Cy­tori bags Aza­ya drugs in as­set pur­chase; Wood­ford of­fers a mea cul­pa on North­west Bio

• Cy­tori is adding a pair of on­col­o­gy drugs to its port­fo­lio with the ac­qui­si­tions of as­sets from San An­to­nio-based Aza­ya. Aza­ya has been at work on nanopar­ti­cle drugs. Their lead pro­gram is re­served for ATI-0918, “an off-patent, com­plex, gener­ic nanopar­ti­cle li­po­so­mal for­mu­la­tion of dox­oru­bicin hy­drochlo­ride, a wide­ly used chemother­a­peu­tic agent of­ten used to treat breast can­cer, ovar­i­an can­cer, mul­ti­ple myelo­ma, and Ka­posi’s sar­co­ma.” Cy­tori is pay­ing $2 mil­lion in stock and pay­ing off a cou­ple of mil­lion in debt. Aza­ya al­so stands to gain up to $166 mil­lion for a va­ri­ety of mile­stones and deal con­tin­gen­cies. Cy­tori says AI-0918 could be ready for launch in Eu­rope in 2019, if every­thing works out.

Neil Wood­ford

• Neil Wood­ford’s Wood­ford Pa­tient Cap­i­tal Trust con­tin­ues to apol­o­gize for blun­der­ing in­to a bad bet on North­west Bio $NWBO. Here’s the lat­est from Mitchell Fras­er-Jones: “We are of­ten asked what went wrong with this in­vest­ment and what lessons have we learned. As Neil said at the an­nu­al gen­er­al meet­ing back in May last year, the de­ci­sion to in­vest in North­west Bio­ther­a­peu­tics was an er­ror of judg­ment. We were ini­tial­ly at­tract­ed to the com­pa­ny’s unique tech­nol­o­gy. From the out­set, we were aware of the po­ten­tial gov­er­nance is­sues but we un­der­es­ti­mat­ed their ex­tent. Fur­ther­more, we over­es­ti­mat­ed our abil­i­ty to in­flu­ence change at the com­pa­ny. We will al­ways do every­thing that we can to en­sure pos­i­tive long-term out­comes for our in­vestors, but this case study sug­gests that it is not al­ways enough. The gov­er­nance is­sues at North­west Bio­ther­a­peu­tics have con­tin­ued to con­spire to shred in­vestor con­fi­dence in the busi­ness.”

• The FDA has for­mal­ly kicked off its On­col­o­gy Cen­ter of Ex­cel­lence un­der Richard Paz­dur, which will co­or­di­nate re­views for all can­cer drugs, bi­o­log­ics and de­vices.

 

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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