No­var­tis swoops in to bag Se­lexys and its sick­le cell drug in $665M deal

Bruno St­rig­i­ni, CEO No­var­tis On­col­o­gy

What­ev­er Ok­la­homa City-based Se­lexys Phar­ma­ceu­ti­cals just saw in its new­ly-wrapped Phase II study for sick­le cell dis­ease, the da­ta must have been im­pres­sive. Phar­ma gi­ant No­var­tis has stepped in and closed the loop on its 2012 buy­out op­tion, bag­ging the com­pa­ny in a deal val­ued at up to $665 mil­lion.

The ob­ject of No­var­tis’s de­sire is SelG1, an an­ti-P-se­lectin an­ti­body de­signed to slash the num­ber of va­so-oc­clu­sive pain crises pa­tients with sick­le cell dis­ease suf­fer. In­ves­ti­ga­tors will re­lease the de­tails on the mid-stage da­ta at ASH in ear­ly De­cem­ber.

These pain crises oc­cur as the sick­le-shaped red blood cells of pa­tients ob­struct the flow of blood through blood ves­sels.

For No­var­tis, the fol­low through to buy the com­pa­ny ex­pands its fo­cus on hema­tol­ogy and blood dis­eases. It al­so adds to the phar­ma gi­ant’s late-stage pipeline as No­var­tis works to con­vince in­vestors that it has the ex­per­i­men­tal prod­ucts need­ed to boost its rev­enues. But the sin­gle-as­set fo­cus and rel­a­tive­ly small deal terms won’t change any­one’s mind about its near-term prospects.

The buy­out is al­so good for MPM Cap­i­tal, which pro­vid­ed a $23 mil­lion round to Se­lexys at the same time the biotech com­plet­ed its deal with No­var­tis in 2012.

It’s rare to see any biotech com­pa­nies in Ok­la­homa, far from the beat path in biotech re­search cir­cles. And the play­ers wast­ed no time in elim­i­nat­ing its on­line foot­print. Click­ing on the com­pa­ny web site this morn­ing takes you straight to No­var­tis.

“Sick­le cell dis­ease af­fects mil­lions of peo­ple around the world and there are lim­it­ed ther­a­pies avail­able for treat­ment of va­so-oc­clu­sive pain crises, a very com­mon com­pli­ca­tion of the dis­ease,” said Bruno St­rig­i­ni, CEO of No­var­tis On­col­o­gy. “With this ac­qui­si­tion, No­var­tis is able to lever­age its lead­er­ship in hema­tol­ogy re­search to ad­vance de­vel­op­ment of a po­ten­tial new treat­ment op­tion for pa­tients liv­ing with this de­bil­i­tat­ing con­di­tion.”

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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