According to BioWorld, almost $85 billion was raised by public and private biopharma companies globally in the second and third quarters alone, bringing the dollars generated to date to more than $100 billion – a total that smashes the existing record of about $69 billion that was raised in 2015.
Sessions at the European Society for Medical Oncology Virtual Congress, that has just concluded, provided an excellent opportunity for investors and analysts alike to familiarize themselves with the late-stage progress of new therapeutics aimed at improving cancer treatment. Overall, data presented at the meeting appear to have been positively received, a factor that has helped push up the value of the price-weighted BioWorld Cancer index this month.
Antibody-drug conjugates (ADCs) are making a comeback. After a relatively slow start with Adcetris (brentuximab vedotin, Seattle Genetics Inc.) and Kadcyla (ado-trastuzumab emtansine, Roche Holding AG) approved by the FDA in 2011 and 2013, respectively, the regulatory activity has swelled with four FDA approvals over the last nine months.
Though falling short of the outright takeover that some may have hoped for, Merck & Co. Inc.’s dual tie-ups with Seattle Genetics Inc. (Seagen) put the latter in solid position to shop for acquisitions of its own.
Second-quarter earnings reports, flowing fast in the last days of July, delivered a bevy of contrasting results, from A to V. Stymied by the pandemic, Aimmune Therapeutics Inc. booked exactly zero net sales during the quarter for its expected blockbuster peanut allergy treatment, Palforzia. Vertex Pharmaceuticals Inc. and Seattle Genetics Inc. beat top-line expectations, driven primarily by strong sales of new products.
The share prices of blue-chip biopharmaceutical companies closed out the month on a high note to contribute to their stellar collective performance during the second quarter, with the BioWorld Biopharmaceutical index increasing almost 20%.
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
Five Prime Therapeutics Inc. said it's licensing a family of monoclonal antibodies (Mabs) to Seattle Genetics Inc. for inclusion in new early stage cancer-killing antibody-drug conjugate (ADC) candidates, all directed to a single target. The deal holds $5 million up front for Five Prime, plus up to $525 million in milestone payments for the first two candidates. South San Francisco-based Five Prime's shares (NASDAQ:FPRX) rose about 18% on the deal, which interim CEO William Ringo said allows the firm "to realize value from our preclinical pipeline while prioritizing our clinical investments based on upcoming data readouts."
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
While the general markets are leaning toward positive territory following a quiet summer period, the enthusiasm for biopharma equities remains muted. One of the most closely monitored therapeutic areas is oncology. Earlier this year, public companies developing innovative medicines in that area had enjoyed strong support; however, investors now appear to be more selective in backing companies in that sector.
