Car­lyle Group in­jects $260M in­to a lead­ing car­dio play­er in Chi­na, grab­bing a seat at the deals ta­ble

The Car­lyle Group is in­vest­ing $260 mil­lion to grab a mi­nor­i­ty stake in Shen­zhen Salu­bris Phar­ma­ceu­ti­cal, a sto­ried gener­ic mak­er that’s in­creas­ing­ly in­vest­ing in new drug R&D.

The cash is good for a 5% stake in Shen­zhen-list­ed Salu­bris, giv­ing the pri­vate eq­ui­ty play­er ac­cess to a port­fo­lio of treat­ments and de­vices in the car­dio­vas­cu­lar, on­col­o­gy and an­ti-in­fec­tive ar­eas. As the Chi­nese gov­ern­ment’s re­im­burse­ment re­forms spur con­sol­i­da­tion in the gener­ic drug mar­ket, some play­ers are poised to gain mar­ket share, Car­lyle not­ed in a state­ment.

While Salu­bris’ rev­enues have his­tor­i­cal­ly been dri­ven by sales of main­stays like the blood thin­ners clopi­do­grel and bi­valirudin, the com­pa­ny’s been up­ping its bet on ear­ly-stage drug de­vel­op­ment.

That means in-li­cens­ing enar­o­du­s­tat, a hy­pox­ia-in­ducible fac­tor pro­lyl hy­drox­y­lase (HIF-PH) in­hibitor, from Japan’s JT; tak­ing the lead on back­ing Virac­ta, a biotech work­ing on vi­ral-as­so­ci­at­ed can­cers; as well as push­ing through in­ter­nal­ly dis­cov­ered can­di­dates, in­clud­ing an an­giotensin re­cep­tor-NEP in­hibitor and a re­com­bi­nant fu­sion pro­tein for heart fail­ure.

Lever­ag­ing Car­lyle’s ex­per­tise, net­work and re­sources, Salu­bris says it is look­ing to ex­pand both do­mes­ti­cal­ly and glob­al­ly — with plans to do more tri­als over­seas. M&A is al­so on the ta­ble.

For Car­lyle, it’s a chance to tap in­to “one of the strongest fran­chis­es” in the car­dio- and cere­brovas­cu­lar (CCV) seg­ment in Chi­na, said Ling Yang, a man­ag­ing di­rec­tor of the Car­lyle Asia Buy­out ad­vi­so­ry team. Salu­bris is now the sec­ond largest do­mes­tic com­pa­ny in the space, ac­cord­ing to Car­lyle.

The firm boasts of long-stand­ing op­er­a­tions in Chi­na built over 20 years, in­vest­ing more than $9.5 bil­lion worth of eq­ui­ty as it en­tered the sec­ond half of 2020.

More promi­nent in its Chi­na deal streak are the in­vest­ments in the pep­tide API man­u­fac­tur­er Am­bio and the clin­i­cal lab­o­ra­to­ry Adi­con, among oth­er moves in medtech and health­care.

Glob­al­ly, Car­lyle — which has re­cruit­ed re­tired Pfiz­er chief Ian Read to be a deal scout — has been known for its role as a ma­jor in­vestor in con­tract re­search or de­vel­op­ment/man­u­fac­tur­ing or­ga­ni­za­tions, in­clud­ing PPD and AM­RI. Most re­cent­ly it struck a deal with In­dia’s Pi­ra­mal Phar­ma to pur­chase around 20% of its shares for $490 mil­lion.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.