Author Archives: admin

JSM could lead to improved arthritis treatment

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

An algorithm to monitor the joints of patients with arthritis, which could change the way that the severity of the condition is assessed.

An algorithm to monitor the joints of patients with arthritis, which could change the way that the severity of the condition is assessed, has been developed by a team of engineers, physicians and radiologists led by the University of Cambridge.

The technique, which detects tiny changes in arthritic joints, could enable greater understanding of how osteoarthritis develops and allow the effectiveness of new treatments to be assessed more accurately, without the need for invasive tissue sampling.

Osteoarthritis is the most common form of arthritis in the UK. It develops when the articular cartilage that coats the ends of bones and allows them to glide smoothly over each other at joints, is worn down, resulting in painful, immobile joints. Currently, there is no recognised cure and the only definitive treatment is surgery for artificial joint replacement.

Osteoarthritis is normally identified on an x-ray by a narrowing of the space between the bones of the joint due to a loss of cartilage. However, x-rays do not have enough sensitivity to detect subtle changes in the joint over time.

Joint space in hip, knee and ankle joints as analyzed by the JSM algorithm. – Tom Turmezei

 

“In addition to their lack of sensitivity, two-dimensional x-rays rely on humans to interpret them,” said lead author Dr Tom Turmezei from Cambridge’s Department of Engineering. “Our ability to detect structural changes to identify disease early, monitor progression and predict treatment response is frustratingly limited by this.”

The technique developed by Dr Turmezei and his colleagues uses images from a standard computerised tomography (CT) scan, which isn’t normally used to monitor joints but produces detailed images in three dimensions.

The semi-automated technique, called joint space mapping (JSM), analyses the CT images to identify changes in the space between the bones of the joint in question, a recognised surrogate marker for osteoarthritis. After developing the algorithm with tests on human hip joints from bodies that had been donated for medical research, they found that it exceeded the current ‘gold standard’ of joint imaging with x-rays in terms of sensitivity, showing that it was at least twice as good at detecting small structural changes. Colour-coded images produced using the JSM algorithm illustrate the parts of the joint where the space between bones is wider or narrower.

“Using this technique, we’ll hopefully be able to identify osteoarthritis earlier, and look at potential treatments before it becomes debilitating,” said Dr Turmezei, who is now a consultant at the Norfolk and Norwich University Hospital’s Department of Radiology. “It could be used to screen at-risk populations, such as those with known arthritis, previous joint injury, or elite athletes who are at risk of developing arthritis due to the continued strain placed on their joints.”

While CT scanning is regularly used in the clinic to diagnose and monitor a range of health conditions, CT of joints has not yet been approved for use in research trials. According to the researchers, the success of the JSM algorithm demonstrates that 3D imaging techniques have the potential to be more effective than 2D imaging. In addition, CT can now be used with very low doses of radiation, meaning that it can be safely used more frequently for the purposes of ongoing monitoring.

“We’ve shown that this technique could be a valuable tool for the analysis of arthritis, in both clinical and research settings,” said Dr Turmezei. “When combined with 3D statistical analysis, it could be also be used to speed up the development of new treatments.”

The results are published in the journal Scientific Reports.

SOURCE: www.europeanpharmaceuticalreview.com/news/76547

Kids are taking more alternative medicines than ever, and pediatricians are worried

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Supplements such as melatonin are marketed to parents, but not tested by the FDA.

Children and teens are turning to alternative medicines in soaring numbers, and the trend has pediatricians worried.

Children’s use of herbal products and nutritional supplements nearly doubled between 2003 and 2014, a study published Monday by the Journal of the American Medical Association found. Researchers at the University of Illinois at Chicago analyzed national health surveys of more than 4,400 young people and found that 6.7% took alternative medicines in 2014, compared to 3.7% in 2003. Some 33.2% of children and teens took a dietary supplement of some kind in 2014, including multivitamins.

