Market Place
We usher in 2023 with the key highlights of the US Food and Drug Administration’s December 2022 list of Off-Patent, Off-Exclusivity (OPOE) Drugs with No Approved Generics. With this list, the FDA hopes to bolster competitiveness
in the generics market.The OPOE list gets updated every six months. Such updates are a part of FDA’s initiative to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since 2017, the FDA has been publishing the OPOE list of drugs without an approved generic. For a year now, the FDA has been publishing two versions of the OPOE list — one for prescription drug products and one for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Four
new applications added to Dec 2022 list; 96 first generics approved last yearWhile the FDA’s June 2022 list of OPOE Drugs with No Approved Generics had 98 new applications for prescription drugs, the December 2022 list saw a sharp decline — only four new applications were added during this period. We had witnessed a similar trend in 2021 — the December 2021 list had only 16 new applications as
opposed to 35 new applications in the June 2021 list.The four new applications were for diclofenamide (a drug to treat glaucoma), ephedrine sulfate (a drug used to treat asthma and
heart failure that also acts as a central nervous system stimulant), meloxicam (an arthritis drug) and pemetrexed (a chemotherapy medication). In
May 2022, the FDA approved the first generics for pemetrexed injection
developed by several companies, including Accord Healthcare, Fresenius Kabi, Apotex, Qilu Pharmaceutical, Biocon, Dr. Reddy’s Laboratories and
Zydus, to treat non-small cell lung cancer (NSCLC) and mesothelioma. Almost one-third of the prescription products – 184 out of 505 – are drug products delivered as injectables, and 68 entries are for oral solid dosage forms (such as tablets, capsules and modified release forms).In the June 2022 list, a total of 60 OTC
drug products were listed. This time too, the same number of OTC drug products
figured in the OPOE list. These include antiseptic agent chlorhexidine gluconate,
non-steroidal anti-inflammatory drug ibuprofen, anti-allergy drug loratadine and painkiller acetaminophen. Of these, 19 are delivered as
oral solid dosage forms (such as
tablets, capsules and modified release forms).In 2022, the FDA approved 96 first generics. This is slightly higher than
the 93 approved by the agency in 2021.As the name suggests, “first generics” are the first approvals handed by the FDA to manufacturers to market a generic product in the United States. The agency considers first generics to be important to public health, and prioritizes review of these submissions.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)AbbVie’s Humira, Novartis’ Entresto to finally face generic competitionAbbVie is facing one of the steepest patent cliffs in the industry’s history, with Humira slated to face the onslaught
of eight biosimilars this year. The blockbuster drug had generated US$ 21.2 billion in 2021. Amgen’s Humira biosimilar – Amjevita – will hit the market this month. The other Humira
biosimilars that will be launched this year include Abrilada (Pfizer), Cyltezo (Boehringer), Hadlima (Samsung Bioepis), Hyrimoz (Sandoz), Hulio (Viatris) and Yusimry (Coherus BioSciences). In mid-December, Fresenius Kabi became the latest
company to win US approval for its Humira copycat — Idacio.Novartis’ heart failure drug Entresto will also go off patent this month. The blockbuster drug had generated US$ 3.5 billion in 2021.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Our viewIn our previous OPOE drug listing, we had talked about FDA’s intent to bring down drug prices, with the agency putting 98 new applications of prescription drugs in the OPOE list for June 2022. That intent has only become stronger with the US Patent and Trademark Office (USPTO) and the FDA joining hands to promote
competition. The two bodies are working towards improving the patent system in an effort to stop its misuse through “patent thickets”, “evergreening” and “product-hopping”. With this clear intent to lower drug prices in the US, the OPOE lists for 2023 and beyond are likely to get more interesting. For now, all eyes are set on what generic competition will do to blockbusters like AbbVie’s Humira and Novartis’ Entresto.
