Pfizer Inc. PFE 6.95% shares were declining steeply Monday after the company said a Phase
3 study dubbed PALLAS that evaluated its Ibrance with standard adjuvant
endocrine therapy in HR+, HER-, early stage breast cancer study is
unlikely to hit the primary goal, citing efficacy and futility analysis
done by an Independent Data Monitoring Committee.
The Pfizer Analyst
Cantor Fitzgerald analyst Louise Chen maintained an Overweight rating on Pfizer shares with a $53 price target.
The Pfizer Thesis
The adjuvant opportunity for the breast cancer drug Ibrance is being
viewed by investors as a key growth driver for Pfizer, Chen said in a
Friday note. (See her track record here.)
The analyst said she expects the consensus sales estimate for Ibrance to come down to reflect a lower opportunity.
Pfizer had earlier said the adjuvant opportunity could double the eligible patient population for Ibrance, she said.
Ibrance is already approved in the U.S. for treating adult patients with HR+, HER- advanced breast cancer.
The Street projects that Ibrance sales will grow from $5 billion in 2019 to $11.5 billion by 2025, Chen said.
The analyst estimates worldwide Ibrance sales of $8.6 billion in
2025, assuming a 33% probability of success for the PALLAS and
PENELOPE-B studies.
The PENELOPE-B study is on track to readout by the second half of 2020, she said.
Yet with mixed data from the PALLAS and a Phase 2 study dubbed
PALLET, expectations for the PENELOPE-B study will be modest, Chen said.
Despite the disappointing news, Pfizer said it remains confident in
its ability to deliver on its goal of at least 6% revenue CAGR through
2025, according to Cantor Fitzgerald.
This assertion will hardly be credible to investors, the analyst said.
“We think PFE’s ability to hit its CAGR target will depend more than
ever on its ability to deliver strong growth from its in-line portfolio
as well as contributions from the pipeline/new product launches.” https://www.benzinga.com/analyst-ratings/analyst-color/20/06/16151451/pfizer-analyst-takes-stock-of-negative-breast-cancer-data-pharma-giants-2025-goals
Drugmaker Eli Lilly And CoLLY 0.48% started a human study of a potential antibody treatment for COVID-19 patients, and CEO David Ricks said on Fox Business that it is the first of its kind.
Lilly’s Brand New Medicine
Eli Lilly’s medicine to treat COVID-19 patients is the first of its
kind, as it consists of antibodies found in a recovered patient’s cells.
In contrast, other drugs and therapies are merely “repurposed” from
other uses, Ricks said.
Eli Lilly scientists collaborated with Canada-based AbCellera to
engineer a treatment out of the “very best one or two” antibodies it can
find out of millions of cells, the CEO said. The initial study will
consist of less than 40 patients, and results are expected in a “couple
of weeks,” he said.
Lilly’s Production Timeline
Eli Lilly has already started the process of ramping up production
for its hopeful therapy despite it being in the early stages of testing,
Ricks said.
The company expects to produce 100,000 or more doses that will be available in the fall, the CEO said.
During the pandemic’s peak, there were around 60,000 people in a
hospital in the U.S., so 100,000 could treat every person, he said.
Important Treatment Before Vaccine
Eli Lilly wants to study how its medicine can be used to treat people
to avoid the need of going to a hospital in the first place as part of
an ambulatory treatment study.
The company also wants to explore later on in the summer months how
its treatment can be used among those most at risk and vulnerable.
“This is an important bridge therapy until a vaccination could arrive
and even perhaps vaccination this kind of therapy could find an
important use,” the CEO said. https://www.benzinga.com/general/biotech/20/06/16151876/eli-lilly-ceo-talks-coronavirus-treatment-progress-this-is-an-important-bridge-therapy
Despite the FDA tied up with COVID-19-related activities, May turned
out to be a positive month for biopharma companies from the perspective
of drug approvals. Three new molecular entities were approved during the
month and several other drugs also received the nod.
