July 2016 Welcome to the Latest Issue of Evaluate’S Calendar of Events Newsletter, Your Monthly Digest of Upcoming Events in the Industry

Market movers and shakers

Key Upcoming Trial Results Key Upcoming Regulatory Dates Top Gains (Past Month) Top Losses (Past Month) Market Moving Events

July 2016 Welcome to the latest issue of Evaluate’s Calendar of Events newsletter, your monthly digest of upcoming events in the industry. Each issue highlights key clinical and regulatory events, as well as providing you with detailed analysis of some of the biggest moving events over the last month and opinion from EP Vantage.

This month’s edition features a look at Amgen’s ABP 501 – Humira’s first biosimilar version, Bayer’s phase II trial of copanlisib in non-Hodgkin lymphoma, and an analysis of several Parp inhibitor products in late-stage development. Ignatius Fogarty, Product Manager

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Key Upcoming Trial Results

KEY UPCOMING TRIAL RESULTS

Company/Product Event NPV Event NPV % Event End Date 2022 Consensus ($m) of Mkt Cap Sales Forecast ($m)

Phase III Trial Results

Alexion Pharmaceuticals – Strensiq 2649 10% Phase III Results – 31/07/16 1128 Hypophosphatasia

Phase II Trial Results

SAGE Therapeutics – SAGE-547 1710 171% Phase II Results – 12/07/16 996 Postpartum Depression

Exelixis – Cometriq 1052 56%3Phase II Results – 1/07/16 487 Non-Small Cell Lung Cancer

Celldex Therapeutics – CDX-011 504 111%3Phase II Results – 1/07/16 188 Metastatic Melanoma

Pharming – Rhucin/Ruconest 167190%3Phase II Results – 1/07/16 10 Prophylaxis of HAE

