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Sunday, March 31, 2019

Circassia Pharmaceuticals: FDA approval of Duaklir for treatment of COPD

Duaklir® launch planned H2 2019
Duaklir® to join Tudorza® in Circassia’s portfolio of US COPD products
Circassia Pharmaceuticals plc (‘Circassia’ or ‘the Company’; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir® is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg) administered twice-daily via the breath-actuated inhaler Pressair®. Circassia is on track to launch Duaklir® in the United States in the second half of 2019 via its dedicated COPD sales force.
In 2017, Circassia and AstraZeneca established a collaboration for the commercialisation of Tudorza® and Duaklir® in the United States. At the end of 2018, Circassia exercised its option over Tudorza® and the Company now has the full US commercial rights to both products. Under the companies’ agreement, a contingent option fee of $20 million becomes due to AstraZeneca within 30 days of the FDA approval of Duaklir®, and final deferred consideration of $100 million is due by 30 June 2019. The Company is in discussions with third-party finance providers to satisfy all or part of these payments. If this financing is not forthcoming, Circassia plans to use a loan facility provided by AstraZeneca under the companies’ agreement to satisfy the outstanding amount.
Duaklir® and Tudorza® are registered trademarks of Almirall S.A.
Pressair® is a registered trade mark of the AstraZeneca group of companies

NY accuses opioid maker Purdue of illegal fund transfers to Sacklers

Purdue Pharma LP fraudulently transferred funds to members of the wealthy Sackler family who control the OxyContin maker despite knowing it faced major liabilities that had made it already insolvent, New York’s attorney general alleged on Thursday.

New York Attorney General Letitia James made the claims in a revised lawsuit already pending against Purdue over its role in the opioid epidemic that added members of the Sackler family and other drug manufacturers and distributors as defendants.
The lawsuit alleged Purdue and other manufacturers engaged in deceptive marketing that downplayed the dangers of the addictive painkillers and accused distributors of failing to detect the diversion of the drugs for illicit purposes.
“As the Sackler family and the other defendants grew richer, New Yorkers’ health grew poorer and our state was left to foot the bill,” James said in a statement.
The revised lawsuit also added as defendants units of opioid manufacturers Johnson & Johnson, Endo International Plc, Teva Pharmaceutical Industries Ltd and distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp.
In a statement, the Sackler family called the lawsuit “a misguided attempt to place blame where it does not belong for a complex public health crisis.”
Representatives for the other defendants did not respond to requests for comment.
The case is among roughly 2,000 lawsuits filed by state and local governments seeking to hold Purdue and other pharmaceutical companies responsible for the U.S. opioid crisis.
Opioids were involved in a record 47,600 overdose deaths in 2017 in the United States, according to the U.S. Centers for Disease Control and Prevention.
The complaint came after Purdue and the Sacklers on Tuesday reached a $270 million settlement with Oklahoma resolving similar allegations. Purdue had been exploring filing for bankruptcy prior the accord’s announcement.
In her lawsuit, James accused Purdue of seeking to “intimidate” states pursuing lawsuits against it by threatening bankruptcy, which would hinder their cases and limit their ability to recover damages.
Yet James said Purdue, which is fighting lawsuits by 34 other states and hundreds of localities, has continued in the face of its liabilities to pay millions of dollars to the Sacklers.
The lawsuit argued Purdue was either insolvent or near insolvency when it transferred those funds, making the transfers illegal under New York law.
The payments meant Purdue, which had average annual sales of $3 billion, no longer had assets that could satisfy the state’s claims, the lawsuit said.

AstraZeneca Selumetinib Designated as Breakthrough Therapy

AstraZeneca said Monday that its Selumetinib drug has been granted a breakthrough therapy designation in the U.S. for neurofibromatosis type 1, a genetic condition which causes tumors to grow in the nervous system.
The drug company said the designation is for treatment of pediatric patients aged three years and older, and means Selumetinib could get an expedited regulatory review.
The designation is based on a phase 2 trial for Selumetinib. The drug is being jointly developed by AstraZeneca and Merck & Co. Inc. (MRK).

