Memorandum

Sanofi 3Q13 Full Report – Diabetes Division up 12%; Lantus up 14% to €1.5 billion; LixiLan on track for 1H14 phase 3 initiation; more U300 data expected 4Q13– November 11, 2013

Executive Highlights

  • Sanofi’s Diabetes Division sales rose 12% as reported (20% operationally) to €1.7 billion ($2.2 billion) in 3Q13, marking the 11th consecutive quarter of double-digit sales growth.
  • Lantus continues as the top-selling diabetes drug worldwide; sales were €1.5 billion ($1.9 billion), up 14% (21%) operationally due largely to strong US performance.
  • As announced in September, Sanofi withdrew its US NDA for Lyxumia to preserve the integrity of the ongoing ELIXA CVOT; LixiLan still on track for 1H14 phase 3 initiation.
  • EDITION III and IV data for U300 insulin glargine expected in 4Q13; submission in the US and EU still expected in 1H14. This is a key area to watch.

Sanofi reported 3Q13 financial results in a call led by CEO Chris Viehbacher. Total Diabetes Division revenue in 3Q13 grew 12% as reported (20% in constant currencies) from 3Q12 to €1.7 billion (~$2.2 billion), marking the eleventh consecutive quarter of double-digit growth, and representing stronger overall reported growth than Novo Nordisk (up 3%) and Lilly (up 8%). Lantus (insulin glargine) accounted for 87% of Sanofi’s Diabetes Division revenue, and it is once again on pace to be the year’s best-selling diabetes drug. Global Lantus sales rose 14% as reported to €1.5 billion (~$1.9 billion), driven primarily by a remarkable 23% growth as reported in the US. Lantus goes off patent in 2015 when it will begin to face competition from biosimilar insulin glargine products; it is hard to say at this stage how much sales will drop if at all. Sanofi reported €3 million (~$4 million) in sales for its once-daily GLP-1 agonist Lyxumia (lixisenatide), up from €1 million (~$1.3 million) in 2Q13. Sanofi’s press release mentioned that the company disagrees with the German G-BA’s negative comparative efficacy ruling on Lyxumia, which (if it stands) will subject the product to reference (generic-level) pricing. The document stated that Sanofi is “evaluating its options,” which (based on the precedent set by other companies) brings up the possibility that the company may withdraw Lyxumia from this market. Notably, we learned during Novo Nordisk’s recent 3Q13 update that Novo Nordisk has initiated a head-to-head study of Victoza (liraglutide) and Lyxumia. Apidra (insulin glulisine) sales grew 28% as reported from 3Q12 to €73 million (~$97 million), continuing their recovery from supply issues in 2012. Amaryl (glimepiride) sales fell 14% as reported to €91 million (~$121 million), while Insuman sales were flat as reported at €34 million (~$45 million). BGM sales rose 30% sequentially to €13 million (~$17 million).

There were no major updates to Sanofi’s diabetes pipeline that had not already been announced during the quarter. As announced in September, Sanofi withdrew its application for Lyxumia from the US FDA in order to preserve the integrity of the ongoing ELIXA cardiovascular outcomes trial. Given the recent uncertainty around regulatory decisions (e.g., the four-year delay for Novo Nordisk’s Tresiba) and the challenges that other companies have faced using interim data to form the basis of approvals (e.g., J&J for Invokana), we are not surprised that Sanofi has taken this conservative route. Management continues to guide for 1H14 initiation of phase 3 for LixiLan (fixed-ratio combination Lyxumia/Lantus) – of course Lyxumia’s delay in the US until ELIXA completes around 2015 means that LixiLan is also delayed in the US – exemplifying another way FDA is impeding innovation in the US. Management announced that it expects to release EDITION III and IV data for its U300 insulin glargine in 4Q13 and reaffirmed that submission is expected in 1H14 in both the US and EU. We think this area is going to be very important to watch. Management did not provide updates on Sanofi’s phase 1 biosimilar insulin program. Finally, as announced in October, management reviewed topline phase 3 data for Sanofi/Regeneron’s PCSK9 inhibitor, alirocumab – this molecule has the potential to be first to market in the PCSK9 class, although management did not comment explicitly on submission timing. This has great potential for patients who cannot take statins, estimated at about 10-20% of those with heart disease.

