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Thursday, July 5, 2018

With brand-new patent, Roche demands royalties on Lilly’s psoriasis drug Taltz


Here’s a patent gambit for you: Roche’s Genentech unit sued Eli Lilly for infringement Tuesday, claiming the Indianapolis drugmaker’s psoriasis drug Taltz steps on one of its patents.
Thing is, Genentech just won that patent this week.
Taltz has been on the market since 2016—long enough to build up to $486 million in U.S. sales last year, despite heavy competition in its field from Novartis’ first-to-market Cosentyx and other newcomers. But Genentech alleges that the drug, which works by inhibiting the immunology pathway IL-17, infringes its own brand-new patent that covers biological drugs that target that specific pathway.
Now that Genentech has that patent, referred to in the lawsuit as the ‘654 patent, it argues Lilly’s “commercial manufacture, use, offer for sale, or sale of Taltz in the United States or importation of Taltz into the United States constitutes an act of infringement” of some patent claims.
An Eli Lilly representative didn’t immediately respond to a request for comment. The lawsuit seeks damages and royalties in lieu of a permanent injunction.
It’s not the first time drugmakers have fought patent disputes over already marketed drugs. Gilead and Merck have litigated for years over hep C patents as Gilead’s Sovaldi and Harvoni raked in billions. Amgen and partners Sanofi and Regeneron have fought over intellectual property in the PCSK9 class of cholesterol drugs, as well.

Genentech’s patent specifies ownership of “humanized monoclonal antibodies that bind to the IL-17A/F heterodimer.” In the new wave of psoriasis drugs, Taltz isn’t the only IL-17A med; Cosentyx works by inhibiting the IL-17A pathway, too. Valeant’s Siliq goes after multiple IL-17 targets, while UCB’s pipeline drug bimekizumab selectively inhibits IL-17 A and IL-17 F, the Belgian pharma says.
Taltz is among a group of new launches Eli Lilly is counting on for growth as its diabetes business continues to face competitive assault. In the first quarter, sales for the drug grew 52% over the same period last year to $146.5 million. But sales were down quarter-over-quarter in the U.S. due to specialty pharmacy buying patterns, the company reported.
Taltz won its original FDA approval in 2016 to treat moderate to severe plaque psoriasis. In 2017, the drug secured a nod in psoriatic arthritis. Eli Lilly also recently presented positive phase 3 data in ankylosing spondylitis.

Regulus cuts workforce by 60%, pauses Phase 1 study


Regulus Therapeutics announced a strategic update and corporate restructuring. With the goal of extending its cash runway, Regulus has taken the following steps: recruitment activities for the RG-012 clinical program in Alport syndrome have been paused while discussions with Sanofi to potentially restructure the partnership are ongoing; preclinical research efforts will be focused on its Hepatitis B virus programs; and a workforce reduction of approximately 60% is being implemented. These actions are anticipated to yield over $20M of annualized savings, which are intended to extend the company’s cash runway into mid-2019. The company also announced that it has voluntarily paused the Phase 1 multiple ascending dose, or MAD, study for RGLS4326 due to unexpected observations in its 27-week mouse chronic toxicity study, which was designed to support the Phase 2 proof-of-concept study in Autosomal Dominant Polycystic Kidney Disease previously planned to start in mid-2019. The observations in the mouse chronic toxicity study were unexpected, given the favorable safety profile of RGLS4326 in previous non-GLP and GLP toxicity studies at the same or similar doses supporting the Investigational New Drug application and Phase 1 program. In consultation with FDA, the Company has initiated investigative studies and is planning a new 27-week mouse chronic toxicity study with certain changes that are believed to address the unexpected findings. The 40-week non-human primate chronic toxicity study continues with no significant findings to date. Importantly, RGLS4326 has been generally safe and well-tolerated in the Phase 1 single ascending dose and MAD studies to date.

