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Monday, December 2, 2019

Indivior tackles opioid addiction stigma, targets recovery with first TV campaign

Indivior is launching its first TV campaign for opioid use disorder drug Sublocade, an injectible the company expects to reach blockbuster sales. (Indivior)

FDA clears RTI Surgical’s Streamline MIS Spinal Fixation System

The FDA grants 501(k) clearance to RTI Surgical’s (RTIX +3.2%Streamline MIS Spinal Fixation System used to create a rigid construct in the thoracolumbar spine (thoracic and lumbar regions) via a percutaneous or mini-open approach.

Kodiak Sciences to sell future royalties on KSI-301 to Baker Bros. Advisors for $225M

Kodiak Sciences (NASDAQ:KOD) gains as the Company agrees to sell a capped 4.5% royalty right on global net sales of KSI-301 to Baker Bros. Advisors, for $225M
KSI-301 is an anti-VEGF antibody biopolymer conjugate, under development for retinal vascular diseases.
BBA will pay the first $100M at the closing of the transaction expected in January 2020, and the remaining $125M upon achievement of pre-determined milestones
Kodiak has an option to repurchase royalty rate of 4.5% on annual sales after 4.5x the funded amount has been paid.

Mylan launches Herceptin biosimilar in U.S.

Mylan N.V. (NASDAQ:MYL) and development partner Biocon Ltd. (OTC:BCNQYannounce the U.S. commercial launch of Ogivri (trastuzumab-dkst), a biosimilar to Roche’s (OTCQX:RHHBY) Herceptin.
Mylan owns exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand, the EU and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan in the rest of the world.

FibroGen up on reimbursement of roxadustat in China

China’s National Healthcare Security Administration has added FibroGen’s (FGEN +2.9%) roxadustat to its National Reimbursement Drug List for the treatment of anemia in chronic kidney disease patients, both dialysis-dependent and non-dialysis-dependent.
The company is collaborating with AstraZeneca (AZN -0.1%) on development and commercialization there.

FDA Action Alert: Celgene, Amgen and Avadel

As we begin the final month of 2019, the U.S. Food and Drug Administration (FDA) has several PDUFA dates to approve drug applications. Here’s a look at those scheduled for the first two weeks of the month.
Celgene’s Luspatercept for Beta-thalassemia-associated Anemia
Celgene had a target action date of December 4, 2019 for its Biologics License Application (BLA) for luspatercept. Luspatercept is an investigational erythroid maturation agent for adults with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adults with beta-thalassemia-associated anemia who require RBC transfusions—it is this second indication for which the company had the December 4 PDUFA date.
Luspatercept is also being reviewed by the European Medicines Agency (EMA). It is a first-in-class erythroid maturation agent (EMA) that regulates late-stage red blood cell maturation. The therapy was jointly developed by Celgene and Acceleron. The application was built on the results from the Phase III COMMANDS trial in ESA-naïve, lower-risk MDS patients and the Phase II BEYOND trial in non-transfusion-dependent beta-thalassemia.
The FDA approved luspatercept-aamt under the brand name of Reblozyl on November 8 for anemia in adults with beta-thalassemia. Beta-thalassemia is a rare, inherited blood disorder caused by a genetic defect in hemoglobin. The target action date for luspatercept for erythroid maturation agent for adults with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions is April 4, 2020.
Amgen’s Biosimilar to Janssen’s Remicade
Amgen has a target action date of December 14 for its BLA of ABP 710, a biosimilar candidate to Janssen Pharmaceutical’s Remicade (infliximab), a drug for various inflammatory diseases such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
ABP 710 (and infliximab) are anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibodies. The BLA submission includes analytical, pharmacokinetic and clinical data in addition to pharmacology and toxicology data. A Phase III study comparing efficacy, safety and immunogenicity was run in patients with moderate-to-severe rheumatoid arthritis and confirmed no clinically meaningful differences between ABP 710 and infliximab.
Avadel’s FT218 for Narcolepsy
Avadel Pharma has a target action date of December 15 for FT218 for narcolepsy. The New Drug Application (NDA) was originally accepted in May 2019 under the FDA’s Priority Review program, which gives it a statutory six-month review. It was then extended by three months as the result of FDA requests for additional analytical information and Avadel’s resultant additional submissions.
FT218 is an investigational drug designed to be administered in one single dose, before bedtime, to treat excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. It was granted orphan-drug designation by the FDA on January 8, 2018 on the theory that is may be clinically superior to the currently marketed, twice-nightly sodium oxybate product.
On November 25, 2019, Avadel announced it had completed patient enrollment of 205 patients in the REST-ON Phase III clinical trial for FT218. The enrollment target was 205 patients. Additional patients may be enrolled if they meet eligibility criteria. Topline data is expected in the second quarter of 2020.
The company says that if the drug is approved, it has the potential to capture a significant share of the twice-nightly sodium oxybate market, which is currently valued at $1.7 billion per year.
The REST-ON trial is a double-blind, randomized, placebo-controlled Phase III study to evaluate the efficacy and safety of once-nightly FT218. It is under a Special Protocol Assessment agreement with FDA.

