Lift off for big drug hopes of 2011

With 2011 now firmly behind us it is time for EP Vantage to take its annual look at the fate of drugs that were touted as being the biggest and brightest launch hopes for last year (Which of 2011's launches will be future blockbusters?, February 3, 2011). All in all it was a good year - the highly anticipated new wave of hepatitis C and blood thinning drugs including Incivek and Brilinta all managed to make it onto the market, making it a good start for some of the blockbuster hopes.

Out of the 20 biggest drug launches predicted for 2011, 13 managed to win approval, a strong result compared to previous years. In 2010 only eight of the top 20 made it to market, after 10 in 2009 (Failure to launch for 2010’s big hopes, January 10, 2010). In what appeared to be a year of triumph for the big players the majority of drugs that failed to make it past the regulators came from smaller companies, such as Protalix BioTherapeutics’ Uplyso and Amsterdam Molecular Therapeutics' Glybera (see table).

Onwards and sometimes upwards

Last year was somewhat of a reversal of 2010 in that conventional drugs fared a lot better than biotechnology drugs. A below par performance saw half of the top 10 biotechnology drugs fail to get off the ground, while eight out of the 10 conventional drugs succeeded in their path to market.

But within the conventional drugs there have been considerable scaling back in forecast sales, with the group as a whole seeing a 10% reduction in sales estimates over the 12 months, led by the 39% fall for Gilead Sciences and Johnson & Johnson’s HIV combination product Complera. Although there had been high hopes for the drug as a replacement for Gilead’s Atripla, these have been dampened by fears that the drug will struggle to achieve big sales due to its perceived lack of efficacy among patients with high viral loads (Gilead snags Complera approval but potential questioned, August 11, 2011).

Hopes have also dwindled for Vertex’s Incivek, but this is more of a reflection on the state of the wider hep C market where many are expecting the second generation of oral drugs, with their shorter treatment times and apparent higher efficacy, to take considerable market share. Its launch will still go down as one of the fastest on record (Incivek set to break record for fastest product launch, November 3, 2011)

In contrast Victrelis has had an easier ride of it during the year with sales forecasts actually trending upwards for the rival protease inhibitor (Merck and Roche strive to level playing field with hep C pact, May 18, 2011).

Progress of biggest products forecast to launch in 2011
Rank Product Company Status 2011 Current status 2016 sales forecast in Jan 2011 ($m) Current 2016 sales forecast ($m) Change
Biotechnology 1 Benlysta (belimumab) Human Genome Sciences + GlaxoSmithKline Filed Marketed 2,845 2,073 (27%)
2 Yervoy (ipilimumab) Bristol-Myers Squibb Filed Marketed 874 1,744 99%
3 Nulojix (belatacept) Bristol-Myers Squibb Filed Marketed 503 434 (14%)
4 Menhibrix/HibMenCY-TT GlaxoSmithKline Filed Filed 400 391 (2%)
5 H1N1 VLP Vaccine Novavax Filed unclear 118 0 (100%)
6 Uplyso (taliglucerase) Protalix BioTherapeutics Filed Filed 77 19 (75%)
7 Glybera Amsterdam Molecular Therapeutics Filed Filed 72 0 (100%)
8 Rhucin Pharming + Santarus  Approved Marketed 50 18 (64%)
9 Imojev Sanofi-Aventis Filed Approved 49 316 550%
10 Prochymal Osiris Therapeutics Filed Filed 36 0 (100%)
Total Biotech Products 5,024 4,995 (1%)
Conventional 1 Incivek Vertex Pharmaceuticals + Johnson & Johnson Filed Marketed 4,058 2,503 (38%)
2 Brilinta (ticagrelor) AstraZeneca Approved Marketed 2,527 2,183 (14%)
3 Eliquis Bristol-Myers Squibb + Pfizer Filed Marketed 2,287 3,420 50%
4 Viibryd (vilazodone) Forest Laboratories + Merck KGaA Approved Marketed 1,147 555 (52%)
5 Jakafi (ruxolitinib) Incyte + Novartis Phase III Marketed 1,069 1,001 (6%)
6 Complera Gilead Sciences + Johnson & Johnson Filed  Marketed 853 517 (39%)
7 Victrelis Merck & Co Phase III Marketed 789 958 21%
8 Latuda (lurasidone) Dainippon Sumitomo Pharma Approved Marketed 770 802 4%
9 Dapagliflozin Bristol-Myers Squibb + AstraZeneca Filed Filed 724 568 (22%)
10 Edarbi (azilsartan) Takeda Filed Marketed 717 424 (41%)
Total Conventional Products 14,940 12,931 (13%)
Grand Total 19,964 17,926 (10%)

