Canada's Bausch to pay $300M in antitrust settlement; Cardiff releases data on mCRC trial
Canadian pharma company Bausch Health has agreed to settle an antitrust class-action suit from a 2015 price increase.
According to Reuters, the class-action lawsuit accused Bausch of maintaining an illegal monopoly on diabetes drug Glumetza, enabling a price hike of nearly 800% in 2015 from $5.72 to $51 per tablet.
Lawyers for companies that bought Glumetza and filed the suit against Bausch revealed the deal in a court filing on Wednesday, asking US District Judge William Alsup in San Francisco to approve it.
The case had been scheduled to go to trial next month.
“Plaintiffs are pleased with the settlement, which recovers for the class a very substantial portion of the overcharges that they suffered,” Steve Shadowen, a lawyer for the purchasers, said in an email.
Cardiff Oncology announces new data from Phase Ib/II trial in KRAS-mutated mCRC
California biotech Cardiff Oncology has new data from its lead clinical program evaluating their PLK1 inhibitor onvansertib in combination with standard-of-care chemotherapies Folfiri/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).
Highlights of the data as of July 2 in the multi-center and single arm study include:
- The combination of onvansertib and SOC chemotherapies resulted in 10% of the patients having G3 or G4 treatment-emergent adverse events (49/490).
- Median progression-free survival rate across evaluable patients is approximately 9.4 months (range of 7.8-not yet reached with 95% confidence).
- Patients achieving a best response of partial response showed the greatest decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle, or 28 days of therapy.
To be considered eligible for the trial, patients must have confirmed metastatic and unresectable colorectal carcinoma harboring a KRAS mutation. They must also have failed treatment with, or be intolerant to the Folfox regimen (fluoropyrimidine and oxaliplatin, with or without bevacizumab).
“Our Phase Ib/II trial continues to generate data suggesting that the addition of onvansertib to SOC results in an objective response rate and median progression-free survival that substantially exceed those previously achieved with SOC alone,” said Cardiff CMO Katherine Ruffner in a statement. “I look forward to the trial’s continued advancement and future data readouts.”
Endo settles New York state opioid cases
Endo International and subsidiaries have settled three cases brought by the state of New York and two major counties for $50 million in a still-ongoing saga regarding the opioid crisis.
The Irish pharma had been accused alongside other companies of deceptive marketing practices and downplaying the risks of opioid addiction. A jury trial on liability has been ongoing since June.
As a result of the settlement, the state and NY counties have ended their cases against Endo. Endo does not admit wrongdoing.
Endo is now shifting its focus to obtaining a global settlement, according to a statement put out by the company yesterday. Endo is exploring other alternatives and said that they may try to implement one or more of those alternatives if a global settlement is not possible.
Agenus forms new subsidiary and immediate collaboration with Ginkgo Bioworks
Agenus announced the launch of its new subsidiary SaponiQx today.
Its goal is to drive innovation in novel adjuvant discovery and vaccine design while building saponin molecules — and to that end, the company is partnering with Ginkgo Bioworks.
According to a statement put out by Agenus, Ginkgo’s experience in metabolic engineering, enzymatic diversification, and process optimization can be applied to discover novel adjuvants and improve current manufacturing processes — which is where SaponiQx comes in and applies best practices toward developing better vaccines.
“Agenus is pleased for SaponiQx to collaborate with Ginkgo Bioworks to develop its novel saponin products from sustainably sourced raw materials, with a goal to meet the current demands placed on the vaccine industry for pandemic vaccines,” said Garo Armen, CEO and Chairman of Agenus and Executive Chairman of SaponiQx
NCI considering Sana’s anti-CD22 CAR-T therapy for patent license
The National Cancer Institute is considering granting an exclusive patent license to Seattle biotech Sana for an anti-CD22 CAR-T therapy.
The document, signed on Tuesday by Richard Rodriguez with the National Cancer Institute, will be published on the federal register on Monday.
The biotech unicorn went public earlier this year, when it raised a massive $587.5 million in its IPO in February. It has set big aims to remake cell therapy with new targets, off-the-shelf products and even in vivo administration.
There is no update on when Sana’s therapy will be ready for the clinic.
Other companies have gone after CD-22 before —most notably Juno, which worked in concert with the NCI. Bristol Myers Squibb, though, has offered few updates on the candidate since buying out the biotech in 2018.