It was a busy week for the biotech sector, with updates from quite a few players. While Amgen AMGN reported positive data on its multiple myeloma drug combination, Biogen’s BIIB studies in Alzheimer’s disease disappointed. Meanwhile, Alder ALDR surged as it signed an acquisition agreement with Danish pharmaceutical company, Lundbeck and Aimmune Therapeutics AIMT got a favorable recommendation from an FDA committee.
Recap of the Week’s Most Important Stories:
Biogen Stops Late-Stage Studies on Alzheimer's Candidate: Biogen and its Japan-based partner Eisai announced the discontinuation of two late-stage studies evaluating their Alzheimer’s disease (“AD”) candidate, elenbecestat. The decision was taken following a safety review conducted by the Data Safety Monitoring Board. The board’s recommendation to discontinue the studies was due to an unfavorable risk-benefit ratio. The two phase III studies with identical protocols were evaluating elenbecestat, an oral BACE inhibitor, in patients with mild cognitive impairment or mild AD, collectively known as early AD. The companies will also halt the long-term extension of the phase II study (Study 202) on elenbecestat as part of this decision. Biogen continues to develop another AD candidate, BAN2401, in a phase III Clarity AD study.
Amgen’s Multiple Myeloma Combo Positive in Phase III: Amgen announced that a three-drug combination regimen of its multiple myeloma (MM) drug, Kyprolis, improved progression-free survival (PFS) in a phase III study. The phase III CANDOR study evaluating Amgen's Kyprolis + dexamethasone and Darzalex in patients with relapsed or refractory multiple myeloma met the primary endpoint of PFS compared to only Kyprolis + dexamethasone (Kd). In the study, treatment with the three-drug combo (KdD) led to a reduction in the risk of progression or death by 37% in patients with relapsed or refractory MM. The median PFS for patients who received Kd alone was 15.8 months. However, as of the cut-off date, the median PFS has not been reached for patients in the KdD arm. Also, there were a higher number of adverse events like thrombocytopenia, anemia, diarrhea and hypertension, among others, reported in the KdD regimen compared to Kd.
Amgen currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene's Leukemia Drug Meets Endpoints in Study: Celgene CELG announced top-line results from the international phase III study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational CC-486 as maintenance therapy in patients with newly-diagnosed acute myeloid leukemia (AML), who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy. The primary endpoint of the study was overall survival. The results showed that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement.
New CFO for Alexion: Alexion ALXN announced plans for the transition of executive vice president and chief financial officer Paul Clancy later this year. He will be succeeded by Aradhana Sarin, M.D., who is currently the chief strategy and business officer. The transition will take place after the filing of the company’s third-quarter results. Clancy will continue to serve as a senior advisor through mid-2020.
Alder Surges on Acquisition Agreement: Shares of clinical-stage biopharmaceutical company, Alder BioPharmaceuticals skyrocketed after it announced an acquisition agreement with Danish pharmaceutical company, Lundbeck A/S, for $1.95 billion. Per the agreement, Lundbeck will commence a tender offer for all outstanding shares of Alder for an upfront payment of $18.00 per share in cash, a 79% premium to the latter’s share price of $10.06, on Sep 13. Additionally, Alder’s shareholders will receive one non-tradeable Contingent Value Right (CVR) that entitles them to an additional $2.00 per share upon a potential approval of pipeline candidate, eptinezumab, by the European Medicines Agency (EMA). The deal is expected to close in the fourth quarter of 2019, subject to customary closing conditions.
Notably, the company is developing eptinezumab, an investigational monoclonal antibody (mAb), for the preventive treatment of migraine in adults. Apart from eptinezumab, the company is developing ALD1910, a mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention. The addition of eptinezumab will broaden Lundbeck’s brain disease franchise.
Aimmune's Peanut Allergy Drug Gets FDA Committee's Recommendation: Aimmune Therapeutics announced that the Allergenic Products Advisory Committee (APAC) convened by the FDA voted in favor of pipeline candidate, Palforzia. The committee supported the use of the drug in children and teens with peanut allergy. The APAC voted in favor of the candidate’s effectiveness in the ratio of 7 to 2. The committee also voted in the ratio of 8 to 1 in favor of the safety data in conjunction with additional safeguards, which are adequate to support the use of the drug. Palforzia, the proposed trade name of AR101, is a complex, biologic oral immunotherapy (OIT) candidate, which is designed to reduce the incidence and severity of allergic reactions.
As part of its original BLA submission, Aimmune has proposed several risk-management measures in line with the recent Advisory Committee discussion. Trading was halted on Sep 13, owing to the scheduled meeting of APAC.
Acceleron Discontinues Mid-Stage Muscular Dystrophy Study: Acceleron Pharma Inc. XLRN announced the discontinuation of a phase II study evaluating its pipeline candidate, ACE-083, in patients with facioscapulohumeral muscular dystrophy (FSHD). Although ACE-083 demonstrated a robust, statistically significant increase in mean total muscle volume (the primary endpoint of the trial), the increase failed to translate to statistically significant improvements in functional tests. The candidate did not achieve functional secondary endpoints in the study either. Consequently, Acceleron discontinued further development of the candidate in FSHD patients.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 2.07% in the last five trading sessions. Among the biotech giants, Vertex gained 2.92% in the period. Over the past six months, shares of Celgene have gained 12.06%, whereas the Regeneron stock has slumped 29.31%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN’s Lung Cancer Candidate, ALXN’s Deal With Eidos in Focus)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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