A roundup of the biggest stories emerging from Spain’s pharma industry: Grifols pushes to improve governance after accusations of overstated earnings; Rovi and Insud join forces to create Spain’s first semi-public pharmaceutical company; Almirall and Eloxx Pharmaceuticals sign a licensing agreement for a rare dermatological disease asset, and Esteve acquires Perrigo’s HRA rare diseases business.


Spanish drug maker Grifols will bring in independent directors (Reuters)

Spanish drug maker Grifols, battling a plunge in its share price this year, plans to add independent directors to its audit and compensation committees to improve its governance, its chairman said in a newspaper interview published on Sunday.
Grifols’ market value has shed billions of euros since short-sheller Gotham City Research released three reports in early January accusing the company of overstating earnings and understating debt. Grifols has repeatedly denied the claims.


Rovi and Insud to set up the first semi-public pharmaceutical company with the government (El Economista, in Spanish)

Spain’s first semi-public pharmaceutical company becomes a reality. The Ministry of Science, Innovation and Universities, through Innvierte, will own 49% of the company, while Rovi and Insud Pharma will each hold 25.5%. The new entity will be in charge of research and development of advanced therapies. However, the name of the future public-private pharmaceutical company has not yet been revealed, as Rovi told this newspaper, and the exact therapeutic areas to be targeted are not yet known. In any case, it will not be a generic drug venture, but will be linked to cutting-edge science.


Rovi wins FDA nod to make Moderna’s COVID vaccine at Spanish plant (Fierce Pharma)

As part of a long-term partnership between Spain’s Laboratorios Farmacéuticos Rovi and Moderna, the former company is bringing a new plant into the mix for production of COVID-19 vaccines bound for the U.S. market.

During an inspection in January, FDA staffers were satisfied with Rovi’s active substance manufacturing plant in Granada, Spain, effectively allowing Spikevax doses made at the facility to be sold in the U.S., Rovi CEO Juan López-Belmonte said on a Tuesday call with investors.


Almirall to license Eloxx’s ZKN-013 for rare skin conditions (Pharmaceutical Technology)

Almirall has signed an exclusive licence agreement to gain worldwide rights for Eloxx Pharmaceuticals’ ZKN-013 for rare dermatological disease indications. Almirall will develop and market the drug candidate. The exclusive licensing deal includes the development of the asset for orphan skin conditions.

The oral nonsense mutation readthrough drug is designed to enable the production of functional proteins by host cells that address the underlying causes of these conditions.


Esteve to acquire Perrigo’s HRA pharma rare diseases business (The Pharma Letter)

Family-controlled Spanish pharma company Esteve has signed a binding offer with USA-based Perrigo Company (NYSE: PRGO) to acquire the latter’s HRA Pharma Rare Diseases, a specialist in rare and ultra-rare diseases.

As a result, Esteve will increase its portfolio in the rare and severe diseases therapeutic area, adding to its current portfolio three new medicines that address Cushing’s syndrome and adrenocortical carcinoma.


Pharmaceutical company Sanofi announces collective redundancies for 89 people, most of them at its Barcelona site (El Pais, in Spanish)

The pharmaceutical company Sanofi, a French multinational whose subsidiary in Spain has 1,450 workers, has announced this Friday an employment regulation plan (ERE) that will affect 89 people, most of them assigned to the company’s headquarters in Barcelona, although not all of them work in the Catalan capital. The company justifies these redundancies for organisational and productive reasons, ‘with the aim of adapting the structure and operation to the current and future needs of the sector, ensuring its future competitiveness and viability.”

Presentation of the pharmaceutical industry’s strategic plan is imminent (Diariofarma, in Spanish)

The Secretary of State for Health, Javier Padilla, announced the imminent presentation of the pharmaceutical industry’s strategic plan during the conference ‘Main challenges and opportunities for biopharmaceutical innovation in Spain’, organised by the Farmaindustria Foundation and the Federation of Spanish Scientific and Medical Associations (Facme) at the Congress of Deputies.

According to Padilla, ‘in the coming weeks, decisive steps will be taken to have the strategic plan for the pharmaceutical industry ready’, a plan which, for the Secretary of State for Health, will be an ‘example of how to transform relations’ between institutions and a ‘fundamental fabric’ such as biomedical innovation and medicines.


Spanish Biotech Peptomyc Advances MYC Inhibitor in Pancreatic Cancer After Positive Early Data (Precision Medicine Online)

Vall d’Hebron Institute of Oncology spinout Peptomyc is moving its investigational MYC inhibitor into a Phase Ib trial in advanced pancreatic cancer after an encouraging readout from a first-in-human study.

The Barcelona-based firm believes its agent, dubbed OMO-103, is the first pan-MYC inhibitor to show benefit in a Phase I trial, which is a significant feat since the target has historically been considered “undruggable,” said Laura Soucek, Peptomyc CEO and head of VHIO’s Anti-Tumor Therapy Modelling Group.


Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate (Business Wire)

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.

The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.