Though they’re marketed as cures for a range of ailments, alternative supplements and medicines often end up on store shelves without oversight or approval from the federal Food and Drug Administration, the researchers noted. The surge in use was driven by 13 to 18-year-olds using omega 3 fatty acids — which are often sold as a way to boost mental focus — and melatonin, which is marketed as a sleep aid for kids, researchers found.

“We simply do not know if there are any benefits to children that outweigh the potential harms, and this study suggests supplement use is widespread and therefore an important, yet often ignored, public health issue,” said study co-author Dima Qato, assistant professor of pharmacy systems, outcomes and policy at the UIC College of Pharmacy.

“Many dietary supplements have also been implicated in adverse drug events, especially cardiovascular, which is a safety concern,” Qato said.

The findings come as America’s $3 trillion “wellness” industry is booming as consumers seek out alternatives to traditional Western medicine.

SOURCE: www.marketwatch.com/story

Former Theranos CEO faces criminal fraud charges

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

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

Seven million euros for research into chronic inflammatory bowel conditions

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

Roche SMA drug shines in study as costly new therapies advance

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A drug being co-developed by Roche to treat spinal muscular atrophy (SMA) helped improve development scores in babies with the genetic disease, a study released on Monday showed, as the race heats up for therapies destined to be among the drug industry’s most expensive.

PTC Therapeutics, which struck a licensing deal with Roche in 2011 for its SMA program, said more than 90 percent of babies with severe Type 1 SMA given the RG7916 drug achieved a greater than four-point increase in a test to measure their neuromuscular progress six months after treatment began.

PTC shares, which are listed on the Nasdaq, rose as much as 30 percent.

The companies hope their medicine, also known as risdiplam, will be approved to take on rival drug Spinraza from Biogen, which sells for $750,000 for the first year of therapy and about $375,000 annually after that.

Novartis is also quickly advancing in the SMA field with its $8.7 billion acquisition this year of U.S.-based Avexis that is working on a gene therapy for the disorder.

Analysts from Barclays project Novartis’s one-time treatment could run to $1.25 million per patient.

“We are delighted that up to 6.5-fold increase of protein production has translated into clinical impact for these babies,” PTC Chief Executive Stuart Peltz said in a statement about the RG7916 study, adding no babies required a tracheostomy or permanent ventilation since the study began, and no baby lost his or her ability to swallow.

SMA is an often-deadly genetic neuromuscular disorder caused by a missing or defective gene that normally produces a protein needed for development of motor neurons in the spinal cord. This leads to muscle wasting. Many babies with the severest form of the disorder die, while others never stand or walk.

Barclays analyst Emmanuel Papadakis expects that if Roche and PTC’s data holds up on RG7916 with regulators, it could become a fierce competitor to Spinraza, now the only licensed SMA therapy.

Cowen analysts also said on Monday they view PTC’s update as very encouraging for approval — and for competitiveness versus Spinraza, which is administered into the spine about four times a year. Roche’s and PTC’s drug is taken orally.

Novartis Chief Executive Vas Narasimhan also has high hopes for his own newly acquired SMA treatment, saying in April after the Swiss company bought Avexis that its gene therapy has “multi-billion dollar peak sales potential”.

SOURCE: www.pmlive.com/pharma_news

Veteran analyst Eric Schmidt moves over to biotech as Allogene’s new CFO

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Longtime Cowen analyst Eric Schmidt is joining Arie Belldegrun’s latest CAR-T startup, Allogene, as its chief financial officer.

The announcement comes six weeks after Schmidt confirmed that he was considering a job offer from the company, which is working on off-the-shelf CAR-T therapies.

“Eric is an enormously talented individual with a rare blend of insight into multiple facets of the industry and deep relationships within the financial community. We are very fortunate to have him join the Allogene executive team and look forward to him applying his expertise to our vision for allogeneic cell therapy,” said Allogene CEO and President, David Chang, M.D., Ph.D, in a statement.

Schmidt joined Cowen in 1998, where he served as managing director and senior biotechnology analyst. Though he’s leaving his post at Cowen, he will stay on as a senior advisor to the company.

