Zydus Cadila gets FDA nod for prostate condition med

Zydus Cadila has received final approval from the US health regulator to market Dutasteride and Tamsulosin Hydrochloride capsules.

The drug is used to treat symptoms of Benign Prostatic Hyperplasia (BPH) — also called prostate gland enlargement.

The approval has been granted in the strengths of 0.5mg/0.4 mg, the company said in a BSE filing.

Zydus Cadila said the drug will be produced at the group`s formulations manufacturing facility at Moraiya, Ahmedabad.

The group has more than 190 approvals and so far filed over 320 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.

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Quest Diagnostics: Report Shows NJ Workplace Drug Use Down

More than 10 million employment-related drug tests in 2017 showed a drop in opioid-positive results, but an increase in positive results for amphetamine use.

Overall, there was a 12 percent drop in the total of positive results among New Jerseyworkers when compared to 2016, according to the nation’s largest diagnostic services provider.

In a May report from Secaucus-based Quest Diagnostics, the annual overall percentage of positive employment-related drug tests in the state fell to 3.6 from 4.1 percent on the back of decreases in positive tests for opiates, marijuana and PCP.

Quest Diagnostics used more than 10 million urine-based drug tests results from 2017 when compiling its annual survey of workplace positivity rates.

Many of the urine-based tests used in the Quest report were assigned for cause, records show. Some other tests were part of pre-employment, post-accident, random, and screenings for the general workforce and federally-regulated employees.

In New Jersey and nationally, the opiate positivity rate within the employment-related testing dropped by 17 percent compared to 2016.

“The depth of our large-scale analysis supports the possibility that efforts by policymakers, employers and the medical community to decrease the availability of opioid prescriptions and curtail the opioid crisis is working to reduce their use, at least among the working public,” said Kim Samano, scientific director at Quest.

Opiate crackdown

North Jersey’s 2017 Quest opiate positivity rates peak around Paterson in Passaic County. The report shows the positivity rate skews higher than the state average of 0.23 percent.

Northern towns in Passaic, Bergen, Sussex and Morris counties have recorded considerable declines in opiate positivity, however, the Quest report shows. The data shows opiate positivity rate range halved in zip codes starting in 074 from 2016 to 2017. Towns with 074 include Allendale in Bergen County (07401), Bloomingdale in Passaic County (07403), Butler in Morris County (07405).

A statewide clampdown on prescription opiates is making those drugs harder to find, said Eugene “Skip” McLaughlin of New Life Recovery Center in Pompton Lakes. However, what may seem good news can be a double-edged sword, he said.

“Because they are not as prevalent as they used to be, the price goes up. And those who are cut off from the pills will switch over to the heroin,” McLaughlin said.

At the rehab and detox level, medical doctor Jeffrey Berman, with Soba College Recovery of Fairfield said his lab is not seeing a decrease in clients with opiate additions. More clients are just being admitted for addictions that start with street heroin instead, he said.

“The kids that would have started with prescription opioids are now going to heroin,” Berman said.

McLaughlin said more than 80 percent of his clients with opiate addictions started with pills. About 80 percent of them ended up switching over to street heroin, he added.

Others are now starting with street heroin of uncertain purity due to the limited availability and high cost of prescription pills to sometimes deadly effects, McLaughlin said.

Overall decline

New Jersey’s overall work-related drug positivity decline of 0.5 percent from 2016 (4.1 percent) was aided in part by declines in positive tests for opiates (down 17 percent) and marijuana (down 5 percent), records show. PCP positivity rates were also down nearly 10 percent in a state where the rate was nearly 50 percent higher than the national average of 0.020 percent, records show.

However, as positivity rates for several drugs fell, there were increasing numbers of workers in New Jersey testing positive for cocaine (up 4 percent) and amphetamines (up 6 percent) in 2017. The positivity rate for a heroin metabolite also increased from 0.058 to 0.068.

The changes in the state’s positivity rates mirror trends on the national scene, where varying usage patterns may be hindering attempts to curb drug use, said Barry Sample, senior director of science and technology with Quest Diagnostics.

Drug use trends

Between 2013 and 2017, Quest Diagnostics has recorded a 150-percent increase in methamphetamine positivity in New Jersey, New York, and Pennsylvania.

Over the last two years, SOBA College Recovery has seen the number of its clients with methamphetamine use problems rise from about 2 to 5 to 6 percent or more, Berman said. Many are coming from North Jersey’s more rural areas, Berman said.

