Pfizer, Astellas prostate cancer oral med gets FDA OK for label expansion

First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI^® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. XTANDI was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.

“With today’s approval, there is now a new option for men with non-metastatic CRPC, who are in between the failure of androgen deprivation therapy resulting in CRPC and the onset of metastatic disease,” said Jonathan Simons, M.D., Prostate Cancer Foundation President and CEO. “As a foundation that drives research aimed at improving patient outcomes, it is exciting to see approvals like this, which are vital to help address unmet patient needs.”

The updated label is based on results from the Phase 3 PROSPER trial, which demonstrated that the use of XTANDI plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic CRPC. The median for the primary endpoint, metastasis-free survival (MFS), was 36.6 months for men who received XTANDI plus ADT compared to 14.7 months with ADT alone (N=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.0001). The most common adverse reactions (greater than or equal to 10%) that occurred more frequently (greater than or equal to 2% over placebo) in XTANDI plus ADT-treated patients were: asthenic conditions (40% vs 20%), hot flush (13% vs 7.7%), hypertension (12% vs 5.2%), dizziness (12% vs 5.2%), nausea (11% vs 8.6%) and fall (11% vs 4.1%). Grade 3 or higher adverse reactions were reported in 31 percent of men treated with XTANDI plus ADT and in 23 percent of men treated with ADT alone. Data from the PROSPER study were presented at the 2018 Genitourinary Cancers Symposium (ASCO GU) in February and published in the New England Journal of Medicine in June.

“Reducing the risk of disease progression is an important treatment goal in castration-resistant prostate cancer, since the disease becomes harder to treat as it advances,” said Andy Schmeltz, global president, Oncology, Pfizer. “With XTANDI, men with CRPC now have a clinically proven treatment option that reduces the risk of metastasis. This approval delivers on the potential for XTANDI to help men at an earlier stage of the disease, and we are continuing to evaluate the medicine in an extensive development program across additional prostate cancer populations.”

“This approval is important progress for men with CRPC, who now have XTANDI as a treatment option regardless of whether or not they have detectable metastatic disease,” said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. “XTANDI is a standard of care in the treatment of men with metastatic CRPC and has been prescribed to more than 250,000 men worldwide since its initial approval in 2012. The expanded indication based on the PROSPER data builds on the body of evidence for XTANDI.”

Pfizer and Astellas are committed to helping patients access XTANDI by providing them with access and reimbursement support resources regardless of their situation. Patients can visit www.XTANDI.com or call 1-855-898-2634 to learn more.

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Fresenius Had Testing Issues Like Akorn’s, Executive Says

–A Fresenius SE & Co. executive has said his company experienced testing problems similar to those that Fresenius cited as grounds for pulling out of a $4.3 billion deal to buy U.S. generic-drug maker Akorn Inc., Bloomberg reports.

–Mats Henriksson testified on Thursday in Delaware that it took Fresenius two years to address questions raised by the U.S. Food and Drug Administration in 2013 regarding drug-injection testing and test-result storage at a Fresenius plant in India, Bloomberg said.

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Evercore ISI says appeals court decision on Xyrem patents a ‘non-issue’ for Jazz

Evercore ISI says appeals court decision on Xyrem patents a ‘non-issue’ for Jazz. As previously reported, Evercore ISI analyst Umer Raffat called news that an appeals court found that seven Jazz Pharmaceuticals (JAZZ) patents being challenged by Amneal Pharmaceuticals (AMRX) are invalid a “non-issue,” stating that his quick read of today’s decision shows it all relates to the REMS patents and the core basis for patent life is the valproate patents. He said the patents that were ruled invalid “are not particularly relevant for Xyrem’s patent estate” and he does not find today’s ruling “of much significance.” Raffat keeps an Outperform rating on Jazz shares, which are down 2% to $175.48 in morning trading.

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After scandal, Human Longevity lets CFO/COO go, appoints interim leadership

Human Longevity (HLI) has let top executive Nino Fanlo go, FierceBiotech has learned. The CFO/COO departed months after he was implicated in a scandal that engulfed his former employer.

HLI hired Fanlo as CFO in May 2017 and expanded his role to cover operations when other executives departed later that year. A New York Times report on a scandal at Fanlo’s former employer, online lending startup Social Finance, cast a shadow over his tenure, though. The investigation focused on the CEO of SoFi but also included reports of Fanlo’s behavior.

“[Fanlo] sometimes kicked trash cans in the office when angry. He also commented on women’s figures, including their breasts; said that women would be happier as homemakers; and once told two female employees he would give them $5,000 if they lost 30 pounds by the end of the year, according to more than a dozen people who heard the comments and witnessed the weight-loss offer,” the Times reported.

