Market Place
Cancer researchers bag Nobel Prize; Fresenius wins case over terminating merger with Akorn due to data-integrity issues
The big news from the world of pharmaceuticals this week came from two cancer researchers — James P. Allison of the US and Tasuku Honio of Japan — who bagged the Nobel Prize in Physiology or Medicine for unleashing the immune system’s ability to attack cancer.
Phispers also brings you news on Pfizer, where current COO Albert Bourla will succeed Ian Read as CEO from January 1, 2019.
The FDA approved the third migraine treatment since May this year — Eli Lilly’s Emgality. Fresenius won a case in the US over right to terminate merger with Akorn.
And Indian drugmaker Dr. Reddy’s sold off its antibiotics plant in the US to UAE’s Neopharma.
Cancer researchers awarded Nobel prize for medicine
The 2018 Nobel Prize in Physiology or Medicine was awarded on Monday to James P. Allison of the United States and Tasuku Honjo of Japan for their work on unleashing the immune system’s ability to attack cancer, a breakthrough in developing new cancer treatments.
The Nobel committee said the duo’s research amounted to a “landmark in our fight against cancer.”
Their approach, known as immune checkpoint theory, had “revolutionized cancer treatment” and brought lasting remissions to many patients who had run out of options.
Prior to Allison and Honjo’s discoveries, cancer treatment consisted of surgery, radiation, chemotherapy and hormonal treatments. A statement from the Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.”
The first such treatments approved were ipilimumab (brand name Yervoy), nivolumab (Opdivo) and pembrolizumab (Keytruda). Others have since come to market.
“I was told by the Nobel committee when I was called this morning that this was the first prize they’ve ever given for cancer therapy,” said Allison, chair of Immunology and executive director of the Immunotherapy Platform at the University of Texas MD Anderson Cancer Center.
Allison studied a protein that functions as a brake on the immune system. Releasing the brake allowed immune cells to attack tumors, he found.
“I’m a basic scientist. I did not get into these studies to try to cure cancer. I got into them because I wanted to know how T cells work,” he added. T cells, a type of white blood cell, are part of the immune system and help protect the body from infection and may help fight cancer, according to the National Cancer Institute.
Pfizer gets new CEO; Merck extends retirement of existing one
This week, New York-headquartered Pfizer Inc announced its board of directors has unanimously elected Albert Bourla, 56, Pfizer’s Chief Operating Officer (COO), to succeed Ian Read as CEO effective January 1, 2019. Read will transition from his current role as Chairman and CEO to Executive Chairman of Pfizer’s Board of Directors.
“It’s been an honor to serve as Pfizer’s CEO for the past eight years,” stated Read. “However, now is the right time for a leadership change, and Albert is the right person to guide Pfizer through the coming era,” Read added. Bourla has spent 25 years at Pfizer.
Meanwhile, Merck announced its Board of Directors has revoked its policy subjecting the company’s CEO to mandatory retirement at age 65. Merck also announced that its current CEO, Kenneth C. Frazier, has agreed to remain in his position beyond December 2019, when he turns 65.
A year ago, Frazier had made headlines as he had publicly stood up to the Trump administration since he was outraged by the US President Donald Trump’s unwillingness to condemn white supremacists involved in a deadly clash in Virginia. Frazier had also resigned from one of the president’s blue-chip advisory councils.
“CEO succession has been our top priority, and removing the mandatory retirement policy enables the Board to make the best decision concerning the timing of that transition,” said Leslie A. Brun, lead director, speaking on behalf of Merck’s Board of Directors.
Lilly bags FDA approval for migraine drug; may give it for
free to insured patients
Until May this year, there weren't any drugs available for alleviating migraines. Since then, patients who suffer from migraine have seen three new migraine-specific treatments approved by the FDA.
The latest drug to get the FDA approval is Eli Lilly’s Emgality (galcanezumab-gnlm) injection for migraine prevention. Like its competitors, Lilly is offering it at little or no cost to the insured patients in the US for a limited period.
The day Lilly bagged the FDA approval, a federal judge also dismissed two patent infringement lawsuits by Teva Pharmaceutical Industries against Lilly related to Emgality. The drug is also on track for final approval in the European Union.
Galcanezunab is a CGRP (short for calcitonin gene-related peptide) inhibitor, a molecule that researchers have been targeting since the 1980s. A drug from Amgen approved in May and another from Teva approved earlier in September work on the same principle. All three approved migraine drugs require delivery by injection, though Allergan is working on pills that would deliver similar migraine-fighting compounds for preventative and acute treatment.
Emgality will have a list price of US$ 6,900 a year, which is in the same price range as its competitors from Amgen and Teva.
According to the Migraine Research Foundation, migraines affect around 39 million Americans, with 4 million Americans suffering daily symptoms. According to data compiled by Bloomberg, Emgality is forecast to sell US$ 701 million in 2022. And CGRP drugs are expected to become a US$ 2.2 billion market in the US, Bloomberg Intelligence estimates.
Fresenius wins case over terminating merger with Akorn due to
data-integrity issues
This week, German drugmaker Fresenius Kabi won a case in the Delaware Court of Chancery. The court upheld Fresenius’ decision to terminate its agreement to merge with Akorn because of data integrity issues at the latter’s facilities.
“Fresenius’s investigation uncovered serious and pervasive data integrity problems that rendered Akorn’s representations about its regulatory compliance sufficiently inaccurate,” the ruling said.
Back in April 2017, Fresenius had agreed to acquire Akorn, a manufacturer and marketer of prescription and over-the-counter pharmaceutical products based in the US, for approximately US$ 4.3 billion. The transaction was expected to close in early 2018.
In March this year, Fresenius’ CEO Stephan Sturm had said that the company may back out of its planned acquisition of Akorn if an independent probe into data integrity at Akorn yields evidence of wrongdoing.
And in April this year, Fresenius abandoned the deal. In a court filing that had been made public, Fresenius alleged that its investigation uncovered “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations.”
One of Akorn’s own experts said Akorn was not fully transparent with the FDA, the court noted.
“It is difficult to put much faith in Akorn’s claims about its commitment to quality. Having seen the divergence between Akorn’s representations to the FDA during the March 2018 meeting and what Akorn’s internal documents and witness testimony showed, it is equally difficult to have confidence that Akorn is being fully transparent in describing the corrective actions,” the court added.
The decision also noted that John Avellanet of Cerulean Associates, a data integrity consultant, testified that some of Akorn’s data integrity failures “were so fundamental that he would not even expect to see them ‘at a company that made Styrofoam cups,’ let alone a pharmaceutical company manufacturing sterile injectable drugs.”
Dr. Reddy’s sells its antibiotics plant in US to UAE’s Neopharma
India’s Dr. Reddy’s Laboratory (DRL) is selling its antibiotics plant in the US to Abu Dhabi-based drugmaker, Neopharma. The deal involves DRL’s plant and assets in Bristol, Tennessee. With this acquisition, Neopharma will get its first plant in the US.
The manufacturing plant and associated facilities, which DRL bought from GlaxoSmithKline in 2010, primarily makes amoxicillin-based products, including augmentin. A separate 24,000-square-foot plastics-processing facility in Bristol is also included in the transaction. Terms of the deal were not disclosed.
“This sale is in line with our stated priority to streamline and optimize our global cost structures and help us focus on other business priorities to drive growth,” DRL’s COO Erez Israeli said in a statement. “We are pleased that the agreement may provide continued employment opportunities for many of the experienced employees at the site.”
Neopharma plans to increase the number of employees to about 50 from the current 40 by the end of next year. It plans to enlarge the plant and potentially have 100 workers there.
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