KEY UPCOMING REGULATORY DATESCOMMENT ON SAGE – 547 Company/Product Event NPV Event NPV % Event End Date 2022 Consensus Sage Therapeutics’($m) phaseof Mkt CaII ptrial in post-partum depression looks toSales build Forecast on ($m)the KEY UPCOMING TRIAL RESULTS results of a four patient phase I trial which completed in October last year. A key US Product Approval difference in this new trial is the inclusion of a placebo control – however, it is Company/Product Event NPV Event NPV % Event End Date 2022 Consensus Sanoﬁ – Lyxumia high placebo98($m) response31of%U Mktwhich Cap has Sbeen Produc thet Appr baneoval – of many31 a/0 7/CNS16 disorder34Sales3 Forecast trial ($m) in the past. Whilst the majority of 547’sDiabet saleses, type are II (maturit forecasty onset) to come from epilepsy, Phase III Trial Results Zealand Pharma – Lyxumia success in additional2615 indications7% couldUS Produc pusht Appr ovital over – the blockbuster31/07/16 line by 2022. Alexion Pharmaceuticals – Strensiq 2649 10% DiabetPhase es,III Re tysultpe IIs (m– aturity onset) 31/07/16 1128 Hypophosphatasia Progenics Pharmaceuticals – Oral RelistorCOMMENT90 22ON CELLDEX91%U – CDX-011S Product Approval – 19/07/16 46 Phase II Trial Results Constipation, opioid-induced Following Celldex’s discontinuation of the phase III ACT IV study of Rintega in SAValeantGE Therap Pharmaeuticsceuticals – SAGE Inte-5rnat47 ional –March, Oral Relistor CDX-01117101082 is now171%%U the company’sPhaseS Produc II most Retsult Apprs advanced–ov al – asset12/0197//016 7/in16 development.996 ConsPostpatipation,rtum Depression opioid-induc ed Data for the single agent arm of the drug’s phase II trial in metastatic melanoma ExVaelixisleant –Pharma Cometriqceuticals International –is Ve forthcoming,sneo 10765271 with combination561%%3 dataUSPhase Produc IIto Re tsult readApprs –ov alout – later. CDX-0111/2107/0/167/16 is not483367 expected GlNoaucoman-Small Cell Lung Cancer KEY UPCOMING TRIAL RESULTS to launch until 2019, with breast cancer the treatment’s most clinically advanced CelldeNicox –x TherapVesneoeutics – CDX-011 indication to5026 date.184 However,1113%%3 beingUSPhase a Produc cancer II Retsult Apprs –vaccine,ov al – the1/ road2107/0/167/16 to market188 is still GlMetastaticaucoma Melanoma Company/Product fraught with Eventrisk NPVof failure.Event NPV % Event End Date 2022 Consensus KEY UPCOMING TRIAL RESULTS ($m) of Mkt Cap Sales Forecast ($m) PharmingEU Produc –t ApprRhucin/Rucoval onest 167190%3Phase II Results – 1/07/16 10 Prophylaxis of HAE Phase III Trial Results JohnsonCompany/Product & Johnson – Stelara 15Event222 NPV 5%Event NPV % EUEvent Product Approval – End31 Date/07/16 46202290 Consensus ($m) of Mkt Cap Crohn's disease Sales Forecast ($m) Alexion Pharmaceuticals – Strensiq Key Upcoming2649 10% RegulatoryPhase III Results – Dates31/07/16 1128 Hypophosphatasia AbKEYPhasebV UPCOMINGie III – Tr Zinbial Resulryta REGULAts TORY DATES 1033 1% EU Product Approval – 31/07/16 448 Multiple Sclerosis AlPhaseexion II PharmaceuticalsTrial Results – Strensiq 2649 10% Phase III Results – 31/07/16 1128 Company/Product Event NPV Event NPV % EventHypophosphatasia End Date 2022 Consensus Biogen – Zinbryta 57($m)21of%E Mkt Cap U Product Approval – 31/07/16 39Sales0 Forecast ($m) SAGE Therapeutics – SAGE-547 1710 171% MultiplePhase II ScleResultrosis –s 12/07/16 996 Phase II Trial Results Postpartum Depression US Product Approval SAExelixisGE Therap – Cometriqeutics – SAGE-547 17101052 171%56%3Phase II Results – 121//0077//1166 994876 TSanoﬁOP 5 GAINS– Lyxumia 9831%UPoNoSst n-PrpaSmalloducrtum tCell ApprDepression Luovngal C–anc er 31/07/16 343 Diabetes, type II (maturity onset) Celldex Therapeutics – CDX-011 504 111%3Phase II Results – 1/07/16 188 ExEventelixis Date – CometriqCompany/Product 1052 56%3Change %Phase II ResultMarkets – Cap ($m) 1/07/1Event6 Type487 Zealand Pharma – Lyxumia 26157% USNoMetastatic n-ProducSmall tMelanomaCell Appr Luovngal C –anc er 31/07/16 Diabetes, type II (maturity onset) 29/06/16 TESARO – Niraparib108.0%3,548 Phase III Trial Results CelldePharmingx Therap – Rhucin/Ruceutics – onestCDX-01 1 5016714 11190%3%3Phase II Results – 1/07/16 18810 Progenics Pharmaceuticals – Oral Relistor 902291%UMetastaticProphyS Produclaxis tMelanoma Approf HAEov al – 19/07/16 46 06/06/16 Vascular Biogenics – VB-111 72.5%1Constipation, opioid54 -induced Phase I/II Trial Results Pharming – Rhucin/Ruconest 167190%3Phase II Results – 1/07/16 10 22/06/16 Nymox Pharmaceutical – NX-120735.2% 37 Phase III Trial Results Valeant Pharmaceuticals International – Oral Relistor 1082%UProphyS Produclaxist Approf HAEov al – 19/07/16 KEY UPCOMING REGULATORY DATES Constipation, opioid-induced 28/06/16 Xencor – XmAb1404532.1% 164Licensing Announcement Valeant Pharmaceuticals International – Vesneo 76711% US Product Approval – 21/07/16 336 Company/Product Event NPV Event NPV % Event End Date 2022 Consensus 10/06/16 Eagle Pharmaceuticals – Bendeka 27.8%1Glaucoma 81 Patent Challenge KEY UPCOMING REGULATORY DATES ($m) of Mkt Cap Sales Forecast ($m)

