Market Place
In Phispers this week, we bring you news on two new bills in the US that seek to bring in cheaper medicines from Canada, and allow FDA to recall unsafe drugs. We also bring you the real reason why Sanofi, even after offering US$ 30 billion, could not bag Actelion. And, there is news on gene-editing technology CRISPR and Mylan and Biocon’s application for Pegfilgrastim, a proposed biosimilar. Read on.
US introduces bill to allow FDA to recall
unsafe drugs
In the United States, Republican Rosa DeLauro introduced a new bill last week that will allow the US Food and Drug Administration (FDA) to do what many assume it already can require pharmaceutical or over-the-counter drug (OTC) companies to stop marketing unsafe products. The law will also cover homeopathic products.
The bill, once passed, will be known as the Recall Unsafe Drugs Act. Once enacted, this law will give FDA mandatory recall authority over drugs and homeopathic products.
“Most people would be shocked to learn that while the FDA has the authority to order a recall of medical devices and biologic products, such as vaccines and blood products, the agency cannot order recalls of prescription and over-the-counter medications,” DeLauro said.
This loophole is problematic, as some companies can refuse FDA’s calls to remove their pharmaceutical products from the market because they are unsafe.
New bill in US pushes for drug imports from
Canada, while industry resists it
The Trump administration appears committed to providing cheaper medicines. A new bill the Safe and Affordable Drugs from Canada Act would require the FDA to set up a “personal importation program” to allow individuals to import 90-day supplies of their medicines from Canadian pharmacies. The bill has been drafted by Senators Amy Klobuchar, Chuck Grassley and John McCain.
However, the pharmaceutical industry is pushing back. In a statement to FiercePharma, the Pharmaceutical Research and Manufacturers of America (PhRMA) pointed to a Drug Enforcement Administration report last year that mentioned to how counterfeit fentanyl from China made its way to the US through Canada and Mexico, worsening the current opioid crisis.
Imports “would exacerbate these threats,” a PhRMA spokesperson said.
Imported drugs wouldn’t “be subject to the US FDA’s robust safety requirements, and there would be no way to trace the country of origin for the imported products. Even Canada has said it does not and would not be able to guarantee that US citizens would receive products that are safe, effective and of high quality,” the spokesperson added. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.”
A fortnight back, PharmaCompass carried a news on Marathon Pharmaceuticals, which received FDA approval for Emflaza (deflazacort) to treat rare genetic disorder Duchenne muscular dystrophy (DMD). The drug carries a list price of US$ 89,000 for a year’s supply, when patients in the US are importing it from Canada and the UK for around US$ 1,000 to US$ 2,000.
Prospectus highlights Sanofi’s struggles in J&J’s US$ 30 billion acquisition of Actelion
Sanofi made headlines recently, not for the acquisitions it made, but for the one it wasn’t able to close. Late last year, the French pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion, which had started back in January 2016.
The Actelion-J&J deal prospectus offers insights into why Sanofi (identified as Company A) failed in its US$ 30 billion acquisition even though it would have delivered “approximately equivalent value to Actelion’s shareholders”.
According to the deal prospectus, even though Sanofi had bid a higher indicative price, the board of directors of Actelion perceived ‘significant uncertainty’ posed by a potential transaction with Sanofi.
The uncertainty was created when, “Sanofi indicated that it would only be willing to proceed with a transaction on the basis of a price lower than its previously communicated offer price and on different terms”.
While the deliberations have been on since January 2016, last month the board of Actelion felt “J&J’s proposal offered significantly greater transaction certainty because the transaction documentation was nearly final and because J&J had already completed the required due diligence”.
Sarepta sells priority review voucher to
Gilead for US$ 125 million
Sarepta Therapeutics has sold its priority review voucher (PRV) to Gilead for US$ 125 million. The voucher is awarded under the rare pediatric PRV program. It speeds up the US FDA approval process for any future drug or biologic from 10 months to six months.
For Gilead, this is the third PRV it has purchased. Last year, it bought PaxVax’s PRV for about US$ 200 million and in 2014 it bought Knight Therapeutics’ PRV for US$ 125 million.
The voucher was awarded to Sarepta after it won FDA approval for its DMD drug Exondys 51 (eteplirsen) in September 2016.
Sarepta’s pricing is a far-cry from the most expensive PRV ever sold by United Therapeutics to AbbVie for US$ 350 million in August 2015.
It will be interesting to see what Marathon Pharmaceuticals who also received the most recently awarded PRV for its DMD drug Emflaza (deflazacort) uses their voucher for after an “outrageous” pricing controversy paused the sales of their product.
With the passage of the 21st Century Cures law, the number of PRVs on the market is likely to increase. This legislation reauthorizes the rare pediatric PRV program until October 2020.
Broad Institute to keep valuable patents on gene-editing technology — CRISPR
A biological and genomic research center affiliated with MIT and Harvard known as the Broad Institute will keep valuable patents on a revolutionary gene-editing technology known as CRISPR. A US patent agency Patent Trial and Appeal Board in Alexandria, Virginia rejected a claim by a rival team associated with the University of California at Berkeley and University of Vienna in Austria that they invented the technology first.
CRISPR is a biotechnology innovation that makes it easier for scientists to edit DNA in living cells. It works as a type of molecular scissors that can trim away unwanted pieces of genetic material, and replace them with new ones.
The patent rights for Broad Institute could be worth billions of dollars, as the technology could revolutionize treatment of genetic diseases, crop engineering and other areas.
In 2012, a research team led by Berkeley’s Jennifer Doudna and Vienna’s Emmanuelle Charpentier was first to apply for a CRISPR patent.
Months later, a team at Broad Institute, led by MIT’s Feng Zhang, applied for a patent by opting for a fast-track review process. It obtained a CRISPR patent in 2014, and has since obtained additional patents. Meanwhile, Berkeley is not the least bit happy with the ruling and may appeal.
USFDA accepts Mylan and Biocon’s second biosimilar application of Amgen’s Neulasta
Last week, Mylan and Biocon announced that the US FDA has accepted Mylan’s Biologics License Application (BLA) for Pegfilgrastim, a proposed biosimilar.
This product is a biosimilar version of Amgen Inc’s branded drug Neulasta, which is used to reduce the chance of infection due to low white blood cell count and incidence of fever in patients treated with chemotherapy in certain types of cancer.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. Pegfilgrastim is one of the six biologic products co-developed by the companies.
The FDA goal date set under the Biosimilar User Fee Act is October 9, 2017. The two companies have already filed biosimilar pegfilgrastim with regulators in Europe, Australia and Canada.
Mylan President Rajiv Malik commented: “We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.”
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