Prostate cancer ultrasound treatment may be effective as surgery, radiotherapy


Using high energy ultrasound beams to destroy prostate cancer tumours may be as effective as surgery or radiotherapy, but with fewer side effects.
A new study, carried out at six hospitals across the UK, tracked 625 men with  who received a type of  called high-intensity focused ultrasound (HIFU).
The research, published in the journal European Urology, is the largest ever study of HIFU treatment used to target prostate tumours. The treatment is similar to a ‘lumpectomy’ for other cancers – where doctors remove only tumour cells, leaving as much healthy tissue as possible.
The findings, from a number of institutions including Imperial College London, Imperial College Healthcare Trust and University College London, found that after five years the  survival rate from HIFU was 100 per cent. Approximately, 1 in 10 men needed further treatment. The cancer survival rate from  and radiotherapy is also 100 per cent at five years.
The research also showed the risk of side effects of HIFU, such as urinary incontinence and erectile dysfunction, were lower than other treatment options, at 2 per cent and 15 per cent respectively.
The study was funded by the Medical Research Council and SonaCare Inc., who manufacture the ultrasound equipment used in the procedure.
Professor Hashim Ahmed, lead author from the department of Surgery and Cancer at Imperial, said: “Although prostate cancer survival rates are now very good, the side effects of surgery or radiotherapy can be life-changing. Some patients are left requiring multiple incontinence pads every day, or with severe erectile dysfunction.”
He added: “We need to now focus on improving the quality of life for these men following treatment. This latest trial of focal HIFU – which is the largest and longest study of the treatment to date – suggests we may be able to tackle the cancer with fewer side effects.”
Prostate cancer is the most common cancer in men in the UK, with around 47,000 cases every year.
Treatments include surgery to remove the gland, or radiotherapy, which uses radiation to the entire prostate.
However, these treatments can cause collateral damage to surrounding sensitive tissues like nerves, muscles, urine passage, bladder and rectum. The prostate is roughly the size of a walnut and sits between the bladder and the penis.
Surgery and radiotherapy to the entire prostate are effective treatments but can lead to long term risk of urinary problems, like incontinence, of between 5-30 per cent. They also carry a risk of erectile dysfunction of between 30-60 per cent. Radiotherapy can also cause rectal problems like bleeding, diarrhoea and discomfort in 5 per cent of patients.
Ultrasound approach
HIFU is a newer treatment, performed under general anaesthetic, which delivers beams of high energy ultrasound directly into the prostate gland, via a probe inserted up the back passage. There are no needles or cuts to skin. This allows a surgeon to precisely target tumour cells within the gland to millimetre accuracy, with less risk of damage to surrounding tissues.
In the new HIFU study, conducted on men with an average age of 65 and whose cancer hadn’t spread, the risk of urine incontinence (defined as requiring pad use) at five years after the treatment was 2 per cent, and the risk of  15 per cent. The team say the results include patients with medium to high risk cancer.
The scientists also tracked the number of patients who needed further treatment following HIFU, (such as surgery or radiotherapy), to treat any cancer cells that had returned. They found 10 per cent of patients needed further treatment by five years, which is comparable to number of patients needing further treatment after surgery or radiotherapy (5-15 per cent).
The team add that prostate cancer patients should talk through all possible treatments with their healthcare team, so they can consider their options fully.
Further follow-up trials are needed to track progress of the patients after ten years, as well as trials that directly compare HIFU with surgery and radiotherapy.
Dr. Caroline Moore, Reader in Urology from the UCL Faculty of Medical Sciences said: “The registry based data from over 600 men is very encouraging. We started the HIFU programme at UCLH in 2003, and now principally use it as a focal treatment, where we treat the cancer but not the entire prostate.
This means that men are much more likely to preserve urinary and sexual function, compared to traditional surgery or . Focal treatment is particularly suitable for men who have prostate cancer visible on MRI, which is contained to one area of the prostate.”
Anthony Murland underwent HIFU treatment in November last year at Imperial College Healthcare NHS Trust to treat his  cancer. “I first heard of the treatment from a friend, who had the procedure a few months before. My GP hadn’t heard of HIFU, but was very interested, so I ended up educating him about it. He then referred me for the treatment on the NHS” explained the 67-year-old from Suffolk.
“I liked the sound of the treatment as it seemed the least invasive option, with low risk. The treatment was over in a day – I went in first thing in the morning and was out by the evening. I didn’t have any pain, but needed a catheter for five days, which was a bit uncomfortable.
“I’m closely monitored by my GP, and so far the cancer has not returned.”
More information: Stephanie Guillaumier et al. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer, European Urology (2018). DOI: 10.1016/j.eururo.2018.06.006

Johns Hopkins Hospital in Baltimore evacuated due to possible TB exposure


Two buildings at the Johns Hopkins Hospital in Baltimore, Maryland, were evacuated on Thursday because people may have been exposed to tuberculosis, a hospital spokeswoman said.
A small amount of the tuberculosis bacteria may have been released while being transported between two of the hospital’s cancer research buildings, the spokeswoman, Kim Hoppe, said in an email. Tuberculosis, or TB, is a serious airborne infection.
Both buildings were evacuated, and employees who were in the area when the incident occurred have been isolated and will be evaluated by the Fire Department, Hoppe said.
“So far, all indications are that no other individuals have been exposed; however, the buildings will remain evacuated until cleared by public safety officials,” Hoppe said.
Helicopter footage by a news crew showed about two dozen people standing outside one of the hospital’s buildings, with some dressed in hazmat suits.
A spokeswoman for the fire department did not immediately respond to requests for comment.
Johns Hopkins Hospital is considered one of the top hospitals in the United States.
In 2016, about 10.5 million people became ill around the world with tuberculosis, and 1.7 million were killed by it. A tiny fraction of those infections and deaths were reported in the United States.