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Amgen gets FDA OK for osteoporosis med

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia^®(denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. This approval is based on data from a Phase 3 study which showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared to those who received active comparator (risedronate).

“As a leader in bone health with more than 20 years of osteoporosis research experience, we are pleased that Prolia will now be available for patients at high risk of fracture who are suffering from bone loss due to long-term glucocorticoid treatment,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This is a serious condition that leads to rapid decreases in bone mineral density and increased risk of fracture. This approval gives patients and physicians a new treatment option.”

“Patients on long-term systemic glucocorticoid medications can experience a rapid reduction in bone mineral density within a few months of beginning treatment¹,” said study lead Kenneth F. Saag, M.D., M.Sc., professor of medicine at the University of Alabama at Birmingham School of Medicine. “With this approval, patients who receive treatment with glucocorticoids now have a new option to help improve their bone mineral density.”

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mAbxience, Amneal in Pact for US Avastin Biosimilar

mAbxience, a company specialized in the research, development, manufacturing and global commercialization of monoclonal antibody biosimilars, part of the Insud Pharma Group and Amneal Pharmaceuticals, Inc. (NYSE: AMRX), an integrated specialty pharmaceutical company powered by a robust U.S. generics business, have signed an exclusive licensing and supply agreement in the United States for mAbxience’s bevacizumab, a biosimilar candidate for Avastin(R).

Under the milestone based commercial agreement mAbxience will lead product, clinical development and subsequent manufacture while Amneal will guide the product through regulatory approval and have exclusive commercialisation rights in the United States.

“We are very proud to deepen our partnership with Amneal with the bevacizumab biosimilar agreement. We are passionate about increasing access and affordability of biologics in all countries around the world and this latest agreement with Amneal will be an important contribution to public health in the United States,” said Emmanuelle Lepine, General Manager of mAbxience.

mAbxience is progressing its international expansion, and recently established partnerships in Europe and Australia for its bevacizumab biosimilar. Building long lasting partnerships is central to the company’s business philosophy. Biosimilars bring patients a safe, effective, efficient and affordable treatment option, which contributes to the sustainability of healthcare systems worldwide. More than 10,000 patients have now been treated with a mAbxience biosimilar.

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Willis Towers Watson: Health programs fragmented, fall short for Asia workers

• Over half of employees in Asia have elevated levels of stress.
• While employers endeavour to engage them in an increasing array of non-traditional benefits, there is still a disconnect with employees.
• Finding the ‘right’ programs and leveraging technology will be key as employers start to take a more strategic approach toward health

By and large, employers in Asia still miss the mark when it comes to their health and well-being benefits, with many employees feeling that their needs are not met, according to research from leading global advisory, broking and solutions company Willis Towers Watson (NASDAQ: WLTW).

According to the Willis Towers Watson 2017/2018 Global Benefits Attitudes Survey, managing their health is a top priority for two-thirds of employees (67%) in Asia. Moreover, over half (56%) say that they suffer from elevated levels of stress. There’s a role for employers, and many are endeavouring to respond by looking beyond traditional benefits and offering behavioural/health management programs (60%), lifestyle risk management programs (44%), and financial well-being programs (33%) to meet the diverse needs of employees.

However, even though 63% of employees say that their employer-sponsored health care plan meets their needs, only 41% say that their employer-sponsored health and well-being initiatives do so.

‘The danger is that, although well-intentioned, employers will use a scattergun approach and spend valuable resources on creating standalone and fragmented programs that employees do not value,’ said Dr. Amitabh Deka, Regional Consultant, Benefits & Wellness Advisory, Asia & Australia, at Willis Towers Watson. ‘The reality is that health and well-being has broad reaching business implications – employees in good health are more productive in the workplace, as they are more engaged, less stressed, and less likely to take days off. And as employers increasingly recognise this, they also start to approach health and well-being as a strategic issue.’

Employers start to take more strategic approach

It’s encouraging that the move towards being more strategic has already started among Asia employers. By next year, almost all (97%) of employers will have a health and well-being strategy (compared with 64% today) and almost three-quarters plan to differentiate and customise their strategy to make it a key competitive advantage.

