Avidity Biosciences Inc., a preclinical-stage biopharmaceutical
company backed by Eli Lilly & Co., on Monday said it expects to sell
10 million shares at between $14 and $16 apiece in its initial public
offering.
At the $15 midpoint of that range, the La Jolla, Calif., company said
it expects net proceeds of about $136.6 million, or roughly $157.5
million if the underwriters exercise an option to buy an additional 1.5
million shares.
Avidity said it will use proceeds from the IPO to fund development of
its oligonucleotide-based therapies aimed at treating a range of
serious diseases. The company’s lead product candidate, AOC 1001, is
designed to treat myotonic dystrophy type 1, a rare monogenic muscle
disease.
In a filing with the Securities and Exchange Commission, Avidity said
it will have about 32.5 million shares outstanding after the IPO,
assuming exercise of the overallotment option, for a valuation of about
$486.8 million at the $15-a-share midpoint.
Eli Lilly, which last year formed a collaboration with Avidity, currently owns a 10.4% stake in the company.
Avidity said it has applied to list its shares on the Nasdaq Global Market under the symbol RNA.
https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Avidity-Biosciences-Sets-IPO-at-10-Million-Shares-Sees-Pricing-at-14-16-Each-30739020/
Monday, June 8, 2020
Europe wants to make its own drugs, but it needs American blood plasma
Europe wants to be master of its own destiny in producing essential
drugs and finding COVID-19 treatments, but it’s got a problem. It relies
on the United States for a critical ingredient: blood plasma.
As global mistrust deepens, European Union officials are casting around for ways to reduce the bloc’s dependence on American plasma, the liquid component of blood used in a host of drugs and now widely applied in COVID-19 experimental therapies.
The coronavirus crisis should push authorities to overhaul Europe’s blood donation system, according to some industry players. The United States’ steadier plasma supplies are partly due to its system of paying people to donate blood used to develop medicines. In most European countries, donations are unpaid because of safety and ethical reasons.
A strategy for “achieving EU sufficiency” on plasma was discussed at an extraordinary COVID-19 meeting of blood experts organised last week by the European Commission, the EU executive arm, according to the meeting’s agenda.
A spokesman for the Commission had no immediate comment about the outcome of the meeting.
The EU is setting aside a large budget to increase its pharmaceutical independence. It is now funding a project to manufacture a plasma-derived medicinal product against COVID-19 and has also set up a database to share results of therapies applied in European hospitals.
Plasma has long been used to produce critical medicines such as immunoglobulins and medication that helps control bleeding. The global market for these products is worth about $20 billion a year and analysts estimate it will grow.
Around 35% of the plasma for medicines needed by about 300,000 Europeans with chronic diseases comes from the United States, according to the Plasma Protein Therapeutics Association (PPTA), a trading body for the biggest manufacturers of plasma-derived therapies.
“This situation exposes European patients to the risk of sudden interruptions of plasma supplies from the U.S.”, said an official at the European Directorate for the Quality of Medicines and Healthcare (EDQM), a body that sets quality and ethical standards for drugs in Europe.
The PPTA drugmakers body sees a strategy based on unpaid blood donations as counterproductive. It pointed to Germany, the largest collector of plasma in Europe, as one of the few countries that compensate blood donors.
Standard-setters and plasma collectors, however, want Europe to achieve self-sufficiency by boosting unpaid donations.
The debate around payments is not new; critics point to concerns that it is unethical to pay people for parts of their body, and worries that safety standards could be compromised if companies rely financially on plasma collections.
COVID-RELATED SHORTAGES?
An official from the European Blood Alliance (EBA), which brings together non-profit blood collection institutions across Europe, said concerns on supplies have increased in recent months as Europe and the United States have vied to acquire essential resources against the virus, including promising vaccines and personal protective gear..
Europe’s worries on plasma have also been exacerbated by COVID-19 lockdowns, which have kept many donors away from blood collection centres, the EBA official said.
A Commission official said measures had been taken during the pandemic to “mitigate the risk” of plasma shortages, including a temporary softening of regulatory requirements for blood collection centres.
Although no shortages for transfusions were recorded, experts said problems may arise later in the year for supplies of plasma-derived drugs.
The epidemic has boosted demand for unprocessed plasma, as many medics across the world transfuse it directly from COVID-19 survivors to infected people, often with positive results, although its efficacy is still under investigation.
If this so-called convalescent plasma, or a medicine derived from it, prove definitively effective against the disease, that could further strain Europe’s supplies, the EDQM official said, adding that a strategy for its collection at industrial scale should be quickly devised.
Convalescent plasma is also being investigated as a possible prophylaxis to prevent COVID-19 infections as antibodies extracted from it could be transfused to boost immunity defences of vulnerable people.
