Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54764
This week, Phispers brings you an update on Teva’s continuing woes that include fines, plant closures and layoffs. With Laurus Labs’ Vizag unit clearing the US FDA inspection, we evaluate what Laurus’ expansion plans could mean for Mylan. And then there is some bad news on Pfizer, Amgen and AbbVie. While arthritis patients in Scotland sued Pfizer for its anti-inflammatory painkiller, Amgen suffered a setback over its osteoporosis drug and AbbVie’s Humira lost a patent battle. Read on.
Teva
fined in India; may get foreign CEO; to shut down Hungary plant and layoff 500
Teva’s woes are continuing unabated. On Monday, India’s National Green Tribunal (NGT) slapped a fine of US$ 23,139 (INR 1.5 million) on Teva API India Limited for discharging untreated effluents into the Bagad river. The tribunal found the discharge from the sewage treatment plant of Teva API’s Gajraula-based plant in Uttar Pradesh to be below the permissible
standards.
Last month, the
NGT had ordered closure of 13 industrial units in
Uttar Pradesh, including the Gajraula plant of Teva API.
Globally, the
Israel-based generic giant may get a foreigner as its CEO. During a call with analysts recently, Teva’s chairman Sol Barer said: “We are looking around the world for the best candidate.”
Teva’s CEO Erez Vigodman had stepped down in February this year. The company’s CFO Eyal
Desheh has said he is resigning at the end of June. Teva’s Israeli board members are demanding that an Israeli be appointed CFO
if the CEO is a foreigner.
And then there is
more trouble for Teva in Hungary. Last year, PharmaCompass had reported
on Teva’s newly built sterile manufacturing facility in Godollo, Hungary, the issues highlighted by the
FDA in its warning letter and the product recalls
from this unit. Well, Teva is now
winding
up its sterile injectables plant in Godollo,
and laying off 500 workers
in the next few months.
The plant had halted production last year after the FDA found manufacturing shortcomings. According to a Reuters
report, Teva plans to close down or sell the Godollo plant
by 2018-end. The company says its plans do not affect its other two Hungarian
plants in Debrecen and Sajobabony.
However, Teva isn’t the only one cutting jobs. Novartis announced it will cut 500 traditional production and development roles in Switzerland and another 250 job cuts are planned in the United States. This is part of Novartis’ global restructuring efforts.
As
G20 meets on antibiotic resistance, DSM wins an amoxicillin patent battle in
India
Last week, health ministers of the G20 leading economies met for the first time
and agreed to work together to combat issues such as a growing resistance to
antibiotics. They also agreed on implementing national action plans by the end
of 2018.
According to the member countries, infectious diseases were spreading more quickly than before due to increased globalization. The 20 nations pledged to strengthen health systems and improve their ability to react to pandemics and other health risks. The results of the meeting will provide key inputs for a G20 leaders’ summit in Hamburg in July.
A report last year
found that newly resistant strains of bacteria were responsible for more than
25,000 deaths a year in the 28 member nations in the European Union.
Meanwhile, the
Delhi High Court granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement in
India. This was announced by DSM Sinochem
Pharmaceuticals (DSP), a
leading company in the production and commercialization of sustainable,
enzymatic antibiotics, next generation statins and anti-fungals,
This patent, which
is owned by DSP, relates to amoxicillin trihydrate having a low free water content and
processes for the manufacture thereof.
The permanent injunction prevents the manufacture, use, importation, offering for sale and sale of Weiqida’s amoxicillin trihydrate API in India, as well as any drug product that utilizes the API.
Pfizer sued by
70 arthritis patients; study reveals safety risks after drug approvals
The world’s biggest pharma company Pfizer is being sued by 70 arthritis patients in Scotland,
who say they were hit with terrible side effects from Celebrex, an anti-inflammatory painkiller touted
as a wonder drug.
The patients — both men and women in the age group of 60 to 90 years — are collectively seeking US$ 4.54 million (£3.5 million) in damages from the New York-headquartered pharma giant.
They began taking
Celebrex in 2002 to combat the effects of arthritis and muscle and joint
stiffness. However, they went on to suffer health problems, including heart
attacks and strokes.
The Scottish
patients hold good chances of winning the case. A recent study — titled Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010 — claims that almost a third of drugs cleared
by the American regulator pose safety risks that are identified only after
their approval.
