Market Place
In
its continuous endeavor to bolster the competitiveness of the generics
market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’.
The
agency updates this list every six months to improve transparency and to
encourage the development and submission of abbreviated new drug applications
(ANDAs) in markets that have little competition.
The
latest compilation by the FDA, which was published in June, contains 452
entries with 307 classified as Part I (drug products for which FDA could
immediately accept an ANDA without prior discussion), 136 as Part II (drug
products for which ANDA development or approval may raise potential legal,
regulatory, or scientific issues that should be addressed with the Agency prior
to considering submission of an ANDA) and 9 products being added to the Appendix
which indicates one or more ANDAs referencing NDA drug products that have been
approved since the publication of the previous list.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
Injectables make up one-third of the products in June list
A
total of 69 entries, which were present in the December 2019 compilation, are
missing from the recent compilation posted in June 2020, whereas 25 entries
have been added to the December list. The new additions are an outcome of drugs
for which patents and/or exclusivities expired after December 2019. Products
that have been added include the commonly used anti-cancer drug Docetaxel
as well as the peptic ulcer treatment Esomeprazole Magnesium suspension.
Almost one-third of the products in the latest list —158 out of 452 — are drug products delivered as injectables, while there are 83 entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
In
2017, FDA had announced the Drug Competition Action Plan (DCAP)
to encourage robust
and timely market competition for generic drugs and help bring greater
efficiency and transparency to the generic drug review process, without
sacrificing the scientific rigor underlying their generic drug program.
In
February this year, as part of this initiative, the FDA had
approved the first generic of toxoplasmosis drug, Daraprim
(pyrimethamine),
the drug which made ‘pharma bro’ Martin Shkreli infamous in 2015 after he raised the price of the drug, first approved by FDA in 1953, from US$ 17.50 to US$ 750 per tablet.
To date, the FDA has focused its efforts under
the Drug Competition Action Plan on three key areas:
1. Improving the efficiency of the generic drug development, review, and approval process.
2. Maximizing scientific and regulatory clarity with respect to complex generic drugs.
3. Closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
New guidance on CGTs to improve generic competitiveness
In March 2020, FDA had issued the guidance on Competitive Generic Therapies (CGTs). This guidance describes the process
that potential ANDA applicants should follow to request designation of a drug
as a CGT. It also outlines the criteria for designating a drug as a CGT,
provides information on the actions FDA may take to expedite the development
and review of ANDAs for drugs designated as CGTs, and explains how FDA
implements the statutory provisions providing for a 180-day exclusivity period
for certain first approved applicants that submit ANDAs for CGTs.
An
example of the FDA improving generic competitiveness through their various
initiatives is the case of the suspension form of Pfizer’s
Revatio,
which contains the same active ingredient as Viagra (sildenafil)
and is indicated for the treatment of pulmonary arterial hypertension (PAH).
The
drug was first approved in 2012 and generated sales of US$ 227 million in 2018. Since the approval of the first generic in May 2019, there are now seven approved generics of the drug on the US market. As a result, Pfizer reported a 37 percent drop in sales to US$ 144 million in 2019.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
Impressions: 57849
https://www.pharmacompass.com/radio-compass-blog/usfda-s-list-of-drugs-that-need-generic-alternatives
#PharmaFlow by PHARMACOMPASS
16 Sep 2020
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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: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
The year
2018 has witnessed a record-setting pace in approvals of new drugs. By early
November, the US Food and Drug Administration (FDA) had approved 48 new drugs,
as compared to a total of 46 new drugs approved in calendar 2017. This year,
the number of small-molecule drugs (35) approved is significantly higher than
the number of biologic drugs (13).
Although
September witnessed a slight slump in deal making, October witnessed
significant activity. Here is our quick recap:
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Novartis
buys Endocyte for US$ 2.1 billion
Novartis continued to make dealmaking headlines by placing its second bet on radiology with a buyout of Endocyte for US$ 2.1 billion. Endocyte’s experimental treatments attach a radioactive therapeutic atom to a ligand, a molecule that can bind to receptors on the surface of cancer cells. These radioligand therapies are supposed to shrink tumors while sparing healthy tissue from the toxic effects of radiation.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Endocyte’s Phase III lead candidate, 177Lu-PSMA-617, is designed to target the prostate-specific membrane antigen (PSMA) by
delivering the short-range beta-emitting radioactive isotope lutetium (177Lu)
selectively to tumor cells while bypassing non-PSMA-expressing healthy cells.
Last year,
Novartis had signed a US$ 3.9 billion deal to acquire Advanced Accelerator Applications (AAA). In January this year,
AAA won FDA approval for lutetium Lu 177 dotate (Lutathera) — a radiotherapy for neuroendocrine tumors.
AstraZeneca divests Nexium rights
As AstraZeneca’s blockbuster Nexium (esomeprazole) lost its patent protection in most parts of the world, the company agreed to divest the prescription medicine rights to Nexium (esomeprazole) in Europe, as well as the global rights (excluding the US and Japan) of Vimovo (naproxen/esomeprazole) to Grünenthal for a total deal value of US$
922 million.