Others have claimed Fanlo left another former employer following “behavior unbecoming of a senior executive.”

In the NYT report, Fanlo denied disrespecting women and he continued to work at HLI for months after. But HLI let Fanlo go in April, according to someone aware of comings and goings at the firm.

HLI has filled Fanlo’s former COO role on an interim basis. Scott Sorensen, HLI’s chief technology officer, is the interim COO and forms part of a temporary, new look leadership team. Sorensen will work alongside interim CEO David Karow M.D., Ph.D., who previously headed up HLI’s radiogenomics operation.

The creation of the interim leadership team was necessitated by the latest in a string of executive exits. Cynthia Collins joined HLI as CEO at the start of 2017. By the end of the year, Collins was gone. That forced J. Craig Venter, who founded HLI, to return to the CEO chair. But in May he revealed plans to step down and resume research at the J. Craig Venter Institute.

Collins and Venter’s departures were interspersed with the exits of other key executives, including HLI’s CMO, COO and head of oncology. HLI has stayed quiet about the reasons for the exits but they coincided with a period in which it increased its focus on high-end health screening service Health Nucleus.

The identities of the interim leaders are in keeping with the strategic shift. Karow has played a big role in Health Nucleus. And HLI hired Sorensen from consumer genealogy company Ancestry to help it deliver “a state-of-the-art customer experience and patient friendly products.” These activities are distinct from HLI’s focus in its early days, when it talked up the prospect of building the world’s largest database of human genetic variation and using it to make drug development breakthroughs.

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Advocate Aurora Health, Foxconn to collaborate on new tech for health care

Advocate Aurora Health and Foxconn Health Technology Business Group plan to work together to develop new services and products for health care.

The two organizations — one the 10th largest nonprofit health system in the country, the other one of the world’s largest technology companies — envision collaborating in areas such as managing the health of employees, analytics and artificial intelligence.

Charlie Alvarez, vice president-North America of the Foxconn Health Technology Business Group, likens Advocate Aurora Health to “a living lab” for new products and services.

Advocate Aurora Health and Foxconn don’t have a formal agreement but have signed a memorandum of understanding to work together.

“We are starting to have these conversations and have these meetings,” Alvarez said

Wellness programs for employees could be an initial focus.

“We do a really good job of managing our employees’ health care and making it easy for them to be able to track their health and wellness,” Alvarez said.

Foxconn has more than 1 million employees.

The company uses various platforms, including mobile apps, health measurement/assessment kiosks and remote blood pressure meters and weight scales, to collect health information from its employees, according to a document on its website.

That information is accessible through its digital platform — health to you, or h2u — to employees and health care professionals.

Advocate Aurora Health also has experience in managing the health of specific populations of patients.

For example, before its merger this year with Aurora Health Care, Advocate Health Care Network ranked second in the country, out of 432 accountable care organizations, for its performance in a Medicare program in which hospitals and physicians share in the savings when they provide care at a lower cost while meeting quality measures for a specific group of patients.

Artificial intelligence and precision medicine

Advocate Aurora Health and Foxconn also plan to collaborate on developing software for analyzing health information to identify people who are at risk of developing medical conditions, such as diabetes or high blood pressure.

Artificial intelligence and precision medicine — two fields in which Foxconn is doing research — also could be future areas of collaboration. And Alvarez said Foxconn is making and selling products in Asia that it could bring to the U.S. market.

Numerous companies provide similar applications, software and services as those on which Advocate Aurora Health and Foxconn plan to work together. And what shape the collaboration takes hasn’t been determined.

“That amount of detail is still up in the air,” Alvarez said.

But Rick Klein, chief business development officer of Advocate Aurora Health, said the collaboration eventually could result in joint ventures or partnerships.

The collaboration creates a tie between the largest health system in Illinois and Wisconsin and a company that plans to build a $10 billion factory that eventually could employ 13,000 people.

In May, Advocate Aurora Health announced plans  to build a $250 million hospital and medical office building in Mount Pleasant, site of the future Foxconn plant, and to open several new clinics in the Racine area.

 The planned collaboration could also lead to other agreements in which Advocate Aurora Health would provide health care to Foxconn’s future employees and their family members.

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Amgen and UCB Take Another Shot at Osteoporosis Drug

Amgen, headquartered in Thousand Oaks, California, and UCB, based in Brussels, Belgium, resubmitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Evenity (romosozumab).

The FDA rejected the original BLA in July 2017, requesting more data related to adverse cardiovascular events. Evenity is a monoclonal antibody being developed to treat osteoporosis in postmenopausal women. When the companies announced topline data from the Phase III ARCH trial, which compared Evenity to Merck’s Fosamax (alendronate sodium) in May 2017, there was a higher risk of serious cardiovascular events with Evenity than Fosamax.