The study, that appeared in The Jama Network
last week, says there is need for ongoing monitoring of new treatments years
after they hit the market.
Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (or 32 percent) were affected by a post-market safety event. Post-market safety events were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval, the study said.
After
Roche and AstraZeneca, Amgen suffers a setback on its osteoporosis drug
Earlier this
month, both Roche and AstraZeneca had faced setbacks in the late-stage
study of their drugs. Roche had
reported its Tecentriq drug failed
to significantly improve overall survival in a late-stage bladder cancer study.
And an experimental biotech drug for severe asthma
from AstraZeneca failed to meet its goal of significantly reducing attacks in a
late-stage study.
As if to continue
the trend, last week Amgen’s top-stage drug prospect aimed at treatment of osteoporosis — romosozumab — faced some serious setbacks.
What initially seemed like happy news — that the late-stage trial comparing romosozumab to Fosamax hit its primary and key secondary endpoints — turned into some serious questions about the future of romosozamub.
The first big setback was a prominent cardio risk imbalance between romosozumab and Fosamax — 2.5 percent for romosozumab and 1.9 percent for Fosamax.
The second big
setback came from the FDA,
which wants to evaluate the new set of head-to-head data before approving
romosozumab. And that means no decision is expected this summer!
Humira loses key patent battle as J&J tries to block Samsung’s Remicade biosimilar
AbbVie’s Humira — the world’s best selling drug which is a treatment for rheumatoid arthritis — received a setback when the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) handed down a verdict in favor of Coherus BioSciences, a biopharma company in the US.
The verdict struck
down AbbVie’s ‘135 methods patent on Humira after an inter partes review. The patent had been labelled as a shield and “one of the cornerstones of the Humira IP estate,” by Barclays analysts.
However, all IPR
decisions are subject to appeal. In a statement, AbbVie said it does plan to
appeal against the verdict.
Meanwhile, a unit
of Johnson & Johnson filed a lawsuit to block the sale of a copy of its rheumatoid arthritis drug Remicade made by South Korea's Samsung Bioepis in the US. Remicade is J&J’s biggest selling drug, with US sales of about US$ 5 billion a year.
Through the law suit, the J&J company — Janssen Biotech Inc — has sought a preliminary or permanent injunction to block Samsung Bioepis' biosimilar of Remicade, from sale in the US.
Frontida BioPharm gets FDA’s ‘all clear’ for Philadelphia plant bought from Sun
In June last year,
Frontida BioPharm had bought Sun Pharmaceuticals’ finished pharmaceutical plant in
Philadelphia. And barely eight months back, it received an FDA warning letter
for this plant, based on an inspection that took place in 2015.
The warning letter had mentioned that Sun Pharma’s quality unit at the time had knowingly released 27 lots of
various strengths of clonidine HCl tablets, despite evidence that the API
used in manufacturing was potentially contaminated.
The warning letter
had been issued in August 2016, and Frontida knew about the regulatory issues
when it acquired the facilities last year from Sun Pharma, India’s largest drugmaker.
The good news is
that Frontida BioPharm says
the US FDA has given the plant an all-clear. Frontida says Sun helped it address these issues.
With the
regulatory issues behind it, Frontida can now move forward with its expansion
plans.
“The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market,” Frontida CEO Song Li said in a statement.
FDA
warns drug makers to check water systems for BCC contamination
The US FDA has warned manufacturers of non-sterile, water-based drug products
of Burkholderia
cepacia complex (BCC
or B cepacia) contamination,
as there have been recent product recalls due to this and other water-borne
opportunistic pathogens found in pharmaceutical water systems.
The regulator’s warning stems from multi-state outbreak of infections. In March this year, Phispers had carried a news item on
Badrivishal Chemicals & Pharmaceuticals, a manufacturer of docusate sodium. It had been placed on FDA’s import alert list in December last.
The FDA warning
letter issued to Badrivishal talks about adulteration with BCC. The facility
used water as a drug component and for cleaning the facility and equipment. The
water source was a river in the vicinity which passes through farmland, where
it is subject to agricultural runoff and animal waste, before it reaches the
Badrivishal manufacturing site.