Grünenthal will pay US$ 815 million upfront, plus up to US$ 107 million in milestones for the drug rights, which exclude Vimovo in the US and Japan. While Nexium has lost its patent protection, Vimovo holds patents in Europe until 2025.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Huahai gets US$ 43 million in government
support
China’s Zhejiang Huahai Pharmaceutical (ZHP) has been in the news for
supplying commonly used blood pressure medicine valsartan with cancer-causing impurities. In October, the Chinese city government of Linhai in the eastern province of Zhejiang, where the company is based, gave the company 300 million yuan (US$ 43 million). Huahai described the payout as an “industrial development assistance fund” in two announcements made through the Shanghai Stock Exchange.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Quotient Sciences expands its US operations
The month saw a lot of investments in manufacturing. For
instance, Quotient Sciences (a drug development services organization) announced significant expansion of its US operations with the opening of a 45,000-square-foot facility. The investment has been made with an intent to “create a center of excellence for early-phase formulation development and clinical trial manufacturing.”
Here are some other instances of capacity expansion:
— In Italy, Catalent announced the expansion of its softgel manufacturing capabilities.
— Sun Pharma added a sterile injectable manufacturing line in India.
— Abu-Dhabi based Neopharma purchased facilities of Dr Reddy’s in India and
the United States.
— Companies like Astellas,
Lonza,
Sarepta and MaSTherCell announced investments into expanding
their cell therapy manufacturing capabilities, since cell therapies continue to
be regarded as the future of human health.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
GSK announces expansion plan, to make APIs for
its COPD drug
Respiratory drugs remain key to GlaxoSmithKline. The company announced an expansion to make APIs for one of its COPD (chronic obstructive pulmonary disease) drugs that it believes will be a key revenue generator in the future. GSK opened a new £54 million (US$ 70.3 million) production building at a site in Scotland to make APIs for Ellipta, a drug that
treats COPD.
However, not all pharma deals were built around new drugs and manufacturing. For instance, GlaxoSmithKline also awarded its estimated US$ 1.5 billion media planning and buying account to Publicis Media.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
SQZ
expands tie up with Roche
SQZ Biotechnologies, a cell therapy company developing novel treatments for multiple therapeutic areas, announced the expansion of its collaboration with Roche. SQZ and Roche will jointly develop and
commercialize certain products based on antigen presenting cells (APCs) created
by the SQZ platform for the treatment of oncology indications.
Under the
collaboration, SQZ may receive up to US$ 125
million in upfront payment and near-term
milestones. SQZ could earn up to US$ 250 million in clinical, regulatory and sales milestones per
product that emerges from the collaboration. In addition, SQZ may receive development
milestone payments of over US$ 1 billion.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
J&J
in agreement with Arrowhead Pharmaceuticals
Janssen, the research unit of Johnson & Johnson, entered into an agreement with Arrowhead Pharmaceuticals, to develop and commercialize its ribonucleic acid interference (RNAi) therapy candidate being investigated for the treatment of chronic hepatitis B viral infection. The deal makes Arrowhead eligible to receive up to US$ 3.5 billion in milestone payments. When the deal closes, Arrowhead will receive US$ 250 million right away through a US$ 175 million upfront payment and a US$ 75 million equity investment from J&J’s investment arm.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Other
deals and investments
— Dicerna Pharmaceuticals, which is also developing a pipeline of RNAi therapies, announced collaboration deals with Eli Lilly and Alexion Pharmaceuticals.
— Gilead Sciences and Tango
Therapeutics announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer. If the milestones are met, the deal could be worth US$ 1.7 billion.
Click Here to View the Major deals in October 2018 (FREE Excel Version Available)
Impressions: 1988
https://www.pharmacompass.com/radio-compass-blog/pharmaflow-in-october-deal-making-picks-up-pharma-companies-invest-in-capacity-building
#PharmaFlow by PHARMACOMPASS
29 Nov 2018
This week in Phispers, we introduce you to Vas Narasimhan, the new CEO set to head Novartis in February next year. The appointment comes days after the Swiss drugmaker’s CAR-T cell therapy — Kymriah — won the FDA nod. Meanwhile, the US agency wants to improve its inspection efficiency; and Doctors Without Borders has opposed the priority review voucher given by the FDA to an old drug it approved for Chagas disease. Daiichi Sankyo denies receiving a takeover bid from AstraZeneca in 2016; and US
dumps its tie-up with Sanofi to develop
a vaccine for Zika virus.
Post FDA nod for its CAR-T therapy, Novartis names drug development chief as CEO
Swiss drugmaker Novartis’ CEO Joe Jimenez will step down on February 1, 2018. He will hand over the baton to Vasant (Vas) Narasimhan (41), who is currently heading the company’s drug development and is also its chief medical officer.
This will make Narasimhan the first person of Indian origin to head a large pharma multinational.
Narasimhan is the youngest amongst the new CEOs at large drug
companies. For instance, Emma
Walmsley, the new global CEO of GlaxoSmithKline, is
48. And David Ricks, who became the CEO of Eli Lilly in
January this year, is 50.
Narasimhan is a doctor from the Harvard Medical School and a
second-generation immigrant in the US. He joined Novartis in 2005.
Jimenez will retire next year, after being at the helm for eight years.
