This week, Eli Lilly (LLY Quick QuoteLLY - Free Report) announced a deal to take over POINT Biopharma for approximately $1.4 billion. Sanofi (SNY Quick QuoteSNY - Free Report) in-licensed co-development and commercialization rights to Teva’s immunology candidate. Novartis (NVS Quick QuoteNVS - Free Report) announced positive top-line data from a late-stage study on pipeline candidate iptacopan in patients with IgA nephropathy (IgAN). AstraZeneca (AZN Quick QuoteAZN - Free Report) settled its product liability litigation related to its heartburn drugs, Nexium and Prilosec, for $425 million.AbbVie (ABBV Quick QuoteABBV - Free Report) announced that it is buying a private Parkinson’s disease drug developer, Mitokinin.

Recap of the Week’s Most Important Stories

Lilly to Buy POINT Biopharma for $1.4B: Lilly offered to buy POINT Biopharma, a maker of next-generation radioligand therapies for treating cancers, for approximately 1.4 billion in cash, or $12.50 per share. Radioligand therapy is a type of precision cancer treatment, which combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). POINT Biopharma’s lead pipeline candidate is PNT2002, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC) after progression on hormonal treatment. The phase III SPLASH study on PNT2002 is complete and top-line data is expected in the fourth quarter of 2023. The transaction has been approved by the boards of directors of both companies and is expected to be closed by the end of the year

The acquisition of POINT Biopharma, if successfully closed, will bolster Lilly’s portfolio of cancer drugs.

The FDA issued a complete response letter (CRL) to Lilly’s biologic license application (BLA) seeking approval of lebrikizumab for moderate-to-severe atopic dermatitis, also called eczema. The CRL was based on inspection findings at a third-party manufacturer, which included a monoclonal antibody drug substance for lebrikizumab. The CRL did not mention any issues with the clinical data that supported the BLA or the safety or label of the candidate. Lilly plans to work closely with the FDA and the third-party manufacturer to resolve the issue. The BLA includes data from Advocate 1, ADvocate 2 and ADhere studies on lebrikizumab. A regulatory application seeking approval for lebrikizumab is also under review in Europe, with a decision expected later this year.

Sanofi’s Buys Joint Rights to Teva’s IBS Candidate: Sanofi announced a collaboration with Teva to jointly develop and commercialize the latter’s inflammatory bowel disease (“IBD”) candidate, TEV’574, a novel anti-TL1A therapy. TEV’574 is presently being evaluated in a phase IIb study for ulcerative colitis and Crohn's disease, which are two types of IBD. Initial data from the studies are expected in 2024. For the deal, Sanofi will make an upfront payment of $500 million to Teva while also being entitled to make development/launch-related milestone payments of up to $1 billion. Teva and Sanofi will equally share the development costs globally.

Sanofi also announced a deal with J&J for developing and commercializing the latter’s vaccine candidate for 9-valent extraintestinal pathogenic E. coli, which is a leading cause of sepsis, mainly in older adults. The vaccine candidate is currently in late-stage development. For the deal, Sanofi has agreed to make an upfront payment of $75 million to J&J and then some undisclosed milestone payments.

AbbVie Buys Private Parkinson’s Disease Drug Developer: AbbVie announced that it has exercised its exclusive right and acquired Mitokinin to strengthen its neuroscience pipeline. Mitokinin’s lead pipeline compound is a selective PINK1 activator that addresses mitochondrial dysfunction, which plays an instrumental role in the pathogenesis of Parkinson’s disease (‘PD”). The candidate, if successfully developed, could be a potential new treatment option for PD. Pre-clinical data has shown that the compound can selectively enhance the active form of the PINK1 gene, which amends mitochondrial damage and re-instates mitochondrial function.

For the deal, AbbVie is making a payment of $110 million while Mitokinin shareholders will remain eligible for potential development/commercial milestone payments of up to $545 million 

Novartis Iptacopan Phase III IgAN Study Meets Primary Goal:  Novartis’s phase III APPLAUSE study evaluating iptacopan in patients with IgAN, a complement-mediated disease, met its pre-specified interim analysis primary endpoint. Data from the study demonstrated that treatment with iptacopan, an oral factor B inhibitor targeting the alternative complement pathway, led to a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine) in patients with IgAN. The study continues to evaluate iptacopan’s ability to slow IgAN progression by measuring the estimated glomerular filtration rate (eGFR) slope over 24 months. eGFR measure is the primary endpoint at the study’s end with a final readout (24 months) expected in 2025.

Novartis plans to seek accelerated approval for iptacopan for the IgAN indication based on interim data. Novartis has also filed regulatory applications seeking approval of iptacopan for another indication, paroxysmal nocturnal hemoglobinuria, in the United States and EU while the candidate is being studied in phase III for C3 glomerulopathy, atypical hemolytic uremic syndrome and immune complex membranoproliferative glomerulonephritis.

Novartis completed the spin-off of its generic and biosimilar unit, Sandoz, following which Sandoz became an independent company. Novartis maintained its financial outlook for 2023. Sales are expected to grow in high single digits and core operating income is expected to grow in low double digits to mid-teens.

AstraZeneca Agrees to Pay $425 million to Settle Nexium, Prilosec Litigation: AstraZeneca entered into settlement agreements for pending litigations related to its proton pump inhibitors (PPIs), Nexium and Prilosec, for $425 million. Various lawsuits were filed in federal and state courts, claiming that treatment with heartburn drugs, Nexium and Prilosec, have caused the plaintiffs kidney injuries. The lawsuits claim AstraZeneca should have warned the patients about the side effects of the PPI drugs. In August 2017, the pending federal court cases were consolidated in a multidistrict litigation (MDL) proceeding in a district court of New Jersey. In addition to the MDL cases, there were cases filed in several other U.S. state courts.

The latest settlement resolves the claims pending in the MDL cases in New Jersey as well as in courts in Delaware. Only a single case remains pending in a district court of Louisiana, for which a trial is scheduled for Apr 15, 2024.

AstraZeneca’s Farxiga/Forxiga demonstrated clinically meaningful improvements in glycemia control in a pediatric type II diabetes study. Data from the T2NOW phase III study showed that treatment with Farxiga/Forxiga led to a significant reduction in A1C, a marker of average blood sugar, among patients aged 10-17 years compared to placebo. At week 26, the study achieved statistical significance in the primary endpoint and in all secondary endpoints versus placebo.

The NYSE ARCA Pharmaceutical Index declined 0.81% in the last five trading sessions.

Here’s how the eight major stocks performed in the last five trading sessions.

Image Source: Zacks Investment Research

In the last five trading sessions, while Pfizer rose the most (4.3%), Novartis declined the most (6%).

In the past six months, Lilly has risen the most (47%), while Pfizer has declined the most (19.4%).

(See the last pharma stock roundup here:FDA and EMA Regulatory Updates for ABBV, LLY, SNY & MRK’s Drugs)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.