Category Archives: Uncategorized

Agios names former Celgene executive Jacqualyn Fouse as next CEO

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Agios Pharmaceuticals Inc on Tuesday said former Celgene Corp executive Jacqualyn Fouse would be its next chief executive officer, replacing longtime CEO David Schenkein.

Fouse, who rose through the ranks at Celgene to become president and chief operating officer before leaving the biotech company last year, is already a member of the Agios board. She will assume her new role on Feb. 1, 2019, the company said.

Schenkein, who took over as Agios CEO in 2009, will transition to the role of executive chairman and serve on the board’s Science & Technology Committee, the biotech said.

Schenkein led Cambridge, Massachusetts-based Agios from a research company to a $4.68 billion drugmaker with two approved cancer medicines.

Fouse is highly regarded by Wall Street and her name has been bandied about with each high profile executive opening in the biotech industry since her June 2017 “retirement” from Celgene. She also previously served as chief financial officer of food company Bunge Limited.

She said she intends to focus on existing drug candidates in development, as well as strategies for expansion in markets outside the United States, Fouse told Reuters in an interview.

Fouse, who led various divisions at Celgene before becoming president and COO, joined the Agios board last December. Agios has an oncology development deal with Celgene.

Agios in July received U.S. approval for Tibsovo to treat acute myeloid leukemia in patients with a specific genetic mutation. It is the company’s first wholly owned drug. Its first approved leukemia treatment, Idhifa, was partnered with Celgene.

Agios shares have risen 39 percent since the start of the year.

SOURCE: www.uk.reuters.com/article/agios-ceo

Former Theranos CEO faces criminal fraud charges

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Elizabeth Holmes, the founder and former CEO of the blood testing startup Theranos has been criminally charged with fraud, for allegedly making false claims about the effectiveness of the company’s products.

Holmes appeared before a US district court in San Jose, along with the former company president Ramesh Balwani, charged with two counts of conspiracy to commit wire fraud and nine counts of wire fraud.

Both were released on $500,000 bail and ordered to surrender their passports.

As a result of the criminal charges, Holmes has stepped down as CEO of Theranos and has been replaced by the company’s general counsel, David Taylor.

The criminal charges follow civil charges raised by the US Securities and Exchange Commission (SEC) earlier this year after a lengthy scandal where the company’s claims about its supposedly groundbreaking blood-testing technology were exposed as falsehoods.

Holmes founded Theranos in 2003 as a private health care and life sciences company, with a mission to revolutionise medical lab testing through allegedly innovative methods for drawing blood and analysing and interpreting the data.

Balwani was employed from September of 2009 until 2016, and worked in several jobs including as a board director and its chief operating officer.

A federal grand jury indictment alleges Holmes and Balwani used adverts and meetings to encourage and induce doctors and patients to use Theranos blood testing and lab services, even though they knew they were incapable of producing accurate and reliable results for some blood tests.

But tests performed on Theranos technology were likely to contain inaccurate and unreliable results, the charges said.

According to the indictment, Holmes and Balwani used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors.

While they claimed their revolutionary and proprietary analyser was able to perform a full range of clinical tests using small blood samples from a finger stick, the reality was the device had accuracy and reliability problems.

It only performed a limited number of tests and was slower than some competing devices and in some respects could not compete with existing conventional machines.

Catherine Hermsen, acting director, FDA Office of Criminal Investigations, said: “The conduct alleged in these charges erodes public trust in the safety and effectiveness of medical products, including diagnostics. The FDA would like to extend our thanks to our federal law enforcement partners for sending a strong message to Theranos executives and others that these types of actions will not be tolerated.”

SOURCE: www.pharmaphorum.com/news

AbbVie Patent Deal Staves Off Amgen Competition, But Others Lurk

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AbbVie‘s (ABBV) Humira franchise is safe through 2023 after a patent settlement with Amgen (AMGN), an analyst said Monday as he upgraded AbbVie and predicted that its profits would outgrow other large-cap pharmas through 2021.