Though Jimenez undertook several steps to focus on more profitable prescription
medicines, particularly in cancer, Novartis saw its sales being hit as its
top-selling drugs (such as blood cancer treatment Gleevec) lost patent
protection. Its eye business Alcon has
lagged expectations and generics arm Sandoz has
faced intense price pressures in the US.
However, Novartis got a boost last week, when the US Food and
Drug Administration (USFDA) approved its US$ 475,000-per-patient Kymriah
treatment for young people with B-cell acute lymphoblastic leukemia. Known as
CAR-T (short for chimeric antigen receptor T-cell) therapy for cancer,
Kymriah is seen as one of a series of new drugs that can revive sales beginning
next year.
“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” FDA commissioner
Scott Gottlieb said in a statement announcing the approval of Kymriah.
CAR-T therapy also got a shot in the arm when Gilead announced a US$ 11.9 billion acquisition
of Kite Pharma, which
is said to be just months away from the first approval of its own CAR-T
therapy.
Ironically, the same week as Kymriah got approved, Johnson & Johnson (through its subsidiary Janssen Biotech Inc) ended its deal with MacroGenics, a
Rockville-based biotech company that was working on another CAR-T therapy (duvortuxizumab), after patients in the study
experienced neurotoxicity. MacroGenics said enrollment in a Phase I trial of duvortuxizumab to treat B cell malignancies will be
discontinued.
FDA to strengthen inspections and oversight of drug manufacturing
Through an official blog, the FDA commissioner Scott Gottlieb made known the US agency’s intentions to improve its inspection efficiency and reach. As a step toward towards this, the FDA had earlier announced it is restructuring its field activities, to direct its focus and
organization around the programs it regulates, instead of its previous
structure wherein its activities and resources were organized based on
geographic regions.
In the blog dated August 31, Gottlieb
said the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new, historic concept of operations agreement to fully integrate the drug review programs with the
facility evaluations and inspections for human drugs.
As part of the commitments made by the FDA in
the context of the Generic Drug User Fee Amendments II (GDUFA II), the agency
agreed to communicate final surveillance inspection classifications to facility
owners within 90 days of an inspection. The new operating model will be a key
element of meeting these promises. The FDA will start operationalizing this
agreement in fall of this year, in order to more quickly meet this commitment.
The new measures are bound to effect
generic firms based in India and China. This could also mean stricter inspections, D G
Shah, secretary general of industry lobby group Indian Pharmaceutical Alliance,
told Mint. “USFDA’s inspections are likely to get more coordinated and broader,” Rahul Guha, partner and director at the Boston Consulting Group, told the publication.
Daiichi
Sankyo denies it received takeover bid
from AstraZeneca in 2016
Last week, Daiichi Sankyo denied it received a takeover bid in 2016 from British drugmaker AstraZeneca.
The online version of the magazine Nikkei
Business had reported that AstraZeneca had offered to buy the Japanese drug major Daiichi Sankyo in
2016, which has a market value of about US$ 16 billion.
“It was today reported by Nikkei
Business that Daiichi Sankyo Co Ltd received the acquisition offer from AstraZeneca. However, this is not the fact,” the company said in a statement. AstraZeneca has declined to comment on Daiichi’s statement.
Both Daiichi and Astra go back a long way — they have an agreement to jointly commercialize constipation drug Movantik in the US, and have also entered into a deal to supply and
promote blockbuster heartburn treatment Nexium in Japan.
There are some commonalities too — both have interests in cancer drugs. However, last month, Astra’s prospects in cancer suffered a setback when a closely watched immunotherapy combination treatment failed to help patients. That led to speculation that Astra has
itself become a target for takeover.
US backs away from tie-up with Sanofi to
develop Zika
vaccine
French drug major Sanofi received a setback recently when the US government said it is backing away from a
collaboration with it to develop a vaccine for the Zika virus.
Sanofi said in a statement: “On August 17, 2017, Sanofi Pasteur was informed by The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services that they completed an assessment of all Zika-related projects they were funding and have decided to focus on a more limited set of goals and deliverables.”
This decision means Sanofi won’t further develop or license the US Army’s promising Zika candidate. BARDA had committed US$ 43 million in research funding, with another US$ 130 million available if the vaccine advanced into later-stage testing.
After a rather explosive early outbreak, the spread of Zika virus has slowed down. And both BARDA and Sanofi blamed Zika’s “evolving epidemiology” for their change in focus for developing a vaccine. The development of the vaccine has been paused indefinitely, but could be “restarted if the epidemic re-emerges,” Sanofi said.
The collaboration had come under intense
scrutiny this year as critics demanded pricing guarantees if a commercial
vaccine grew out of the taxpayer-funded research.
Zika virus may kill brain cancer cells: A study supported by the
National Institute of Allergy and Infectious Diseases (NIAID), a part of the
National Institutes of Health, says that the Zika virus (ZIKV) may infect and
kill a specific type of brain cancer cells while leaving normal adult brain
tissue minimally affected.
In the paper, published online on September
5 in The Journal of Experimental Medicine, researchers say ZIKV may
behave differently when introduced to an active glioblastoma (an aggressive
cancer that begins in the brain) in a living person. A word of caution though:
Even if further studies continue to yield promising results, any potential
treatment derived from ZIKV would need several years of thorough testing for
safety and efficacy.
