Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115M and a high-pro­file Chi­nese part­ner

For two months, as the nov­el coro­n­avirus swelled from a few ear­ly cas­es tied to a Wuhan mar­ket to a glob­al epi­dem­ic, most of the world’s fo­cus and dol­lars have flowed to­ward emer­gency ini­tia­tives: build­ing vac­cines at a record pace, pluck­ing ex­per­i­men­tal an­tivi­rals out of freez­ers to see what sticks and im­mu­niz­ing mice for new an­ti­bod­ies.

Now a new and well-fund­ed col­lab­o­ra­tion be­tween Har­vard and a top Chi­nese re­search in­sti­tute will play the long game. In a 5-year, $115 mil­lion ini­tia­tive backed by Chi­na Ever­grande Group, re­searchers from the Har­vard Med­ical School, Har­vard T.H. Chan School of Pub­lic Health and Guangzhou In­sti­tute for Res­pi­ra­to­ry Health will study the virus in an ef­fort to de­vel­op ther­a­pies against in­fec­tions by the nov­el coro­n­avirus, known as SARS-CoV-2, and to pre­vent new ones.

The Chi­nese side of the ini­tia­tive is led by Zhong Nan­shan, head of the Chi­nese 2019-nCoV Ex­pert Task­force and the sci­en­tist who iso­lat­ed the SARS virus in 2003. He is al­so di­rec­tor-gen­er­al of the Chi­na State Key Lab­o­ra­to­ry of Res­pi­ra­to­ry Dis­eases.

“Har­vard Med­ical School is unique­ly po­si­tioned to con­vene ex­perts in vi­rol­o­gy, in­fec­tious dis­ease, struc­tur­al bi­ol­o­gy, pathol­o­gy, vac­cine de­vel­op­ment, epi­demi­ol­o­gy, and pub­lic health to con­front this rapid­ly evolv­ing cri­sis,” George Da­ley, dean of the Har­vard Med­ical School, said in a state­ment.

The ini­tia­tive will fo­cus on five ar­eas. That in­cludes de­vel­op­ing tests for rapid di­ag­no­sis, vac­cines, an­tivi­ral treat­ments to short­en the du­ra­tion of the dis­ease and mit­i­gate symp­toms, and oth­er treat­ments for pa­tients with se­vere dis­ease. Re­searchers will al­so try to un­der­stand how the body in­ter­acts with the virus. The hope is that they can find bio­mark­ers that will tell doc­tors if the in­fec­tion is wors­en­ing or will lead to life-threat­en­ing com­pli­ca­tions.

These ar­eas rep­re­sent the con­stel­la­tion of needs and un­knowns for a virus pub­lic health of­fi­cials in­creas­ing­ly fear will reach pan­dem­ic lev­els, and could be­come an an­nu­al in­fec­tion like the flu. Al­though the virus may yet dis­si­pate, ex­perts have em­pha­sized the need for long-term fund­ing that can im­prove readi­ness for fu­ture out­breaks, a need Har­vard un­der­scored in its an­nounce­ment.

The “re­sponse needs to be glob­al, rapid, and dri­ven by the best sci­ence,” Har­vard provost Alan Gar­ber said. “The lessons we learn from this out­break should en­able us to re­spond to in­fec­tious dis­ease emer­gen­cies more quick­ly and ef­fec­tive­ly in the fu­ture.”

Di­ag­no­sis has proven to be a con­tin­u­al chal­lenge through­out the virus’ spread. In Wuhan and the sur­round­ing Hubei province, the num­ber of pa­tients re­port­ing symp­toms rapid­ly out­stripped the sup­ply of nu­cle­ic acid test­ing kits used to con­firm the pres­ence of a virus. De­lays in di­ag­no­sis meant de­lays in quar­an­tine and treat­ment.

At the be­hest of Chi­nese doc­tors, of­fi­cials moved to CT scans to de­tect pneu­mo­nia, a symp­tom of the in­fec­tion, and then lat­er us­ing the test­ing kits as con­fir­ma­tion. But some in­fect­ed pa­tients show up neg­a­tive in CT scans, and as the virus has spilled out be­yond Chi­na’s bor­ders, how to test pa­tients in the fastest and most ac­cu­rate man­ner has be­come an is­sue of glob­al con­cern and a ma­jor point of dis­cus­sion at the World Health Or­ga­ni­za­tion and the US Cen­ter for Dis­ease Con­trol.

Har­vard has not said what forms of treat­ments they will in­ves­ti­gate. Thus far, most of the treat­ments used are an­tivi­rals orig­i­nal­ly de­vel­oped for oth­er pur­pos­es – in­clud­ing remde­sivir, the Gilead drug orig­i­nal­ly de­vel­oped for Ebo­la and Mar­burg virus, and lopinavir, an HIV drug – but doc­tors have flung a wide range of spec­u­la­tive ther­a­pies hop­ing to see what sticks. That in­cludes plas­ma treat­ments, an­ti­bod­ies oth­er coro­n­avirus pa­tients de­vel­oped in re­sponse to the virus and a tra­di­tion­al Chi­nese rem­e­dy drawn from ex­tracts of For­syth­iae fruc­tus. The ear­li­est drugs de­vel­oped specif­i­cal­ly for the virus are at least 5 months away from clin­i­cal tri­als.

Vac­cines ap­pear clos­er, with Mod­er­na and the NIH gun­ning for a clin­i­cal tri­al to start in the spring. How­ev­er, that us­es a tech­nol­o­gy that has yet to pro­duce an ap­proved vac­cine. Oth­er ef­forts, such as Glax­o­SmithK­line’s and Clover’s new part­ner­ship, are us­ing more tra­di­tion­al ap­proach­es but have longer time­lines.

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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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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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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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.

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.

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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