Leerink analyst Geoffrey Porges upgraded AbbVie to an outperform rating and upped his price target to 106 from 89. He noted that the upgrade missed AbbVie’s recently strong performance, but “we believe that there is still further upside.”

“Our valuation for AbbVie is altered based on extending the U.S. market exclusivity for Humira in our model to 2023, from 2020-21 previously after the settlement with Amgen,” he wrote in a note to clients.

Under the settlement, Amgen will pay AbbVie royalties on sales of its Humira copycat. Humira is AbbVie’s most important drug, bringing in 69% of total sales in the second quarter. Humira is an anti-inflammatory med.

By the closing bell on the stock market today, AbbVie climbed 1.7% to finish at 90.39. Shares broke out of a flat base at a 75.14 buy point in late August, and have risen 18.3% since hitting that point.

The settlement allows Amgen to launch a biologic copy of Humira, known as Amgevita, in Europe next October. Its U.S. version, Amjevita, is set to launch in January 2023. Other rivals “are likely to be offered the same 2023 market entry deal,” Porges said.

Boehringer Ingelheim and Coherus Biosciences (CHRS) are closest to entry with biologic copies of Humira. Boehringer’s Cyltezo was approved in August, but the firm is in a patent battle with AbbVie. Coherus is still working to submit its application to U.S. regulators.

Dow components Merck (MRK) and Pfizer (PFE), in addition to Novartis (NVS) and MomentaPharmaceuticals (MNTA), are bound to file for approval of biologic copies of Humira in the coming quarters, but these will likely infringe on AbbVie’s Humira patents.

Any lawsuits would likely be resolved around mid-2022, removing the risk of a launch until right before the 2023 settlement date, Porges said. “As a result, we believe the certainty of U.S. Humira patent protection until 2023 is nearly 100%.”

Porges increased his 2018-19 Humira sales views by 1%-2%. Longer term, his Humira estimates increased 8% and 46% in 2020 and 2021, respectively. He expects AbbVie to hit 49%-50% operating margin from 2019-21.

He projects AbbVie 2017-21 earnings per share commanding an annual growth rate of 15%, topping large-cap pharma peers projected at 11% and mature biopharmas set for mid-single-digit growth.

“The growth horizon, along with the company’s increasingly visible late-stage pipeline, suggests that AbbVie stock should continue to re-rate into the range of these large-cap biopharma peers,” Porges said.

SOURCE: www.investors.com/news/technology

‘Living drug’ may soon be approved by the FDA for treatment of acute lymphoblastic leukaemia

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CAR-T cell immunotherapy recommended for approval and may get FDA go ahead by the end of 2017.

The Oncologic Drugs Advisory Committee at the US Food and Drug Administration (FDA) has unanimously endorsed the approval of a “living drug” that harnesses an individual’s own immune system to attack cancerous cells.

If the FDA follows the recommendation, the personalised treatment, which is called CAR-T cell immunotherapy, could be approved by the end of 2017 and will be the first gene therapy product to be approved by the FDA.

“CAR-T is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells,” explains Eric Althoff, head of global media relations at Novartis, the company seeking the approval.

According to Althoff, to begin the treatment, a patient’s white blood cells, including T cells, are extracted through a specialised blood filtration process called leukapheresis. The T cells are then genetically modified so that they recognise cancer cells and other cells expressing a specific antigen called CD19.

The newly created CAR-T cells then undergo expansion and strict quality testing before being reintroduced back into the patient.

“Within the patient’s body, the CAR-T cells recognise the patient’s cancer cells and other cells expressing a specific antigen, attach to them and initiate direct cell death,” he says.

The therapy is targeted primarily towards children and young people aged three to 25 years old with B cell acute lymphoblastic leukaemia who have failed to respond to traditional treatments.

Novartis presented the results of phase II study to the FDA which showed that 83% of patients achieved complete remission with incomplete blood count recovery within three months of infusion.

Side effects

However, 47% of patients in the study experienced grade three or four cytokine release syndrome as a side effect that results from the release of cytokines from cells targeted by the antibody, as well as immune effector cells recruited to the area. It causes fever, nausea, chills, breathing difficulties, hypotension and tachycardia, and in some patients, life-threatening complications may result from a concentrated release of cytokines, referred to as a cytokine storm.