After creating the first CAR-T for non-Hodgkin lymphoma and selling their company off to Gilead, the former Kite Pharma executives Belldegrun and Chang returned for chapter two—allogeneic, or off-the-shelf CAR-T. They launched the startup in April, with $300 million in series A capital and a suite ofe early-stage allogeneic CAR-T assets, licensed from Cellectis, by way of Pfizer.

Pfizer licensed 16 CAR-T assets from Cellectis in 2014 for $80 million up front and another $185 million per product up for grabs, making the deal potentially worth as much as $2.9 billion. A year later, Pfizer and Servier gained the rights to another CAR-T candidate, UCART19, which has now become Allogene’s lead asset, with phase 2 trials slated to start in 2019.

While Kite and Novartis earned the first approvals for CAR-T treatments in 2017, there remains much room for improvement. Their therapies, Yescarta and Kymriah, are both indicated for blood cancers, with most CAR-Ts seeing limited success in solid tumors. Moreover, CAR-T cells are made by collecting a patient’s T cells, modifying them to better target and destroy cancer and then putting them back into the patient. This makes manufacturing complex and time-consuming. An allogeneic approach uses donor cells, which can be stored and used off the shelf.

“I’ve watched and analyzed dozens of companies as they worked to bring innovative and transformative new therapies to the market,” Schmidt said. “I have greatly admired the team and investors behind Allogene and consider myself very fortunate to be in a position to help make a difference in the lives of patients who are facing cancer.”

SOURCE: www.fiercebiotech.com

AbbVie trial backs chemo-free Imbruvica combo regimen

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news

Prothena guts workforce by more than half, after trial failure

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials for its lead candidate.

The company subsequently ditched NEOD001, when trials revealed that placebo treatment outperformed the drug candidate in the treatment of AL amyloidosis.

The reorganisation sees 63 positions cut away from the Dublin-based company, representing a shedding of 57% of the entire staff at the company.

As is usually the case, the process was necessitated to stymie cash losses during 2018 – it projected its estimated net cash burn for the year to be $40 million to $50 million, driven by a net loss of $170 million to $185 million.

Luckily for the biotech, it’s had some backers that were betting that its work would produce results and so estimates that it still have a relatively healthy $421 million in cash to end the year on.

One notable backer is renowned UK investor, Neil Woodford, who had to defend his investment in biotech in a blog post immediately after the trial failures were announced – pointing out strengths from within the Prothena’s pipeline and suggesting its partnership with Roche was one reason to keep faith with the biotech.

In the announcement regarding its restructuring, Prothena followed suit, with Gene Kinney, President and Chief Executive Officer of Prothena, saying: “As we move forward, we have the resources to support the advancement of our pipeline through meaningful milestones and we will focus on developing neuroscience programs that we believe have a potential to offer significant benefit to patients. This includes our two clinical-stage programs PRX002/RG7935, currently in Phase 2 development in the PASADENA study in patients with early Parkinson’s disease, and PRX004, which recently initiated a Phase 1 study in patients with ATTR amyloidosis.”

PRX002/RG7935 is both being developed in collaboration with Roche and there will be significant hopes placed on this candidate to pull the biotech out of a tricky spot; however, with the treatment being for patients with Parkinson’s disease, it’s a fairly risky bet given the dearth of disease-modifying treatments for the condition.

SOURCE: www.pharmafile.com/news/517476

Eczema drug effective against severe asthma

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies.

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies. Dupilumab, an injectable anti-inflammatory drug, was approved in 2017 by the Food and Drug Administration as a treatment for eczema, a chronic skin disease.

The more than 2,000 patients enrolled in the studies suffered from moderate to severe asthma. All used standard asthma inhalers, and some also took oral steroids to control their severe asthma symptoms.

In one study, the rate of asthma exacerbations was almost cut in half for those taking dupilumab compared with those taking a placebo. On average, patients taking a placebo had close to one exacerbation per day during the year of the study. Exacerbations are periods of sudden worsening of asthma symptoms such as wheezing, coughing, shortness of breath and tightness in the chest.