Nicox – Vesneo 26183% US Product Approval – 21/07/16 US Product Approval Company/Product Event NPV Event NPV % EventGlaucoma End Date 2022 Consensus TOP 5 LOSSES ($m) of Mkt Cap Sales Forecast ($m) Sanofi – Lyxumia 9831%US Product Approval – 31/07/16 343 EU Product Approval Diabetes, type II (maturity onset) EventUS Produc Datet ApprCompany/Productoval Change % Market Cap ($m) Event Type Johnson & Johnson – Stelara 15222 5% EU Product Approval – 31/07/16 4690 SanofiZealand – PharmaLyxumia – Lyxumia 98261531%U7% USS PrProducoduct Approval – 31/07/16 343 20/06/16 BELLUS Health – Kiacta -86.0% Crohn's diseas15e Phase III Trial Results Diabetes, type II (maturity onset) AbbVie – Zinbryta 1033 1% EU Product Approval – 31/07/16 448 29/06/16Progenics PharmaceGalenauticals Biopharma – Oral Reli– NeustorVax 902291%U-82.8% S Product Appr64oval – 19/0Phase7/16 III Trial46 Results Zealand Pharma – Lyxumia 26157% USMultiple Produc Sclet Apprrosisoval – 31/07/16 DiabetConstipation,es, type opioid II (maturit-inducy onset)ed 13/06/16 Marinus Pharmaceuticals – Ganaxolone -69.7%32 Phase III Trial Results Biogen – Zinbryta 5721%EU Product Approval – 31/07/16 390 ProValeantgenic Pharmas Pharmaceceuticalsuticals Inte – rnatOralional Reli stor– Oral Relistor 9010822291%U%US Product Approval – 19/07/16 46 14/06/16 Infinity Pharmaceuticals – Duvelisib -69.2% Multiple Sclerosi67s Phase II Trial Results Constipation, opioid-induced

06/06/16 ProNAi Therapeutics – PNT2258 -67.6%62 Clinical Hold Valeant Pharmaceuticals International – OVeralsneo Relistor 107682711%%UUSS PrProducoduct Approval – 1921/07/16 336 TOP 5 GAINS ConsGlaucomatipation, opioid-induced With a 12 - 2 vote in favour of approval in an AdCom in May, Sanofi’s Lyxumia, Nicox – Vesneo 26183% US Product Approval – 21/07/16 VaEventleant Date PharmaceCompany/Productuticals International –as Ve wellsneo as combo7671 drug1% LixiLanChange (Lyxumia %US Produc +Lantus),t ApprMarketoval –Cap look ($m) likely21/0 Event7/to16 receive Type336 the go Glaucoma ahead from the FDA in July and August respectively. In spite of this, the company 29/06/16 TESARO – Niraparib108.0%3,548 Phase III Trial Results NiEUco Prx oduc– Vetsneo Approval appears to be2618 losing ground3% to NovoUS Produc Nordiskt Approv alwhose – own21 diabetes/07/16 combo Glaucoma 06Johnson/06/16 & JohnsonVascular – Stelara Biogenics – VBXultophy-111 (Victoza15222 + Tresiba)5% 72.5 also%1 securedEU Product Appr a54 positiveoval – panel31 the/0Phase7/16 day I/II Trafter46ial90 Result Sanofi’s.s EU Product Approval Crohn's disease 22/06/16 Nymox Pharmaceutical Both– NX-120 the73 comments from their5.2% respective panels37 and EvaluatePharma’sPhase III Trial Result sellsides

JohnsonAbbVie – & Zinb Johnsonryta – Stelara consensus forecast151022233 indicate5%1% that NovoEU Produc willt Appr outstripoval – its rival31 /0unless7/16 Sanofi4644908 can 28/06/16 Xencor – XmAb1404532.1% 164Licensing Announcement somehow make up the lost groundCrohMultiple throughn's diseasSclerosie sbusiness development. 10/06/16 Eagle Pharmaceuticals – Bendeka 27.8%181 Patent Challenge AbBiogenbVie – ZiZinbnbryrytata 105733211%%EEUU PrProducoduct Approval – 31/07/16 443980 Multiple Sclerosis

