Bristol, Inc.

Courtesy of Getty Images Aurinia Pharmaceuticals has agreed to jointly motion with India's Sun Pharmaceuticals (Sun Pharma) to dismiss the inter parties review of patent No. 10,286,036., the British Columbia-based company announced Tuesday. The proposed dismissal is contingent upon approval by the U.S. Patent Trial and Appeal Board. If approved, this motion would effectively settle a key patent dispute for Aurinia's flagship drug Lupkynis. Lupkynis is the first orally administered lupus nephritis (LN) medication approved by the FDA. Aurinia’s shares jumped by 36% in early morning action Tuesday in response to the news. The key reason behind the biotech’s surging share price is that Aurinia was widely considered a potential takeover target due to Lupkynis’ unique clinical pro sizable commercial opportunity (greater than $1 billion in annual sales at peak). This patent dispute, however, tamped down the buyout fervor that had pushed Aurinia’s shares to a five-year high in late 2021. In fact, the biotech’s shares lost a noteworthy 51% of their value since this patent dispute news became public knowledge last summer. Sun’s Patent Dispute Put the Brakes on Aurinia’s Buyout Thesis On July 26, 2022, the PTAB reportedly initiated an inter parties review following a petition filed by Sun Pharma. The dispute centered around a patent claiming Lupkynis' dosing protocol that extends the drug’s U.S. exclusivity to 2037. This potential settlement agreement with Sun Pharma could remove a key overhang for the Canadian biotech. Moreover, it possibly re-opens the door for a lucrative tender offer down the road. Prior to the patent dispute, Aurinia was rumored to be fetching serious interest from several industry heavyweights including Bristol Myers Squibb. Although Bristol appears to have moved on to other business development deals since these rumors first surfaced, Aurinia may still interest a number of big pharmas on the hunt for value-creating acquisitions. That being said, Lupkynis’ commercial trajectory hasn’t quite lived up to expectations – a fact that may lower the drugmaker’s appeal to potential buyers. Thanks to a slowdown in LN diagnoses and patient visits due to the pandemic, Aurinia was forced to lower its 2022 annual revenue guidance to between $100 million and $105 million during its Q3 earnings call. Previously, the drugmaker was guiding for $115 million to $135 million in annual revenue for the year. What’s more, Aurinia’s initial 2023 fiscal guidance only calls for revenue of between $120 million to $140 million. Lupkynis, in turn, may take a lot longer than originally anticipated to hit blockbuster status, although a big pharma with a larger sales infrastructure might be able to dramatically improve its commercial performance.

Courtesy of Sarah Silbiger/Getty Images As we move into 2023, BioSpace takes a pause to reflect on the year gone by and some of the most remarkable news bits. Today, we look at the top five noteworthy FDA drug and biologic therapy approvals in 2022. These newly approved medicines stand out as significant advancements in treating certain forms of cancer, cardiovascular disease and rare inherited disorders. 1. Mirati Therapeutics’ Krazati (adagrasib) In early December, the FDA granted accelerated approval to Krazati for adults with KRAS G12C mutated, metastatic non-small cell lung cancer. Krazati is a potent oral small molecule inhibitor of KRAS G12C. Krazati is only the second KRAS inhibitor approved by the agency – a cancer target that was once believed to be undruggable. Amgen’s Lumakras was the first KRAS inhibitor to hit the market in May 2021. While estimates vary, Wall Street’s peak sales forecast has the novel lung cancer therapy generating more than $1 billion in sales at peak. Mirati has been a staple of the buyout rumor mill in 2022 due to these upbeat sales predictions. On the clinical side, “It's always good to have more than one class because some people do tolerate one better than the other one," said Alexander Spira, M.D., an oncologist and co-director of the Virginia Cancer Specialists Research Institution, in a prepared statement. 2. Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) In June, the FDA approved Alnylam’s Amvuttra for hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy. Amvuttra belongs to an emerging class of novel treatments known as RNA interference therapeutics (RNAi for short). This approval is important for two reasons. Clinically, Amvuttra's green light from the FDA for hATTR with polyneuropathy provides another viable treatment option for patients with this devastating nerve disorder. Michael Polydefkis, M.D., Johns Hopkins Neurology and HELIOS-A Study investigator, said the approval is very encouraging for the hATTR amyloidosis community, adding that Amvuttra has demonstrated the potential to halt or reverse polyneuropathy progression in patients with an acceptable safety profile. Secondly, Amvuttra's approval in this setting could set the stage for a run on RNAi drugmakers next year. Alnylam, for its part, is likely a top target within the RNAi space. 3. Bristol Myers Squibb’s Camzyos (mavacamten) In April, BMS announced the FDA approval of Camzyos to treat symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos was the centerpiece of Bristol’s $13.1 billion buyout of MyoKardia in late 2020. With peak sales estimated at more than $4 billion per year, the heart failure medication is widely expected to play a vital role in the pharma giant’s battle against a wave of upcoming patent expiries for top-selling products like Opdivo and Eliquis. Camzyos is the only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM, according to the company. "With this approval, cardiologists now have a new pharmacological option for eligible patients that targets the underlying pathophysiology of the disease,” said Milind Desai, M.D., director of the Hypertrophic Cardiomyopathy Center and director of clinical operations in Cleveland Clinic’s Heart Vascular & Thoracic Institute. 4. bluebird bio’s Skysona (eli-cel) In September, bluebird bio notched its second FDA approval of the year with Skysona, a single-use gene therapy indicated for patients with the rare neurological disorder cerebral adrenoleukodystrophy (CALD). Skysona is noteworthy for two reasons. First, the one-time infusion will reportedly cost $3 million, making it the priciest therapeutic on the market. Second, it adds to a growing list of commercially available gene therapies in the U.S. Not all that long ago, the field of gene therapy was marred by unsightly safety issues and less-than-stellar efficacy results. Next-generation developers like bluebird, however, have radically changed the space with safer and more efficacious products. 5. Amylyx Pharmaceuticals’ Relyvrio (AMX0035) In September, the FDA green-lit Amylyx’s hotly contested amyotrophic lateral sclerosis (ALS) drug, Relyvrio. ALS is also known as Lou Gehrig's disease. Relyvrio is an interesting story for two big reasons. First and perhaps most importantly, no disease-modifying treatments were available to ALS patients prior to Relyvrio’s approval. As such, this FDA approval qualifies as a significant advancement in the treatment paradigm for this progressive neurodegenerative disease. Second, Relyvrio’s regulatory review was anything but business as usual. In March, the FDA’s panel of experts initially voted against approving the drug, despite the high unmet medical need in ALS. However, the agency later agreed to a second expert panel vote after the company submitted new analysis. This new analysis led to a positive panel vote, paving the way for Relyvrio’s approval. Wall Street expects Relyvrio to rake in nearly $500 million per year at peak commercial performance.

