Aspen CEO Stephen Saad (L) and South Africa Minister of Trade Ebrahim Patel

Rid­ing Covid-19 high, As­pen plans new ad­di­tions at South African pro­duc­tion site

Changes are com­ing to As­pen Phar­ma­care’s plant in Gqe­ber­ha, South Africa.

The com­pa­ny will open the largest anes­thet­ics man­u­fac­tur­ing line in the south­ern hemi­sphere at the same site that it fills and pack­ages the J&J Covid-19 vac­cine, the com­pa­ny’s CEO Stephen Saad told re­porters Mon­day.

The ex­pan­sion could gen­er­ate an­oth­er $542 mil­lion in rev­enue a year. In 2018, As­pen start­ed man­u­fac­tur­ing drugs for late-stage can­cer, au­toim­mune ill­ness­es and Parkin­son’s dis­ease. Just last year, it start­ed fill-fin­ish op­er­a­tions for the J&J jab.

“This fa­cil­i­ty will help en­sure no African is ever de­nied these treat­ments like anes­thet­ics and vac­cines again,” Saad said. “We thank J&J for giv­ing us the ca­pa­bil­i­ty to cre­ate our own man­u­fac­tur­ing fa­cil­i­ties. So we’ve been able to pro­duce vac­cines in Africa and now to al­so bring anes­thet­ics home.”

The move will al­low the com­pa­ny to slide in­to vac­cine pro­duc­tion, and shift away from gener­ic med­i­cines. As­pen’s cur­rent­ly en­gaged in talks with J&J to ful­ly man­u­fac­ture the Covid-19 jab, Bloomberg re­ports. It’s cur­rent­ly in the fi­nal stages of the fill and fin­ish deal.

The com­pa­ny al­so will ramp up its Covid-19 ca­pac­i­ty to 1.3 bil­lion dos­es a year by Feb­ru­ary 2024, Saad told Reuters on Mon­day. That would re­quire a tremen­dous amount of ramp up, as the com­pa­ny’s cur­rent out­put is some­where around 250 mil­lion dos­es.

“We have got an ab­solute com­mit­ment to 700 mil­lion dos­es till Feb­ru­ary 2023 … with­in a year af­ter that, we could get (to) 1.3 bil­lion dos­es,” Saad said to Reuters at the open­ing of As­pen’s fa­cil­i­ty at Gqe­ber­ha.

Ebrahim Pa­tel, the min­is­ter of trade and in­dus­try, said that 100% of the vac­cines pro­duced at As­pen’s site will stay in Africa from Sep­tem­ber, on.

The com­pa­ny was a part of some neg­a­tive head­lines in Au­gust, at no fault of its own. De­spite re­ceiv­ing a $200 mil­lion in­vest­ment from Pres­i­dent Joe Biden’s ad­min­is­tra­tion to up pro­duc­tion on the con­ti­nent, the New York Times re­port­ed that much of the vac­cines pro­duced at the site were ac­tu­al­ly ex­port­ed to Eu­rope, as J&J cap­i­tal­ized on a stip­u­la­tion in a con­tract that re­quired South Africa to waive its right to ex­port re­stric­tions. All this was hap­pen­ing as Africa had just 2% of its peo­ple vac­ci­nat­ed, com­pared with 60% of all adults in Eu­rope. J&J’s vac­cine is ben­e­fi­cial in Africa, par­tic­u­lar­ly the rur­al parts, be­cause it is a sin­gle shot, mak­ing it eas­i­er for those who have to trav­el long dis­tances to be­come ful­ly in­oc­u­lat­ed.

The African Union has or­dered 400 mil­lion dos­es for its coun­tries, but few have ar­rived so far. South Africa has hand­ed out just 2 mil­lion of its 31 mil­lion dos­es.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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