Biogen – Zinbryta Top 5 57Gains21%E (PastU PrMonth)oduct Approval – 31/07/16 390 TOP 5 LOSSES Multiple Sclerosis TOP 5 GAINS Event Date Company/Product Change % Market Cap ($m) Event Type Event Date Company/Product Change % Market Cap ($m) Event Type T20/06/16OP 5 GAINS BELLUS Health – Kiacta -86.0% 15 Phase III Trial Results 29/06/16 TESARO – Niraparib108.0%3,548 Phase III Trial Results Event29/06/16 Date Company/ProductGalena Biopharma – NeuVax Change-82.8% % Market64 Cap ($m) EventPhase TIIIype Trial Results 06/06/16 Vascular Biogenics – VB-111 72.5%154 Phase I/II Trial Results 29/013/06/166/16 TESAMarinusRO Pharmaceuticals – Niraparib1 – Ganaxolone -6908.7.0%3%3,5482 Phase III TrTrialial ResultResults 22/06/16 Nymox Pharmaceutical – NX-120735.2% 37 Phase III Trial Results 0614/06/16/06/16 VaInﬁnityscular Pharmaceuticals Biogenics – VB –-111 Duvelisib 72.5-69.2%%16754 Phase I/IIII T rialTrial R Resultesultss 28/06/16 Xencor – XmAb1404532.1% 164Licensing Announcement 2206/06/16/06/16 NymoProNAix PharmaTherapeuticsceutical – PNT2258– NX-12073-675..62%%6372 PhaseClinical III Hold Trial Results 10/06/16 Eagle Pharmaceuticals – Bendeka 27.8%181 Patent Challenge 28/06/16 Xencor – XmAb1404532.1% 164Licensing Announcement

10/06/16 Eagle Pharmaceuticals – Bendeka 27.8%181 Patent Challenge TOP 5 LOSSES Top 5 Losses (Past Month) Event Date Company/Product Change % Market Cap ($m) Event Type TOP 5 LOSSES 20/06/16 BELLUS Health – Kiacta -86.0% 15 Phase III Trial Results Event Date Company/Product Change % Market Cap ($m) Event Type 29/06/16 Galena Biopharma – NeuVax -82.8% 64 Phase III Trial Results 20/06/16 BELLUS Health – Kiacta -86.0% 15 Phase III Trial Results 13/06/16 Marinus Pharmaceuticals – Ganaxolone -69.7%32 Phase III Trial Results 29/06/16 Galena Biopharma – NeuVax -82.8% 64 Phase III Trial Results 14/06/16 Inﬁnity Pharmaceuticals – Duvelisib -69.2% 67 Phase II Trial Results 13/06/16 Marinus Pharmaceuticals – Ganaxolone -69.7%32 Phase III Trial Results 06/06/16 ProNAi Therapeutics – PNT2258 -67.6%62 Clinical Hold 14/06/16 Inﬁnity Pharmaceuticals – Duvelisib -69.2% 67 Phase II Trial Results

06/06/16 ProNAi Therapeutics – PNT2258 -67.6%62 Clinical Hold

FEATURE ARTICLES Tesaro shows that Lynparza was no fluke Just a few years ago the Parp inhibitor class was thought to be dead and buried, but then AstraZeneca’s Lynparza surprisingly got approval on a re-examination of phase II data. The overwhelming phase III success of Tesaro’s niraparib in ovarian cancer yesterday suggests that this was no fluke. However, only half of niraparib’s $1.1bn 2022 consensus revenue forecast comes from ovarian cancer, EvaluatePharma data suggest. The key to meeting expectations for all Parp inhibitors is additional indications like breast cancer, and here the future is far less certain (see table below). This is not to detract from Tesaro’s achievement in the Nova study; niraparib blew expectations out of the water, showing a highly statistically significant progression-free survival advantage over placebo in BRCA -mutant ovarian cancer patients – Lynparza’s approved indication – as well as germline BRCA -negative patients, with a 79% and 62% reduction in risk of progression respectively. Leerink analysts said the non-BRCA mutant success was unexpected, and marked niraparib as being competitive with, if not superior to, Lynparza. They also highlighted the lack of outstanding safety/tolerability concerns; niraparib is to be filed in the US and EU in the fourth quarter, Tesaro said.

Valuation However, the issue is one of valuation, and it is important for investors to consider whether expectations might be getting a little overblown (Therapy focus – Parp inhibitor class set to come of age in 2016, March 1, 2016). Tesaro climbed 108% yesterday, to close with an enterprise value of over $7bn. Apart from niraparib its only other notable asset is the marketed antiemetic Varubi, but since this is expected to generate 2022 sales of only $471m most of the group’s valuation hinges on niraparib, which based on current forecasts at 75% probability – for all possible indications – has an NPV of $2.7bn.

