Destiny Pharma Plc has decided to exit the AIM market of the London Stock Exchange and go private in order to raise money for the Phase 3 development of its lead antibiotic product XF-73 Nasal. The wholly-owned product delivered promising data in a Phase 2 study and has been poised for the next stage pending a licensing partner.
A syndicate of leading European and US investors has raised €63 million for SciRhom GmbH of Germany which is developing a treatment for autoimmune diseases by modulating an enzyme controlling several major signalling pathways. The Series A financing will enable SciRhom to bring its lead product candidate – a monoclonal antibody – into clinical development before the end of the year. The investment round was co-led by Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital and Wellington Partners. PhiFund Ventures of the US also participated.
Eli Lilly and Co is to pay $3.2 billion to acquire a US company with a pipeline of preclinical and clinical assets targeting integrin molecules for the treatment of gastrointestinal and other chronic diseases. The company, Morphic Holding Inc, is located near Boston and has a lead product, MORF-057, in Phase 2 for the potential treatment of ulcerative colitis and Crohn’s disease. Lilly is to pay $57 per share in cash for the company, which represents a premium of about 79% over the company’s closing share price on 5 July.
The US Food and Drug Administration has approved Eli Lilly and Co’s drug for early symptomatic Alzheimer’s disease, less than a month after it received the unanimous support from an outside panel of advisers. The Peripheral and Central Nervous System Drugs Advisory Committee voted 11 to zero on 10 June to recommend approval. The drug, Kisunla (donanemab), is a treatment for early symptomatic disease including people with mild cognitive impairment.
The US Food and Drug Administration has approved a new drug for chronic obstructive pulmonary disease, the third leading cause of death worldwide. Ohtuvayre (ensifentrine), developed by Verona Pharma Plc, is an inhaled therapy for the maintenance treatment of COPD, a disease that is mainly caused by tobacco smoking. It was authorised by the FDA on 26 June.
Zealand Pharma A/S completed an upsized equity offering on 26 June with the placement of 8.35 million shares with investors raising gross proceeds of DKK 7 billion ($1 billion). This will enable it to finance its prospective peptide-based medicines for obesity and metabolic and rare diseases well into the future. The directed share issue and private placement exceeded the initial targeted amount by $100 million.
Denmark-based Zealand Pharma A/S has announced an offering of new shares which is expected to raise DKK 6.3 billion ($900 million). This will be done by way of a private placement directed at institutional and professional investors in Denmark and elsewhere. Zealand Pharma is one of a growing number of companies developing new drugs for obesity and fibrosis. Its peptide-based medicines, also intended to treat rare diseases, include two marketed products and three in late-stage development.
The European Medicines Agency has given a conditional marketing authorisation to a gene therapy for haemophilia B which is a one-time treatment for the rare inherited blood disorder. Announced on 31 May, the decision is for fidanacogene elaparvovec, an adeno-associated virus based therapy that is designed to deliver a functional copy of the Factor 9 gene into the body enabling patients to produce Factor 9 protein themselves. The developer is Pfizer Inc which received US regulatory approval for the same therapy in late April.
The US Food and Drug Administration has expanded the permitted medical use of a gene therapy for Duchenne muscular dystrophy (DMD), making it available to patients who are both ambulatory and non-ambulatory. DMD is a genetic disorder characterised by a progressive deterioration of muscle due to abnormalities in, or the absence of, dystrophin protein which helps keep muscle cells intact.
Formycon AG of Germany has started clinical development of a candidate biosimilar of Keytruda (pembrolizumab), the checkpoint inhibitor for melanoma and other cancers that has revolutionised medical practice by blocking the interaction between two proteins and activating the immune system to kill cancer cells. To date, Keytruda has been approved for 48 medical indications.