Novartis pays $310 million upfront for inflammation specialist IFM

Novartis on Monday said it had agreed to pay $310 million (£238 million) upfront, with the possibility for more later, for some assets of Boston-based inflammation specialist IFM Therapeutics as the Swiss drugmaker seeks to expand its immunology pipeline.

The deal for the IFM subsidiary IFM Tre could eventually reach nearly $1.6 billion, IFM said in a statement, should the portfolio of clinical and preclinical molecules meet milestones. IFM has one molecule, IFM-2427, in an early Phase 1 trial, as well as other less-developed assets.

FDA Action Alert: Evoke Pharma, IntelGenx and ADMA Biologics

Three companies are looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Evoke Pharma’s Gimoti Runs Into Trouble
Evoke Pharma’s Gimoti has a target action date of April 1. On March 4, the Solana Beach, Calif.-based company received a multi-disciplinary review (DR) letter from the FDA in association with its New Drug Application (NDA) for Gimotti. A DR letter is used by the FDA to communicate its early thinking on deficiencies observed in an initial review of an NDA. Gimotti is designed to treat gastroparesis, a debilitating, episodic condition characterized by slow or delayed gastric emptying of the stomach after meals, often resulting in symptom flare-ups that include nausea, vomiting, abdominal pain and bloating. It occurs disproportionately in adult women.
There were three sections of the NDA that the agency had concerns about. They were chemistry, a combination of product quality control and reproducibility connected to the commercially available sprayer device used with the drug; clinical—lack of enough data to support sex-based efficacy differences; and clinical pharmacology, specifically that the maximum concentration wasn’t within the parameters of the bioequivalence for abbreviated NDAs.
In theory, the DR letter doesn’t reflect a final FDA decision, but it does throw the April 1 target action date into a cloud of uncertainty.
On March 14, Evoke submitted a response to the DR and requested a meeting with the agency over the April 1 target action date. The meeting was held on March 21, but at this time no information has been released about the content of that meeting.

IntelGenx’s Rizaport for Acute Migraine
Saint Laurent, Quebec-based IntelGenx Corp. has an April 1 target action date for the resubmitted NDA for Rizaport, a VersaFilm oral soluble film to treat acute migraines. The company has five inspectional observations from a January Pre-Approval Inspection as part of the company’s Health Canada-certified cGMP manufacturing facility in Montreal by the FDA. At the time, Horst G. Zerbe, president and chief executive officer of IntelGenx said, “We appreciate the thoroughness of the FDA’s review of our facility, and we are confident that we will be able to address the FDA’s observations within the 15-day response timeframe.” As we continue to advance through the NDA process, IntelGenx is excited to have completed another important milestone toward U.S. approval.”
Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt.
ADMA Biologics’ Resubmission of Bivigam
ADMA Biologics, headquartered in Ramsey, NJ, has a target action date of April 2 for Bivigam for the treatment of Primary Immunodeficiency Disease (PIDD). PIDD is a class of inherited genetic diseases that result in a deficient or absent immune system. The FDA issued a Complete Response Letter (CRL) on December 19, 2018 for Bivigam. On January 7, 2019, ADMA submitted its response and provided supplemental information.
Bivigam is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency. That includes agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. Bivigam holds a broad range of antibodies similar to those observed in normal human plasma. The antibodies are directed against bacteria and viruses, and help protect PIDD patients against serious infections.
https://www.biospace.com/article/fda-action-alert-evoke-pharma-intelgenx-and-adma-biologics/

Opioid Crisis: Action News investigates safe injection sites

Safe injection sites are places for opioid addicts to go use their drugs in a controlled environment.
There is a push to bring such sites to Philadelphia, but not everyone is on board with the idea. So Action News traveled to Toronto, Canada where safe injection sites are already up and running to get a first-hand look.
We found a mixed reaction.
There are still many hurdles before they become reality here in Philly, but they’ll be largely modeled after sites in Canada.
There’s no question these sites save lives and prevent disease, but their location can create concern from residents. We met Farrah Morrison in one of those sites. She was getting a fix with a clean needle inside a sterile room, all while being monitored in case of an overdose.
“You cannot use alone because you will die,” she said. “You will die.”

