As India deals with new currency
notes and the US elects Donald Trump as its new President, Phispers brings you
the latest pharma news from both these countries. Probe into price collusion in
the US resulted in pharma stocks tumbling in India. There is also news on a likely
breakthrough in the treatment of diabetes, the latest on the vaccine scandal in
China, compliance news from across the globe and more.
Drug
firms in US face probe into price collusion; feel the pressure in pricing
Last week, Senator Bernie Sanders asked the US
Department of Justice and the Federal Trade Commission to investigate three insulin makers for
price collusion. Citing 13 instances since 2009, he said the prices of Lantus
(Sanofi’s
blockbuster diabetes medication) and Levemir
(Lantus' direct competitor, made by Novo Nordisk), “have gone up in tandem in the US”. And from 2014 to 2015, the price of both medications “went up by 29.9 percent”. Sanders’ letter also cites that Eli Lilly and other companies have been fined in Mexico for colluding on insulin
pricing.
The letter has been sent at a time when Andy Slavitt, the acting administrator
for the Centers for Medicare & Medicaid Services (CMS), condemned drug
makers for cost increases.
Total prescription drug spending in 2015 was about US $
457 billion, or 16.7 percent of healthcare spending. Based on recent trends,
Slavitt said CMS is estimating average annual increases of 6.7 percent until
2025.
However, drug makers are already feeling the pricing pressure.
GlaxoSmithKline
CEO Andrew Witty said the company has seen a 2 percent
dip in net prices in the US this year, and expects further reductions driven by
payer and hospital consolidation.
In addition, new data-driven flexible pricing
schemes being offered by Swiss drug-maker Roche and other drug companies are replacing the current “pay-per-pill” approach. These mechanisms are more popular in cancer treatment. Roche has introduced flexible pricing for cancer drugs in about a dozen European countries, including Italy, Belgium, Hungary, Switzerland and Austria.
Indian pharma stocks
crash due to price collusion probes in the US
The probes in the US
are impacting share prices of Indian pharmaceutical companies, which together comprise the
second-biggest suppliers of generic medicines to the US. The share prices of
Indian pharma dipped amid mounting concerns about potential pressures on drug
prices in the US, after news of a Justice Department probe. Prosecutors in the
US are investigating generic pharmaceutical companies for suspected price collusion.
Among the drug makers
to have received subpoenas are companies like Mylan, Teva Pharmaceutical Industries, Actavis (which Teva bought from Allergan Plc in August), Lannett Co, Impax Laboratories, Covis Pharma Holdings Sarl, Sun Pharmaceutical Industries, Mayne Pharma Group, Endo International’s subsidiary Par Pharmaceutical Holdings and Taro Pharmaceutical Industries.
More arrests in
Chinese vaccine scandal case In a crackdown on the black market sale of vaccines, China’s eastern province of Shandong saw 27 additional arrests, taking the total number of people arrested to 324. Nearly US $ 90 million worth of illegal
vaccines are estimated to being sold in dozens of provinces across China. A mother-daughter duo — Pang Hongwei, a former pharmacist at a hospital in Shandong and her 21-year-old daughter — were caught peddling 25 kinds of unrefrigerated vaccines, which could have compromised inoculations and resulted in
paralysis and even death. Probes found 300 illegal distributors aiding Pang
across 24 provinces and regions. The drug regulator in Shandong said it would work with police forces and the health ministry to inspect vaccine stocks to ascertain where US $ 88 million worth of vaccines had ended up. The case – involving vaccines against meningitis, rabies and other illnesses – underlines the challenge being faced by China to regulate its fragmented supply chain.
Fake vaccines scandals have been a
public-health menace in other countries as well. For instance, it was learnt that
substandard products had been distributed across Indonesia since 2003. As a result, the
Indonesian government will reinoculate children
aged 10 and below. A diabetes
breakthrough? Insulin resistance reversed by removal of proteinA team of investigators
led by researchers from the University of California School of Medicine
reportedly reversed diabetic insulin resistance and glucose intolerance in mouse models of obesity and diabetes by removing the protein – galectin-3 (Gal3).When you bind Gal3 to
insulin receptors on cells, the protein prevents the insulin from attaching to the receptors,
resulting in cellular insulin resistance. The researcher showed that by
genetically removing Gal3 or using pharmaceutical inhibitors to target it,
insulin sensitivity and glucose tolerance could be returned to normal, even
among older mice. However, obesity remained unchanged.
“This study puts Gal3 on the map for insulin resistance and diabetes in mouse model,” said senior author of the study. “Our findings suggest that Gal3 inhibition in people could be an effective anti-diabetic approach,” the author added.
Sanofi,
Novartis, GSK do not effectively disclose clinical trial data, finds online
tool
A new
online tool was launched last week by AllTrials, a consortium of researchers and medical journals that has
been pushing the pharmaceutical industry to do a better job of disclosing
clinical trial data.
This
is an important, though a contentious issue because without access to such
data, independent researchers are unable to verify results that can lead to
improved treatments, better healthcare, and lower costs.