Financial Updates

  • In 3Q13, worldwide Diabetes Division sales (Lantus, Apidra, Amaryl, Insuman, BGStar, iBGStar, and Lyxumia) grew a strong 12% as reported and 20% operationally from 3Q12 to €1.7 billion ($2.2 billion). As management highlighted during the call, this is Sanofi Diabetes’ 11th consecutive quarter of double-digit growth. The comparison for 3Q13 growth was fairly challenging, given the 28% reported and 18% operational YOY growth seen in 3Q12. In 3Q13 Lantus accounted for the lion’s share (87%) of Diabetes Division revenue, consistent with 3Q12. It accounted for 89% of growth in the third quarter.
    • Sanofi Diabetes Care experienced stronger growth than its major insulin manufacturer competitors: Novo Nordisk reported Diabetes Care revenue growth of 3% as reported (10% in local currencies) to ~$2.8 billion, while Lilly reported Diabetes franchise revenue of $616 million, up 8% as reported from 3Q12.
    • Management noted that the relative strength of the Euro in 3Q13 led to substantial differences between operational and reported growth values outside Europe. Presumably, the company made this point to underscore the fact that local sales performance was stronger than the reported values might suggest. 

Table 1: Diabetes Division sales by region

 

3Q13 Sales (in millions)

Operational/Reported Growth from 3Q12

Reported Growth from 2Q13

Diabetes Division Sales

€1,670 ($2,212)

20.1% / 12.4%

3.0%

     United States

€1,014 ($1,343)

30.9% / 23.7%

9.3%

     Western Europe

€262 ($347)

3.5% / 2.7%

-1.5%

     Emerging Markets

€291 ($385)

8.5% / -1.0%

-10.7%

     Rest of the World (ROW)

€103 ($136)

10.3% / -12.0%

2.0%

     *USD estimates assume a conversion rate of €1 to 1.3244 USD; ROW consists of Japan, Canada, Australia, New Zealand