FDA’s concern was that contaminated water has been the root cause of multi-state outbreak of infections and multiple recalls by other drug manufacturers of non-sterile liquids, including instances of adulteration with BCC.
“BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” the FDA said.
Detecting BCC
bacteria is a challenge and requires validated testing methods that take into
consideration the unique characteristics of different BCC strains.
Laurus Labs to enter the US generics market;
how will this impact Mylan?
Last week, Laurus Labs
announced that its API facility at Unit 2 in Vizag (India) cleared the US FDA inspection without any Form 483 observations. The unit
manufactures APIs and finished dosage formulations (FDFs).
This successful inspection will help the company
as it plans to foray into the highly regulated US generics market.
Does this suggest trouble for US generic drug
giant Mylan? We think so.
Laurus was started by Dr Satyanarayana Chava in 2007, and is a key manufacturer and supplier of APIs.
With almost US $ 300 million in revenues, it holds its own against better-known
competitors like Mylan.
In fact, Laurus and Mylan have a lot in common.
Both the companies are headed by men who worked together at Matrix
Laboratories. Mylan acquired a controlling stake in Matrix around the time
Chava founded Laurus Labs. Until then, Chava was the chief operating officer of
Matrix, which was being headed by Rajiv Malik, the current president of Mylan.
Laurus has also carved a niche for itself by
supplying antiretroviral or ARVs (used to fight infections caused by
retroviruses like HIV), hepatitis C and oncology drugs. And despite being a relatively new player, its clients include giants like
Pfizer, Teva and Merck.
APIs generally make up for 20 to 35 percent of
the total cost of a drug, but the ones that Laurus develops, like ARVs,
constitute 70 to 75 percent of the cost of the drug.
Both companies have a stronghold in the treatment
of AIDS. Globally, Laurus has achieved a leadership in the manufacture of ARV
APIs. And in the case of Mylan, nearly 50 percent of patients receiving treatment for HIV/AIDS in
the developing world rely on its product, all of which are made in India. In
fact, Mylan is India's third largest pharmaceutical exporter.
So seems like Mylan should watch out for Laurus as
it forward integrates into making finished formulations. Laurus recently filed
2 Abbreviated New Drug Applications in the United States and submitted a
dossier to the WHO (World Health Organization).
Impressions: 4088
This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim. US Senate clears Cures Act — the biggest reform on medical treatments On Wednesday, the US Senate passed the landmark 21st
Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”The 21st Century Cures Act is a labyrinthine bill
that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades. The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.It includes
ambitious goals to advance biomedical science, and will inject US $ 4.8 billion
into a long-stagnating National Institute of Health budget.Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.Indian
court quashes ban on fixed dose combination drugs
As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’. A government order banning 344 FDC drugs was overturned last week when the court was hearing a
plea filed by pharmaceutical companies challenging the March 10, 2016 order
which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and
anti-diabetes combinations.Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug
The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP
84.2 million) for its role in increasing the cost of an epilepsy drug by a
whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP
5.2 million) for overcharging for phenytoin
sodium capsules.The ruling comes at a time when there is a growing debate both in the US and
Europe about the ethics of price hikes for old off-patent medicines that have
little competition.Pfizer
used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said.“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour,” Marsden addedPfizer, Regeneron CEOs get into a shouting match at
healthcare summit
At the Forbes Healthcare Summit held last week, a panel featuring
Gilead CEO
John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO
David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO
Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.While the panel discussed middlemen and adding value, Schleifer offered his
own take.“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.Schleifer’s response: “You’re not entitled to a fraction of the GDP.” What followed was a shouting match, until a member of the panel interjected.
The pharma industry surely needs a unified message to send out to the world.
Spain’s Interquim gets FDA warning letter for using dirty equipmentThe latest
company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.” Inadequate
removal of residues from manufacturing equipment during cleaning can lead to
cross-contamination of API subsequently manufactured, using the same equipment.Investigators
also questioned the impact on API quality of the product produced from
equipment whose interior surfaces were discolored even after an equipment
maintenance contractor had previously noted the damage and repaired it.Interquim
is a part of Ferrer, an international group of more than 50 companies with
activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed
and food sectors. Headquartered in Spain, its products are sold in more than 70
countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc.
Explosion
at excipient manufacturer in India claims two livesAn explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others. While initial news reports claimed a boiler explosion, a
report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court.