AbbVie wins reversal of $140 million verdict in case over AndroGel risks


A U.S. judge on Thursday overturned a $140.1 million verdict against AbbVie Inc in a lawsuit by a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack.
U.S. District Judge Matthew Kennelly in Chicago ordered a retrial in the lawsuit brought by Tennessee resident Jeffrey Konrad, whose case is one of thousands AbbVie faces nationally over injuries blamed on AndroGel.
In October, jurors awarded Konrad $140,000 in compensatory damages and $140 million in punitive damages after finding that AbbVie was negligent and made misrepresentations related to AndroGel that helped cause his 2010 heart attack.
But Kennelly said the jury’s finding on the negligence claim was inconsistent with its decision to find AbbVie not liable on another claim as both involved determining if AndroGel was unreasonably dangerous and caused his heart attack.
“When this happens, the court cannot accept one of the two inconsistent verdicts while discarding the other; both of them have to go,” Kennelly wrote.
AbbVie did not immediately respond to a request for comment. A lawyer for Konrad also did not respond to a request for comment.
Chicago-based AbbVie has said it faces 4,500 cases nationally in which plaintiffs claim the company did not adequately warn about risks of heart attacks, strokes and blood clots that could result from using AndroGel.
The verdict in Konrad’s lawsuit came in one of a series of test trials in federal litigation consolidated before Kennelly over AndroGel aimed at helping both sides gauge the range of damages and define settlement options.
Konrad had alleged that he had been using AndroGel for two months in 2010 when he suffered a heart attack. He has since recovered from his injuries.
Thursday’s ruling marked the second time Kennelly has ordered a retrial in one of the test, or bellwether, cases.
In December, he overturned a verdict in which jurors awarded $150 million in punitive damages but no compensatory damages to Oregon resident Jesse Mitchell, who said he suffered a heart attack after using AndroGel.
Mitchell’s case was retried, and jurors in March ordered AbbVie to pay him $3.2 million.
The lawsuits by Konrad and Mitchell are among four to date that have gone to trial over AndroGel. The company won the other two cases that went to trial.
The case is In Re: Testosterone Replacement Therapy Products Liability Litigation, U.S. District Court, Northern District of Illinois, No. 14-cv-01748.

Ironwood to detail Phase 2 data on diabetes-hypertension med


Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, announced that the company will present clinical and preclinical data for the company’s soluble guanylate cyclase (sGC) stimulator praliciguat (IW-1973) during the American Diabetes Association’s (ADA) 78th Scientific Sessions in Orlando, Fla., June 22 through June 26, 2018. Praliciguat is currently being studied in Phase II clinical trials in patients with diabetic nephropathy and in patients with heart failure with preserved ejection fraction (HFpEF) (see also Ironwood Pharmaceuticals Inc.).
Data from a Phase IIa 14-day study of praliciguat in patients with diabetes and hypertension will be featured as an oral presentation during the Emerging Targets for Diabetes Treatment session, presented by John P. Hanrahan, M.D., M.P.H., of Ironwood. In addition, a Phase IIa rapid dose escalation study of praliciguat in patients with diabetes and hypertension will be presented during a poster session. Finally, new data will be presented in a moderated poster discussion on praliciguat’s effect on glucose tolerance, insulin sensitivity and triglycerides in a preclinical diet-induced obesity model.
sGC plays an important role in regulating many critical physiological processes; therefore dysregulation of sGC may play a role in multiple serious diseases. Ironwood’s sGC stimulators, including praliciguat, are believed to harness the nitric oxide/sGC/cyclic guanosine monophosphate (NO/sGC/cGMP) pathway by working synergistically with NO to improve blood flow and metabolism and decrease inflammation and fibrosis. Praliciguat has the potential to address the underlying causes of devastating diseases such as diabetic nephropathy and HFpEF by improving NO signaling, which may improve vascular and metabolic function and decrease the inflammatory and fibrotic consequences associated with these diseases.

Mallinckrodt Has Interim Data Of H.P. Acthar Studies


Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, recently reported preliminary interim data from ongoing H.P. Acthar® Gel (repository corticotropin injection) studies, including the company’s Phase 4 Rheumatoid Arthritis (RA) clinical trial and its prospective observational registry for Multiple Sclerosis (MS) relapse. Details on both the RA (available here) and MS (available here) data presentations were posted to Mallinckrodt’s website (see also Mallinckrodt Pharmaceuticals).
“We are pleased to see continued advancement of our evidence base to support the effectiveness of H.P. Acthar Gel and build on the decades of clinical experience for the product,” said Steven Romano, MD, Chief Scientific Officer and Executive Vice President of Mallinckrodt. “The progress of these studies may help prescribers and payers further understand how the drug may provide benefit to appropriate patients.”