Despite the country being hard hit with Covid-19, Italian pharma seems to be getting back to business as usual with two oncology-related biotech acquisitions in the last week. 

The most recent acquisition was of French immuno-oncology company ElsaLys Biotech by Mediolanum Farmaceutici, a pharmaceutical group based in Milan. 

The French biotech has several candidate drugs in development. The most advanced of these is Leukotac, a monoclonal antibody that can be used to treat steroid-resistant graft-versus-host disease — a serious complication that affects some patients given stem cell transplants or CAR-T cell therapy to treat blood cancer. 

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ElsaLys acquired the worldwide development and commercialization rights for Leukotac from Irish biotech Jazz Pharmaceuticals in 2017. It also has other candidate antibodies in development that have anti-cancer and immune regulatory properties.

No financial details of the acquisition were released. Mediolanum Farmaceutici is already known for its oncology pipeline. “Leukotac perfectly fits into Mediolanum’s existing R&D portfolio aimed at offering new treatments to patients suffering from severe diseases improperly addressed so far,” Loris Spampinato, Business Development Director at Mediolanum Farmaceutici, told me. 

ElsaLys’s drug has already been made available to French patients through a local ‘Temporary Use Authorization’. “The development of Leukotac is ongoing but intrinsic characteristics of the product are highly promising and we are very confident that we’ll receive positive opinions from the regulatory authority shortly,” said Patrice Mauriac, Managing Director and Head Pharmacist at the Leurquin Mediolanum Laboratories.

Last week, the private Florence-based pharma company the Menarini Group agreed to acquire US-based Stemline Therapeutics for €616M ($667M), which is listed on the Nasdaq stock exchange. The transaction will be finalized at the end of the year.

Similar to Mediolanum Farmaceutici, Menarini has a strong interest in oncology and Stemline is therefore a good fit for them. Stemline’s lead drug Elzonris is the only FDA-approved therapy for a rare kind of blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN) and is expecting EMA approval soon. It will also allow the Italian pharma company to expand into the US market.

Elzonris is a fusion protein drug combining an immune system protein called interleukin 3 with the diphtheria toxin. The drug is able to target and kill cancer cells expressing a protein specific to blood cancers called CD123. It was launched in 2018 in the US and since then sales have been slow. Only 534 BPDCN patients were recorded in the US in 2018 and by the end of 2019 sales were only €10.9M ($11.8M). 

However, Elzonris is currently being trialed to treat several other blood cancers expressing the same protein, including the more common cancer acute myeloid leukemia, justifying the interest of Menarini and the size of the acquisition price. Stemline has a focus on oncology and has several other small molecule and immuno-oncology candidate drugs in development. 

The current global crisis has negatively impacted businesses around the world. Italy has been badly hit by the virus, with its citizens now slowly coming out from a long period of strict lockdown. Things still have a long way to go, but these recent acquisitions seem to indicate that the Italian pharma industry at least is slowly getting back to normal.

As an important pharmaceutical industry member, Mediolanum faced the double challenge of protecting its employees from the virus and maintaining the availability of its marketed medicines for patients,” said Spampinato. “Now the situation seems to become better every day than the day before. Lots of effort was made, a lot still has to be done, but the team is on duty.

In addition, the biotech startup scene in Italy may be starting to pick up, with recent investments by the French VC firm Sofinnova’s Telethon Fund in Italian startups addressing rare diseases.


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