There’s more bad news for the an­tibi­otics R&D field Thurs­day evening.

Ken Hillan

A few weeks af­ter the FDA green-light­ed Achao­gen’s $AKAO an­tibi­ot­ic Zem­dri (pla­zomicin) for uri­nary tract in­fec­tions but shunt­ed aside their ap­pli­ca­tion on blood­stream in­fec­tions, the biotech is lay­ing off rank-and-file re­searchers and let­ting go its top re­search ex­ecs.

Al­to­geth­er the com­pa­ny says it is cut­ting 80 jobs — 28% of the staff — as it chops spend­ing on ear­ly-stage re­search and de­vel­op­ment, tech­ni­cal op­er­a­tions and gen­er­al and ad­min­is­tra­tive ex­pens­es.

Lee Swem

Ken Hillan, pres­i­dent R&D, will leave in mid-Oc­to­ber, while CSO Lee Swem will de­part a few weeks ear­li­er.

Re­search will be nar­rowed to fo­cus on C-Scape, an oral be­ta-lac­tam/be­ta-lac­ta­mase in­hibitor com­bi­na­tion, and new amino­gly­co­side an­tibi­otics, which can count on some non-di­lu­tive fund­ing com­mit­ments to con­tin­ue the work. The main task at Achao­gen will be com­mer­cial­iz­ing their ap­proved prod­uct while hunt­ing a Eu­ro­pean OK to ex­pand that work.

For the past 10 years pub­lic health of­fi­cials have been rais­ing a hue and cry for new an­tibi­otics as old stan­dards strug­gle against a ris­ing tide of drug re­sis­tance. But the bulk of the need can still be met with cheap stand­by ther­a­pies, mak­ing it hard to prof­it by them. As a re­sult, Big Phar­ma bowed out large­ly, un­der­scored by No­var­tis’ re­cent de­ci­sion to join the ex­o­dus out of the field. As­traZeneca and oth­ers had done it years ago.

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.