Although the drug significantly reduced asthma symptoms for all patients, dupilumab worked particularly well in patients with high numbers of a specific type of white blood cell, called eosinophils, circulating in the bloodstream. For those patients, asthma exacerbations were cut by two-thirds.

“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” said Dr Mario Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine. “That’s important because these patients have a chronic disabling disease that worsens over time with the loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they don’t improve lung function.”

The first study included about 1,900 patients of at least 12 years of age and with moderate to severe asthma requiring they use at least three different inhalers to control their symptoms. One inhaler contained a corticosteroid that reduces inflammation, another contained a long-acting bronchodilator that relaxes airway muscles, and the third was a “rescue” inhaler filled with albuterol, a short-acting bronchodilator that quickly opens up the airway in the event of a more severe asthma attack.

Patients taking these inhaled medications then were randomly assigned to receive either dupilumab or a placebo for one year. Patients receiving dupilumab — an injectable antibody — also were randomly assigned to a higher or lower dose of the drug. Neither patients nor their doctors knew whether they were receiving the drug or the placebo.

In addition to reduced symptoms, the patients receiving dupilumab showed improved lung function in a test of “forced expiratory volume.” This test measures the amount of air a person can force from the lungs during a deep exhale. Patients receiving dupilumab, regardless of dose, improved their lung function by approximately 130-200 millilitres greater than those receiving the placebo. In general, there were no significant differences between the patients receiving high and low doses of dupilumab.

Rates of emergency room (ER) visits and hospitalisations also were improved for patients receiving the drug. In the placebo group (with 638 patients), on average, 6.5 percent of the patients required an emergency room visit or hospitalisation due to asthma during the study. In the dupilumab group (with 1,264 patients), on average, 3.5 percent of patients needed emergency care or hospitalisation due to asthma.

Based on the second study, Dr Castro said another benefit of the drug could be the ability to wean severe asthma patients off of chronic oral steroids, which can cause debilitating long-term side effects, including stunted growth, diabetes, cataracts and osteoporosis. The second study included about 200 patients using the same inhaled asthma medications as patients in the larger trial, plus additional oral steroids — usually prednisone — to control their more severe symptoms. Half of the patients receiving dupilumab in this study were able to completely eliminate prednisone use. And 80 percent of dupilumab-treated patients were able to at least cut their doses in half. Patients on placebo also reduced prednisone use but to a lesser degree, likely because the protocols of participating in a clinical trial help asthma control generally.

Dr Castro said doctors would like to help patients rely less on steroids for asthma control because those with severe asthma can be forced to take these drugs for decades to enable them to breathe.

“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe they can no longer function in the workplace,” Dr Castro said. “I’m excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies and they still can’t breathe. It can become a very disabling disease.”

Patients receiving dupilumab did experience known side effects of the drug, including pain and swelling at the injection site and a short-term bump in the number of eosinophil cells in the blood. Five patients who received dupilumab and three patients who received placebo died during the study period. According to the investigators and descriptions of these patients’ medical histories, all suffered from multiple severe medical conditions, and none of the deaths was deemed related to the study protocol.

The studies will be published online in The New England Journal of Medicine.

SOURCE: www.europeanpharmaceuticalreview.com/news/75890

Sun Pharma drug combo scores FDA approval in advanced castration-resistant prostate cancer

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients.

Yonsa has been designed using Churchill Pharmaceuticals’ SoluMatrix Fine Particle Technology manufacturing process to offer a micronised formulation of abiraterone acetate tablets, allowing it to be more efficiently absorbed in the body. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).

As part of an existing deal between the pair, Churchill Pharmaceuticals will receive upfront, commercial milestone payments and royalties related to sales of the drug in the US, where Churchill will handle marketing duties.

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” commented Sun Pharma’s North American CEO Abhay Gandhi.

SOURCE: www.pharmafile.com/news/517442