Impressions: 2698
https://www.pharmacompass.com/radio-compass-blog/fda-s-list-of-off-patent-drugs-suggests-higher-approvals-of-first-generics-in-2022
#PharmaFlow by PHARMACOMPASS
05 Jan 2023
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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: 54754
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
This week, Phispers brings you two tales
of alleged misuse of information involving former employees of Teva and
AstraZeneca. Latin America is presenting more challenges for pharma MNCs,
especially with Brazil under recession. Meanwhile, FDA is investing US$ 500
million under the Cures Act, passed by the Obama Administration in December
last year. And Eli Lilly has won a long-drawn patent dispute against Actavis
over its cancer best-seller.
Teva sues ex-exec romantically involved with Apotex’s CEO
Last week, Teva filed a lawsuit against its ex-employee Barinder Sandhu who was Senior Director, Regulatory Affairs, US Generics at Teva USA, until her termination in October, 2016.
Also named in the lawsuit is Jeremy Desai, who is President and CEO of Teva’s direct competitor — Apotex, a Canada-headquartered drug firm.
Teva has claimed that Sandhu breached her confidentiality agreement by sharing trade secrets and other confidential information to benefit Apotex’s own competitive product development.
According to the lawsuit, Sandhu “emailed Teva USA documents containing trade secrets and other confidential information, many specifically marked ‘Confidential’, to Desai at his Apotex email account.”
She also allegedly sent information to her personal email account, in violation of Teva USA’s policies, used USB flash drives on her work-issued computer laptop and used a cloud-based drive to share “hundreds of Teva USA documents”.
The information shared by Sandhu relates to a project whose identity has been concealed in the lawsuit as ‘Product X’. Teva claims that Desai and/or Apotex used the “misappropriated information to gain a competitive advantage over Teva USA”.
According to the complaint, Apotex employees openly discussed Teva USA’s trade secrets and other confidential information related to ‘Product X’ and participated in roundtable discussions in an effort to advance Apotex’s potential market position of its competing generic product.
The lawsuit mentions that in the summer of 2016, Teva USA learned through a former Apotex employee that Sandhu had provided Desai with a copy of highly confidential correspondence from the FDA to Teva USA known as a Complete Response Letter (“CRL”).
This letter from the FDA provided comment on an application for ‘Product X’, which was circulated amongst Apotex employees.
After accusing former protege of info misuse, is AstraZeneca’s CEO leaving to take the top job at Teva?
There was more news last week, pertaining to the potential misuse of confidential information — AstraZeneca accused former executive
Luke Miels of misusing confidential information and documents to win
the top pharma job at GlaxoSmithKline.
According to court
documents obtained by the Times, Miels
alleged that Pascal Soriot, AstraZeneca CEO and Miels’ former mentor, took Miels' decision to resign and join GSK very personally and “sought to threaten and punish” him by enforcing a 12-month notice period.
AstraZeneca, on the other hand, alleged that Miels, who was paid US$ 1.67 million (£1.3 million) last year, “had access to information that was confidential beyond his 12-month notice period” that would damage Astra if it was obtained by a competitor.
Miels’ lawyers responded by stating that AstraZeneca was in no position to complain about him using AstraZeneca’s documents in his job negotiations since AstraZeneca had shared confidential information with Soriot before he left Roche to become Astra’s CEO.
The
story may take another unexpected twist as Israeli news reports say that AstraZeneca CEO Pascal Soriot has agreed to take the top job at
Teva. Soriot is expected to earn twice as much as Teva’s previous CEO and receive a bonus upon signing the contract, estimated at about $20 million.
Pfizer bows out with sale of Teuto in
Brazil
Not long ago, Brazil
was one of the hottest emerging markets for
drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that
has dampened drug demand.
Back in 2010, when
the going was good, Pfizer had struck a US$ 240 million deal for a 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro. But the joint venture never really took off. And recently, Pfizer has accepted a payment of 1 Brazilian Real — or US$ 0.30 — to relinquish its stake to the heirs of Laboratório Teuto’s founder.
For nearly a year, Pfizer had been trying to offload Teuto. A spokesperson for Pfizer said: “Since 2010, both companies have worked together to improve access to medicines in Brazil.” However, Pfizer arrived at this decision as a result of a “desire to focus resources on ensuring the success of its existing portfolio and pipeline.”
Pfizer’s exit follows challenging acquisition experiences by Sanofi and Teva in Latin America.