In the study, there were no deaths or fatal brain swelling from CRS, although 15% of patients experienced grade three neurologic events.

Overall, patients had an 89% chance of surviving at six months and a 79% chance of surviving one year or more, with the majority being relapse-free at that point.

Jane Maher, joint chief medical officer at Macmillan Cancer Support, says the therapy is a “promising” one but that she will await the results of further trials.

“Immunotherapy is an exciting, fast developing area of cancer treatment,” she says. “[But] in order to see what sort of side effects this drug might have, we will have to wait and see the results of proper clinical trials.

“It is absolutely essential that all patients and their parents are fully informed about all possible side effects, as well as the often well-publicised benefits,” she adds.

SOURCE: www.pharmaceutical-journal.com/news-and-analysis

Over-the-counter devices hold their own against costly hearing aids

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Hearing aids that can cost more than $2,000 apiece are only slightly more effective than some over-the-counter sound-amplification devices that sell for just a few hundred dollars, according to a recent study.

The study bolsters legislation pending in Congress, which would have the Food and Drug Administration set regulations for cheaper over-the-counter products and is designed to make the devices more widely accessible and safer. Consumers with mild to moderate hearing loss would be able to purchase the devices without a prescription and without a medical exam, knowing they meet federal safety standards.

For the study, researchers compared how well 42 older adults with mild to moderate hearing loss repeated sentences spoken in the presence of background noise. The researchers first tested their ability to understand the speaker without any devices. Then they tested the subjects successively with a hearing aid and with five “personal sound amplification products” sold over the counter.

The hearing aid used in the study was a brand commonly dispensed in audiology clinics. The personal sound amplification products (PSAPs) that were selected either had the best electroacoustic properties or were commonly available in retail pharmacies. PSAPs perform like hearing aids but can’t be marketed as hearing aids because they don’t meet standards set by the FDA.

The results, published this month in JAMA, found very little difference between the hearing aid, which costs about $1,900 per ear, and some of the PSAPs, which mostly cost between $300 and $350 each.

On average, study participants were able to accurately repeat about three-quarters of the words spoken to them without using any device. Using the hearing aid boosted their understanding to an average 88.4 percent. And four out of the five PSAPs were nearly as effective as the hearing aid, with average word understanding ranging from 81.4 percent to 87.4 percent. The fifth PSAP performed poorly: People could hear better with their naked ears.

Age-related hearing loss is a common problem, but only about a quarter of the roughly 30 million people who have it use hearing aids, said Nicholas Reed, an audiology instructor at Johns Hopkins School of Medicine who was the study’s lead author.

“That’s a lot of people who aren’t getting in through the door,” he said.

Cost is a deciding factor for many consumers. Medicare doesn’t cover hearing aids, nor do most private health insurance plans.

Identical versions of the bipartisan Over-the-Counter Hearing Act of 2017 were introduced in the House and Senate this year. The text of those bills has been added as an amendment to the FDA Reauthorization Act of 2017, a bill that is key to FDA operations because it sets the government’s system for collecting fees during the drug approval process.

Not surprisingly, hearing aid manufacturers and distributors are against the bill. So are gun owners, who claim that regulating hearing amplifiers, which some hunters use to detect game, is in effect a way to regulate hunting and undermine their Second Amendment rights.

Reed said that by requiring the FDA to issue regulations on over-the-counter hearing aids, the proposed amendment would improve the products sold. Many of them, he said, are not effective and some are dangerous because there’s no control over amplification levels.

“When it gets to a certain amplification, it will just blow your hearing out,” he said. “Over-the-counter hearing measures would regulate these devices and force them to meet standards.”

SOURCE: www.news-medical.net/news/20170725

$1.1 billion swoop for promising Parkinson’s drug developer

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Mitsubishi Tanabe Pharma Corporation (MTPC) has announced that it has moved to acquire Israeli pharma company, NeuroDerm, in a deal worth $1.1 billion.

