Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a pub­lic health cri­sis (think Ebo­la, Zi­ka) spurred by a rogue pathogen trig­gers a small-biotech ral­ly, as drug­mak­ers emerge from the wood­work with am­bi­tious plans to treat the mount­ing out­break. In most cas­es, that en­thu­si­asm nev­er quite de­liv­ers.

Things are no dif­fer­ent, as the coro­n­avirus out­break in Wuhan, Chi­na takes hold. There have been close to 300 con­firmed hu­man in­fec­tions in Chi­na, and at least four deaths. Coro­n­avirus­es are a large fam­i­ly of virus­es, which in­clude MERS and SARS. On Tues­day, the CDC re­port­ed the virus was de­tect­ed in a US trav­el­er re­turn­ing from Wuhan.

Shares of Mary­land-based vac­cine de­vel­op­er, No­vavax, which has seen a steady stream of set­backs with its RSV vac­cine and is cur­rent­ly in late-stage de­vel­op­ment with a flu vac­cine, saw its shares $NVAX cat­a­pult on Tues­day — clos­ing up more than 71% at $9.82. The com­pa­ny’s tech­nol­o­gy has al­so been used to de­vel­op ex­per­i­men­tal vac­cines for MERS and SARS.

In an email to End­points News on Wednes­day, the com­pa­ny said it ex­pects to de­vel­op a vac­cine can­di­date from the ge­net­ic se­quence of the Wuhan coro­n­avirus. The stock was down near­ly 16% at $8.25 on Wednes­day morn­ing, af­ter the drug­mak­er al­so dis­closed plans to sell $100 mil­lion worth of shares in a pub­lic of­fer­ing af­ter the mar­ket closed on Tues­day.

Mean­while, mR­NA-fo­cused Mod­er­na al­so un­veiled its plans on Wednes­day. The com­pa­ny is­sued a state­ment say­ing it is work­ing with NIH’s vac­cine re­search cen­ter on a po­ten­tial vac­cine re­sponse to the cur­rent pub­lic health emer­gency. Shares of the Cam­bridge, Mass­a­chu­sets-based de­vel­op­er $MR­NA — which pulled off a his­toric $604 mil­lion IPO in late 2018 — were up near­ly 9% at 22.80.

“Mar­kets tend to bot­tom with the peak in new cas­es and news flow,” JP Mor­gan an­a­lysts said, as cit­ed by Mar­ket­Watch. “A pos­i­tive bias is ap­pro­pri­ate on phar­ma stocks broad­ly and mak­ers of di­ag­nos­tic kits and pro­tec­tive equip­ment (like gloves).”

An­tho­ny Fau­ci NI­AID

Ther­a­peu­tics will like­ly make the cut be­fore vac­cines do, An­tho­ny Fau­ci, di­rec­tor of NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID), sug­gest­ed in an in­ter­view with Bio­Cen­tu­ry.

The agency plans to in­ves­ti­gate the ef­fi­ca­cy of ex­ist­ing an­tivi­rals and mon­o­clon­al an­ti­bod­ies, as well as de­vel­op a ther­a­py us­ing an­ti­bod­ies de­rived from blood drawn from a pa­tient di­ag­nosed in the state of Wash­ing­ton (the trav­el­er) to fight the Chi­na coro­n­avirus strain, he said in the re­port.

Oth­er biotech stocks al­so rose as new coro­n­avirus cas­es came to light.

Shares of a de­vel­op­er of nano-med­i­cines for vi­ral in­fec­tions, NanoVi­ri­cides, jumped more than 150% on Tues­day, but the shares $NNVC pared gains on Wednes­day, falling more than 52% to $4.07. Aethlon Med­ical $AEMD, a de­vice mak­er de­vel­op­ing a he­mo­p­u­ri­fi­er to com­bat vi­ral dis­eases, jumped more than 15% to $2.6. Shares of In­ovio Phar­ma­ceu­ti­cals $INO — which is work­ing on a MERS vac­cine — al­so ticked high­er on Tues­day, al­though the stock was in the red on Wednes­day. BioCryst Phar­ma­ceu­ti­cals, which is de­vel­op­ing a yel­low fever and Mar­burg virus drug that has shown ear­ly promise in coro­n­avirus­es, al­so saw its shares $BCRX rise about 5.5% to $3.09 on Wednes­day.

Max­im Ja­cobs, man­ag­ing ed­i­tor of in­vest­ment re­search firm Edi­son, sug­gest­ed the out­cry over coro­n­avirus­es was mis­placed.

Source: Twit­ter, 2020

Click on the im­age to see the full-sized ver­sion

Coro­n­avirus­es typ­i­cal­ly cir­cu­late among an­i­mals, such as camels, cats, and bats. Rarely, there is an­i­mal-to-per­son trans­mis­sion, as is sus­pect­ed in the Wuhan out­break. Many pa­tients af­flict­ed in Chi­na were linked to a large seafood and an­i­mal mar­ket, al­though there are cas­es where pa­tients were not ex­posed to the mar­ket at all, which sug­gests there is “lim­it­ed per­son-to-per­son spread…though it’s un­clear how eas­i­ly or sus­tain­ably this virus is spread­ing be­tween peo­ple,” the CDC said.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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