Ngozi Okonjo-Iweala, Director general of WTO (Salvatore Di Nolfi/Keystone via AP Images)

The Covid-19 vac­cine IP waiv­er is back at the WTO, with a new dead­line. Can it muster enough sup­port?

World Trade Or­ga­ni­za­tion di­rec­tor-gen­er­al Ngozi Okon­jo-Iweala called on mem­bers late last week to move swift­ly and forge at least a draft agree­ment on the di­vi­sive IP waiv­er for Covid-19 vac­cines by the end of Feb­ru­ary.

Those ad­vo­cat­ing for such a waiv­er, in­clud­ing coun­tries like the US, In­dia and South Africa and oth­er aid groups like Doc­tors With­out Bor­ders, have called to help more coun­tries man­u­fac­ture their own vac­cines more quick­ly, a task that has lost sig­nif­i­cant time due to these long ne­go­ti­a­tions. Some like MSF ar­gue that the waiv­er shouldn’t just in­clude vac­cines but should pro­vide a “crit­i­cal le­gal path­way for coun­tries to fa­cil­i­tate more di­ver­si­fied and sus­tain­able pro­duc­tion and sup­ply” of all Covid-re­lat­ed tools, in­clud­ing tests and ther­a­peu­tics too.

Even Eu­ro­pean lead­ers, who at first balked at the idea, seemed to have come around in re­cent months.

On the oth­er side of the de­bate, the vac­cine de­vel­op­ers that de­vel­oped the cur­rent suite of prod­ucts (of­ten with sig­nif­i­cant gov­ern­ment sup­port) ar­gue that the IP waiv­er is not what’s con­strain­ing pro­duc­tion. Pfiz­er and BioN­Tech say they ex­pect to pro­duce 4 bil­lion dos­es of their vac­cine in 2022, and the IF­P­MA has said that man­u­fac­tur­ers in the US, EU, In­dia and Chi­na will like­ly make more than 12 bil­lion dos­es by mid-2022.

“We don’t want to cre­ate a sit­u­a­tion where peo­ple com­pete for re­sources, where there are dif­fer­ent ver­sions of the prod­uct,” BioN­Tech CEO Uğur Şahin told End­points News in an in­ter­view in No­vem­ber. “We re­al­ly be­lieve the way to deal with that is to ask the ques­tion of how — how this can be pro­duced, and to be re­al­ly pa­tient. It took us 10 years to de­vel­op this; there are 50,000 steps, it’s not just the man­u­fac­tur­ing, but the an­a­lyt­i­cal as­says, dozens of which need to be val­i­dat­ed.”

Re­gard­less, WTO’s Okon­jo-Iweala is push­ing ahead with her plan, de­spite an al­ready-missed De­cem­ber dead­line on the waiv­er.

“We should strive to get this re­sult out by the end of Feb­ru­ary. It will be re­al­ly sad if this or­ga­ni­za­tion keeps talk­ing and de­bat­ing on this pan­dem­ic, and that by the time we come up with a re­sponse peo­ple will not think it rel­e­vant. I think we should re­al­ly move with all speed to try and con­clude this by the end of Feb­ru­ary,” she said in a state­ment.

On Feb. 11, the WTO will hold a tech­ni­cal work­shop to sup­port these on­go­ing dis­cus­sions around Covid-19 vac­cine R&D, man­u­fac­tur­ing and dis­tri­b­u­tion, with rep­re­sen­ta­tives from As­traZeneca and No­vavax speak­ing.

“I have heard that there could be some sort of deal by then. No de­tails yet But I know that the EU, In­dia, South Africa, and the Unit­ed States have been meet­ing at the min­is­te­r­i­al lev­el on this,” Thiru Bal­a­sub­ra­ma­ni­am, the Gene­va rep­re­sen­ta­tive of the NGO Knowl­edge Ecol­o­gy In­ter­na­tion­al, told End­points.

Re­gard­ing these small-group dis­cus­sions on the IP-re­lat­ed as­pects of the pan­dem­ic re­sponse, Okon­jo-Iweala asked for WTO mem­bers’ pa­tience.

“This is a very dif­fi­cult is­sue. If it were easy, it would have been re­solved in the al­most two years that this dis­cus­sion has been go­ing on (in the TRIPS Coun­cil). This small group process … is go­ing on but it is very tough. I have to say there is no easy road,” she added.

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.

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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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

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.

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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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.

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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‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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