Japanese pharmaceutical giant Takeda is co-leading a global corporate alliance aimed at developing a plasma-based treatment for COVID-19, for which clinical trials will begin in July.
https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-COM-6491073/news/Takeda-Pharmaceutical-Europe-wants-to-make-its-own-drugs-but-it-needs-American-blood-plasma-30739196/
As global mistrust deepens, European Union officials are casting around for ways to reduce the bloc’s dependence on American plasma, the liquid component of blood used in a host of drugs and now widely applied in COVID-19 experimental therapies.
The coronavirus crisis should push authorities to overhaul Europe’s blood donation system, according to some industry players. The United States’ steadier plasma supplies are partly due to its system of paying people to donate blood used to develop medicines. In most European countries, donations are unpaid because of safety and ethical reasons.
A strategy for “achieving EU sufficiency” on plasma was discussed at an extraordinary COVID-19 meeting of blood experts organised last week by the European Commission, the EU executive arm, according to the meeting’s agenda.
A spokesman for the Commission had no immediate comment about the outcome of the meeting.
The EU is setting aside a large budget to increase its pharmaceutical independence. It is now funding a project to manufacture a plasma-derived medicinal product against COVID-19 and has also set up a database to share results of therapies applied in European hospitals.
Plasma has long been used to produce critical medicines such as immunoglobulins and medication that helps control bleeding. The global market for these products is worth about $20 billion a year and analysts estimate it will grow.
Around 35% of the plasma for medicines needed by about 300,000 Europeans with chronic diseases comes from the United States, according to the Plasma Protein Therapeutics Association (PPTA), a trading body for the biggest manufacturers of plasma-derived therapies.
“This situation exposes European patients to the risk of sudden interruptions of plasma supplies from the U.S.”, said an official at the European Directorate for the Quality of Medicines and Healthcare (EDQM), a body that sets quality and ethical standards for drugs in Europe.
The PPTA drugmakers body sees a strategy based on unpaid blood donations as counterproductive. It pointed to Germany, the largest collector of plasma in Europe, as one of the few countries that compensate blood donors.
Standard-setters and plasma collectors, however, want Europe to achieve self-sufficiency by boosting unpaid donations.
The debate around payments is not new; critics point to concerns that it is unethical to pay people for parts of their body, and worries that safety standards could be compromised if companies rely financially on plasma collections.
COVID-RELATED SHORTAGES?
An official from the European Blood Alliance (EBA), which brings together non-profit blood collection institutions across Europe, said concerns on supplies have increased in recent months as Europe and the United States have vied to acquire essential resources against the virus, including promising vaccines and personal protective gear..
Europe’s worries on plasma have also been exacerbated by COVID-19 lockdowns, which have kept many donors away from blood collection centres, the EBA official said.
A Commission official said measures had been taken during the pandemic to “mitigate the risk” of plasma shortages, including a temporary softening of regulatory requirements for blood collection centres.
Although no shortages for transfusions were recorded, experts said problems may arise later in the year for supplies of plasma-derived drugs.
The epidemic has boosted demand for unprocessed plasma, as many medics across the world transfuse it directly from COVID-19 survivors to infected people, often with positive results, although its efficacy is still under investigation.
If this so-called convalescent plasma, or a medicine derived from it, prove definitively effective against the disease, that could further strain Europe’s supplies, the EDQM official said, adding that a strategy for its collection at industrial scale should be quickly devised.
Convalescent plasma is also being investigated as a possible prophylaxis to prevent COVID-19 infections as antibodies extracted from it could be transfused to boost immunity defences of vulnerable people.
Japanese pharmaceutical giant Takeda is co-leading a global corporate alliance aimed at developing a plasma-based treatment for COVID-19, for which clinical trials will begin in July.
https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-COM-6491073/news/Takeda-Pharmaceutical-Europe-wants-to-make-its-own-drugs-but-it-needs-American-blood-plasma-30739196/
Lilly Phase 1 Study Starts for Potential Covid-19 Antibody Treatment
Eli Lilly and Co. said its partner Junshi Biosciences has dosed the
first healthy volunteer in a study of a potential neutralizing antibody
treatment designed to fight Covid-19.
Junshi Biosciences and Lilly are co-developing the investigational medicine, referred to as JS016, with Junshi leading development in Greater China, Lilly said. Lilly said it has exclusive rights in the rest of the world and will begin dosing patients in a complementary Phase 1 study in the U.S. in the coming days.
Both Phase 1 studies aim to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who haven’t been diagnosed with Covid-19.
Lilly shares rose 1.2% to $150.99 premarket.
This is Lilly’s second neutralizing antibody to start clinical trials, following LY-CoV555, which recently entered Phase 1 and is currently being tested in hospitalized Covid-19 patients.
https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Lilly-Phase-1-Study-Starts-for-Potential-Covid-19-Antibody-Treatment-30739212/
Junshi Biosciences and Lilly are co-developing the investigational medicine, referred to as JS016, with Junshi leading development in Greater China, Lilly said. Lilly said it has exclusive rights in the rest of the world and will begin dosing patients in a complementary Phase 1 study in the U.S. in the coming days.
