Ery­tech shares soar on pos­i­tive re­sults for PhI­Ib pan­cre­at­ic can­cer tri­al; Ar­Qule’s tivan­ti­nib fails yet again in PhI­II can­cer study

→ France’s Ery­tech Phar­ma says it gar­nered pos­i­tive da­ta in a Phase IIb study of eryas­pase com­bined with chemo for sec­ond-line metasta­t­ic pan­cre­at­ic can­cer, send­ing shares $ERYP rock­et­ing up 75%. The drug hits its co-pri­ma­ry end­points with sig­nif­i­cant im­prove­ments for pro­gres­sion-free sur­vival as well as over­all sur­vival. Pas­cal Ham­mel, prin­ci­pal in­ves­ti­ga­tor of the study, com­ment­ed: “These re­sults gen­er­at­ed by eryas­pase in com­bi­na­tion with the stan­dard of care are high­ly en­cour­ag­ing and com­pare fa­vor­ably to gem­c­itabine or FOL­FOX treat­ment ad­min­is­tered alone. The re­sults of this study sup­port eryas­pase as a po­ten­tial treat­ment op­tion for pa­tients with metasta­t­ic pan­cre­at­ic can­cer in the sec­ond-line set­ting.”

→ You can score an­oth­er flop for Ar­Qule’s tivan­ti­nib. The biotech and its part­ners at Ky­owa Hakko say that the drug failed a Phase III study for 190 Japan­ese pa­tients with c-Met di­ag­nos­tic-high in­op­er­a­ble he­pa­to­cel­lu­lar car­ci­no­ma. That like­ly came as no great sur­prise to the biotech’s al­ready dis­ap­point­ed in­vestors, who had to deal with an­oth­er Phase III bomb for the same drug in liv­er can­cer back in Feb­ru­ary. That fail­ure fol­lowed tri­al set­backs in 2013 and 2012.

→ In­di­an CRO Mi­cro Ther­a­peu­tic Re­search Labs has been busy mis­rep­re­sent­ing study da­ta while mis­han­dling doc­u­men­ta­tion re­lat­ed to hun­dreds of gener­ic drugs now on the mar­ket, and the EMA wants to jerk them off phar­ma­cy shelves un­til reg­u­la­tors can get a han­dle on the sit­u­a­tion. The EMA says that da­ta from a 4-year stretch are un­re­li­able and wants to see new bioe­quiv­a­lence da­ta be­fore re­turn­ing sus­pect drugs to the mar­ket. Any gener­ics now un­der re­view from the CRO should be shelved.

→ Shares of Im­pax Lab­o­ra­to­ries $IPXL shot up 20% this morn­ing, af­ter the com­pa­ny named Paul M. Bis­aro as its pres­i­dent and CEO, ef­fec­tive March 27. Bis­aro will suc­ceed J. Kevin Buchi, who has served as in­ter­im CEO since De­cem­ber of 2016. Bis­aro, the for­mer CEO at Ac­tavis, is a high-pro­file ex­ec in the in­dus­try. Im­pax was caught up in a price-fix­ing probe last fall.

As­traZeneca’s Tagris­so, a bright spot in the phar­ma gi­ant’s can­cer fran­chise, has won ap­proval in Chi­na.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it's free.

Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

Read the full sponsored article

Please signup to continue — it's fast and free. This article is sponsored by Catalent and produced by Endpoints Studio.

Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it's free.

Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it's free.

vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.