The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.
Swiss industry welcomes agreement with India, pharma more cautious (Le Figaro, in French)
Swiss industry has welcomed the free trade agreement with India as an “enormous” opportunity, while pharmaceuticals, Switzerland’s largest export sector, is more cautious, calling for intellectual property standards to be respected. After 16 years of negotiations, the European Free Trade Association (EFTA), which includes Switzerland, Norway, Iceland and Liechtenstein, signed an agreement with India on Sunday. This agreement will “abolish or partially liberalise” the currently very high customs duties affecting 95.3% of the industrial products that the Alpine country exports to India, with the exception of gold, “with immediate effect or at the end of transitional periods”, according to the Swiss Ministry of Economic Affairs.
Roche shares fall on modest 2024 outlook (Reuters)
Episologen, Lonza manufacture first IgE to treat ovarian cancer (BioProcess International)
According to the firm, immunoglobulin G (IgG)-based products take at least 12 months to achieve manufacturing, a feat they achieved in less than ten months. The process development and production for clinical supply was carried out at the contract development and manufacturing organization’s (CDMO’s) Slough, UK site.
“Together, we have achieved the first GMP manufacturing of an immunoglobulin E (IgE) antibody at scale for clinical supply in less than ten months at Lonza’s site in Slough, UK,” a spokesperson for Lonza told BioProcess Insider.
Swiss pharma’s big bet on Slovenia (SWI)
Pharmaceutical giant Novartis invested billions in Slovenia, helping turn the country into a global player in generic drug production. Now, as cheap Asian competitors increasingly dominate the market, Swiss drug companies see the tiny Balkan nation playing a key role in their shift to more complex, expensive medicines.
Roche to shrink product development team, mainly impacting contractors (Fierce Biotech)
Roche plans to lay off a few hundred people in its product development team, the pharma confirmed to Fierce Biotech.
The Swiss drug developer chalked the layoffs up to a normal review of the business “to ensure ongoing improvement and sustained readiness,” according to a statement from a company spokesperson on Friday. Roche says it expects “the majority of the proposed headcount reduction to impact external contractors” with less than 6% of the permanent product development team potentially impacted.
Novartis, zeroing in on innovative meds, launches strategic review of India outfit (Fierce Pharma)
A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.
As part of a strategic review unveiled Friday, Novartis said it’s evaluating its 70.68% position in Novartis India Limited, a local unit listed on BSE. Based on the closing price at the end of 2023, the shares owned by the parent group were worth $161 million, according to the Swiss pharma’s annual report (PDF).
The review won’t necessarily be completed in 2024, Novartis said, and there’s no guarantee that any transaction will come out of it.
Novartis will see modest boost to blood cancer portfolio with MorphoSys acquisition (Clinical Trials Arena)
Novartis announced its acquisition of the prominent biopharmaceutical company MorphoSys AG. This deal provides Novartis with two late-stage pipeline therapies, pelabresib and tulmimetostat. The most prominent of the two is the highly anticipated first-in-class bromodomain (BET) inhibitor pelabresib, which is currently undergoing a Phase III clinical trial for treatment-naïve myelofibrosis (MF) patients in combination with Incyte/Novartis’s Jakafi/Jakavi (ruxolitinib), a Janus kinase inhibitor (JAKi).
The disease is characterised by severe anaemia and an enlarged spleen. JAKis have emerged as a primary treatment option for patients with various types of MF within the last decade. This drug class has also created some difficulty in the current treatment pathway as patients who discontinue existing JAKi treatment consistently have poor survival durations and there is a lack of alternative treatment options.
EraCal Therapeutics: Collaboration and license agreement with Novo Nordisk (Swiss Biotech)
EraCal Therapeutics Ltd. today announced that it has entered into a collaboration and license agreement with Novo Nordisk A/S to develop and commercialize EraCal’s oral, small molecule program. The asset was discovered with EraCal’s platform technology and is believed to target a novel mechanism of action controlling appetite and body weight to treat obesity. “This is an important agreement for EraCal Therapeutics as it showcases the team’s capabilities to identify new mechanisms of action and to discover and develop small molecules to target these biological pathways,” said Josua Jordi, CEO of EraCal Therapeutics. “We consider Novo Nordisk the ideal partner to bring this program to patients and are excited to join forces to lead innovation.”
Aurealis Therapeutics’ lead candidate for chronic wounds receives PRIME status from EMA (Swiss Biotech)
Aurealis Therapeutics today announced that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Aurealis Therapeutics’ lead product candidate AUP-16 (AUP1602-C) for the treatment of non-healing Diabetic Foot Ulcers (nhDFU).
EMA acknowledges that nhDFU is a serious, debilitating and potentially life-threatening condition, with an unmet need for therapies that improve healing outcomes compared to available options. EMA also recognizes that the high rate of wound closure observed with AUP-16 sufficiently demonstrates the potential to address the unmet medical need in nhDFU to a significant extent.