Meanwhile, Blueprint Medicines Corp BPMC 1.68%
faced disappointment at the FDA altar, as its NDA for avapritinib for
treating fourth-line gastrointestinal stromal tumor was clamped with a
complete response letter.
Here are the key PDUFA dates scheduled for the unfolding month. Merck’s Antibiotic Combo Up Before FDA For Label Expansion
Indication: hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
Date: June 4
Recarbrio is a combination of imipenem, a penem antibacterial,
cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a
betalactamase inhibitor, indicated for the treatment of complicated
urinary tract infections and complicated intra-abdominal infections.
Viela Eyes Commercial Status With its Autoimmune Disorder Drug Approval
Indication: neuromyelitis optica spectrum disorder, or NMOSD
Date: June 11
The FDA accepted the BLA for the investigational anti-CD19 monoclonal
antibody on April 27, 2019. NMOSD is a rare autoimmune disease
characterized by unpredictable attacks that often lead to severe,
irreparable disability including blindness and paralysis.
The company said in its first-quarter earnings release it has begun
preparations for potential regulatory approval, hiring and training
market access and sales teams and deploying MSLs. The company expects to
commercialize the drug shortly after.
Can Merck’s Wonder Cancer Drug Snag Another Approval
Company: Merck
Type of Application: sBLA
Candidate: Keytruda
Indication: solid tumors
Date: June 16
Merck announced April 7 FDA acceptance of the application with priority review. Keytruda
as a monotherapy is being evaluated for treating adult and pediatric
patients with unresectable or metastatic solid tumors with tissue tumor
mutational burden-high, as determined by an FDA-approved test, who have
progressed following prior treatment and who have no satisfactory
alternative treatment options
Ultragenyx Seeks Label Expansion For Partnered Drug To Treat Low Serum Phosphate Levels
Company: Ultragenyx Pharmaceutical Inc RARE 1.67% and Kyowa Kirin
Type of Application: sBLA
Candidate: burosumab
Indication: hypophosphatemia
Date: June 18
The FDA accepted the application for priority review Feb. 27.
Burosumab is a fully human monoclonal IgG1 antibody, which works against
the phosphaturic hormone FGF23. This hormone reduces serum levels of
phosphorus and active vitamin D by regulating phosphate excretion and
active vitamin D production by the kidney.
It has already been approved for the treatment of X-linked
hypophosphatemia in adult and pediatric patients 6 months of age and
older. The companies are now seeking label expansion to include the
indication FGF23-related hypophosphatemia associated with phosphaturic
mesenchymal tumors that cannot be curatively resected or localized.
Epizyme Looks To Strike It Rich With Another Tazemetostat Approval
Tazemetostat
was initially approved for epithelioid sarcoma in January, and has been
sold under the brand name Tazverik. The regulatory application, which
was accepted for priority review, seeks approval for the drug for
patients with relapsed or refractory follicular lymphoma who have
received at least two prior lines of systemic therapy.
Indication: complicated urinary tract infection or cUTI
Date: June 19
Nabriva’s original NDA was rejected by the FDA in April 2019, with
the regulatory agency handing down a complete response letter on the
pretext of issues related to facility inspections and manufacturing
deficiencies at one of Nabriva’s contract manufacturers.
The company resubmitted the application in late December, and the FDA acknowledged the resubmission in mid-January.
Evoke Knocks The FDA Altar After A Prior Rejection
Evoke faced a rejection at the FDA altar once, and resubmitted the
application, which was accepted for review in January. GimotI is a nasal
spray product candidate for the relief of symptoms in adult women with
acute and recurrent diabetic gastroparesis.
Karyopharm Blood Cancer Drug On Track For Second Approval?
Indication: relapsed or refractory diffuse large B-cell lymphoma
Date: June 23
Karyopharm announced on Feb. 19 FDA acceptance of the regulatory
application, which sought accelerated approval for oral Selinexor
tablets for the treatment of adult patients with relapsed or refractory
diffuse large B-cell lymphoma, not otherwise specified, who have
received at least two prior therapies.
