La Jolla feels the burn of rival malaria approval; With another $10B, Bayer could finally weed out its herbicide problem
→ La Jolla Pharmaceutical‘s shares $LJPC tumbled about 20% to $5.48 on Wednesday morning after another company — Maryland-based Amivas — was granted FDA approval for an IV formulation of an artesunate product for malaria. Artesunate is the active ingredient used in La Jolla’s lead experimental product, LJPC-0118, which is being developed for use in severe malaria. The Amivas news comes as a big blow to La Jolla’s prospects as FDA regulations state that the agency will not approve another sponsor’s marketing application for the same drug for the same use or indication within 7 years of the initial approval.
→ German drugmaker Bayer, which has lost roughly $30 billion in market value since its $63 billion buyout of US agricultural giant Monsanto in 2018, has long suffered the headache of dealing with the fallout of Roundup, the herbicide it inherited with the acquisition. Bloomberg on Wednesday reported a large proportion of about 125,000 US plaintiffs who allege Roundup causes cancer have verbally agreed to a $10 billion settlement to wrap up all legal claims against the weedkiller, citing people familiar with the matter.
→ Mersana Therapeutics $MRSN got a boost today after sharing updated Phase I expansion data on their lead drug XMT-1536. Their highlights include: “Among those patients with higher NaPi2b expression, two (2/14) patients achieved a CR, and two (2/14) achieved a PR. Two (2/2) patients with NaPi2b expression not yet determined at the time of data cutoff achieved confirmed PRs. One (1/4) patient with lower NaPi2b expression (H-score of 90) achieved a confirmed PR.”
Mersana adds that it expects to define the patient selection strategy based on the total data set from patients treated with XMT-1536. That was good for a 25% bump in the share price, though there are still plenty of questions to be answered about competitiveness and durability.
→ NICE, UK’s cost-effectiveness watchdog, has worked out a deal with Roche to lower its price for the company’s flagship checkpoint inhibitor behind closed doors. The Swiss drugmaker’s Tecentriq has now been recommended for use in combination with chemotherapy — carboplatin and etoposide — as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in the UK in a draft guidance. Around 2,400 people in England have ES-SCLC, of whom around 1,200 people will be eligible for treatment with Tecentriq. The US approved the combo in the same indication last year.