Parp inhibitors in late-stage development

Project Company 2022e Note sales ($m)

Lynparza AstraZeneca 930 Marketed for BRCA -mut ovarian cancer; forecast includes breast cancer

Niraparib Tesaro 1,118 Around 50% of 2022 forecast is breast cancer

Veliparib Abbvie 1,714 Lead focus is triple-negative breast and lung cancers

Talazoparib Medivation 64 Lead focus is metastatic breast cancer

Rucaparib Clovis 567 Lead focus is ovarian cancer

This shows not only how reliant Tesaro is on further successes, but also how vital it is that it beats competition from Abbvie as well as Astra. At present niraparib is licensed to Johnson & Johnson specifically for prostate cancer; for ovarian and breast cancers Tesaro is on its own. An interesting side effect of niraparib’s positive phase III hit were corresponding share price increases yesterday for Medivation, up 5%, and Clovis Oncology, up 22%. The Parp inhibitor rucaparib is now Clovis’s lead project, after the failure of rociletinib, and despite the surge the group is down 82% in the past year. For Medivation talazoparib is not the main focus, but this Parp inhibitor is becoming increasingly important as the company fights off an unwelcome takeover approach by Sanofi. The French group is now trying to unseat Medivation’s board, while the target company plays up a valuation in which talazoparib plays an important role. And here might lie part of the problem: at a recent presentation Medivation management suggested that the market for Parp inhibitors might be worth $30bn. While these lofty expectations have yet to be reflected in sellside forecasts for talazoparib the Parp class has benefited as a whole, and niraparib’s success will do little to dent enthusiasm. Bang on cue Tesaro today announced a secondary equity offering to raise up to $345m. Niraparib’s next hurdle will be the Bravo study in Her2-negative, BRCA -mutated breast cancer, reading out in about a year’s time. For Tesaro the Nova readout is an unexpectedly good start, but there is still some way to go before the most bullish expectations become reality.

MARKET MOVING EVENTS Event – Humira biosimilar faces its clinical hurdle While the crown of Abbvie’s Humira as the biggest-selling drug of all time remains in place, it might still come as a surprise just how bright a future the sellside is forecasting for Amgen’s ABP 501, likely Humira’s first biosimilar version. With a staggering NPV of $6.2bn, based on EvaluatePharma sellside consensus, ABP 501 is one of pharma’s most valuable assets awaiting approval. And while it is still unclear when it might enter the US market – this will largely be determined by the courts – next month it could get its biggest endorsement to date when a US FDA adcom is convened to consider regulatory approval.

Company Amgen

Project ABP 501

Market cap $110bn

Project NPV $6.2bn

% of market cap 6%

Event type US adcom

Date July 12, 2016

The US approval process for biosimilars is new relative to that in regions like the EU, and the relevant pathway, 351(k), has only been in place for six years. But at least by now there is precedent to go on: two biosimilars, Zarxio and Inflectra, have already successfully negotiated this route to secure the FDA’s blessing. The advent of Humira biosimilars has been seen as a far more significant test of the system, largely on account of the market size. As such the issue of interchangeability will remain key; the Inflectra precedent is that a biosimilar cannot be substituted for the brand product at a pharmacy, and thus marketing and pricing become more important. The fundamental basis of the US advisory panel, the arthritis advisory committee, will be a review of the available data Amgen has generated. The key clinical studies are in moderate to severe plaque psoriasis and rheumatoid arthritis, and both demonstrated ABP 501’s clinical equivalence to Humira. However, Amgen will be looking not just to show ABP 501’s potential in these uses but also in most of Humira’s other approved indications, including Crohn’s disease, ulcerative colitis and ankylosing spondylitis. As long as there is sufficient justification to extrapolate the bioequivalence – based, for instance, on mechanistic attributes – these other indications should also make it onto ABP 501’s label. The FDA has set a biosimilar user fee act – BSUFA, as opposed to the more common PDUFA, which applies to standard product filings – date of September 25.

When? Of course, the more important issue is when a Humira biosimilar might be launched commercially if it gets the US regulatory nod. US patents on the MAb start to expire this year, but Abbvie has vowed to keep biosimilars off the market until 2022 (Can Humira still dominate in 2022?, April 21, 2016). One legal dispute has already played out, and it went in Abbvie’s favour, with an Amgen inter partes review challenge to two recently granted Humira formulation patents being rejected. Still, the battle is nowhere near over. As is to be expected, Amgen’s plans remain secret. “It remains unclear to us whether Amgen expects to be launching in 2017, or wants to be in a position to launch, if the patent defences by Abbvie are unsuccessful,” wrote Leerink analysts recently. It is not even clear whether Amgen and Abbvie have engaged in the so-called patent dance – a procedure whereby the biosimilar and reference product manufacturers exchange information on production processes to determine if they violate any unexpired patents. This was thought to have been a requirement under biosimilars legislation, but a year ago the Federal Appeals Court ruled that it was merely optional. The case that decided this was between Sandoz and Amgen, and since Amgen lost it can rely on first-hand knowledge. This is another precedent that, if played out in the Humira biosimilar battle, Abbvie will surely pursue far more avidly than did Sandoz. Still, a biosimilar version of Humira is not a question of if but of when, and next month’s panel should clarify at least some of the uncertainty.

