currently, Organon’s women’s health portfolio – and that of the company as a whole – is led by the Nexplanon birth control implant. Injured by the pandemic, sales of the product fell 13.6% to $ 680 million in 2020. However, as clinical visits rebound, the company believes the underlying demand for the long-acting reversible contraceptive will remain strong. It is also conducting studies to extend the use of Nexplanon from the current three-year indication to five years. When all is said and done, Ali expects Nexplanon to go beyond blockbuster sales.

Another contraceptive product, NuvaRing, was the previous sales king in the Organon portfolio. But it fell off the U.S. patent cliff in late 2019, and then sales plummeted 73.2% to $ 236 million last year.

By 2022, the company will have “washed out” the effects of NuvaRing’s loss of exclusivity, Ali said. Looking at the portfolio as a whole, Organon expects very low single-digit generic losses from 2022 as many of its established brands have been out of patent for many years, he said.

China and international markets offer stability

At launch, a large portion – 78.5% by 2020 – of Organon’s business, including almost its entire portfolio of established brands, will be outside of the United States. Plus, no single product accounts for more than 10% of sales. No single market accounts for more than 20% of the company’s business.

Ali described this sales structure as the stability of the new company. “When you have such a diverse business, you can essentially handle shocks to the business,” he said. It is also a blessing to have your established drug segment outside of the US because “there is more and more pressure in the” [U.S.] System ”under what he called“ Commoditized Generic Products ”.

RELATED: The Top 20 Pharmaceutical Companies by Sales in 2020 | 4. Merck & Co.

China, Organon’s second largest market with $ 873 million in 2020 sales, is still a relatively unstable element in what Ali calls “the last big market with a large reimbursed segment” for Organon’s established brands designated. The country has introduced the volume-based procurement program in recent years, which aims to significantly lower the prices of off-patent drugs by offering large chunks of the hospital business to the successful bidders. As more and more aging products are added to the program, multinational drugmakers’ businesses in China have come under pressure.

Ali said about 60% of Organon’s established portfolio in the country has gone through the process to date and another 20% will be involved in the program in the coming year. So the negative effects of future discounts will come from an already reduced base, he said.

Prior to Organon, Ali led Merck’s international commercial operations for markets outside the United States. Previously, he was president of the company’s emerging markets region.

Kevin Ali, CEO of Organon (Getty Images) During his tenure, Merck sought to transform its established Chinese drug business into the private sector, a strategy followed by several other overseas drug companies including AstraZeneca. Now within Organon, the portfolio makes up about 40% – and growing – of its retail sales, Ali said.

“There are more and more sections of the population in China who are willing to pay out of pocket for access to high-quality, trustworthy brands,” said Ali. “Whenever you have an expense market, it’s more resilient because governments are really focusing on the reimbursement market to push prices down. So I think we’ll see more stability in the next five or six years. “

Beyond the old brands, Ali also sees great potential in China for Organon’s women’s health portfolio. The country is experiencing a decline in birth rates, and women in China today are choosing to postpone their families to a later life in order to focus on their careers, Ali observed. This is where Organon’s fertility offerings could come in and help, he said.

M&A to drive expansion

Organon’s women’s health ambitions go beyond contraception and fertility. Lack of internal R&D capacity, the company’s move towards mergers and acquisitions for expansion.

Shortly before the official spin-off, Merck acquired Alydia Health for Organon with a deposit of $ 50 million and $ 165 million from Organon once it goes on its own, plus possible milestone payments. Through the deal, Organon will receive the Jada device, which is designed to treat postpartum bleeding, one of the leading causes of childbirth-related death.

This is just one example of the potential areas that Organon could seek to help do business. The company could also investigate other conditions that are unique to women or that affect women disproportionately, including uterine fibroids, menopausal symptoms and endometriosis.

In total, the company has identified over 140 active ingredients in drugs and devices at various stages of development that it could take a closer look at for M & As in order to build its pipeline “slowly and carefully and, above all, carefully”, said Ali.

RELATED: Merck Establishes $ 240 Million Buyout of Alydia Health to Reinforce its Future Women’s Health Spinout from Organon

Ultimately, innovation is the company’s main focus for M&A. The company plans to use its M&A war chest on “one-offs” like Alydia, Ali explained. What is not interested in buying? Big deals with a broad, established portfolio.

“I’m not interested in looking for something bigger, like a large product portfolio with older products that are a bit out there and have some kind of life cycle because it’s not geared towards innovation,” he said.

This is as clear as it is possible for a CEO to say “no” to AbbVie’s women’s health portfolio. It is said that AbbVie recently revived the potential auction of Allergan’s older women’s health products that the botox maker tried to sell prior to the $ 63 billion merger between the two companies. The franchise is reportedly worth $ 5 billion and includes drugs like the Lo Loestrin birth control pill.

