Róbert Wessman, Alvotech CEO

Alvotech rais­es $137M months af­ter FDA re­ject­ed Hu­mi­ra biosim­i­lar

Alvotech has com­plet­ed a pri­vate place­ment worth $137 mil­lion at $11.57 per share di­rect­ed on­ly in­to Ice­land, a lit­tle over a month af­ter an­nounc­ing a pri­vate place­ment to pay off a loan to Alvo­gen.

The biosim­i­lar com­pa­ny has been on the hunt for cash in the last few months, com­plet­ing two pri­vate place­ments as well as a fa­cil­i­ty loan in No­vem­ber that se­cured $136 mil­lion.

The place­ment for “pro­fes­sion­al clients or el­i­gi­ble coun­ter­par­ties” was tak­en from trea­sury shares held by Alvotech’s sub­sidiary, Alvotech Man­co, the com­pa­ny an­nounced Mon­day. The in­flux of cash will be used for “gen­er­al cor­po­rate pur­pos­es.”

In De­cem­ber, Alvotech com­plet­ed an­oth­er pri­vate place­ment of $70 mil­lion of bonds to pay off a $50 mil­lion un­se­cured sub­or­di­nat­ed loan from Alvo­gen.

Alvotech hit a snag in Sep­tem­ber when the FDA sent along a re­jec­tion let­ter for the com­pa­ny’s Hu­mi­ra biosim­i­lar, cit­ing “cer­tain de­fi­cien­cies re­lat­ed to the Reyk­javik fa­cil­i­ty and stat­ed that sat­is­fac­to­ry res­o­lu­tion of the de­fi­cien­cies is re­quired be­fore FDA may ap­prove.” Alvotech part­nered with Te­va for com­mer­cial­iza­tion in the US.

Ice­landic bil­lion­aire and Alvotech founder Róbert Wess­man pre­vi­ous­ly sang the prais­es of the com­pa­ny’s abil­i­ty to be the first to get fil­ing ac­cep­tance with the FDA in the US with a high­er-con­cen­trat­ed biosim­i­lar of Ab­b­Vie’s Hu­mi­ra. But com­pe­ti­tion would be fierce; the FDA has al­ready ap­proved biosim­i­lars to Hu­mi­ra.

The FDA’s 483 for the Reyk­javik fa­cil­i­ty list­ed sev­er­al prob­lems af­ter it was in­spect­ed in March. The FDA found that the fa­cil­i­ty had a lack of pro­ce­dur­al con­trols to en­sure that in­com­ing ma­te­ri­als were prop­er­ly qual­i­fied, and that the fa­cil­i­ty couldn’t pre­vent bac­te­ria and mold. The FDA told the com­pa­ny an­oth­er in­spec­tion would be done in the first quar­ter of 2023 and the date for an ap­proval de­ci­sion on Alvotech’s li­cense ap­pli­ca­tion for AVT02, the Hu­mi­ra biosim­i­lar, is April of this year. An ap­proval of the li­cense is con­tin­gent on a pos­i­tive rein­spec­tion.

AVT02 has al­ready re­ceived mar­ket­ing ap­proval in 35 coun­tries with a Ju­ly 1 li­cense en­try date in the US.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.