Friday Five – the pharma week in review

Ref: Friday Five Desk

GlaxoSmithKline doubles down in oncology deal-making

GlaxoSmithKline's push to reassert itself as a key player in the oncology market has continued with a deal to in-license Merck KGaA's bifunctional cancer therapy M7824.

This is a product we have been watching closely for the past two years and one which Merck KGaA has bullishly predicted could exceed the bar set by PD-1 inhibitors. To its credit, a head to -head study against Merck & Co.'s Keytruda is already under way in first-line non-small-cell lung cancer (NSCLC).

Latest Q4 results

Speaking of which, quarterly Keytruda sales exceeded $2 billion for the first time in Q4 2018, setting up an impressive set of results for Merck & Co.

Elsewhere Gilead Sciences found its shares under pressure, owing partly to a Q4 profit miss. The company also announced an impairment charge of $820 million in the quarter related to a now scrapped BCMA CAR-T development programme inherited through the 2017 acquisition of Kite Pharma.

Eli Lilly, Regeneron Pharmaceuticals, GlaxoSmithKline and Sanofi all also reported their fourth-quarter earnings this week.

Analysis - Key takeaways from Eli Lilly's fourth-quarter and full-year earnings call, Key takeaways from Gilead's fourth-quarter and full-year earnings call and Key takeaways from GlaxoSmithKline’s fourth-quarter and full-year earnings call.

MacroGenics impresses with Herceptin competitor

There were a number of notable late-stage clinical disclosures made this week, including confirmation that Sanofi's CD38 antibody isatuximab (a potential competitor to Johnson & Johnson's Darzalex) met its primary endpoint in a Phase III multiple myeloma study and positive results from two pivotal stage trials of Eli Lilly's JAK inhibitor Olumiant in moderate-to-severe atopic dermatitis.

Perhaps the most surprising though was MacroGenics' confirmation that the experimental drug margetuximab delivered a superior progression-free survival benefit versus Roche's Herceptin in heavily pre-treated HER2-positive breast cancer patients with metastatic disease.

A high bar to overcome for sure and a result that will increase anticipation for full data from the SOPHIA study, which is expected later this year - see ViewPoints: MacroGenics may hit the jackpot with Herceptin 2.0.

Setbacks in gene therapy and gene editing space

Advocates of two pioneering therapeutic approaches - gene therapy and genome editing - were dealt sobering updates from Solid Biosciences and Sangamo Therapeutics, respectively, on Thursday.

Solid Biosciences announced the first data from its Phase I study of the Duchenne muscular dystrophy gene therapy SGT-001, showing a level of detectable microdystrophin below the benchmark it had publicly set at the JP Morgan healthcare conference last month. Furthermore, detectable microdystrophin was only seen in one of three patients. The company suggests higher dosing could solve this issue, but saw its shares plunge 70 percent, while rival DMD player Sarepta Therapeutics (which last year published preliminary, but highly promising, data for its own gene therapy) saw its shares rise 7 percent. Focus now will shift to whether dosing can be escalated without compromising the safety profile of SGT-001.

Sangamo Therapeutics also saw its chances for a near-term gene therapy success crumble, this time for its zinc finger gene editing platform. The company released results from two separate clinical studies using its platform to deliver a copy of the iduronate-2-sulfatase (IDS) enzyme, but failed to show convincing evidence of gene insertion or efficacy at the available doses. While it waits for better news from higher doses and more extensive follow-up, Sangamo says that it will start up programmes testing its new-and-improved zinc finger technology, featuring modifications to improve editing efficiency and specificity. Investors were quick to drop their interests, however, with share values dropping 30 percent - see ViewPoints: Sangamo pivots to 'second-gen' gene editing tech after questionable efficacy update.

Triple jeopardy for Tecfidera

Biogen has dodged two bullets on an all-important dosing patent covering Tecfidera (dimethyl fumarate), as a US Patent and Trademark Office review board has twice sided with the bellwether biotech in inter partes review (IPR) challenges. The company will now have to dodge a third after yet another review request from Mylan was instituted this week.

Shares of Biogen tumbled more than 7 percent on February 7 but the blockbuster multiple sclerosis (MS) drug is not going away anytime soon. A final decision on the IPR will be made in 12 months, and an appeal of that will take most of another year, meaning year-end 2020 is the earliest generics could arrive on the scene.

What’s more, Biogen has another card left to play in diroximel fumarate, a next-generation successor licensed from Alkermes that is under review at the FDA. The commercial viability of the agent is still up in the air, however, and may depend on results from a head-to-head study against Tecfidera that are expected in mid-2019 – see ViewPoints: Biogen loses IP skirmish on Tecfidera but many battles lay ahead.