MSF opposes priority review voucher given
to old drug approved for Chagas disease
Earlier this year, Marathon Pharmaceuticals was in the spotlight after
it received an FDA approval for Emflaza (deflazacort) tablets and oral suspension to treat patients aged five years and older with Duchenne muscular dystrophy (DMD) — a rare genetic disorder that causes progressive muscle deterioration and weakness. Marathon had planned a list price of US$ 89,000 for a year’s supply of Emflaza.
Since the drug has been available outside the US for decades, patients in the US imported the drug from Canada and the UK, where it’s available at a price between US$ 1,000 or US$ 2,000 a year.
Last week, the FDA approved another old drug — benznidazole — as treatment for Chagas disease. The
drug has been used outside the United States for years. In the US, benznidazole
is the first treatment approved for Chagas disease. This time the point of
contention is not the price of the drug but the issuance of a priority review voucher (PRV) which can get sold for hundreds of
millions of dollars.
A
nonprofit group including Chemo Group won this FDA approval and pledged to make it available at low cost to patients. “The fact that a company can receive an innovation award for registering a medicine that has been used to treat Chagas for years shows how far removed we are from the original intent of this program,” said Jennifer Reid, advocacy and research officer at Doctors Without Borders (MSF).
Chagas disease, or American trypanosomiasis,
is a parasitic infection that
can be transmitted through contact with the feces of a certain insect, through
blood transfusions, or in the womb from the mother to the child. After years of
infection, the disease can cause serious heart ailment, and can also affect
swallowing and digestion. Chagas disease primarily affects people living in
rural parts of Latin America. According to estimates, around 300,000 persons in
the US suffer from Chagas disease.
“People suffering from Chagas and other neglected diseases still desperately need innovation and new research to save their lives and improve treatment and prevention options. They should be able to use and afford these medicines no matter where they live. Before a company can receive this prize, US Congress should mandate that only new medicines receive a PRV and that companies ensure access and affordability for all patients,” she added.
Impressions: 1833
https://www.pharmacompass.com/radio-compass-blog/fda-to-strengthen-drug-manufacturing-inspections-a-person-of-indian-origin-to-head-novartis
#PharmaFlow by PHARMACOMPASS
07 Sep 2017
In less than three weeks, Donald Trump will assume office as the
President of the United States. He has mentioned that he wants Medicare (a
national social insurance program) to directly negotiate the price it pays for prescription drugs.
Medicare provides health insurance to Americans aged 65 or more, who
have worked and paid into the system through the payroll tax. It also provides
health insurance to younger people with some disabilities or end-stage renal
disease and amyotrophic lateral sclerosis.
In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people.
As we flag off the New Year, PharmaCompass
provides insights into drug prices and prescription patterns in the US in order
to help professionals make informed decisions. We believe that the cost of
medicines in the US, which have been a subject of much public outcry and
discussions in the recent years, will continue to be scrutinized during 2017.
Medicare data for 2014
Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers
who collectively prescribed approximately US $121 billion worth of prescription
drugs paid for under this program.
For each prescriber and drug, the dataset
includes the total number of prescriptions that were dispensed (including
original prescriptions and any refills), and the total drug cost.
The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).
The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not
include information in cases where 10 or fewer prescriptions were dispensed.
Top
Ten Drugs by Cost, 2014 [Most expensive for Medicare]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Sofosbuvir
109,543
33,028
7,323
$3,106,589,192
Esomeprazole Magnesium
7,537,736
1,405,570
286,927
$2,660,052,054
Rosuvastatin Calcium
9,072,799
1,752,423
266,499
$2,543,475,142
Aripiprazole
2,963,457
405,048
130,933
$2,526,731,476
Fluticasone/Salmeterol
6,093,354
1,420,515
281,775
$2,276,060,161
Tiotropium Bromide
5,852,258
1,211,919
253,277
$2,158,219,163
Lantus
Solostar
(Insulin Glargine)
4,441,782
972,882
224,710
$2,016,728,436
Sitagliptin Phosphate
4,495,964
789,828
190,741
$1,775,094,282
Lantus
(Insulin Glargine)
4,284,173
787,077
223,502
$1,725,391,907
Lenalidomide
178,373
27,142
9,337
$1,671,610,362
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Average Cost Per Claim
Adagen
13
$1,224,835
$94,218
Elaprase
100
$6,560,225
$65,602
Cinryze
1,820
194
196
$96,155,785
$52,833
Carbaglu
60
$2,901,115
$48,352
Naglazyme
129
$6,189,045
$47,977
Berinert
538
73
68
$25,685,311
$47,742
Firazyr
1,568
269
232
$70,948,143
$45,248
H.P. Acthar
9,611
2,932
1,621
$391,189,653
$40,702
Procysbi
314
41
47
$12,542,911
$39,946
Folotyn
15
$598,210
$39,881
Top
Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Lisinopril
38,278,860
7,454,940
464,747
$281,614,340
Levothyroxine Sodium
37,711,869
6,245,507
416,518
$631,855,415
Amlodipine Besylate
36,344,166
6,750,062
451,350
$303,779,661
Simvastatin
34,092,548
6,768,159
387,651
$346,677,118
Hydrocodone-Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Omeprazole
33,032,770
6,707,964
475,122
$529,050,385
Atorvastatin Calcium
32,603,055
6,740,061
419,327
$747,635,818
Furosemide
27,133,430
5,176,582
456,047
$135,710,772
Metformin HCl
23,475,787
4,509,978
364,273
$203,948,989
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Hydrocodone/Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Ciprofloxacin HCl
7,253,018
4,926,835
568,201
$46,728,353
Amoxicillin
6,298,980
4,384,899
557,614
$31,193,739
Cephalexin
5,040,219
3,529,303
557,048
$36,987,401
Azithromycin
7,339,954
5,274,010
544,625
$70,699,119
Prednisone
11,032,986
4,505,821
536,108
$86,537,932
Tramadol HCl
14,250,227
4,272,724
515,816
$125,343,514
Sulfamethoxazole /Trimethoprim
4,833,758
3,090,944
500,790
$29,231,511
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
Amoxicillin/Potassium Clav
3,551,452
2,710,244
478,361
$61,713,432
The findings from CMS
data
The CY 2014 data represented a 17 percent
increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.
Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail
drugs and US $ 128 billion (28.1 percent) was for non-retail drugs.
The drug pricing process in the US is complex and
reflects the influence of numerous factors, including manufacturer list prices,
confidential negotiated discounts and rebates, insurance plan benefit designs,
and patient choices.
An IMS study found that across 12 therapy classes widely used in Medicare Part D,
medicine costs to plans and patients in Medicare Part D are 35 percent below
list prices.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
While the CMS does not
currently have an established formulary, Part D drug coverage excludes drugs
not approved by the US Food and Drug Administration, those prescribed for off-label
use, drugs not available by prescription for
purchase in the US, and drugs for which payments would be available under Parts
A or B of Medicare.
Part D coverage
excludes drugs or classes of drugs excluded from Medicaid coverage,
such as:
Drugs used for anorexia, weight loss, or weight gain
Drugs used to promote fertility
Drugs used for erectile dysfunction
Drugs used for cosmetic purposes (hair growth, etc.)
Drugs used for the symptomatic relief of cough and colds
Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations
Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee
Our view
The Medicare program is designed such that the
federal government is not permitted to negotiate prices of drugs with the drug
companies, as federal agencies do under other programs.
For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D.
If Trump administration kick starts direct
negotiations on Medicare drug prices with drug companies, 2017 will surely turn
out to be a year for the pharmaceutical industry to remember.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Impressions: 7923
https://www.pharmacompass.com/radio-compass-blog/drug-costs-and-prescription-trends-in-the-united-states-analyzing-medicare-s-121-billion-spend
#PharmaFlow by PHARMACOMPASS
05 Jan 2017
In April 2016, the US Food and Drug Administration (FDA) came
down heavily on Semler Research Center over issues of data manipulation. The
FDA had told drug firms that their applications seeking
approvals on the basis of studies done by the Bangalore-based firm will not
be accepted. It had also asked firms to furnish additional clinical research from
other approved entities to get the FDA nod.The action had been taken as a result of an inspection of
Semler's bioanalytical facility in Bangalore conducted between September 29,
2015, and October 9, 2015. Generics relying on
data from Semler are not considered equivalent to the brand The FDA also changed the therapeutic equivalence (TE) rating in the Orange Book (also called the Approved Drug Product with Therapeutic Equivalence Evaluations) for any approved ANDA that relied on data from Semler to “BX.” A BX rating indicates that data reviewed by the agency are
insufficient to determine therapeutic equivalence, i.e., substitutability, of
the generic product to the drug it references.As drug regulators across the world invalidate clinical
studies conducted at Semler Research that demonstrate equivalence of the
generic drugs to branded products, PharmaCompass
brings to you the impact of this scandal on various products and drug companies.
