Friday Five - The week in review

Generic Copaxone leads Gottlieb's charge

On Monday, FDA commissioner Scott Gottlieb said the agency would take measures to improve access to complex generics; two days later he made good to his word, as the FDA approved the first generic version of Teva's Copaxone 40mg.

Approval comes earlier than expected and provides an additional challenge for new Teva CEO Kare Schultz. The ex-Lundbeck man has inherited extensive cost-cutting initiatives and, as a result of losing US exclusivity on its best-selling drug now, may have to dig deeper on this front. Teva shares were down 12 percent – ViewPoints: A fatal blow to Teva's Copaxone empire?

Biosimilar battleground

Though not mentioned specifically in his statement, one has to assume that Gottlieb's stance extends to biosimilars. That said, matters appear to be largely out the FDA's hands.

The agency has approved seven biosimilar products to date, but just three have reached the market, while Pfizer has launched legal action against Johnson & Johnson citing anti-competitive behaviour. Illustrating further that FDA approval marks only a small first step in allowing patients to access potentially cheaper biosimilars, AbbVie and Amgen reached a settlement late last week that will see the latter's biosimilar Humira product launched in 2023 despite its approval by the FDA last year.

A short-term win for AbbVie, but one loaded with potential long-term consequences for the industry at large.  

Biogen's freaky Friday

While Gottlieb's policies have won considerable industry favour since his appointment as commissioner in May, the FDA did appear to make something of a misstep by opening public access to its Adverse Event Reporting System (FAERS) database late last week.

Those looking to find an investment edge were among the first to utilise access to FAERS, but unaccustomed to both complexities and subtleties of the database erroneously raised toxicity concerns around a number of drugs marketed by Sarepta Therapeutics, Biogen and Ionis Pharmaceuticals.

With analysts quick to point out the limitations of using raw data from FAERS, share prices quickly recovered, although in Biogen and Ionis' case, the toxicity scare somewhat overshadowed a potential competitive threat to its spinal muscular atrophy (SMA) treatment Spinraza of greater substance – ViewPoints: Investors may have missed the real threat during Biogen's freaky Friday.

Notable R&D updates

Zogenix announced impressive late-stage data for its experimental Dravet syndrome treatment ZX088, prompting its share price to leap almost 200 percent. What impact will these results have on a competing treatment being developed by GW Pharmaceuticals?

Shares in Ablynx rose as much as 25 percent in response to positive Phase III data for the acquired thrombotic thrombocytopenic purpura (aTTP) treatment caplacizumab. The case for approval – already under way in Europe – now looks considerably stronger.

Vaccitech's universal influenza vaccine has moved into mid-stage trials. The company is using a T-cell vaccine to target conserved proteins, which it believes should offer universal protection that is durable beyond one year.

Merck & Co. is considering a late change to its much anticipated Keynote-189 study – which is assessing Keytruda plus chemotherapy in first-line non-small-cell lung cancer (NSCLC) patients – note analysts at Morgan Stanley. Currently boasting a singular primary endpoint of progression-free survival, Merck may incorporate a co-primary endpoint of overall survival based on results from the smaller Keynote-021 (Cohort G) trial, said R&D head Roger Perlmutter.

See also…

ViewPoints: For CAR-T cell therapies, who will be running the show in a post-CD19 world?

ViewPoints: CRISPR poised to take over in sickle cell disease as gene therapy doubts follow bluebird

ViewPoints: New ATB200/AT2221 data put Lumizyme directly in Amicus’ crosshairs

ViewPoints: And the crowd goes… meh – why investors brushed off Phase III success of Myovant’s relugolix

Key Licensing deals and other investments

Amgen entered an agreement with CytomX Therapeutics to co-develop a CytomX Probody T-cell engaging bispecific against EGFR, a highly validated oncology target expressed on multiple human cancer types. Amgen will make an upfront payment of $40 million and purchase $20 million of CytomX common stock. CytomX will be eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR programme. CytomX will also receive the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific programme.

Cancer immunotherapy player Immatics announced completion of its series E financing, raising $58 million, supported by Amgen. The large-cap biotech signed a collaborative agreement with Immatics in January potentially worth $1 billion, focused on the development of T-cell engaging bispecific immunotherapies.

AnalysisViewPoints: Immatics gets the cash for its TCR platform, but is it Amgen that needs the help?

Arbutus Biopharma is to receive $116 million in strategic investment from Roivant Sciences, the parent company of Axovant Sciences – which recently suffered a setback to its Alzheimer's disease aspirations. The two companies are hoping to develop a curative therapy for hepatitis B.

Nimbus Therapeutics and Celgene entered a long-term strategic immunology alliance to develop programmes for patients with autoimmune disorders. The collaboration follows previous deals Nimbus has signed with Gilead Sciences (in NASH) and Roche's Genentech unit (in oncology) over the past two years.

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