Eli Lilly wins patent dispute against
Actavis over its best-selling cancer drug
Last week, Eli Lilly won a long-drawn patent dispute
with Actavis after the UK Supreme Court ruled that the generic drugmaker's versions of Lilly's top-selling cancer drug — Alimta — directly infringes on certain Lilly patents in Britain, France, Italy and Spain.
The generic version
of Alimta (pemetrexed)
is now owned by Teva,
after it bought Allergan's generic business — Actavis — in August last year.
Alimta is Lilly's
top-selling oncology treatment. It generated sales of US$ 2.3 billion last
year.
This decision
reportedly applies to about US$ 300 million worth of annual sales.
Merck’s purchase of Sigma Aldrich under EU scanner
The European
Commission has raised objections to the purchase
of Sigma Aldrich by German drugmaker Merck. In a Statement of Objections sent out to Merck and Sigma-Aldrich, the Commission alleged that these companies breached EU merger rules. The companies could face a fine equivalent to 1 percent of the combined firm’s annual revenue, the Commission said.
According to the
Commission, when Merck and Sigma-Aldrich disclosed their merger plan in 2015 they did not share details of a project “with relevance for certain laboratory chemicals at the core of the Commission’s analysis.”
The Commission
said the project was being developed by one of the parts of the Sigma business
that was acquired by Honeywell in October 2015. The technology
developed as a result of the project was subsequently licensed to Honeywell,
the Commission added.
“Honeywell now has the technology it should have received with the divested business. However, this happened with a delay of almost one year and only because the Commission was subsequently made aware of the issue by a third party,” the Commission said.
FDA to invest US$ 500 million innovation
fund under Cures Act
Last week, the FDA
laid out its plans of
investing the US$ 500 million innovation fund earmarked in the 21st Century
Cures Act, passed last year under the Obama Administration. The fund will be
spent from this year, until 2025, and is subject to annual appropriations from
the US Congress.
Scott Gottlieb, FDA’s Commissioner, in a blog post, said the agency’s plans for investing the innovation fund are steps that will both improve public health (by facilitating biomedical innovation) and reduce drug costs (by cutting the burden of unnecessary regulation).
FDA’s plans for the innovation fund include allocating US$ 25.8 million to advance patient-focused drug development, and US$ 95.3 million to regulatory science initiatives, including qualification of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases, and to award grants to advance continuous manufacturing technology. The largest expenditure from the innovation fund — US$ 168.2 million — is earmarked for FDA’s initiatives designed to improve the collection of evidence about safety and efficacy.
“FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit,” Gottlieb said in his blog.
Did Gilead use Chinese API claiming it came from an approved
South Korean manufacturer?
The United States
Court of Appeals for the Ninth Circuit reversed a federal judge’s 2015 ruling in the Gilead Sciences’ case. The US drugmaker is back in court to defend accusations that it made false statements about complying with federal regulations on HIV drugs.
There were allegations that Gilead had netted billions of dollars in government purchases, and that it had fired a whistleblower — a senior employee who spoke against the company’s illicit conduct.
The ex-employees claim that Gilead used a company called Synthetics China to produce unapproved emtricitabine, at unregistered facilities, to
save money.
For almost one and a half years, beginning in 2007, Gilead imported emtricitabine
API from Synthetics China to use in its finished drugs, claiming that the API
had come from its approved South Korean manufacturer.
Emtricitabine is used by Gilead to produce several HIV
drugs, such as Atripla, Emtriva and Truvada.
The Ninth Circuit three-judge appeals panel held that former Gilead employees Jeff and Sherilyn Campie had adequately pleaded that Gilead’s conduct opened it to liability under the False Claims Act (FCA). In 2008 and 2009, the government paid more than US$ 5 billion for the HIV drugs, the court held.
Impressions: 8760
https://www.pharmacompass.com/radio-compass-blog/teva-sues-ex-exec-romantically-involved-with-apotex-s-ceo-pfizer-bids-adieu-to-brazil-s-teuto
#PharmaFlow by PHARMACOMPASS
13 Jul 2017
This week in Phispers, read about the extortion cyberattack and how it impacted hospitals in the UK. There is news on GSK, and its plans to buyout Novartis’ stake in their consumer health JV. Its blockbuster Advair got a shot in the arm as another generic failed endpoints. There is also news on mergers, acquisitions and layoffs and how the US FDA’s new commissioner is reorganizing its inspection staff.