CAMBRIDGE, Mass.--( BUSINESS WIRE )--LifeMine Therapeutics Inc., a biopharmaceutical company refashioning drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere, today announced the appointment of Elliot Ehrich, M.D., as chief medical officer and executive vice president of translational science, and of Lata Jayaraman, Ph.D., as executive vice president and head of biology. “Elliot and Lata are truly distinguished and accomplished drug development professionals. We welcome them with great enthusiasm to crucial leadership positions on the LifeMine expeditionary force,” said Gregory Verdine, Ph.D., co-founder, president and chief executive officer of LifeMine. “Their deep expertise, spanning target selection and preclinical discovery through all phases of clinical investigation and on to FDA approval, will be critical as we continue to source mechanistically and structurally novel small molecule leads and drive them toward the clinic with unparalleled speed, predictability and scalability." Elliot Ehrich, M.D., appointed to CMO and EVP, translational science Dr. Ehrich most recently served as president of Skyhawk Therapeutics. Before joining Skyhawk as the company’s chief medical officer, Dr. Ehrich served as a venture partner at 5AM Ventures and as chief medical officer at Expansion Therapeutics, a 5AM Ventures portfolio company. Dr. Ehrich previously spent 17 years at Alkermes, leading the development and successful FDA registration of multiple new medicines as chief medical officer and executive vice president of R&D. Prior to Alkermes, Dr. Ehrich held positions of increasing responsibility in clinical pharmacology and clinical research at Merck. Dr. Ehrich received his M.D. from Columbia University, completed a residency in internal medicine and a fellowship in immunology and rheumatology at Stanford University Medical School followed by postdoctoral training in the Department of Microbiology and Immunology. He received a B.A. in biochemistry from Princeton University. Lata Jayaraman, Ph.D., appointed to EVP, head of biology Dr. Jayaraman most recently served as head of oncology drug discovery at the Mechanisms of Cancer Resistance (MoCR) Thematic Research Center (TRC) at Bristol Myers Squibb, Cambridge. She began her career over 20 years ago as a research investigator at BMS, Lawrenceville leading multiple small and large molecule projects across diverse target classes within oncology and immuno-oncology. Prior to rejoining Bristol Myers Squibb in 2019, she served as senior director and head of tumor immunotherapy at Seres Therapeutics and as director of pharmacology and translational research at Cerulean Pharma. Earlier, Dr. Jayaraman served as director, oncology at Merck. Dr. Jayaraman earned her Ph.D. in cancer biology at Columbia University and completed her postdoctoral training in cancer biology at the Memorial Sloan-Kettering Cancer Center. About LifeMine Therapeutics LifeMine Therapeutics is refashioning drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere. Through its proprietary, evolutionarily-derived genomic drug discovery platform, LifeMine is bringing unparalleled speed, predictability and scalability to small molecule drug discovery. LifeMine has discovered, in genomic space, hundreds of potentially high-impact drug candidates relevant to targets across all major disease areas, and has an initial focus on advancing highly impactful precision medicines in oncology and immune modulation. The company was founded in 2017 by renowned entrepreneur/scientists Gregory Verdine, Ph.D., and Richard Klausner, M.D., and entrepreneur/company-builder WeiQing Zhou. Headquartered in Cambridge, Mass., with offices in Gloucester Harbor, Mass. and Basel, Switzerland, LifeMine has raised more than $295 million from leading life science investors. For additional information, please visit www.lifeminetx.com .