Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has of­fi­cial­ly come up short in its bid to de­vel­op a mi­graine patch.

The FDA re­ject­ed the com­pa­ny’s ap­pli­ca­tion to re­pur­pose the trip­tan zolmitrip­tan in a new de­liv­ery sys­tem as Qtryp­ta, Zosano said Wednes­day morn­ing, is­su­ing a CRL for the mi­cronee­dle patch. Reg­u­la­tors cit­ed in­con­sis­tent ex­po­sure lev­els across mul­ti­ple clin­i­cal tri­als as the main rea­son for the thumbs down.

Steven Lo

In­vestors did not take too kind­ly to the news, with Zosano shares plunk­ing down around 25%. The com­pa­ny is re­quest­ing a Type A meet­ing to “pro­vide clar­i­ty on the next steps for the pro­gram,” CEO Steven Lo said in a state­ment.

Wednes­day’s re­jec­tion may have al­ready been in the cards for Zosano, as the com­pa­ny not­ed last month that the FDA is­sued a dis­ci­pli­nary let­ter cit­ing high plas­ma con­cen­tra­tion lev­els of zolmitrip­tan in five pa­tients. At the time, Zosano not­ed in a press re­lease that ap­proval for the drug was “not ex­pect­ed.”

Those con­cerns were again list­ed in the CRL, ul­ti­mate­ly mud­dy­ing the wa­ters to in­ter­pret the drug’s safe­ty da­ta. To rec­ti­fy the sit­u­a­tion, the FDA rec­om­mend­ed that Zosano con­duct a re­peat bioe­quiv­a­lence study be­tween three of the lots used dur­ing de­vel­op­ment.

Reg­u­la­tors added in their let­ter that they were un­able to ex­am­ine Qtryp­ta’s man­u­fac­tur­ing line due to re­stric­tions on gov­ern­ment trav­el, Zosano said, but will con­duct such eval­u­a­tions should the com­pa­ny re-sub­mit its ap­pli­ca­tion.

Zosano’s ap­pli­ca­tion for Qtryp­ta was based on a Phase II/III tri­al com­plet­ed in 2017. That study met both its co-pri­ma­ry end­points, with 41.5% of pa­tients treat­ed with the 3.8 mg dose of Qtryp­ta achiev­ing pain free­dom at 2 hours and 68.3% re­port­ing free­dom from their most both­er­some symp­tom al­so at 2 hours.

In a long-term safe­ty study, Zosano said 95% of side ef­fects were mild, and more than 80% re­solved with­in 48 hours. Less than 2% of pa­tients re­port­ed trip­tan-like neu­ro­log­i­cal side ef­fects typ­i­cal­ly found in the class, such as dizzi­ness and pares­the­sia.

Qtryp­ta it­self is a re­for­mu­la­tion of zolmitrip­tan, de­liv­ered through ti­ta­ni­um nee­dles coat­ed with the drug.

Zosano has had a rocky his­to­ry af­ter rais­ing $50 mil­lion for an IPO at the be­gin­ning of 2015. Soon af­ter de­but­ing, the com­pa­ny’s $11 share price was shred­ded when its two big part­ners — Eli Lil­ly and No­vo Nordisk — both pulled out of their col­lab­o­ra­tions. Though the piv­otal Phase III for Qtryp­ta dou­bled Zosano’s stock af­ter the read­out, the com­pa­ny has been in the pen­ny stock range for most of 2020.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Eiger nabs the first FDA ap­proval for Prog­e­ria, an ul­tra-rare pre­ma­ture ag­ing dis­ease, with an old Mer­ck drug

Eiger BioPharmaceuticals $EIGR has received an FDA OK for a drug Merck licensed to them at no cost — and now reportedly plans to charge a level consistent with other ultra-rare disease medicines.

The biotech announced Friday evening that regulators had approved lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome, also known as Progeria, as well as some progeroid laminopathies in children older than one year. It’s the first approval granted for the condition, and the drug will be marketed and sold as Zokinvy.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.