Selinexor was approved in July 2019 as a combo treatment option along
with dexamethasone for the treatment of adult patients with relapsed
refractory multiple myeloma, who have received at least four prior
therapies.
Zogenix’s Hopes For No Jitters On Seizure Drug Review
Indication: seizures associated with Dravet syndrome
Date: June 25
Zogenix’s regulatory filing for Fintelpa was accepted for priority
review in November 2019, with a PDUFA date of March 25. The FDA extended
the review period by three months to give itself time to look at the
additional data provided by the company.
Heron’s HTX-011 is a combo drug consisting of bupivacaine and a low
dose of non-steroidal anti-inflammatory drug meloxicam, and is a
non-opioid pain drug. The NDA was originally submitted in October 2018,
and in response to the application, the FDA issued a complete response
letter in April 2019, citing the need for additional CMC and
non-clinical information.
Heron resubmitted the NDA in October 2019, and in February the
company said the FDA extended the review period by three months,
rendering the PDUFA data on June 26.
If approved HTX-011 will compete with Pacira Biosciences Inc’s PCRX 1.43%
Exparel, Guggenheim Securities analyst Dana Flanders said in a recent
note. Citing the firm’s post-operative pain survey, Flanders said
HTX-011 is likely to see significant growth at the expense of Exparel.
The analyst said price point may be key in driving significant uptake.
Can Chiasma Cross The FDA Hurdle This Time Around?
The FDA accepted Chiasma’s originally submitted NDA in August 2015.
Mycapssa, or octreotide capsules, is an oral drug being evaluated for
the maintenance therapy of adult patients with acromegaly. A complete
response letter was issued by the FDA in April 2016, seeking an
additional clinical trial to establish the efficacy. Following a
resubmission in Dec. 2019, the FDA accepted the application in January,
giving it a PDUFA date of June. 26.
Acromegaly is a hormonal disorder that is caused by the production of
too much hormone by the pituitary gland during adulthood, causing bone
size to increase.
Indication: fibrosis due to non-alcoholic steatohepatitis
Date: June 26
NASH has become a tough nut to crack for biotech companies, with no
approved drug yet despite a plethora of ongoing research. Intercept
filed the NDA in November 2019 following positive Phase 3 results from
the GENERATE study. The PDUFA date, which was originally fixed as March
26, was extended by three months.
AstraZeneca PLC and Merck & Co. Monday said the European
Medicines Agency’s Committee for Medicinal Products for Human Use
recommended approval of the cancer drug Lynparza in a form of pancreatic
cancer.
The drugmakers said the recommendation covers Lynparza as monotherapy
for the maintenance treatment of adults with germline BRCA1/2 mutations
who have metastatic adenocarcinoma of the pancreas and haven’t
progressed after a minimum of 16 weeks of platinum treatment within a
first-line chemotherapy regimen.
The indication now awaits approval from the European Commission, which generally follows the CHMP’s recommendations.
AstraZeneca and Merck in 2017 formed a collaboration to co-develop and co-commercialize Lynparza for multiple cancer types.
Air passengers should have
restricted access to toilets on flights as part of wide-ranging
coronavirus safety recommendations, a UN agency has said.
The International Civil Aviation Organization (ICAO) guidelines also
include limiting or suspending food and drink services on short-haul
flights.
The new guidelines are designed to protect air passengers and workers from the Covid-19 virus as lockdown eases.
Airlines could see revenues plunge £314bn in 2020, the ICAO added.
The aviation industry has been struggling as lockdown measures around the world have limited flights and passenger numbers.
As those travel restrictions begin to ease, the ICAO has issued
guidelines for governments, with the aim of airlines and airports having
a unified response when trying to keep passengers and staff safe from
coronavirus.
The ICAO stopped short of saying that passengers must be
socially-distanced on planes, but it did say they should be seated
separately “when occupancy allows it”.
Passengers should travel as lightly as possible, with small hand
luggage stowed under their seat. Newspapers and magazines should be
removed, and duty free sales should be temporarily limited, the UN’s
civil aviation body said.
