Corporate and regulatory developments over the Christmas period

On the corporate front Astellas continued to buy, while Qiagen decided that it was not, after all, up for sale.

The quiet period between Christmas and the New Year saw several developments on the corporate and regulatory front, with Morphosys, Immunomedics and Beigene giving their respective investors reasons for cheer.

And, just as the holiday period got under way, Astellas found time to complete one more acquisition. For Qiagen investors, meanwhile, it was what their company did not do that might have spoiled some festive cheer.

December 30:

With the New Year celebrations about to get under way Pharming slipped out news that its deal with Sobi covering Ruconest had been scrapped, and that it was having to pay Sobi €7.5m to get the rights back.

Sobi had held Ruconest rights in the EU, but actually it was the US where trouble had been brewing, with a 2018 complete response letter in a key label extension. Valeant had held Ruconest rights in the US, but handed those back to Pharming in 2016 (The other shoe drops for Pharming, September 19, 2018).

There was better news from Morphosys, which met its promise to file tafasitamab for relapsed/refractory lymphoma by the end of 2019 (Why a 2020 spotlight will fall on tafasitamab, December 24, 2019). Shortly before that the group started a study that will target the much larger first-line opportunity.

And Immunomedics got a June 2 PDUFA date for its long-suffering sacituzumab govitecan in triple-negative breast cancer, after the FDA accepted a filing resubmission following a Jan 2019 complete response letter (US regulator wipes the smile off Immunomedics’ face, January 18, 2019).

December 27:

Beigene’s tislelizumab was approved in China for 3rd-line classical Hodgkin’s lymphoma, becoming the seventh anti-PD-(L)1 MAb to be get the nod in that country. Being far behind the competition and not yet having secured US approval has not prevented the drug from attracting a $1.3bn 2024 sales forecast, according to EvaluatePharma; this is higher than Merck KGaA/Pfizer’s Bavencio.

Anti-PD-1/PD-L1 MAb approvals in China
Approval date Therapy Indication Notes
Baizean/tislelizumab (Beigene)
27 Dec 2019 Monotherapy 3rd-line classical Hodgkin's lymphoma  
Ailituo/camrelizumab (Jiangsu Hengrui)
31 May 2019 Monotherapy 3rd-line classical Hodgkin's lymphoma  
Tyvyt/sintilimab (Innovent Biologics)
27 Dec 2018 Monotherapy 3rd-line classical Hodgkin's lymphoma  
Tuoyi/JS001/toripalimab (Shanghai Junshi Bioscience)
17 Dec 2018 Monotherapy 2nd-line melanoma  
Imfinzi (Astrazeneca)
12 Dec 2019 Monotherapy 2nd-line stage III NSCLC Pacific study
Keytruda (Merck & Co/Taiho)
26 Nov 2019 Chemo combo 1st-line squam NSCLC Keynote-407 study
2 Oct 2019 Monotherapy 1st-line PD-L1+ve NSCLC Keynote-042 study
29 Mar 2019 Chemo combo 1st-line non-squam NSCLC Keynote-189 study
26 Jul 2018 Monotherapy 2nd-line melanoma  
Opdivo (Bristol-Myers Squibb/Ono)
8 Oct 2019 Monotherapy 2nd-line squamous head and neck cancer Checkmate-141 study
15 Jun 2018 Monotherapy 2nd-line NSCLC  

December 26:

Not content with its $3bn purchase of the gene therapy player Audentes in early December, Astellas Pharma on Boxing Day picked up another group with a hot technology – this time, Car-T. At just $120m up front, the Japanese group’s takeout of Xyphos Biosciences is much smaller than the Audentes deal.

This befits a company with no projects in clinical development. Xyphos’s technology is based on an engineering the NKG2D receptor, found mainly on natural killer cells, to make it inert; activation comes from antibodies designed to bind the receptor and tumour antigens, resulting in immune cells bearing these Car-like constructs being directed at the tumour.

Xyphos calls this modular approach “convertible” Car-T cells, and the most advanced candidate is scheduled to start its first human study in 2021, presumably triggering a milestone payment. The deal will be of interest especially to Celyad, a Belgian group pursuing an NKG2D-based Car-T approach.

Xyphos's pipeline
Product Pharmacological class Indication 
XYP-117 Car-T General cancer indications
XYP-217 Anti-CD20 Car-T Non-Hodgkin lymphoma
Research project
XYP-317 Her2  Car-T Solid tumour indications
XYP-418 Anti-IL-2 Car-T General cancer indications
XYP-X19/X20 Series NKG2D Car-T General cancer indications
Source: EvaluatePharma, company website.

December 24:

After market close on December 24, Qiagen took itself off the auction block. The diagnostics group has had a tricky time towards the end of the year, and had said it was entertaining several buyout offers (Who will buy Qiagen?, November 20, 2019). It now says none of these bids was good enough, and that it will remain a standalone business, prompting its shares to fall 21%.

How Qiagen’s management intend to get the underperforming, unprofitable business back on its feet is unclear. Certainly, Qiagen is not a lost cause, with a top line forecast to grow at a healthy 8% annually to 2024. But it will take time and effort to turn the ship around, and investors cannot be blamed for being disappointed that a quick and easy answer has been denied them.

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