Press review


Manoeuvres to protect drug patents 'unsustainable' - analyst

BERLIN, Oct 13 (APM) - Recent attempts by pharma companies to prolong patent protection for their blockbuster drugs through legal manoeuvres are unsustainable and alarming, Handelsblatt reported on Tuesday (p20).
Standard& Poor rating analyst Arthur Wong told the paper that these attempts are not a sustainable strategy and suggest the companies lack alternative means.
Allergan's controversial tribal deal on dry eye drug Restasis (cyclosporine) (APMHE 54637) is an example of a pharma desperate to protect an established source of income, the paper said.
Pfizer's U.S. lawsuits against Johnson & Johnson for stifling biosimilar competition with "exclusionary contracts" on Remicade (infliximab) suggest Pfizer is grasping at straws (APMHE 54790).
AbbVie, too, filed several patents on manufacturing and technical processes related to Humira (adalimumab) right after the drug patent expired, in order to deter biosimilar manufacturing.
Sanford Bernstein analyst Ronny Gal told Handelsblatt he is convinced that all companies are now either employing or considering such strategies.

Bayer acquisition of Monsanto will be costly

Despite delays, Bayer's $66 billion acquisition of Monsanto is likely to be approved by regulators but will cost Bayer "dearly", Die Welt reported on Saturday (p9).
A further delay of the deal is expected after the Brazilian antitrust authority postponed its decision, saying the anticipated merger-related efficiencies were insufficient to mitigate its competition concerns and recommending further "structural solutions", the paper said.
The European Commission said last week it was "stopping the clock" in the investigation while waiting for "an important piece of information" to be supplied.
Growing concerns about Monsanto's "dubious" business practices are another obstacle, the paper wrote.
Some Monsanto managers recently refused to appear before the European Parliament for a hearing on herbicide Roundup (glyphosate), which is still suspected of causing cancer in humans. In response, parliamentarians quickly withdrew the group's lobbyists' access card - something that had never happened before in Brussels, the paper said.
Monsanto's latest invention, genetically modified seeds resistant to weedkiller Dicamba, is also controversial. Over 2,200 cases of farmers complaining that they cause considerable damage to crops in neighbouring fields are being investigated in the U.S., the paper wrote.

Boehringer expects many partnerships with IT firms

Boehringer Ingelheim sees vast opportunities in the movement toward healthcare digitisation and intends to increase its partnerships with IT companies, Frankfurter Allgemeine Zeitung (FAZ) wrote in an interview with CFO Simone Menne on Wednesday (p21) (APMHE 55101).
Digitisation trends can no longer be ignored by the pharma industry and in addition to partnerships, Boehringer is making moves to develop a niche of its own in the field. "As a pharmaceutical company, we need to develop expertise and a competitive edge" in designing healthcare technology applications, she told the paper.
In 2017, the pharma will invest about 10 million euros in digital initiatives including the BI X digital lab, whose employees are supposed to harness disruptive trends and find ways to make them work for the company's benefit. But digitisation is taking place "throughout the company" and will not be designated to just one department or management position, she said.

First gene therapy for inherited vision loss nears approval

The first gene therapy for vision loss due to an inherited retinal disease may be soon approved in the U.S., raising hopes among doctors and patients, reported FAZ on Wednesday (p30).
The U.S. Food and Drug Administration (FDA) has planned to give its decision on January 18, 2018 for a treatment for patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease, the paper said - without naming Spark Therapeutics' Luxturna (voretigene neparvovec) (APMHE 53957).
The European Medicines Agency (EMA) is planning a response to the EU filing in the second half of 2018, the paper said.
It would be a major breakthrough even if patients recover only partial vision, doctors said. German ophthalmologist Hendrik Scholl hopes that the approval will cover all patients with RPE65 associated diseases and not just a sub-group.

Pfizer considers selling OTC

Pfizer is considering selling its over-the-counter (OTC) business, worth $3.4 billion in sales, because it differs significantly from its core business, Handelsblatt reported briefly on Wednesday (p17) (APMHE 55082).
This comes after German rival Merck's September announcement on a similar reflection over its OTC business, which generates 860 million euros of turnover.
It is expected to take a decision in 2018.

Perceived drug cost influences negative side-effects

A small study from the University of Hamburg shows that patients are more likely to experience negative side effects when taking a drug they think is more expensive than an equivalent but cheaper alternative, reported Der Spiegel on Saturday (p129) and SZ on Monday (p14).
The study included 49 participants given a placebo for itching that they were told might help but could also increase sensitivity to pain. Some were given a placebo they were told was expensive and presented in high-quality packaging. The others were given a 'cheaper' version, simply packaged.
Those who received the 'expensive' product later complained more about pain, the paper wrote. The "nocebo" effect, or the worsening of symptoms caused by an inert substance, became more pronounced over time, it said.

German health minister considers cutting health contribution

Germany's health minister Herman Groehe is considering a reduction of 0.1 point to the additional contributions paid by statutory health insurees thanks to the positive financial outlook for 2018, report FAZ (p19) and Die Welt (p10) on Friday.
According to projections, the additional contribution may be lowered from 1.1% to 1.0% because health insurance revenue is expected to grow given the high level of employment and favourable economic climate.
Umbrella payer group GKV-Spitzenverband (GKV-SV) has opposed the proposal, saying the "process of financial stabilisation" is still ongoing.
Groehe has until November 1 to decide.



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