David Ricks, Eli Lilly CEO, steps away from the podium at the White House (Evan Vucci/AP Images)

UP­DAT­ED: US paus­es use of Eli Lil­ly's Covid-19 treat­ment na­tion­wide due to vari­ants

Due to the pres­ence of vari­ants, the US said Fri­day that it’s paus­ing ship­ments of Eli Lil­ly’s mon­o­clon­al an­ti­body com­bo for the treat­ment of Covid-19 on a na­tion­al ba­sis un­til fur­ther no­tice.

The pause, which could amount to the loss of about $375 mil­lion in sales ac­cord­ing to one biotech an­a­lyst, is an­oth­er blow to Lil­ly’s ef­forts to treat Covid-19 out­side of the hos­pi­tal, as the com­pa­ny pre­vi­ous­ly had its EUA for bam­lanivimab re­voked.

“The CDC iden­ti­fied that the com­bined fre­quen­cies of the SARS-CoV-2 P.1/Gam­ma vari­ant (first iden­ti­fied in Brazil) and the B.1.351/Be­ta vari­ant (first iden­ti­fied in South Africa) through­out the Unit­ed States now ex­ceed 11% and are trend­ing up­ward,” John Redd, CMO of the Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse, said in a let­ter ob­tained by End­points News.

“Re­sults from in vit­ro as­says that are used to as­sess the sus­cep­ti­bil­i­ty of vi­ral vari­ants to par­tic­u­lar mon­o­clon­al an­ti­bod­ies sug­gest that bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er are not ac­tive against ei­ther the P.1 or B.1.351 vari­ants,” Redd wrote.

Pre­vi­ous­ly, dis­tri­b­u­tion of the com­bo of bam­lanivimab and ete­se­vimab was halt­ed in 9 states, in­clud­ing Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon, Illi­nois, Mass­a­chu­setts, Rhode Is­land and Wash­ing­ton, as the com­bined fre­quen­cy of the Covid-19 vari­ants first iden­ti­fied in Brazil and South Africa ex­ceed­ed 10% then.

Lil­ly said in an emailed state­ment, “Bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er do not re­tain neu­tral­iza­tion ef­fects against the Gam­ma or Be­ta vari­ant. The U.S. Food and Drug Ad­min­is­tra­tion (FDA) rec­om­mends that health care providers in the U.S. use al­ter­na­tive au­tho­rized mon­o­clon­al an­ti­body ther­a­pies un­til fur­ther no­tice. As we have seen over the last sev­er­al months, preva­lence of vari­ants varies by state, re­gion and even coun­try and can change rapid­ly. Lil­ly con­tin­u­al­ly mon­i­tors the glob­al COVID-19 en­vi­ron­ment, as­sess­ing the neu­tral­iza­tion of our an­ti­body ther­a­pies against a wide ar­ray of ex­ist­ing and emerg­ing mu­ta­tions and vari­ants as well as the avail­able ther­a­pies.”

States will still have the op­tion of us­ing two mon­o­clon­al an­ti­bod­ies de­vel­oped by Re­gen­eron and Vir/GSK as the vari­ants do not evade ei­ther of those treat­ments as well as they did with the Lil­ly treat­ments.

Bern­stein biotech an­a­lyst Ron­ny Gal said in a note to in­vestors late last month that the mar­ket will now like­ly shift in Re­gen­eron’s fa­vor.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Lil­ly.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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