  • Lantus sales in 3Q13 rose 14% as reported and 21% operationally to €1.5 billion ($1.9 billion), the eighth consecutive quarter that sales exceeded €1 billion. This strong performance came against a challenging comparison, as worldwide Lantus sales grew 32% as reported and 21% operationally in 3Q12. Sequentially, 3Q13 sales rose 3% as reported. At this pace, Lantus sales could annualize at around €5.6 billion (more than $7 billion), which would be a substantial increase over the €5.0 billion ($6.4 billion) in total 2012 sales. It would be great to see it hit this milestone given all the hard work on the product and all the controversy it has endured. Lantus outperformed Merck’s Januvia franchise, which brought in $1.4 billion in revenue in 3Q13; Lantus will undoubtedly be the best-selling diabetes drug of the year, as Merck’s Januvia (sitagliptin) franchise is on track for annual sales of approximately $5.6 billion.
    • Lantus’ growth in 3Q13 was due in large part to the product’s 23% YOY sales growth as reported (30% operationally) in the US. US sales totaled $1.3 billion. Supplemental slides attributed this strong performance to price increases as well as patient switches from vials to the SoloStar pen, which commands a higher price. The SoloStar is now responsible for 57% of total US Lantus sales, as compared to 52% in 3Q12 and 47% in 3Q11.
    • Lantus growth in Western Europe, Emerging Markets, and the Rest of the World was less robust. Year-over-year, Lantus grew 2% (3% operationally) in Western Europe, fell 3% (and grew 6% operationally) in Emerging Markets, and fell 8% (and grew 13% operationally) in the Rest of the World. During the call, management noted that pharmaceutical sales in China had slowed down during 3Q13, a likely result of the pharmaceutical industry probes currently underway in the country. Sanofi is one of a number of pharmaceutical companies under investigation by Chinese authorities over alleged inappropriate business practices, including bribery. We were quite surprised that US growth varied as dramatically as it did.
    • The press release mentioned that in October, the US FDA approved the inclusion of ORIGIN safety data on Lantus’ label. This follows a similar decision by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in June of this year. As background, the ORIGIN cardiovascular outcomes trial found that Lantus had a neutral effect on cardiovascular disease and mortality — read our ORIGIN full report for more details on the trial’s design, results, and implications. Sanofi’s press release did not state exactly how the revised label would read. The label change is a win for Sanofi as it allays previously-held concerns that insulin initiation, especially early insulin initiation, could be associated with increased cardiovascular disease or cancer risk because insulin causes weight gain and is theorized to be mitogenic.
    • While Lantus’ 3Q13 performance was strong, the product will face headwinds in coming years from insulin glargine biosimilars. Sanofi itself is working on a U300 insulin glargine formulation that it expects to file in 1H14 (see details below in the Pipeline Updates section).
      • Recently, during Merck’s 3Q13 update, we heard mention that the company is potentially developing a biosimilar candidate (MK-1293). See our Merck 3Q13 report for more details.
      • Lilly/BI are also developing a biosimilar glargine (submitted in the EU as a biosimilar, and timing/pathway for US submission uncertain, but management has previously guided for 2013 US submission).
      • Biocon/Mylan’s biosimilar glargine is expected to enter phase 3 in 2013 for a possible 2015 launch in “large, semi-regulated” markets.
    • Additionally, several other companies are also developing novel basal insulin analogs. Novo Nordisk's ultra-long-acting Tresiba (degludec) is marketed outside of the US and will be resubmitted to the FDA in 2016 or 2017. Lilly is also working on a phase 3 novel basal insulin analog, LY2605541, for which it expects internal data readouts in 2013 and public topline data disclosure in 2014.

Table 2: Sanofi’s Lantus sales by region

 

3Q13 Sales (in millions)

Operational/Reported Growth from 3Q12

Reported Growth from 2Q13

Lantus Sales

€1,456 ($1,928)

21.2% / 13.8%

3.0%

United States

€985 ($1,305)

30.4% / 23.1%

9.1%

Western Europe

€201 ($266)

3.0% / 2.0%

-1.0%

Emerging Markets

€198 ($262)

5.9% / -2.9%

-13.9%

Rest of World (ROW)

€72 ($95)

12.8% / -7.7%

-1.4%

     *USD estimates assume a conversion rate of €1 to 1.3244 USD; ROW consists of Japan, Canada, Australia, New Zealand