The deal sees MTPC gain access to NeuroDerm’s promising Parkinson’s disease treatment, ND0612, with the hope that approval could see it strengthen its stake in the US market.

ND0612 has already received promising Phase 2 results where it performed strongly, and led to favourable comparisons beyond AbbVie’s Duodopa for the management of Parkinson’s. The product will be used to treat those who cannot control their motor problems with oral levodopa. ND0612, instead, will be delivered as a continuous dose over a 24-hour period by a belt pump (image above) or patch pump.

In Phase 2 trials, it was shown to have a strong safety profile and displayed improved usage. As the administration process is continuous, it also resulted in the reduction of fluctuation in the level of plasma levodopa concentrations in patients compared with placebo treatment.

The drug is now undergoing Phase 3 trials and MTPC mentioned that it believes the product will launch in 2019. In its statement explaining the decision to acquire NeuroDerm, MTPC stated: “the acquisition of ND0612 through this transaction is intended to enable MTPC to achieve its US sales of 80 billion yen by FY2020.”

For NeuroDerm, it represents one of the largest acquisitions of an Israeli firm and the $1.1 billion deal in cash represents a premium of 17% on stock prices on Friday.

“We believe that this transaction will yield important benefits for NeuroDerm’s shareholders and the Parkinson’s disease patients that urgently need new therapies,” said Oded S. Lieberman, CEO of NeuroDerm. “MTPC has demonstrated development and commercialization expertise in the field of neurology and we are confident that the combination of their resources and the robust data supporting ND0612, our Phase III Parkinson’s disease product candidate, will help make this important new therapy available as broadly and rapidly as possible.”

The deal is expected to close by the end of 2017.

SOURCE: www.pharmafile.com/news/514684

Collaboration between CRF Health and the University Hospital Basel

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CRF Health collaborate with a research group at the University Hospital Basel led by Professor Ludwig Kappos to develop an electronic implementation of the Neurostatus-Expanded Disability Status Scale an established assessment and documentation tool for Multiple Sclerosis clinical trials.

The newly developed electronic version of the Neurostatus-Expanded Disability Status Scale (Neurostatus-EDSS) replaces the traditional paper forms, which suffer from the typical associated issues, such as data inaccuracies and administration costs.

Its ability to streamline data collection via an electronic form, facilitates the capture of higher quality data and enables fast access to consistent data for further analysis.

The new electronic version allows Expanded Disability Status Scale (EDSS) raters to review and track any inconsistencies in data entries and assessments at the click of a button. The EDSS rater can reconsider their scoring, because of a unique algorithm created by the University Hospital Basel (UHB), which identifies inconsistencies within the data.

Rachael Wyllie, CEO at CRF Health, said: “With the form already utilised in a number of clinical studies, the introduction of the electronic Neurostatus-EDSS documentation tool will facilitate much improved data collection for potential drugs for neurological conditions and significantly speed up the development process. CRF Health has recently provided the eCOA technology platform, which supported a top global pharmaceutical company in gaining FDA approval for a MS drug.”

The EDSS rater can communicate with an expert team at the UHB. Furthermore, the electronic Neurostatus-EDSS form was created with in-built explanatory notes and icons designed to assist raters. The need for them to refer to paper based guidance documents is eliminated, saving valuable time and allowing more time to focus on the patient and the assessment.

The Neurostatus-EDSS form along with the expert and rater interaction during the review process is all completed in the CRF Health TrialManager environment and all comments and score changes are fully audit trailed.

Dr Marcus D’Souza, Neurologist and Head of Neurostatus-UHB at the UHB, said: “We are delighted to have collaborated with CRF Health on this project to help create this electronic Neurostatus-EDSS assessment and documentation tool and are very much looking forward to seeing sponsors reap the benefits this new form promises for neurological clinical trials.”

CRF Health is a provider of patient centred eSource technology and service solutions for the life sciences industry.

SOURCE: www.manufacturingchemist.com/news

MSD makes €280m pledge

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Biopharmaceutical giant MSD is creating more than 300 jobs at its Carlow and Cork manufacturing sites as part of a €280m (£245m) investment.