For
instance, the tracker found that Sanofi had the largest number of missing trial results – there are 285 missing results from 435 eligible trials, which meant the company has not shared 65 percent of its findings.
Among
other transgressors is Novartis, which did not disclose results
for 201 studies, or nearly 38 percent of 534 eligible trials. And
GlaxoSmithKline failed to release findings for 183 trials, or almost 23 percent
of 809 eligible studies.
Compliance
news: Valeant, Resonance Labs in trouble; Mylan settles dispute with
Strides
FDA’s warning letter for Valeant: There is fresh trouble for Valeant Pharmaceuticals, which has been dealing with
several problems, including a government probe into its accounting and pricing
practices. The US Food and Drug Administration (FDA) has sent a warning letter to Valeant
for its manufacturing problems that reflect an inability to integrate some of
the products that have come into its fold through acquisitions.
The
letter describes how a Valeant production plant in Rochester (New York), which mostly
makes products for the Bausch + Lomb division, experienced various
problems with the OraPharma ONSET Mixing Pen — a compounding and dispensing device used for mixing two solutions together. “Organizational structure has not assured that acquired products are adequately integrated into your quality management system,” the letter said. Valeant acquired OraPharma in 2012.
Compliance trouble for Resonance Labs: Indian API manufacturer Resonance Labs is in compliance trouble as Health Canada
has placed it on its Inspection Tracker, based on information obtained from a
regulatory partner regarding general GMP observations. Usually alerts from
Health Canada are followed by either a warning letter from the FDA or a Non-Compliance
Report from the European authorities.
Mylan and Agila settle dispute over pending payments: Mylan NV’s US $ 1.6 billion cash acquisition of Agila Specialties (a developer, manufacturer and marketer of high-quality generic injectable products) in 2013 from India’s Strides Arcolab had run into compliance
problems. Within a year of acquiring Agila, Mylan had received a notice from the FDA regarding
violations of GMPs. But last week, Mylan settled its two-year old dispute over pending payments
with Strides. Mylan received US $ 170 million as final settlement.
Lupin receives EIR from FDA for Goa plant: In June we had asked how long it would take for Lupin to address FDA’s concerns
pertaining to its Goa facility. And we were positively
surprised this week when Lupin
announced a successful closure of the inspection. Lupin received the Establishment Inspection Report
(EIR) from the US health regulator for its Goa plant leading to closure of all
outstanding inspections of the facility.
Old Ranbaxy facility being inspected by FDA: Next up is Sun Pharmaceuticals, as the US FDA commenced its scheduled inspection of the Mohali manufacturing site of Ranbaxy.
Sun had acquired Ranbaxy two years back as part of a US $ 4 billion deal with
Japanese drug maker Daiichi Sankyo. As per news reports, the inspection started on
November 7, and may continue for a week.
GSK sues Pfizer, as both companies announce plant
closures
Last week, both GlaxoSmithKline and Pfizer made
announcements regarding shutting down manufacturing plants. GSK Consumer
Healthcare announced it will close its manufacturing facility
in Ermington (Australia) in 2020. And US drugs behemoth Pfizer said it will close two manufacturing sites
in the UK by
2020, resulting in 370 job losses. The Park Royal site in London, which Pfizer inherited when it acquired Hospira
in September this year, will shut down by May 2017. The site takes liquid medicines and puts
them into dosed vials, which are then sold to hospitals. The global cold chain packaging and
distribution site in Portsmouth will shut by the end of 2020. The Pfizer
spokesperson said the decision has nothing to do with Brexit. The global
packaging site will be consolidated in Puurs (Belgium), “where there are better production capabilities to support the product pipeline”,
the spokesman added.
Meanwhile, British drug giant, GSK has filed a patent infringement lawsuit against Pfizer over allegedly copying its popular meningococcal group B vaccine – Bexsero. The drug competes with Pfizer’s Trumenba. Meningococcal disease is a
potentially fatal bacterial infection of the bloodstream, brain and the spinal
cord lining. GSK’s
Bexsero is currently the only vaccine against the disease that is available in
most markets. And the legal step taken by GSK represents its desire to protect the drug’s powerful market share.
Biotech startup Cempra’s woes continue
Last week, Wockhardt’s ambitious
turnaround plans received a serious setback when Cempra — a clinical-stage pharma company focused on developing antibiotics — learnt that the US FDA may not allow it to use an active
pharmaceutical ingredient (API) produced by Wockhardt for approval and in the
commercial use of its product Solithromycin.
A regulatory panel of experts on November 4 narrowly recommended that Solithromycin — an antibiotic from Cempra being
projected as an answer to the menace of antibiotic resistance — should be approved for use. The 7-to-6 votes in
favour of Solithromycin suggests that there is an unmet
need for new treatments that outweigh the safety concerns surrounding the
product.
The Wall Street had forecasted
Solithromycin to be a blockbuster. Little wonder then that the investors were
rattled last week and the stock plunged 58 percent after the US FDA disclosed its review.
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