Differences to Viatris

The spin-off from Organon comes shortly after Mylan’s and Pfizers Upjohn’s established drug portfolios are merged into Viatris, another major new independent drug company. Both Viatris and Organon have large portfolios of off-patent drugs, and both aim to use the steady cash flow generated from them to drive big business. In addition, thanks to their large trading and production locations, both companies have positioned themselves as preferred trading partners. The business models of the two companies are so similar that Bernstein analyst Ronny Gal recently thought a merger would make sense.

However, Ali sees a “significant difference” between the two companies. Organon does not sell “Commoditized Generics”, only patent-free originals; it does not face some reputational problems such as that associated with opioids; and despite an established drug business, Organon is focused on being a leader in women’s health, which it expects to be over a third of its business by 2025, Ali said.

“This is a women’s health company,” Ali said of Organon. “We believe the world needs a company that doesn’t water down, but focuses on women’s health and solving those needs. And this vision and this passion and this purpose are what drives us. “

Women’s Health

Israeli CEO seeks quantum of solace for women’s diseases – Sponsored Content

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Severe stomach pain. Nausea. Fatigue. Infertility. These are just some of the symptoms that millions of women with endometriosis suffer – an incurable disease caused when tissue that lines the uterus grows elsewhere in the abdomen.

Shahar Keinan, the Israeli CEO of Polaris Quantum Biotech, is working with another female CEO in the field to use superfast quantum computers to find a cure for endometriosis that doctors estimate affects around 10% of women worldwide.

“This will help bring drugs to market quickly, especially in areas that have long been neglected,” says Keinan of her company’s new partnership with Californian Auransa Inc., which is using artificial intelligence to find new treatments . “This really solves an unmet need.”

The two companies will also work together to find treatments and cures for ovarian and breast cancer and polycystic ovarian syndrome.

“I believe that we will be able to combine our individual expertise in biology and chemistry to develop high quality solutions for these very difficult to control or neglected diseases that affect women’s health,” says Pek Lum, Auransa’s CEO.

Solutions to these diseases are just a fraction of what Polarisqb, a North Carolina-based quantum computing startup, is researching in the fast-growing field of computational chemistry, where scientists use computer models instead of laboratory equipment to identify new compounds that stop or prevent can disease.

The technology, which is dramatically accelerating drug development, holds great promise in areas that are still under-researched – such as women’s health – and rare diseases, where drug companies often have poor return on investment.

Polarisqb is currently conducting an investment round. Private investors can find out more about OurCrowd and participate.

Traditional laboratory-based drug development methods are now becoming more expensive. Each new drug costs about $ 1 billion on average, a price that includes the many failed trials and studies, according to the Journal of the American Medical Association. The costs are passed on to the patients.

The quantum computing used by Polarisqb calculates up to 10,000 times faster than conventional computers, helps to make more drugs available faster and at lower prices, and to reduce the average time to market for a drug from 10 to seven years, says Keinan.

To test the concept, Polarisqb’s scientists built on previous Novartis laboratory research on dengue fever, which it took about four years to identify molecules that could stop the disease that causes nausea, rash and limb pain, and in patients can be fatal about 25% of the cases. Although there is a vaccine for certain age groups, it can only be given to people who have had the virus in the past. The virus infects up to 400 million people worldwide every year.

“We were able to use our platform and identify the same molecules from a library of billions in less than a minute. We also use the system to identify new molecules in order to overcome the problems with the old ones, ”said Keinan. The company will now commercialize these molecules to pharmaceutical companies.

The same work can be done with conventional computers, but “it’s a long and complicated operation,” says Keinan, and it would not save much compared to laboratory research. “We were looking for something faster and more efficient to be able to scale.”

Quantum computers allow the system to do super-fast calculations to figure out which molecules are best to use and quickly eliminate those that don’t work.

The platform works by scanning computer models of billions of different molecules. It identifies the molecules that could treat a particular disease by attacking and stopping the activity of a particular protein that changes the course of the disease. In cancer, certain molecules could stop the cancer cells’ DNA from replicating. In viruses, certain molecules could stop the replication of the RNA.

“Finding these molecules will stop the disease,” says Keinan, adding that these molecules then become prescriptions or blueprints for drugs.

“We’re just trying to find the perfect molecule or key that fits exactly into the protein’s keyhole,” she says.

Polarisqb used a digital annealer, a quantum-inspired technology developed by Fujitsu that is able to perform parallel optimization calculations in real time with a speed, precision and size that is unmatched by classical computing. The collaboration with Fujitsu expands the number of molecules sought from 10 million to trillions of molecules and thus increases the probability of finding new, useful drug candidates.

“The new solution from Polarisqb and Fujitsu shortens the time frame for drug discovery and lead optimization from up to 48 months to just eight months,” says Alex Brown, Drug Discovery Consultant at Fujitsu.

Traditionally, scientists have done this in laboratories and conducted experiments to exclude molecules or find effective ones. But this process of trial and error is lengthy and costly, and one of the reasons why the average drug takes about a decade to develop.