Ransomware attack cripples NHS in the UK; such threats likely to grow
The ‘ransomware’ extortion cyberattack took the world by a storm last week. And if the UK’s National Cyber Security Centre is to be believed, more cases of the ransomware are expected to come to light, “possibly at a significant scale”.
Last weekend, a
huge extortion cyberattack hit
countries across the globe, holding computer data for ransom at hospitals and
several firms.
Two security firms — Kaspersky Lab and Avast —said they had identified the malware behind the attack that impacted over 70 countries. Russia was hit hardest.
The attack hit National Health Service (NHS) — UK’s health service — forcing hospitals to close wards and emergency rooms. Across the country, hospitals found themselves without access to their computers and phone systems. Many patients were sent home as their records could not be accessed.
While there has
not been any fresh attack so far, according to a BBC news report, at least 16 trusts out of 47 of the NHS that were hit are still facing
issues, leading to further cancellations and delays to services.
Ransomware is a
type of malicious software that blocks access to a computer system until a sum
of money is paid, usually via bitcoin (the digital currency), to release
it. According to news reports, the
ransomware threats are likely to grow across private and public sectors.
Thermo Fisher
buys Patheon; INC merges with inVentiv; Paraxel plans layoffs
Thermo Fisher Scientific Inc continued its acquisition spree last
week with the US$ 5.2 billion purchase of drug-development technology company Patheon NV.
Thermo Fisher has emerged as one of the world’s
biggest manufacturers of diagnostic and testing equipment through deals. Over
the last five years, Thermo Fisher has made acquisitions worth US$ 22 billion.
It will pay US$ 35 a share in cash for Patheon — a 35 percent increase over Patheon’s closing price on Friday last.
Meanwhile, INC
Research Holdings Inc announced last week that it would merge with private
equity-owned inVentiv Health Inc, another contract research organization (CRO),
in a US$ 4.6 billion all-stock deal.
The deal is expected to help INC win contracts with large pharma companies.
Another CRO — Paraxel — plans to lay off staff, as rumors
of a potential buyout gather steam after the company projected lower revenues. In a filing with the SEC on May 4, the
Massachusetts-based company outlined plans to cut 1,200 jobs at the global
clinical trial operation.
Weeks after
staff plotted to destroy drugs, EU probes Aspen for price
gouging
Last month, Phispers
had carried a news nugget on Africa’s leading drug company — Aspen Pharmacare — and how its employees had reportedly plotted to destroy stocks of
life-saving medicines during a price dispute with the Spanish health service in
2014.
This week, the
European Commission initiated a formal probe into
concerns that Aspen Pharma is charging excessive prices for five life-saving
cancer medicines. The Commission will investigate whether Aspen has abused a
dominant market position and breached EU antitrust rules. If found guilty, this
could lead to a hefty fine for
Aspen.
The investigation is around Aspen's pricing practices for niche medicines containing the active pharmaceutical ingredients (APIs) — chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan. These APIs are used for treating cancer
and are sold with different formulations and under multiple brand names. Aspen
acquired these drugs after their patents expired.
The investigation
will cover all of Europe except Italy, which hit the company with a Euro 5
million fine in October last year for price hikes up to 1,500 percent for some
key drugs.
Investors fume over GSK’s plan to buyout Novartis stake in consumer health
GlaxoSmithKline has informed its shareholders that it
plans to buy out Swiss drugmaker Novartis’ 36.5 per cent stake in GSK Consumer Healthcare.
GSK is planning to offer £8 billion (US$ 10.3
billion) to Novartis for this stake and industry observers say Novartis could
use the gains to fund a megatakeover.
And its potential target is AstraZeneca. Novartis’ buyout of AstraZeneca, if realized, could reshape the oncology landscape.
