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Thursday, November 8, 2018

AbbVie slaps NHS England with lawsuit over hepatitis C drug procurement


In an aggressive push to end hepatitis C in England, health authorities there are in the process of weighing bids in NHS England’s “largest ever” drug procurement process. But AbbVie isn’t happy with the negotiations, and it’s suing the health service for treating bidders unfairly, according to England’s Health Service Journal (HSJ).
AbbVie, which makes the fast-growing Mavyret, claimed the National Health Service broke procurement rules in its effort to buy hundreds of millions of pounds worth of hepatitis C drugs, HSJ reported. The NHS wants to buy the drugs in bulk to keep costs down as it works to eliminate hep C in England by 2025.
Along with AbbVie, Gilead Sciences, Janssen and Merck & Co. have also bid, according to the publication. Merck is known as MSD in England.
A spokesperson for AbbVie told HSJ that the company “has entered into legal action against NHS England. We cannot comment any further as the legal proceedings are not yet concluded.”
NHS England denied the allegations, according to HSJ. Both parties are preparing for a trial.
NHS England originally wanted to get the drugs to patients starting in October, but an expert with the British Liver Trust told HSJ that stakeholders were told the program is delayed until January at the earliest.
NHS England wants to buy large quantities of new hep C antivirals with high efficacy and a more tolerable side effect profile than older drugs. Gilead’s Sovaldi launched in the class first, back in 2014, and brought in megablockbuster sales, followed by Gilead’s own Harvoni. The California biotech’s initial success in hep C has waned over time as newer competitors have launched—including AbbVie’s Mavyret.
Since its launch last year, AbbVie’s pan-genotypic hep C drug Mavyret has been on a tear for the company. In the third quarter, the Illinois drugmaker’s hep C revenues came in at $862 million.
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Hikma to produce injectables in Vietnam with deal for Medlac Pharma Italy


Hikma Pharmaceuticals has established itself as a top sterile injectables manufacturer in the U.S. and is building its business in Europe. Now the Mideast-based drugmaker is moving into Asia, picking up a production plant in Vietnam.
Hikma Wednesday said it had a deal to buy Medlac Pharma Italy Co., a Vietnamese injectables manufacturing company established a decade ago as a Vietnamese and Italian joint venture. The acquisition includes an injectables facility in Hanoi which began production in 2012.
It also includes adjacent vacant land, Medlac’s portfolio of 23 injectable products, as well as its pipeline and all employees. Its drugs include anti-infectives and cardiovascular products. Terms of the deal were not disclosed.
Aman, Jordan-based Hikma pointed out that Vietnam has a rapidly growing population, government healthcare reforms and has been the fastest-growing pharmaceutical market in Southeast Asia in recent years.

“Vietnam is an attractive market with significant growth potential,” Riad Mechlaoui, Hikma president of injectables, said in a statement. “We are confident that by leveraging Hikma’s global expertise, we can add significant value to Medlac’s business.”
The announcement came a day before Hikma reported earnings in which it raised its 2018 guidance and said it expected revenues from injectables to range from $825 million to $850 million and produce a core injectables operating margin of between 39% and 40%.
Some drugmakers, like Sanofi, have been manufacturing drugs in Vietnam for years while others have established themselves with manufacturing facilities more recently. In 2016, AbbVie acquired Glomed, a deal that gave the pharma giant two manufacturing facilities.
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AstraZeneca chief: Europe should pay more for drugs—U.S. should pay less


President Donald Trump has routinely bashed “global freeloading” on pharmaceuticals, and his administration last month unveiled a plan to try and lower some U.S. drug prices to international levels. Now, a top pharma CEO says he’s right—at least in principle.
In an interview with Bloomberg TV, AstraZeneca CEO Pascal Soriot said a “readjustment” of prices, to slightly raise European prices and slightly cut U.S. prices, would be warranted.
After all, he said, the world is “benefiting” from the United States’ high prices that have incentivized R&D—and help fund it.
Thing is, he doesn’t know how those pricing tweaks would happen.
“Whether that can be done, I don’t know,” he said in the interview. “It’s probably unlikely.” Soriot said Japanese prices are a “good benchmark.”
Soriot’s remarks follow the Trump administration’s plan last month to create an international price index and gradually lower Medicare Part B drug prices. In conjunction with the plan, the HHS released a report that showed, for the top 27 drugs that account for the most in Medicare Part B drug spending, prices in the U.S. are 180% higher, on average, than they are in countries with similar economies.

