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Pharma - Industry News.

FindADoc will bring you news and developments in new drug therapies and diseases.

We are specifically interested in advances in Hepatitis C treatment, in part because there are so much fewer ways  for physicians to stay abreast of the changes. Prior to the Sunshine Act, Healthcare providers were kept fully informed of developments in drug development from lecture programs and symposia. These allowed interaction between specialists that traded patient experience and shaed new information on clinical problems. The pace of drug development, in the case of hepatitis C was painfully slow and doctors found it very easy to keep up. Like all technology, drug devlopment in the second half of this decade has grown exponentially. The need for education in drug development has never been greater.

So, now tell me, Lawmakers and designers of the Sunshine Act - who suffers? Rich doctors, who at the end of a gruelling 15-hour day, during which they are forced to see patients at the rate of one every 15 minutes, they are enticed to Steak dinners with fancy wines at fancy restaurants, instead of warminng-up with their parent-deprived families, cosy chairs and warm beds ? Or patients, who cannot now benefit from the well-informed opinions of these learned intermediaries? 

We will leave it to the reader to decide. However, as best we can, FindADoc will bring you nuggets of information, richly distilled and presented like nouvelle cuisine, in small delicious packages. Just keep coming!! 

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Meeting Coverage > BSR cme/ce

Targeting IL-17A: A Winner in PsA

Ixekizumab was effective in patients who had failed TNF inhibitors

 

 

MedpageToday

  • Ixekizumab, a high-affinity monoclonal antibody that selectively targets IL-17A, improved arthritis, physical function, psoriasis, and quality of life compared with placebo, in patients with active psoriatic arthritis (PsA) who had inadequate response or intolerance to prior TNF-inhibitors.
  • Note that PsA is a chronic inflammatory condition which can be associated with extra-articular manifestations and metabolic morbidity, and approximately 30% to 40% of patients do not respond to anti-TNF therapy.
 LIVERPOOL -- Psoriatic arthritis patients with inadequate response to tumor necrosis factor (TNF) inhibitors had improvements in their arthritis and psoriasis when treated with the interleukin (IL)-17A blocker ixekizumab (Taltz), according to a phase III study presented here at the annual conference of the British Society for Rheumatology.

Among 363 patients who were randomized to subcutaneous placebo or ixekizumab, 80 mg every 4 or 2 weeks following an initial baseline dose of 160 mg, significantly more of those those receiving ixekizumab showed ACR20 responses (20% improvements on American College of Rheumatology criteria) at week 24 compared with those given placebo, reported Helena Marzo-Ortega, MD, of the University of Leeds in England.

For those given 80 mg every 4 weeks, ACR20 responses were seen in 53.3%, while for those given 80 mg every 2 weeks, ACR20 responses were seen in 48%. In the placebo group, the response rate was only 19.5%.

In addition, ACR50 responses for the every 4 weeks, every 2 weeks, and placebo groups were 35.2%, 33.3%, and 5.1%, respectively, while ACR70 responses were seen in 22.1%, 12.2%, and 0% in the three groups. The study was sponsored by Eli Lilly and Company.

"Psoriatic arthritis is a chronic inflammatory condition which can be associated with extra-articular manifestations and metabolic morbidity," she explained. Approximately 30% to 40% of patients do not respond to anti-TNF therapy.

The high-affinity monoclonal antibody ixekizumab is approved for use in plaque psoriasis and has previously been shown to improve disease activity and physical function in patients with active PsA who had not received biologic treatment in a phase III study known as SPIRIT 1. The current study, SPIRIT 2, extended the treatment experience to patients who had not responded or were intolerant of TNF inhibition. A total of 56.2% had failed one TNF inhibitor, 35.3% had failed two, and 8.5% were TNF-inhibitor intolerant. More than one-third were on concomitant methotrexate.

The full 24 weeks of the trial was completed by 87% of participants; rescue therapy was available for nonresponders at week 16. Skin outcomes were assessed among patients who had involvement of at least 3% of their body surface area at baseline.

 Patients' mean age was 52, and the sexes were evenly divided. The mean tender and swollen joint counts were 15 and 11, respectively.

Substantial improvements were already seen by week 2. "The response was very quick," she said.

A state of minimal disease activity was achieved at week 24 by 27.9% of the every 4 week group, by 23.6% of the every 2 week group, but by only 3.4% of the placebo group.

Significantly more patients who had 3% or more body surface area psoriasis at baseline had 75% improvements on the Psoriasis Area and Severity Index (PASI), with PASI-75 responses of 55.9% in the every 4 week group and 60.3% in the every 2 weeks group compared with 14.9% of the placebo group.

"One of the remarkable things was that nearly one-third achieved PASI-100s, and this is one of the first times we've seen this skin response," Marzo-Ortega said.

 
An itch numeric rating score of 0 was significantly more common in the ixekizumab groups, at 23.5% for both ixekizumab groups and none of the placebo patients. Significantly more achieved itch resolution or a dermatology life quality index score of 0 or 1 also was higher in the ixekizumab groups, at 32.4% of the every 4 week group and 25.6% of the every 2 week group compared with 3% of the placebo group.

For patient-reported outcomes, improvements also were seen in the active treatment groups on various indices including the Short Form 36 physical and mental component scales and the Work Productivity and Activity Impairment index.

More injection site reactions were seen in the active treatment groups, with most being mild. Other adverse events such as sinusitis and nasopharyngitis occurred with similar frequency in the three groups, at 68%, 73.2%, and 64.4%, respectively. There also were a couple of cases of esophageal candidiasis, she noted.

 The study was sponsored by Eli Lilly and Company.