Evenity works by inhibiting the activity of sclerostin. This results in increased bone formation and reduced bone resorption.

The resubmission added data from two more pivotal Phase III trials, the ARCH trial, an alendronate-active comparator trial that included 4,093 postmenopausal women with osteoporosis who had a fracture, and the BRIDGE study, which included 245 men with osteoporosis. The original FDA submission had data from Phase I and II trials and the Phase III placebo-controlled FRAME trial, which included 7,180 postmenopausal women with osteoporosis.

“A fracture due to osteoporosis can be a life-altering event, and Evenity has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” said Sean Harper, Amgen’s executive vice president of Research and Development, in a statement. “We look forward to continuing our work with the FDA to demonstrate the benefit:risk profile for Evenity. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”

Fifty percent of women over the age of 50 in the U.S. will have a fracture related to osteoporosis, and as the population ages, that percentage is expected to be higher.

According to research firm GlobalData, if approved, Evenity is likely to become the leading branded product in the osteoporosis market by 2027, holding a 17 percent market share.

According to The Pharma Letter, “The osteoporosis market is likely to undergo significant changes over the next 10 years, growing at a compound annual growth rate (CAGR) of 4.3 percent, despite being dominated by generic bisphosphates, according to a recent report from data and analytics company. The value of the market sector is expected to reach $11.2 billion by 2027.”

Evenity was part of a collaboration deal signed in 2004 between Amgen and UCB to develop antibody therapeutics targeting sclerostin.
The therapeutic is currently being reviewed by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA).

“The burden of osteoporosis can have tremendous impact on a patient’s life,” said Pascale Richetta, UCB’s head of bone and executive vice president, in a statement. “We are one step closer in our ability to bring this first of its kind treatment to thousands of women affected by fragility fractures each year.”

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ShangPharma Innovation Incubator Expansion Takes Strong Root in Bay Area

In March venture capital firm ShangPharma Innovations announced its plans to expand its life sciences incubator in San Francisco by 40 percent, including state-of-the-art laboratory infrastructure upgrades to its facility.  That investment is paying off as the incubator is growing.

The San Francisco Business Times reported that the Bay Area incubator is snagging new tenants as it provides much-needed space for life science companies in the crowded (and expensive) San Francisco real-estate market. But, for ShangPharma, it’s not just about the number of tenants in its life science incubator. The Times reported that the venture capital firm does not require those accepting its seed funding or early funding to set up shop in the incubator. Nor, the Times added, does it require those companies that do take space in the incubator to tap into ShangPharma’s financial resources.

The ShangPharma Innovation expansion provided 9,000 square feet to the already 32,000 square feet of space. The incubator is co-located with ShangPharma Innovation’s venture capital team, which makes seed-stage and Series A investments in life science entrepreneurs, and with Shanghai ChemPartner, a leading contract research organization providing services spanning discovery chemistry, discovery biology and preclinical development through manufacturing for small molecules and biologics.

The provision of space is important for many companies, particularly smaller companies and startups that cannot afford their own offices in the pricey Bay Area. But ShangPharma Innovation provides more than space. It also provides financial support through its grant programs and seed funding programs.

But, for ShangPharma’s leadership, the money is not that high on the list of important things the facility offers tenants. In an interview with the Times, ShangPharma Innovation Chief Executive Officer Walter Moos said the “least valuable thing we provide companies is the actual dollars.” He said that “dollars are in abundance” but said perhaps the most important asset is that the incubator provides a place for “mind share.” Meaning that startups and other young companies have access to seasoned professionals who can provide advice on a myriad of related subjects. That kind of philosophy, the Times said, goes to ShangPharma Innovation’s parent company, Shanghai-based ShangPharma Group.

Companies that have accepted ShangPharma’s hospitality include IDEAYA Biosciences, Inc. and Circle Pharma, Inc.

Moos said that one of the strengths of ShangPharma Innovations strategy is that its strategy is actually flexible as it supports the industry.

“Sometimes we do equity, sometimes we don’t,” Moos told the Times. “We don’t have a single model that works. We try to make it work for everybody.”

The Bay Area is well known as a stronghold of biotech innovation. That’s one reason companies like ShangPharma Innovation have established incubators and space for life science companies. There are numerous sites that have been set up to provide housing for the biopharma industry. The Cove, a large life science development, broke ground in 2015. The campus includes seven buildings ranging in size from 102,000 square feet to 158,000 square feet in both single- and multi-tenant building configurations. Some noted tenants include AstraZeneca, LakePharma, Five Prime Therapeutics, Denali Therapeutics and CytomX Therapeutics.

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