Cannabis cultivation to get boost due to upcoming
approvalsGW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost
cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in
treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.It was just
last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical
to market medical cannabis in Israel for pain management.
Will
Apple launch FDA regulated cardiac monitoring products soon?A
collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA,
indicates that since July 2016, Apple has been in discussions with the FDA
about two FDA-regulated products in the cardiac monitoring space.In an
interview with the Telegraph last year, Apple CEO Tim Cook had also
hinted at a regulated medical device from Apple.“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said.
J&J to pay over US $1 billion in Pinnacle
hip implants caseLast week, a
federal jury in Dallas ordered Johnson
& Johnson and its unit DePuy Orthopaedics to pay more than US $ 1
billion to six plaintiffs who said they were injured by the Pinnacle hip implants.According to the jurors, the metal-on-metal Pinnacle hip implants were
defectively designed. And both companies failed to warn consumers about the
risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the
devices.However, verdicts of such size are often lowered by courts. In July, the
judge presiding over this case reduced a US $ 500 million verdict in an earlier
Pinnacle implant case to US $ 151 million by citing a Texas state law that
limits punitive damages awards.
Impressions: 2070
Here’s this week’s pharma news capsule – Phispers (Pharmaceutical Whispers) – which includes compliance issues at a Spanish vaccine manufacturer, positive news on diabetes drug metformin and Sanofi’s
takeover bid for Medivation.
Capsules in India may
turn veg, as regulator plans ban on animal-derived gelatin First it was the ban on cow slaughter, then it was the ban
of fixed dose combination (FDC) drugs and now the Indian drug authority is considering
a proposal to replace the use of gelatin in capsules with cellulose. While a
majority
of capsules (around 95 percent) are made from gelatin, there have been concerns
over the safety of animal derived gelatin in the past. Drug used by 40
percent pork producers maybe carcinogenic; FDA takes step to withdraw itThe FDA took the first step toward rescinding its
approval for the use of carbadox to treat swine because “the drug may leave trace amounts of a carcinogenic residue.” Carbadox,
sold commercially as Mecadox, was
first approved in the early 1970s. An estimated 40 percent pork producers rely on the medicine to treat and prevent disease in swine, as well as fatten the animals. The manufacturer of Mecadox – Phibro Animal Health – intends to request a hearing and refute the allegations. Metformin found safe
by the FDA for patients with reduced kidney function There have been questions on how Metformin,
one of the most commonly prescribed treatments for type 2 diabetes, should be used in patients with reduced kidney function. Last week, the FDA Concluded from the review of studies published in medical literature that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” A Dutch
review had reached a similar conclusion earlier. Pfizer spinout, RaQualia’s next-gen ‘Nexium’ getting ready for China launchA spin-out of Pfizer
Japan, RaQualia has been evaluating tegoprazan (CJ-12420) as the
next-generation version of AstraZeneca’s ‘purple-pill’, Nexium. While still in Phase III clinical trials, the product received a shot in the arm with RaQualia’s Korean
partner CJ Group, reaching a development and
licensing deal with China’s Shandong
Luoxin Pharmaceutical Group. The deal, estimated to reap US $ 91 million in profit, will
sell this new version of Nexium in China. Nexium treats gastroesophageal reflux
disease. Multi-billion-dollar
shareholder lawsuit against Pfizer revivedA federal appeals court in
the US revived a class-action
lawsuit accusing Pfizer of causing tens of billions of dollars of losses to shareholders by misleading them about the safety of its pain-relieving drugs – Celebrex and Bextra. The lawsuit began in 2004, and covers
investors who bought Pfizer stock between October 31, 2000 and October 19,
2005. Compliance issues at
Spanish vaccine manufacturerSpanish regulator has issued a recall of vaccines produced
at an Inmunotek
facility in Madrid and temporarily suspended the plant's manufacturing license
after an inspection last month found critical issues with production and
sterility at the company's San Sebastian de los Reyes site. FDA problems drag
Ipca into more troubleIndia’s Ipca
Laboratories had received a