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Novartis cooperating with Mueller team after paying Michael Cohen $1.2 million for healthcare consulting

 
 

Pharmaceutical giant Novartis said it has been questioned by special counsel Robert Mueller after revealing it paid President Trump’s personal lawyer $1.2 million for healthcare consulting.

“Novartis cooperated fully with the Special Counsel’s office and provided all the information requested,” Novartis spokeswoman Sofina Mirza-Reid said in a statement early Wednesday. “Novartis considers this matter closed as to itself and is not aware of any outstanding questions regarding the agreement.”

The acknowledgment comes after Novartis was named in a document Tuesday night made public by Michael Avenatti, the lawyer representing porn star Stormy Daniels.

 
 
 Daniels is suing Trump lawyer Michael Cohen to be released from a contract she signed to keep quiet about an alleged affair with Trump. Cohen paid her $130,000 to stay quiet.

[Rudy Giuliani: Trump repaid Michael Cohen for $130,000 in hush money to Stormy Daniels]

Last month, FBI agents in New York raided Cohen's home and office after a “referral” from Mueller, and he is currently under federal criminal investigation in the Southern District of New York.

According to Avenatti, Cohen paid Daniels through Essential Consultants, a firm that was hired by Novartis, and other companies including AT&T and Columbus Nova.

In a lengthier statement Wednesday, Novartis said it entered into a one-year agreement with Essential Consultants in February 2017 because they believed Cohen “could advise the company as to how the Trump administration might approach certain U.S. healthcare policy matters, including the Affordable Care Act.”

The contract paid Essential Consultants $100,000 monthly for a year for a total of $1.2 million.

But after one meeting with Cohen in March 2017, Novartis said it determined Essential Consultants would be “unable to provide the services” it anticipated and decided “not to engage further.” And because the contract could only be “terminated for cause,” payments to Cohen continued until its end in February 2018.

The engagement of Essential Consultants and Cohen predated Vas Narasimham becoming Novartis CEO, the statement says, and that he was in “no way involved” with the contract.

On Tuesday, Avenatti alleged Cohen was involved in payments from his Essential Consultants bank account totaling more than $4.4 million from October 2016 to January 2018.

Of that, more than $200,000 was paid from AT&T and $500,000 from Columbus Nova.

In addition to Novartis, AT&T and Columbus Nova have confirmed in statements they had business relationships with Cohen.

Columbus Nova is U.S.-based, and Avenatti claims Russian oligarch Viktor Vekselberg and his cousin Andrew Intrater — who is a U.S. citizen — control it through their equity firm Renova Group.

In a statement, Columbus Nova said it hired Cohen as "a business consultant regarding potential sources of capital and potential investments in real estate and other ventures.”

Columbus Nova also denied that Vekselberg “used Columbus Nova as a conduit for payments to Michael Cohen,” and that is is “not owned by any foreign entity or person" and has been "100 percent owned" by U.S. citizens.

Vekselberg — Russia's fourth wealthiest person with close ties to Russian President Vladimir Putin — is the chairman of Renova Group, a large Russian conglomerate, and attended Trump’s swearing-in last year. He is one of two Russian oligarchs who was reportedly stopped by FBI investigators earlier this year as part of Mueller’s probe.

Last month, the U.S. Treasury Department put Vekselberg on a list of sanctioned Russians because of Ronova’s work in the aluminum, oil, energy and telecoms sectors.

“Viktor Vekselberg is being designated for operating in the energy sector of the Russian Federation economy,” the Treasury said in its announcement.

A 2007 Security and Exchange Commission filing identifies Columbus Nova as "the U.S.-based affiliate of the Renova Group of companies, one of the largest Russian strategic investors in the metallurgical, oil, machine engineering, mining, chemical, construction, housing and utilities and financial sectors."

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HCV Drug Appears Safe in CKD

The direct-acting antiviral drug sofosbuvir (Sovaldi) appeared to be safe and effective for treating hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD), according to an observational study.

After 12 to 24 weeks of treatment with a sofosbuvir-based combination regimen, 81% of patients achieved a sustained virologic response, and their kidney function remained stable, reported researchers led by Meghan Sise, MD, of Massachusetts General Hospital in Boston.

 

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U.S Rate of Maternal HCV Infection Nearly Doubles

In the five year period between 2009 and 2014, the rate of HCV infection in pregnant women in the USA increased by 89 percent (MMWR)

 

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Saturated Hepatitis C Market

Viral Hepatitis Research and Development to Focus on Addressing Significant Unmet Needs in Chronic Hepatitis B 

CORK, Ireland, September 11, 2017 - Janssen Sciences Ireland UC (Janssen), today announced a strategic decision to discontinue further development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals - AL-335, odalasvir and simeprevir. The ongoing phase II studies with JNJ-4178 will be completed as planned, but there will be no additional development thereafter. This decision was made in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C.

“Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists.  Our scientists are energized by this challenge and our research ambition is to achieve a functional cure of hepatitis B which affects over a quarter of a billion people globally,” said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen. “At Janssen, we focus our research and development on areas of greatest unmet medical need where we can combine our excellent internal science with the best available external innovation to bring optimized solutions and maximum benefit to patients.”

Janssen pioneered the advancement of the first innovations in hepatitis C for nearly a decade when it co-developed telaprevir, a first-in-class protease inhibitor used in combination therapy for the treatment of chronic hepatitis C virus.1 In collaboration with Medivir AB, Janssen subsequently developed and launched the second generation protease inhibitor OLYSIO® (simeprevir),2 which is approved in countries around the world.

Today, people living with hepatitis C have a much more diverse range of therapies available following a wave of innovative treatments securing approval. For most, the standard of care for hepatitis C therapy has a duration of 8-12 weeks offering a cure to around 92-100% of people treated.3

 

 

 

 

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