The proposed cash injection is as a result of increased global demand for MSD’s medicines and vaccines produced in Ireland, with both sites to expand production facilities and capacity.

The majority of the 330 roles will be based in Cork, with about 120 in Carlow. Available positions will include technical, engineering, biochemistry, biology, quality and operations.

Minister Mary Mitchell O’Connor said she “warmly welcomed” the new investment and additional jobs.

“MSD has been at the cutting edge of biopharmaceutical innovation over recent years and their Irish operations are at the heart of many of the company’s exciting new products,” she added.

Sanat Chattopadhyay, MSD executive vice president and president of the company’s manufacturing division, added: “Today’s announcement is a reflection of MSD Ireland’s positive standing in our global network, a vote of confidence in our people and their work, and a sign of MSD’s future commitment to Ireland.

“The expansion of our presence in Ireland is a testament to the talent of our Irish employees. In recent years our Irish businesses have played an increasingly important role in the production of some of MSD’s most important breakthrough medicines for the global market.”

MSD currently employs more than 1,600 staff across four sites in Ireland – Carlow, Cork, Dublin and Tipperary.

SOURCE: www.insidermedia.com/insider/ireland

Johnson Matthey reveals refreshed identity

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200-year company brand refresh reflects Johnson Matthey’s position as a science-led company for cleaner and healthier life.

This week, Johnson Matthey, a global leader in science that provides cleaner air, improved health and more efficient use of natural resources, reveals a refreshed brand identity: “Inspiring science, enhancing life.”

Johnson Matthey is involved in an array of science, from catalysts that enable cleaner air to pharmaceutical ingredients. Its work is unified by a common theme: to enhance quality of life.

Work by the company includes reshaping battery technology for the automotive industry with new materials; and optimising efficiency of world scale processes used to produce important chemical intermediates.

Company progress

200 years after Percival Norton Johnson founded the company, it is celebrating global operations on all continents and annual sales of more than £3bn.

More than 90% of the company’s sales come from technologies that have an explicit environmental, health or sustainability benefit.

Today, the company employs 13,000 people in 30 countries worldwide. One pound in every twenty generated is reinvested in research and development. Last year alone, Johnson Matthey invested £188m in research and development projects around the globe.

SOURCE: www.manufacturingchemist.com/news

New drug therapy ‘reverses’ diabetes in mice

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A team of researchers at the University of California, San Diego (UCSD) have developed a drug therapy which has shown to ‘reverse’ the effects of diabetes in mice by restoring the body’s sensitivity to insulin, opening the door for potential new methods to rectify abnormal blood sugar levels.

The therapy is a daily, oral pill which inhibits low molecular weight protein tyrosine phosphatase (LMPTP), an enzyme which contributes towards insulin resistance in cells. This leads to the reactivation of insulin receptors on cell surfaces which absorb excess sugar from the blood in the presence of insulin.

The drug was administered to mice that had been fed a high-fat diet, causing them to develop type 2 diabetes. It did not seem to prompt any adverse reactions in the animals.

Past therapies have focused in the same area, on a similar tyrosine phosphatase enzyme, but have run into difficulties targeting it without causing unwanted side effects. These findings could lead to entirely new ways of approaching diabetes treatment.

“Finding a way to make cells respond to insulin again is an important and exciting strategy,” remarked Diabetes UK’s Emily Burns. “So far, the drug has only been tested in mice, and while some research in human genetics suggests this approach could work in people too, we need more research before we know how relevant this could be for people with type 2 diabetes.”

“Our inhibitor increased activation of the insulin receptor in the liver, and reversed diabetes without any apparent negative side effects,” explained Stephanie Stanford, leader of the team at UCSD. “Our compound is very specific for the target, and we do not see any side effects after treatment in mice for a month, but the next step is to rigorously establish if it’s safe for use in clinical trials,”

The number of people with diabetes in the UK is on the rise, growing by 65% over the last ten years to reach over four million in 2016.

SOURCE: www.pharmafile.com/news/513690