Long the bane of the FDA’s ex­is­tence, com­pound­ing phar­ma­cies have seen a mi­nor resur­gence in the past year as short-term sav­iors for hos­pi­tal drug short­ages. Now, a 503(b) com­pa­ny spe­cial­iz­ing in hos­pi­tal meds has earned a big backer to keep ex­pand­ing its 200-drug strong port­fo­lio.

Alex Chi

Gold­man Sachs and Owl Rock Cap­i­tal Part­ners have doled out a $275 mil­lion debt loan to Qu­Va Phar­ma, a 503(b)-cer­ti­fied out­sourc­ing fa­cil­i­ty pro­vid­ing com­pound­ed drugs to hos­pi­tals, the com­pa­ny said Thurs­day.

The com­pa­ny sports Bain Cap­i­tal as a share­hold­er and will use the pro­ceeds from the loan to ex­pand its net­work of part­nered hos­pi­tals and add new prod­ucts to grow its more than 200-prod­uct port­fo­lio, ac­cord­ing to a state­ment. Mean­while, the com­pa­ny plans to add up to 75,000 square feet of space at its Sug­ar Land, TX site south­west of Hous­ton by 2022, it said.

“We be­lieve Qu­Va of­fers a com­pelling val­ue propo­si­tion to hos­pi­tals in need of a re­li­able, cost-ef­fec­tive sup­ply of es­sen­tial in­jectable med­ica­tion,” said Alex Chi, Gold­man Sachs’ head of pri­vate cred­it in­vest­ing group in the Amer­i­c­as, in a state­ment.

Qu­Va re­cent­ly added 80,000 square feet of floor space in New Jer­sey, bring­ing the com­pa­ny’s to­tal foot­print be­fore the Texas ex­pan­sion to 240,000 square feet. With all the new el­bow room, Qu­Va said it hopes to bring its to­tal work­force to more than 1,000 as well as “im­ple­ment in­no­v­a­tive au­toma­tion ini­tia­tives unique to the in­dus­try” at its sites.

Long a tar­get for FDA reg­u­la­tors over the con­sis­ten­cy of the drugs they pro­duce, com­pound­ing phar­ma­cies have seen a turn of for­tune dur­ing the pan­dem­ic as hos­pi­tal sys­tems have looked for a con­stant sup­ply of drugs. Com­pa­nies in the 503(b) pro­gram have far more over­sight — and ac­cep­tance — than a stan­dard com­pound­ing phar­ma­cy with the FDA re­quir­ing them to sell specif­i­cal­ly to health­care sys­tems for of­fice use.

Back in April 2020, the FDA loos­ened its no­to­ri­ous­ly tight re­stric­tions on the com­pound­ing in­dus­try in the ear­ly days of the pan­dem­ic, al­low­ing hos­pi­tals to source med­i­cines di­rect­ly from those firms. It was an un­prece­dent­ed de­ci­sion the FDA at the time said was tied di­rect­ly to chron­ic short­ages.

Stu­art Hinchen

Those short­ages have high­light­ed the need for a sta­ble sup­ply of cheap med­i­cines, par­tic­u­lar­ly anes­thet­ics used in sur­gi­cal care, and pri­vate in­dus­try has seen enough, ap­par­ent­ly, to jump on board.

“This new fund­ing re­flects the na­tion­al scale Qu­Va has achieved as the in­dus­try leader, and the im­por­tance of the 503B in­dus­try in meet­ing hos­pi­tal’s high qual­i­ty stan­dards and cost ef­fec­tive­ness re­quire­ments,” Stu­art Hinchen, Qu­Va Phar­ma’s co-founder and CEO, said in a state­ment.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

The discovery arm of the healthcare investment player Deerfield Management Company is getting a major financial boost.

Deerfield Discovery and Development will receive $25 million, over five years, from the state of New York and Empire State Development, a state organization that offers grants, loans and other assistance to companies. Another $25 million will come from Deerfield Management.

The funds will go toward the buildout of a 6,000-square-foot lab space at Cure, a healthcare campus founded by Deerfield at 345 Park Ave. South in New York City. The money will also be used for purchasing equipment and software, operating costs and other items.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.