Could life insurance go up in smoke for some vapers?

Global reinsurers are stepping up their warnings to life insurer clients about the potential risks of vaping, putting pressure on underwriters to charge certain vapers higher rates than smokers, or even exclude them altogether.

U.S. authorities said last month that there had been 47 deaths this year from a lung illness tied to vaping. The health concerns about vaping have grown despite evidence showing e-cigarettes help smokers to quit, and has led to bans in some countries including India and Brazil.
U.S. authorities said last month that there had been 47 deaths this year from a lung illness tied to vaping. The health concerns about vaping have grown despite evidence showing e-cigarettes help smokers to quit, and has led to bans in some countries including India and Brazil.
Reinsurers insure the insurers, and often have large research arms which help their clients by modelling risk. They give broad advice to insurers, rather than specific policy or pricing recommendations, but can potentially refuse to provide reinsurance or can raise premiums if their guidance is ignored.
Most insurers have long treated smokers and vapers the same, meaning they can pay close to double the premiums of non-smokers or non-vapers. But three major reinsurers have provided updated advice on vaping in the past three months, with new warnings, while others are considering their approach.
The new warnings focus on young vapers and the vaping of liquids containing marijuana ingredient THC, which is legal and prevalent in some U.S. states and has been linked to lung illnesses in the country.
The shift in the reinsurance and insurance sector represents a further blow to the vaping industry, which markets its products as healthier alternatives to smoking.
Hannover RE, which already advised life insurers to treat vapers like smokers, has asked them to be particularly cautious about insuring people aged under 25 following the “epidemic” of lung injuries in the United States, said Nico van Zyl, the reinsurer’s U.S. medical director.
The question of whether to offer coverage to this higher risk group should be a consideration for life insurers, he said.
French reinsurer SCOR said in a paper on Oct. 24 that e-cigarettes contain nicotine which may have toxic effects, including on brain development in teenagers and young adults.
SCOR recommends life insurers treat vaping like smoking, and exclude individuals who use vaping products considered by U.S. authorities likely to cause lung issues – namely, those containing THC (tetrahydrocannabinol).
Swiss Re also treats vapers like smokers. In addition, Global Chief Medical Officer John Schoonbee said the reinsurer has told insurers in recent months to make extra checks on whether vapers are using cannabis products.
AMERICAN WARNING
The U.S. Centers for Disease Control and Prevention has urged people not to use e-cigarettes containing THC, some of which contain vitamin E acetate, a “chemical of concern” among people with the vaping-associated lung injury EVALI.
Stephen Cooley, Chief Medical Underwriter at PartnerRe Life & Health, said more research on the long-term effects of vaping was needed and that life insurance rates for vapers would be the same as smoker rates “at best”.
Munich Re and Gen Re said they were monitoring the recent developments in EVALI.
Proponents of vaping as a tool to stop smoking say the insurers’ and reinsurers’ approach is harsh.
“Getting insurance is really expensive for people who have taken steps to quit tobacco,” said Simon Manthorpe, CEO of British vaping product manufacturer Vapemate.
Vaping in Britain and elsewhere in Europe is more heavily regulated than in the United States. Vapes containing THC or cannabis oil of any kind are banned in Britain, and Public Health England says vaping is at least 95% safer than smoking.