This week’s most eye-catching news was AstraZeneca’s AZN collaboration deal —potentially costing as much as $6.9 billion —with Japan’s Daiichi Sankyo to jointly develop and commercialize a promising cancer treatment. In other news, AbbVie ABBV gained approval for risankizumab in Japan, which marked the first global approval for this key pipeline candidate. Novartis’ NVS multiple sclerosis candidate siponimod, which targets patients whose disease has progressed, gained FDA approval while AstraZeneca’s type II medicine, Forxiga, gained approval in EU and Japan for type-I diabetes.
Recap of the Week’s Most Important Headlines
AstraZeneca’s $6.9B Collaboration Deal with Daiichi Sankyo: AstraZeneca announced a collaboration deal with Japan’s Daiichi Sankyo to jointly develop and commercialize the latter’s cancer candidate trastuzumab deruxtecan for an upfront payment of $1.35 billion as well as contingent payments of up to $5.55 billion. Daiichi, however, retained exclusive rights to the drug in Japan. The companies will equally share development and commercialization costs. AstraZeneca informed that it will fund the transaction partly through a share issue of up to $3.5 billion.
AstraZeneca claims that trastuzumab deruxtecan, a proprietary antibody-drug conjugate (ADC), has the potential to redefine the standard of care in cancer treatment. It is being developed in five pivotal late-stage studies for HER2-expressing cancers, including breast and gastric cancer and in mid-stage studies for HER2-expressing advanced colorectal cancer and metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC. A first regulatory application is expected to be filed in the second half of 2019 for advanced or refractory breast cancer.
AstraZeneca’s type II medicine, Forxiga gained approval in EU and Japan for a new indication — as an oral adjunct treatment to insulin in adults with type-I diabetes. It is under review in the United States for the same indication with a decision expected in the second half of 2019. Farxiga/Forxiga, a key driver of AstraZeneca’s top line, recorded sales of almost $1.4 billionin 2018, representing growth of 30%.
Novartis Multiple Sclerosis Drug Gets FDA Approval: Novartis gained FDA approval for Mayzent (siponimod) to treat relapsing forms of multiple sclerosis including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS). With the approval, Mayzent became the first oral medicine approved to treat active SPMS. The approval was based on data from the phase III EXPAND, which had shown that Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline. Mayzent is also under review in Europe.
AbbVie Gets First Regulatory Approval for Risankizumab: AbbVie announced the first global approval for its key pipeline candidate, risankizumab. The Japanese regulatory authority granted approval to risankizumab, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis. Risankizumab, which will be marketed by the trade name of Skyrizi, is under review in the United States and EU for plaque psoriasis. A decision in the United States is expected in the first half of the year. It is being studied in late-stage studies for Crohn’s disease.
Bayer/J&J Settle Xarelto Litigations: Bayer BAYRY and partner J&J JNJ settled all ongoing lawsuits, including cases in federal and state courts, in connection with blood thinner Xarelto for $775 million. The more than 25,000 lawsuits were filed by patients who suffered a bleeding injury after taking Xarelto. The settlement resolves all pending claims related to Xarelto, thereby removing an overhang on the company and eliminating litigation expenses.
New Immunology Collaboration for Lilly: Eli Lilly LLY gained an exclusive, worldwide license to develop and commercialize a novel immunometabolism target from private biotech, ImmuNext for an upfront payment of $40 million. The novel target can be developed into new medicines to treat autoimmune diseases. In addition to the upfront payment, Lilly will be entitled to pay up to approximately $565 million in development and commercialization milestone payments as well as future royalties on product sales to ImmuNext.
J&J Files sBLA for Darzalex: J&J filed a supplemental biologics license application (sBLA) seeking approval of its immunotherapy, Darzalex in combination with its proteasome inhibitor Velcade (bortezomib), thalidomide and dexamethasone (VTd)) in newly-diagnosed, transplant eligible multiple myeloma patient population. The filing was based on data from a phase III CASSIOPEIA study.
J&J also filed a supplemental new drug application (sNDA) to the FDA seeking approval to include data from the phase III CREDENCE study on the label of its type II diabetes medicine, Invokana. The study evaluated Invokana for slowing the progression of chronic kidney disease in patients with type II diabetes and chronic kidney disease who are at high risk of experiencing kidney failure.
Aldeyra Eye Drug Achieves Primary Endpoint in Phase III: Aldeyra Therapeutics’ phase III ALLEVIATE study evaluating its experimental eye drop for allergic conjunctivitis, reproxalap, met the primary as well as the key secondary endpoints for both concentrations of this lead candidate. The company plans to meet with the FDA to discuss a drug application in the second half of the year. Reproxalap is also being studied in a late-stage study for dry eye disease.
The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions:
It was a mixed performance in the last five trading sessions. While Glaxo recorded the highest gain of 1.6%, Bristol-Myers BMY declined the most (2.2%).
In the past six months, Lilly has been the biggest gainer (19.9%) while Bristol-Myers declined the most (22.9%).
(See the last pharma stock roundup here: Regulatory Updates from MRK, PFE, J&J, AGN & Others)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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