Other top pharma CEOs voiced their thoughts on the plan during their third-quarter conference calls. Pfizer CEO Ian Read, for instance, said he doesn’t think it “makes sense” because the plan involves “importing one country’s industrial policy … into a country that’s based on innovation.” Allergan’s Brent Saunders said the proposal “could have a destabilizing effect on how we think about investing for innovation in our industry.”
The debate over international pricing is part of a larger conversation over U.S. prices. Apart from the Part B plan, the Trump administration has been pushing for drug prices in TV ads, and the FDA has been approving more generics than ever in an effort to provide relief. In May, the administration released its pricing blueprint, with a goal to increase competition and negotiation for pharmaceuticals, as well as lower list prices and out-of-pocket costs for patients.
After the midterm elections, industry watchers expect continued attention to pricing and potential new headaches for pharma in the form of investigations and committee hearings.
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Primatene Mist Returns After 7-Year Absence


Primatene Mist, the over-the-counter epinephrine inhaler for quick asthma relief, can go back on the market in a reformulated version, the FDA said Thursday.
Now using a hydrofluoroalkane (HFA) propellant in place of the banned chlorofluorocarbon (CFC) used in the original Primatene product (and most other asthma inhalers), the new version is approved for “temporary relief of mild, intermittent asthma,” the agency said.
Manufacturer Amphastar Pharmaceuticals noted that it may be used by patients as young as 12. In addition to the HFA propellant, the new version comes with a built-in spray indicator and a metal canister. The original Primatene Mist came in a glass container.
That product was taken off the market in 2011because of the CFC propellant, as the U.S. completed the process of removing all CFC chemicals from consumer products. An international treaty in 1999 had banned CFCs worldwide to preserve the Earth’s high-altitude ozone layer; as part of its implementation, the FDA ordered makers of asthma inhalers with CFC propellants in 2008 to take them off the market. All the major types were then reformulated with more environmentally friendly propellants, mainly HFA, although the switch generally led to higher prices and complaints from patients.
Amphastar had sought to reintroduce its reformulated Primatene in 2014. But an FDA advisory committee voted against recommending approval, citing safety problems with the new device, as well as concerns about allowing patients with a serious illness to medicate themselves without having to consult a healthcare professional. In 2016, the FDA told Amphastar to conduct a “Human Factor validation study to assess consumers’ ability to use the product without the guidance of a doctor or pharmacist,” and to make changes to the product’s labeling, before it would approve the product.
In announcing the final approval on Thursday, top FDA officials said they were now satisfied that most patients would use the new Primatene Mist safely, while also acknowledging that risks still remain.
“In the OTC space, it’s always important that the consumers understand how to safely and effectively use a new product. The scientific information we reviewed to approve the new version of OTC Primatene Mist shows there is a narrow population of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler,” said FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the agency’s drugs division, in a statement.
“But the product has certain cautions,” they continued. “Making sure that patients can understand and apply the instructions for use was a critical consideration for the FDA. The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Patients with more severe asthma should not rely on it. Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition. You’ll see that this risk is addressed in the instructions on how to use the product safely and a warning to seek medical care if the patient is using it regularly as overuse of the product is a risk.”
Gottlieb and Woodcock urged providers who recommend Primatene Mist to let patients know the new version works differently from the original, and therefore they should pay close attention to the label information on dosing.
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Lilly Scraps Program for Alzheimer’s


It seems that the sands of time are slowly running out on Eli Lilly’s BACE program for treating Alzheimer’s disease.
This week during its third quarter conference call, David Ricks, Eli Lilly’s Chief Executive Officer, slid in the fact that the company has scrapped a Phase II clinical trial for N3pG, a humanized IgG1 monoclonal antibody, plus BACE in the treatment of Alzheimer’s. Ricks did note that Eli Lilly was still studying N3pG as a monotherapy.
Lilly’s throwing-in of the towel on the BACE program sends a signal that a treatment for Alzheimer’s is still somewhere in the future. BACE, also known as beta-site amyloid precursor protein cleaving enzyme 1, is seen as a precursor to amyloid-beta, which is believed to be the leading cause of Alzheimer’s disease. The scrapping of this program is another setback for Eli Lilly in the ever-futile-seeming quest to develop a treatment for this dreaded form of dementia.
It was only a few months ago that Eli Lilly and its developmental partner AstraZenecaannounced they had shut down two late-stage clinical trials of lanabecestat, a BACE inhibitor, for Alzheimer’s disease. The decision to shut down the trials was made following an analysis conducted by an independent data monitoring committee. The committee concluded that the primary endpoints of that trial were not likely to be met. The companies said they would continue to work together in an attempt to develop a treatment for Alzheimer’s.
Eli Lilly certainly isn’t the first company to scrap a BACE inhibitor. In February, Merck & Co.halted its APECS Phase III clinical trial that was studying verubecestat, a BACE inhibitor for treatment of Alzheimer’s disease. The decision to shutter that trial was also made following an analysis from an independent data monitoring committee. However, the reason for closing down the Merck trial had more to do with safety than efficacy. The committee said the likelihood of benefit from the drug did not outweigh the safety risks.
In addition to Merck shutting down the verubecestat program, Johnson & Johnson announced in May that it was also ending its BACE program for atabacestat. Much like Merck, Johnson & Johnson’s Janssen division said it was closing down the atabacestat trial due to safety concerns. The data showed that patients in the EARLY Phase IIb/III trial were showing elevated liver enzymes. The patients participating in that trial were considered to have preclinical Alzheimer’s disease. The EARLY trial was scheduled to conclude in 2024.
While it seems that companies are reporting multiple failures in Alzheimer’s on a near-weekly basis, the companies that have been in the thick of researching potential treatments for Alzheimer’s have stressed they are not giving up hope on developing a therapy. Biogen is still driving forward with its amyloid-plaque targeting drug, aducanumab.
Alzheimer’s and other forms of dementia are a growing healthcare concern. In the United States, Alzheimer’s disease is the sixth-leading cause of death across all ages and the fifth-leading cause of death in people over 65 years of age. By 2050, the number of global patients is expected to hit 131.5 million.
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Stada, Angelini among final bidders for $1 billion Bristol-Myers’ OTC unit