‘Key to customisation of benefits will also be businesses recognising the interconnectedness between health and well-being issues. For example, from our research we know that an individual’s job, relationships, financials, and health are leading sources of stress, and therefore mental health,’ said Cedric Luah, Head of Health & Benefits, Asia and Australasia at Willis Towers Watson.

‘We suggest that employers rethink how their programs are designed and incentivise to create and encourage long-term behavioural changes. Part of this will also be ensuring that they are centred on the employee. Employees do not want to be told what to do; rather, they want to be supported with programs that lead to improved well-being. It’s an essential balance that’s not very easy to achieve.’

What employers can do

What steps can employers take to achieve this balance? We suggest the following:

1. Use medical claims and health risk data to establish a baseline and test the effectiveness of healthcare and well-being programs through financial and non-financial metrics. This approach ensures relevant changes to make programs effective. There’s a positive increase in the percentage of those who plan to use organisational or analytics to test the effectiveness of programs by 2019 (currently 20% to 81% by 2019).
2. It is critical to introduce the ‘right’ programs. Employers should first understand which health and well-being programs are valued by their employees, and what will generate positive outcomes rather than introduce one-off programs which could be costly and ineffective. Once you have a better understanding of your particular workforce, you can design your benefits to be more relevant as well as providing greater flexibility and choice.
3. Employers can leverage technology in their programs, policies and culture, as 62% of employees are already using it to manage their own health. Just over two in five (41%) use wearables to monitor fitness activity or sleep, while 40% use technology to monitor a health condition, and 34% to track eating habits.

‘While online tools help employees make better decisions about health choices, the real change will come from solutions that connect individuals and employers,’ noted Dr. Deka. ‘Technology can be key to integrate these programs that link multiple areas of an employee’s life and help to create a consumer-grade experience that is critical to attracting employees and sustaining employee engagement.’

About the Global Benefits Attitudes Survey

The Willis Towers Watson 2017/2018 Global Benefits Attitudes Survey measured attitudes of over 30,000 private sector employees in 22 countries – including 9,462 responses from Asia Pacific, specifically from Australia, China, Hong Kong, India, Japan, Philippines and Singapore. The survey was conducted in July and August 2017.

About the Asia Pacific Benefit Trends Survey

The 2017/2018 Asia Pacific Benefit Trends survey is the fifth in our biennial series. It focuses on high-level trends around benefit strategy, benefit design, health and wellness, retirement plans, benefit delivery and benefit cost. This year’s survey was conducted between April and June 2017, and received responses from over 1,141 large Asia Pacific employers.

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Casma Therapeutics Launches with $58.5 Million

Casma Therapeutics, located in Cambridge, Massachusetts, closed on a Series A round totaling $58.5 million. The company was solely funded by Third Rock Ventures.

The company will focus on stimulating autophagy to stop or reverse rare genetic diseases and other illnesses, including neurodegeneration. Autophagy is a natural process, where extra or abnormal proteins are broken down by the cells. Other materials are also broken down, including organelles like mitochondria, viruses and other pathogens.

The materials are then recycled as a source of energy or as materials for new structures. If autophagy is functioning abnormally, the materials accumulate, causing a cascade of potential problems related to numerous illnesses.

The company’s focus is built on the work of Tokyo Institute of Technology’s Institute of Innovative Research cell biologist Yoshinori Ohsumi, who won the Nobel Prize in Medicine in 2016. Ohsumi is not one of the company’s founders, but four other experts in autophagy are. They are Beth Levine, director of the Center for Autophagy Research at the University of Texas Southwestern Medical Center; Andrea Ballabio, founder and director of the Telethon Institute of Genetics and Medicine of Pozzuoli; James Hurley, Judy C. Webb Chair and professor of biochemistry, biophysics and structural biology of the University of California Berkeley; and Herbert Virgin, the current chief scientific officer and executive vice president for research of Vir Biotechnology.

The company’s chief executive officer is Keith Dionne, a serial entrepreneur. Leon Murphy,most recently at Novartis Institutes for BioMedical Research, is Casma’s senior vice president, biology. Frank Gentile is the interim chief operating officer. Bob Tepper is the interim chief scientific officer. He is the co-founder of Third Rock Ventures and previous president of R&D at Millennium Pharmaceuticals. Cary Pfeffer is the interim chief business officer, a partner at Third Rock.