  • Sanofi reported €3 million ($4 million) in sales for Lyxumia, up from €1 million ($1.3 million) in 2Q13. As background, this was only the second quarter that Sanofi reported sales for the once-daily GLP-1 agonist, which was developed in collaboration with Zealand Pharma. The product was first launched in Germany and the UK in March, and is now also available in other EU nations (including Spain) as well as Japan and Mexico. In 2Q13, Lyxumia was responsible for 0.9% of the growth of the GLP-1 agonist class despite its recent launch and small base. At the exhibit hall at this year’s EASD, we noticed that Sanofi was marketing Lyxumia primarily as a “positive addition” to basal insulin therapy with Lantus. We would assume it would be a stand-alone alternative for some patients who do not need insulin first.  
    • As discussed during Novo Nordisk’s recent 3Q13 update that the Novo Nordisk has initiated a head-to-head trial of its once-daily GLP-1 agonist Victoza (liraglutide) and Lyxumia. The randomized, open-label, 26-week trial will investigate the efficacy and safety of Victoza 1.8 mg versus Lyxumia’s 20 microgram dose as an add-on to metformin in 400 type 2 diabetes patients (ClinicalTrials.gov Identifier: NCT01973231). The study’s primary outcome will be change in A1c, with changes in fasting plasma glucose, body weight, and adverse event profiles included as secondary outcome measures. The study is slated to end in November 2014. During their call, Novo Nordisk management appeared confident that Victoza would demonstrate superiority by a margin of at least 0.3% A1c. Sanofi management did not mention this trial during its conference call.
    • Sanofi’s 3Q13 press release addressed the German Federal Joint Committee (G-BA) comparative efficacy decision that Lyxumia shows “no additional benefit” over sulfonylurea. As background, the German comparative efficacy procedure (and its effect on reimbursement) has affected a number of companies in the diabetes care arena in recent years. The German Institute for Quality and Efficiency in Healthcare (IQWiG) conducts the primary analysis as per the rules of the G-BA, and comes up with a recommendation (in this case, it was “no additional benefit”). Notably, the ruling for Lyxumia (and for many other diabetes therapies, including most of the DPP-4 inhibitor class) was not based on the candidates’ efficacy, but rather was delivered because the drugs’ clinical trial programs did not meet the G-BA’s strict guidelines regarding comparator therapies. The G-BA sometimes adopts a more pragmatic view than IQWiG, but in Lyxumia’s case the G-BA confirmed IQWiG’s “no additional benefit” ruling, meaning that the product’s pricing will be non-negotiable. Sanofi’s press release states that it “disagrees with the decision of the G-BA and is evaluating its options” — we wonder if Sanofi would consider withdrawing Lyxumia from the market if the decision stands, as other companies that have lost pricing negotiation ability have done or have suggested they might do. 
    • As a reminder, Sanofi made a bold call in September by withdrawing Lyxumia’s US FDA submission in order to wait for the full results from the ELIXA cardiovascular outcomes trial rather than disclose interim data from the study. This development is discussed in more detail in the pipeline section of this report; you can also read our initial coverage of this development.
  • Apidra continues to trend upwards as it recovers from supply issues that resolved in 2012. Worldwide sales increased 28% as reported (37% operationally) to €73 million ($97 million), accounting for 8% of Sanofi’s reported growth in 3Q13. This growth came against a relatively easy comparison, as 3Q12 sales rose only 8% as reported. Sequentially, sales grew 7%. Management did not discuss Apidra’s performance during the call, but the press release characterized its performance as “dynamic.” These results are a continuation of the strong recovery seen in recent quarters: YOY reported growth for Apidra was 27% in 1Q13 and 21% in 2Q13. For comparison, in 3Q13 Novo Nordisk’s NovoLog rose just 2% as reported (8% in local currencies) and sales of Lilly’s Humalog rose 7% as reported (albeit both grew from substantially higher bases than Apidra). Apidra’s value-share of the rapid-acting insulin analog market in 3Q13 remains around 5%. Meanwhile, Lilly’s Humalog holds 33% of the rapid-acting analog market by value; NovoLog holds 39%; and NovoMix holds 22%. Geographically, Apidra’s strongest performance was seen in the US, with reported growth of 71% year-over-year.

Table 3: Apidra sales by region

 

3Q13 Sales (in millions)

Operational/Reported Growth from 3Q12

Reported Growth from 2Q13

Apidra Sales

€73 ($97)

36.8% / 28.1%

7.4%

United States

€29 ($38)

76.5% / 70.6%

26.1%

Western Europe

€21 ($28)

10.5% / 10.5%

0.0%

Emerging Markets

€16 ($21)

38.5% / 23.1%

0.0%

Rest of World (ROW)

€7 ($9)

12.5% / -12.5%

-12.5%

     *USD estimates assume a conversion rate of €1 to 1.3244 USD; ROW consists of Japan, Canada, Australia, New Zealand

