Market Place
This week, Phispers brings you the latest on the EpiPen price-hike controversy, on Amgen’s biosimilar for AbbVie’s Humira, investors’ reaction to a woman CEO at GSK, and raid on the largest factory that makes anti-impotency drugs in Poland.
Pfizer won’t split, after all
This week, Pfizer announced it won’t split itself into two publicly-traded companies by separating its generics from its patent-protected branded medicines.
Instead, both these would operate as separate businesses within Pfizer. For several years, Pfizer has weighed whether a split makes sense or not. The reason – its patent-protected medicines routinely enjoy sales growth, while its portfolio of generics usually reports a drop in sales.
Investors increased hopes of a split in Pfizer when the American drug maker walked away from a US $ 160 billion deal to acquire Ireland-based Allergen Plc. in April this year. The merger was scrapped after new US Treasury rules sought to curb deals in which American companies move overseas to cut taxes, known as inversions.
Scientific American investigates how FDA controls the media
An article in the October 2016 issue of the Scientific American narrates how, over the years, the FDA has been “arm-twisting journalists into relinquishing their reportorial independence.”
The investigative report quotes a deal the FDA tried to strike with the NPR and other media outlets in April 2014, where select media outlets would get a scoop in exchange of abandoning its reportorial independence. “The FDA would dictate whom NPR’s reporter could and couldn't interview,” the article said.
According to the article, a large proportion of science and health stories are the product of embargoes. “Most of the major science journals offer reporters advance copies of upcoming articles—and the contact information of the authors—in return for agreeing not to run with the story until the embargo expires…,” the article said. Through embargoes, the FDA attempts to control sourcing of news, the article adds.
Mylan CEO draws flak for flying a private jet as Congress questions EpiPen profits
On September 21, Mylan CEO Heather Bresch testified before the US Congress to defend the US $ 600 retail price of EpiPen – a life-saving auto-injection system that administers adrenaline to those suffering from severe allergy attacks.
According to Bresch, Mylan did nothing wrong. She offered no apology for the US $ 300 million in compensation awarded to top Mylan executives while the price of EpiPen rose 500 percent in about a decade.
Bresch received more flak for flying a private jet from the company’s headquarters in Pennsylvania to Washington D.C, along with other employees to testify before the Congress.
“It is a little stunning to see that so much money could be spent on whether you're traveling around on a jet while we have this discussion here about whether Americans are being bilked for a lifesaving drug like EpiPen,” Republican Bonnie Watson Coleman said.
In her testimony, Bresch said Mylan doesn’t take in profits anywhere near the US $ 600 list price for a two-pack of EpiPens. “After rebates and various fees, Mylan actually receives US $ 274. Then you must subtract our cost of goods which is US $ 69. This leaves a balance of US $ 205. After subtracting all EpiPen auto-injector related costs, our profit is around US $ 50 per pen,” she said.
Members of the House Oversight Committee expressed dismay at how the EpiPen’s profit could be so low. “I find that a little hard to believe,” Oversight Committee chairman Jason Chaffetz said.
Amgen gets FDA approval for AbbVie’s biosimilar for Humira
On September 23, the FDA approved Amgen’s Amjevita – a biosimilar to AbbVie’s blockbuster drug Humira. Amjevita is the first adalimumab biosimilar approved by the FDA. It has been approved for the treatment of seven inflammatory diseases – rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis, Crohn's disease and ulcerative colitis.
Humira generated US $ 14 billion in revenue for AbbVie last year. For Amgen, this is the first approved biosimilar. The company has eight other biosimilars in its development pipeline.
However, an ongoing patent dispute may forestall Amjevita’s launch. AbbVie hopes to preserve Humira’s patent protection until 2022 or beyond by suing Amgen. Even if the two companies settle out of court, the federal law requires manufacturers of biosimilars to wait 180 days after FDA approval before marketing their products. This means Amgen can’t sell Amjevita until March 2017.
Raid on the world’s largest factory making anti-impotence drug
The Polish police recently made an extraordinary raid on a factory that produced counterfeit pills for erectile dysfunction and steroids. The factory, located in the northern Poland (in the city of Bydgoszcz), had a stockpile of over 100,000 Viagra-like pills and 43,000 vials of steroids when the police raided it.