Upcoming events – Lymphoma data from Bayer and Novartis Welcome to your weekly digest of approaching regulatory and clinical readouts. In the third quarter Bayer should report the second part of a phase II trial in non-Hodgkin lymphoma of copanlisib, which has previously shown impressive efficacy, but which alongside other PI3K inhibitors has issues with toxicity. Another company, Novartis, is also expecting NHL data, this time from a phase III trial of the anti-CD20 MAb Arzerra. Arzerra is already on the market for chronic lymphocytic leukaemia, but NHL might come as a welcome addition to the label for a drug that has long struggled commercially.

Bayer’s PI3K test Chronos -1 is an open-label uncontrolled trial testing copanlisib in patients with relapsed, indolent or aggressive NHL. The primary endpoint is tumour response at 10 months, and secondary measures include duration of response, progression-free survival (PFS), overall survival and safety. The second part of the trial involves an expansion cohort in 120 patients with aggressive lymphoma who have progressed after two or more lines of treatment. Results from the phase IIa part were reported at ASH in 2014. In 32 evaluable patients in the indolent group there was one complete response, one uncertain complete response and 13 partial responses. The median PFS was 7.9 months, and the most common adverse events of all grades were hyperglycaemia (70%), hypertension (70%), fatigue (64%), diarrhoea (36%), neutropenia (36%) and anaemia (33%). PI3K inhibitors have had a troubled history, struggling with a limited clinical benefit, as with Infinity’s duvelisib, and safety issues, with Zydelig suffering recently (Therapy focus – TG could benefit from Zydelig setback, March 29, 2016). Gilead Sciences ‘Zydelig, an oral drug, was the first PI3K inhibitor to reach the market, but 2020 sales now sit at $484m, according to consensus from EvaluatePharma, nearly half of what they were a year ago. Copanlisib’s 2022 forecast sales are $262m. One problem is that copanlisib looks undifferentiated from Zydelig, though Bayer has said that an intravenous formulation could help avoid some of the gastrointestinal toxicity seen with existing oral agents. Copanlisib also has a slightly different mode of action, in that it targets both alpha and delta PI3K isoforms; Zydelig only targets delta. These latest results will need to impress twice over to spark renewed interest.

Arzerra’s CD20 challenge The third quarter could also see initial phase III data from Arzerra in indolent B-cell NHL. The Complement A+B trial tests the effect of adding Arzerra on top of bendamustine, and recruits patients who did not respond to Rituxan or a Rituxan -containing regimen. The primary endpoint is PFS, with secondary outcomes including clinical benefit, overall response rate, overall survival, duration of response and safety. Arzerra has previously struggled in NHL, showing an overall response rate in Rituxan -refractory patients of just 10% back in August 2009. Genmab, which co-owned the drug with Glaxo at the time, saw its shares plummet 32% (Genmab punished as Arzerra stumbles in crucial pivotal trial, August 18, 2009). The antibody is approved in combination with chlorambucil for treating CLL. Last year sales were $89m, and these are not expected to grow hugely, with forecasts at $158m by 2022, according to EvaluatePharma. The drug is owned by Novartis since the Glaxo asset swap in 2014. Sales of the biggest product in the space, Roche’s Rituxan, also an anti-CD20 MAb, are forecast to reach $4bn in 2022, with 80% of this coming in NHL. After peaking this year at $7.6bn revenue is set to drop, partly owing to the entry of biosimilars. Arzerra is not expected to challenge Rituxan’s crown, but having NHL on the label could provide a sentiment boost.

Product Study Trial ID

Copanlisib Chronos -1 NCT01660451

Arzerra Complement A+B NCT01077518

Dates for your Diary

BioPharm America | Sept 13-15, 2016 Pharma CI Conference & Exhibition USA | Sept 13-14, 2016 8th European Pharma Licensing Symposium | Sept 22-23, 2016

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