Both Phase 1 studies aim to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who haven’t been diagnosed with Covid-19.
Lilly shares rose 1.2% to $150.99 premarket.
This is Lilly’s second neutralizing antibody to start clinical trials, following LY-CoV555, which recently entered Phase 1 and is currently being tested in hospitalized Covid-19 patients.
https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Lilly-Phase-1-Study-Starts-for-Potential-Covid-19-Antibody-Treatment-30739212/
Vaccine maker Vaxcyte to offer 14 million shares in planned IPO priced at $14 to $16
Vaxcyte Inc. PCVX,
set terms for its planned initial public offering on Monday, with plans
to offer 14 million shares priced at $14 to $16 each. The company has
applied to list on Nasdaq under the ticker symbol “PCVX.” BofA
Securities, Jefferies and Evercore ISI are lead underwriters on the deal
with Cantor and Needham acting as co-managers. “We are a
next-generation vaccine company seeking to improve global health by
developing superior and novel vaccines designed to prevent or treat some
of the most common and deadly infectious diseases worldwide,” says the
prospectus. Proceeds of the deal will be used top fund clinical
development and for general corporate purposes.
https://www.marketwatch.com/story/vaccine-maker-vaxcyte-to-offer-14-million-shares-in-planned-ipo-priced-at-14-to-16-each-2020-06-08
https://www.marketwatch.com/story/vaccine-maker-vaxcyte-to-offer-14-million-shares-in-planned-ipo-priced-at-14-to-16-each-2020-06-08
Generation Bio to offer 7.4 million shares in planned IPO, priced at $16 to $18
Generation Bio Co. GBIO,
set terms for its planned initial public offering on Monday, with plans
to offer 7.4 million shares priced at $16 to $18 each. The company
would raise $133.2 million at the top end of that range. The company has
applied to list on Nasdaq, under the ticker symbol “GBIO.” J.P. Morgan,
Jefferies, Cowen and Wedbush PacGrow are underwriting the deal.
Proceeds will be used to fund R&D, to develop platform technologies
and for general corporate purposes. “We are an innovative genetic
medicines company creating a new class of gene therapy utilizing our
proprietary non-viral gene therapy platform to provide durable,
redosable treatments for millions of patients living with rare and
prevalent diseases,” the company says in its prospectus.
https://www.marketwatch.com/story/generation-bio-to-offer-74-million-shares-in-planned-ipo-priced-at-16-to-18-each-2020-06-08
https://www.marketwatch.com/story/generation-bio-to-offer-74-million-shares-in-planned-ipo-priced-at-16-to-18-each-2020-06-08
Sanofi to present data on Pompe enzyme replacement therapy June 16
Sanofi (NASDAQ:SNY) will host a virtual scientific session
on Tuesday, June 16, at 8:00 am ET to present Phase 3 data on enzyme
replacement therapy avalglucosidase alfa in patients with late-onset
Pompe disease.
Pompe is
an inherited disorder caused by the buildup of glycogen in the body’s
cells due to mutations in the gene that codes for an enzyme called acid
alpha-glucosidase.
https://seekingalpha.com/news/3580997-sanofi-to-present-data-on-pompe-enzyme-replacement-therapy-june-16Astellas’ roxadustat successful in late-stage anemia study
Astellas Pharma (OTCPK:ALPMF) announces positive results from a Phase 3 clinical trial, DOLOMITES,
evaluating roxadustat for the treatment of anemia in
non-dialysis-dependent adults with stage 3-5 chronic kidney disease. The
data were virtually presented at the European Renal
Association-European Dialysis and Transplant Association Congress.
The study demonstrated the non-inferiority (no worse than) of roxadustat to Amgen’s (NASDAQ:AMGN)
Aranesp (darbepoetin alfa) as measured by hemoglobin response up to
week 24. Specifically, the change in hemoglobin in the roxadustat cohort
was 89.5%, compared to 78.0% in the darbepoetin alfa cohort.
Roxadustat demonstrated superiority over
darbepoetin alfa in reducing low-density lipoprotein cholesterol (“bad”
cholesterol), a secondary endpoint.
The safety profiles were similar.
The company’s marketing application in Europe is under EMA review.
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF)
prolyl hydroxylase. HIF is a protein transcription factor that “turns
on” the production of red blood cells (erythropoiesis). Its value
proposition is the ability to maintain hemoglobin levels without
affecting inflammation and potentially avoiding the need for ongoing
intravenous iron repletion therapy as needed with bone marrow
stimulating agents like Aranesp and Johnson & Johnson’s (NYSE:JNJ) Procrit (epoetin alfa).
https://seekingalpha.com/news/3581007-astellas-roxadustat-successful-in-late-stage-anemia-study
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