  • While Sanofi does not directly report BGStar and iBGStar sales, we estimate 3Q13 sales to be ~€13 million (~$17 million), coming almost exclusively from Western Europe. These figures represent a YOY rise of roughly 30% and a sequential rise of roughly 8%, as reported. A few months ago, we had heard that Walgreens might stop selling the iBGStar, but as of the publication of this report the device is available at Walgreens (although we could no longer find it on the Apple Store website). Read our report on the iBGStar for more information on the meter. As a reminder, Sanofi received 510(k) clearance from the FDA in 2Q13 for use of the iBGStar and its software with the iPhone 5 and iPod Touch 5, although the adapter’s size is a bit clunky.
  • Worldwide Amaryl (glimepiride) sales fell 14% as reported and down 1% at constant exchange rates year-over-year to €91 million (~$121 million). This continues the downtrend in Amaryl sales seen in FY2012 and 1H13. As with 2Q13, management attributed Amaryl’s 3Q13 decline primarily to generic competition in Japan, where sales decreased 13%. Amaryl sales have been relatively strong in Emerging Markets (now responsible for over two-thirds of overall Amaryl sales), where the cost advantage of sulfonylureas makes them a particularly attractive proposition. On the whole, however, we expect to see the sulfonylurea class stay stagnant or even shrink in coming years with increasing awareness of their relatively weaker tolerability and safety profile.

Table 4: Amaryl sales by region

 

3Q13 Sales (in millions)

Operational/Reported Growth from 3Q12

Reported Growth from 2Q13

Amaryl Sales

€91 ($121)

-0.9% / -14.2%

-8.1%

     United States

€0 ($0)

-100% / -100%

-100%

     Western Europe

€5 ($7)

-16.7% / -16.7%

-16.7%

     Emerging Markets

€65 ($86)

7.4% / -4.4%

-8.5%

     Rest of the World (ROW)

€21 ($28)

-12.9% / -32.3%

0.0%

     *USD estimates assume a conversion rate of €1 to 1.3244 USD; ROW consists of Japan, Canada, Australia, New Zealand

  • Total worldwide Insuman sales were flat as reported and up 3% operationally to €34 million (~$45 million). The past few years have generally been a tug-of-war between shrinking sales in Western Europe and growing sales in Emerging Markets. In 2Q13, Insuman sales fell a striking 27% sequentially in Emerging Markets, which we took as a potential sign of weakness for the product’s overall growth moving forward, but the 50% sequential growth seen in 3Q13 for Emerging Markets seems to indicate that the 2Q13 results may have just been a hiccup. Management did not discuss Insuman during the call, nor was it discussed in the press release.

Table 5: Insuman sales by region

 

3Q13 Sales (in millions)

Operational/Reported Growth from 3Q12

Reported Growth from 2Q13

Insuman Sales

€34 ($45)

2.9% / 0%

6.3%

     Western Europe

€22 ($29)

-12% / -12%

-4.3%

     Emerging Markets

€12 ($16)

