Bio­phar­ma's Chi­na plan gets a boost from patent pro­tec­tions sealed in now of­fi­cial trade deal

As in­ter­na­tion­al re­la­tions ex­perts con­tin­ue to cast skep­ti­cism on the “phase one” US-Chi­na trade deal signed Wednes­day, multi­na­tion­al drug­mak­ers found much to be cheer­ful about.

Specif­i­cal­ly, the doc­u­ment in­cludes three pro­vi­sions re­lat­ed to phar­ma­ceu­ti­cal patent dis­pute res­o­lu­tion, patent term ex­ten­sion and coun­ter­feit med­i­cines, promis­ing to strength­en pro­tec­tion for drugs at a time Chi­na’s reg­u­la­to­ry agency has sped up re­views and short­ened the time gap be­tween over­seas and Chi­nese OKs.

“The trade agree­ment has re­solved many long-con­tro­ver­sial is­sues,” Chang Lee, VP of con­sult­ing for the Asia Pa­cif­ic re­gion at the CRO Parex­el, told End­points News. “These changes all re­flect the un­prece­dent­ed pro­tec­tion of drug patents of in­no­v­a­tive drugs, and they are not a small step for­ward.”

For in­stance, he not­ed, one of the key re­view cri­te­ria for biotech IPOs in ei­ther Hong Kong or Chi­nese mar­kets. Any bio­phar­ma look­ing to raise mon­ey via that av­enue could ben­e­fit from the new rules.

The first pro­vi­sion, Ar­ti­cle 1.11, stip­u­lates that Chi­na would set up a mech­a­nism com­mon­ly known as patent link­age in the US, as es­tab­lished in the Hatch-Wax­man Act of 1984. Ac­cord­ing to LEK Con­sult­ing, it func­tions “much like a traf­fic con­trol sys­tem” in­volv­ing the FDA, the USP­TO and the court.

To set it up, Chi­na would need to en­sure three things:

  1. A patent hold­er or li­censee would be no­ti­fied when some­one is look­ing to mar­ket a gener­ic or biosim­i­lar dur­ing the patent term of their ap­proved prod­uct
  2. There is enough time and op­por­tu­ni­ty for the patent hold­er to seek reme­dies be­fore the mar­ket­ing of the al­leged­ly in­fring­ing prod­uct
  3. Pro­ce­dures for ju­di­cial or ad­min­is­tra­tive pro­ceed­ings are in place to re­solve the dis­putes in a time­ly man­ner

Fur­ther­more, ac­cord­ing to Ar­ti­cle 1.12 of the trade deal, Chi­na has com­mit­ted to ex­tend­ing patent terms for un­rea­son­able, lengthy de­lays that aren’t the ap­pli­cant’s fault. The com­pen­sa­tion will not ex­ceed 5 years and the re­sult­ing ef­fec­tive patent term — count­ing from the date of mar­ket­ing ap­proval in Chi­na — will be no more than 14 years.

Last­ly, Ar­ti­cle 1.18 prods Chi­na to take quick ac­tion against coun­ter­feit phar­ma­ceu­ti­cal prod­ucts in­clud­ing API, bulk chem­i­cals or bi­o­log­i­cal sub­stances. Among them is a re­quire­ment to share in­spec­tion in­for­ma­tion with the US and pub­lish da­ta on en­force­ment mea­sures on­line every year, “in­clud­ing seizures, re­vo­ca­tions of busi­ness li­cens­es, fines, and oth­er ac­tions.”

The crack­down on coun­ter­feit med­i­cines come amid in­creased FDA scruti­ny on Chi­nese man­u­fac­tur­ers af­ter a car­cino­gen scare forced a re­call on some com­mon heart pres­sure pills with API from Chi­na.

Fur­ther­more, Lee point­ed out, the deal al­lows su­u­ple­men­tal ex­per­i­men­tal da­ta, which was for­bid­den in the past — mean­ing drug­mak­ers can now add new ev­i­dence to sup­port con­sid­er­a­tion of their patents af­ter they first filed for it.

“Lit­er­al­ly, Ar­ti­cle 1.10 of the Agree­ment is a ma­jor ad­just­ment to the pre­vi­ous sup­ple­men­tary da­ta pol­i­cy,” he said. “This means that no mat­ter whether it is the ex­am­i­na­tion pro­ce­dure of the In­tel­lec­tu­al Prop­er­ty Of­fice, the re­view pro­ce­dure of the Re­ex­am­i­na­tion Board, or the ad­min­is­tra­tive pro­ce­dure, the paten­tee can sup­ple­ment the da­ta.”

On the oth­er end of the spec­trum are ma­jor phar­ma play­ers such as As­traZeneca and Bay­er, for whom Chi­na has be­come a “CEO-lev­el pri­or­i­ty” both for its mas­sive mar­ket and fer­tile ground for drug de­vel­op­ment.

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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Chart-top­ping ven­ture cash? Strong deal flow? In the month Covid-19 ripped around the globe? Yup

It turns out that even sending everyone from the CEO to rank-and-file staffers home to work in the middle of a Category 5 pandemic wasn’t enough to put a crimp in the flow of venture cash into biopharma. And even dealmaking held its own against the howling winds of misfortune — largely because a group of savvy players was quick to adjust to the new reality.

Our deal expert Chris Dokomajilar ran the numbers for us on a month-to-month basis and found that not only was venture money flowing during the panicky month of March, but it was also hitting home in record sums compared to the last 26 months of deal flow.

Say what?

As you can see in the top chart below, Dokomajilar outlined how the industry racked up $2.41 billion in total for March, just barely ahead of one other topper during the heady days of August 2018.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.