According to the police, it was the world's largest factory making anti-impotence drugs. The confiscated drugs were valued at over US $ 4 million – one of the biggest drug seizures of its kind.
The products used for manufacturing the drugs originally came from China, but were shipped to the factory in Poland from other countries such as Greece, Great Britain and Romania, the police said.
With the advent of the internet, the counterfeit drug market has been booming. Several websites are licensed to legally sell prescription drugs. However, majority of drugs purchased online come from illegal or barely regulated plants that produce drugs of varying quality.
Investor’s not happy with Big Pharma’s first female CEO
Last week, GlaxoSmithKline announced that its head of consumer healthcare – Emma Walmsley – was being elevated as CEO to succeed Andrew Witty. This was being seen as a milestone in the push to increase the representation of women in boardrooms. As the first female CEO of Big Pharma, Walmsley will be one of the most influential figures in British business.
However, this week, there have been reports that investors are unhappy with Walmsley’s elevation. A report said some investors would have rather seen an external candidate appointed.
“I’ve spoken to quite a lot of investors and they’re not very happy,” a shareholder told The Telegraph. “People wanted an external appointment,” the investor added. However, a company insider insisted shareholders were “comfortable” with the appointment, the report said.
Sanofi sues Merck for patent infringement; its skin drug accepted for priority review by FDA
Last week, Sanofi filed a patent infringement suit against Merck in a US district court and claimed that Merck infringed 10 patents covering similar products and methods of delivery.
In early August, Merck had filed a new drug application with the FDA seeking approval of an insulin glargine drug product for patients with diabetes. In its filing, Merck challenged all 10 Sanofi patents for Sanofi’s Lantus and Lantus SoloStar insulin products.
A Merck spokeswoman said, "We are confident that the new drug application for our investigational insulin glargine product, MK-1293, does not infringe any valid claim of the asserted patents for the originator insulin glargine, Lantus.”
Meanwhile, Sanofi and Regeneron announced that the FDA has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease. The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017.
Mylan, Lupin to bid for Bayer’s skin business; little-known Novum hikes skin gel price to US $ 9.5K
Bayer AG is selling its assets ahead of its US $ 66-billion acquisition of Monsanto. And both Mylan NV and Lupin are considering bids for the German company’s dermatology business.
Bayer’s assets, which include Desonate for eczema and Finacea for rosacea, are drawing interest from a wide range of drug companies. According to a Bloomberg report, companies like Leo Pharma, Cadila Healthcare and Torrent Pharmaceuticals are also considering making bids. Non-binding bids for Bayer’s dermatology unit could fetch more than US $ 1.1 billion.
Meanwhile, a lesser known pharmaceutical company – Novum Pharma – hiked the price of a gel to cure scaly skin by 128 percent, taking its price to US $ 9,500 a tub overnight. According to a news report, Novum Pharma bought three gels to treat skin conditions in March of 2015. Two months after it acquired them, it raised prices tenfold. And this month, it boosted prices again.
Is the industry ready for accelerated approvals of generics in the US?
The FDA will meet on October 21 to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which the FDA will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.
Meanwhile, a bill has also been introduced in the US Congress this month that seeks to provide for fast track review of certain generic drugs.
Since 2010, at least 315 generics have doubled in price. The price rise has been steep in the case of medicines that do not have competition. As a result, the speed at which the FDA reviews and approves ANDAs has become a hot topic of discussion.
However, the industry doesn’t seem ready for accelerated approval of generics. In a Congressional hearing last week where Senator Jerry Moran discussed generic approvals with FDA’s Janet Woodcock, the later informed that the “median time it takes for the FDA to approve a generic is now 47 months” despite the addition of about 1,000 new FDA employees and new user fee funds.
More than 4,000 generic applications are awaiting FDA approval, out of which 1,575 applications are awaiting a response from the industry, and only 369 ANDAs have yet to receive some kind of a review communication from the FDA.
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Image Credit : Emirates’ Airbus 319 Luxury Private Jet Service ‘Emirates Executive’ by Roderick Eime is licensed under CC BY 2.0
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