33.3% / 33.3%

50.0%

     *USD estimates assume a conversion rate of €1 to 1.3244 USD

Pipeline Updates

  • As announced in September, Sanofi withdrew its application for the once-daily GLP-1 agonist Lyxumia (lixisenatide) from the US FDA because it was unsatisfied with the FDA’s proposed process for safeguarding interim data for Lyxumia’s cardiovascular outcomes trial, ELIXA. In order to preserve trial blinding and integrity (given that the likely requirement for an FDA Advisory Committee would result in potential public disclosure of interim data), Sanofi is choosing to re-submit the NDA in 2015 upon completion of ELIXA. While not highlighted during the 3Q13 conference call, management stressed at the time of the announcement that there is no reason to believe that this decision resulted from any safety concerns or deficiencies in the NDA. With the recent uncertainty around regulatory decisions, especially the four-year delay of Novo Nordisk’s Tresiba, we are not surprised that Sanofi is taking this conservative route. Of course, Lyxumia’s delay in the US now also means that the most valuable part of the Lyxumia franchise, LixiLan (fixed-ratio combination Lyxumia/Lantus [lixisenatide/insulin glargine]), is also delayed in the US pending Lyxumia’s regulatory fate. Please see our September 12 report on the original announcement for more details.
  • Management continues to guide for 1H14 initiation of phase 3 for LixiLan (fixed-ratio combination Lyxumia/Lantus [lixisenatide/insulin glargine]). As a reminder, during Sanofi’s 1Q13 update, the company announced that it would focus on developing a fixed-ratio combination product rather than the more complex fix-flex product that would have allowed for variable Lantus doses at a fixed Lyxumia dose. The company hoped to speed up LixiLan’s development timeline to have the chance to be the first GLP-1 agonist/basal insulin combination product to market in the US after Novo Nordisk’s Tresiba (insulin degludec) received a complete response letter delaying a potential Tresiba approval for four years and, thus, delaying submission of Novo Nordisk’s IDegLira (insulin degludec/liraglutide [Novo Nordisk’s Victoza] fixed-ratio combination) for at least that long. Now that Lyxumia has also been delayed, LixiLan and IDegLira submission timing may ultimately be pretty close (Lyxumia may be re-submitted in 2015 at the earliest, and Tresiba in 2016 at the earliest).
  • Management announced that it expects to release EDITION III and IV data for its U300 insulin glargine in 4Q13 and reaffirmed that submission is expected in 1H14 in both the US and EU. According to ClinicalTrials.gov, EDITION III and IV have estimated primary completion dates of October 2013 and March 2014, respectively, but neither of these listings have been updated since September 20, 2013. We presume, then, that EDITION IV must have completed earlier than scheduled. EDITION III investigated people with type 2 diabetes who, at baseline, were not on insulin therapy. EDITION IV investigated U300 glargine in type 1 diabetes patients.
    • The U300 insulin glargine’s phase 3 program comprises six trials: EDITION I, II, III, IV, JP I, and JP II (see table below for details). Sanofi reported full results of EDITION I at ADA 2013 and EASD 2013, demonstrating that its U300 insulin glargine reduced nocturnal hypoglycemia by 21% compared to Lantus. Topline EDITION II data were also announced in June, corroborating these findings. During its Diabetes Update at ADA, Sanofi management highlighted that EDITION I and II enrolled patients with the hardest-to-manage diabetes (participants required >42 units/day of insulin at baseline). 

 

Background Therapy

Population

N

Estimated Primary Completion

CT.gov Identifier

EDITION I

Mealtime insulin ± metformin

Type 2 diabetes

800

Completed

NCT01499082

EDITION II

Oral antidiabetic drugs

Type 2 diabetes

800

Completed

NCT01499095

EDITION III

Non-insulin antidiabetic therapy

Type 2 diabetes

800

October 2013

NCT01676220

EDITION IV

Mealtime insulin

Type 1 diabetes

500

March 2014

NCT01683266

EDITION JP I

Mealtime insulin

Japanese patients with type 1 diabetes

240

November 2013

NCT01689129

EDITION JP II

Oral antidiabetic drugs

Japanese patients with type 2 diabetes

240

November 2013

NCT01689142

 