Dr. Reddy’s generic Nexium gains as competitor gets impactedThe violations uncovered at Semler Research have impacted
the global generic pharmaceutical business. While most companies have been
adversely impacted by the Semler data integrity scandal, there are some that
have gained as well. For instance, Dr. Reddy’s North American business has got an unanticipated
sales boost due to the
issues at Semler. This was because the FDA mandated that competitor Hetero’s
generic Nexium
(an acid reflux medication) repeat its bioequivalence trials to be considered
as an equivalent generic of the brand drug. This reclassification of Hetero’s drug has increased market share gains for Dr. Reddy’s Esomeprazole
Magnesium – a generic equivalent of Nexium launched in the US in September last year. 96 European marketing
authorizations to get impactedPharmaCompass’ assessment has uncovered 96
marketing authorizations in Europe for which “clinical and bioanalytical parts of the bioequivalence studies were performed at the Semler Research Center (SRC)”. Of these, 20 marketing authorizations are in France alone, followed by 10 each in Germany, the Netherlands and the United Kingdom. Click here to receive your copy of the European Marketing
Authorizations Landscape due to the data-integrity violations at Semler A marketing authorization application is an application
submitted by a drug manufacturer seeking permission to bring a newly developed
medicine or a medicinal product to the market.In all probability, the maximum fallout of the Semler
episode will be on Sandoz, as 29
marketing authorizations of Sandoz are likely to be recommended for repeat
studies by authorities. Other generic majors who will possibly repeat studies are Mylan (15
marketing authorizations), Teva
(nine marketing authorizations), Ratiopharm
(six marketing authorizations) and Venipharm (five marketing
authorizations). Changes in therapeutic status of Hetero, Lupin’s drugsWhile Hetero has to repeat its studies for generic Nexium in
the United States, six Hetero filings in Europe have been listed by authorities
for which the clinical studies were conducted at Semler.In the United States, the FDA has also changed the therapeutic
status of Hetero’s Losartan
Potassium along with Lupin’s filing
for the same product to one (i.e. BX) where the product is no longer considered
equivalent to the brand. Lupin’s Azithromycin,
Upsher-Smith’s
Propranolol
Hydrochloride and Unique Pharma’s Tinidazole
are other products which have seen their therapeutic code category get changed (to
one of not being bioequivalent) by the FDA in the past month.Click here to receive your copy of the European Marketing
Authorizations Landscape due to the data-integrity violations at Semler WHO questions
findings of Semler studiesWhile the FDA and European regulators are busy dealing with
the aftermath of the problems at Semler, the World Health Organization (WHO) has
also been very active. In the Notice
of Concern (NOC) issued by the WHO to Semler, as an outcome of WHO’s own inspections and discussions, Semler acknowledged that “four FDA studies and one WHO study have questionable data”. The WHO recommended “an immediate stop for all submissions of dossiers relying in whole or in part on involvement from Semler”. The WHO has questioned the findings of 11 studies performed at Semler for products which meet WHO’s pre-qualification criteria. The studies were performed on behalf of Mylan (three studies),
Lupin (five studies), Micro Labs
(one study) and Strides
Ltd (two studies). Additionally, the WHO has also revealed 12 studies for
which the products are currently under assessment but not yet pre-qualified. Our viewSemler’s data integrity concerns have made drug regulators question the equivalency of over 110 generic drug applications. Concerns have been highlighted by the FDA, European Medicines Agency (EMA) and the WHO. And the steps taken by the regulators indicate the magnitude of the fallout of these inspections. For the generic pharmaceutical industry, life has become a
lot more challenging. In addition to concerns about in-house manufacturing
compliance problems, they also need to worry about data integrity issues at
clinical research firms. Clinical
trial falsification issues at the laboratories of Quest Life Sciences, GVK
Biosciences, Alkem
Laboratories and Semler indicate that a sustained supply of generics can no
longer be taken for granted.Click here to receive your copy of the European Marketing
Authorizations Landscape due to the data-integrity violations at Semler
Impressions: 5652
https://www.pharmacompass.com/radio-compass-blog/sandoz-mylan-hetero-lupin-face-the-heat-due-to-data-manipulation-at-semler
#PharmaFlow by PHARMACOMPASS
02 Jun 2016
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: 3954
https://www.pharmacompass.com/radio-compass-blog/phispers-india-may-ban-animal-derived-gelatin-capsules-fda-warning-letter-trends-next-gen-nexium-more
#PharmaFlow by PHARMACOMPASS
14 Apr 2016
Each year,
the US Food and Drug Administration (FDA) approve hundreds
of new medications. A small subset of approvals, classified as novel drugs, are considered to
be truly innovative products that often help advance clinical care.
In 2015, the
FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).
This week, PharmaCompass focuses on the new dosage
forms of existing drugs that got approved last year.
Modified blockbusters
Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:
Jadenu (deferasirox): With
almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a
tablet for use in a suspension. Novartis, the innovator,
got approval in March 2015
for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation
of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has
simplified daily treatment administration for patients with chronic iron
overload.
Nexium
24HR (esomeprazole magnesium): Also
known as the Purple Pill, Nexium – Astra
Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as
Nexium 24HR. Last year, the FDA granted approval to the tablet form of the
drug.
Iressa
(gefitinib): AstraZeneca re-introduced Iressa in
the US market in 2015. The
FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved
as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets
from the market, as post-marketing studies had failed
to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted.
Onivyde (irinotecan): Liposomal formulation of anti-cancer
drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the
treatment of patients with metastatic pancreatic cancer, sold under the brand
name Onivyde.
Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines
because of its high price (more than US $ 300,000 a year). Price concerns
aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.
Extended release versions
Many of
the approvals granted by the FDA last year were to extended release
formulations (a pill formulated so that the drug is released slowly) of
existing drugs.
Kremers Urban’s
extended release version of Methylphenidate
capsules made headlines last year because of a reclassification of the drug by
the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may
not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc.
In
addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus
and Morphine Sulphate also received green signals for a market launch.
First generic opportunities
Last year, PharmaCompass
shared the names of some drugs which had no generic competition and were also
not protected by patents. (Read: “Litigation Free, first generic opportunities list”).
Deferiprone (a drug that chelates iron and is
used to treat iron overload in thalassemia major) met the criteria. But it still
has no generic competitor and is now available as a new dosage form.
Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades
without generic competition in the US. Albendazole is a medication used for the
treatment of a variety of parasitic worm infestations. In 2015, patients were
provided access to chewable tablets of Albendazole.
New combinations at work
The FDA also approved
multiple combination drugs where the individual active ingredients had been brought
to market previously.
Most of the combination drugs
approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc.
Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and
Tradjenta (linagliptin) approved in 2011, were
combined and the combination drug product Glyxambi was approved in 2015. Another
combination of empagliflozin, with metformin – Synjardy – was also approved in August last
year.
Lesser known companies also
got combination drugs approved. UK-based
development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine
polistirex.
Similarly, US-based biopharmaceutical startup, Spriaso LLC, also
working in the cold and cough therapeutic area, got an extended release tablet
containing codeine phosphate and chlorpheniramine maleate approved.
Symplmed, a company which is
developing various forms of Perindopril, got approval for Prestalia (a
combination of perindopril arginine and amlodipine besylate) for the
treatment of hypertension.
Our view
Each year, the FDA approves several
pharmaceutical drugs in order to improve patient care; and often versions of
these drugs are marketed and distributed across the globe.
PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy.
Accelerate your drug development
PharmaCompass has also launched
the Drug Development Assistance tool on its platform.
Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate
the various drug products approved in the United States.
Impressions: 5419
https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs
#PharmaFlow by PHARMACOMPASS
14 Jan 2016
Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total payment of $1.2 billion as part of a ‘pay-for-delay’ settlement reached with the Federal Trade Commission (FTC) last week.
What exactly did Cephalon, for which Teva paid $6.8 billion, do so wrong? Isn’t ‘pay-for-delay’ common practice in the pharmaceutical industry?
First of all what is a
pay-for-delay?
‘Pay for delay’ or reverse payment patent settlements, are agreements where the brand name drug manufacturer compensates generics, not to market the generic product for a specific period of time.
These settlements allow the brand manufacturers to extend their
patent monopolies and according to an FTC study, these deals
cost consumers and taxpayers $3.5 billion in higher drug costs every year.
What exactly happens and
why is it a big deal now?
Cephalon allegedly paid four generic drug companies (Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceuticals, and Barr Laboratories), over $300 million in total. In return the generics agreed to drop their patent challenges and forgo marketing of their generic versions of Cephalon’s blockbuster sleep-disorder drug Provigil, for six years, until April 2012.
An extended monopoly for Provigil, in the absence of generic competition, was “$4 billion in sales that no one expected”, the CEO of Cephalon reportedly said when the deal was struck.
While in Europe, regulators have been going after pay-for-delay cases for years, it was only as recently as 2013, in FTC v. Actavis, that the U.S. Supreme Court made clear that reverse payment patent settlements are subject to the same antitrust rules that govern general U.S. business conduct.
The payment made by Teva will compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct, is the first positive outcome for the FTC after the Supreme Court ruling.
How common are ‘pay-for-delay’ settlements?
Based on data provided by the FTC, for the past few years, more
than 100 settlements are reached annually between brand and generic
pharmaceutical companies.
Over 30% of these settlements have the potential of being ‘pay-for-delay’ agreements.
Table// Potential
pay-for-delay settlements reached between brand and generic companies:
Financial Year
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
Final Settlements:
between brand and generic companies
14
11
28
33
66
68
113
156
140
145
Involving First Generic Filing
8
5
11
16
29
32
49
54
43
41
Potential Pay-for-Delay:
Involving First Generic Filing
2
9
11
13
15
26
18
23
13
Settlements
3
14
14
16
19
31
28
40
29
How severe are the penalties for ‘pay-for-delay’ settlements in Europe?
The European Commission has
fined Johnson
& Johnson (J&J) just under 10.8 million
euros and Novartis 5.49 million euros, after discovering a ‘pay-for-delay’ deal on the painkiller Duragesic (fentanyl).
The amount pales in comparison to
the whopping €428m fine on Servier and several other companies (Niche/ Unichem; Matrix, which is now part of Mylan; Teva; Krka and Lupin) for conspiring to delay generics of the widely-used blood pressure drug Coversyl/ Aceon (perindopril).
In yet another settlement, agreements which operated in 2002 and
2003 between the Danish originator Lundbeck, and other
generic companies, resulted in Euro
146 million in fines.
What should we expect in the future?
Based on an FTC
presentation made in September 2014, they highlighted 19 Cases to Watch, which has them targeting almost every
major brand and generic pharmaceutical company. However, with the complexities
involved, this list is continuously evolving:
The
cases (by name of the brand product) Actos,
Adderall,
Aggrenox,
AndroGel,
Cipro,
Effexor,
K-Dur, Lamictal, Lidoderm,
Lipitor,
Loestrin,
Nexium,
Niaspan,
Opana,
Provigil,
Skelaxin,
Solodyn,
Wellbutrin.The
brand companies involvedAbbvie,
Abbott,
AstraZeneca,
Bayer,
Besins,
Biovail,
Boehringer,
Cephalon,
Endo,
GlaxoSmithKline,
King,
Medicis,
Pfizer,
Shire,
Schering,
Takeda,
Warner
Chilcott, Wyeth.The
generic companies Actavis
, Barr,
Duramed,
Dr. Reddy’s, HMR, Impax,
Lupin,
Mutual,
Mylan, Par, Perrigo,
Ranbaxy,
Rugby, Sandoz,
Teva,
Upsher
Smith.
