Less than a month af­ter pub­lish­ing pos­i­tive long-term da­ta for an ex­per­i­men­tal gene ther­a­py, Or­chard Ther­a­peu­tics has qui­et­ly ter­mi­nat­ed its li­cens­ing agree­ment over the pro­gram.

In an 8-K fil­ing to the SEC last Fri­day, Or­chard re­port­ed that it is end­ing the li­cense re­lat­ed to its OTL-101 can­di­date, in de­vel­op­ment to treat adeno­sine deam­i­nase se­vere com­bined im­mun­od­e­fi­cien­cy or ADA-SCID, known col­lo­qui­al­ly as “bub­ble boy syn­drome.” It’s a rare ge­net­ic dis­ease where pa­tients have al­most no im­mune sys­tem what­so­ev­er.

The move comes af­ter Or­chard pub­lished long-term re­sults in the New Eng­land Jour­nal of Med­i­cine show­ing all 50 pa­tients who re­ceived the treat­ment were still alive af­ter at least two years. Event-free sur­vival was al­so high, with 97% of US pa­tients and 95% of UK par­tic­i­pants not need­ing to re­turn to pri­or ther­a­pies.

Or­chard had been de­vel­op­ing the ther­a­py af­ter sign­ing the agree­ment with UCLA and Uni­ver­si­ty Col­lege Lon­don back in Feb­ru­ary 2016. The biotech has an­oth­er ther­a­py for ADA-SCID known as Strimvelis, ap­proved in Eu­rope in 2016, but halt­ed dos­ing af­ter a pa­tient treat­ed un­der com­pas­sion­ate use be­gan see­ing treat­ment for leukemia.

The idea be­hind OTL-101 is to use a lentivirus with hematopoi­et­ic stem cells, ad­min­is­tered ex vi­vo, to in­sert a func­tion­al copy of the ADA gene in­to pa­tients’ cells. Or­chard had been look­ing for an ap­proval for a while, hav­ing pre­vi­ous­ly won break­through ther­a­py des­ig­na­tion for OTL-101 from the FDA.

An FDA green­light had elud­ed Or­chard with the Covid-19 pan­dem­ic forc­ing them to push back plans to sub­mit a rolling ap­proval ap­pli­ca­tion. But last week’s SEC re­port may have been in the works for at least a year.

Back in May 2020, Or­chard an­nounced a new op­er­a­tional strat­e­gy in­volv­ing lay­ing off 25% of its staff and re­struc­tur­ing its pipeline to fo­cus less on rare dis­eases. Part of that re­struc­tur­ing, Or­chard said at the time, was to re­duce in­vest­ment in OTL-101 and an­oth­er pro­gram — steer­ing re­sources in­stead to­ward four oth­er can­di­dates clas­si­fied as “top near-term pri­or­i­ties.”

The pro­grams in­volved are be­ing set up to treat: metachro­mat­ic leukody­s­tro­phy (OTL-200), Wiskott-Aldrich syn­drome (OTL-103), Mu­copolysac­cha­ri­do­sis type I (OTL-203) and Mu­copolysac­cha­ri­do­sis type II­IA, al­so known as San­fil­ip­po syn­drome type A (OTL-201).

Or­chard went pub­lic in 2018, rid­ing a $200 mil­lion IPO af­ter two oth­er nine-fig­ure rounds with a $110 mil­lion Se­ries B and $150 mil­lion Se­ries B. The biotech worked with Glax­o­SmithK­line, too, ac­quir­ing the Big Phar­ma’s rare dis­ease unit — in­clud­ing Strimvelis — in ex­change for rough­ly 20% eq­ui­ty, al­so in 2018. The lack of an FDA-ap­proved prod­uct at this stage, how­ev­er, has left an­a­lysts with ques­tions.

So­cial im­age: Bob­by Gas­par, Or­chard Ther­a­peu­tics CEO

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.