“Either you do it slowly and very expensive,” says Keinan. “Or you find a new technology; and we do. “

You can find more information about investing in Polaris Quantum Biotech HERE.

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Women’s Health

Why a former Ro exec set out to start her own digital health startup

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Rachel Blank left Ro last year to start Allara. The startup focuses on helping women cope with PCOS and other complex diseases. Image credit: Allara

After serving two years as Director of Strategy for Digital Health Unicorn Ro, Rachel Blank set out last year to start a new company based on her own health experiences.

In September, she founded Allara Health with the aim of helping women treat polycystic ovarian syndrome (PCOS), a condition that affects an estimated one in ten women. It’s a common cause of infertility, but it affects much more than that – a large percentage of people with PCOS are also insulin resistant, and the condition is also linked to anxiety and depression.

In most cases, it takes years to diagnose and little is known about what actually causes the disease.

Blank found this out from personal experience. She was diagnosed with PCOS 10 years ago after dealing with unexplained health problems for years.

“That was not only a surprise, but especially for me because I grew up the daughter of a gynecologist,” she said in a Zoom interview. “Even when I was diagnosed, I didn’t feel like I ever made a good path in the healthcare system. I never knew where to go, which doctors to see, what to do. I found doctors very dismissive or said things like, ‘If you’re not trying to get pregnant, I don’t really know what to do for you.’ “

The pandemic spurred her to think more about her health and she started doing her own research. She found large communities of women on the internet trying to put together the same questions she was faced with.

“That was that big aha moment for me,” she said. “I can bring in not only my personal experience, but also my professional experience in the field of digital health and, to be honest, build something better.”

Blank is no stranger to women’s health. While at Ro, she ran one of the company’s direct-to-consumer brands, Rory, which offered prescription and wellness treatments for menopausal women. Before that, she worked as an investor for General Catalyst.

At Allara, her goal is to focus more on improving access to specialized treatments, an area that is often overlooked by other women’s health startups that are more focused on primary care or fertility.

“Where I saw this massive void was the specialty care,” she said. “What to do if you not only need contraception but are also not ready for IVF? There is really nowhere you can go in traditional healthcare or digital healthcare right now. “

The New York startup offers virtual visits to gynecologists and endocrinologists as well as nutritional advice and coaching. You also have the option of ordering diagnostics such as a blood test or medication if necessary. Allara currently charges a $ 125 monthly subscription model for all of its services, although going forward, Blank said the company plans to offer it as an employee benefit and offer more point solutions.

Allara currently operates in six states but hopes to be in all 50 states by the end of the year. The company has started visiting patients in the past few months. Around 35,000 women have either signed up for the service or expressed their interest.

In the longer term, Blank hopes to expand to other, often overlooked diseases such as endometriosis and uterine fibroids.

“This motivates me and motivates my entire team to understand the massive impact we have not only on a woman’s everyday life and her daily feelings, but also on her health outcomes,” she said, “.

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Women’s Health

County needs a trauma-informed facility for female inmates

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On Tuesday, June 15, the Travis County Commissioners Court will vote on whether or not to approve a $ 4.3 million design services contract for the proposed Travis County Trauma Informed Women’s Facility Project. The design of the project is influenced by the tremendous efforts of an advisory committee that issued recommendations based on months of work with interviews with female inmates and research into best practices.

The purpose of this project is not to increase detention capacity; Rather, it is about replacing outdated and inefficient facilities and building a holistic facility that houses female inmates in one building, with access to on-site gender-specific medical services, trauma-informed care and counseling, psychosocial support system, vocational training and other programs.

This project is the first of many outlined in Travis County’s current prison facilities master plan, which suggests that at least seven buildings in the prison complex are in disrepair and have been in use for longer than originally intended. I do not support the replacement of all of these buildings. I support the proposed women’s facility that addresses the needs of women from a trauma-informed perspective. If women were placed in a facility with only women and their medical needs attended to, the facility would be safer for women and the officials who protect them.

In addition, a facility that enables the continuous supply of mental health and vocational training services can begin to address the core issues related to the social determinants of health critical to the inmate’s rehabilitation and ensure successful re-entry into the to ease society after they have served their time.

Many prisoners have a background of poverty. The simple fact is that for people living near the poverty line, the prison is the primary place for mental health and medical care. I am not happy about this, but as a Travis County Commissioner, it is my duty to provide for the primary needs of the people who are in our care. I will not fail to improve the existing services without a specific program to replace these much-needed services.

The best of intentions without the appropriate resources can withhold necessary treatment options from members of the community. Lawyers who oppose the Women’s Facility Project fail to recognize the complexities of the issues or the fact that neither the state nor the local government has invested in the necessary resources to provide mental health services outside of prison. Travis County needs more access to drug beds and services for commonly diagnosed mental health problems.

I support parallel efforts to increase these services and provide more distraction, and I am ready to work with anyone who can help solve these complex problems; However, I cannot support pursuing this work at the expense of providing trauma-informed services to incarcerated women who, for various reasons, remain in our prison and under our care.

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