My­lan is in­creas­ing its pres­ence in Eu­rope with a high-dol­lar ac­qui­si­tion of a blood clot port­fo­lio.

The gener­ic drug­mak­er is pay­ing more than three-quar­ters of a bil­lion dol­lars to gob­ble up As­pen Phar­ma­care’s throm­bo­sis busi­ness on the con­ti­nent. The ex­act sum of €641.9 mil­lion, or about $757 mil­lion, will be divvied up in­to an up­front pay­ment of about 41% of the to­tal, with the re­main­ing be­ing de­ferred to next June.

Ra­jiv Ma­lik

Tues­day’s deal, which is ex­pect­ed to close at the end of 2020, “will not on­ly make My­lan the sec­ond largest sup­pli­er of these prod­ucts to pa­tients in Eu­rope, ac­cord­ing to IQVIA, but al­so bol­ster our ex­ist­ing com­mer­cial in­fra­struc­ture to fur­ther ex­pand ac­cess to com­plex in­jecta­bles,” My­lan pres­i­dent Ra­jiv Ma­lik said in a state­ment.

As­pen, a phar­ma­ceu­ti­cal com­pa­ny based in South Africa, will re­tain the li­cens­ing rights to its throm­bo­sis drugs in emerg­ing mar­kets. The drug­mak­er saw shares go up 6% in off-hour trad­ing, while My­lan stock perked up a lit­tle over 2%.

With the ac­qui­si­tion, My­lan gains ac­cess to an­ti­co­ag­u­lants sold un­der the brand names Ar­ix­tra, Frax­i­parine, Mono-Em­bolex and Or­garan, which net­ted a com­bined sales to­tal of about $272 mil­lion in the 12-month pe­ri­od end­ing June 2020. As­pen will be man­u­fac­tur­ing and sup­ply­ing the prod­ucts, where­as My­lan will ac­quire com­mer­cial­iza­tion rights and re­lat­ed in­tel­lec­tu­al prop­er­ty of the busi­ness.

That in­cludes prod­uct reg­is­tra­tions and mar­ket­ing au­tho­riza­tions, in ad­di­tion to buy­ing out the Eu­ro­pean port­fo­lio.

There isn’t ex­pect­ed to be any over­lap with this trans­ac­tion and the merg­er of My­lan and Pfiz­er-spin­out Up­john, ini­ti­at­ed in Ju­ly 2019. That deal is al­so ex­pect­ed to close be­fore 2020 is out, My­lan said Tues­day, and will in­volve re­nam­ing the com­bined com­pa­ny to Vi­a­tris.

The merg­er orig­i­nal­ly came to­geth­er af­ter the US gener­ics mar­ket saw loss­es in re­cent years due to com­pe­ti­tion from man­u­fac­tur­ers in low­er- and mid­dle-in­come coun­tries like In­dia. Larg­er gener­ic drug­mak­ers had been con­sol­i­dat­ing, hop­ing the ex­tra cash could al­low fur­ther in­vest­ment and stave off the oth­er copy­cats. In 2018, In­dia’s Au­robindo Phar­ma bought parts of No­var­tis’ gener­ics unit for $1 bil­lion, and in 2015, Te­va swal­lowed Al­ler­gan’s gener­ic busi­ness for $40.5 bil­lion.

At the time, some an­a­lysts such as Cowen’s Ken Cac­cia­tore did not be­lieve the My­lan-Up­john deal would solve any­thing. Though he had “long felt that stand­alone My­lan was ab­solute­ly bro­ken,” the es­ti­mat­ed rev­enue from Vi­a­tris came in un­der his own pro­jec­tions.

“This on­ly adds con­vic­tion to our orig­i­nal the­sis that this merg­er will solve noth­ing, and that the pres­sure and neg­a­tive view of the com­bi­na­tion will like­ly on­ly in­crease in­to the even­tu­al close,” he wrote.

Up­john had been based in Shang­hai to pro­duce drugs for emerg­ing mar­kets, and once in­clud­ed knock­offs of block­buster prod­ucts such as Lip­i­tor, Vi­a­gra and Lyri­ca.

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.