Biogen's Alzheimer's Hope Tops The Sector's Most Valuable Pipeline Projects

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Is it telling of some frothiness in the market that the industry's most valuable late-stage asset is thought to be Biogen's (NASDAQ:BIIB) Alzheimer's antibody aducanumab? This is the opinion of the sellside, which values the project at a cool $10.3bn, according to EvaluatePharma, ahead of more validated and arguably lower-risk compounds.

Of course Alzheimer's remains a huge unmet need, and if aducanumab succeeds in arresting cognitive decline that net present value estimate will look low. But the area remains incredibly speculative, and a look at biopharma's other highly rated projects reveals some that look more likely to live up to hopes (see tables below).

Lilly's (LLY) abemaciclib is one such example. The breast cancer therapy will be third to market in its class, but data in a front-line setting, from a trial called Monarch 3, could set it apart. The study will be a huge draw at the Esmo cancer conference next month. Similarly, Gilead's (GILD) new HIV triple therapy is also thought to represent a big challenge to Glaxosmithkline's (GSK) blockbuster Triumeq.

Clearly risks remain to both of these assets; highly motivated, entrenched competitors arguably represent the biggest threat to the lofty valuations.

The list of the most highly rated biopharma assets awaiting approval also shows how valuable the CAR-T therapies are considered, relative to other pipeline projects. These NPVs are calculated by EvaluatePharma, based on a consensus of sellside analysts' forecasts.


The industry's most valuable projects awaiting regulatory approval
Product Company Project type/indication Today's NPV ($bn) Event
Abemaciclib Lilly CDK 4 & 6 inhibitor; breast cancer 9.13 US approval expected Q1'18
Axicabtagene ciloleucel Kite Pharma Anti-CD19 CAR-T therapy; NHL 7.81 PDUFA 29 Nov '17
Bictegravir/F/TAF Gilead Sciences HIV triple therapy 7.23 PDUFA 12 Feb '18
Semaglutide Novo Nordisk Weekly GLP 1 agonist; type II diabetes 5.12 PDUFA 5 Dec '17
CTL019 Novartis Anti-CD19 CAR-T therapy; ALL 4.90 PDUFA 3 Oct '17
Source: EvaluatePharma

The failure rate in Alzheimer's has not deterred Biogen from heavy pursuit of this therapy area, and aducanumab is its biggest bet to date. The company hopes that the antibody's ability to bind to more insoluble forms of amyloid beta than other similarly targeted antibodies will make a difference. But with data some years away the project remains an unknown quantity.

Much nearer on the horizon are data from the Spartan study of J&J's (JNJ) Zytiga follow-on, apalutamide, one of the company's most important potential new growth drivers. According to clinicaltrials.gov the primary completion date was in June, a date that has already been pushed back.

Abbvie (ABBV) is also gearing up to release pivotal data on its expensively acquired antibody-drug conjugate Rova-T (Event - Abbvie's long shot at proving Rova-T doubters wrong, 24 July 2017). And by the end of the year Roche (OTCQX:RHHBY) expects to release data from two trials of lampalizumab in geographic atrophy. There is no treatment for this degenerative condition, also known as advanced dry age-related macular degeneration, so while the project is risky the rewards could be high.


Biopharma's most valuable phase III assets
Product Company Project type/indication Today's NPV ($bn) Event
Aducanumab Biogen Anti-A-beta Alzheimer's antibody 10.33 Phase III data 2019/2020
Apalutamide Johnson & Johnson Anti-androgen; prostate cancer 9.97 Phase III data due H2'17
Ozanimod Celgene S1P 1 & 5 modulator; MS 8.29 US filing due by YE
Rova-T Abbvie Anti-DLL 3 antibody-drug conjugate; lung cancer 7.14 Phase III data due H2'17
Lampalizumab Roche Anti-complement factor D MAb; geographic atrophy 6.01 Phase III data due by YE
Source: EvaluatePharma

Predictably, of the filed and phase III assets in these analyses, all apart from Kite's (KITE) CAR-T therapy are in the hands of big biopharma. A look at what the sellside considers high value in phase II reveals more small company names - however, here valuations are much more arbitrary, and of course the risks much greater.

Leading the pack is Juno's (JUNO) lead CAR-T therapy, which has some big partner endorsement from Celgene (CELG), owner of ex-US and China marketing rights. The NPV in this table relates entirely to Juno - Celgene analysts have yet to put a value on the asset.

Most definitely wholly owned are Iovance's (IOVA) LN-144 and Kura's (KURA) tipifarnib; the former was until recently known as Lion Biotechnologies. Both have attracted very bullish sales forecasts for their cancer projects, although investors do not share this optimism. Iovance's market cap stands at $315m, while Kura's is $174m.


Biopharma's most valuable phase II assets
Product Company Project type/indication Today's NPV ($bn) Event
JCAR017 Juno Therapeutics Anti-CD19 CAR-T therapy; DLBCL 3.40 Pivotal study in DLBLC to start in H2'17
Neladenoson bialanate Bayer Adenosine A1 receptor agonist; heart failure 1.81 Phase II data 2018
LN-144 Iovance Biotherapeutics Tumour infiltrating lymphocyte infusion; melanoma 1.76 Interim data due by YE
ABL001 Novartis BCR-ABL inhibitor; CML 1.71 Phase I data due 2018; phase III due to start this year
Tipifarnib Kura Oncology Farnesyl transferase inhibitor; SCCHN 1.65 Phase II data H2'17; phase III due to start 2018
Source: EvaluatePharma

Among the big pharma names, Bayer's (OTCPK:BAYRY) neladenoson bialanate is one of several heart failure projects being pursued by the German conglomerate. And ABL001 is Novartis' (NVS) attempt to retain a presence in chronic myeloid leukemia in the wake of Gleevec's patent expiry.

The follow-on asset is primarily being tested in patients refractory to existing TKIs, but the Swiss company has a larger prize in sight. The compound binds to a different site on the aberrant BCR-ABL protein than existing therapies, so when used in combination it could help to prevent resistance mechanisms that lead to treatment failure with drugs like Gleevec.

The usual caveat with drug development holds for all of these examples here, of course - not all these assets will reach the market, or proceed as quickly as assumed. For example, only a few weeks ago J&J's RA asset sirukumab would have made the top five filed projects, but a surprise negative adcom vote caused it to be knocked out.

Sentiment towards the biopharma sector has been buoyant this year, boosted by a encouraging regulatory trends and several big pipeline wins. Progress or not for the high-profile assets in this analysis will help determine whether the good mood prevails.


Valuing the industry's pipeline
Stage NPV Aug 2017 ($bn)
Filed 115.81
Phase III 299.67
Phase II 78.97
Phase I 25.08
Preclinical 6.79
Research project 0.21
Total 526.33
Source: EvaluatePharma

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

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EP Vantage is a forward-looking comment and analysis service tailored to the needs of pharma and finance professionals, focusing on the events that will define the future of companies, products and therapy areas. Written by experienced journalists, EP Vantage provides timely financial analysis of regulatory and patent decisions, marketing approvals, licensing deals, and M&A, giving fresh angles and insight to both current and future industry triggers. EP Vantage is powered by EvaluatePharma, the industry leader in consensus forecasts.

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