  • Other next-generation insulin glargines include Lilly/BI’s new insulin glargine formulation, Merck’s insulin glargine biosimilar, and Biocon’s biosimilar insulin glargine. Lilly/BI have not yet released data on their new insulin glargine formulation (submitted in the EU as a biosimilar, and timing/pathway for US submission uncertain, but management has previously guided for 2013 US submission). Biocon/Mylan's biosimilar glargine is expected to enter phase 3 in 2013 for a possible 2015 launch in "large, semi-regulated" markets.
  • Several other companies are also developing novel basal insulin analogs. Novo Nordisk's ultra-long-acting Tresiba is marketed outside of the US and may be resubmitted to the FDA in 2016 or 2017. Lilly is also working on a phase 3 novel basal insulin analog, LY2605541 (PEGylated insulin lispro), for which it expects internal data readouts in 2013 and public topline data disclosure in 2014.
  • Management did not mention Sanofi’s phase 1 biosimilar insulin program. The program began in late 2012 and early 2013, and the insulins’ identities are unknown, though management stated they were not biosimilars of Sanofi’s own molecules. This comment lead us to speculate that they may be second-generation versions of Novo Nordisk’s Novolog and Lilly’s Humalog, which have formulation patent expirations in 2017 and 2013, respectively. Sanofi’s interest in the biosimilar arena lends an air of credence to the field, which has so far been surrounded by a degree of uncertainty regarding the FDA’s guidelines for biosimilar approval. Thanks to their established marketing channels, manufacturing expertise, and brand name recognition, insulin heavyweights such as Sanofi and Lilly have a significant advantage in marketing biosimilars compared to companies entering the insulin arena as biosimilar sponsors.
  • During Sanofi’s 1Q13 call, management made a number of strategic comments on the biosimilar market during Q&A. Specifically, management stated that Sanofi’s entry into the biosimilar arena should be seen as an effort to broaden its portfolio rather than the initiation of a price war. As a result, biosimilars will compete more on market share than on price. See our Sanofi 1Q13 report for greater detail.
  • In October, Sanofi and Regeneron announced topline phase 3 data for its PCSK9 inhibitor, alirocumab. ODYSSEY MONO compared alirocumab monotherapy to the cholesterol-lowering drug ezetimibe (an alternative to statins that prevents absorption of dietary cholesterol; this mechanism is not as effective for lowering LDL as the mechanism by which statins act). Alirocumab injected once every two weeks demonstrated three-times the LDL-lowering efficacy as ezetimibe (47% vs. 16%, p<0.0001). In addition, most patients achieved the 70 mg/dl goal on the initial low 75 mg dose without having to escalate to the high 150 mg dose in this treat-to-goal study. The incidence of injection site reactions was less than 2% in both groups. We believe it is likely that PCSK9 inhibitors, should they reach the market, will be targeted towards the roughly 10-20% of patients who cannot tolerate statins. 
    • Alirocumab is the first PCSK9 inhibitor to report phase 3 results. Other companies with PCSK9 inhibitors include Amgen (AMG 145 [evolocumab]; phase 3 results expected in 1Q14), Pfizer (PF-04950615 [bococizumab], phase 3 and PF-05335810, phase 1), Roche (RG7652, phase 2 and looking to partner), Lilly (LY3015014, phase 2), and Catabasis (CAT-2003, phase 2 and CAT-2054, preclinical).

 

Questions and Answers

Q: On your PCSK9, I just wondered if you had any comments related to Pfizer's claims yesterday that the outcomes trial on its new PCSK9 that it started as part of its phase 3 program are differentiated versus yours and Amgen's because they investigate a population of patients not at goal despite being on statin, and they look at LDL reduction levels below 70 mgs per deciliter.

A: On PCSK9, yes, I read the comments overnight from Pfizer. I'm not so sure I would agree with the comments. I think all the populations that Pfizer is talking about are actually covered in ours. There is a primary prevention study, which we believe would be in the familial hypercholesterolemia population; there is one where we actually have those patients in there as well. We have a number of high-risk patients. I think between all of the studies that Amgen’s doing, that Sanofi’s doing, I’d be surprised if there’s too many holes between the two. The interesting thing I think you’re going to find is that with Pfizer climbing in, you’re probably going to have about 60,000 patients on PCSK9. And if you go back to the statin class, I think a lot of those studies really drove quite a big market. So one wouldn’t ever underestimate Pfizer with their experience out of Lipitor, that’s for sure. But equally, for us, the competitor is Amgen, because it is we and Amgen who are ahead. But I think, in general, more studies out there will demonstrate the value and importance of this class of medicine and probably make this a more interesting class for all of the participants.

 

--by Manu Venkat, Jessica Dong, and Kelly Close