Buying out Novartis would give GSK control over the world’s biggest consumer health operations. And a firm control over its strong brands like Horlicks, Nicorette and Beechams. The move is in line with GSK’s new CEO Emma Walmsley’s recent statements.
However, GSK’s shareholders have not taken the news well. GSK’s star investor Neil Woodford was pushing for a company-wide breakup. GSK, however, preferred to hang onto the business, and Walmsley—who was the former head of the JV—confirmed the strategy on the company’s first-quarter earnings call. As a result, Woodford decided to sell his (£1.2 billion) GSK holding.
Woodford held his shares in GSK for more than 15 years. ‘The sum of the parts is significantly greater than the whole,” he said. “My viewpoint, and that of other like-minded institutional investors, has been heard but ultimately ignored – repeatedly,” he added. Woodford wanted GSK to split into more focused businesses.
New FDA
Commissioner reorganizing inspection staff
The US Food and Drug Administration’s new commissioner — Scott Gottlieb — wants federal inspectors to specialize in certain areas, in order to ensure the safety of America’s food and medical products.
In a memo,
Gottlied announced that workers in the US FDA’s Office of Regulatory Affairs will begin focusing on overseeing specific product areas — such as pharmaceuticals or medical devices — rather than activities in their US geographic regions.
“This organizational approach replaces a management structure based on geographic regions,” says the FDA website.
The US FDA’s staff of 4,000 probes consumer complaints, oversees imported goods, and inspects domestic and foreign facilities to ensure compliance with the agency’s standards.
The refocusing “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work,” Gottlieb said in the memo. “We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have,” he added.
The initiative was
proposed four years ago, with implementation set to start this month.
Merck’s Keytruda approved for lung cancer; AstraZeneca, Roche suffer setbacks
Merck’s Keytruda got approved by the US FDA for treatment of advanced lung cancer, when used in combination with
chemotherapy. This bolsters Merck's lead position in the field of medicines
that help the immune system fight cancer.
Lung cancer is by
far the largest oncology market and the approval significantly expands the
number of patients available for the Keytruda therapy, in combination with Eli Lilly's Alimta.
Roche,
AstraZeneca drugs fail trial:
AstraZeneca suffered a setback last week when its Phase III asthma drug tralokinumab — IL13 — saw a late-stage failure.
This drug had
already failed a Phase IIb trial for asthma, raising questions why the company
went ahead with the trial and plans to continue a major late-stage effort. But
the researchers at the time said they were encouraged by a subgroup analysis
that pointed to success.
Roche too suffered a setback as its drug tecentriq (atezolizumab)
failed the late-stage confirmatory study in bladder cancer. The drug failed to
significantly improve overall survival. The blow raises questions about the
fate of this drug.
After Mylan, Hikma’s Advair generic runs into “major” problems
GSK’s blockbuster lung drug Advair may escape generic competition
in the United States this year. In March, Mylan’s application for a cut-price equivalent was turned down by the US FDA. And last week, the application of Hikma Pharmaceuticals and its partner Vectura was turned down by the American regulator.
Industry analysts
believe the generic threat has now been pushed back until mid-2018, providing
GSK with a short-term profit boost.
According to
Hikma, there were major issues with the application, which is why the US FDA
decided not to approve its version of the inhaled treatment for asthma and
chronic lung disease at this time. The firm said it was unlikely to receive approval
this year.
Hikma and Mylan have received complete response letters from the FDA that were categorized as ‘major’. Dealing with a major amendment to a generic drug application means a delay of 10 months for an FDA response.
Meanwhile, Mylan
President Rajiv Malik said last week that the company disagrees with US FDA’s reasoning behind not approving its generic for GSK’s Advair in March.
Malik said the FDA was asking it to comply with standards set out in draft guidance the agency had issued. But the company believes it is not required to do so. Mylan made the comments while reporting its first-quarter earnings.
Impressions: 2766
https://www.pharmacompass.com/radio-compass-blog/fda-reorganizes-inspection-staff-thermo-fisher-buys-patheon-for-5-2-billion
#PharmaFlow by PHARMACOMPASS
18 May 2017
Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3086
https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production
#PharmaFlow by PHARMACOMPASS
03 Apr 2015
