Novartis will spend more than $100 million over five years to develop new treatments for malaria. The funds will support clinical trials for two antimalarial drug candidates, KAF156 and KAE609, which are both in midstage clinical studies. Malaria deaths have dropped by 60% between 2000 and 2015. But the infection continues to kill more than 400,000 people each year. Novartis says it will make the drugs affordable in the countries that need them the most. (See more details on c&en)
Novartis plans to acquire the neurological gene therapy firm AveXis for $8.7 billion. The purchase will bolster the Swiss giant’s standing as a big pharma leader in the emerging gene therapy field.
AveXis’s leading drug candidate is its gene therapy to treat infants with spinal muscular atrophy type 1 (SMA1), a devastating genetic disease, sometimes called “floppy baby syndrome,” that causes weak muscles and difficulty breathing. Only 8% of afflicted infants survive to 20 months of age. Those that do rely on ventilation support and will never walk.
Chinese premier Li Keqiang said China will nix import tariffs on foreign anticancer drugs, a plan that could benefit drugmakers like Roche, Novartis and AstraZeneca, while prompting local pharmas to amp up their games.
“We aim to further bring down overall tariffs across the importing process, with tariff rates for important day-to-day consumer goods, including drugs, slashed. And we also plan to phase in zero tariff for the much-needed anti-cancer drugs,” said Li during a televised press conference at the close of the country’s annual congress conference on Tuesday.
Without providing a detailed timeline, Li also said the country will open up further to stimulate market vitality and public creativity.
In what may be the first foray by Big Pharma into the sale of medical marijuana products, Novartis has struck a deal with a Canadian company that sells medical cannabis products not only in its home country but also in Europe.
Nanaimo, British Columbia-based Tilray announced today that it has a binding agreement with Sandoz Canada to be its exclusive supplier of “non-smokable/non-combustible medical cannabis products.”
“We are thrilled to form a strategic alliance with Tilray to strengthen our portfolio,” Michel Robidoux, president and GM of Sandoz Canada, told the newspaper in a statement. “We are committed to making every reasonable effort to respond to patients’ medical needs by increasing the number of high-quality, adequately dosed non-smokable, non-combustible medical cannabis products at the disposal of doctors.”
Novartis will use its expertise to educate pharmacists about the products and to help Tilray develop new products and dose forms.
Just months after picking up Advanced Accelerator Applications in a $3.9 billion buyout, Novartis is getting a quick boost with the U.S. approval for Lutathera. The FDA approved the first-in-class med as a treatment for rare cancers of the digestive tract the other day.
Lutathera is first the peptide receptor radionuclide therapy to win U.S. approval, according to a release from AAA. Approved to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the drug works by binding to the receptors and then using radiation to fight cancer.
Jefferies analysts have predicted $500 million to $1 billion in peak sales for the drug, while Baader Helvea analyst Bruno
Bulic has been more optimistic. At the time of the AAA acquisition by Novartis last year, he predicted $2 billion in peak sales, according to Reuters.
Novartis and Biocon, which have each had success developing biosimilars on their own, will now see what they can do together. The two have formed a partnership to produce “next generation” biosimilars.
They announced the collaboration today saying they would share the costs equally for developing and commercializing multiple biosimilars in immunology and oncology. Sandoz, the generics unit of Novartis, will market them in the U.S., Canada and most of Europe, while India’s Biocon will take the rest of the world.
They said the partnership is an important part of their strategy to address the “next wave of biosimilar opportunities globally.”
Even as Celgene reportedly considers buying CAR-T player Juno Therapeutics, Novartis has its own plans to keep a leadership position in the field. On Wednesday, the drugmaker announced that Kymriah won regulatory milestones on both sides of the Atlantic as it seeks to grow its prospects with the cutting-edge technology.
CAR-T drug Kymriah picked up an FDA priority review in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) for adults who can’t have an autologous stem cell transplant or for those who relapse after the procedure, the drugmaker announced. In Europe, regulators granted an accelerated assessment for children and adults with r/r B-cell acute lymphoblastic leukemia (r/r ALL) and for adults with r/r DLBCL.
Novartis won the world’s first CAR-T nod in August for Kymriah to treat r/r ALL patients up to 25 years old. CAR-T drugs are one-time treatments made of cells that are collected from each patient, re-engineered and then infused back into the patient to attack cancer.