H1 of June: What’s been happening in pharma?

The first half of June has seen some great news stories from the pharma industry. Still dominated by the COVID pandemic, and against a backdrop of strong innovation and collaboration, some of the top stories are summarized here.

Companies reporting advances with their COVID treatments over the past couple of weeks include Eli Lilly and its partner Junshi Biosciences, following the dosing of the first healthy volunteer in a Phase I study of their investigational neutralizing antibody treatment. Meanwhile, Sun Pharma’s potential treatment candidate is already at Phase II, and FSD Pharma has just received approval to proceed with a Phase IIa study of its candidate FSD-201. Dosing has also begun in the UK Government-backed Phase II clinical trial assessing BerGenBio's bemcentinib in hospitalized COVID-19 patients. Shanghai Junshi Biosciences has also started human tests for a COVID antibody drug, while CTI Biopharma has announced enrolment of the first patient in its COVID-19 trial.

At earlier stages of development, IGY Life Sciences has announced a collaboration with the CRO MMS Holdings to advance the preclinical development of its anti-COVID-19 therapeutic antibody, and South Korea-based Daewoong Pharmaceutical has reported some success with its anti-parasitic drug niclosamide against COVID-19 in animal studies. AbbVie has also announced a new collaboration with Harbour BioMed, Utrecht University and the Erasmus Medical Center to develop a monoclonal antibody against COVID-19.

Much of the world’s focus remains on the search for a COVID-19 vaccine. AstraZeneca last week announced a $750 million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the University of Oxford’s vaccine, in addition to a licencing agreement with Sii to supply one billion doses for low- and middle-income countries. The Oxford University vaccine is currently being tested in a Phase II/III trial in 10,000 adult volunteers, making it a front-runner in the race for finding a viable vaccine, closely followed by Johnson & Johnson, which has just announced acceleration of its COVID-19 vaccine candidate – the company’s Phase 1/2a trial will begin next month (July 200).

Much hope has been pinned on the Oxford and J&J candidates, although news from other research teams make it clear that other potential vaccines remain in the running. These include recently-announced collaborations between Novavax and AGC Biologics, MilliporeSigma and Baylor, Intravacc and EpiVax, Panacea Biotec and Refana, Tonix and Fijifilm, Catalent and Spicona, among others.

Since the onset of the COVID-19 pandemic, the FDA has issued a series of temporary emergency approvals, ranging from diagnostic tests to treatments such as Gilead Sciences’ antiviral drug remdesivir. One very recent approval, announced last week, was for Phosphorus’s at-home saliva test for COVID-19. Following similar rapid approval last month (May 2020), Omega Bio-tek launched its own new viral RNA extraction kit for COVID-19 testing last week, declaring a production capacity for 6 million tests a month. It is hoped that tests like this will offer quick and convenient COVID testing, which is widely considered an important step in getting back to normal.

Of course, other diseases still exist, and regulatory agencies across the world have been busy reviewing and approving novel products to ensure patients have access to latest innovations. Most recently, these included approvals by the FDA for Viela Bio’s Uplizna (inebilizumab-cdon) injection for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients with a particular antibody, and AlgoTherapeutix’s ATX01 (proprietary topical amitriptyline) has been granted Orphan Drug Designation for the treatment of erythromelalgia. The FDA has also approved Merck & Co’s Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia; Astella Pharma’s solifenacin succinate for the treatment of bladder dysfunction in pediatric patients; Strides Pharma Science’s triamcinolone acetonide ointment for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; Roche’s atezolizumab, plus bevacizumab, for unresectable hepatocellular carcinoma; and Bristol-Myers Squibb’s nivolumab plus ipilimumab for the treatment of metastatic NSCLC. AstraZeneca has also secured FDA approval for a new indication for its heart disease drug Brilinta (ticagrelor), which can now be used to minimise the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

Meanwhile, Johnson & Johnson’s Janssen Pharmaceutical has secured approval from the European Commission for its subcutaneous formulation of daratumumab for the treatment of multiple myeloma in adult patients. The European Commission has also given the nod to Pierre Fabre's Braftovi (encorafenib) for use alongside Erbitux (cetuximab) in adults with BRAFV600E-mutant metastatic colorectal cancer, and to Sanofi’s Sarclisa (isatuximab) with pomalidomide and dexamethasone (pom-dex) to treat adults with relapsed and refractory multiple myeloma.

The FDA has also approved two generic products owned by Lupin: the company’s albendazole tablets are a generic equivalent of Impax Laboratories’ Albenza tablets for lesions caused by tapeworm infection, and its meloxicam capsules are a generic equivalent of Zyla Life Science’s Vivlodex Capsules for the management of osteoarthritis pain. The FDA has also approved Biocon and Mylan’s Semglee, which is a biosimilar to Sanofi’s Lantus for controlling high blood sugar in patients with diabetes. The European Commission has granted marketing authorization for Lupin and Mylan’s Nepexto, a biosimilar to Enbrel (etanercept), for various arthritis indications.

Pharma’s resilience in the face of a global economic slow-down is evidenced by several reported expansions and developments. Perhaps unsurprisingly, new investments announced in the past two weeks have focussed on capacity for biologics. For example, Fujifilm has committed $928 million to expand its biologics facility in Denmark, with the aim of doubling the site's manufacturing capacity. On the other side of the Atlantic, WuXi announced plans to open a new clinical manufacturing facility in New Jersey, USA, to include a total bioreactor capacity of 6000L. Meanwhile, POINT Biopharma, a company specializing in the development and production of radiopharmaceuticals for cancer treatments, has unveiled plans to establish its first US manufacturing facility in Indiana.

Similarly, for many of those working in mergers and acquisitions, it’s still ‘business as usual’! Among recent announcements this month so far, UCB has acquired Engage Therapeutics, a clinical-stage pharma company developing Staccato Alprazolam for the rapid termination of an active epileptic seizures, for $125 million in cash, and as much as $145 million in further potential milestone payments. Elsewhere, Dr Reddy’s has completed the acquisition of Wockhardt’s branded generics business, which comprises a portfolio of 62 brands across various therapeutic areas, and a manufacturing plant located in India; Ajinomoto Bio-Pharma Services has completed the acquisition of Granules OmniChem Private Limited, purchasing the remaining 50% ownership interest from its joint venture partner, Granules India Limited; and AGC Biologics has purchased a state-of-the-art commercial biopharma facility formerly owned by AstraZeneca in Colorado, USA.

These news stories and others can be found on the new Pharmasources.com website. 

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. She subsequently began a new career in publishing as Editor of Speciality Chemicals Magazine, and then Editorial Director at Chemicals Knowledge. She now focusses on providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.