Short-haul food and drinks services should be limited or suspended, or be sold in sealed, pre-packaged containers.
Access to toilets should also be restricted, the ICAO said. Where
possible, one toilet should be set aside for use by cabin crew, and
passengers should use a designated lavatory based on which seat they
have.
‘Biometrics for duty free’
The new recommendations cover airports, aircraft, crew and cargo.
In general, face masks should be worn in line with public health
guidelines, and social distancing should be made possible where it is
feasible, the UN body said.
Areas should be routinely cleaned, and passengers should be checked
for signs of coronavirus, by screening temperatures, for example.
Contact tracing methods should also be explored.
At airports, staff should have adequate personal protective
equipment, which “could include gloves, medical masks, goggles or a face
shield, and gowns or aprons,” the guidelines said.
Passengers should be encouraged to check-in before getting to the airport, and to use mobile boarding passes.
Airports should also use contactless technology, including facial and
iris scanning, for “self-service bag drops, various queue access,
boarding gates and retail and duty-free outlets”, the guidelines say.
“This will eliminate or greatly reduce the need for contact with
travel documents between staff and passengers,” the UN agency added.
The recommendations are extensive and detailed – a blueprint for
aviation in the Covid-19 era; and one fact stands out. Flying, for a
while at least, is not going to be a whole lot of fun.
From the moment you arrive at the terminal building, armed with your
pre-printed boarding pass and luggage tags, human contact will be
limited, social distancing the norm. Masks will be obligatory, and
supplies of hand sanitiser everywhere.
If you don’t like potentially intrusive technology, tough – ICAO
suggests that “contactless biometrics such as facial or iris recognition
” should be used wherever possible, to reduce physical contact between
staff and passengers.
And it continues on board the plane: there are instructions to “limit
interaction on board” – so no striking up a conversation with your
neighbour – to reduce or suspend food and drink services, and to
restrict lavatory access.
What ICAO is trying to do here is create a common and consistent
framework for the industry to follow around the world – allowing people
to travel, while placating even the strictest health authorities.
It insists the new measures should be temporary.
But for the moment, anything that was left of the once-lauded romance
of flying looks set to disappear in a pungent cloud of disinfectant.
Airlines and aerospace firms have been struggling amid the coronavirus crisis.
At the beginning of May, Virgin Atlantic said it would axe 3,000 jobs and quit Gatwick. Later in the month, engine-maker Rolls Royce said it would cut 9,000 jobs.
There has been a huge reduction in air travel, with daily flights down about 80% since the start of the year.
But now carriers are making plans to get airborne again, with plans to reintroduce some schedules. https://www.bbc.com/news/business-52765157
George Floyd was killed by “asphyxia due to neck and back
compression” — and died at the scene, according to an independent
medical examiner’s report released Monday.
“Sustained pressure on the right side of Mr. Floyd’s carotid artery
impeded blood flow to the brain, and weight on his back impeded his
ability to breathe,” said the report by medical examiners hired by
Floyd’s family and obtained by the Minneapolis Star-Tribune.
“The independent examiners found that weight on the back, handcuffs
and positioning were contributory factors because they impaired Mr.
Floyd’s diaphragm to function.
“From all the evidence, the doctors said it now appears Mr. Floyd died at the scene.”
A preliminary official autopsy said Floyd
died from the combined effects of being restrained, possible
intoxicants and underlying health issues including heart disease,
Minnesota officials have said.
Floyd, who is black, died May 25 after having his neck knelt on by a
white Minnesota cop for nine minutes, even as he cried, “I can’t
breathe.” https://nypost.com/2020/06/01/george-floyd-died-of-asphyxia-to-neck-family-mes-report/
The FDA accepts for review AVEO Oncology’s (AVEO-2.9%) marketing application seeking approval of tivozanib for relapsed/refractory renal cell carcinoma.
The agency’s action date is March 31, 2021. No advisory committee meeting is planned.
