Philip Morris nabs over 20% of Vectura's shares; Oncopeptides drug may be headed for adcomm, CEO says
About a week after Vectura’s board of directors said they would unanimously back a Philip Morris takeover, the tobacco giant now has control of more than a fifth of the respiratory drugmaker’s shares.
Shareholders with 22.61% of Vectura’s shares have tendered their stock to Philip Morris, Reuters reported on Wednesday. The move is part of the cigarette company’s $1.5 billion bid to buy Vectura. Philip Morris, best known for its Marlboro products, offered 165 pence per share, beating out a 155 pence per share offer by the private equity firm The Carlyle Group.
Though the deal has drawn skepticism from consumer advocates, charities, anti-smoking groups and the UK’s business secretary, Vectura’s board issued a statement last week that it considers Philip Morris’ offer “fair and reasonable.”
“Tobacco companies should not profit from the illnesses their products cause,” a group of representatives from more than 20 anti-smoking and lung health organizations wrote to Vectura’s board.
CEO Jacek Olczak says the deal is in line with his “beyond nicotine” strategy, which would position the company to generate more than half its revenue from smoke-free products by 2025. — Nicole DeFeudis
Oncopeptides drug may be headed for adcomm, CEO says
Following the FDA placing a partial hold on its confirmatory trial for Pepaxto, Oncopeptides said Thursday that the agency may call for an adcomm to discuss the study.
In its second quarter report, CEO Marty Duvall wrote in a letter to investors that regulators “indicated that a public meeting may be held later this year to discuss the safety findings and the continued marketing of the drug in the US.” The FDA placed the hold on all trials involving Pepaxto on July 8 after the drug flopped the overall survival measure.
Three weeks later, the agency alerted patients and healthcare providers with more specific information, explicitly noting the drug resulted in an increased risk of death. Some cost-cutting “measures” may be taken due to all the uncertainty surrounding the drug, Duvall added in this letter.
Pepaxto won accelerated approval in February, comparing the drug in combination with dexamethasone to a Bristol Myers Squibb/steroid combo in patients with relapsed or refractory multiple myeloma. — Max Gelman
Bristol Myers nets EU approval for Abecma
About five months after getting FDA approval for its BCMA CAR-T therapy Abecma, Bristol Myers Squibb has now won an OK in Europe.
The European Commission approved the drug for adults with relapsed and refractory multiple myeloma who had previously failed at least three earlier lines of therapy, Bristol Myers announced Thursday. The prior therapy lines must have included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and patients had to have demonstrated disease progression on the last therapy, the drugmaker added.
“The EC approval of Abecma is an important milestone for the treatment of multiple myeloma, and moves us closer to offering a first-in-class, personalized therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care,” CMO Samit Hirawat said in a statement.
Bristol Myers has been pushing Abecma for multiple myeloma alongside another drug, Breyanzi, which was approved for third-line diffuse large B cell lymphoma back in February. — Max Gelman
Third time, like the first and second, is the charm for Adagene, Merck
Adagene apparently loves working with Merck so much they’re going back for thirds.
The San Francisco biotech announced its third clinical trial collaboration on Thursday, aiming to pair its experimental anti-CD137 candidate with Merck’s Keytruda in advanced or metastatic solid and/or hematological malignancies. The new clinical study will build on monotherapy and combination therapy data from a Phase I trial of the candidate, called ADG106.
“While PD-1 drugs have advanced the cancer treatment paradigm, there are still a substantial number of patients with advanced metastatic solid and hematological malignancies who either relapse or are unresponsive, highlighting the need for new approaches,” Adagene CEO Peter Luo said in a statement.
ADG106 is an agonistic anti-CD137 IgG4 monoclonal antibody being evaluated in a Phase Ib/II combination study in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Adagene’s Phase I trials have been completed with enrollment of nearly 100 patients in both the US and China, the biotech said. — Max Gelman