Alongside hep C drugs blood thinners also had a good year for approvals, with doctors finally getting more options in the field of oral anticoagulation with both Brilinta and Eliquis making it to the market. It was a long wait for AstraZeneca for US approval, which finally came in July, but a welcome one given that the drug is set to be the biggest growth driver at the UK company over the next five years (Brilinta approval fails to unite widely divided views, July 21, 2011).

Having failed to achieve lift off in 2010 both Human Genome Sciences lupus drug, Benlysta, and BMS’s transplant drug, Nulojix, both finally got off the launch pad (Nulojix approval another stepping stone for BMS, June 16, 2010).

For Benlysta is was not the start of rocket-like trajectory; the drug has struggled to meet high expectations set for its launch, its novelty as the first new treatment for Lupus in nearly five decades not helping. Analysts, however, now seem to be grasping the fact that it is more likely to be a gradual launch as physicians used to the drug and reimbursement issues are ironed out (HGS suffers the launch blues as Benlysta forecasts slump, September 22, 2011).

Having seen the problems around the market’s high expectations for launches, Incyte took the somewhat controversial decision to bar the release of weekly prescription information to data tracking services, following approval of Jakafi, the first Jak inhibitor to reach the market, in November (Incyte hoping JAK be nimble and quick, November 17, 2011).

After receiving priority review status, Bristol-Myers Squibb’s anti-neoplastic monoclonal antibody Yervoy was approved in March last year for the first line treatment of inoperable or metastatic melanoma. Forecasted to reach over $1.7bn sales by 2016, the company’s second biggest growth driver after the anti-coagulant Eliquis has seen big upgrades to sales forecasts over the year (Week of good Yervoy news boosts BMS fortunes, March 28, 2011).

After US approval in October 2010 for the treatment of adults with schizophrenia, Latuda was launched in February last year. Currently it is Dainippon’s biggest growth driving product with European launch expected in December, 2012. Latuda is currently also in phase III trials for bipolar disorder and depression.

Fizzling out

For the drugs that failed to make it to the market, industry observers might take heart in the fact that the majority of them were among the smaller high-risk biotechnology drugs and the most of them had not been forecast to have sales much above $400m by 2016.

For Amsterdam Molecular, its gene therapy drug Glybera experienced its second and what must be its final EU rejection and with little cash to hand the little biotech’s future is not looking rosy (AMT's second rebuff for gene therapy could be a fatal blow, October 25, 2011).

Protalix got its knock back a little earlier in the year when the FDA questioned the chemistry, manufacturing and controls for its novel plant-based Gaucher’s disease treatment Uplyso and requested more data from ongoing trials (Opportunity slipping from Protalix's grasp, February 28, 2011). The group was dealt a further blow in December when the FDA announced that it would be delaying its scheduled February 1 PUDFA date by three months.

Hopes for Novavax’s H1N1 vaccine have faded along with the threat of the virus itself, with so-called “swine flu” being overshadowed by other more worrying strains of influenza. The vaccine, which was filed in 2009 for approval in Mexico, generated encouraging clinical data but the company ambitions for launch in the country have faded and while the drug might technically still be filed there, it seems unlikely to launch as a standalone product.

However, one big failure to launch among the large cap companies was BMS and AstraZeneca’s dapagliflozin. The drug has been beset by safety concerns including incidents of bladder and breast cancer as well as a case of liver damage, which prompted an FDA advisory committee voting against approval. A final decision from the FDA is due by January 27, but few are predicting that dapa will be on the market any time soon (Dapa doubts validate Bristol-Myers decision to share the risk, July 20, 2011).

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