Xconomy wrote, “Casma plans to use small molecule drugs to induce autophagy in situations where the process is either slowed down because of disease, or needs to speed up to deal with the buildup of a toxic substance. The goal: stop, or even reverse the course of these diseases, though Casma is a few years from human testing and will have to prove it can interfere with this cellular process without causing other problems. ‘We think we’re working on a fundamentally safe pathway,’ Dionne told Xconomy. ‘We just have to induce it in the correct way.’”

Dionne joined Third Rock Ventures as entrepreneur-in-residence in 2011. Prior to that he led Alantos Pharmaceuticals and Surface Logix, which were both sold. Prior to Casma, he was chief executive officer of Constellation Pharmaceuticals, which was formed by Third Rock in 2008. Dionne took over the job as chief executive in 2012, only two months after it had signed a broad alliance with Genentech that included a buyout option. That deal faded in 2015, with Dionne at the time saying he regretted that the deal with Genentech had ever been signed, because it probably prevented Constellation from launching an initial public offering.

Dionne left Constellation in 2016. The company is still privately held. Since then, Dionne has been incubating Casma. He’s excited to be making the decisions from the beginning, rather than taking over after many critical decisions have been made. He told Xconomy, “I wanted to do this from the beginning, when you really have the chance to mold the company from the very start.” His plan to do that “just took a hiatus during Constellation.”

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Escient Pharmaceuticals Launches with $40 Million

Escient Pharmaceuticals launched in San Diego with a Series A financing round worth $40 million. The round was syndicated by The Column Group and 5AM Ventures, and joined by Osage University Partners.

The new company will focus on developing fist-in-class G Protein-Coupled Receptor (GPCR)-targeted drugs. It will look at specific orphan GPCRs, including the family of Mas-Related G-Protein Receptors (Mrgprs) in neuro-immuno-inflammatory and autoreactive diseases.

“GPCR-targeted drugs account for a large percentage of today’s best-selling medicines,” said Alain Baron, the company’s co-founder and chief executive officer, in a statement. “And, yet, this broad success has hinged upon exploiting a relatively small set of GPCRs, leaving significant opportunity to mine the potential of numerous unexplored GPCRs, including the specific receptors we are focused on at Escient. We look forward to building a world-class team in the coming months dedicated to translating our proprietary insights about the functions and biology of these target GPCRs to develop novel therapies that address serious, unserved clinical needs of patients impacted by our lead indications.”

Baron is the chief executive officer, co-founder and president of Elcelyx Therapeutics. He previously was a Venture Partner at Lightstone Ventures.

Marcus Boehm is the company’s chief scientific officer. He was co-founder and former chief technology officer of Receptos until it was acquired by Celgene Corporation in 2015.

The company’s third co-founder is Xinzhong Dong, a Howard Hughes Medical Instituteinvestigator and professor of Neuroscience, Neurosurgery and Dermatology with the Solomon H. Snyder Department of Neuroscience at Johns Hopkins University School of Medicine.Dong will serve on the company’s Scientific Advisory Board.

The technical journal Nature indicates that about one third to half of all marketed drugs act by binding to GPCRs. Nature says, “GPCRs are a large family of cell surface receptors that respond to a variety of external signals. Binding of a signaling molecule to a GPCR results in G protein activation, which in turn triggers the production of any number of second messengers. Through this sequence of events, GPCRs help regulate an incredible range of bodily functions, from sensation to growth to hormone responses.”

Escient believes that it can develop drugs that target GPCRs whose function isn’t yet known. The company is staying mum about what specific targets or diseases it is targeting, although Baron told FierceBiotech, “We are excited about being able to pursue a novel class that has been quite mysterious. … We are excited to crack this nut and bring forth novel therapies for serious diseases.”

The company’s board of directors will include Robert Tjian, Discovery Partner at The Column Group and professor of Biochemistry and Molecular Biology at the University of California, Berkeley; JJ Kang, Principal at The Column Group; Andrew Schwab, founder and Managing Partner at 5AM Ventures; and Charles Zuker, professor of Biochemistry, Molecular Biophysics and Neuroscience at Columbia University and a Howard Hughes Medical Institute investigator.

“We quickly recognized the tremendous opportunity of the orphan GPCRs that Escient is targeting,” Tjian said in a statement. “Alain and Marcus’ GPCR-specific experience and previous entrepreneurial successes, coupled with Xinzhong’s indisputable scholarship in this area, well position Escient in this historically productive area of drug discovery and development.”

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