maker Stada and Italian healthcare company Angelini are the only industry players to be shortlisted to make final bids for Bristol-Myers Squibb’s French over-the-counter drugs business, four sources close to the deal said.

Two private equity firms, CVC Capital Partners and PAI Partners, have also made it through to the final round of the auction for UPSA, the maker of Dafalgan and Efferalgan painkillers, the sources told Reuters.
The sale, which is handled by Jefferies and Deutsche Bank, is worth about 1 billion euros (839.95 million pounds).
Bristol-Myers Squibb (BMS), Stada, CVC and PAI declined to comment while Angelini was not immediately available for comment.
BMS has given bidders a deadline of late November to submit final proposals, the sources said.
The U.S. firm took full control of the unit, which also produces effervescent aspirin and vitamin C, 24 years ago.
It is now looking to concentrate on high-margin prescription drugs, particularly for cancer, and hopes to sell UPSA for a multiple of 7.5 to 8 times its core earnings of 120 million-130 million euros, the sources said.
Germany’s Stada, which is backed by private equity firms Bain Capital and Cinven, is widely seen as the frontrunner for the deal as it seeks to build scale through major acquisitions, the sources said.
Italy’s Angelini, which is advised by BNP Paribas, is also willing to embark on a big deal, two of the sources said.
The sale initially drew interest from other big industry players including U.S.-run drugmaker Mylan NV and Japanese healthcare firm Taisho Pharmaceutical which subsequently walked away from the process, the sources said.
UPSA generated revenue of 425 million euros in 2017 and employs about 1,500 people in France.
The sale comes amid a series of high-profile deals in the consumer health industry including Procter & Gamble’s acquisition of Merck KGaA’s vitamin brands in April and GlaxoSmithKline deal to buy Novartis out of their consumer healthcare joint venture for $13 billion.
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Dutchman, 69, brings lawsuit to lower his age 20 years


A Dutch “positivity trainer” has launched a legal battle to change his age and boost his dating prospects.
Emile Ratelband, 69, wants to shift his birthday from 11 March 1949 to 11 March 1969, comparing the change to identifying as being transgender.
“We live in a time when you can change your name and change your gender. Why can’t I decide my own age?” he said.
A local court in the eastern city of Arnhem is expected to rule on the case within four weeks.
However officials were sceptical about the case, believing there was no legal mechanism allowing a person to change their birth date, local reports said.
One of the judges wanted to know what would become of the 20 years that Mr Ratelband wanted to erase. “Who were your parents looking after then? Who was that little boy?” he was quoted as saying.

‘Making the most of life’

Mr Ratelband argues he feels discriminated against because of his age, and that it was affecting his employment chances and his success rate on the dating app, Tinder.
“When I’m 69, I am limited. If I’m 49, then I can buy a new house, drive a different car. I can take up more work,” he said.
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“When I’m on Tinder and it says I’m 69, I don’t get an answer. When I’m 49, with the face I have, I will be in a luxurious position.”
Mr Ratelband further argued that according to his doctors he has the body of a 45-year-old, and described himself as a “young god”.
He went on Facebook last year to describe how he had made the decision one day standing in front of a mirror, not because he feared getting old but because he wanted to make the most of life for as long as possible.

He also said he would renounce his pension if he switched his birth date.
Mr Ratelband, a media personality and motivational guru, converted to Buddhism earlier this year and is a trainer in neurolinguistic programming.
He voiced the character Vladimir Trunkov in the Dutch-language version of the Pixar film Cars 2.
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