The key biopharma catalysts of 1Q18

FirstWord takes a closer look at some of the key inflection points that will dominate industry news flow and dictate investor sentiment over the first quarter of 2018...

JANUARY

Biogen’s Tysabri (stroke) – early January

Biogen recently launched its Ionis-partnered Spinraza (nusinersen) and is working on what could be one of the sector’s biggest sellers ever in Alzheimer’s disease (AD) candidate aducanumab, but with conclusions about the latter still some years off the bellwether biotech could benefit from adding another near-term growth driver. One possibility is Biogen’s attempt to expand Tysabri (natalizumab) beyond multiple sclerosis (MS) into acute ischemic stroke. Expectations are relatively muted for the high-risk, high-reward endeavour but results from a Phase IIb trial expected early this month could significantly boost investor sentiment. (See ViewPoints: Tysabri is dead in the water for stroke, right?)

Eli Lilly’s Verzenio – mid-January

Eli Lilly’s PDUFA date for an application for Verzenio (abemaciclib) to include use as part of initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer is thought to be on or around January 10, and if successful would bring the CDK4/6 inhibitor’s label more in-line with competitors like Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib). (See Physician Views Poll Results: Like Kisqali, there is some room for Verzenio in an Ibrance-dominated market.)

Synergy’s Trulance – January 24

Synergy Pharmaceuticals’ PDUFA date for an application for Trulance (plecanatide) to include treatment of irritable bowel syndrome with constipation (IBS-C), and if successful would bring the guanylate cyclase-C (GC-C) agonist’s label more in line with its major competitor in Linzess (linaclotide) from Allergan and Ironwood Pharmaceuticals. (See KOL Views: Leading gastroenterologist says there is room for both Linzess and Trulance to thrive in CIC, though one has a slightly better profile.)

Advanced Accelerator’s Lutathera – January 26

Novartis is in the midst of buying Advanced Accelerator Applications for $3.9 billion in order to get its hands on Lutathera, a radiopharmaceutical approved for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in the EU that also has a PDUFA date of January 26 from the FDA. (See ViewPoints: Novartis silences the rumour mill with Advanced Accelerator acquisition.)

FEBRUARY

Gilead’s bictegravir – February 12

Gilead Sciences’ PDUFA date for a fixed-dose triple combination of bictegravir, emtricitabine and tenofovir alafenamide (TAF), which if successful will provide the company with some much-needed ammunition with which to fight back against ViiV Healthcare (majority owned by GlaxoSmithKline), which has picked up a lot of momentum in the HIV space with its Tivicay and Triumeq brands. (See Physician Views Poll Results: ViiV's Juluca faces an uphill task.)

Vertex’s ivacaftor/tezacaftor – February 28

Vertex Pharmaceuticals’ PDUFA date for a fixed-dose combination of marketed CFTR potentiator Kalydeco (ivacaftor) plus tezacaftor, a second-generation CFTR corrector, to treat cystic fibrosis. The product is believed to offer better safety and efficacy than the company’s initial fixed-dose combination, Orkambi (ivacaftor/lumacaftor), and more importantly will serve as the backbone for triplet combinations that are expected to enter Phase III testing this year and could drastically expand the number of cystic fibrosis (CF) patients who are amenable to therapy. (See KOL Views Results: Leading pulmonologist excited about potential of Vertex’s CF triplets but concerned about economic consequences and ViewPoints: Galapagos comes up short of a triple play, but still chugs along.)

MARCH

Bristol-Myers Squibb’s Opdivo (monthly dosing) – March 5

Bristol-Myers Squibb’s PDUFA date for an application to modify the recommended dosing schedule for Opdivo (nivolumab) to every four weeks from every two weeks across all tumour types for which it is indicated as monotherapy. The change would turn a currently modest competitive disadvantage versus Merck & Co.’s Keytruda and Roche’s Tecentriq (atezolizumab), which are administered every three weeks, into a potential selling point. AstraZeneca’s Imfinzi (durvalumab) and Pfizer/Merck KGgA’s Bavencio (avelumab) are dosed every two weeks.

FIRST QUARTER 2018 [unspecified date]

BioHaven’s rimegepant

Calcitonin gene-related peptide (CGRP) class inhibitors are expected to revolutionise the treatment of chronic migraines, and a handful of mAbs lead by Amgen/Novartis’ Aimovig (erenumab) are nearing approval in the US, and BioHaven Pharmaceutical and partner Bristol-Myers Squibb are hoping to do the same for patients with acute migraines with all-important readouts expected for a pair of Phase III trials of small molecule rimegepant. (See KOL Views Results: Leading neurologist opines on what is likely to differentiate anti-CGRP mAbs in marketplace.)

Celgene’s Revlimid (follicular lymphoma)

Celgene has another near-term opportunity to expand use of the blockbuster Revlimid (lenalidomide) beyond myeloma thanks to a readout from the Phase III AUGMENT trial in relapsed/refractory follicular. The company has been stung by several recent disappointments, including Revlimid’s failure in the RELEVANCE study in front-line follicular lymphoma and mongersen’s discontinuation in Crohn’s disease, meaning positive results from AUGMENT would be welcomed by investors anxious about its growth prospects.

Eli Lilly/Pfizer’s tanezumab

Drug candidates targeting nerve growth factor have run into some hurdles during clinical testing but a handful of groups have persisted in developing them based on the broad potential they are thought to have in treating chronic pain, especially in light of the opioid epidemic with which the US is still coming to grips. Eli Lilly and partner Pfizer are slated to report results from Phase III trials of tanezumab to treat chronic low back pain and osteoarthritis in “early 2018”, which may be an important litmus test for that anti-NGF mAb as well as others being developed by Amgen and Regeneron/Teva (along with Mitsubishi Tanabe). (See KOL Views: Despite question marks, leading expert believes anti-NGF mAbs will play major role in treating chronic pain and combating opioid epidemic.)

Regeneron/Sanofi’s Praluent

Sales for the two leading anti-PCSK9 mAbs have been sluggish, and findings from the Phase III FOURIER outcomes trial of Amgen’s Repatha (evolocumab) have not moved the needle, but the drug class gets a shot at redemption this quarter when Regeneron and partner Sanofi unveil results from the Phase III ODYSSEY-OUTCOMES of Praluent (alirocumab). Investors will be particularly keen to see whether the agent manages to significantly prevent the risk of cardiovascular death, something that Repatha was unable to achieve in FOURIER. (See The Q&A: Contextualising Repatha’s FOURIER performance – the four key questions and Physician Views Poll Results: Cardiologists suggest magnitude of benefit seen with PCSK9s will be key to driving broader adoption of drug class.)

ViiV’s dolutegravir/lamivudine

ViiV Healthcare is seeking to prize an increasingly large share of the HIV market away from Gilead Sciences by focusing on fixed-dose doublets, and results from the Phase III GEMINI 1 trial of dolutegravir plus lamivudine will be closely watched to see how much better and worse the ViiV combination fares on safety and development of resistance, respectively.

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