warning letter from the FDA for its API plants in February with inspectors citing data manipulation and falsification. Now, the warning letter has dragged Ipca into more problems. The shares of Ipca plummeted by over 14 per cent after an international financing organization – The
Global Fund – decided not to allocate any volume of artemisinin-based combination therapy (ACTs) to the company in light of recent FDA warning issued to Ipca. Medivation snubs Sanofi’s initial takeover bidAmerican biopharmaceutical company Medivation Inc is learnt
to have rebuffed a recent
takeover bid from French drug maker Sanofi. Medivation, which focuses on
treatments for hard-to-cure cancers, is seeking a higher price than what the initial
proposals have indicated. If news reports are accurate, there are other suitors
for Medivation too. Sanofi, on the other hand, is also open to making a hostile
bid, a Bloomberg news report said. Are we entering an
era of responsible drug pricing?KaloBios Pharmaceuticals Inc – a biotechnology company that was earlier led by controversial former drug executive Martin Shkreli – has vowed
not to engage in aggressive pricing and to develop a transparent and 'responsible' pricing model for its products. KaloBios fired its chief executive Shkreli last December following his arrest on charges of securities fraud. Shkreli had sparked outrage last year when as the head of Turing Pharmaceuticals he had raised the price of a drug to treat a parasitic infection from US $ 13.50 to US $750. Let’s hope the KaloBios vow is a signal that the world of pharmaceuticals is entering an era of responsible drug pricing. FDA’s Warning Letter trends in FY2016In case you’re interested in learning how active the FDA has been halfway through their fiscal year, Barbara Unger has shared her compilation
of warning letter trends and compared them with previous years.
Impressions: 3956
Almost immediately after our analysis on why “Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States”, a stock analyst stated
that there were “hopes of US FDA resolution of Srikakulam plant”. What does the future hold for API manufacturing at Dr. Reddy’s, currently the third largest API seller in the world? As part of the Reuters story, CLSA, a stock brokerage covering Dr. Reddy’s, based their assessment that Dr. Reddy’s troubles are behind them as “one of its customers has received approval for a product, referencing a drug master file from this facility”. While the CLSA report is very positive for Dr. Reddy’s, it’s strange that other than CLSA nobody else has covered this important event. In an attempt to verify CLSA’s statement, we compiled a list of all recent generic approvals (since March 15) which were cross referenced using the Dr. Reddy’s @ PharmaCompass database to determine the active ingredients produced at their Srikakulam facility.
Date
Product
Application
Holder
March 26, 2015
Tolcapone
Par Pharma
March 23, 2015
Argatoban Injection
Fresenius Kabi
USA
March 19, 2015
Zoledronic Acid
Hospira Inc
March 18, 2015
Tenofovir Disoproxil Fumarate
Teva
Pharmaceutical USA
March 17, 2015
Lacosamide (Tentative Approval)
Aurobindo Pharma
March 16, 2015
Celecoxib
Lupin
March 16, 2015
Fluoxetine Hydrochloride
Sciegen
Pharmaceuticals
While Dr. Reddy’s produces 4 out of these 7 recently approved products (Zoledronic Acid, Lacosamide, Celecoxib and Fluoxetine Hydrochloride), only Lacosamide is produced at the Srikakulam facility. The assessment is based
on the Written Confirmations granted by the Indian Drug Regulator which serve
as a good guide to know which products are being manufactured in which
facility. The issuance of the Written Confirmation requires physical
verification of production at the site by the local authorities, which is not
necessarily true in the case of DMFs and CEPs.
The possibility of Aurobindo Pharma’s generic approval of Lacosamide being dependent on Dr. Reddy’s active ingredient is low, as Aurobindo Pharma supports their own USDMF. However, Aurobindo doesn’t have a Written Confirmation for Lacosamide.In
their 2014 annual report, Dr. Reddy’s, defined their revenues from the Pharmaceutical Services and Active Ingredients (PSAI) division, which declined 21.9%, as a “low point” of their overall business. However, Dr. Reddy’s also acknowledges that PSAI is a strength, as it provides vertical integration to their global generics business. While Dr. Reddy’s has announced plans to the Ministry of
Environment, to triple the size of their manufacturing capacity across three
different production facilities, the facility in question, Srikakulam, is not
part of the announced expansion plan. There
still seems to be significant risk to Dr. Reddy’s North American business on account of the USFDA inspection of their Srikakulam API
facility. Read
more about: Dr. Reddy’s expansion plans for API production
Impressions: 4963