Our view:
Pharmaceutical companies,
lawyers and the FTC will be busy for the coming few years, since there are a
series of suits, which will be challenging settlements reached between brand
and generic pharmaceutical companies.
While patents
provide temporary monopolies to promote innovation, brand drug manufacturers
will need to resort to more innovative ways of sustaining their profits.
Click here and learn about the different strategies adopted in the United States to block generics?
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04 Jun 2015
When a generic drug comes to the U.S.
market, sales of brand drugs crash. The drop is more than 80% by the time a second- or third- generation
generic arrives.For brand companies, used to high profits for years, the imminent generic threat leads to an aggressive search for ‘solutions’, and creative strategies to maximize returns from their products. What kind of blocking tactics are
used to stop generic competition?In an attempt to delay generic competition, here are some of the
commonly used approaches. 1/ Go legal:While a new drug patent
is difficult to invent around, there are brand drugs with weak
patents which may not withstand scrutiny. In such cases, the
brand drug manufacturer files a patent infringement complaint with the FDA. The
mere filing of the complaint triggers an automatic 30-month stay of FDA
approval, as per the provisions of the Hatch-Waxman Act. Understanding the Hatch-Waxman Act:In
1984, a United States federal law was designed
to encourage the manufacture of generic
drugs by pharmaceutical industry. The amendments of the Act protect the first generic (the ‘first-filer’) to challenge the brand’s patent, by mandating that the FDA not approve any additional generic competitors until 180 days, after the first-filer launches its product. 2/ Sample obstruction:Brands attempt to prevent
generic firms from accessing samples of the brand drug necessary to perform equivalence studies. The reason provided is
that the brand drug falls under restricted distribution, part of the FDA-mandated
programs, known as Risk Evaluation and Mitigation Strategies (REMS). Brand firms also
implement distribution restrictions for drugs that are not subject to REMS.3/ Destroy the product:Brand name pharmaceutical companies try to preserve the profits on a patented drug by making modest reformulations that offer little or no therapeutic advantages. This tactic is known as ‘product-switching’ or ‘product hopping’. In addition, prior to a generic launch, the brand drug simply withdraws its original product forcing patients to switch to the reformulated drug, so consumers don’t benefit from generic competition of the old version of the drug. Actavis’ ongoing Namenda litigation covers this example
perfectly.4/ Change the rule of the game:In order to overcome the
patents of the brand drugs, generic medicines are manufactured slightly
differently, when compared with the brand product. Citizen petitions are
filed with the FDA, at the behest of brand manufacturers, questioning the
safety of the generic drug, due to the difference between the brand and generic
products. A successful petition,
changes the regulatory requirements, and makes it harder for generics to obtain
FDA approval. The brand manufacturers were filing so many frivolous
citizen petitions that the FDA has been denying
them in record numbers. In the event, generic companies do manage to make significant inroads, and threaten the brand drug’s monopoly, there is a ‘pay-for-delay’ playbook. How does the ‘pay-for-delay’ game get played?Settlements are reached between brand and generic manufacturers in which
the brand incentivizes the generic not to market their products. The incentives can involve any of the following options:- Cash payment made from the brand to the generic that claims to reimburse some or all of the generic’s litigation fees.- A side business deal
between brand and generic manufacturers such as an agreement to buy active
pharmaceutical ingredient (API) from the generic manufacturer, even though the
brand has adequate supply of the API for their own needs (e.g. AstraZeneca, Ranbaxy’s Nexium deal).- Brand manufacturer promises not
to market an Authorized Generic (AG) in competition with the generic manufacturer’s product for some period of time. AGs are pharmaceutical products, which are approved as brand-name drugs,
but marketed as generic drugs. No authorized generics significantly reduce the
competition for the generic player allowing them to secure greater market share
and extract higher prices: e.g.
GlaxoSmithKline (GSK) paid Teva Pharmaceuticals to delay entry by promising
not to compete with authorized generic versions of the drug Lamictal.- Brand allows the generic to market an authorized generic of a different product: e.g. AbbVie’s Androgel case against Teva had Teva asking for supply of an authorized
generic of TriCor, a cholesterol drug with 2011 sales of more than $1 billion. - Other forms of compensation are offered to the generic patent
challenger. For example, an agreement containing a declining royalty structure in which, the intellectual property is
licensed by the brand to the generic. Alternativelly, a co-development deal can be struck for a new drug. Our view:The battle between brands and generics will continue for time to come,
and regardless of antitrust scrutiny, there will be a high degree of innovation
in the strategies devised by brand firms to maximize profits. However, drug companies aren’t the only ones innovating. Hayman Capital wins our vote for the most innovative approach taken. The hedge fund’s “Dispute the patent, short the stock” formula is designed to try and make money regardless of the outcome. How exactly the healthcare system benefits from these different approaches
is a completely different story!Click here and learn about the latest ‘pay-for-delay’ cases in Europe and America
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04 Jun 2015
