This week Pfizer (PFE - Free Report) and Teva (TEVA - Free Report) gained marketing approval from the European Commission for their new medicines. While Pfizer gained approval for its new lung cancer medicine, Vizimpro, Teva’s CGRP injection, Ajovy was approved in EU. Meanwhile, Novartis (NVS - Free Report) announced plans to acquire IFM Tre, a subsidiary of privately held IFM Therapeutics. The acquisition will give Novartis full rights to IFM’s two NLRP3 inhibitors. Meanwhile, Novartis’ blockbuster psoriasis drug, Cosentyx was approved in China while Merck’s (MRK - Free Report) Keytruda was approved in the country for first-line lung cancer as a combination therapy.
Recap of the Week’s Most Important Headlines
Teva & Pfizer’s Medicines Get Approval in EU: Teva’s CGRP injection, Ajovy was granted marketing approval by the European Commission for the prophylaxis of migraine in adult patients who experience at least four migraine days per month. Ajovy (fremanezumab), for prevention of chronic/episodic migraine, was approved in the United States in September last year and has been enjoying strong demand since launch.
Pfizer also gained marketing approval in EU for its new lung cancer medicine, Vizimpro (dacomitinib) that was approved in the United States last September. Vizimpro (dacomitinib), a tyrosine kinase inhibitor, is now approved in EU for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations.
Novartis’ New Immunology Acquisition: Novartis announced plans to acquire IFM Tre, a subsidiary of Boston-based IFM Therapeutics, for an upfront payment of $310 million upfront. In addition, IFM will also be eligible to earn up to $1.265 billion in milestone payments. The deal will give Novartis full rights to IFM’s two NLRP3 inhibitors - one clinical and two preclinical. These medicines target the NLRP3 inflammasome, a key component of the innate immune system, thereby providing a novel approach to preventing chronic inflammation that results in serious disease. The deal complements Novartis’ existing pipeline of anti-inflammatory medicines. The transaction is expected to close in the second quarter of 2019.
Meanwhile, Novartis’ blockbuster psoriasis drug, Cosentyx was approved in China. Cosentyx, a first-in-class interleukin-17A (IL-17A) inhibitor, is the first biologic approved in China for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Novartis’ generic arm, Sandoz announced re-submission of its regulatory application to the FDA looking for approval of its biosimilar version of Amgen’s neutropenia drug, Neulasta. Novartis had earlier in June 2016 received a complete response letter from the FDA for the same. Neutropenia is one of the most serious side effects of chemotherapy.
Novartis also notified of a dispute with Amgen relating to their collaboration agreement for the newly launched migraine medicine, Aimovig. Novartis said that Amgen issued a notice of termination of the agreement on Apr 2. Novartis strongly disputes the notice and has sued Amgen accusing the biotech of making an unjustifiable attempt to end the collaboration with Novartis.
Merck’s Keytruda Gets Approval in China for First-Line Lung Cancer: Merck announced that the Chinese regulatory authority has granted conditional approval to Keytruda in combination with Lilly’s Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The approval was based on significant survival benefit demonstrated in a key late-stage lung cancer study, KEYNOTE-189. Notably, data from the KEYNOTE-189 study is already included in Keytruda’s U.S. and EU label.
FDA Grants AstraZeneca/Merck’s Selumetinib Breakthrough Therapy Status: AstraZeneca (AZN - Free Report) and Merck’s MEK 1/2 inhibitor, selumetinib was granted Breakthrough Therapy designation by the FDA for the treatment of neurofibromatosis type 1 (NF1) related plexiform neurofibromas, an incurable genetic condition that affects newborns. Selumetinib is being evaluated in a phase II SPRINT study in pediatric patients with inoperable NF1-related PN, which formed the basis of the designation.
Allergan’ Abicipar Shows Better Inflammation in AMD Study: Allergan’s (AGN - Free Report) phase III MAPLE study evaluating a 12-week dose of its long-acting anti-VEGF candidate, abicipar pegol, demonstrated decreased intraocular inflammation in patients with age-related neovascular macular degeneration (nAMD). MAPLE used a modified manufacturing process to test an optimized 12-week formulation of abicipar in nAMD patients. Following the improved manufacturing process, it was observed that the incidence of intraocular inflammation (IOI) in the study was lower than previous phase III studies. In the MAPLE study, the reported incidence of IOI was 8.9%, which was less than around 15% observed in the previous studies, SEQUOIA and CEDAR. The companies plan to file a biologics license application (BLA) for abicipar in the first half of 2019.
Pfizer/Sangmo Announce Promising Data on Gene Therapy Candidate: Pfizer and its partner, Sangamo Therapeutics announced encouraging interim data from a phase I/II study evaluating their gene therapy candidate, SB-525, for treating hemophilia A. Data from the study showed that patients treated with the highest dosage of SB-525 (3e13 vg/kg) achieved normal factor VIII levels. Dose dependent increase in factor VIII levels was observed in eight patients treated with SB-525 gene therapy across the four dosage cohorts. Excess levels of factor VIII increase blood clotting, which is a major symptom of haemophilia. Based on the data from the study, the Safety Monitoring Committee (SMC) recommended expansion of the 3e13 vg/kg cohort.
Meanwhile, Pfizer’s breast cancer drug Ibrance in combination with an aromatase inhibitor or fulvestrant gained FDA’s approval for the treatment of men with HR+, HER2- metastatic breast cancer.
The NYSE ARCA Pharmaceutical Index declined 1% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All the stocks were in the red in the last five trading sessions, except Pfizer, which rose 1.1%. AstraZeneca declined the most (5.7%).
In the past six months, Merck has been the biggest gainer (14.5%) while Bristol-Myers (BMY - Free Report) declined the most (25.8%).
(See the last pharma stock roundup here: AZN Inks Cancer Deal, ABBV, NVS & Others Get Drug Approvals)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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