Market Place
This week, Phispers brings you news on FDA meeting its generic drug approval goal, M&A deals in the world of pharma, Obama’s article in JAMA, Abbott’s new bio-degradable stent for heart patients, Amgen’s predicament in the field of biosimilars and more.
FDA meets generic drug approval goal a year ahead of schedule
The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog.
The GDUFA required the FDA to meet this goal by September 30, 2017, which is the end of the five-year funding period authorized under the GDUFA. This way, the FDA has achieved its backlog commitment more than one year ahead of schedule. This information was provided by Janet Woodcock, director of the CDER.
Amgen’s double-standards on biosimilars; China to lead the biotech boom
Amgen is playing on the offense as well as on defense insofar as biosimilars are concerned. Last week, the FDA approved Amgen’s biosimilar of AbbVie’s Humira. And, if FDA insiders are to be believed, Novartis’ generics division Sandoz may soon get the nod for its biosimilar of the US $ 9 billion drug Enbrel. Amgen sells Enbrel in the US.
Amgen’s Humira biosimilar threatens AbbVie’s US $ 14 billion franchise. While Amgen is fighting to get its biosimilar on the market, it’s also fighting Novartis tooth and nail to guard its drug Enbrel. It has waged a legal war against Novartis’ development strategy, which studied the drug only for psoriasis but is now looking for an approval on a full slate of indications.
Meanwhile, a survey of international companies found that 85 percent of the respondents believe that China is set to have the fastest growing biologics sector over the next decade, while 65 percent predict patented new chemical entities (NCEs) will be discovered and developed within China in as little as five years. The driving force behind these findings is the growing biotechnology and R&D industry, which is heavily supported by the Chinese government.
2016 shows lively M&A activity, but deal sizes are smaller
Merger and acquisitions in the world of pharma picked up in the April-June quarter of 2016. According to market intelligence firm EvaluatePharma, pharma and biotech companies announced transactions worth US $ 22.1 billion. However, the size of the M&A deals were a lot smaller, with AbbVie’s US $ 9.8 billion acquisition of Stemcentrx being the largest deal in the April-June quarter.
The pickup in M&A activity is an encouraging sign for the industry that has been concerned about fears of a slowdown. This week also saw Japanese drug maker Nichi-iko acquire Sagent Pharmaceuticals in an all-cash deal of US $ 736 million. Yet, 2016 might not match the last two years in terms of deal value.
Theresa May says Britain will defend its pharma sector from takeovers
While Britain mulls a second Brexit referendum, Theresa May, the new prime minister of the UK, indicated in a press conference that she would help shield the nation’s pharmaceutical industry from takeovers, considering it an important sector for Britain.
This announcement comes after US giant Pfizer failed in its bid to acquire AstraZeneca and GlaxoSmithKline has been rumored to be a takeover target.
British drug companies Shire, AstraZeneca and GSK have been picked as potential takeover targets by Pfizer, which had earlier tied up with Ireland's Allergan before the deal got cancelled. Analysts say Pfizer needs to find a partner in its quest to relocate its headquarters and lower its tax burden. And the three British drug companies fit the bill.
A new industrial strategy is needed to enable the government to “defend a sector that is as important as pharmaceuticals is to Britain,” May said in a press conference in London this week.
Abbott’s dissolving stent offers long-term benefits to heart patients
Cardiologists and heart patients in the US now have a new option for treating blockages in coronary arteries. Last week, cardiologists began implanting Absorb – Abbott Laboratories’ new biodegradable stent – in patients after it got FDA’s approval on July 5.
Unlike the permanent metal devices that have been used to prop open clogged vessels for more than 20 years, Absorb is designed to fully dissolve within two to three years of its deployment.
Proponents of the new device say it holds the potential for long-term benefits over metal stents, including widely used drug-coated stents that have dominated the market since 2003.
Drug makers financially supported lawmakers who opposed Medicare Part B overhaul
Four months ago, the Obama administration had unveiled a proposal to overhaul Medicare Part B, a medical insurance that covers necessary services and supplies for American citizens. A large number of lawmakers had opposed the effort.
This week, a new analysis has revealed that drug makers, who were worried that the Obama administration’s proposal to overhaul Medicare Part B will cut into their revenues, gave lawmakers who opposed the overhaul considerably more financial support than lawmakers who have not raised objections.
According to an analysis by a consumer advocacy group, 310 lawmakers who opposed the overhaul or were critical of it received a total of more than US $7.2 million from drug and health product firms for their 2016 campaigns. The amount given to each representative averaged more than US $ 23,300.
Obama tells drug makers to renew their commitment to improving public health
US President Barack Obama has written a game plan on healthcare for the next president, including a crackdown on prices of prescription drugs. In a first for a sitting president, Obama wrote a scholarly article in the Journal of the American Medical Association (JAMA) that examines the passage of the Affordable Care Act – his landmark health law.
He also proposes future improvements to the US healthcare system. Obama reprimanded drug makers for their stance on pharmaceutical pricing and challenged companies to renew their commitment to improving public health. He also castigated the Congress for refusing to work with him to provide health coverage more quickly.
Cadila, Lupin, Alembic close issues with the FDA
After weeks of news pertaining to non-compliance by India’s drug companies, the country’s pharmaceutical industry heaved a sigh of relief as Cadila, Lupin and Alembic reported closure of some issues with the FDA.
“This receipt of EIR (Establishment Inspection Report) only indicates closure of the inspection points (483s) raised, based on the inspection carried out between August 28, 2014 and September 05, 2014. What is ‘closed’ is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said in a regulatory filing.
Gilead wins lawsuit against AIDS activist group; gets approval for hepatitis C drug
It’s been a good fortnight for Gilead Sciences. Last week, a lawsuit against the drug maker by an AIDS activist group was dismissed by a US federal court judge. The lawsuit accused Gilead Sciences of manipulating the patent system in order to thwart competition for its HIV medicines.
In its lawsuit, the AIDS Healthcare Foundation had charged that Gilead not only violated antitrust laws, but also prevented countless HIV patients from access to a newer and safer treatment.
Gilead Sciences also recently won FDA approval for another groundbreaking hepatitis C drug. This first of its kind oral, once-a-day drug – known as Epclusa – can treat all six major subtypes of hepatitis without patients taking any other drug, including the debilitating ribavirin. But the cost of Epclusa is prohibitive. The company said Epclusa would be priced at US $ 74,760 for a 12-week course of treatment, which works out to US $ 900 per tablet.
In 2013, Gilead was criticized for initially pricing its first hepatitis C drug – Sovaldi – at US $ 1,000 a pill. Its second-generation drug Harvoni was also launched at around the same price.
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