It’s been nearly a year since Toronto opened its first federally approved safe injection site.
“We offer all the supplies that they’d need: tourniquet, sterile water, cookers, and then they can select the needle that most meets their needs,” said Shaun Hopkins, who runs a site in the heart of Toronto’s tourism district. “We intervened, so far, from August 2017, in about 170 overdoses either with Naloxone or oxygen. So you could say we’ve saved those lives,” she said.
In Toronto, roughly 300 people died from an opioid-related overdose in 2017. Not one of those deaths happened in one of these facilities. Naloxone, commonly known by the brand name Narcan, is readily available. After a user injects, they’re urged to go to an observation room.
When asked about public support for the facility, and whether it has increased or decreased, Hopkins said, “I think public support for this facility is difficult.”
And this is why: Over the two days we sat outside several of Toronto’s safe injection facilities, we witnessed prevalent drug use out front, drug deals, and even violence. We watched as one man harassed several people passing by on the sidewalk, even putting one in a chokehold. One guy decided to fight back and security arrived.
Christine Wittick owns the Football Factory, a bar neighboring one of the city’s half-dozen operational safe injection sites. She understands the need, but feels the rights of the addicts often come before those in the community.
“We started to have drug dealers and prostitutes across the street. Crime started to escalate, neighbors have had their homes broken into, my husband has been punched in the face by a man who was very, very high in front of customers,” Wittick said.
In Moss Park, we met a woman named April. Like many users, she’s addicted to both crack and heroin. We found her using just a few hundred feet from a supervised injection site.
“I go and get a lot of supplies and don’t stick around,” she said. April admits that the site attracted more users and dealers, but said the impact is worth it to save lives.
“If you use alone, you die alone,” she said. “You’ve got to weigh the negative with the positive. Saving a life is a lot more important that the other things that come along with it.”

Bill Coldin lives across the street from the park. He admits there was drug usage there before the facility opened last year, but says it’s increased since. We asked: What would your message be to Philadelphians?
“Be careful where you put them,” he said. “You are going to need increased policing around them.”
He says the site in his neighborhood is not being used for its intended purpose.
“What bothers me is no one is using is the facility. And if they are using it, they are using it to socialize and talk right there,” said Coldin.
Toronto City Councilor Giorgio Mammoliti is an outspoken critic of the safe injection sites. He believes the facilities should be placed in hospitals and have a greater emphasis on treatment. But Canadian health officials say you can’t push addicts into treatment.
If you do, they say, addicts won’t use the sites. First, they say, trust needs to be established and it’s inside these walls where that will happen.
Here in Philadelphia, city leaders have been selling the public on the idea that so-called comprehensive user engagement sites will be a bridge to rehab.
“Every city is going to address this in a different way. We believe strongly in getting people in treatment is our goal, and pushing that at every step in the process,” said Philadelphia Health Commissioner Tom Farley.
Farley said he hopes to open a supervised injection site within the year, but says the biggest obstacles are the legal issues and whether the United States Attorney General’s office will take action if one opens.
Research on the effectiveness of supervised injection sites being a path to treatment have been inconclusive. Toronto was unable to provide any statistics regarding its sites. However, the city of Vancouver’s original facility, Insite, reports out of 7,300 users in 2017, just six percent accessed its detox treatment facility, and the average stay was just 11 days.
After shooting up her latest hit, Farrah Morrison said she was ready to get off drugs and connect with her three children. She’s using this site as the road to that recovery, but where it ends is unclear.
“Wish me luck,” she said.

Bayer downgraded to Hold from Buy at Deutsche Bank

https://thefly.com/landingPageNews.php?id=2886432